Commission Regulation (EC) No 1950/2006 of 13 December 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)
Date: 2006-12-13
Institutions: European Commission
Subjects: equidae, pharmaceutical legislation, veterinary drug, veterinary legislation

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 1950/2006

of 13 December 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 COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 2001/82/EC of
the European
Parliament and of the Council of 6 November 2001 on the
Community code relating to veterinary medicinal products (1),
and in particular Article 10(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

State

No veterinary medicinal product may be placed on the
market of a Member State unless a marketing author-
isation has been issued by the competent authorities of
that Member
in accordance with Directive
2001/82/EC or in accordance with Regulation (EC) No
726/2004 of the European Parliament and of the Council
of 31 March 2004 laying down Community procedures
the authorisation and supervision of medicinal
for
products for human and veterinary use and establishing
a European Medicines Agency (2).

for

Veterinary medicinal
food-producing
products
animals including equidae may be authorised only on
conditions that guarantee that the foodstuffs produced
will be harmless to consumers as regards any residues
of such medicinal products, in accordance with Council
Regulation (EEC) No 2377/90 of 26 June 1990 laying
down a Community procedure for the establishment of
maximum residue limits of veterinary medicinal products
in foodstuffs of animal origin (3).

For the reasons set out in the Communication from the
Commission to the Council and the European Parliament
on ‘Availability of veterinary medicinal products’ (4), the
authorised veterinary medicinal
available
products, particularly for
is
food-producing animals,
gradually decreasing.

range of

Consequently, measures
sustainable
broadening of therapies are required in order to meet

aimed

at

a

(1) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(2) OJ L 136, 30.4.2004, p. 1.
(3) OJ L 224, 18.8.1990, p. 1. Regulation as

Commission Regulation
30.9.2006, p. 37).

(4) COM(2000) 806 final, 5.12.2000.

(EC) No 1451/2006 (OJ

last amended by
L 271,

(5)

(6)

(7)

(8)

(9)

the health-care and welfare needs of
food-producing
animals, such as animals of the equidae family, without
compromising the high level of consumer protection.

By means of the derogation provided for in Directive
2001/82/EC, equidae intended for slaughter for human
consumption may be administered substances essential
substances’,
for
subject to a withdrawal period of at least six months.

treatment, hereinafter

‘essential

their

For the purpose of that derogation, the list of essential
substances should therefore be established. A substance
in exceptional
should only be included in that
circumstances
alternative
no
treatment for a therapeutic indication is authorised and
if untreated, create unne-
where the condition would,
cessary suffering for the animal.

list
satisfactory

where

Specific disease conditions or zootechnical purposes
might require a choice of substances to be available in
order to cater for different requirements related to the
age and utilisation of equidae.

are not

authorised

to Directive 2001/82/EC,

the treatment of equidae,

substances
Since, pursuant
II or III to Regulation (EEC) No
listed in Annexes I,
in products
2377/90 which
in certain circumstances, be
intended for equidae may,
used for
those substances
should not appear on the list of essential substances.
Furthermore, no substances listed in Annex IV to Regu-
lation (EEC) No 2377/90 should be included in the list.
Consequently, the inclusion of a substance in Annexes I
to IV to Regulation (EEC) No 2377/90 should preclude
its use as an essential substance for the purposes of this
Regulation.

control mechanisms

been treated with
the

It is necessary to ensure an appropriate surveillance of
essential
equidae which
have
substances. Therefore,
laid
down in Commission Decision 93/623/EEC of 20
October 1993 establishing the identification document
and
(passport)
Decision 2000/68/EC of 22 December 1999 amending
Commission Decision 93/623/EEC and establishing the
identification of equidae for breeding and production (6)
to safeguard consumer health should apply.

accompanying

equidae (5)

registered

(5) OJ L 298, 3.12.1993, p. 45.
(6) OJ L 23, 28.1.2000, p. 72.

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(10)

(11)

is

subject

substances

evaluation carried out by

It is necessary to ensure that any amendment of the list
to a harmonised
of essential
scientific
the European
Medicines Agency established by Regulation (EC) No
726/2004. In addition, the Member States and veterinary
professional
requested an
associations which have
amendment of that list should duly substantiate their
request and provide relevant scientific data.

The measures provided for in this Regulation are in
accordance with
Standing
the
the
Committee on Veterinary Medicinal Products,

opinion

of

HAS ADOPTED THIS REGULATION:

Article 1

The list of substances essential for the treatment of equidae,
hereinafter ‘essential substances’, applicable by way of dero-
gation from Article 11 of Directive 2001/82/EC, is set out in
the Annex to this Regulation.

Article 2

for

the specific disease
Essential substances may be used,
conditions, treatment needs or zootechnical purposes specified
in the Annex, where no medicinal product authorised for
equidae or referred to in Article 11 of Directive 2001/82/EC
would yield equally satisfactory results in terms of successfully
treating the animal, avoiding unnecessary suffering for the
animal, or ensuring the safety of those treating the animal.

For the purposes of the first paragraph, the alternatives listed in
the Annex shall be considered.

