OXYTOCIN ANIMEDICA
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
06-12-2016
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Virkt innihaldsefni:
OXYTOCIN PH. EUR. 0.018 MG EQUIVALENT TO
Fáanlegur frá:
aniMedica GmbH
ATC númer:
QH01BB02
INN (Alþjóðlegt nafn):
OXYTOCIN PH. EUR. 0.018 MG EQUIVALENT TO
Skammtar:
10 IU/ML
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
POM
Meðferðarhópur:
Bovine, Canine, Caprine, Equine - Food, Feline, Ovine, Porcine
Lækningarsvæði:
Oxytocin
Ábendingar:
Hormone
Leyfisstaða:
Authorised
Leyfisdagur:
1999-10-01
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytocin aniMedica
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Equine, Bovine, Porcine, Ovine, Caprine, Canine and Feline.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Oxytocin aniMedica is indicated for obstetric use (stimulation of paturition, promotion of uterine involution and control
of post partum haemorrhage) and the treatment of agalactia in the mare, cow, sow, ewe, goat, bitch and cat.
4.3 CONTRAINDICATIONS
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.
Each ml contains:
ACTIVE SUBSTANCE
Oxytocin
10
I.U. (Voegtlin units)
EXCIPIENTS
Chlorobutanol hemihydrate 3.00 mg
Ethanol (96 %)
40.10 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/11/2016_
_CRN 7024717_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When Oxytocin aniMedica 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.
Excessive doses of Oxytocin aniMedica may delay parturition by producing uncoordinated uterine contractions which
interfere with the progress of the foetus especially in multiple pregnancies.
SPECIAL PRECAUTIONS TO BE TAKEN BY
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