Morlam Intravaginal Sponge

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

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Download Productkenmerken (SPC)
12-06-2017
Download DSU (DSU)
28-04-2023

Werkstoffen:

Medroxyprogesterone acetate

Beschikbaar vanaf:

Laboratories Ovejero S.A

ATC-code:

QG03DA02

INN (Algemene Internationale Benaming):

Medroxyprogesterone acetate

Dosering:

60 mg/sponge

farmaceutische vorm:

Medicated sponge

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Sheep

Therapeutisch gebied:

medroxyprogesterone

therapeutische indicaties:

Hormone

Autorisatie-status:

Authorised

Autorisatie datum:

1987-10-01

Productkenmerken

                                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
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