The details of a treatment with essential substances must
2.
be recorded in accordance with the instructions laid down in
Section IX of the identification document for equidae set out in
Decisions 93/623/EC and 2000/68/EC.

Article 4

Any substance that is entered in one of the lists in Annexes I to
IV to Regulation (EC) No 2377/90, or the use of which for
equidae is prohibited by Community legislation, shall no longer
be used as an essential substance for the purposes of this Regu-
lation.

Article 5

The European Medicines Agency shall, at the request of
1.
the Commission, ensure that
the Committee for Medicinal
Products for Veterinary Use carries out a scientific evaluation
of any draft amendment to the list set out in the Annex.

Within 210 days of receiving such a request, the European
Medicines Agency shall deliver an opinion to the Commission
on the scientific suitability of the amendment.

Where appropriate, the European Food Safety Authority shall
also be consulted.

2. When Member States or veterinary professional asso-
ciations ask the Commission to amend the list set out in the
Annex they shall duly substantiate their request and include any
relevant scientific data available.

Article 3

Article 6

Essential substances may be used only in accordance with

1.
Article 10(1) of Directive 2001/82/EC.

This Regulation shall enter into force on the third day following
its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 December 2006.

For the Commission

Günter VERHEUGEN
Vice-President

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ANNEX

List of substances essential for the treatment of 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
(and antagonism)

Acepromazine

Purpose: premedication prior to general anaesthesia, mild sedation.

Identification of alternatives: detomidine, romfidine, 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 benzodia-
zepines (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 cardiovascular and respiratory side effects. Anti-convulsant, essential for treatment of seizures.

Identification of alternatives: acepromazine, detomidine, romfidine, 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 intubation.
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.

Midazolam

Purpose: premedication and induction of anaesthesia. Mild (benzodiazepine)
tranquilisation with
minimal cardiovascular and respiratory side effects. Anti-convulsant, for treatment of seizures, parti-
cularly adult horses with tetanus.

Identification of alternatives: acepromazine, detomidine, romfidine, xylazine, diazepam, primidone,
phenytoin.

Discussion of the specific advantages: similar to diazepam but water soluble, thus suitable for intra-
venous 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 intubation.

Mode of action (acts at GABA receptor) and unique tranquilisation without cardiorespiratory
depression cannot be produced by the α-2 agonist sedatives (detomidine, romifidne and xylazine) or
acepromazine.

Naloxone

Purpose: opioid-antidote, emergency medicine.

Identification of alternatives: none identified.

Discussion of the specific advantages: no alternatives available.

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Indication

Active substance

Justification and explanation of use

Propofol

Purpose: intravenous anaesthetic. Induction of anaesthesia in foals.

Identification of alternatives: inhalation anaesthetics such as 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, periosteal stripping, cyst or lump excisions, repair of facial fractures, cast
applications and umbilical hernia repairs.

Zolazepam

Purpose: dissociative anaesthetic similar to ketamine, especially used for field anaesthesia. Used in
combination with tiletamine.

Identification of alternatives: ketamine.

Discussion of the specific advantages: benzodiazepine tranquilliser, which is longer acting than either
diazepam or 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 anaesthesia with
laryngotomies, periosteal
ketamine combinations is too short. Typical applications are castrations,
stripping, cyst or lump excisions, repair of facial fractures, cast applications and umbilical hernia
repairs.

— Hypotension or

respiratory stimu-
lation during
anaesthesia

Dobutamine

Purpose: treatment of hypotension during anaesthesia.

Identification of alternatives: dopamine.

Discussion of the specific advantages: positive inotrope therapy, probably more used than dopamine
but preferences vary. Horses usually develop hypotension during anaesthesia, and maintenance of
normal blood pressure has been shown to reduce the incidence of serious post-operative rhabdo-
myolysis. 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 dobu-
tamine. In foals dopamine is used in preference to dobutamine. Additionally required for treatment of
intraoperative bradydysrhythmias that are resistant to atropine.

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Indication

Active substance

Justification and explanation of use

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 catecholamines 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 contrac-
tility 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. Anticholinergics 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
(norepinephrine)

Purpose: cardiovascular failure. Infusion for the treatment of cardiovascular failure in foals.

Identification of alternatives: none identified.

Discussion of the specific advantages: the animal’s catecholamine 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. Noradrenaline acts primarily
on alpha-1 receptors to vasoconstrict 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 anaesthesia. 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
used in modern veterinary medicine for treating severe perioperative and chronic pain.

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Indication

Active substance

Justification and explanation of use

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 spasmolytic properties. More sedation and less potential for excitement than other
opioids in horses.

— Muscle relaxants
and associated
substances

Atracurium

Purpose: muscle relaxation during anaesthesia.

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.

Edrophonium

Purpose: reversal of atracurium muscle relaxation.

Identification of alternatives: other cholinesterase inhibitors.

Discussion of the specific advantages: cholinesterase inhibitor, essential for reversal of neuromuscular
blockade. Edrophonium has least side effects of the cholinesterase 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, halothane, enflurane.

