<p> Revised: June 2010 ATC Vet Code Amended</p><p>SUMMARY OF PRODUCT CHARACTERISTICS</p><p>1. NAME OF THE VETERINARY MEDICINAL PRODUCT</p><p>Monzaldon 100 mg/ml Solution for Injection.</p><p>2. QUALITATIVE AND QUANTITATIVE COMPOSITION</p><p>Active substance Vetrabutine hydrochloride 100mg/ml</p><p>Excipients Phenol 5mg/ml</p><p>For a full list of excipients, see section 6.1.</p><p>3. PHARMACEUTICAL FORM</p><p>Solution for injection. Clear solution.</p><p>4. CLINICAL PARTICULARS</p><p>4.1 Target species</p><p>Sows and bitches.</p><p>4.2 Indications for use</p><p>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.</p><p>4.3 Contraindications</p><p>Not recommended by intravenous route Do not use in cats</p><p>4.4 Special warnings for each target species</p><p>None known.</p><p>4.5 Special precautions for use</p><p>None known.</p><p> i. Special precautions for use in animals</p><p>None known.</p><p>Page 1 of 4 Revised: June 2010 ATC Vet Code Amended</p><p> ii Special precautions to be taken by the person administering the veterinary medicinal product to animals</p><p>Pregnant women and women of child bearing age should exercise great care when administering the product to avoid the danger of accidental self inoculation. </p><p>If accidental self-injection occurs, seek medical advice and show a copy of the label/package leaflet to the doctor.</p><p>4.6 Adverse reactions (frequency and seriousness)</p><p>None known.</p><p>4.7 Use during pregnancy, lactation or lay</p><p>Only recommended for use around the time of parturition.</p><p>4.8 Interaction with other medicinal products and other forms of interaction</p><p>None known.</p><p>4.9 Amounts to be administered and administration route</p><p>A single intramuscular injection. In bitches the dose can be repeated at 30-60 minute intervals for up to three times.</p><p>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</p><p>4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary</p><p>No treatment specified.</p><p>4.11 Withdrawal period(s)</p><p>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. </p><p>5. PHARMACOLOGICAL PROPERTIES</p><p>ATC Vet Code : QG02CA90</p><p>Pharmacotherapeutic Group: Other gynecologicals, Sympathominmetics, labour repressants</p><p>Page 2 of 4 Revised: June 2010 ATC Vet Code Amended 5.1 Pharmacodynamic properties</p><p>Vetrabutine is a chemical derivative of papaverine. It exerts a specific relaxant or antispasmodic action on the uterus. .</p><p>5.2 Pharmacokinetic particulars</p><p>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.</p><p>6. PHARMACEUTICAL PARTICULARS</p><p>6.1 List of excipients</p><p>Phenol Water for Injections</p><p>6.2 Incompatibilities</p><p>None known.</p><p>6.3 Shelf life</p><p>Shelf life of the veterinary medicinal product as packaged for sale: 5 years Shelf life of the veterinary medicinal product once opened : 28 days</p><p>6.4 Special Precautions for Storage</p><p>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.</p><p>6.5 Nature and composition of immediate packaging</p><p>Amber glass (type II) vial containing 50 ml of the product, sealed by a grey bromobutyl rubber bung secured with an aluminium overseal. </p><p>6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products</p><p>Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.</p><p>Page 3 of 4 Revised: June 2010 ATC Vet Code Amended 7. MARKETING AUTHORISATION HOLDER</p><p>Boehringer Ingelheim Ltd, Ellesfield Avenue Bracknell, Berks, RG12 8YS</p><p>8. MARKETING AUTHORISATION NUMBER(S)</p><p>Vm 00015/4043</p><p>9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION</p><p>Date of first authorisation : 16 July 1996 Date of renewal of the authorisation : 21 December 2006</p><p>10. DATE OF REVISION OF THE TEXT</p><p>June 2010</p><p>PROHIBITION OF SALE, SUPPLY AND/OR USE</p><p>Not applicable</p><p>Page 4 of 4</p>