1. NAME OF THE VETERINARY MEDICINAL PRODUCT PGF Veyx forte 0.250 mg/ml solution for injection for cattle and pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: Active substance: Cloprostenol 0.250 mg (corresponding to 0.263 mg cloprostenol sodium) Excipients: Chlorocresol 1.0 mg For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution.
4. CLINICAL PARTICULARS
4.1 Target species Cattle (heifers, cows) and pigs (sows)
4.2 Indications for use, specifying the target species Cattle (heifers, cows): To schedule the time of oestrous and ovulation and for cycle synchronization in animals with an ovulatory cycle when applied during the diestrus (induction of oestrus in non-detected oestrus, synchronisation of oestrus) Anoestrus and uterine disorders caused by a progesterone-induced oestrous cycle blockade (induction of oestro

us in anoestrus, endometritis, pyometra, corpus luteal cysts, follicular luteal cysts, shortening of the sexual rest period) Induction of abortion up to day 150 of pregnancy Mummified foetuses Induction of parturition Pigs (sows): Induction or synchronisation of farrowing from day 114 of pregnancy onwards (day 1 of pregnancy is the last day of insemination). 4.3 Contraindications Do not use for intravenous administration Do not use in pregnant animals where the induction of abortion or parturition is not intended Do not use in case of spastic diseases of the respiratory tract and gastrointestinal tract BVL-2401539 DE/V/0146/002/DC x 152 SPC PGF Veyx forte Version 04 HB 04/2012
4.4 Special warnings for each target species None
4.5 Special precautions for use Special precautions for use in animals To reduce the risk of anaerobic infections care should be taken to avoid injection through contaminated areas of skin. Clean and disinfect injection sites thoroughly before application. Pigs: Use only if the cover dates are known. Too early an administration could adversely affect the viability of the piglets. This is the case when the injection is given more than 2 days before the average gestation period of the stock. Day 1 of pregnancy is the last day of insemination. The gestation period is generally 111-119 days. Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product must be handled carefully to avoid accidental self-injection or contact with the skin or mucous membranes of the user.

 Prostaglandins of the F2α type may be absorbed through the skin and may cause bronchospasm or miscarriage.

 Pregnant women, women in childbearing age, asthmatics and people with other respiratory tract diseases should wear waterproof gloves during administration of the product.

 Accidental spillage on the skin should be washed off immediately with soap and water.

 In case of accidental self-injection, seek medical advice and show the package leaf-let to the doctor. Should respiratory distress result from accidental inhalation or injection, a rapid acting bronchodilator, e.g. isoprenaline or salbutamol by inhalation is indicated.

4.6 Adverse reactions (frequency and seriousness) Anaerobic infections may occur if anaerobic bacteria are introduced into the tissue by the injection, in particular following intramuscular injection. Cattle: When used for induction of parturition, the incidence of retained placenta may be increased depending on the time of treatment. Pigs: The abnormal behaviour that might occur in pigs immediately after treatment, when the drug has been used to induce parturition, is similar to that of sows before normal birth and normally subsides within one hour.
4.7 Use during pregnancy, lactation or lay Do not use in pregnant animals when abortion or induction of parturition is not intended. Safety of the product has not been established during lactation.
4.8 Interaction with other medicinal products and other forms of interaction Concurrent use of oxytocin and Cloprostenol increases the effects on the uterus.
4.9 Amounts to be administered and administration route BVL-2401539 DE/V/0146/002/DC x 153 SPC PGF Veyx forte Version 04 HB 04/2012 For intramuscular injection in cattle (heifers, cows). For deep intramuscular injection in pigs (sows) (with a needle at least 4 cm long). Cattle (heifers, cows): 0.5 mg Cloprostenol/animal corresponding to 2.0 ml PGF Veyx forte/animal In order to synchronise oestrus in a cattle herd, it is recommended that the product is administered on two occasions with an 11-day interval between treatments. Pigs (sows): 0.175 mg Cloprostenol/animal corresponding to 0.7 ml PGF Veyx forte/animal Use automatic syringe equipment for the 50 ml vials. Single administration. The rubber stopper of the vial may be safely punctured up to 25 times. Otherwise, automatic syringe equipment, or a suitable draw-off needle, should be used for the 50 ml vials to avoid excessive puncturing of the closure. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In case of overdose the following symptoms may occur: Increased heart rate, increased respiratory rate, bronchoconstriction, increased rectal temperature, increased defecation and urination, salivation, nausea and vomiting. No antidotes are available.
4.11 Withdrawal period(s) Cattle, pigs (meat and offal): 2 days Cattle (milk): zero hours
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties Pharmacotherapeutic group: prostaglandin-F2α -agonist ATCvet code: QG02AD90 Cloprostenol belongs to the group of prostaglandin-F2α-agonists, which exert a luteolytic effect dependent on species and time of treatment. Furthermore, this group of substances has a contractile effect on the smooth muscles (uterus, gastro-intestinal tract, respiratory tract, vascular system). Treatment during diestrus or in the case of persistent corpus luteum causes luteolysis. The associated removal of the negative feed-back mechanism induced by progesterone leads in animals with cyclic ovarian function to a premature onset of heat and ovulation. Cloprostenol produces a 200- to 400-fold luteolytic effect compared to prostaglandin-F2α; however, the effect on the smooth muscles appears to be equally strong.
5.2 Pharmacokinetic particulars Peak plasma concentrations were observed within 15 minutes to 2 hours after intramuscular injection of Cloprostenol in cattle and pigs. The subsequent rapid elimination phase is characterised by a half-life from 1 to 3 hours, with a subsequent phase of slow elimination over a period of up to 48 hours, with a half-life of 28 hours. BVL-2401539 DE/V/0146/002/DC x 154 SPC PGF Veyx forte Version 04 HB 04/2012 Cloprostenol is distributed evenly throughout the tissues. Excretion via the faeces and urine is virtually equal. Less than 0.4% of the applied dose in cattle is eliminated via the milk. Maximum concentrations are measured approx. 4 hours post application.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients Chlorocresol Citric acid monohydrate Sodium chloride Sodium hydroxide (for pH-adjustment) Sodium citrate Water for injections
6.2 Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 2 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. Keep the vial in the outer carton.
6.5 Nature and composition of immediate packaging Vial of colourless glass, type I, with a fluorinated bromobutyl stopper and an aluminium cap; 1 vial (10 ml) in a cardboard box. 1 vial (20 ml) in a cardboard box. 1 vial (50 ml) in a cardboard box. Not all pack sizes may be marketed. 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 materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. BVL-2401539 DE/V/0146/002/DC x 155 SPC PGF Veyx forte Version 04 HB 04/2012 7. MARKETING AUTHORISATION HOLDER Veyx-Pharma GmbH Söhreweg 6 34639 Schwarzenborn Germany
8. MARKETING AUTHORISATION NUMBER(S) …………………………………..
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION …………………………………..
10. DATE OF REVISION OF THE TEXT ………………………………….. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.