English Русский   
Produsele noastre

Toate produsele
Tractul digestiv şi Metabolism
Preparate antimicrobiene de uz sistemic
Preparate antiparazitare
Organe hematopoietice şi single
Sistemul Cardiovascular
Dermatologia
Sistemul Uro-genital
Sistemul locomotor
Sistemul Nervos
Sistemul Respirator
Preparate planificate




Antiinfectives for Systemic Use

Replonem (Injections)
(Meropenem)



CONTENT:
One vial contains meropenem (as a trihydrate) 500mg or 1000mg.

PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Meropenem is a synthetic carbapenem antibiotic. Meropenem is stable against hydrolysis by renal dehydropeptidase 1(DHP-1) and does not require concomitant administration of DHP-1 inhibitor cilastatin. The antibacterial activity of meropenem results from inhibition of bacterial cell wall synthesis. Meropenem usually is bactericidal in action. Meropenem has a broad spectrum of antibacterial activity and is active against most of the clinically important gram-positive and gram- negative bacteria and some anaerobic bacteria. PHARMACOKINETICS. Meropenem is distributed into most body tissues and fluids, including bronchial mucosa, lung, bile, gynecologic tissue (endometrium, myometrium, ovary, cervix, fallopian tube), muscle, heart valves, skin, interstitial and peritoneal fluid, and CSF. Plasma protein binding is approximately 2%. The drug is partially metabolized to at least one microbiologically inactive metabolite. About 70% of an IV dose is eliminated in urine as unchanged drug by tubular secretion and glomerular filtration. The plasma half-life of meropenem is approximately 1 hour.
 
THERAPEUTIC INDICATIONS:
The drug is indicated for the treatment of polymicrobial and mixed infections, caused by
sensitive strains of aerobic and anaerobic bacteria and also for first-line therapy before
the identification of causative agents. The drug is indicated for the treatment of such
conditions as:
- intra-abdominal Infections;
- community-acquired pneumonia;
- nosocomial pneumonia;
- septicemia;
- skin and skin structure infections; urinary tract infections;
meningitis;
- empiric therapy in febfile neutropenia;
- meropenem can be used as monotherapy or in combination with other agents for treatment of polymicrobial infections.
 
CONTRAINDICATIONS:
Known hypersensitivity to meropenem, other carbapenems, or any ingredient in the formulation.
History of anaphylactic reaction to |3-lactams.
 
DOSAGE AND ADMINISTRATION:
Meropenem is administered by IV injection for 3-5 minutes or IV infusion for 15-30 minutes. For direct intermittent IV injection, 10 or 20 mL of sterile water for injection should be added to a vial labeled as containing 500 mg or 1 g, respectively, of to provide a solution containing approximately 50 mg/mL. For IV infusion, vials, labeled as containing 500 mg or 1 g of meropenem, should be diluted in a compatible IV solution. Alternatively, vials labeled as containing 500 mg or 1 g may be reconstituted as directed for direct intermittent IV injection and the resulting solution added to an IV container and further diluted with a compatible Ivsolution. Usage in adult patients. The usual adult dosage of meropenem for the treatment of intraabdominal infections is 1 g every 8 hours. For the treatment of pneumonia 1 g every 8 hours is recommended. For the treatment of bacterial meningitis dosage of 40 mg/kg every 8 hours daily (up to 6 g daily) is used. The usual adult dosage of meropenem for the treatment of complicated skin and skin structure infections is 500 mg every 8 hours. Use in pediatric patients. Children with weight more than 50 kg should receive the usually recommended adult dose of meropenem. For the treatment of intra-abdominal infections, children 3 months of age and older weighing 50 kg or less should receive 20 mg/kg (up to 1 g) every 8 hours. For the treatment of meningitis, children 3 months of age and older weighing 50 kg or less should receive 40 mg/kg (up to 2 g) every 8 hours. For the treatment of complicated skin and skin structure infections, children 3 months of age and older weighing 50 kg or less should receive 10 mg/kg (up to 500 mg) every 8 hours. Dosage of meropenem should be modified according to the degree of renal impairment in adults with creatinine clearances of 50 mL/minute or less. Adults with creatinine clearances of 26-50 mL/minute can receive the usual dose every 12 hours, those with creatinine clearances of 10-25 mL/minute can receive half the usual dose every 12 hours, and those with creatinine clearances less than 10 mL/minute can receive half the usual dose every 24 hours.
 
PACKAGING:
Vial in internal carton package.
10 internal carton packages with leaflet in carton
 
 
Pagina principală    |     Contacte    |     Ului    |     Intimitatea politica    |     Termenii si conditiile
 
 
"Rotapharm" Toate drepturile rezervate