Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE; NEOMYCIN SULPHATE
DYNAPHARM (M) SDN BHD
BETAMETHASONE; NEOMYCIN SULPHATE
15 gm
DYNAPHARM (M) SDN BHD
Consumer Medication Information Leaflet (RiMUP) DYNAVATE-N CREAM Betamethasone-17-Valerate / Neomycin Sulphate (0.1% / 0.5%) 1 What is in this leaflet 1. What Dynavate-N Cream is used for 2. How Dynavate-N Cream works 3. Before you use Dynavate-N Cream 4. How to use Dynavate-N Cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Dynavate-N Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Dynavate-N Cream is used for Inflammatory skin disease responsive to medications which are applied directly to the skin, when bacterial infection is present or suspected. How Dynavate-N Cream works It is responsible for anti-inflammatory effects to topical application of corticosteroid. Before you use Dynavate-N Cream - When you must not use it Do not use this cream if: - Skin diseases - Acne - Inflammation around mouth - Viral infections (such as herpes simplex, chickenpox). - Hypersensitivity to the preparation. - In the treatment of skin changes due to disease caused by infection with fungi or bacteria. - Infections due to yeast. - Skin disease in children under 1 year of age, including dermatitis and napkin eruptions. Pregnancy and lactation Do not take Dynavate-N Cream if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Dynavate-N Cream if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - Before you start use it Preparations containing neomycin should not be used for the treatment of otitis externa (condition that causes inflammation (redness and swelling) of the external ear canal) when the ear drum is perforated, because of the risk of ototoxicity (loss of hearing). - Taking other medicines Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. How to use Dynavate-N Cream - How much to use Apply thinly, to the affected parts, two to three times daily. Follow all direction Прочитать полный документ
DYNAVATE-N CREAM MAL19950248AZ DESCRIPTION: CREAM Colour : White Fragrance : Baby Jo CONTENT: Betamethasone 17-Valerate equivalent to Betamethasone .... 0.1% w/w Neomycin Sulphate .................................................... 0.5% w/w (Preservative: Chlorocresol 0.1% w/w) PHARMACODYNAMICS: Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be ultimately responsible for anti-inflammatory effects to topical application of corticosteroid. Neomycin and other aminoglycoside antibiotics interfere with bacterial protein synthesis by binding primarily to the 30S sub-unit of bacterial ribosomes. PHARMACOKINETICS: Corticosteroids in the circulation are extensively bound to plasma proteins, mainly to globulin and less so to albumin. The corticosteroid-binding globulin has high affinity but low binding capacity, which the albumin has low affinity but large binding capacity. Only unbound corticosteroid has pharmacological effects or is metabolised. Corticosteroids are metabolised mainly in the liver but also in the kidney, and are excreted in the urine. The slower metabolism of the synthetic corticosteroids with their lower protein-binding affinity may account for their increased potency compared with the natural corticosteroids. Neomycin is poorly absorbed from the alimentary tract, about 97% of an orally administered dose being excreted unchanged in the faeces. Doses of 3 g by mouth produce peak plasma concentrations of up to 4 µg/ml and absorption is similar after administration by enema. Absorption has also been reported to occur from the peritoneum, respiratory tract, bladder, wounds, and inflammed skin. Once neomycin is absorbed it is rapidly excreted by the kidneys in the active form. It has been reported to have a half-life of 2 to 3 hours. INDICATION: Inflammatory dermatoses responsive to topical Прочитать полный документ