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  • Vaniqa Cream
    / Medison


    Active Ingredient
    Eflornithine (as HCl monohydrate) 11.5 g / 100 g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cream

    30 gr

    not in the basket chart 68867 22272

    Dosage

    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 0-18 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.


    recommended drugs

    Indications

    Treatment of unwanted facial hirsutism in women.


    Contra-Indications

    Hypersensitivity to the active ingredient, to the excipients.


    Special Precautions

    Serious underlying disorders causing excessive hair growth should be considered. For cutaneous use only. Contact with eyes or mucous membranes should be avoided. If skin irritation or intolerance develops, the frequency of application should be temporarily reduced to once daily. If irritation continues, treatment should be discontinued. Severe renal impairment. Hepatic/renal impairment: Safety and efficacy have not been established. 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.
    Children and adolescents: Safety and efficacy have not been established. Pregnancy and lactation: Women who are pregnant or planning pregnancy should use an alternative means. Should not be used whilst breast-feeding.


    Side Effects

    Acne, pseudofolliculitis barbae, alopecia, stinging skin, burning skin, dry skin, pruritus, erythema, tingling skin, irrritated skin, rash, folliculitis.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed.


    Manufacturer
    Almirall S.A, Spain
    Licence holder
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