Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
ACICLOVIR
GLAXO SMITH KLINE (ISRAEL) LTD
S01AD03
OPHTALMIC OINTMENT
ACICLOVIR 3 %W/W
OCULAR
Required
JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP (JHSGP), CANADA
ACICLOVIR
ACICLOVIR
Indicated for the treatment of herpes simplex keratitis.
2014-05-31
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_The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in_ _June 2014_ ZOVIRAX ™ OPHTHALMIC OINTMENT SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Zovirax Ophthalmic Ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aciclovir 3.0% W/W For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ophthalmic Ointment CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of herpes simplex keratitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical administration to the eye. ADULTS: 1cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day at approximately four hourly intervals, omitting the night time application. Treatment should continue for at least 3 days after healing is complete. CHILDREN: As for adults USE IN THE ELDERLY: As for adults. 4.3 CONTRA-INDICATIONS Zovirax Ophthalmic Ointment is contra-indicated in patients with a known hypersensitivity to aciclovir or valaciclovir, or any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients should be informed that transient mild stinging immediately following application may occur. Patients should avoid wearing contact lenses when using Zovirax Ophthalmic Ointment. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION No clinically significant interactions have been identified. 4.6. FERTILITY, PREGNANCY AND BREAST-FEEDING _PREGNANCY _ A post-marketing aciclovir 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 described amongst Zovirax exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non- Izlasiet visu dokumentu