FLUGESTONE ACETATE INTERVET 20MG VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUGESTONE ACETATE

Available from:

INTERVET ( ISRAEL) LTD

Pharmaceutical form:

SPONGE

Composition:

FLUGESTONE ACETATE 20 MG

Administration route:

VAGINAL

Prescription type:

Required

Manufactured by:

INTERVET PRODUCTIONS SA., FRANCE

Therapeutic indications:

In Ewe and Ewe lambs, in combination with PMSG (Pregnant Mare Serum Gonadotrophin):Induction and synchronisation of oestrus and ovulation (non-cycling ewes during seasonal anoestrus and ewe lambs).Synchronization of oestrus ovulation (cycling ewes and ewe-lambs).

Authorization date:

2022-01-31

Patient Information leaflet

The format of this leaflet was determined by the Ministry of Health
and its content checked
and approved in February 2017.
CONSUMER PACKAGE INSERT FOR A VETERINARY MEDICINAL PRODUCT
The medicine is dispensed with a veterinarian’s prescription only
For animal use only
1. NAME OF THE MEDICINE:
FLUGESTONE ACETATE INTERVET 20 MG VETERINARY,
vaginal sponge
2. COMPOSITION:
Each polyester polyurethane sponge contains
Active ingredient(s)
Flugestone acetate, 20 mg
A list of inactive ingredients is detailed in the section “Further
Information”.
3. WHAT IS THE MEDICINE INTENDED FOR:
In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum
Gonadotropin)
-
Induction and synchronization of oestrus and ovulation (in ewes during
seasonal
anoestrus and ewe lambs)
-
Synchronization of oestrus and ovulation (in cycling ewes during
seasonal oestrus and
ewe-lambs).
Therapeutic group: Progestagen
4.
CONTRAINDICATIONS:
Do not use during pregnancy.
Do not use together with alcohols, cresols, phenols, “sheep dips”
or similar disinfectants.
5. SIDE EFFECTS:
A muco-purulent discharge may occasionally be observed upon sponge
removal. This
discharge is not associated with clinical signs and does not affect
fertility.
Side effects may be reported to the Ministry of Health by clicking on
the link “Report Side
Effects of Drug Treatment” found on the Ministry of Health homepage
(www.health.gov.il) that
directs you to the online form for reporting side effects, or by
entering the link:
https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic
@moh.gov.il
6. TARGET ANIMALS:
Sheep (ewes and ewe lambs)
7. ADMINISTRATION AND DOSAGE:
Intra-vaginal sponge.
The dose is one sponge per animal irrespective of body weight, breed,
type (dairy or meat)
and season.
8. ADMINISTRATION OF PRODUCT:
The sponge is inserted intra-vaginally using an applicator.
Leave the sponge in place for 14 days. At the end of the
administration period, gently remove
the sponge by pulling on the string.
To obtain optimal sync

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flugestone Acetate Intervet 20 mg Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each polyester polyurethane sponge contains
ACTIVE SUBSTANCE(S)
Flugestone acetate, 20 mg.
LIST OF EXCIPIENTS
Excipients qsp 1 sponge.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Vaginal sponge.
White cylindrical polyester polyurethane foam equipped with string.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep (ewes and ewe-lambs).
4.2
INDICATIONS FOR USE
In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum
Gonadotrophin)
- Induction and synchronization of oestrus and ovulation (non cycling
ewes during
seasonal anoestrus and ewe lambs).
- Synchronization of oestrus and ovulation (cycling ewes and
ewe-lambs).
4.3
CONTRAINDICATIONS
Please refer to section 4.7 and section 4.8.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
-
The repeated treatment with the product combined with PMSG may trigger
the appearance of PMSG antibodies in some ewes. This in turn may
affect
the time of ovulation and result in reduced fertility when combined
with
fixed time artificial insemination at 55h following sponge removal.
-
The repeated use of sponges within one year has not been studied.
-
The use of a vaginal applicator designed for ewes or ewe lambs is
recommended to correctly insert sponges and to avoid vaginal injuries.
(ii) Special precautions to be taken by the person administering the
medicinal
product to animals
-
Direct contact with the skin should be avoided. Personal protective
clothing
(single use gloves) should be worn when handling the product. If
accidental contact with the skin occurs, wash the affected zone with
soap
and water. Wash hands after treatment and before meals.
-
Human exposure to this product can affect fertility.
-
Women who are pregnant, or suspected to be pregnant, must not use the
product.
4.6
ADVERSE REACTIONS
A muco-purulent discharge may