SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OFthe VETERINARY MEDICINAL PRODUCT FOLLOWED BY THE STRENGTH AND THE PHARMACEUTICAL FORM

Oxytocin-S, 10 iu/ml, solution for injection

2. NAME AND PROPORTION OF EACH ACTIVE SUBSTANCE, AND OF ANY EXCIPIENT, IF KNOWLEDGE OF THE EXCIPIENT IS NEEDED FOR SAFETY REASONS

Active substance per ml:

Oxytocin acetate 0.018mg

(equivalent to 10iu oxytocin at 560iu per mg)

Chlorbutanol hemihydrate 5.254mg

(equivalent to 5mg Chlorbutanol)

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Clear aqueous solution

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, horses, pigs, sheep, goats, cats and dogs

4.2 Indications for use, specifying the target species

Injections with this product will initiate strong, regular and purposeful contractions of the uterine muscle especially in the later stages of pregnancy and post-partum. It also evokes the 'let-down' of milk although it has no action on the smooth muscles of the gut or urinary bladder, nor is it effective in the treatment of diabetes insipidus. The absence of vasopressor and antidiuretic effects make it particularly suitable for obstetric use (stimulation of parturition, promotion of uterine involution and control of post-partum haemorrhage) and the treatment of agalactia.

The product is indicated for:

- stimulation of uterine contraction to facilitate parturition in the presence of a fully dilated cervix

- to promote involution of the post-parturient uterus and thus aid the passage of retained placenta

- to aid in control of post-partum haemorrhage

- promotion of milk 'let-down' in cases of agalactia and to facilitate ‘stripping out’ of infected quarters in the treatment of mastitis in cows.

4.3 Contra-indications

4.4 Special warning for each target species

None

4.5 Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals

i. Special precautions for use in animals

Use aseptic precautions.

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

Care should be taken to avoid accidental self-injection. Should self-injection occur, medical advice should be sought immediately. Women, particular during lactation or the later stages of pregnancy should avoid handling the product as it could cause smooth muscle (e.g. uterine) contraction.

4.6 Adverse reactions (frequency and seriousness)

Excessive doses of the product may delay parturition by producing incoordinated uterine contractions which interfere with the progress of the foetus especially in multiple pregnancies.

4.7 Use during pregnancy, lactation or lay

Used to promote parturition and milk let-down. Not to be used in late pregnancy unless the intention is to promote parturition.

4.8 Interaction with other medicinal products and other forms of interaction

Stimulation of beta -adrenergic receptors may reduce the effect of oxytocin on the uterus or mammary gland.

4.9 Amounts to be administered and administration route

The product should normally be given by deep intramuscular injection.

Species Dosage

Queen 2-5 iu 0.2 -0.5 ml

Bitch 2-10 iu 0.2 -1 ml

Ewe, goat, sow 2-10 iu 0.2 -1 ml

Mare 10-40 iu 1- 4 ml

Cow 10-40 iu 1- 4 ml

Other indications 10-40 iu 1- 4 ml

Adjunct to mastitis treatment

A single dose of up to 80 iu (8 ml) prior to stripping out before first mastitis treatment followed by repeated doses of 20 iu (2 ml) prior to each stripping out 2 or 3 times daily while mastitis treatment continues.

Where the intravenous route is used, these doses should be reduced to one-quarter of the intramuscular dose and the injection given slowly at a dilution of 1 in 10 Water for Injections Ph.Eur. Where speed of onset is not a priority, the product may be given by the subcutaneous route.

A low initial dosage is recommended by any route as repeat administration is permissible.

Large doses may be employed in post-parturient animals.

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

Might cause uncoordinated uterine contractions. Low initial dosage is recommended as repeat administration is permissible.

4.11 Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero

Cattle, sheep, pigs, horses and goats: Meat – Zero days

Cattle, sheep and goats: Milk – Zero hours

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code:QH01BB02

Pharmacotherapeutic group:Pituitary and hypothalamic hormones and analogues, Posterior pituitary lobe hormones, Oxytocin and analogues

5.1 Pharmacodynamic properties

The active ingredient is synthetic oxytocin which is a nature-identical nanopeptide. Oxytocin is a hormone which enhances the contractivity of the uterus muscle especially during parturition and post partum, it also evokes let-down of milk. It has no vasopressor or antidiuretic activity.

5.2 Pharmacokinetic particulars

Following injection, oxytocin has a rapid onset of activity as physiological effects are usually detected within minutes following administration.. Oxytocin is cleared very fast, as its mean half life of distribution is around 2 minutes while its half life of elimination is around 12 minutes.

6 PHARMACEUTICAL PARTICULARS

Chlorbutanol hemihydrate

Sodium chloride

Acetic acid or sodium hydroxide used for pH adjustment

Water for injections

6.2 Incompatibilities

None Known

6.3 Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time

Shelf life of veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Store in a refrigerator (between +2^oC and +8^oC). Protect from light.

6.5 Nature and composition of immediate packaging

Colourless glass (Type II) vial, closed with bromobutyl rubber stoppers and sealed with aluminium caps.

Pack size: 25 ml.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd.

Walton

Walton Manor

Milton Keynes

MK7 7AJ

8. MARKETING AUTHORISATION Number

Vm01708/4314

9. Date of first AUTHORISation or date of renewal of the authorisation

Date:29 July 2004

10. Date of Revision of text

Date:July 2012