Summary of Product Characteristics s13

Revised: June 2010 ATC Vet Code Amended

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Monzaldon 100 mg/ml Solution for Injection.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance Vetrabutine hydrochloride 100mg/ml

Excipients Phenol 5mg/ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection. Clear solution.

4. CLINICAL PARTICULARS

4.1 Target species

Sows and bitches.

4.2 Indications for use

A specific uterine relaxant and musculotropic stimulator for sows and bitches only. Vetrabutine dilates the soft birth canal and co-ordinates uterine contractions to ease and shorten parturition. The product may be useful in cases of dystocia where there is insufficient relaxation of the birth canal.

4.3 Contraindications

Not recommended by intravenous route Do not use in cats

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

None known.

i. Special precautions for use in animals

None known.

of 4 Revised: June 2010 ATC Vet Code Amended

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

Pregnant women and women of child bearing age should exercise great care when administering the product to avoid the danger of accidental self inoculation.

If accidental self-injection occurs, seek medical advice and show a copy of the label/package leaflet to the doctor.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Only recommended for use around the time of parturition.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

A single intramuscular injection. In bitches the dose can be repeated at 30-60 minute intervals for up to three times.

Sows 2-4 ml i.e. approximately 2.0 mg/kg bodyweight Bitches 0.25-1 ml i.e. approximately 2.0 mg/kg bodyweight

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

No treatment specified.

4.11 Withdrawal period(s)

Animals must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 28 days from the last treatment.

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code : QG02CA90

Pharmacotherapeutic Group: Other gynecologicals, Sympathominmetics, labour repressants

of 4 Revised: June 2010 ATC Vet Code Amended 5.1 Pharmacodynamic properties

Vetrabutine is a chemical derivative of papaverine. It exerts a specific relaxant or antispasmodic action on the uterus. .

5.2 Pharmacokinetic particulars

Experiments with in situ rat uterus have demonstrated that Monzaldon produces a strong and sustained decrease of muscular tone and regulates and increases the amplitude of the contractions.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Phenol Water for Injections

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years Shelf life of the veterinary medicinal product once opened : 28 days

6.4 Special Precautions for Storage

Discard any unused material. Avoid the introduction of contamination during use. Should any apparent growth or discoloration occur, the product should be discarded. Following withdrawal of the first dose, use the product within 28 days.

6.5 Nature and composition of immediate packaging

Amber glass (type II) vial containing 50 ml of the product, sealed by a grey bromobutyl rubber bung secured 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

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

of 4 Revised: June 2010 ATC Vet Code Amended 7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Ltd, Ellesfield Avenue Bracknell, Berks, RG12 8YS

8. MARKETING AUTHORISATION NUMBER(S)

Vm 00015/4043

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation : 16 July 1996 Date of renewal of the authorisation : 21 December 2006

10. DATE OF REVISION OF THE TEXT

June 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable