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Imipenem And Cilastatin Sodium - Iv (Primaxin)

Trade Name : PRIMAXIN

Merck Sharp & Dohme Corp.

INJECTION, POWDER, FOR SOLUTION

Strength 500500 mg/100mLmg/100mL

IMIPENEM; CILASTATIN SODIUM Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [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 Imipenem And Cilastatin Sodium - Iv (Primaxin) which is also known as PRIMAXIN and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 500; 500 mg/100mL; mg/100mL per ml. Read more

Imipenem And Cilastatin Sodium - Iv (Primaxin) 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

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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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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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  • No data
  • PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria:
  • Limitations of Use:
  • Usage:
  • To reduce the development of drug resistant bacteria and maintain the effectiveness of PRIMAXIN and other antibacterial drugs, PRIMAXIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ().
  • No data
  • The dosage of PRIMAXIN in adult patients should be based on suspected or confirmed pathogen susceptibility ().
  • For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1000 mg every 8 hours OR 1000 mg every 6 hours ().
  • See full prescribing information for dosage recommendations in pediatric patients ().
  • A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min ().
  • Patients with creatinine clearances of less than 15 mL/min should not receive PRIMAXIN unless hemodialysis is instituted within 48 hours ().
  • Reconstitute PRIMAXIN vial with appropriate diluent and dilute the reconstituted suspension with an appropriate infusion solution before administering by intravenous infusion ().
  • For Injection PRIMAXIN is a sterile powder mixture for reconstitution in single-dose containers including vials containing:
  • For Injection: PRIMAXIN is a sterile powder mixture for reconstitution in single-dose containers including vials containing:
  • 500 mg imipenem (anhydrous equivalent) and 500 mg cilastatin sodium ()
  • PRIMAXIN is contraindicated in patients who have shown hypersensitivity to any component of this product.
  • Known hypersensitivity to any component of PRIMAXIN ()
  • No data
  • Hypersensitivity Reactions:
  • Seizure Potential:
  • Increased Seizure Potential Due to Interaction with Valproic Acid:
  • Clostridium difficile-Associated Diarrhea (CDAD):
  • The following serious adverse reactions are described in greater detail in the Warnings and Precautions section.
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The most frequently occurring adverse reactions (u2265 0.2%) in adults were phlebitis, nausea, diarrhea, vomiting, rash, pain injection site, fever, hypotension, seizures, erythema at injection site, dizziness, pruritus, vein induration, urticaria, somnolence ().
  • The most frequently occurring adverse reactions (>1%) in pediatric patients greater than or equal to 3 months of age were diarrhea, rash, phlebitis, gastroenteritis, vomiting, IV site irritation, urine discoloration ().
  • The most frequently occurring adverse reactions (>1%) in neonates to 3 months of age were convulsions, diarrhea, oliguria/anuria, oral candidiasis, rash, tachycardia ().
  • No data
  • Ganciclovir: Generalized seizures have been reported in patients who received ganciclovir. Do not co-administer unless benefit outweighs risk ().
  • Probenecid: Concomitant administration of PRIMAXIN and probenecid results in increases in the plasma level and half-life of imipenem. Concomitant administration is not recommended ().
  • Valproic acid/divalproex sodium: Concomitant use with PRIMAXIN is generally not recommended. Consider other antibacterial drugs to treat infections in patients whose seizures are well-controlled on valproic acid or divalproex sodium (, ).
  • No data
  • Renal Impairment: Dosage adjustment is necessary in patients with renal impairment ().n
  • In the case of overdosage, discontinue PRIMAXIN, treat symptomatically, and institute supportive measures as required. PRIMAXIN is hemodialyzable.
  • PRIMAXIN (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. PRIMAXIN is an antibacterial drug for intravenous administration.
  • Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by . Its chemical name is (5,6)-3-[[2-(formimidoylamino)ethyl]thio]-6-[()-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is CHNOSu2219HO, and its structural formula is:
  • Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium ()-7[[()-2-amino-2-carboxyethyl]thio]-2-[()-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is CHNOSNa, and its structural formula is:
  • PRIMAXIN is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed PRIMAXIN 500 contains 37.5 mg of sodium (1.6 mEq). Solutions of PRIMAXIN range from colorless to yellow. Variations of color within this range do not affect the potency of the product.
  • No data
  • Long term studies in animals have not been performed to evaluate carcinogenic potential of imipenem/cilastatin. A variety of bacterial and mammalian tests were performed to evaluate genetic toxicity. The tests used were: V79 mammalian cell mutagenesis assay (cilastatin sodium alone and imipenem alone), Ames test (cilastatin sodium alone and imipenem alone), unscheduled DNA synthesis assay (imipenem/cilastatin sodium) and mouse cytogenetics test (imipenem/cilastatin sodium). None of these tests showed any evidence of genetic alterations.
  • Impairment of fertility or reproductive performance was not observed in male and female rats given imipenem/cilastatin at intravenous doses up to 80 mg/kg/day and at a subcutaneous dose of 320 mg/kg/day. In rats, a dose of 320 mg/kg/day was approximately equal to the highest recommended human dose based on body surface area.
  • No data
  • No data
  • Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • Copyright u00a9 2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk0787b-iv-1909r043
  • NDC 0006-3514-58
  • 250PRIMAXIN I.V.(IMIPENEM AND CILASTATIN FOR INJECTION)
  • IMIPENEM 250 mg (Anhydrous Equivalent)CILASTATIN EQUIVALENT 250 mgCAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLYNOT FOR DIRECT INFUSION
  • Rx onlyn
  • Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • 3514
  • 1 PACKAGE (25 VIALS)
  • 500PRIMAXIN I.V.(IMIPENEM AND CILASTATIN FOR INJECTION)
  • Not to be divided.
  • tttttttIMIPENEM 500 mg (Anhydrous Equivalent) CILASTATIN EQUIVALENT 500 mgInactive ingredient: sodium bicarbonate 20 mg added to each vial as a buffer.n n For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: Seeaccompanying circular. Color changes in solution from colorless toyellow do not affect potency. Store dry material below 25u00baC. tttttt
  • Rx only
  • Merck Sharp & Dohme Corp., a subsidiary ofn n Whitehouse Station, NJ 08889, USA
  • NDC 0006-3551-58
  • Single-dose ADD-Vantage vial
  • 250
  • PRIMAXIN I.V.
  • (IMIPENEM AND CILASTATIN FOR INJECTION)
  • IMIPENEM 250 mg (Anhydrous Equivalent)CILASTATIN EQUIVALENT 250 mg
  • CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLYNOT FOR DIRECT INFUSION
  • PRIMAXIN is a registered trademark of Merck Sharp & Dohme Corp.
  • ADD-Vantage is a registered trademark of ABBOTT LABORATORIES, Inc.
  • 9960800
  • For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See accompanying circular.
  • Store dry material below 25u00b0C.
  • After constitution as directed, the solution maintains satisfactory potency for 4 hours at room temperature.
  • Consult accompanying INSTRUCTIONS FOR USE.
  • Use only with ADD-Vantage Diluent Containers.
  • Rx only
  • 250 mg | No. 3551
  • Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA
  • NDC 0006-3552-59
  • Single-dose ADD-Vantage vial
  • 500
  • PRIMAXIN I.V.
  • (IMIPENEM AND CILASTATIN FOR INJECTION)
  • IMIPENEM 500 mg (Anhydrous Equivalent)CILASTATIN EQUIVALENT 500 mg
  • CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLYNOT FOR DIRECT INFUSION
  • PRIMAXIN is a registered trademark of Merck Sharp & Dohme Corp.
  • ADD-Vantage is a registered trademark of ABBOTT LABORATORIES, Inc.
  • 9940700
  • For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See accompanying circular.
  • Store dry material below 25u00b0C.
  • After constitution as directed, the solution maintains satisfactory potency for 4 hours at room temperature.
  • Consult accompanying INSTRUCTIONS FOR USE.
  • Use only with ADD-Vantage Diluent Containers.
  • Rx only
  • 500 mg | No. 3552
  • Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA

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