Amprol 12% W/V Solution For Use In Drinking Water
Issued June 2016
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Amprol 12% w/v Solution for use in drinking water
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains:
Qualitative composition Quantitative composition
Amprolium hydrochloride 120 mg (equivalent to 106 mg amprolium)
Sorbic acid (E200) 1 mg
3. PHARMACEUTICAL FORM
Solution for use in drinking water
The solution is clear, yellow in colour.
4. CLINICAL PARTICULARS
4.1 Target species
Chickens (broilers, pullets, layers, breeder hens) and turkeys.
4.2 Indications for use, specifying the target species
For the treatment of intestinal coccidiosis caused by Eimeria spp susceptible to amprolium.
Do not use in cases of known hypersensitivity to the active substance or any of the excipients.
4.4 Special warnings for each target species
As with all anticoccidials, prolonged use may result in the development of resistant strains. Use of anticoccidial drugs having the same mode of action should be avoided due to the development of cross-resistance.
4.5 Special precautions for use
i) Special precautions for use in animals
The product is not intended for a preventive use.
This product should be reserved in case of coccidiosis outbreaksdue tonon-availability of vaccine, in case of lack of efficacy of vaccine and in vaccinated flocks if a severe coccidial challenge is diagnosed before immunity has fully developed.
ii) Special precautions for the person administering the veterinary medicinal product to animals
This is an irritant and corrosive product. It could cause airway, eye and skin irritation. Wear impervious gloves and protective glasses when handling the product.
The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.
Avoid inhalation of vapours.
Avoid contact with the skin and eyes. In the case of contact with skin or eyes, wash the affected area with clean running water immediately and remove any contaminated clothes. If irritation persists, seek medical advice and show the leaflet or the labelto the doctor.
This product is harmful when ingested. In case of accidental ingestion, rinse the mouth with fresh water, seek medical advice immediately and show the package leaflet or label to the doctor.
iii) Other precautions
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Studies in laboratory animals have not produced any evidence of teratogenic effects. The safety of amprolium has not been investigated in laying birds.
Use only according to the risk benefit assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
Amprolium is a thiamine analogue. Therefore, the efficacy of amprolium may be reduced during the simultaneous administration of products containing vitamin B complex.
4.9 Amount(s) to be administered and administration route
For oral administration via drinking water.
The target dose is 20 mg amprolium per kg bodyweight per day (approximately equivalent to 2ml of product per 10 kg bodyweight) for 5 to 7 days. Dilute into drinking water based on the animals’ water consumption requirements over a 24 hour period to obtain the correct dosage (mg/kg).
Gentle mixing is required. Renew medicated water every 24 hours. No other source of drinking water should be available during the medication period.
The medicinal product should not be used in contact with metal pipework or containers.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The adverse effects of amprolium at high doses are caused by thiamine deficiency. Such deficiency can be compensated for by increasing thiamine intake.
Prolonged use can cause thiamine deficiencies. Should symptoms appear, thiamine should be supplemented.
4.11 Withdrawal period(s)
Chickens (broilers, pullets, layers, breeder hens)
Meat and offal: Zero days
Eggs: Zero days
Meat and Offal: Zero Days
5. PHARMACOLOGICAL PROPERTIES
Antiparasitic products, other antiprotozoal agents
ATC Vet Code:
5.1 Pharmacodynamic properties
Amprolium hydrochloride is a coccidiostat belonging to the thiamine (Vitamin B1) analogue group. It acts as a competitive antagonist of thiamine transport mechanisms
Amprolium affects coccidia by competing with thiamine in their metabolic enzyme system, thus interfering with metabolism of carbohydrates necessary for multiplication or survival of coccidia
5.2 Pharmacokinetic properties
Amprolium is poorly absorbed after oral administration. Plasma concentration reaches its maximum after 4 hours.
5.3 Environmental properties
Amprolium is persistent in soil.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbic acid (E 200)
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 12 weeks
Shelf life after dilution according to directions: 24 hours
6.4 Special precautions for storage
Medicated drinking water should be replaced every 24 hours
6.5 Nature and composition of immediate packaging
High density polyethylene bottles of 1 litre and 5 litre, closed with a polyethylene screw cap with integral heat seal liner
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Pharmsure International Ltd
Unit 28, Moorlands Trading Estate
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT
14 June 2016
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