SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

(IE, UK, DK, IS)

Vetocin 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats (NO)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Oxytocin 16.6 µg

(equivalent to 10 IU Oxytocin)

Excipients:

Chlorobutanol hemihydrate 3.0 mg

3. PHARMACEUTICAL FORM

Solution for injection.

Clear colourless solution.

4. CLINICAL PARTICULARS

4.1 Target species

Horses, cattle, pigs, sheep, goats, dogs and cats.

4.2 Indications for use, specifying the target species

In the mare, cow, sow, ewe, goat, bitch and cat the product is indicated for:

4.3 Contraindications

Do not use in any form of obstructive dystocia.

4.4 Special warnings for each target species

Adrenaline at physiological levels markedly reduces the effect of Oxytocin on the uterus or mammary gland. For this reason the animal should not be frightened when complete Oxytocin effect is desired to cause either milk "let-down" or uterine contractions.

4.5 Special precautions for use

When Oxytobel 10 IU/ml is used as an aid in parturition cervical dilation must be confirmed prior to administration to prevent risk of foetal death and possible uterine rupture.

Pregnant or lactating women should avoid handling the product as it could cause smooth muscle (e.g. uterine) contraction.

When administering the product, care should be taken to avoid accidental self-injection.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

The product is indicated for use, as appropriate, during parturition and lactation. It should not be used in the pre-partum pregnant animal.

4.8 Interaction with other medicinal products and other forms of interaction

There are no specific interactions and this product may with benefit be used concurrently with other medicaments - e.g. with antibiotics in the treatment of endometritis.

4.9 Amounts to be administered and administration route

Administered by subcutaneous or intramuscular injection.

Mare & Cow 4 – 6 ml

Sow 1 – 3 ml

Ewe & Goat 1 – 2 ml

Bitch & Cat 0.25 – 1 ml

For treatment of agalactia the stated higher dosage level should be used.

The product may be administered by slow intravenous injection at dose rates one third of the above.

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

This is a relatively non-toxic active. Enhanced dose rates will not result in proportionally increased pharmacological effects and there are no other toxic effects. Treatment of overdose is palliative and there are no specific antidotes.

Excessive doses of Oxytobel 10 IU/ml may delay parturition by producing uncoordinated uterine contractions which interfere with the progress of the foetus especially in multiple pregnancies.

4.11 Withdrawal periods

Meat and offal: zero days.

Milk: zero hours.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Systemic hormonal preparations; Posterior pituitary lobe hormones; Oxytocin.

ATCvet code: QH01BB02

Oxytocin is a hormone of the posterior lobe of the hypophysis. It influences the rhythmic contraction of the oxytocin sensitive smooth muscle apparatus. Of special significance is the increase of strength and frequency of the uterine contractions at the beginning of labour.

In the lactating cow the myoepithelial cells, which cover the alveoli of the mammary glands, are contracted by the influence of oxytocin and the milk is passed into the milkducts.

Oxytobel 10 IU/ml is a sterile, aqueous, protein-free injectable solution of synthetic oxytocin which corresponds chemically as well as pharmacologically with naturally occurring oxytocin.

5.2 Pharmacokinetic particulars

Following injection, oxytocin has a rapid onset of activity as physiological effects fast, as its mean half life of distribution is about 2 minutes while its half life of elimination is around 12 minutes.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorobutanol Hemihydrate

Acetic Acid, Glacial

Ethanol 96 %

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: 18 months

Shelf-life after first opening the immediate packaging: 7 days

6.4. Special precautions for storage

Keep the container in the outer carton in order to protect from light.

Store in a refrigerator (2°C – 8°C).

Once opened do not store above 25°C.

6.5 Nature and composition of immediate packaging

Type I (10 ml, 25 ml) or type II (50 ml, 100 ml) brown glass vials closed with bromobutylrubber stopper and sealed with aluminiumcaps.

1 x 10 ml in a cardboard box

5 x 10 ml in a cardboard box

12 x 10 ml in a cardboard box

1 x 25 ml in a cardboard box

10 x 25 ml in a cardboard box

1 x 50 ml in a cardboard box

12 x 50 ml in a cardboard box

6 x (1 x 50 ml) wrapped with clear foil (multipack)

1 x 100 ml in a cardboard box

12 x 100 ml in a cardboard box

6 x (1 x 100 ml) wrapped with clear foil (multipack)

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

Bela-Pharm GmbH & Co. KG

Lohner Straße 19

D - 49377 Vechta

Germany

Distributor

Bela-Pharm GmbH & Co. KG

Lohner Straße 19

D - 49377 Vechta

Germany

8. MARKETING AUTHORISATION NUMBER

Vm: 41816/4000

9. DATE OF FIRST AUTHORISATION

Date: 06 August 2014

10. DATE OF REVISION OF THE TEXT

Date:May 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

06 August 2014