Veteglan
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
23-02-2013
Summary of Product characteristics
(SPC)
23-02-2013
Active ingredient:
cloprostenol sodium salt 0.08 mg
Available from:
Calier Portugal, S.A.
ATC code:
QG02AD90
Pharmaceutical form:
Solution for injection
Therapeutic group:
cloprostenol
Therapeutic area:
Cattle, Horses, Pigs
Authorization date:
2007-10-24
Patient Information leaflet
LABORATORIOS CALIER
VETEGLAN 0.075 mg/ml, Solution for injection
Part 1B – SmPC, Label and Package Insert
PACKAGE LEAFLET
The proposed wording for the package leaflet to be included
with this medicinal product is
included on the following pages.
LABORATORIOS CALIER
VETEGLAN 0.075 mg/ml, Solution for injection
Part 1B – SmPC, Label and Package Insert
PACKAGE LEAFLET
VETEGLAN
0.075 MG/ML SOLUTION FOR INJECTION
D- CLOPROSTENOL (SODIUM SALT)
FOR COWS, SOWS AND MARES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE
FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
CALIER PORTUGAL, S.A.
Centro Empresarial Sintra-Estoril II, Edif. C
SINTRA
PORTUGAL
Manufacturer:
LABORATORIOS CALIER, S.A.
C/ Barcelonès, 26 (Pla de Ramassà)
LES FRANQUESES DEL VALLÈS, (Barcelona) SPAIN
KERN PHARMA S.L.
Pol. Ind. Colon II, c/Venus 72
08228 Terrasa
Barcelona SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETEGLAN 0.075 mg/ml Solution for injection for cows, sows and
mares
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
EACH ML CONTAINS:
ACTIVE SUBTANCE
d- Cloprostenol ...................................................................................... 0.075
mg
equivalent to
d-Cloprostenol sodium salt……………...…………….…
0.079 mg
EXCIPIENT:
Chlorocresol ........................................................................................... 1.000
mg
Excipients
q.f……………………………………………..…………… 1.000
ml
LABORATORIOS CALIER
VETEGLAN 0.075 mg/ml, Solution for injection
Part 1B – SmPC, Label and Package Insert
4.
INDICATION(S)
COWS
Induction and synchronisation of
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
VETEGLAN 0.075 mg/ml Solution for injection for cows, sows
and mares
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
Active substance
d-
Cloprostenol ………………...0.075 mg
equivalent to d-
Cloprostenol sodium salt .…0.079 mg
Excipient
Chlorocresol........................................... 1.000 mg
Excipients q.s.............................................1.000 ml
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Clear aqueous solution
4. CLINICAL PARTICULARS
4.1.TARGET SPECIES
Bovines (cows), porcines (sows) and equines (mares).
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
COWS
Induction and synchronisation of oestrus
Induction of parturition
Ovarian dysfunction due to persistent _corpus luteum_: postpartum anoestrus,
silent heat, irregular and anovulatory cycles, persistent _corpus luteum_, luteal
cysts;
Pyometra, endometritis;
Interruption of pregnancy (first stage of gestation) including foetal
mummification;
Post-puerperium uterine dysfunctions, delayed uterine involution;
Therapy associated to the treatment of follicular cysts (10-14 days after
administration of GnRH or hCG)
SOWS
Induction of parturition
MARES
Induction of parturition
Induction of oestrus
4.3. CONTRA-INDICATIONS:
Do not use in pregnant animals unless it is
desirable to induce parturition or interruption
of pregnancy and to animals with spastic dysfunctions of the gastrointestinal tract and/or
respiratory system.
Do not use in case of hipersensibility
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