Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METRONIDAZOLE
PHARMANIAGA MANUFACTURING BERHAD
METRONIDAZOLE
1000 Tablets; 100 Tablets; 500 Tablets
PHARMANIAGA MANUFACTURING BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PHARMANIAGA METRONIDAZOLE TABLET Metronidazole (200mg, 400mg) WHAT IS IN THIS LEAFLET 1. What Pharmaniaga Metronidazole Tablet is used for 2. How it works 3. Before you use Pharmaniaga Metronidazole Tablet 4. How to use Pharmaniaga Metronidazole Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Pharmaniaga Metronidazole Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PHARMANIAGA METRONIDAZOLE TABLET IS USED FOR It is used to treat certain infections caused by bacteria and other organisms in different parts of the body. It is also used to prevent or treat certain infections that may occur during surgery. HOW PHARMANIAGA METRONIDAZOLE TABLET WORKS Pharmaniaga Metronidazole Tablet is an antibiotic that belongs to a group of medicines called nitroimidazoles. This medicine works by killing or stopping the growth of bacteria and other organisms causing these infections. BEFORE YOU USE PHARMANIAGA METRONIDAZOLE TABLET Inform your doctor if you are affected by Cockayne syndrome. Cases of severe liver toxicity/acute liver failure in patients with Cockayne syndrome have been reported with product containing metronidazole. Stop taking Pharmaniaga Metronidazole Tablet and tell your doctor immediately if you develop: stomach pain, decreased appetite, nausea, vomiting, fever, unusual tiredness, yellowing of the skin & the whites of the eyes, dark•coloured urine, light or clay- coloured stools or itching. _-When you must not use it _ Do not use Pharmaniaga Metronidazole Tablet if you have ever had an allergic reaction to: • Pharmaniaga Metronidazole Tablet or any other nitroimidazoles derivation • Trichomoniasis - Individuals having Sexually Transmitted Disease (STD) • Or individuals having a first trimester of pregnancy _Pregnancy and Lactation _ Do not take Pharmaniaga Metronidazole Tablet if you are pregnant, trying to get pregnant or think you may be pregnant without discussing with yo Pročitajte cijeli dokument
TM METRONIDAZOLE TABLET DESCRIPTION _PHARMANIAGA METRONIDAZOLE TABLET 200 MG_ Yellow, round, biconvex, film-coated tablets with ‘RMB’ breakline on one side and plain on the other. _PHARMANIAGA METRONIDAZOLE TABLET 400 MG_ Yellow, round, biconvex tablet with Pharmaniaga icon on one side and plain on the other. COMPOSITION _PHARMANIAGA METRONIDAZOLE TABLET 200 MG_ Each film-coated tablet contains Metronidazole 200 mg. _PHARMANIAGA METRONIDAZOLE TABLET 400 MG_ Each tablet contains Metronidazole 400 mg. ACTIONS Metronidazole is active against most obligate anaerobic bacteria and protozoa by undergoing intracellular chemical reduction via mechanisms unique to anaerobic metabolism within the organism. Reduced metronidazole, which is cytotoxic but short-lived, interacts with microorganisms DNA to cause a loss of helical structure, strand breakage and resultant inhibition of nucleic acid synthesis and cell death. Metronidazole is well absorbed orally with a bioavailability of at least 80%. Peak plasma concentrations of 6, 12 and 40 mcg/mL are achieved within 1 to 2 hours of a 250 mg, 500 mg and 2 g single oral doses respectively. Absorption may be delayed, but is not reduced overall by administration with food. Metronidazole is widely distributed. It appears in most body tissues and fluids including bile, bone, breast milk, saliva, seminal fluid, liver and liver abscesses, lungs and vaginal secretions. It also crosses the placenta and the blood brain barrier. Not more than 20% is bound to plasma proteins. Metronidazole is metabolised in the liver by side-chain oxidation and glucuronide conjugation to 2-hydroxymethyl (also active) and other metabolites. The half-life of metronidazole in normal adults is 8 hours and in patients with alcoholic liver disease 18 hours. Metronidazole and its primarily metabolites are rapidly removed from the blood by haemodialysis but is not significantly removed by peritoneal dialysis. INDICATIONS Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and ma Pročitajte cijeli dokument