Package Leaflet
OXYTOCINE PRODIVET, 10 IU/ml, Injectable solution
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
PRODIVET Pharmaceuticals sa
Hagbenden 39C
B -4731 EYNATTEN
NAME OF THE VETERINARY MEDICINAL PRODUCT
OXYTOCINE PRODIVET, 10 IU/ml, Injectable solution
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance: Oxytocine10 IU/ml
Excipients: Chlorobutanol hemihydrate– Ethanol 96% - Acetic Acid - Water for injection up to 1 ml.
INDICATION(S)
Horses
- Parturition induction
- Retention of the placenta
Bovine, ovine and caprines:
- Retention of the placenta
- Evacuation of the residual milk
- Stimulation of the uterine involution following a spontaneous abortion
- Inertia of uterus during the delivery
- Helps to replace the uterus in case of prolapse
Porcine
- Acceleration of parturition in case of uterine inertia
- Help in the treatment of the metritis-mammitis-agalactia (MMA) complex
Dogs and cats
- Inertia of uterus during the delivery
CONTRAINDICATIONS
- Closed pyometra
- Partial cervical closing or opening
- Mechanical obstacle to parturition
- Anomaly of presentation, posture or position
- Convulsive labour
- Risk of uterine rupture
- Uterine torsion
- Too large foetus or deformations of the birth canal
ADVERSE REACTIONS
Vomiting and emission of stools due to contractions of the smooth gastro-intestinal musculature may sometimes happen.
In rare cases, OXYTOCINE PRODIVET may induce a uterine rupture.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
TARGET SPECIES
Equines, bovines, ovines, caprines, porcines, dogs and cats
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Usual posology:
Target specie |
Posology |
|
Unity to inject
(U.I.)
|
Volume to inject
(ml)
|
Mares
|
10 – 20
|
1 – 2
|
Cows
|
30 – 60
|
3 – 6
|
Sows
|
20 – 40
|
2 – 4
|
Ewes
|
10 – 15
|
1 – 1,5
|
Goats
|
10 – 15
|
1 – 1,5
|
Dogs
|
5 – 10
|
0,5 – 1
|
Cats
|
3 – 5
|
0,3 – 0,5
|
Way of administration
To be administered by slow intravenous or intramuscular injection.
If the administration needs to be repeated, wait 2 hours between the administrations.
ADVICE ON CORRECT ADMINISTRATION
Special precautions of use in the animal
To assure a precise dosing and a correct administration of the product, a dilution in physiological serum is advised for small doses to inject (0.3-0.5 ml).
Interaction with other medicinal products and other forms of interaction
Prostaglandins may potentiate the action of. OXYTOCINE PRODIVET.
Overdose (symptoms, emergency measures, antidotes)
In case of overdose or too fast intravenous injection, vomiting, hypertension and tachycardia can occur. The treatment of this overdose must be symptomatic.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
WITHDRAWAL PERIOD
Meat and offals: 0 days
Milk: 0 days
SPECIAL STORAGE PRECAUTIONS
Keep out of reach and sight of children.
Store cool (2° - 8° C).
Shelf life after opening: 28 days, below 25 °C
SPECIAL WARNING(S)
Special precautions to be taken by the person who administers the veterinary medicinal product to the animals
- The product must not be administered by pregnant women or women in post-delivery period or nursing women, this to prevent an accidental self-injection.
- In case of accidental self-injection seek immediately medical advice and show the package leaflet or the label to the physician.
- People who have a known hypersensitivity to Oxytocine should avoid every contact with the product.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Any unutilised veterinary medicinal product or waste derived from this drug must be eliminated in accordance with the local requirements
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
October 2012
OTHER INFORMATION
PRODIVET Pharmaceuticals S.A./N.V.
Hagbenden 39c
B - 4731 EYNATTEN
Phonel : 00 32 (0)87 85 20 25
E-mail : info@prodivet.com
Available on prescription only
OXYTOCINE_NOT_GB_V1_20121003