Forketos Oral Solution For Cattle And Sheep
Revised: 25 June 2008
AN: 02094/2007
SUMMARY OF PRODUCT CHARACTERISTICS
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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Forketos Oral Solution for Cattle and Sheep |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Active substancesQualitative composition Propylene glycol Cobalt sulphate heptahydrate (Equivalent to 0.21 mg/ml elemental cobalt) ExcipientsFor a full list of excipients, see section 6.1. |
Quantitative composition 80 % v/v 0.1 % w/v |
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3. |
PHARMACEUTICAL FORM |
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Oral solution. A clean, bright, pale pink, odourless solution. |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Cattle and sheep. |
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4.2 |
Indications for use, specifying the target species |
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As an aid in the treatment of acetonaemia (ketosis) in cattle and pregnancy toxaemia in sheep. |
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4.3 |
Contraindications |
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None known. |
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4.4 |
Special warnings for each target species |
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No special warnings. |
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4.5 |
Special precautions for use |
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i. |
Special precautions for use in animals |
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None known. |
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ii. |
Special precautions for the person administering the veterinary medicinal product to animals |
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In case of accidental eye contact, wash eyes with plenty of clean water. If irritation occurs, seek medical attention. In case of contact with skin, remove any contaminated clothing and wash affected area thoroughly with soap and water. If irritation occurs seek medical advice. Wash hands after use. |
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4.6 |
Adverse reactions (frequency and seriousness) |
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None known. |
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4.7 |
Use during pregnancy, lactation or lay |
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No special precautions. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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None known. |
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4.9 |
Amount(s) to be administered and administration route |
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To be administered orally as a drench. Cattle: 150 - 200 ml twice daily for 3 - 4 days. Sheep: 2 ml/kg bodyweight up to a maximum of 120 ml. This dose may be repeated 7 - 8 hours later if necessary. Do not exceed stated dose. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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Propylene glycol toxicity can result in incoordination and narcosis. Signs of cobalt overdose are loss of weight, anorexia and muscular incoordination. |
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4.11 |
Withdrawal period(s) |
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Meat: zero days Milk: zero hours |
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5. |
PHARMACOLOGICAL PROPERTIES |
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Pharmacotherapeutic group: |
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Drugs for treatment of acetonaemia. |
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ATC Vet Code: |
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QA16QA01 |
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5.1 |
Pharmacodynamic properties |
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Propylene glycol is a glucose precursor. Cobalt is an essential trace element. |
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5.2 |
Pharmacokinetic properties |
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Propylene glycol is metabolised and excreted rapidly. Cobalt is converted in the rumen to Vitamin B12 by bacterial flora. |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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Water, purified |
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6.2 |
Incompatibilities |
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None known. |
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6.3 |
Shelf life |
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Shelf life of the veterinary medicinal product as packaged for sale: 3 years. |
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6.4 |
Special precautions for storage |
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Do not store above 25°C Protect from light. Protect from frost. |
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6.5 |
Nature and composition of immediate packaging |
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1 litre and 25 litre high density polyethylene bottles with a high density polyethylene cap (screw fit). Not all pack sizes may be marketed. |
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6.6 |
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate |
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Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. |
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7. |
MARKETING AUTHORISATION HOLDER |
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Dechra Limited Dechra House Jamage Industrial Estate Talke Pits Stoke-on-Trent Staffordshire ST7 1XW |
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8. |
MARKETING AUTHORISATION NUMBER(S) |
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10434/4036 |
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9. |
DATE OF FIRST AUTHORISATION |
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09/06/1993 |
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10. |
DATE OF REVISION OF THE TEXT |
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25 June 2008 |
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