HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
13.2.2013 Official
Journal
of
the
European
Union
L
42/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 122/2013
of 12 February 2013
amending Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of
the European Parliament and of the Council on the Community code relating to veterinary
medicinal products, a list of substances essential for the treatment of equidae
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
modes of actions, different pharmacokinetic or phar
macodynamic profiles, different lengths of treatment or
different routes of administration.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Substances
listed
in
the
Annex
to
Commission
Regu
Having regard to Directive 2001/82/EC of the European
lation (EU) No 37/2010 of 22 December 2009 on phar
Parliament and of the Council of 6 November 2001 on the
macologically active substances and their classification
Community code relating to veterinary medicinal products (
regarding maximum residue limits in foodstuffs of

1 ),
and in particular Article 10(3) thereof,
animal origin ( 4 ) should not appear on the list of
essential substances and substances bringing added
clinical benefit. Therefore, it is necessary to amend the
Whereas:
list in the Annex to Regulation (EC) No 1950/2006 to
remove from that list any substances listed in Regulation
(EU) No 37/2010.
(1) Commission
Regulation
(EC)
No
1950/2006
( 2 ) estab
lished a list of substances essential for the treatment of
equidae which, by way of derogation from Article 11 of
Directive 2001/82/EC, may be administered to equidae
(5) It
is
also
appropriate
to
remove
from
the
list
in
the
intended for slaughter for human consumption subject to
Annex to Regulation (EC) No 1950/2006 several
a withdrawal period of not less than six months.
substances identified as alternatives to the substances

listed, which are not available for the treatment of
horses because they are not listed as ‘essential substances’
(2) Regulation
(EC)
No
470/2009
of
the
European
or ‘substances bringing added clinical benefit’ under
Parliament and of the Council of 6 May 2009 laying
Regulation (EC) No 1950/2006 nor listed in the Annex
down Community procedures for the establishment of
to Regulation (EU) No 37/2010.
residue limits of pharmacologically active substances in
foodstuffs of animal origin ( 3 ) amended Article 10(3) of
Directive 2001/82/EC in order to include in the list of
(6) Due
to
changes
in
Union
legislation
since
the
adoption
substances referred to in that Article substances which
of Regulation (EC) No 1950/2006, the references in that
bring added clinical benefit compared to other treatment
Regulation to the relevant legislation on control mech
options available for equidae, hereinafter ‘substances
anisms for equidae and on maximum residue limits
bringing added clinical benefit’, in addition to essential
should be updated.
substances.
(3) A
substance
should
only
be
included
in
the
list
as
a (7)
The amended list set out in the Annex to this Regulation
‘substance bringing added clinical benefit’ where it
has been subject to a scientific evaluation carried out by
provides a clinically relevant advantage based on
the Committee for Veterinary Medicinal Products of the
improved efficacy or safety or a major contribution to
European Medicines Agency established by Regulation
treatment. This may be the result, inter alia, of different
(EC) No 726/2004 of the European Parliament and of
the Council ( 5 ).
( 1 ) OJ L 311, 28.11.2001, p. 1.
( 2 ) OJ L 367, 22.12.2006, p. 33.
( 4 ) OJ L 15, 20.1.2010, p. 1.
( 3 ) OJ L 152, 16.6.2009, p. 11.
( 5 ) OJ L 136, 30.4.2004, p. 1.

---

L 42/2
EN
Official Journal of the European Union
13.2.2013
(8) Regulation
(EC)
No
1950/2006
should
be
amended
For the purposes of the first and second subparagraphs, the
accordingly.
alternatives listed in the Annex shall be considered.’;
(9) The
measures
provided
for
in
this
Regulation
are
in (4) Articles 3 and 4 are replaced by the following:
accordance with the opinion of the Standing
Committee on Veterinary Medicinal Products,
‘Article 3
HAS ADOPTED THIS REGULATION:
1. Essential substances and substances bringing added
clinical benefit shall be used only in accordance with
Article 1
Article 10(1) of Directive 2001/82/EC.
Regulation (EC) No 1950/2006 is amended as follows:
2. The
details
of
a
treatment
with
essential
substances
shall be recorded in accordance with the instructions laid
(1) the title of Regulation (EC) No 1950/2006 is replaced by
down in Section IX of the identification document for
the following:
equidae set out in Commission Regulation (EC) No
504/2008 (*).
‘Commission Regulation (EC) No 1950/2006 of
13 December 2006 establishing, in accordance with
Article 4
Directive 2001/82/EC of the European Parliament and
of the Council on the Community code relating to
Any substance that is entered in one of the lists in the
veterinary medicinal products, a list of substances
Annex to Commission Regulation (EU) No 37/2010 (**),
essential for the treatment of equidae and of substances
or the use of which for equidae is prohibited by Union
bringing added clinical benefit’;
legislation, shall no longer be used for the purposes of
this Regulation.
(2) Article 1 is replaced by the following:
___________
‘Article 1
(*) OJ L 149, 7.6.2008, p. 3.
The list of substances essential for the treatment of equidae,
(**) OJ L 15, 20.1.2010, p. 1.’;
hereinafter “essential substances”, as well as of substances
which bring added clinical benefit compared to other
treatment options available for equidae, hereinafter “sub
(5) in Article 5, paragraph 2 is replaced by the following:
stances bringing added clinical benefit”, applicable by way
of derogation from Article 11 of Directive 2001/82/EC, is
‘2. Where
Member
States
or
veterinary
professional
set out in the Annex to this Regulation.’;
associations request the Commission to amend the list set
out in the Annex, they shall duly substantiate their request
(3) in Article 2, the second subparagraph is replaced by the
and include any relevant scientific data available.’;
following:
(6) the Annex to Regulation (EC) No 1950/2006 is replaced by
‘Substances bringing added clinical benefit may be used, for
the Annex to this Regulation.
the specific disease conditions, treatment needs or
zootechnical purposes specified in the Annex, where they
Article 2
provide a clinically relevant advantage based on improved
efficacy or safety or a major contribution to treatment
This Regulation shall enter into force on the third day following
compared to medicinal products authorised for equidae or
that of its publication in the Official Journal of the European
referred to in Article 11 of Directive 2001/82/EC.
Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 February 2013.
For the Commission
The President
José Manuel BARROSO

