Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
betamethasone dipropionate, Quantity: 0.64 mg/g (Equivalent: betamethasone, Qty 0.5 mg/g)
ORGANON PHARMA PTY LTD
Betamethasone dipropionate
Cream
Excipient Ingredients: liquid paraffin; monobasic sodium phosphate dihydrate; phosphoric acid; white soft paraffin; cetomacrogol 1000; cetostearyl alcohol; sodium hydroxide; chlorocresol; purified water
Topical
50g, 5g(E), 15g, 2g(sample)
Medicine Registered
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
INDICATIONS AS AT 22 November 1995: Diprosone is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. These include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.
Visual Identification: A smooth, uniform white cream, free from lumps and foreign matter; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-08
DIPROSONE ® _Betamethasone dipropionate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DIPROSONE. It does not contain all the available information. 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 DIPROSONE against the benefits it is expected to 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 DIPROSONE IS USED FOR The name of your medicine is DIPROSONE. It contains the active ingredient called betamethasone dipropionate. It is a type of cortisone and belongs to the group of medicines called corticosteroids. DIPROSONE is classified as a high potency topical corticosteroid. There are three forms of DIPROSONE: cream, ointment and lotion. DIPROSONE is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as: • psoriasis (a stubborn skin disorder with raised, rough, reddened areas covered with dry, fine silvery scales) • eczema (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling) • other types of dermatitis DIPROSONE Lotion is also used on the scalp and hairy parts of the body. Your doctor may have prescribed DIPROSONE for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DIPROSONE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU USE DIPROSONE _WHEN YOU MUST NOT USE IT_ DO NOT USE DIPROSONE IF YOU HAVE HAD AN ALLERGIC REACTION, SUCH AS WHEEZING, RASH OR HIVES, TO DIPROSONE, ANY OTHER CORTICOSTEROID, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT USE DIPROSONE IF YOU HAVE: • A VIRAL SKIN INFECTION, SUCH AS COLD SORES, SHINGLES OR CHICKEN POX • A FUNGAL SKIN INFECTION, SUCH AS THRUSH, TINEA OR RINGWORM • TUBERCULOSIS OF THE SKIN • ACNE ROSA Les hele dokumentet
Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION DIPROSONE ® (BETAMETHASONE DIPROPIONATE) CREAM, OINTMENT AND LOTION 1 NAME OF THE MEDICINE Betamethasone dipropionate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05% w/w). DIPROSONE CREAM_ _(0.05% w/w): Each g contains betamethasone dipropionate equivalent to betamethasone 0.5 mg. DIPROSONE OINTMENT_ _(0.05% w/w_)_: Each g contains betamethasone dipropionate equivalent to betamethasone 0.5 mg. DIPROSONE LOTION_ _(0.05% w/w): Each mL contains betamethasone dipropionate equivalent to betamethasone 0.47 mg. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DIPROSONE is supplied as cream, ointment, lotion 0.05% w/w. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DIPROSONE is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. These include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis. DIPROSONE Lotion is indicated wherever hair impedes access to the skin in the treatment of corticosteroid-responsive dermatoses particularly on the scalp, chest and underarms, etc. It is also indicated in the treatment of seborrhoea and psoriasis of the scalp. 4.2 DOSE AND METHOD OF ADMINISTRATION DIPROSONE Cream, Ointment: Apply a small amount to the affected area twice daily. For some patients adequate maintenance therapy may be achieved with once daily application. DIPROSONE Lotion: Apply twice daily. Part the hair with a comb, then apply with nozzle directly on the scalp. Squeeze bottle gently. In most cases, 4 weeks continuous treatment should be considered the maximum. Children: Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. 4.3 CONTRAINDICATIONS Hypersensitivity to betamethasone dipropionate, other corticosteroi Les hele dokumentet