Meropenem - Iv (Merrem)

Trade Name : MERREM

Pfizer Laboratories Div Pfizer Inc

INJECTION

Strength 500 mg/20mL

MEROPENEM Carbapenems [CS],Penem Antibacterial [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Meropenem - Iv (Merrem) which is also known as MERREM and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 500 mg/20mL per ml. Read more

Meropenem - Iv (Merrem) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • MERREM IV is a penem antibacterial indicated for the treatment of:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM IV and other antibacterial drugs, MERREM IV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ()
  • Complicated intra-abdominal infections (adult and pediatric patients). ()
  • Bacterial meningitis (pediatric patients 3 months of age and older only). ()
  • Pediatric patients 3 months of age and older
  • Pediatric patients less than 3 months of age
  • 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. When treating infections caused by , a dose of 1 gram every 8 hours is recommended. ()
  • 1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. ()
  • 1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. ()
  • Dosage should be reduced in adult patients with renal impairment. ()
  • Single dose clear glass vials of MERREM IV containing 500 mg or 1 gram (as the trihydrate blended with anhydrous sodium carbonate for re-constitution) of sterile meropenem powder.
  • 500 mg meropenem for Injection Vial ()
  • 1 gram meropenem for Injection Vial ()
  • MERREM IV is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (u03b2)-lactams.
  • Known hypersensitivity to product components or anaphylactic reactions to u03b2-lactams. ()
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  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving u03b2-lactams. ()
  • Severe cutaneous adverse reactions have been reported in patients receiving MERREM IV. ()
  • Seizures and other adverse CNS experiences have been reported during treatment. ()
  • Co-administration of MERREM IV with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. (, )
  • Clostridium difficile-
  • In patients with renal dysfunction, thrombocytopenia has been observed. ()
  • The following are discussed in greater detail in other sections of labeling:
  • Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • Co-administration of MERREM IV with probenecid inhibits renal excretion of meropenem and is therefore not recommended. ()
  • The concomitant use of MERREM IV and valproic acid or divalproex sodium is generally not recommended. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. (, )
  • No data
  • Renal Impairment: Dose adjustment is necessary, if creatinine clearance is 50 mL/min or less. (, )
  • In mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.
  • Intentional overdosing of MERREM IV is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours. At this dosage, no adverse pharmacological effects or increased safety risks have been observed.
  • Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. Consider symptomatic treatments. In individuals with normal renal function, rapid renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.
  • MERREM IV (meropenem for injection) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is CHNOSu22193HO with a molecular weight of 437.52. Its structural formula is:
  • MERREM IV is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.
  • When re-constituted as instructed, each 1 gram MERREM IV vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg MERREM IV vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [].
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  • MERREM IV is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20u00b0u201325u00b0C (68u00b0u201377u00b0F) [see USP].
  • 500 mg Injection Vial (NDC 0069-0313-01) Pack of 10 u00d7 500 mg Injection Vials (NDC-0069-0313-10)1 gram Injection Vial (NDC 0069-0314-01)Pack of 10 u00d7 1 g Injection Vials (NDC-0069-0314-10)
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  • LAB-1020-3.0
  • NDC 0069-0314-01For Intravenous Use Only
  • MERREM IVmeropenem for injection
  • 1 gmeropenem equivalent
  • Pfizer Injectables
  • 1 g
  • For Intravenous Use Only
  • MERREM IVmeropenem for injection
  • 1 g meropenem equivalent
  • NDC 0069-0313-01For Intravenous Use Only
  • MERREM IVmeropenem for injection
  • 500 mg meropenem equivalent
  • Pfizer Injectables
  • 500 mg
  • For Intravenous Use Only
  • MERREM IVmeropenem for injection
  • 500 mg meropenem equivalent

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