Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Medroxyprogesterone acetate
Laboratories Ovejero S.A
QG03DA02
Medroxyprogesterone acetate
60 mg/sponge
Medicated sponge
POM: Prescription Only Medicine as defined in relevant national legislation
Sheep
medroxyprogesterone
Hormone
Authorised
1987-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Morlam Intravaginal Sponge 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sponge contains: Medroxyprogesterone Acetate 60 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Vaginal sponge. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The induction and synchronisation of oestrus in late anoestrus and the normal breeding season. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Animals in poor condition, whether from illness, inadequate nutrition or other factor, may respond poorly to treatment. The sponge treatment is not a substitute for good husbandry and management and will not correct fertility or improve fertility in barren ewes. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Sponges should only be inserted by means of the special applicator provided. The applicator should be cleaned between each application, using an antiseptic suitable for application to body tissues, used according to label recommendations. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS For reasons of hygiene and to avoid the possibility of percutaneous absorption of progestagen, disposable plastic gloves should be worn when administering and removing the Morlam sponge. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Signs of local irritation are rare but a vaginal discharge may occur. This should resolve spontaneously after removal of the H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lees het volledige document