---

EN
13.2.2013 Official
Journal
of
the
European
Union
L
42/3
ANNEX
‘ANNEX
List of substances essential for the treatment of equidae and substances bringing added clinical benefit compared
to other treatment options available for equidae
The withdrawal period for each of the substances on the following list shall be six months.
Indication Active
substance
Justification and explanation of use
Anaesthetics, analgesics and substances used in association with anaesthesia
Sedation and premedication Acepromazine Purpose:
premedication
prior
to
general
anaesthesia,
mild
(and antagonism)
sedation.
Identification of alternatives: detomidine, romifidine,
xylazine, diazepam, midazolam.
Discussion of the specific advantages: acepromazine has
consistently been shown to reduce risk of anaesthetic
death. Mode of action (on limbic system) and unique
quality of sedation cannot be produced by the alpha-2
agonist sedatives (detomidine, romifidine and xylazine) or
the benzodiazepines (diazepam, midazolam).
Atipamezole Purpose:
α-2 adrenoceptor antagonist used for reversal of
α-2 agonists.
Identification of alternatives: none identified.
Discussion of the specific advantages: only treatment for
hypersensitive individual and overdose. Emergency
medicine. Specifically used in cases of respiratory
depression.
Diazepam Purpose:
premedication
and
induction
of
anaesthesia.
Mild
(benzodiazepine) tranquilisation with minimal cardiov
ascular and respiratory side effects. Anti-convulsant,
essential for treatment of seizures.
Identification of alternatives: acepromazine, detomidine,
romifidine, xylazine, midazolam, primidone, phenytoin.
Discussion of the specific advantages: in modern medicinal
standards an essential component of anaesthetic induction
protocols with very considerable equine experience. Used
with ketamine for induction of anaesthesia, producing
essential relaxation that allows smooth induction and intu
bation. Mode of action (acts at GABA receptor) and unique
tranquilisation without cardiorespiratory depression cannot
be produced by the α-2 agonist sedatives (detomidine,
romifidine and xylazine) or acepromazine.
Flumazenil Purpose:
intravenous
reversal
agent
for
benzodiazepines.
Reversal of benzodiazepine effect during recovery from
Total Intravenous Anaesthesia (TIVA) techniques.
Identification of alternatives: sarmazenil.
Discussion of the specific advantages: different mode of
action from sarmazenil providing additional means of
benzodiazepine reversal at the end of TIVA techniques.
Sarmazenil is partial inverse agonist of benzodiazepine
receptors whereas flumazenil is an antagonist competitively
inhibiting the benzodiazepine binding site at the GABA
receptor.
Midazolam Purpose:
premedication
and
induction
of
anaesthesia.
Mild
(benzodiazepine) tranquilisation with minimal cardiov
ascular and respiratory side effects. Anti-convulsant, for
treatment of seizures, particularly adult horses with tetanus.

---

L 42/4
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
Identification of alternatives: acepromazine, detomidine,
romifidine, xylazine, diazepam, primidone, phenytoin.
Discussion of the specific advantages: similar to diazepam
but water soluble, thus suitable for intravenous injection
and essential for intravenous infusion in combination with
anaesthetics. Shorter acting than diazepam. More suitable
than diazepam for foals.
Anti-convulsant, for treatment of seizures, particularly adult
horses with tetanus – better than diazepam for use over
several days due to water solubility.
Used with ketamine for induction of anaesthesia, producing
essential relaxation that allows smooth induction and intu
bation.
Mode of action (acts at GABA receptor) and unique tran
quilisation without cardiorespiratory depression cannot be
produced by the α-2 agonist sedatives (detomidine,
romifidine and xylazine) or acepromazine.
Naloxone Purpose:
opioid-antidote,
emergency
medicine.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.
Propofol Purpose:
intravenous
anaesthetic.
Induction
of
anaesthesia
in foals.
Identification of alternatives: sevoflurane or isoflurane.
Discussion of the specific advantages: rapidly cleared
injectable anaesthetic. Recent reports demonstrate vast
improvement in cardiovascular stability and quality of
recovery over inhalation anaesthesia.
Sarmazenil Purpose:
benzodiazepine
antagonist.
Identification of alternatives: flumazenil.
Discussion of the specific advantages: clean reversal of
benzodiazepine sedation required after infusion during
total intravenous anaesthesia. Widest clinical experience
with sarmazenil compared to other potential candidates
for essential substances.
Tiletamine Purpose:
dissociative
anaesthetic
similar
to
ketamine,
especially used for field anaesthesia. Used in combination
with zolazepam.
Identification of alternatives: ketamine.
Discussion of the specific advantages: the use in
combination with zolazepam is essential in cases when
there is no access to inhalation anaesthesia such as for
field anaesthesia. Combination is also essential where
anaesthesia with ketamine combinations is too short.
Typical applications are castrations, laryngotomies, peri
osteal stripping, cyst or lump excisions, repair of facial
fractures, cast applications and umbilical hernia repairs.
Zolazepam Purpose:
benzodiazepine
tranquilisation
especially
used
for
field anaesthesia in combination with tiletamine.
Identification of alternatives: diazepam or midazolam.
Discussion of the specific advantages: benzodiazepine tran
quiliser, which is longer acting than either diazepam or

