País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOXACILLIN SODIUM
KOMEDIC SDN BHD
CLOXACILLIN SODIUM
1000 Capsules
MEDOCHEMIE LTD (Factory B)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MONOCLOX CAPSULE Cloxacillin sodium (250mg) 1 WHAT IS IN THIS LEAFLET 1. What Monoclox is used for 2. How Monoclox works 3. Before you use Monoclox 4. How to use Monoclox 5. While you are using it 6. Side effects 7. Storage and disposal of Monoclox 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MONOCLOX IS USED FOR Monoclox capsules is used to treat many different types of bacterial infections. Monoclox capsules treats infections of the skin, soft tissue, heart, lungs, urinary tract, bone, muscles, joints and intestines. HOW MONOCLOX WORKS Monoclox capsule contains the active ingredient cloxacillin. Cloxacillin is an antibiotic in penicillin class. It acts by inhibiting bacterial cell-wall formation and subsequently killing the bacteria. _ _ BEFORE YOU USE MONOCLOX _- When you must not use it _ - Do not take Monoclox if you are allergic (hypersensitive) to cloxacillin, to penicillins, cephalosporins or any other ingredients of this medicine (listed in Product Description) - Do not give Monoclox to children below 6 years old _ _ _- Before you start to use it _ Monoclox may cause severe allergy and serious skin reactions. Stop using Monoclox and seek medical assistance immediately if you experience any of the following symptoms: - skin reddening, blisters, rash, fever, sore throat or eye irritation Tell your doctor or pharmacist: - if you have ever had an allergic reaction to another penicillin, cephalosporin, carbapenem, other beta-lactam or any other antibiotics. - if you suffer from kidney or liver disorders - if you develop severe watery or bloody diarrhoea, even if it occurs several weeks after you have stopped taking this medicine - if you have or had history of seizure or brain infection _Pregnancy and breast-feeding _ Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast- feeding before using any medicine. If you are pregnant, please take Monoclox capsule with caution Llegiu el document complet
spccloxcaps4.1-CY 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MONOCLOX 250mg hard gelatin capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250mg of cloxacillin as cloxacillin sodium monohydrate. Excipients with known effect: sunset yellow, sodium. Each capsule contains 0.16 mg sunset yellow and 13.2 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gelatine Capsule Οrange/orange printed “Medochemie” hard gelatin capsules for oral administration 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Monoclox is indicated for the treatment of infections caused by gram-positive microorganisms including infections caused by penicillin-resistant staphylococci:- Skin and soft tissue infections: boils, abscesses, carbuncles, furunculosis, infected wounds, infected burns Infected skin conditions like ulcers, eczema or acne Respiratory tract infections Osteomyelitis, enteritis, endocarditis UTI 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual dose of cloxacillin is the equivalent of 500mg four times daily by mouth or 250mg in 1.5ml of water for injection or if necessary 0.5% lignocaine hydrochloride solution, by intramuscular injection every 4 to 6 hours. The equivalent of 500mg in 10ml of water for injections may be given by slow intravenous injection over 3 to 4 minutes every 4 to 6 hours or by intravenous infusion. Cloxacillin has been administered by intra-articular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intraplueral injection in doses of 500mg daily. Using powder for injection, up to 250mg has been dissolved in 3ml of sterile water and inhaled by nebuliser four times daily. Doses may be doubled in severe infections. Children up to 2 years of age may be given one-quarter the adult dose and those aged 2 to 10 years, one-half the adult dose. In staphylococcal meningitis systemic treatment has been supplemented with intrathecal injections of cl Llegiu el document complet