GYNO-TRAVOGEN OVULE 600 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ISOCONAZOLE NITRATE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

G01AF07

Dosage:

600 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

ISOCONAZOLE NITRATE 600 mg

Administration route:

VAGINAL

Prescription type:

Pharmacy Only

Manufactured by:

BAYER DE MEXICO, S.A. DE C.V.

Authorization status:

ACTIVE

Authorization date:

1989-05-26

Patient Information leaflet

GYNO-TRAVOGEN OVULE 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ovule contains 600 mg isoconazole nitrate 

INDICATIONS 
Fungal infections of the vagina including mixed infections with
gram-positive bacteria. 

DOSAGE AND METHOD OF ADMINISTRATION 
Dosage 
1-day treatment: 1 vaginal suppository (containing 600 mg isoconzole)
is used as one 
single dose. 

Method of administration 
The ovulum must be inserted deep into the vagina. This is best done in
the lying position 
in the evening before going to sleep. The enclosed finger stalls
should be used to assist 
insertion. The treatment is not to be carried out during
menstruation. 

CONTRAINDICATIONS 
Hypersensitivity to the active substance or to any of the
excipients. 

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
For treatment of the external genital region or for simultaneous
prophylactic treatment of 
the partner it is recommended to use Travogen cream. 

During treatment and in the following week vaginal douching should be
avoided. 

To avoid renewed infection, personal linen (face-cloth, towels,
underwear – preferably of 
cotton) should be changed daily and boiled. 

DRUG INTERACTIONS 
None so far known. 

PREGNANY AND LACTATION 
The experience with the use of isoconazole-containing preparations
during pregnancy 
does not indicate a teratogenic risk in humans. 

Because of the only slight absorption (less than 10% of the dose
administered) and the 
short duration of the therapy, damage to the baby from isoconazole
nitrate transferred 
with the breast milk can be ruled out. 

UNDESIRABLE EFFECTS 
Local concomitant symptoms such as smarting, burning
and itching occur occasionally.  
Local symptoms such as erythema or vesiculation may occur in isolated
cases under 
treatment with Gyno-Travogen.

Gynotravogen PI_SG_CCT Version 4.0_12 May 09 
In rare cases allergic reactions of the skin or of the mucosa may
occur. 

PHARMACOLOGICAL PROPERTIES 

PHARMACODYNAMIC PROPERTIES 
Gyno

Summary of Product characteristics

1.4.3_Clean Gyno-Travogen Ovule PI_CCT 04_09 Mar 2023
RESTRICTED
GYNO-TRAVOGEN OVULE
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ovule contains 600 mg isoconazole nitrate
INDICATIONS
Gyno-Travogen suppository is indicated in fungal infections of the
vagina including
mixed infections with gram-positive bacteria.
DOSAGE AND METHOD OF ADMINISTRATION
Dosage
1-day treatment: 1 vaginal suppository (containing 600 mg isoconazole)
is used as one
single dose.
Method of administration
The ovulum must be inserted deep into the vagina. This is best done in
the lying position
in the evening before going to sleep. The enclosed finger stalls
should be used to assist
insertion. The treatment is not to be carried out during menstruation.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For treatment of the external genital region or for simultaneous
prophylactic treatment of
the partner it is recommended to use Travogen cream.
During treatment and in the following week vaginal douching should be
avoided.
To avoid renewed infection, personal linen (face-cloth, towels,
underwear – preferably of
cotton) should be changed daily and boiled.
Some of the excipients in Gyno-Travogen suppository may reduce the
effectiveness of
latex products such as condoms and diaphragms.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
Concomitant
treatment
with
intra-vaginal
isoconazole
nitrate
and
coumarin
type
anticoagulants (e.g., warfarin) might lead to increased plasma levels
of the anticoagulant.
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
The experience with the use of isoconazole-containing preparations
during pregnancy
does not indicate a teratogenic risk in humans.
1.4.3_Clean Gyno-Travogen Ovule PI_CCT 04_09 Mar 2023
RESTRICTED
LACTATION
It is unknown whether isoconazole/isoconazole nitrate is excreted in
human milk. A risk
of exposure to the suckling child cannot be excluded.
FERTILITY
Preclin