---

EN
13.2.2013 Official
Journal
of
the
European
Union
L
42/5
Indication Active
substance
Justification and explanation of use
midazolam. The use with tiletamine is essential in cases
when there is no access to inhalation anaesthesia such as
for field anaesthesia. Combination is essential where anaes
thesia with ketamine combinations is too short. Typical
applications are castrations, laryngotomies, periosteal
stripping, cyst or lump excisions, repair of facial fractures,
cast applications and umbilical hernia repairs.
Hypotension or respiratory Dobutamine Purpose:
treatment
of
hypotension
during
anaesthesia.
stimulation during
anaesthesia
Identification of alternatives: dopamine.
Discussion of the specific advantages: positive inotrope
therapy, probably more used than dopamine but pref
erences vary. Horses usually develop hypotension during
anaesthesia, and maintenance of normal blood pressure
has been shown to reduce the incidence of serious post-
operative rhabdomyolysis. Dobutamine is invaluable during
volatile anaesthesia in horses.
Dopamine Purpose:
treatment
of
hypotension
during
anaesthesia.
Identification of alternatives: dobutamine.
Discussion of the specific advantages: dopamine is required
in horses that do not respond to dobutamine. In foals
dopamine is used in preference to dobutamine.
Additionally required for treatment of intraoperative brady
dysrhythmias that are resistant to atropine.
Ephedrine Purpose:
treatment
of
hypotension
during
anaesthesia.
Identification of alternatives: dopamine, dobutamine.
Discussion of the specific advantages: required where
dopamine and dobutamine are ineffective. A unique
sympathomimetic agent, which is structurally similar to
adrenaline. It is impossible to use the action of catecho
lamines on specific receptors in the body to the benefit of
equine patients without recourse to the use of a number of
catecholamines, each active at a different receptor profile.
Hence ephedrine, which causes noradrenaline release at the
nerve endings, thereby increasing cardiac contractility and
obtunding hypotension, is used when dobutamine and
dopamine are ineffective. Ephedrine lasts minutes to
hours and is effective after a single intravenous injection,
whereas dobutamine and dopamine last only a few seconds
or minutes and must be given by infusion.
Glycopyrrolate Purpose:
prevention
of
bradycardia.
Anticholinergic.
Anti
cholinergics are fundamental treatment for prevention of
parasympathetic effects such as bradycardia and are routine
components of eye and airway surgery.
Identification of alternatives: atropine.
Discussion of the specific advantages: glycopyrrolate has a
limited central effect and is more suitable in conscious
horses (before and after anaesthesia) than atropine.
Noradrenaline
Purpose: cardiovascular failure. Infusion for the treatment
(norepinephrine)
of cardiovascular failure in foals.
Identification of alternatives: none identified.
Discussion of the specific advantages: the animal’s catecho
lamine receptor profile responds precisely to medicines
acting at different sites. Hence a range of catecholamines
acting more or less exclusively on different types of
adrenergic receptors is used to produce a precise effect.

---

L 42/6
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
Noradrenaline acts primarily on alpha-1 receptors to vaso
constrict arterioles, thereby increasing blood pressure and
maintaining central circulation. In foals, noradrenaline is
commonly the only catecholamine effective in treatment
of hypotension.
Analgesia Buprenorphine Purpose:
analgesia,
used
with
sedatives
for
restraint.
Identification of alternatives: butorphanol, fentanyl,
morphine and pethidine.
Discussion of the specific advantages: partial μ-agonist
opioid analgesic. μ-receptor activity produces better
analgesia than κ-agonist opioids such as butorphanol.
Long-acting analgesic. Due to partial agonist characteristic,
has limited addictive and respiratory depressant properties.
Long and short-acting opioids have different indications,
hence the need for more than one alternative substances
as choice.
Fentanyl Purpose:
analgesia.
Identification of alternatives: butorphanol, buprenorphine,
morphine and pethidine.
Discussion of the specific advantages: μ-agonist opioid, μ-
receptor activity produces better analgesia than κ-agonist
opioids such as butorphanol. Very short acting due to
rapid metabolism and excretion. Fentanyl is the only
opioid used in horses that is suitable for infusion and
skin patch administration. Highly effective for pain
management.
Morphine Purpose:
analgesia.
Identification of alternatives: butorphanol, buprenorphine,
pethidine and fentanyl.
Discussion of the specific advantages: full μ-agonist opioid
analgesic. μ-receptor activity produces the best analgesia.
Used with sedatives for restraint, used for epidural anaes
thesia. Mid duration analgesic. Morphine is the μ-opioid
agonist with the best solubility characteristics for epidural
administration. It provides long-acting analgesia with few
systemic effects by this route. This technique is widely used
in modern veterinary medicine for treating severe peri
operative and chronic pain.
Pethidine Purpose:
analgesia.
Identification of alternatives: butorphanol, buprenorphine,
morphine and fentanyl.
Discussion of the specific advantages: a μ-agonist opioid
analgesic about 10 times less potent than morphine.
Short-acting opioid that has been proven to be effective
to treat spasmodic colic in horses. Only opioid with spas
molytic properties. More sedation and less potential for
excitement than other opioids in horses.
Muscle relaxants and
Atracurium Purpose:
muscle
relaxation
during
anaesthesia.
associated substances
Identification of alternatives: guaifenesin.
Discussion of the specific advantages: non-depolarising
neuromuscular blocking agent. Neuromuscular blocking
agents are used in particular for eye and deep abdominal
surgery. Edrophonium is required for reversal. Atracurium
and edrophonium have the most extensive clinical support
data.

