Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

PGF Veyx 0.0875 mg/ml Solution for Injection for Cattle and Pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml solution for injection contains:

Active substance:

Cloprostenol 0.0875 mg (corresponding to 0.092 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):

• Induction of abortion up to day 150 of pregnancy

• Mummified foetuses

• Induction of parturition

Pigs (sows):

4.3 Contraindications

4.4 Special warnings for each target species

None

4.5 Special precautions for use

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.

• 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. In very rare cases, anaphylactic-type reactions can be observed which might be life threatening and require rapid medical care.

Pigs:

The abnormalbehaviour 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

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 5.7 ml PGF Veyx/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 2.0 ml PGF Veyx/animal

Single administration.

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 periods

Cattle, pigs (meat and offal): 2 days

Cattle (milk): zero hours

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: prostaglandin-F_2α -agonist

ATCvet code: QG02AD90

Cloprostenol belongs to the group of prostaglandin-F_2α-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-F_2α; 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.

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 hydoxide (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 colourlessglass, type I, with a fluorinated bromobutyl stopper andan 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.

7. MARKETING AUTHORISATION HOLDER

Veyx-Pharma GmbH

Söhreweg 6

34639 Schwarzenborn

Germany

8. MARKETING AUTHORISATION NUMBER

Vm:27569/4001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date:10 October 2012

10. DATE OF REVISION OF THE TEXT

Date:October 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

30 October 2013