Document: Zerofen vet. oral powder ENG SmPC change

• Zerofen vet, oral powder SmPC
• Zerofen vet. oral powder ENG SmPC

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Summary of the Product Characteristics

Zerofen vet. 4% Oral Powder for Swine

Active substance(s)

1g contains:

Fenbendazole 40 mg

Excipient(s)

Lactose monohydrate 960 mg

Oral powder

A white to off-white powder

4 Clinical Particulars

4.1 Target species

Pigs from the age of weaning

4.2 Indications for use, specifying the target species

The product is a broad spectrum anthelmintic for the treatment of pigs infected with nematodes of the gastro-intestinal tract:

Red stomach worms: Hyostrongylus rubidus (mature and immature forms)

Nodular worms: Oesophagostomum spp. (mature and immature forms)

Eel worms: Ascaris suum (mature forms)

4.3 Contraindications

None known.

4.4 Special Warnings

• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

• Underdosing, which may be 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”.

4.5 Special precaution(s) for use

Special precautions for use in animals

Intolerance to lactose is seen in animals who lack the intestinal enzyme lactase, which can lead to diarrhoea, abdominal discomfort, distension and flatulence.

The frequent and repeated use of benzimidazoles can develop resistances.

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

Because of possible sensitisation and contact dermatitis, direct skin contact and inhalation should be avoided. When handling, suitable protective equipment such as rubber gloves and filtering masks should be used. Hands should be washed after handling the finished feed. Product is harmful if swallowed.

4.6 Adverse reactions (frequency and seriousness)

See Section 4.5.

4.7 Use during pregnancy, lactation or lay

Since benzimidazoles may possess embryotoxic effects restrictive use in the first stage of pregnancy is recommended.

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

None known.

4.9 Amounts to be administered and administration route

The product should be administered orally, mixed with feed.

The normal dose rate is 5 mg of fenbendazole per kg bodyweight, given as a single dose, which corresponds to 1.2 g of powder per 10 kg of bodyweight.

Calibrated scales should be used in order to weigh accurate dosing amounts.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

For use in individual pigs on farms where only a small number of pigs are to receive the medicine.

The product should be mixed thoroughly to achieve a homogenous and stable mixture.

It has to be ensured that the calculated dose is completely taken up by the animals. Consideration must be given to pigs whose daily feed intake is reduced or restricted.

The product is not intended for medicated feed manufacturing. It should not be administered in the drinking water.

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

No known risks.

4.11 Withdrawal period(s)

Meat and offal: 3 days.

Pharmacotherapeutic group: Anthelmintic. ATCvet-code: QP52AC13

5.1 Pharmacodynamic Properties:

The product is a broad spectrum anthelmintic for the treatment of pigs infected with mature and immature forms of nematodes of the gastro-intestinal and respiratory tracts. It has an ovicidal effect in some genera of parasites. The active substance in the product is fenbendazole, which belongs to the group of benzimidazoles. Fenbendazole is a white, tasteless powder without smell, which is insoluble in water and insoluble or difficult to dissolve in conventional solvents. Fenbendazole has a broad safety margin and can be given to young animals.

The anthelmintic effect of fenbendazole is exercised by inhibition of the glucose uptake, as it binds to nematode tubulin, a protein necessary for the formation and viability of microtubules. This occurs primarily in the intestinal cells of the nematode, which leads to a ceased absorption of nutrients, especially glycogen, resulting in starvation of the parasite.

Structural differences have been showed to exist between tubulin from mammalian respectively helmintic sources. This explains why fenbendazole is toxic for the parasite but not for the host.

5.2 Pharmacokinetic Properties:

Fenbendazole exerts its main effect in the gastro-intestinal tract. Only approximately 30% of the dose is absorbed in pigs. After a dose of 5mg/kg bodyweight, maximal plasma concentration is achieved in 4.5-10 hours. Elimination half-life in plasma is approximately 10 hours in pigs. Elimination of fenbendazole takes place by >50% via faeces and by 30% via urine.

6 Pharmaceutical Particulars

Lactose Monohydrate

Not applicable.

4 years.

6.4 Special precautions for storage

Keep the container tightly closed. Keep in the original container.

6.5 Nature and composition of immediate packaging

The product is presented in pack sizes of 500 g, 1 kg, 2.5 kg, 5 kg and 10 kg, packed into LDPE bags in polypropylene containers.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal products or waste materials derived from such medicinal products should be disposed of in accordance with local requirements.

7. Marketing Authorization Holder

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

15111

9. Date of First Authorization/Renewal of the Authorization

2000-11-17/2005-11-17

24/04/2014

Prohibition of Sale, Supply and/or Use

Not applicable.