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HSA Approval

GYNO-TRAVOGEN OVULE 600 mg

SIN02961P

GYNO-TRAVOGEN OVULE 600 mg

GYNO-TRAVOGEN OVULE 600 mg

May 26, 1989

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantBAYER (SOUTH EAST ASIA) PTE LTD
Licence HolderBAYER (SOUTH EAST ASIA) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore Classification

Formulation Information

SUPPOSITORY

**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.

VAGINAL

Medical Information

**Indications** Gyno-Travogen suppository is indicated in fungal infections of the vagina including mixed infections with gram-positive bacteria.

**Contraindications** Hypersensitivity to the active substance or to any of the excipients.

G01AF07

isoconazole

Manufacturer Information

BAYER (SOUTH EAST ASIA) PTE LTD

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

Active Ingredients

ISOCONAZOLE NITRATE

600 mg

Isoconazole

Documents

Package Inserts

GYNO-TRAVOGEN OVULE PI.pdf

Approved: December 27, 2021

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