البلد: جنوب أفريقيا
اللغة: الإنجليزية
المصدر: South African Health Products Regulatory Authority (SAHPRA)
Sandoz South Africa (Pty) Ltd
See ingredients
INJECTION
EACH VIAL CONTAINS MEROPENEM TRIHYDRATE EQUIVALENT TO MEROPENEM 1,0 g
Canceled
2017-09-04
RANBAXY PHARMACEUTICALS (PTY) LTD INJECTION, 500 MG & 1 G MERCIDE 500/ MERCIDE 1 G (MEROPENEM) DATE OF AMENDMENT: APRIL 2021 Page 1 of 11 1.5.5 CLEAN PROPOSED PATIENT INFORMATION LEAFLET SCHEDULING STATUS: MERCIDE 500 (Injection) MERCIDE 1 G (Injection) Meropenem Sugar free READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN MERCIDE Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist, nurse or other health care provider. MERCIDE has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours WHAT IS IN THIS LEAFLET 1. What MERCIDE is and what it is used for 2. What you need to know before you are given MERCIDE 3. How MERCIDE will be administered 4. Possible side effects 5. How to store MERCIDE 6. Contents of the pack and other information S4 RANBAXY PHARMACEUTICALS (PTY) LTD INJECTION, 500 MG & 1 G MERCIDE 500/ MERCIDE 1 G (MEROPENEM) DATE OF AMENDMENT: APRIL 2021 Page 2 of 11 1. WHAT MERCIDE IS AND WHAT IT IS USED FOR MERCIDE contains meropenem. Meropenem belongs to a group of medicines known as carbapenem antibiotics. MERCIDE is used for treatment of a variety of infections caused by susceptible bacteria. MERCIDE is used to treat the following in adults and children aged 3 months and older: Infection affecting the lungs (pneumonia) Complicated urinary tract infections Inflammatory infections affecting the pelvic area Skin Infections Acute bacterial infection of the brain (meningitis) A serious bloodstream infection (Septicaemia) Infections in the abdomen MERCIDE may be used in the management of neutropenic patients 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE MERCIDE MERCIDE SHOULD NOT BE ADMINISTERED TO YOU IF: if you have ever had an allergic reaction to meropenem or to any of the ingredient in MERCIDE listed in section 6 of the leaflet (an allergic reaction may include skin rash, itching, swelling o اقرأ الوثيقة كاملة
RANBAXY PHARMACEUTICALS (PTY) LTD INJECTION, 500 MG & 1 G MERCIDE 500/ MERCIDE 1 G (MEROPENEM) DATE OF AMENDMENT: APRIL 2021 Page 1 of 21 1.5.5 CLEAN PROPOSED PROFESSIONAL PRESCRIBING INFORMATION SCHEDULING STATUS 1. NAME OF THE MEDICINE MERCIDE 500 (Injection) MERCIDE 1 G (Injection) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MERCIDE 500 Each vial contains: Meropenem (sterile) equivalent to anhydrous meropenem 500 mg. Sugar free MERCIDE 1 G Each vial contains: Meropenem (sterile) equivalent to anhydrous meropenem 1g. Sugar Free 3. PHARMACEUTICAL FORM White to pale yellow crystalline powder in clear glass vial. After reconstitution a clear, colourless to pale yellow coloured solution is formed. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS MERCIDE is indicated for treatment of the following infections caused by single or multiple susceptible bacteria and as empiric therapy prior to the identification of the causative organisms: ACUTE EXACERBATION OF CHRONIC BRONCHITIS AND PNEUMONIA DUE TO: _Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus spp, Escherichia _ _coli, Haemophilus influenzae, Haemophilus parainfluenzae, Pseudomonas aeruginosa, _ S4 RANBAXY PHARMACEUTICALS (PTY) LTD INJECTION, 500 MG & 1 G MERCIDE 500/ MERCIDE 1 G (MEROPENEM) DATE OF AMENDMENT: APRIL 2021 Page 2 of 21 _Branhamella catarrhalis, Klebsiella pneumoniae, Klebsiella spp, Enterobacter cloacae, _ _Enterobacter spp., Acinetobacter. _ PNEUMONIA IN CHILDREN DUE TO: _Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, _ _Pseudomonas aeruginosa. _ URINARY TRACT INFECTIONS IN ADULTS AND CHILDREN, INCLUDING COMPLICATING INFECTIONS DUE TO: _Escherichia coli, Haemophilus influenzae, Pseudomonas aeruginosa, Enterobacter _ _cloacae, Morganella morganii, Proteus mirabilis, Serratia marcescens, Citrobacter _ _freundii. _ PELVIC INFLAMMATORY DISEASE (INCLUDING TUBO-OVARIAN ABSCESS) AND ENDOMETRITIS DUE TO: _Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus haemolyticus, _ _Staphylococcus spp., Staphy اقرأ الوثيقة كاملة