Equest Pramox
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Equest Pramox 19.5 mg/g + 121.7 mg/g oral gel for horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substances
Moxidectin 19.5 mg
Praziquantel 121.7 mg
Excipients
Benzyl alcohol (E1519) 220.0 mg
Butylhydroxytoluene (E321) 0.8 mg
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral Gel.
Pale yellow to orange/pink oral gel.
4. CLINICAL PARTICULARS
4.1 Target species
Horses.
4.2 Indications for use, specifying the target species
For the treatment of mixed cestodes and nematodes or arthropods infections, caused by
moxidectin and praziquantel sensitive strains of:
Large strongyles:
Strongylus vulgaris (adult stages)
Strongylus edentatus (adult stages)
Triodontophorus brevicauda (adults)
Triodontophorus serratus (adults)
Triodontophorus tenuicollis (adults)
Small strongyles (adults and intraluminal larval stages):
Cyathostomum spp
Cylicocyclus spp
Cylicostephanus spp
Cylicodontophorus spp
Gyalocephalus spp
Ascarids:
Parascaris equorum (adults)
Other species:
Oxyuris equi (adult stages)
Habronema muscae (adults)
Gasterophilus intestinalis (L2, L3)
Gasterophilus nasalis (L2, L3)
Strongyloides westeri (adults)
Trichostrongylus axei (adult stages)
Tapeworm (adults):
Anoplocephala perfoliata
Anoplocephala magna
Paranoplocephala mammillana
The egg reappearance period of small strongyles is 90 days.
The veterinary medicinal product is effective against (developing) intramucosal L4 stages
of small strongyles. At 8 weeks after treatment, early (hypobiotic) EL3 stages of small
strongyles are eliminated.
4.3 Contraindications
Do not administer to young foals less than 6.5 months old.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
The veterinary medicinal product has been formulated specifically for use in horses only.
Dogs and cats may be adversely affected by the concentration of moxidectin in this
veterinary medicinal product if they are allowed to ingest spilled gel or have access to
used syringes.
4.4 Special warnings for each target species
Care should be taken to avoid the following practices, because they increase the risk of
development of resistance and could ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class, over an
extended period of time;
-
Under-dosing which may due to underestimation of body weight, misadministration of
the product, or lack of calibration of the dosing device (If any). -
Suspected clinical cases of resistance to anthelmintics should be further investigated
using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of
the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different mode of action
should be used.
For optimum control of bots, the veterinary medicinal product should be administered in
the autumn, after the end of the fly season and before spring as the larvae may start to
pupate and therefore are less sensitive to treatment.
Parasite resistance to a particular class of anthelmintic may develop following frequent,
repeated use of an anthelmintic of that class. The veterinarian should give advice regarding
appropriate dosing programmes and stock management to achieve adequate parasite control
for both tapeworm and roundworm infestations.
4.5 Special precautions for use
Special precautions for use in animals
To avoid overdosing, care should be taken to accurately dose foals, especially low body
weight foals or pony foals.
Do not use the same syringe to treat more than one animal unless horses are running
together or in direct contact with each other in the same premises.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This veterinary medicinal product may cause eye irritation, skin irritation and skin
sensitisation.
Avoid contact with skin and eyes.
Personal protective equipment consisting of protective gloves should be worn when
handling the veterinary medicinal product.
Wash hands or any exposed area after use.
Do not smoke, drink or eat while handling the veterinary medicinal product.
In case of eye contact, flush the eye with copious amounts of clean water and seek
medical advice immediately and show the package leaflet or the label to the physician.
In case of accidental ingestion, seek medical advice immediately and show the package
leaflet or the label to the physician.
Special precautions for the protection of the environment
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT)
substance; therefore, exposure of the environment to moxidectin must be limited to the
extent possible. Treatments should be administered only when necessary and should be
based on faecal egg counts or evaluation of the risk of infestation at the animal and/or
herd level. In order to reduce the emission of moxidectin to surface water and based on
the excretion profile of moxidectin when administered as the oral formulation to horses,
treated animals should not have access to watercourses during the first week after
treatment.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target
organisms:
Faeces containing moxidectin excreted onto pasture by treated animals may temporarily
reduce the abundance of dung feeding organisms. Following treatment of horses with
the veterinary medicinal product, levels of moxidectin that are potentially toxic to dung
beetles and flies may be excreted over a period of more than 1 week and may decrease
dung fauna abundance.
Moxidectin is inherently toxic to aquatic organisms including fish. The veterinary
medicinal product should be used only according to the label instructions.
In order to limit the impact of moxidectin on dung fauna, and due to insufficient data
regarding environmental risk of praziquantel, horses should not be turned out onto pasture
within 3 days of treatment.
Other precautions
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Horses:
(1 to 10 animals / 10,000 animals Swollen muzzle1
treated): Ataxia1, Droopy lower lip1
Anorexia1
Very rare Digestive tract disorder (e.g. colic, loose stool)
(<1 animal / 10,000 animals treated, Tremor1
including isolated reports): Lethargy1
1 These adverse effects are transient and disappear spontaneously.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
4.7 Use during pregnancy, lactation or lay
The veterinary medicinal product has been shown to be safe for use in breeding, pregnant and
lactating mares.
The administration of the veterinary medicinal product does not adversely affect the fertility of the
mares.
4.8 Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin.
