Willcain Solution For Injection
Revised: 11 June 2008
AN: 02100/2007
SUMMARY OF PRODUCT CHARACTERISTICS
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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Willcain Solution for Injection |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Active substancesQualitative composition Procaine hydrochloride Epinephrine bitartrate (equivalent to Epinephrine 0.002 % w/v) ExcipientsChlorocresol Sodium metabisulphate For a full list of excipients, see section 6.1. |
Quantitative composition 5.0 % w/v 0.0036 % w/v 0.1 0.1 |
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3. |
PHARMACEUTICAL FORM |
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Solution for injection. A clean, bright, colourless mobile solution for injection. |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Horses, cattle, cats and dogs. |
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4.2 |
Indications for use, specifying the target species |
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For use as a local anaesthetic, by field block or perineural administration, in minor surgical procedures including dehorning and disbudding in cattle. |
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4.3 |
Contraindications |
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Do not administer by intravenous, intra-articular or epidural injection. |
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4.4 |
Special warnings for each target species |
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Use with caution in horses due to risk of coat colour at injection site turning permanently white. |
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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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Care should be taken not to inject the drug into a vein. Vasoconstrictors should be used with caution in lower limb blocks due to the risk of digital ischaemia. |
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ii. |
Special precautions for the person administering the veterinary medicinal product to animals |
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Take care to avoid accidental self-injection. In the event of accidental self-injection, seek medical attention and show the label to the physician. Immediately wash off any splashes to the eyes or skin with copious amounts of water. Seek medical attention if irritation occurs. 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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Nil. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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Procaine may inhibit the action of sulphonamides and their concurrent administration should be avoided. |
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4.9 |
Amounts to be administered and administration route |
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By subcutaneous injection: Cats and dogs 0.25 - 1.0 ml Cattle and horses 2.0 - 5.0 ml Do not exceed the recommended dosage. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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None known. |
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4.11 |
Withdrawal period(s) |
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Cattle: Meat: zero days Milk: zero hours Horses: Meat: zero days |
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5. |
PHARMACOLOGICAL PROPERTIES |
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Pharmacotherapeutic group: |
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Procaine, combinations. |
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ATC Vet Code: |
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QN01BA52 |
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5.1 |
Pharmacodynamic properties |
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Procaine hydrochloride is a local anaesthetic. |
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5.2 |
Pharmacokinetic properties |
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The in-vitro half-life in plasma is less than 1 minute. It is only slightly bound to plasma protein (5.8 %) and has a duration of anaesthetic effect of about 50 minutes in man. The addition of adrenaline to procaine causes a prolongation of local effect by vasoconstriction. The longer action is accompanied by a significant decrease in systemic toxicity, since the rate of hydrolysis exceeds the rate of absorption into the systemic circulation. The recommended level of adrenaline is 1 in 50,000; higher concentrations may cause tissue damage. |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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Chlorocresol Sodium metabisulphite Sodium chloride Water for injection |
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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. Shelf life after first opening the immediate packaging: 28 days. |
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6.4 |
Special precautions for storage |
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Do not store above 25°C. Protect from light. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. |
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6.5 |
Nature and composition of immediate packaging |
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100 ml type I amber glass multidose vial, fitted with a red chlorobutyl bung, with an aluminium overseal. |
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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 |
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10434/4046 |
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9. |
DATE OF FIRST AUTHORISATION |
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26/07/1994 |
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10. |
DATE OF REVISION OF THE TEXT |
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11 June 2008 |
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