Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
ivermectin, Quantity: 10 mg/g
Galderma Australia Pty Ltd
Ivermectin
Cream
Excipient Ingredients: glycerol; isopropyl palmitate; carbomer copolymer (type B); dimeticone 20; disodium edetate; citric acid monohydrate; cetyl alcohol; stearyl alcohol; ceteareth-20; sorbitan stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; phenoxyethanol; propylene glycol; oleyl alcohol; sodium hydroxide; purified water
Topical
30 g, 45 g, 15 g, 2 g, 60 g
(S4) Prescription Only Medicine
SOOLANTRA is indicated for the topical treatment of inflammatory lesions of rosacea (papulo-pustular) in adult patients 18 years and over.
Visual Identification: White to pale yellow cream; Container Type: Tube; Container Material: PP/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-09-14
SOOLANTRA 1 SOOLANTRA ® CREAM _ _ _Ivermectin 10mg/g (1% w/w) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SOOLANTRA. It does not contain all the available information. It does not use the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using SOOLANTRA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT SOOLANTRA IS USED FOR SOOLANTRA contains the active substance ivermectin that belongs to a group of medicines called avermectins. SOOLANTRA is used to treat pimples and spots found with rosacea. Your doctor, however may prescribe it for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SOOLANTRA HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. SOOLANTRA is not addictive. BEFORE YOU USE SOOLANTRA _WHEN YOU MUST NOT USE IT _ DO NOT USE SOOLANTRA: if you have an allergy to any medicine containing ivermectin if you have an allergy to any of the ingredients listed at the end of this leaflet for any children under 18 years of age Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body rash, itching or hives of the skin DO NOT USE SOOLANTRA AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. _BEFORE YOU START TO USE IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. SOOLANTRA contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis), methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E217) which may Baca dokumen lengkap
1 AUSTRALIAN PRODUCT INFORMATION SOOLANTRA ® (IVERMECTIN) CREAM 1. NAME OF THE MEDICINE Ivermectin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of SOOLANTRA cream contains 10 mg (or 1.0% w/w) of ivermectin. EXCIPIENTS WITH KNOWN EFFECT Methyl hydroxybenzoate Propyl hydroxybenzoate For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3. PHARMACEUTICAL FORM SOOLANTRA is a white to pale yellow hydrophilic cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SOOLANTRA is indicated for the topical treatment of inflammatory lesions of rosacea (papulo-pustular) in adult patients 18 years and over. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE One application a day for up to 4 months. SOOLANTRA should be applied daily over the treatment course. The treatment course may be repeated. In case of no improvement after 3 months, the treatment should be discontinued. For optimal facial treatment, it is recommended that five small pea-size amounts, the total estimated to be no more than 1 g, are applied to the main areas of the face (i.e. forehead, chin, nose, each cheek) daily. The cream should be spread as a thin layer across the entire face, avoiding the eyes and lips. After SOOLANTRA has dried, a high sunscreen protection factor (SPF) sunscreen should be applied to treated areas that are likely to be exposed to the sun, or other sun-exposure reduction methods should be used (e.g. hats, clothing). Cosmetics and sunscreens may also be applied after SOOLANTRA has dried. SOOLANTRA should be applied only to the face. Hands should be washed after applying SOOLANTRA. 2 SOOLANTRA is not for oral, ophthalmic, or intravaginal use. Special populations _Elderly patients _ No dosage adjustment is necessary in the geriatric population (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE , USE IN THE ELDERLY ). _Paediatric population _ The safety and efficacy of SOOLANTRA in children and adolescents aged less than 18 years have not been established. No data are available. 4.3 CONTRAINDICATIONS Hypersensiti Baca dokumen lengkap