País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
ACYCLOVIR
GLAXOSMITHKLINE PTE LTD
D06BB03
5% w/w
CREAM
ACYCLOVIR 5% w/w
TOPICAL
Prescription Only
GLAXO WELLCOME OPERATIONS
ACTIVE
1988-05-14
Singapore proposed PI_clean _ZOVIRAX_ TM CREAM QUALITATIVE AND QUANTITATIVE COMPOSITION Cream containing 5% w/w acyclovir PHARMACEUTICAL FORM Cream CLINICAL PARTICULARS INDICATIONS _ZOVIRAX _Cream is indicated for the treatment of _herpes simplex_ virus infections of the skin including initial and recurrent genital herpes and _herpes labialis. _ DOSAGE AND ADMINISTRATION Adults and children:- _ZOVIRAX_ Cream should be applied five times daily at approximately 4-hourly intervals omitting the night time dose. _ZOVIRAX_ Cream should be applied to the lesions or impending lesions as early as possible after the start of an infection. It is particularly important to start treatment of recurrent episodes during the prodromal period or when the lesions first appear. Treatment should be continued for 5 days. If healing has not occurred treatment may be continued for up to 10 days. CONTRA-INDICATIONS _ZOVIRAX_ Cream is contra-indicated in patients known to be hypersensitive to acyclovir, valacyclovir, propylene glycol or any of the excipients of _ZOVIRAX_ Cream. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE _ZOVIRAX_ Cream is not recommended for application to mucous membranes, such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye. In severely immune-compromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral _ZOVIRAX_ dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection. DRUG INTERACTIONS No clinically significant interactions have been identified. USE IN PREGNANCY AND LACTATION A post-marketing acyclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation o Leia o documento completo
Singapore proposed PI_clean _ZOVIRAX_ TM CREAM QUALITATIVE AND QUANTITATIVE COMPOSITION Cream containing 5% w/w acyclovir PHARMACEUTICAL FORM Cream CLINICAL PARTICULARS INDICATIONS _ZOVIRAX _ Cream is indicated for the treatment of _herpes simplex_ virus infections of the skin including initial and recurrent genital herpes and _herpes labialis. _ DOSAGE AND ADMINISTRATION Adults and children:- _ZOVIRAX_ Cream should be applied five times daily at approximately 4-hourly intervals omitting the night time dose. _ZOVIRAX_ Cream should be applied to the lesions or impending lesions as early as possible after the start of an infection. It is particularly important to start treatment of recurrent episodes during the prodromal period or when the lesions first appear. Treatment should be continued for 5 days. If healing has not occurred treatment may be continued for up to 10 days. CONTRA-INDICATIONS _ZOVIRAX_ Cream is contra-indicated in patients known to be hypersensitive to acyclovir, valacyclovir, propylene glycol or any of the excipients of _ZOVIRAX_ Cream. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE _ZOVIRAX_ Cream is not recommended for application to mucous membranes, such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye. In severely immune-compromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral _ZOVIRAX_ dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection. DRUG INTERACTIONS No clinically significant interactions have been identified. USE IN PREGNANCY AND LACTATION A post-marketing acyclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of _ZOVIRAX_ . The registry findings have not shown an increase in the number of birth defects amongst _ZOVIRAX_ exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a com Leia o documento completo