SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Willcain Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances

Qualitative composition Quantitative composition

Procaine hydrochloride 5.0 % w/v

Epinephrine bitartrate 0.0036 % w/v

(equivalent to Epinephrine 0.002 % w/v)

Excipients 0.1

Chlorocresol 0.1

Sodium metabisulphate

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

A clean, bright, colourless mobile solution for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Horses, cattle, cats and dogs.

4.2 Indications for use, specifying the target species

For use as a local anaesthetic, by field block or perineural administration, in minor surgical procedures including dehorning and disbudding in cattle.

4.3 Contraindications

Do not administer by intravenous, intra-articular or epidural injection.

4.4 Special warnings for each target species

Use with caution in horses due to risk of coat colour at injection site turning permanently white.

4.5 Special precautions for use

i. Special precautions for use in animals

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.

ii. Special precautions for the person administering the veterinary medicinal product to animals

Take care to avoid accidental self-injection. In the event of accidental selfinjection, 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.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Nil.

4.8 Interaction with other medicinal products and other forms of interaction

Procaine may inhibit the action of sulphonamides and their concurrent administration should be avoided.

4.9 Amounts to be administered and administration route

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.

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

None known.

4.11 Withdrawal period(s)

Cattle: Meat: zero days Milk: zero hours

Horses: Meat: zero days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Procaine, combinations.

ATC Vet Code:

QN01BA52

5.1 Pharmacodynamic properties

Procaine hydrochloride is a local anaesthetic.

5.2 Pharmacokinetic properties

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorocresol

Sodium metabisulphite

Sodium chloride

Water for injection

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Do not store above 25°C.

Protect from light.

Following withdrawal of the first dose, use the product within 28 days.

Discard unused material.

6.5 Nature and composition of immediate packaging

100 ml type I amber glass multidose vial, fitted with a red chlorobutyl bung, with an aluminium overseal.

6.6 Special precautions for the disposal of unused veterinary medicinal product 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

Alfasan Nederland B.V.

Kuipersweg 9

3449 JA Woerden The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 36408/4014

9. DATE OF FIRST AUTHORISATION

26 July 1994

10. DATE OF REVISION OF THE TEXT

August 2021

Approved: 18/08/21