Equitape contra-indications, dosage, administration and pharmaceutical strengths

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SUMMARY OF PRODUCT CHARACTERISTICS

 

1.         NAME OF THE VETERINARY MEDICINAL PRODUCT

 

Droncit 9% Oral Gel for Horses                    [AT, DE, PT]

Droncit vet oral gel (for horses)                    [DK, FI, IS, NO, SE]

Equitape 90 mg/g Oral Gel for Horses        [IE, UK]

Droncit 9% Gel Oral Cheval                         [FR]

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Active substance

               Praziquantel                                                             90.0 mg

Excipients

               Propyl Parahydroxybenzoate (E 216)                    0.2 mg

               Methyl Parahydroxybenzoate (E 218)                    1.4 mg

Excipients ad                                                                            1.0 g

For a full list of excipients, see section 6.1

 

3.         PHARMACEUTICAL FORM

 

Oral Gel

White  soft gel

 

4.         CLINICAL PARTICULARS

 

4.1.    Target species

 

Horse

 

4.2.    Indications for use, specifying the target species

 

Treatment of infections with cestodes of the species Anoplocephala perfoliata, sensitive to praziquantel.

 

4.3.    Contraindications

 

None known

Milk: see  section  4.11

(Do not use in mares from which milk is taken for human consumption)

 

4.4.    Special warnings for each target species

 

As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is not considered necessary.

In order to limit excretion of the product and its metabolites on the pasture horses should remain stabled for 2 days after treatment.

Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

 

MRLs for milk have not been established

See section 4.11 Withdrawal periods

 

4.5.    Special precautions for use

 

  1. Special precautions for use in animals

 

None.

 

  1. Special precautions to be taken by the person administering the medicinal products to animals

 

Wash hands thoroughly after treating animals.

Any spillage of the product onto human skin should be removed by washing with soap and water.

Do not eat, drink or smoke during application

 

4.6.    Adverse reactions (frequency and seriousness)

 

In case of very high infestation levels, destruction of the tapeworms may cause a mild transient colic and loose faeces in the treated horse.

 

4.7.    Use during pregnancy, lactation or lay

 

The studies conducted in laboratory animals (rat, rabbit) have revealed no evidence of teratogenic, embryotoxic or maternotoxic effects following administration of praziquantel at therapeutic doses. The safety of the veterinary medicinal product following administration to mares during gestation and lactation has not been studied. The product should only be used in mares during pregnancy and lactation after assessment of the benefit/risk balance by the veterinarian.

 

4.8.    Interaction with other medicinal products and other forms of interaction

 

None known.

In the absence of compatibility studies this veterinary product must not be mixed with other medicinal products.

 

4.9.    Amount to be administered and administration route

 

Dosage

The recommended dose rate is 1 mg Praziquantel/kg body weight. This corresponds to 6.67 g gel per 600 kg bw.

 

Administration and duration of treatment

Oral use.

The gel is administered using a measured dose applicator, each graduation of which is marked out to deliver the dose required to treat 50 kg bodyweight

 

Single treatment only.

 

 

4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary

 

No adverse effects were reported after the administration of the product for 3 consecutive days up to 5 times the recommended dose.

 

4.11. Withdrawal periods

 

Edible tissues: Zero days

Milk: Do not use in mares from which milk is taken for human consumption

 

5.         PHARMACOLOGICAL PROPERTIES

 

Pharmacotherapeutic group: Anthelmintics

ATCVet Code: QP52AA01

 

5.1.    Pharmacodynamic properties

 

Praziquantel, a pyrazinoisoquinoline derivative, is used as an anthelmintic in various animal species.

Praziquantel is very rapidly absorbed via the surface of the parasites and evenly distributed in the parasite. Severe damage to the parasite integument occurs very rapidly in vitro and in vivo, resulting in contraction and paralysis of the parasites. The basis for this rapid onset of action is, in particular, the change in Ca++ permeability of the parasite membranes triggered by praziquantel and the resulting disruption of the parasite metabolism.

 

5.2.    Pharmacokinetic particulars

 

Praziquantel is absorbed very rapidly and almost completely in the stomach and small intestine following oral administration in horses. Maximum serum levels are already reached within the first hour post application. Praziquantel is very rapidly distributed into all organs. The elimination half-live of 14C-praziquantel and its metabolites is 5 hours in horses. Praziquantel is rapidly metabolised in the liver. The main metabolite occurring is the 4-hydroxycyclohexyl derivative of praziquantel. In horses, 24 h after administration, approximately 31 % of the administered dose was eliminated via urine and approximately 24% of the dose was eliminated via faeces.

 

6.         PHARMACEUTICAL PARTICULARS

 

  1. List of excipients

 

Propyl Parahydroxybenzoate (E 216)

Methyl Parahydroxybenzoate (E 218)

Glycerol

Carbomer

Sodium hydroxide

Purified water

 

 

  1. Incompatibilities

 

In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

 

  1. Shelf-life

 

2 years

Shelf life after first opening the container: discard after first opening.

  

  1. Special precautions for storage

 

No special precautions for storage

 

  1. Nature and composition of immediate packaging

 

6.67 g of 9% gel

High density polyethylene syringe with cap made of high density polyethylene and plastic plunger made of polystyrol with arreting ring.

 

Presentations to be marketed

Box with one graduated applicator containing 6.67 g gel

 

  1. Special precautions for the disposal of unused veterinary medicinal product or  waste materials derived from the use of such products, if appropriate

 

Any unused product or waste material should be disposed of in accordance with the national requirements.

7.         MARKETING AUTHORISATION HOLDER

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

 

8.         MARKETING AUTHORISATION NUMBER

Vm: 00010/4118

 

9.         DATE OF FIRST AUTHORISATION

Date: 31 January 2002

 

10.      DATE OF REVISION OF THE TEXT

Date: May 2014