Mesalin 0.2 mg/ml Solution for Injection
Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Caracteristicilor produsului
(SPC)
09-06-2010
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Ingredient activ:
Oestradiol Benzoate
Disponibil de la:
Intervet UK Ltd
Codul ATC:
QG03CA03
INN (nume internaţional):
Oestradiol Benzoate
Statutul autorizaţiei:
Expired
Caracteristicilor produsului
Revised: 11 June 2008
AN: 02355/2007
1.
NAME OF
THE V
ETERINARY MEDICINAL PRODUCT
Mesalin 0.2 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of product contains:
Active substance:
Estradiol benzoate
0.2 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, oily, sterile solution.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (bitches)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated solely for the prevention of pregnancy
following mismating
(mesalliance) in the bitch.
4.3 CONTRA-INDICATIONS
Do not administer to cats.
4.4 SPECIAL WARNING FOR EACH TARGET SPECIES
Because the amount of oestrogen
given to the bitches is low when the product is used,
prolonged oestrus with the risk of further, possibly
fertile, matings is largely avoided. False
pregnancies, pyometra and
vaginal discharges are commonly seen after oestrus in normally
cycling unmated bitches and may occur with similar
frequency following the
administration of the product.
In trial work, pregnancy was found to continue in up to 5%
of bitches despite Mesalin
treatment. It is suggested that owners are advised
accordingly before the treatment is
commenced.
4.5 SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
None.
Revised: 11 June 2008
AN: 02355/2007
(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.
If accidental self-injection occurs,
seek medical advice immediately and show the doctor the label.
Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Large doses of oestrogens have been associated in the dog with blood dyscrasias and
pathological changes in the uterus.
4.7 USE DURING P
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