দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
METRONIDAZOLE
Maco Pharma (UK) Ltd
J01XD01
METRONIDAZOLE
0.5 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Imidazole derivatives
Authorised
2000-06-23
WHAT IS IN THIS LEAFLET 1. What Metronidazole MacoPharma 0.5%w/v Solution for Infusion is and what it is used for 2. What you need to know before you are given Metronidazole MacoPharma 0.5%w/v Solution for Infusion 3. How Metronidazole MacoPharma 0.5%w/v Solution for Infusion is given 4. Possible side effects 5. How to store Metronidazole MacoPharma 0.5%w/v Solution for Infusion 6. Contents of the pack and other information 1. WHAT METRONIDAZOLE MACOPHARMA 0.5%W/V SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Metronidazole is an antibiotic used in adults and children to treat severe infection caused by certain anaerobic bacteria, ie bacteria which do not live or grow in the presence of oxygen. It may also be used to prevent infection in patients who cannot be treated by mouth. The solution is mainly used in abdominal and gynaecological surgery and will be given to you by slow injection into a vein by a doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN METRONIDAZOLE MACOPHARMA 0.5%W/V SOLUTION FOR INFUSION YOU MUST NOT BE GIVEN this solution if you have ever had: • an ALLERGY (hypersensitivity) to metronidazole or any of the other ingredients in the solution (see Section 6) • ACUTE PANCREATITIS, or pancreatitis as a serious side effect to metronidazole. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse if you: • have LIVER DISEASE (the amount of medicine you are given may be reduced or given less often) • have any disease or condition affecting the BRAIN OR NERVOUS SYSTEM • are receiving the solution intensively, or for MORE THAN 10 DAYS – you will be closely monitored • are PREGNANT, think you may be pregnant, or are BREASTFEEDING Treatment will be stopped if signs of nervous system problems develop. OTHER MEDICINES AND METRONIDAZOLE MACOPHARMA 0.5%W/V SOLUTION FOR INFUSION Tell your doctor if you are taking or have recently taken any other medicines. In particular, the following medicines may affect, or be affected by, metronidazole: • ANTI-COAGULANTS (blood thin সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metronidazole MacoPharma 0.5%w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Metronidazole 500mg/100ml Excipients: contains sodium (as sodium chloride and disodium phosphate anhydrous), 15mmol (340mg) per 100ml dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear pale yellow infusion solution without visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metronidazole is indicated in adults and children for the treatment of severe infections due to anaerobic bacteria and for prophylaxis against such infections in patients for whom oral medication is not practical. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Metronidazole MacoPharma 0.5%w/v Solution for Infusion should be infused intravenously at a rate of approximately 5ml per minute, and should be substituted with oral medication as soon as possible. Metronidazole MacoPharma 0.5%w/v Solution for Infusion may be administered concurrently (but separately) with other appropriate antimicrobial agents in parenteral dosage forms. Treatment of established anaerobic infections: Intravenous medication can be used in patients with severe anaerobic infections for whom oral medication is precluded. Treatment for 7 days should suffice in most cases but this period may be extended depending on clinical and microbiological assessments and the site of infection. Regular clinical and laboratory monitoring is advised if administration continues for more than 10 days (see section 4.4 Warnings and Precautions for Use). Adults: Infuse 500mg (100ml) 8 hourly. Children > 8 weeks to 12 years of age: The usual dai সম্পূর্ণ নথি পড়ুন