Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
isotretinoin, Quantity: 5 mg
Douglas Pharmaceuticals Australia Pty Ltd
Isotretinoin
Capsule, soft
Excipient Ingredients: sorbitol solution (70 per cent) (non-crystallising); glycerol; purified water; butylated hydroxyanisole; hydrogenated vegetable oil; titanium dioxide; disodium edetate; Soya Oil; dl-alpha-tocopherol; Gelatin; yellow beeswax; partially hydrogenated soya oil
Oral
15 capsules, 60 capsules, 90 capsules, 30 capsules
(S4) Prescription Only Medicine
Treatment of patients with severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.
Visual Identification: Faint pinkish/cream to cream coloured oval, soft gelatin capsules, containing a yellow/orange, viscous liquid.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-02-09
ORATANE ® Consumer Medicine Information Isotretinoin 5mg, 10mg, 20mg, 30mg and 40mg capsules _ _ WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about ORATANE capsules. 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 taking ORATANE capsules against the benefits the medicine is expected to 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 IS ORATANE ® USED FOR The active ingredient in ORATANE capsules is isotretinoin, a substance very similar to vitamin A. ORATANE belongs to a group of medicines called retinoids. ORATANE _ _capsules are used to treat acne. Of the many acne medicines, ORATANE _ _is used for more severe cases. ORATANE capsules work by cutting down the amount of oily substances (sebum) made by glands in your skin. ORATANE capsules will also help to reduce bacteria, inflammation and open clogged pores. YOUR DOCTOR MAY HAVE PRESCRIBED ORATANE CAPSULES FOR ANOTHER PURPOSE. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ORATANE CAPSULES HAVE BEEN PRESCRIBED FOR YOU. ORATANE capsules are not addictive. BEFORE YOU TAKE ORATANE ® _ _ _WHEN YOU MUST NOT TAKE ORATANE_ _ CAPSULES _ Do not take ORATANE capsules if: 1. YOU ARE PREGNANT OR FOR AT LEAST ONE MONTH BEFORE YOU INTEND TO BECOME PREGNANT. If you fall pregnant while taking Oratane Capsules, there is an extremely high risk of having a baby that is severely deformed. This means that you must use effective contraception for one month before, during and one month after treatment with Oratane Capsules. 2. YOU ARE BREASTFEEDING . Breastfeeding must stop before Oratane treatment can start. Do not breastfeed while taking Oratane Capsules. 3. YOU HAVE HAD AN ALLERGIC REACTION TO ORATANE _ _ Կարդացեք ամբողջական փաստաթուղթը
1 AUSTRALIAN PRODUCT INFORMATION – ORATANE (ISOTRETINOIN) SOFT CAPSULES 1 NAME OF THE MEDICINE Isotretinoin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oratane® capsules contain either 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of isotretinoin. Isotretinoin is related to both retinoic acid and retinol (Vitamin A). Isotretinoin is a yellow - orange to orange crystalline powder that is practically insoluble in water, soluble in methylene chloride, sparingly soluble in ether and slightly soluble in alcohol. It is sensitive to air, heat and light, especially in solution. Excipients with known effect: soy bean oil For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Oratane 5 mg capsules are soft, oval, faint pinkish/cream to cream in colour containing a yellow/orange liquid. Oratane 10 mg capsules are light violet coloured soft capsules containing a yellow/orange viscous liquid. Oratane 20 mg capsules are maroon coloured soft capsules containing a yellow/orange viscous liquid. Oratane 30 mg capsules are pink coloured soft capsules containing a yellow/orange viscous liquid. Oratane 40 mg capsules are orange coloured soft capsules containing a yellow/orange viscous liquid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Oratane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because 2 of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics. 4.2 D OSE AND METHOD OF ADMINISTRATION The therapeutic response to isotretinoin is dose related and varies between patients. This necessitates in Կարդացեք ամբողջական փաստաթուղթը