Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Meropenem Trihydrate
Star Pharmasin Ltd
J01DH02
Meropenem Trihydrate
1 gram(s)
Powder for solution for injection/infusion
meropenem
Not marketed
2020-12-18
Size : 450 x 380 mm 500 mg (milligrams) 1 g (gram) 1.5 g 10 ml (millilitres) 20 ml 30 ml DOSE OF MEROPENEM AMOUNT OF ‘WATER FOR INJECTIONS’ NEEDED FOR DILUTION 2 g 40 ml PACKAGE LEAFLET: INFORMATION FOR THE USER - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. WHAT IS IN THIS LEAFLET 1. What Meropenem Star Pharmasin is and what it is used for READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 3. How to use Meropenem Star Pharmasin 4. Possible side effects 2. What you need to know before you use Meropenem Star Pharmasin 5. How to store Meropenem Star Pharmasin 6. Contents of the pack and other information • Infection affecting the lungs (pneumonia) • Lung and bronchial infections in patients suffering from cystic fibrosis • Infections that you can catch during or after the delivery 1. WHAT MEROPENEM STAR PHARMASIN IS AND WHAT IT IS USED FOR Meropenem Star Pharmasin contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections. Meropenem Star Pharmasin is used to treat the following in adults and children aged 3 months and older: • Complicated infections in the abdomen • Complicated urinary tract infections In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem. • Probenecid (used to treat gout). • Oral anti-coagulant agent (used to treat or prevent blood clots). Tell your doctor, pharmac Baca dokumen lengkapnya
Health Products Regulatory Authority 18 December 2020 CRN008TSX Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meropenem Star Pharmasin 1 g Powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. Excipients with known effect: Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4 mEq of sodium (approximately 90.2 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to slight yellow crystalline powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meropenem Star Pharmasin is indicated for the treatment of the following infections in adults and children aged 3 months and older (see sections 4.4 and 5.1): • Severe pneumonia, including hospital and ventilator-associated pneumonia. • Broncho-pulmonary infections in cystic fibrosis • Complicated urinary tract infections • Complicated intra-abdominal infections • Intra- and post-partum infections • Complicated skin and soft tissue infections • Acute bacterial meningitis Meropenem Star Pharmasin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The tables below provide general recommendations for dosing. The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types o Baca dokumen lengkapnya