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וניקה VANIQA (EFLORNITHINE AS HYDROCHLORIDE MONOHYDRATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

חיצוני : TOPICAL

צורת מינון:

קרם : CREAM

Posology : מינונים

4.2    Posology and method of administration

Posology
Vaniqa cream should be applied to the affected area twice daily, at least eight hours apart. Efficacy has only been demonstrated for affected areas of the face and under the chin. Application should be limited to these areas. Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Improvement in the condition may be noticed within eight weeks of starting treatment.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction with Vaniqa. In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.

Special population
Elderly: (> 65 years) no dosage adjustment is necessary.

Paediatric population:
The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established. There is no data available to support use in this age group.


Hepatic/renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established. As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients.
No data are available.

Method of administration
A thin layer of the cream should be applied to clean and dry affected areas. The cream should be rubbed in thoroughly. The medicinal product should be applied such that no visual residual product remains on the treated areas after rub-in. Hands should be washed after applying this medicinal product. For maximal efficacy, the treated area should not be cleansed within four hours of application. Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.

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בעל רישום

MEDISON PHARMA LTD

רישום

136 36 30246 11

מחיר

0 ₪

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21.08.22 - עלון לרופא 15.11.22 - עלון לרופא

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21.08.22 - עלון לצרכן אנגלית 21.08.22 - עלון לצרכן עברית 21.08.22 - עלון לצרכן ערבית 15.11.22 - עלון לצרכן עברית 30.01.14 - החמרה לעלון

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