---

EN
13.2.2013 Official
Journal
of
the
European
Union
L
42/7
Indication Active
substance
Justification and explanation of use
Edrophonium Purpose:
reversal
of
atracurium
muscle
relaxation.
Identification of alternatives: none identified.
Discussion of the specific advantages: cholinesterase
inhibitor, essential for reversal of neuromuscular
blockade. Edrophonium has least side effects of the choli
nesterase inhibitors in horses.
Guaifenesin Purpose:
muscle
relaxation
during
anaesthesia.
Identification of alternatives: atracurium.
Discussion of the specific advantages: essential alternative
to α-2/ketamine regimens in horses where α-2 agents and
ketamine are contraindicated such as in horses not
responding to these agents or horses having shown
adverse effects during a previous administration. Invaluable
in combination with ketamine and α-2 agents for
remarkably safe field anaesthesia for which no effective
alternative intravenous techniques have been developed.
Inhalation anaesthetics Sevoflurane Purpose:
inhalation
anaesthesia
for
horses
with
limb
fractures and other orthopaedic injuries and mask
induction of anaesthesia in foals.
Identification of alternatives: isoflurane.
Discussion of the specific advantages: sevoflurane is a
volatile anaesthetic with minor metabolism and fast
excretion. While there is an MRL for isoflurane in the
EU, isoflurane is not suitable for all equine anaesthetic
cases due to its recovery characteristics where excitement
may lead to the horse breaking a leg. Sevoflurane is
essential in certain equine surgeries where a smooth
recovery is vital, as it has been shown to produce a
smoother, more controlled recovery in horses. It is
therefore selected in preference to isoflurane for horses
with limb fractures and other orthopaedic injuries.
Furthermore sevoflurane is essential for mask induction
of anaesthesia in foals as it is completely non-irritant as
opposed to isoflurane, which is irritant and therefore
causes coughing and breath holding.
Local anaesthetics Bupivacaine Purpose:
local
anaesthesia.
Identification of alternatives: lidocaine.
Discussion of the specific advantages: long-acting local
anaesthetic. Long duration of action required for peri
operative analgesia and treatment of chronic severe pain
such as laminitis. Bupivacaine is a longer-acting local
anaesthetic than the commonly used lidocaine. Lidocaine
alone gives approximately one hour of local anaesthesia.
Addition of adrenaline may prolong the effect to two
hours, but runs the risk of cutting the local blood
supply, and this combination therefore is unsuitable in a
number of conditions. Bupivacaine provides four to six
hours of local anaesthesia and is therefore much better
suited to post-operative analgesia and for management of
laminitis because a single injection is often sufficient; this is
essential on welfare grounds than repeated hourly lidocaine
injections. Shorter acting local anaesthetics are therefore
not suitable for the above as they require frequent repeat
injections with the attendant increased risk of adverse
reactions and unacceptability for animal welfare reasons.
Oxybuprocaine Purpose:
local
anaesthesia
for
use
in
eyes.
Identification of alternatives: none identified.

---

L 42/8
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
Discussion of the specific advantages: widest clinical
experience with oxybuprocaine compared to other
potential candidates for essential substances.
Prilocaine Purpose:
local
anaesthesia
prior
to
intravenous
catheteri
sation.
Identification of alternatives: none identified.
Discussion of the specific advantages: in specific prep
arations (eutectic mixture of local anaesthetics) for topical
application to skin where it is absorbed intradermally in 40
min. Used to facilitate intravenous catheterisation,
especially in foals.
Anti-inflammatory substances
Corticosteroids Triamcinolone
acetonide Purpose:
intra-articular
medication
for
degenerative
joint
disease and osteoarthritis.
Identification of alternatives: methylprednisolone.
Discussion of the specific advantages: different cellular and
biosynthetic effects from the alternative corticosteroid
intra-articular medication methylprednisolone; triamci
nolone is chondroprotective and promotes cartilage
repair. More effective than systemic treatments (NSAIDs
and chondroitin sulphate), and other (non-corticosteroid)
intra-articular treatments for control of joint inflammation,
pain and lameness in acute and chronic joint disease,
especially degenerative joint disease and osteoarthritis.
Only effective non-surgical treatment for subchondral
bone cysts.
Flumethasone Purpose:
short-term
systemic
corticosteroid
therapy
including shock, anti-inflammatory and anti-allergy
therapy.
Identification of alternatives: dexamethasone, prednisolone.
Discussion of the specific advantages: different clinical
effects from alternatives with more rapid onset, longer
duration and greater efficacy. Different mode of action
from alternatives (no appreciable mineralocorticoid activ
ity).
Anti-endotoxins Pentoxifylline Purpose:
systemic
and
oral
treatment
for
endotoxaemia.
Laminitis.
Identification of alternatives: flunixin, acepromazine.
Discussion of the specific advantages:
Endotoxaemia: different mode of action (methylated
xanthine derivative phosphodiesterase inhibitor) and
different clinical effects to alternative (flunixin). Decreases
endotoxin-mediated release of pro-inflammatory cytokines
and leukotrienes from macrophages and neutrophils,
reduces systemic response to endotoxins.
Laminitis: different mode of action of improving blood
flow to the digit than alternative (acepromazine); reduces
blood viscosity and improves blood flow to the digit.
Polymyxin B Purpose:
systemic
treatment
for
endotoxaemia
associated
with severe colic and other gastrointestinal diseases.
Identification of alternatives: flunixin, bismuth subsalicylate.
Discussion of the specific advantages: different mode of
action (endotoxin binding agent) to systemic alternative
(flunixin), acting earlier in the endotoxin-induced cascade.
Different mechanism of binding, different route of adminis
tration and different site of action to oral alternative
bismuth. Aids in prevention of initiation of inflammatory
cascade induced by binding endotoxin and preventing
binding to Toll-like receptors.

