Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
MEROPENEM AS TRIHYDRATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J01DH02
POWDER FOR SOLUTION FOR INJECTION
MEROPENEM AS TRIHYDRATE 1000 MG/VIAL
I.V
Required
ASTRA ZENECA UK LIMITED
MEROPENEM
MEROPENEM
Meronem is indicated for treatment in adults and children of the following severe infections caused by single or multiple susceptible bacteria sensitive to meropenem: - Pneumonias and nosocomial pneumonias. - Pulmonary infections in patients with cystic fibrosis. - Urinary tract infections. - Intra-abdominal infections. - Gynecological infections such as endometritis and pelvic inflammatory disease. - Skin and skin structure infections. - Meningitis. - Septicemia. Meronem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections. There is no experience in pediatric patients with neutropenia or primary or secondary immunodeficiency.
2012-01-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור :ךיראת 29.12.2013 םש רישכת :תילגנאב MERONEM 500MG MERONEM 1G רפסמ םושיר 1041128624 1040828622 םש לעב םושירה : הקינזהרטסא מ"עב )לארשי( אפורל ןולע םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח CONTRAIN DICATION Hypersensitivity to any other carbapenem antibacterial agent . Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins Special warnings and special precautio ns for use Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8) . Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) lactation Meropenem has been reported to be excreted in human milk Undesir able Effects Frequency adverse reaction Renal and urinary disorders Uncommon Blood creatinine increased, blood urea increased Reporting Rate of Adverse Reactions (data derived from a combination of post-marketing clinical trial and spontaneous sources) General disorders and administration site conditions Not known Pain at the injection site Incomp atibilitie s Meronem should not be mixed with or added to other drugs Meronem is compatible with the following infusion fluids: 0.9% Sodium Chloride solution 5% or 10% Glucose solution 5% Glucose solution with 0.02% Sodium Bicarbonate 5% Glucose and 0.9% Sodium Chloride solution 5% Glucose with 0.225% Sodium Chloride solution 5% Glucose with 0.15% Potassium Chloride solution Mannitol 2.5% or 10% solution. Meronem should not be mixed with or added to other drugs Meronem is compatible with the following infusion fluids: 0.9% Sodium Chloride solution 5% or 10% Glucose solution Baca dokumen lengkap
Meronem LPD CC 12032020 Page 1 of 16 2017-0028183, 2017-0028195, 2017-0028196, 2017-0034326, 2017-0034646,2018-0036353 MERONEM 500MG MERONEM 1G 1. NAME OF THE MEDICINAL PRODUCT Meronem 500mg Meronem 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Meronem 500mg Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Excipients with known effect: Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). Meronem 1 g 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 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meronem IV is indicated for treatment, in adults and children, of the following infections caused by single or multiple bacteria sensitive to meropenem. Meronem LPD CC 12032020 Page 2 of 16 2017-0028183, 2017-0028195, 2017-0028196, 2017-0034326, 2017-0034646,2018-0036353 • Pneumonias and Nosocomial Pneumonias • Pulmonary infections in patients with cystic fibrosis • Urinary Tract Infections • Intra abdominal Infections • Gynaecological Infections, such as endometritis and pelvic inflammatory disease • Skin and Skin Structure Infections • Meningitis • Septicaemia Meronem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections. There is no experience in paediatric patients with neutropenia or primary or secondary immunodeficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient. The recommended daily dosage is as follows: 500 mg IV every 8 hours in the treatment of pneumonia, UTI, gyna Baca dokumen lengkap