4.9 Amount(s) to be administered and administration route
Oral use.
A single oral dose of 400 g moxidectin/kg body weight and 2.5 mg praziquantel/kg body
weight using the calibrated syringe of one gradation per 25 kg live weight.
A single syringe treats a 700 kg horse.
To ensure administration of a correct dosage, body weight should be determined as
accurately as possible; accuracy of the dosing should be checked.
Use of a scale or weight tape is recommended to ensure accurate dosing.
Dosing instructions:
Before the first dose, hold the syringe with the capped end pointing to the left and so that
you can see the weight measurements and tick marks (small black lines). Set the syringe
to zero by moving the dial ring so the left side is set at the first full black mark and depress
the plunger, safely discarding any paste that is expelled.
To dose the veterinary medicinal product, hold the syringe as previously described. Each
tick mark relates to 25 kg of body weight and to 10 mg moxidectin/62.5 mg praziquantel.
Turn the dial ring until the left side of the ring lines up with the weight of the animal.
In the case of cestode treatment the dose of praziquantel in the veterinary medicinal
product has been selected to the top end of the dosing range.
Veterinary advice should be given on appropriate dosing programmes and stock
management to achieve optimum parasite control.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Transient adverse reactions may occur at the recommended treatment dose in foals. In
adults transient adverse reactions may occur at 3 times the recommended dose. The
symptoms are depression, inappetence, ataxia, flaccid lower lip in the 8 to 24 hours
following treatment. Symptomatic treatment is not generally necessary and recovery is
generally complete within 24 to 72 hours. There is no specific antidote.
4.11 Withdrawal period(s)
Meat and offal: 64 days.
Milk: Not authorised for use in animals producing milk for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiparasitic product, endectocide
ATCvet code: QP54AB52
5.1 Pharmacodynamic properties
Moxidectin is a parasiticide active against a wide range of internal and external parasites
and is a second generation macrocyclic lactone of the milbemycin family. Moxidectin
interacts with GABA receptors and chloride channels. The net effect is to open the chloride
channels on the postsynaptic junction to allow the inflow of chloride ions and induce an
irreversible resting state. This results in flaccid paralysis and eventual death of parasites
exposed to the drug.
Praziquantel is a parasiticide widely used in many species as an anthelmintic.
Praziquantel is quickly absorbed via the tegument of the parasite and distributed. In vitro
and in vivo important lesions of the tegument of the parasite are seen that provoke
contraction and paralysis of the parasite. Praziquantel modifies the permeability of the
parasitic membrane to calcium ions, which disrupts the metabolism of the parasite.
The veterinary medicinal product is effective against benzimidazole resistant strains of
cyathostomes.
5.2 Pharmacokinetic particulars
Moxidectin is absorbed orally and maximum blood concentration is achieved
approximately 6 to 8 hours after administration.
The drug is distributed throughout the body tissues but due to its lipophilicity it is
selectively concentrated in the fat.
The elimination half-life is 11days.
Moxidectin undergoes partial biotransformation by hydroxylation in the body and the only
significant route of excretion is the faeces.
Praziquantel is quickly and almost totally absorbed in the body, rapidly distributed to all
organs, half life elimination is less than 1 hour in horses. Praziquantel is rapidly
metabolised in the liver. Its principal metabolite is a related 4-hydroxycyclohexyl
component.
5.3 Environmental properties
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT)
substance. In particular, in acute and chronic toxicity studies with algae, crustaceans and
fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:
Organism EC50 NOEC
Algae S. capricornutum >86.9 g/l 86.9 g/l
Crustaceans Daphnia magna (acute) 0.0302 g/l 0.011 g/l
(Water Daphnia magna 0.0031 g/l 0.010 g/l
fleas) (reproduction)
Fish O. mykiss 0.160 g/l Not determined
L. macrochirus 0.620 g/l 0.52 g/l
P. promelas (early life Not 0.0032 g/l
stages) applicable
Cyprinus carpio 0.11 g/l Not determined
EC50: the concentration which results in 50% of the test species individuals being
adversely affected, i.e. both mortality and sub-lethal effects.
NOEC: the concentration in the study at which no effects are observed.
This implies that when allowing moxidectin to enter water bodies, this may have a severe
and lasting impact on aquatic life. To mitigate this risk, all precautions for use and disposal
must be adhered to.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol (E1519)
Butyl hydroxytoluene (E321)
Anhydrous colloidal silica
Ethanol, anhydrous
Polysorbate 80
Ethyl cellulose
Propylene glycol dicaprylate/dicaprate
6.2 Major incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 6 months.
6.4 Special precautions for storage
Do not store above 25C.
6.5 Nature and composition of immediate packaging
High density polyethylene syringe containing 14.4 g of gel with a graduated polypropylene
plunger with a low density polyethylene piston and cap packed as follows:
Box containing one syringe.
Box containing 10 individually boxed syringes.
Box containing 20 individually boxed syringes.
Box containing 20 syringes.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or
waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste material derived from such veterinary
medicinal products should be disposed of in accordance with local requirements. The
veterinary medicinal product should not enter water courses as moxidectin may be
dangerous for fish and other aquatic organisms.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/5148
9. DATE OF FIRST AUTHORISATION
29 June 2006
10. DATE OF REVISION OF THE TEXT
July 2024
PROHIBITION OF SALE, SUPPLY AND/OR USE
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.