Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Benzoyl peroxide 66.7 mg/g; Clindamycin phosphate 12.8 mg/g;
GlaxoSmithKline NZ Limited
Benzoyl peroxide 66.7 mg/g
1%w/w, 5%w/w
Topical gel
Active: Benzoyl peroxide 66.7 mg/g Clindamycin phosphate 12.8 mg/g Excipient: Carbomer 940 Colloidal silicon dioxide Dimeticone Disodium edetate dihydrate Disodium lauryl sulfosuccinate Glycerol Poloxamer Purified water Sodium hydroxide
Tube, aluminium, 5 g
Prescription
Prescription
Arkema Inc
For the topical treatment of comedo, papular and pustular acne vulgaris.
Package - Contents - Shelf Life: Tube, aluminium, - 5 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 6 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, Physican's samples 10 x 6g - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 25 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 45 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 50 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 55 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 70 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze)
2004-03-25
DUAC ® 1 DUAC ® _ONCE DAILY GEL _ _Active ingredients: clindamycin 1% w/w (as phosphate) and benzoyl peroxide 5% w/w _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Duac Once Daily Gel. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the benefits of you using Duac Once Daily Gel against the risks he expects it may 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 IS DUAC ONCE DAILY GEL AND WHAT IS IT USED FOR? Duac Once Daily Gel contains clindamycin and benzoyl peroxide. Clindamycin is an antibiotic, which prevents the growth of bacteria which are involved in acne. Benzoyl peroxide acts to reduce comedones (blackheads and whiteheads). It is also effective at killing the bacteria, which are involved in acne, and makes the skin less oily. Duac Once Daily Gel is used on the skin to treat acne. It helps to: • reduce the bacteria or germs, which are implicated in acne; • reduce the number of acne spots; • reduce the likelihood of new blackheads and whiteheads from forming; and • make your skin less oily. Your doctor may have prescribed Duac Once Daily Gel for another purpose. Ask your doctor if you have any questions about why Duac Once Daily Gel has been prescribed for you. Duac Once Daily Gel is for use by adults and adolescents (aged 12 and above) with acne. Duac Once Daily Gel is not addictive. Duac Once Daily Gel is only available with a doctor's prescription. BEFORE YOU USE DUAC ONCE DAILY GEL _WHEN YOU MUST NOT USE IT _ DO NOT USE DUAC ONCE DAILY GEL: • IF YOU HAVE AN ALLERGY TO DUAC ONCE DAILY GEL OR ANY OF THE INGREDIENTS IN DUAC ONCE DAILY GEL LISTED AT THE END OF THIS LEAFLET. • IF YOU HAVE A KNOWN SENSITIVITY TO BENZOYL PEROXIDE, CLINDAMYCIN OR LINCOMYCIN. • YOU HAVE OR HAVE EVER HAD: − Przeczytaj cały dokument
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Duac Once Daily Gel contains 1% w/w clindamycin (as phosphate) and 5% w/w benzoyl peroxide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Duac Once Daily Gel contains 1% w/w clindamycin (as phosphate) and 5% w/w benzoyl peroxide. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Gel Duac Once Daily Gel is a white to slightly yellow homogenous gel for topical use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of comedo, papular and pustular acne vulgaris, in adults and adolescents aged 12 years and above. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Dose Duac Once Daily Gel is for topical use only. Duac Once Daily Gel is recommended for a maximum duration of 11 weeks. Australian Therapeutic Guidelines, Antibiotics, Version 12 recommend addition of topical antibiotics (topical clindamycin) if there is insufficient response to topical keratolytics alone in the treatment of acne vulgaris of moderate severity. Adults and Adolescents (aged 12 years and above) Duac Once Daily Gel should be applied once daily as a thin film in the evening, to affected areas after the skin has been thoroughly washed, rinsed with warm water, and gently patted dry. If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted. Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. Paediatric population The safety and efficacy of Duac Once Daily Gel has not been established in prepubescent children (under 12 years of age), since acne vulgaris rarely presents in this age group . 2 4.3 CONTRAINDICATIONS Duac Once Daily Gel is contraindicated in: patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl peroxide or any components of the formulation. Patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic- associated colitis (including pseudome Przeczytaj cały dokument