국가: 이스라엘
언어: 영어
출처: Ministry of Health
EFLORNITHINE AS HYDROCHLORIDE MONOHYDRATE
MEDISON PHARMA LTD
P01CX03
CREAM
EFLORNITHINE AS HYDROCHLORIDE MONOHYDRATE 11.5 %W/W
TOPICAL
Required
ALMIRALL S.A., SPAIN
EFLORNITHINE
EFLORNITHINE
Vaniqa is indicated for the reduction of unwanted facial hair in women.
2022-02-28
Vaniqa-cream-11.5-PIL-ENG-D4-F Vaniqa-PIL-0622-V1 1986 - REGULATIONS (PREPARATIONS) PHARMACISTS' PATIENT LEAFLET IN ACCORDANCE WITH THE This medicine is dispensed with a doctor’s prescription only VANIQA CREAM 11.5% W/W ACTIVE INGREDIENT: EFLORNITHINE 11.5% W/W (AS HYDROCHLORIDE MONOHYDRATE ) Inactive ingredients and allergens in the medicine - See section 2 "IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS" and section 6 "ADDITIONAL INFORMATION". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Vaniqa is indicated for reduction of excessive facial hair growth (hirsutism) in women. Vaniqa contains the active substance eflornithine. Eflornithine slows down the growth of hair by its effect on a specific enzyme (a protein in the body involved in hair production). THERAPEUTIC GROUP: ornithine decarboxylase enzyme inhibitor. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to eflornithine or to any of the other ingredients in this medicine (see section 6). • You are pregnant or breastfeeding SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE USING VANIQA, TELL YOUR DOCTOR OR PHARMACIST IF: • You suffer from other medical problems (particularly those related to kidneys or liver) • You suffer from polycystic ovary syndrome (PCOS) • You suffer from specific hormone producing tumors • You take medicines that can accelerate hair growth, e.g.: o cyclosporine (for prevention of transplant rejection) o glucocorticoids (for treatment of joint disease or allergies) o minoxidil (for treatment of hypertension) o phenobarbitone, phenytoin (for treatment of epilepsy) o hormone replacement therapy 전체 문서 읽기
1 Physician Prescribing Information 1. NAME OF THE MEDICINAL PRODUCT Vaniqa 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate). Excipients with known effect: Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of stearyl alcohol, 0.8 mg of methyl parahydroxybenzoate and 0.32 mg of propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White to off white cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Vaniqa is indicated for the reduction of unwanted facial hair in women. 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. 2 _Hepatic/renal impairment: _ the safety and efficacy of Vaniqa in women with hepatic or renal impairment h 전체 문서 읽기