---

EN
13.2.2013 Official
Journal
of
the
European
Union
L
42/9
Indication Active
substance
Justification and explanation of use
Cardiovascular medicines
Amiodarone Purpose:
anti-dysrhythmic.
Systemic
and
oral
treatment
of
atrial fibrillation, supraventricular and ventricular tachyc
ardias.
Identification of alternatives: quinidine sulphate, procain
amide, propranolol.
Discussion of the specific advantages: different mode of
action to alternatives (class III anti-dysrhythmic). New
evidence that amiodarone is effective and safe in atrial
fibrillation and better than alternative quinidine sulphate;
effective for different types of arrhythmias including
ventricular arrhythmias.
Allopurinol Purpose:
treatment
of
neonatal
ischaemia-reperfusion
injury.
Identification of alternatives: vitamin E.
Discussion of the specific advantages: different mode of
action to alternative for reperfusion injury; allopurinol is
a xanthine oxidase inhibitor inhibiting free radical
production during reperfusion following ischaemia.
Vasopressin Purpose:
treatment
of
circulatory
collapse
in
foals
and
adults.
Identification of alternatives: dopamine/dobutamine
Epinephrine.
Discussion of the specific advantages: specific agonist
acting via V1 receptors. Has a different mode of action
to the other authorized substances which regulate blood
pressure: epinephrine (an adrenergic receptor agonist) and
dopamine/dobutamine (D1-5 receptors regulating cardiac
output and blood vessel tone). Used in situations when
dopamine/dobutamine and epinephrine have been unsuc
cessful and an alternative pharmacological approach is
needed.
Digoxin Purpose:
treatment
of
heart
failure.
Identification of alternatives: none identified.
Discussion of the specific advantages: additionally digoxin
is the only treatment for the side effects of quinidine treat
ment.
Quinidine sulfate and
Purpose: treatment of cardiac arrhythmias.
quinidine gluconate
Identification of alternatives: procainamide, propranolol.
Discussion of the specific advantages: anti-dysrhythmic
agent. Use is rare but important therapeutic choice,
different mode of action necessary for different types of
arrhythmias. Treatment of choice for atrial fibrillation.
Procainamide Purpose:
treatment
of
cardiac
arrhythmias.
Identification of alternatives: quinidine sulfate and
quinidine gluconate, propranolol.
Discussion of the specific advantages: anti-dysrhythmic
agent. Use is rare but important therapeutic choice,
different mode of action necessary for different types of
arrhythmias.
Propranolol Purpose:
treatment
of
cardiac
arrhythmias.
Identification of alternatives: quinidine sulfate and
quinidine gluconate, procainamide.
Discussion of the specific advantages: anti-hypertensive,
which is used because it also exerts some anti-arrhythmic

---

L 42/10
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
activity. Use is rare but important therapeutic choice. Due
to the different pathophysiology of arrhythymias it is
essential to have a variety of different acting medicines in
order to be able to treat the specific condition. Use of these
medicines consists usually of a single treatment to convert
back to normal rhythm, which may have to be repeated on
only rare occasions.
Convulsions
Phenytoin Purpose:
anti-convulsant
therapy
in
foals.
Treatment
of
rhabdomyolysis. Treatment of stringhalt.
Identification of alternatives: diazepam, primidone,
dantrolene sodium (for rhabdomyolysis).
Discussion of the specific advantages: essential anti-
convulsant in foals. Phenytoin is generally added to the
treatment of seizure control if primidone/phenobarbital
does not control the seizures. Phenytoin is a calcium
channel-blocking agent and useful for the treatment of
recurrent forms of rhabdomyolysis.
Primidone Purpose:
anti-convulsant
therapy
in
foals.
Identification of alternatives: diazepam, phenytoin.
Discussion of the specific advantages: primidone is
indicated as follow-on from diazepam therapy or as an
alternative.
Gastrointestinal agents
Bethanechol
Purpose: treatment of ileus, treatment of gastroduodenal
stricture in foals, treatment of recurrent small colon
impactions in adults.
Identification of alternatives: metoclopramide,
erythromycin.
Discussion of the specific advantages: betanechol is a
muscarinic cholinergic agonist that stimulates acetylcholine
receptors on gastrointestinal smooth muscles, causing them
to contract. It has been shown to increase the rate of
gastric and caecal emptying. Both betanechol and metoclo
pramide have been shown to be beneficial in the treatment
of post-operative ileus.
Codeine Purpose:
diarrhoea
treatment.
Identification of alternatives: bismuth subsalicylate.
Discussion of the specific advantages: different mode of
action to bismuth subsalicylate. Opioid motility
modulator acting on mu receptors in the gut that
provides effective symptomatic management of non-
infectious diarrhoea, especially in foals. Frequently used in
combination with loperamide. Similarity in mode of action
to loperamide brings synergistic action.
Loperamide Purpose:
diarrhoea
treatment
in
foals.
Identification of alternatives: bismuth subsalicylate.
Discussion of the specific advantages: different mode of
action to bismuth subsalicylcate. Opioid motility
modulator acting on mu receptors in the gut that
provides more effective symptomatic management of
non-infectious diarrhoea in foals than other substances.
Frequently used in combination with codeine. Similarity
in mode of action to codeine brings synergistic action.
Metoclopramide Purpose:
treatment
of
post-operative
ileus.
Identification of alternatives: bethanechol, erythromycin.

