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HSA Approval

NEO-PENOTRAN PESSARY

SIN11180P

NEO-PENOTRAN PESSARY

NEO-PENOTRAN PESSARY

October 7, 1999

INTEGA PTE LTD

INTEGA PTE LTD

Regulatory Information

INTEGA PTE LTD

INTEGA PTE LTD

Therapeutic

Prescription Only

Formulation Information

SUPPOSITORY

**Posology and method of administration** _**Posology**_ Do not use without consulting a physician. If it is not advised otherwise by a physician; One ovule should be inserted at night and in the morning for 7 days. In recurrent cases, application of one ovule in the morning and one ovule at night for 14 days is recommended. It is not recommended that the administration of NEO-PENOTRAN® in the menstrual period because of the impaired efficacy of the product or facing some difficulties during administration. _**Method of administration**_ Only for intravaginal use. NEO-PENOTRAN® should be applied in lying position, high into the vagina. Not to be swallowed or applied by other routes. Additional information on special populations: _**Renal/Liver failure:**_ In renal failure, the half-life of metronidazole is not changed. In serious liver function failures, metronidazole clearance may be impaired. Metronidazole may increase encephalopathy symptoms due to increased plasma levels and therefore should be used carefully in hepatic encephalopathy patients. _**Paediatric population:**_ Not recommended for children. _**Geriatric population:**_ Same dose as for adults is administered in elderly over 65 years.

VAGINAL

Medical Information

**Therapeutic indications** It is used in the treatment of candidal vulvovaginitis due to Candida albicans, in bacterial vaginosis due to anaerobic bacteria and Gardnerella vaginalis, in trichomonal vaginitis due to Trichomonas vaginalis and in mixed vaginal infections.

**Contraindications** NEO-PENOTRAN® should not be used; - In patients known to be hypersensitive to the active ingredients or their derivatives, - In patients using alcohol during the treatment or at least 3 days after the treatment, - In patients using disulfiram during the treatment or within 2 weeks, - During the first trimester of pregnancy, - In pregnant women who have trichomonal vaginitis in the first trimester, - In cases of porphyria, epilepsy, and serious liver function disorders.

G01AF01

metronidazole

Manufacturer Information

INTEGA PTE. LTD.

Exeltis IIac San. Ve Tic. A.S.

Active Ingredients

MICONAZOLE NITRATE

100 mg

Miconazole

METRONIDAZOLE

500 mg

Metronidazole

Documents

Package Inserts

07b. Neo-Penotran Pessary PI Proposed Clean.pdf

Approved: November 12, 2020

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