Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Betamethasone dipropionate 0.064 mg/g Equivalent to 0.5 mg Betamethasone dipropionate;
Organon (New Zealand) Limited
Betamethasone dipropionate 0.064 mg/g (Equivalent to 0.5 mg Betamethasone dipropionate)
0.05% w/w
Topical ointment
Active: Betamethasone dipropionate 0.064 mg/g Equivalent to 0.5 mg Betamethasone dipropionate Excipient: Propylene glycol Propylene glycol monostearate White beeswax White soft paraffin
Tube, HDPE cap, 30 g
Prescription
Prescription
Crystal Pharma SA
Package - Contents - Shelf Life: Tube, HDPE cap - 30 g - 24 months from date of manufacture stored at or below 25°C
1981-07-28
DIPROSONE OV 1 DIPROSONE OV _(OPTIMISED VEHICLE) _ _Betamethasone dipropionate 0.05% _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Diprosone OV Cream and Ointment. 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 OV against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DIPROSONE OV IS USED FOR Diprosone OV contains the active ingredient betamethasone dipropionate. Betamethasone dipropionate is a very strong corticosteroid used to decrease inflammation, redness, itchiness and discomfort of some skin conditions. Diprosone OV Cream and Ointment are used to treat persistent or severe: • dermatitis • eczema (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling) • acute or chronic psoriasis (a stubborn skin disorder with raised, rough, reddened areas covered with dry, fine silvery scales) Your doctor may have prescribed Diprosone OV for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DIPROSONE OV HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU USE DIPROSONE OV _WHEN YOU MUST NOT USE IT _ DO NOT USE DIPROSONE OV IF YOU HAVE HAD AN ALLERGIC REACTION TO: • other medicines containing betamethasone dipropionate • any other corticosteroid(s) • any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction include wheezing, skin rash and hives. DO NOT USE DIPROSONE OV IF YOU HAVE: • a viral infection (such as cold sores, shingles or chicken pox) • a fungal infection (such as thrush, ringworm or tinea) • tuberculosis of the skin • acne rosacea • inflammation around the mou Belgenin tamamını okuyun
1 S-CCDS-MK1460-DPL-MTL-082017 DATA SHEET 1. DIPROSONE OV DIPROSONE OV (0.05% w/w) cream DIPROSONE OV (0.05% w/w) ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05% w/w). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DIPROSONE OV Cream is a white cream in an optimised vehicle. DIPROSONE OV Ointment is a white ointment in an optimised vehicle. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DIPROSONE OV Cream and Ointment are indicated for the relief of the inflammatory and pruritic manifestations of resistant or severe corticosteroid-responsive dermatoses. These include atopic eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus and psoriasis. DIPROSONE OV Ointment is also indicated for the maintenance of remission in chronic psoriasis. 4.2 DOSE AND METHOD OF ADMINISTRATION DIPROSONE OV Cream and Ointment: Apply a thin film once or twice daily to cover completely the affected area. Patients with chronic psoriasis who have achieved at least a marked improvement in their psoriatic lesion(s) (i.e., approximately ≥ 80% improvement) with DIPROSONE OV may be maintained in remission with a pulse dosing regimen consisting of three consecutive applications of up to 3.5 g each of DIPROSONE OV Ointment, twelve hours apart (e.g., morning, evening, following morning) to the previously affected areas once each week. For this purpose, DIPROSONE OV Ointment should be applied to the lesion sites previously affected and treated. Patients on this pulse dose regimen who relapse should be reverted back to the conventional dosing regimen. 4.3 CONTRAINDICATIONS Hypersensitivity to betamethasone dipropionate, other corticosteroids or any components in DIPROSONE OV. Like other topical corticosteroids, DIPROSONE OV is contraindicated in viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also tuberculosis, acne rosacea, fungal skin infections (moniliasis) Belgenin tamamını okuyun