---

EN
13.2.2013 Official
Journal
of
the
European
Union L
42/11
Indication Active
substance
Justification and explanation of use
Discussion of the specific advantages: Metoclopramide is a
substituted benzamide with several mechanisms of action:
(1) it is a dopamine receptor antagonist; (2) it augments the
release of acetylcholine from intrinsic cholinergic neurons;
and (3) it has adrenergic blocking activity. It is effective in
restoring gastrointestinal coordination post operatively and
it decreases the total volume, rate and duration of gastric
reflux. Metaclopramide is a prokinetic drug, which acts
more in the proximal gastrointestinal tract. Both
betanechol and metoclopramide have been shown to be
beneficial in the treatment of post-operative ileus.
Phenoxy-benzamine Purpose:
diarrhoea
treatment;
colitis.
Identification of alternatives: bismuth subsalicylate; flunixin.
Discussion of the specific advantages: has different mode of
action (alpha-1 antagonist and antisecretion agent)
compared to other authorised treatments and codeine.
Provides useful symptomatic management of diarrhoea
and colitis.
Propantheline bromide Purpose:
anti-peristaltic.
Identification of alternatives: atropine, lidocaine given
diluted intrarectally as an enema.
Discussion of the specific advantages: propantheline
bromide is a synthetic quaternary ammonium anticholi
nergic which inhibits gastrointestinal motility and spasm
and diminishes gastric acid secretion. It also inhibits the
action of acetylcholine at the postganglionic nerve endings
of the parasympathetic nervous system. Its effects are
similar to those of atropine although they last longer (six
hours). Propantheline bromide is an important choice for
decreasing peristalsis to avoid rectal tearing during rectal
palpation or to explore and treat a potential rectal tear
where it can be difficult to get a lidocaine enema to
work effectively.
Ranitidine Purpose:
gastric
ulcer
prophylaxis
in
neonates.
Identification of alternatives: omeprazole.
Discussion of the specific advantages: different mode of
action from omeprazole. Route of administration (intra
venous) brings added benefit over all other anti-ulcer medi
cations as these require oral administration. Intravenous
ranitidine preparation essential in foals that have absent
gastrointestinal motility, the group that are at high risk
for ulcers.
Sucralfate Purpose:
gastric
ulcer
prophylaxis
in
neonates.
Identification of alternatives: omeprazole.
Discussion of the specific advantages: different mode of
action from omeprazole and valuable adjunctive gastric
ulcer prophylaxis. Unique mode of action (mucosal
adherent) provides physical lesion stabilisation.
Rhabdomyolysis
Dantrolene sodium Purpose:
treatment
of
rhabdomyolysis.
Treatment
of
malignant hyperthermia during anaesthesia.
Identification of alternatives: phenytoin.
Discussion of the specific advantages: dantrolene exhibits
muscle relaxation activity by direct action on muscle as it
inhibits the release of calcium from the sarcoplasmic
reticulum and thus causes a dissociation of excitation-
contraction coupling. Both phenytoin and dantrolene
sodium have been found to be useful in the treatment of
recurrent forms of rhabdomyolysis.

---

L 42/12
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
Antimicrobials
Klebsiella spp. infections Ticarcillin Purpose:
treatment
of Klebsiella spp. infections.
Identification of alternatives: none identified.
Discussion of the specific advantages: specific antibiotic for
Klebsiella spp. infections.
Rhodococcus equi infections Azithromycin Purpose:
treatment
of Rhodococcus equi infections.
Identification of alternatives: erythromycin.
Discussion of the specific advantages: standard treatment in
combination with rifampicin, better tolerated in foals than
erythromycin.
Rifampicin Purpose:
treatment
of Rhodococcus equi infections.
Identification of alternatives: none identified.
Discussion of the specific advantages: treatment of Rhodo
coccus equi in combination with erythromycin or
azithromycin. Treatment of choice.
Septic arthritis Amikacin Purpose:
treatment
of
septic
arthritis.
Identification of alternatives: gentamicin or other aminog
lykosides.
Discussion of the specific advantages: better tolerated in
foals than gentamicin or other aminoglykosides.
Respiratory medicines
Ambroxol Purpose:
stimulation
of
surfactant
in
the
premature
foal.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.
Budesonide Purpose:
inhalation
corticosteroid
for
control
of
allergic
pulmonary disease.
Identification of alternatives: beclomethasone.
Discussion of the specific advantages: inhalation corticos
teroid therapy causes less adreno-cortical suppression, with
more rapid return to normal function after therapy ends,
and fewer systemic side effects than systemic corticosteroid
therapy because of limited systemic absorption. Inhalation
allows reduced doses and local delivery of high concen
trations of active substance and hence greater efficacy.
Especially useful for control of mild-moderate disease and
long-term maintenance therapy. Additional substances with
greater potency and different durations of effect than
beclomethasone are required to titrate the dose based on
clinical response and provide optimum disease control.
Budesonide has intermediate potency between beclome
thasone and fluticasone.
Fluticasone Purpose:
inhalation
corticosteroid
for
control
of
allergic
pulmonary disease.
Identification of alternatives: beclomethasone.
Discussion of the specific advantages: inhalation corticos
teroid therapy causes less adreno-cortical suppression with
quick rebound after therapy ends and fewer systemic side
effects than systemic corticosteroid therapy because of
limited systemic absorption. Inhalation allows local
delivery of high concentrations of active substance and
hence greater efficacy. Especially useful for control of

