Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
betamethasone valerate, Quantity: 1.21 mg/g (Equivalent: betamethasone, Qty 1 mg/g)
Aspen Pharmacare Australia Pty Ltd
Betamethasone valerate
Cream
Excipient Ingredients: purified water; white soft paraffin; liquid paraffin; chlorocresol; cetostearyl alcohol; cetomacrogol 1000; monobasic sodium phosphate; phosphoric acid; sodium hydroxide
Topical
100g, 30g, 2g sample pack
(S4) Prescription Only Medicine
INDICATIONS AS AT 23 APRIL 2004 : Eczema including : atopic, infantile, stasis and discoid eczemas. Besnier's (flexural) prurigo. Otitis externa. Neurodermatoses including lichen simplex, lichen planus. Seborrheic dermatitis, contact sensitivity reactions and allergies.
Visual Identification: A soft white cream with an odour faintly of chlorocresol. Free from visible foreign contamination.; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-08-13
BETNOVATE cream and ointment - Consumer Medicine Information Page 1 of 4 BETNOVATE CREAM AND OINTMENT _betamethasone valerate _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BETNOVATE. It does not contain all the available information about this medicine. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using BETNOVATE against the benefits this medicine is expected to have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IS BETNOVATE USED FOR BETNOVATE contains the active ingredient betamethasone valerate (a type of cortisone) and belongs to the group of medicines called corticosteroids. BETNOVATE is available as a cream and an ointment. It is a topical corticosteroid, which is applied to the body surface (skin). It is used to help relieve the redness, swelling, itching and discomfort of various skin problems such as: • eczema • other types of dermatitis. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY BETNOVATE HAS BEEN PRESCRIBED FOR YOU. Your doctor knows which skin conditions BETNOVATE is helpful for. The cream and ointment are only available with a doctor's prescription. BEFORE YOU USE IT _ _ _WHEN YOU MUST NOT USE IT _ DO NOT USE BETNOVATE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • betamethasone valerate or any other corticosteroid • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction to BETNOVATE may include red, itchy skin rashes or a lumpy rash (“hives”). It may also include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever or fainting. DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT OR BREAST FEED. Your doctor will discuss the risks and benefits of using BETNOVATE duri Olvassa el a teljes dokumentumot
1 AUSTRALIAN PRODUCT INFORMATION BETNOVATE (BETAMETHASONE VALERATE) CREAM, OINTMENT & SCALP APPLICATION 1 NAME OF THE MEDICINE Betamethasone valerate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BETNOVATE cream and ointment contain 1.0 mg/g of betamethasone, present as 1.21 mg/g of betamethasone-17 α -valerate. BETNOVATE 1/2 cream and ointment contain 0.5 mg/g of betamethasone, present as 0.61 mg/g of betamethasone-17 α -valerate. BETNOVATE 1/5 cream contains 0.2 mg/g of betamethasone, present as 0.24 mg/g of betamethasone-17 α -valerate. BETNOVATE scalp application contains 1.0 mg/g of betamethasone, present as 1.21 mg/g of betamethasone-17 α -valerate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM BETNOVATE cream: A soft white cream with an odour faintly of chlorocresol. Free from visible foreign contamination. BETNOVATE ointment: A smooth greyish-white translucent mass. Free from undispersed particles and visible foreign contamination. BETNOVATE scalp application (1 mg/g): Colourless, hazy, slightly viscous liquid with an odour of isopropyl alcohol. Free from visible foreign contamination. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Eczema including: atopic, infantile, stasis and discoid eczemas. Besnier's (flexural) prurigo. Otitis externa. Neurodermatoses including lichen simplex, lichen planus. Seborrheic dermatitis, contact sensitivity reactions and allergies. 4.2 D OSE AND METHOD OF ADMINISTRATION A small quantity should be applied to the affected area once or twice daily until improvement occurs. If necessary, cover the area with a dry dressing. BETNOVATE 1/5 may be applied up to four times daily. 2 Different presentations of topical corticosteroids may demonstrate variable activity as measured by skin blanching tests and treatment should be monitored for efficacy and safety in individual patients. 4.3 C ONTRAINDICATIONS • Hypersensitivity to the preparations • Rosacea and acne vulgaris • Perioral dermatitis, perianal and genital pruritus • Olvassa el a teljes dokumentumot