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 perioperative 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.

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Indication

Active substance

Justification and explanation of use

Oxybuprocaine

Purpose: local anaesthesia for use in eyes.

Identification of alternatives: other local anaesthetics for use in eyes such as amethocaine, proxyme-
tacaine.

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 catheterisation.

Identification of alternatives: none identified.

Discussion of the specific advantages: in specific preparations (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.

Cardiovascular medicines

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 treatment

Quinidine sulfate
and quinidine
gluconate

Purpose: treatment of cardiac arrhythmias.

Identification of alternatives: procainamide, propanolol.

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, propanolol.

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.

Propanolol

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 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.

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Indication

Active substance

Justification and explanation of use

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: neostigmine, metoclopramide, cisapride, erythromycin and other
prokinetic substances.

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 metoclopramide
have been shown to be beneficial in the treatment of post-operative ileus.

Dioctyl sodium
sulfosuccinate

Purpose: treatment of impactions.

Identification of alternatives: mineral oil.

Discussion of
intestinal contents when
compared to mineral oil as it potentiates the penetration of water into the impacted faecal mass.

the specific advantages: achieves improved softening of

Metoclopramide

Purpose: treatment of post-operative ileus.

Identification of alternatives: bethanechol, neostigmine, cisapride, erythromycin and other prokinetic
substances.

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 acet-
ylcholine 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.

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
anticholinergic 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.

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.

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Indication

Active substance

Justification and explanation of use

Antimicrobials

— Klebsiella ssp.
infections

Ticarcillin

Purpose: treatment of Klebsiella ssp. infections.

Identification of alternatives: none identified.

Discussion of the specific advantages: Specific antibiotic for Klebsiella ssp. infections.

— Rhodococcus equi

Azithromycin

Purpose: treatment of Rhodococcus equi infections.

infections

Identification of alternatives: erythromycin.

Discussion of the specific advantages: standard treatment
tolerated in foals than erythromycin.

in combination with rifampicin, better

Rifampicin

Purpose: treatment of Rhodococcus equi infections.

Identification of alternatives: none identified.

Discussion of the specific advantages: treatment of Rhodococcus equi in combination with erythromycin
or azithromycin. Treatment of choice.

— Septic arthritis

Amikacin

Purpose: treatment of septic arthritis.

Identification of alternatives: gentamicin or other aminoglykosides.

Discussion of the specific advantages: better tolerated in foals than gentamicin or other aminogly-
kosides.

Respiratory medicines

Ambroxol

Purpose: stimulation of surfactant in the premature foal.

Identification of alternatives: none identified.

Discussion of the specific advantages: no alternatives available.

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.

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Indication

Active substance

Justification and explanation of use

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-sulfonamide.

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.

— 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 therapeutic choice.

Latanoprost

Purpose: treatment of glaucoma. Topical use.

Identification of alternatives: dorzolamide, timolol maleate.

Discussion of the specific advantages:
Important therapeutic choice.

its specific mode of action as a prostaglandin F2α-analogue.

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.

22.12.2006

EN

Official Journal of the European Union

L 367/43

Indication

Active substance

Justification and explanation of use

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 available.

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: ciprofloxacin, cefamandole, commonly employed ophthalmic antibiotic
treatments

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.

Discussion of the specific advantages: Rose Bengal has some antiviral acticity 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.

Hydroxypropyl
methylcellulose

Purpose: corneal protection, topical use.

Identification of alternatives: none identified.

Discussion of the specific advantages: no alternatives available.

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 available.

L 367/44

EN

Official Journal of the European Union

22.12.2006

Indication

Active substance

Justification and explanation of use

Fungal infections

Miscellaneous

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,
microsporum, and epidermophyton.

Ketoconazole

Purpose: systemic antifungal use. Treatment of fungal pneumonia and guttural pouch mycosis.

Identification of alternatives: other azoles such as itraconazole.

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.

Chondroitin
sulphate

Purpose: cartilage healing. Chondroprotection. Treatment of arthritis.

Identification of alternatives: none identified.

Discussion of the specific advantages: clinical improvement is likely attributable to anti-inflammatory
effects, including inhibition of PGE2 synthesis and inhibition of cytokine release.

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.

Hydroxyethylstarch

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 available.

22.12.2006

EN

Official Journal of the European Union

L 367/45

Indication

Active substance

Justification and explanation of use

Thyrotropin
releasing hormone

Purpose: diagnostic used for the confirmation of thyroid and pituitary disorders.

Identification of alternatives: none identified.

Discussion of the specific advantages: no alternatives available.

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 available.

Iohexol

Purpose: radiographic contrast agent used for lower urinary tract studies, arthrography, myelography,
sino- or fistulography and dacryocystography.

Identification of alternatives: iopamidol.

Discussion of
iopamidol are equally acceptable.

the specific advantages: non-ionic low osmolar contrast agent. Both iohexol and

Iopamidol

Purpose: radiographic contrast agent used for lower urinary tract studies, arthrography, myelography,
sino- or fistulography 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.