---

EN
13.2.2013 Official
Journal
of
the
European
Union L
42/13
Indication Active
substance
Justification and explanation of use
mild-moderate disease and long-term maintenance therapy.
Additional substances with greater potency and different
durations of effect than beclomethasone are required to
titrate the dose based on clinical response and provide
optimum disease control. Fluticasone is 50
% more
potent than beclomethasone and has longer half life (6
hours versus 2,8 hours), providing added benefit for
more severely affected or refractory cases.
Ipratropium bromide Purpose:
bronchodilation.
Identification of alternatives: none identified.
Discussion of the specific advantages: anticholinergic
action. Necessary as therapeutic choice as in some cases
more efficacious than β-agonists.
Oxymetazolin Purpose:
treatment
of
nasal
oedema.
Identification of alternatives: phenylephrine.
Discussion of the specific advantages: α-adrenoceptor
agonist with strong vasoconstrictive properties which is
used in preference to phenylephrine due to the fact that
it is longer-acting.
Antiprotozoal agents
Isometamidium Purpose:
treatment
of
equine
protozoal
myeloencephalitis.
Identification of alternatives: pyrimethamine.
Discussion of the specific advantages: disease sometimes
refractory to treatment with pyrimethamine, and
therefore an alternative is required.
Ponazuril Purpose:
equine
protozoal
myelitis
(Sarcocystis
neurona)
treatment.
Identification of alternatives: isometamidium, pyrime
thamine.
Discussion of the specific advantages: different mode of
action compared to other authorised substances, useful as
alternative therapy when disease refractory to other treat
ments. Reduced incidence of side effects (diarrhoea)
compared to pyrimethamine/sulphonamide treatments;
increased clinical efficacy compared to isometamidium
and pyrimethamine.
Pyrimethamine Purpose:
treatment
of
equine
protozoal
myeloencephalitis.
Identification of alternatives: isometamidium.
Discussion of the specific advantages: at least 75 % success
rate when used in conjunction with sulfadiazine-sulfona
mide.
Ophthalmic medicines
Ocular ulcers Acyclovir Purpose:
treatment
of
ocular
ulcers
(antiviral
medicine).
Topical use.
Identification of alternatives: idoxuridine.
Discussion of the specific advantages: both acyclovir and
idoxuridine have been shown to be equally effective in the
treatment of ulcerative herpetic keratitis.
Idoxuridine Purpose:
treatment
of
ocular
ulcers
(antiviral
medicine).
Topical use.
Identification of alternatives: acyclovir.
Discussion of the specific advantages: both acyclovir and
idoxuridine have been shown to be equally effective in the
treatment of ulcerative herpetic keratitis.

---

L 42/14
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
Glaucoma Phenylephrine Purpose:
treatment
of
glaucoma,
epiphora,
nasal
oedema
and splenic entrapment.
Identification of alternatives: tropicamide, (for glaucoma),
otherwise none identified.
Discussion of the specific advantages: both phenylephrine
and tropicamide have been shown to be equally effective in
the treatment of glaucoma.
Tropicamide Purpose:
treatment
of
glaucoma.
Topical
use.
Identification of alternatives: phenylephrine.
Discussion of the specific advantages: both phenylephrine
and tropicamide have been shown to be equally effective in
the treatment of glaucoma.
Dorzolamide Purpose:
treatment
of
glaucoma.
Topical
use.
Identification of alternatives: latanoprost, timolol maleate.
Discussion of the specific advantages: its specific mode of
action as a carbonic anhydrase inhibitor. Important thera
peutic choice.
Latanoprost Purpose:
treatment
of
glaucoma.
Topical
use.
Identification of alternatives: dorzolamide, timolol maleate.
Discussion of the specific advantages: its specific mode of
action as a prostaglandin F2α-analogue. Important thera
peutic choice.
Timolol maleate Purpose:
treatment
of
glaucoma.
Topical
use.
Identification of alternatives: dorzolamide, latanoprost.
Discussion of the specific advantages: its specific mode of
action as a non-selective beta-adrenergic receptor blocking
agent, causes vasoconstriction, which in turns leads to
decrease of the aqueous humour. Important therapeutic
choice.
Cyclosporin A Purpose:
immunosuppressive
used
for
the
treatment
of
autoimmune diseases of the eye.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.
Ketorolac Purpose:
treatment
of
eye
pain
and
inflammation,
non-
steroidal anti-inflammatory medicine, eye drops, topical
use.
Identification of alternatives: none identified.
Discussion of the specific advantages: widest clinical
experience with ketorolac compared to other potential
candidates for essential substances.
Ofloxacin Purpose:
treatment
of
eye
infections
resistant
to
commonly
used ophthalmic antibiotic treatments.
Identification of alternatives: none identified.
Discussion of the specific advantages: widest clinical
experience with ofloxacin compared to other potential
candidates for essential substances. Compared to
commonly employed ophthalmic antibiotic treatments
ofloxacin should only be used as a reserve antibiotic in
individual cases.
Fluoresceine Purpose:
diagnostic
tool
for
corneal
ulceration,
topical
use.
Identification of alternatives: Rose Bengal.

