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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
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