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Date: Saturday, May 18, 2024 10:47

Description: MSD-AH
Release 2.62
Oxytocin-S, 10 iu/ml, solution for injection
 
Species: Cats, Cattle, Dogs, Goats, Horses and other equidae, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Pituitary hormones
Active ingredient: Oxytocin
Product:Oxytocin-S, 10 iu/ml, solution for injection
Product index: Oxytocin-S
Cattle - milk: Zero hours
Cattle - meat: Zero days
Sheep - meat: Zero days
Pig - meat: Zero days
Withdrawal notes: Horse and Goat Zero days
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active substance:
Oxytocin 10 iu
(equivalent to 0.018 mg oxytocin)
Excipients:
Chlorbutanol 5 mg
(Added as Chlorbutanol hemihydrate 5.254 mg as a preservative)
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Solution for Injection
Clear aqueous solution
Clinical particulars
Target Species
Cattle, horses, pigs, sheep, goats, cats and dogs
Indications for use
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.
Contraindications
1. When the product is used as an aid to parturition, cervical dilation must be confirmed prior to administration to prevent the risk of foetal death and possible uterine rupture.
2. The product is contraindicated in any form of obstructive dystocia.
3. 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. The effects of daily dosages of 100 iu or more (to facilitate ‘stripping out’ of infected quarters in the treatment of mastitis in cows) on the oestrous cycle have not been fully investigated and the cycle length may be altered.
5. 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 'letdown' or uterine contractions.
Special warnings for each target species
None
Special precautions for use
Use aseptic precautions.
Operator warnings
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.
Adverse Reactions
None known
Use during pregnancy or lactation
Used to promote parturition and milk let-down. Not to be used in late pregnancy unless the intention is to promote parturition.
Interactions
Stimulation of beta-adrenergic receptors may reduce the effect of oxytocin on the uterus or mammary gland.
Amounts to be administered and administration route
The product should normally be given by deep intramuscular injection.
Species
Dosage
mls
Queen
2-5 iu
0.2-0.5 ml
Bitch
2-10 iu
0.2-1.0 ml
Ewe,goat,sow
2-10 iu
0.2-1.0 ml
Mare
10-40 iu
1.0-4.0 ml
Cow
Indications other than mastitis as listed in section 'Indications'. For mastitis treatment see below
10-40 iu
1.0-4.0 ml
Adjunct to mastitis treatment in cows:
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.
Overdose
Excessive doses might cause uncoordinated uterine contractions (also refer to contraindications).
Withdrawal periods
Cattle, sheep, pigs, horses and goats: Meat – Zero days
Cattle, sheep and goats: Milk – Zero hours
Pharmacological particulars
ATC Vet Code: QH01BB02
Pharmacotherapeutic group
Pituitary and hypothalamic hormones and analogues, Posterior pituitary lobe hormones, Oxytocin and analogues
Pharmacodynamic properties
The active ingredient is synthetic oxytocin which is a nature-identical nanopeptide. Oxytocin is a hormone which enhances the contractility of the uterus muscle especially during parturition and post partum, it also evokes let-down of milk. It has no vasopressor or antidiuretic activity.
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.
Pharmaceutical particulars
Excipients
Chlorbutanol hemihydrate
Sodium chloride
Acetic acid or sodium hydroxide used for pH adjustment
Water for injections
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Store in a refrigerator (between +2oC and +8oC). Protect from light.
Immediate packaging
Colourless glass (Type II) vial, closed with bromobutyl rubber stoppers and sealed with aluminium caps.
Pack size: 25 ml.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local
requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4314
Significant changes
Date of the first authorisation or date of renewal
29 July 1994.
Date of revision of the text
November 2019.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Oxytocin-S 1x25ml:
GTIN:08713184006059