Medine.co.uk

Beaphar Worming Syrup, 9.4% W/V, Oral Solution

Revised: 08 June 2010

AN: 00311/2010

SUMMARY OF PRODUCT CHARACTERISTICS


1. Name of the Veterinary Medicinal Product


Beaphar Worming Syrup, 9.4% w/v, oral solution.


2. Qualitative and Quantitative Composition

Active substance % w/v

Piperazine Citrate 9.4


Excipients

Methyl Parahydroxybenzoate 0.040% w/v

Ethyl Parahydroxybenzoate 0.010% w/v

Propyl Parahydroxybenzoate 0.005% w/v

Butyl Parahydroxybenzoate 0.015% w/v

For full list of excipients, see section 6.1


3. Pharmaceutical form


Oral solution.

Bright reddish brown, clear solution.


4. Clinical Particulars


4.1 Target species


Dogs and cats.


4.2 Indications for use, specifying the target species


For the treatment of roundworms (Ascarids) in puppies and kittens.


4.3 Contra-indications


Do not exceed stated dose.

Do not repeat treatment if vomiting occurs shortly after dosing.

4.4 Special warnings for each target species


Consult a veterinary surgeon before treating pregnant animals, or those with a history of epilepsy or severe renal disfunction.


4.5 Special precautions for use


i. Special precautions for use in animals


Do not exceed the recommended dosage.


ii. Special precautions to be taken by the person administering the medicinal product to animals


Following accidental skin or eye contact, wash the affected area with plenty of water. If irritation persists, seek medical advice.

Following accidental ingestion, drink plenty of water and seek medical attention.

Wash hands after use.


4.6 Adverse reactions (frequency and seriousness)


Overdosage (see section 4.10).


4.7 Use during pregnancy, lactation or lay


Consult a veterinary surgeon before treating pregnant animals.

Nursing female animals should be treated 2 weeks after giving birth and every two weeks at the same time as the puppies or kittens until weaning.


4.8 Interaction with other medicinal products and other forms of interaction


None known.


4.9 Amounts to be administered and administration route


For oral administration.

Administer directly into the corner of the mouth, or mixed with a little food. The rest of the meal should be offered afterwards to ensure all the syrup is taken.

Shake the bottle and prime dispenser before use by slowly depressing the plunger repeatedly, up to 5 times.


Animal Weight/kg Number of pumps

Up to 0.9 1 (1.1 ml)

0.91 - 1.8 2 (2.2 ml)

1.81 - 2.7 3 (3.3 ml)

2.71 - 3.6 4 (4.4 ml)

3.61 - 4.5 5 (5.5 ml)

4.51 - 5.4 6 (6.6 ml)


For every additional 0.9 kg bodyweight, an extra single pump volume should be administered.


Puppies and kittens should be treated for roundworms at 2 weeks of age.

They should be re-treated at 4, 6, 8, 10 and 12 weeks of age, and thereafter at 2 to 3 monthly intervals.


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


Symptoms: Vomiting and diarrhoea, depression, ataxia, muscle weakness, and fits.


Emergency Procedures: Consult a veterinary surgeon.

Treat symptomatically and supportively.

Keep animal warm and calm.

Symptoms reverse in 24 - 48 hours.


4.11 Withdrawal period(s)

Not applicable


5. Pharmacological properties


ATCvet code:QP52AH01


5.1 Pharmacodynamic properties


Worms are killed in the gastro-intestinal tract and may be expelled in the faeces or digested in their passage through the tract.


5.2 Pharmacokinetic particulars


None given.


6. Pharmaceutical particulars


6.1 List of excipients


Methyl Parahydroxybenzoate

Ethyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Butyl Parahydroxybenzoate

Sorbitol Solution 70% w/w (Non-Crystallising)

Imitation Chocolate Flavour 1470

Caramel T6

Water Deionised

6.2 Incompatibilities


None known.


6.3 Shelf life


Shelf life of the veterinary medicinal product as packaged for sale:3 years.


6.4 Special precautions for storage


Do not store above 25°C.


6.5 Nature and composition of immediate packaging


Size: 45 ml

Container: Round, amber Type III glass bottle.

Closure: White, tamper-evident polypropylene cap (screw fit) with low-density polyethylene liner.

Dosing device: Pump dispenser nominally delivering 1.1 ml per stroke

Use Orientation: Upright


6.6 Special precautions for the disposal of unused veterinary medicinal products 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


Beaphar UK Ltd.

Homefield Road

Haverhill

Suffolk

CB9 8QP

8. Marketing authorisation number


Vm13907/4008


9. Date of first authorisation/renewal of the authorisation


Date of first authorisation: 21 September 1994


10. Date of revision of the text


June 2010


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