---

EN
13.2.2013 Official
Journal
of
the
European
Union L
42/15
Indication Active
substance
Justification and explanation of use
Discussion of the specific advantages: Rose Bengal has
some antiviral activity while fluoresceine has no significant
effect on virus replication. Thus, the diagnostic use of Rose
Bengal prior to viral culture may preclude a positive result.
Therefore fluoresceine is the diagnostic tool of choice when
a viral culture is planned.
Rose Bengal Purpose:
diagnostic
tool
for
early
corneal
damage,
topical
use.
Identification of alternatives: fluoresceine.
Discussion of the specific advantages: Rose of Bengal is the
diagnostic tool of choice to ascertain very early corneal
damage.
Hyperlipaemia
Insulin Purpose:
treatment
of
hyperlipaemia,
used
in
combination
with glucose therapy, diagnosis of metabolic disorders.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.
Fungal infections
Griseofulvin Purpose:
systemic
antifungal
use.
Treatment
of
ringworm.
Identification of alternatives: none identified.
Discussion of the specific advantages: griseofulvin given
orally has good activity against trichophyton, micro
sporum, and epidermophyton.
Ketoconazole Purpose:
systemic
antifungal
use.
Treatment
of
fungal
pneumonia and guttural pouch mycosis.
Identification of alternatives: none identified.
Discussion of the specific advantages: widest clinical
experience with ketoconazole compared to other
potential candidates for essential substances.
Miconazole
Purpose: treatment of fungal infections of the eye.
Identification of alternatives: none identified.
Discussion of the specific advantages: topical use on the
affected eye, wider antifungal activity and/or lesser irritation
than other antifungal agents.
Nystatin Purpose:
treatment
of
yeast
infections
for
eyes
and
genital
tract.
Identification of alternatives: none identified.
Discussion of the specific advantages: specific activity
against yeast infections.
Diagnostic imaging
Radiopharma-ceutical
Purpose: scintigraphy.
Tc99m
Identification of alternatives: none identified.
Discussion of the specific advantages: most sensitive diag
nostic imaging modality for identification of early bone
pathology and fractures — more sensitive than radi
ography. Allows quantitation and enables imaging of
regions not amenable to radiography. Essential imaging
technique safeguarding welfare of performance horses
through early injury detection and prevention of cata
strophic fractures. Short half life (6,01 hours) of Tc99m
results in rapid clearance of detectable radioactivity (< 72
hours) from the horse.

---

L 42/16
EN
Official Journal of the European Union
13.2.2013
Indication Active
substance
Justification and explanation of use
Miscellaneous
Carbamazepine Purpose:
headshaking
syndrome.
Identification of alternatives: none identified.
Discussion of the specific advantages: carbamazepine is
acting as anti-convulsant with sodium channel-blocking
effects. Used mainly for treatment and diagnostic confir
mation of trigeminal neuralgia (headshaking syndrome).
Cyproheptadine Purpose:
headshaking
syndrome.
Identification of alternatives: none identified.
Discussion of the specific advantages: horses exhibiting
signs of photic headshaking respond favourably to
treatment with the antihistaminic drug cyproheptadine. In
addition to antihistaminic action, cyproheptadine has anti
cholinergic action and is a 5-hydroxytryptamine (serotonin)
antagonist. Relief from the behaviour is usually seen within
24 hours of beginning cyproheptadine therapy and often
resumes within 24 hours of discontinuing therapy. Other
antihistamines are not effective at eliminating headshaking.
Domperidone Purpose:
agalactia
in
mares.
Identification of alternatives: none identified.
Discussion of the specific advantages: dopamine antagonist
and up-regulates prolactin production.
Oxytocin is not a suitable alternative because it produces
milk letdown as opposed to increasing milk production,
which is the aim of domperidone therapy. Additionally,
oxytocin is likely to cause abdominal pain if used in
large doses.
Gabapentin Purpose:
neuropathic
pain.
Identification of alternatives: buprenorphine, fentanyl,
morphine, pethidine.
Discussion of the specific advantages: different mode and
different site of action to alternative authorized substances.
GABA-like substance which blocks calcium channels and
inhibits formation of new synapses. Novel treatment for
neuropathic pain with evidence suggesting added clinical
benefit in the management of pain related to neuropathy
e.g. foot pain, laminitis and abdominal pain.
Hydroxyethyl-starch Purpose:
colloidal
volume
substitution.
Identification of alternatives: none identified.
Discussion of the specific advantages: practical and readily
available alternative to blood or plasma.
Imipramine Purpose:
pharmacologically
induced
ejaculation
in
stallions
with ejaculatory dysfunction.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.
Thyrotropin releasing
Purpose: diagnostic used for the confirmation of thyroid
hormone
and pituitary disorders.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.
Barium sulphate Purpose:
radiographic
contrast
agent
used
for
oesophageal
and gastrointestinal contrast examinations.
Identification of alternatives: none identified.
Discussion of the specific advantages: no alternatives avail
able.

---

EN
13.2.2013 Official
Journal
of
the
European
Union L
42/17
Indication Active
substance
Justification and explanation of use
Iohexol Purpose:
radiographic
contrast
agent
used
for
lower
urinary
tract studies, arthrography, myelography, sino- or fistu
lography and dacryocystography.
Identification of alternatives: iopamidol.
Discussion of the specific advantages: non-ionic low
osmolar contrast agent. Both iohexol and iopamidol are
equally acceptable.
Iopamidol Purpose:
radiographic
contrast
agent
used
for
lower
urinary
tract studies, arthrography, myelography, sino- or fistu
lography and dacryocystography.
Identification of alternatives: iohexol.
Discussion of the specific advantages: non-ionic low
osmolar contrast agent used for. Both iohexol and
iopamidol are equally acceptable.’

---

Document Outline

• �

---