Ertapenem Sodium (Invanz)

Trade Name : INVANZ

Merck Sharp & Dohme Corp.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 1 g/1

ERTAPENEM SODIUM 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 Ertapenem Sodium (Invanz) which is also known as INVANZ and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 1 g/1 per ml. Read more

Ertapenem Sodium (Invanz) 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

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No data

To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ()

To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Treatment
INVANZ is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms n
INVANZ is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria:
INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. ()

Complicated intra-abdominal infections. ()
Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ()
Community-acquired pneumonia. ()
Complicated urinary tract infections including pyelonephritis. ()
Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections. ()

Do not mix or co-infuse INVANZ with other medications. Do not use diluents containing dextrose (u03b1u2013Du2013glucose)
INVANZ should be infused over 30 minutes in both the Treatment and Prophylactic regimens. ()
Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis. (, )
Treatment regimen:u00a0
Prophylaxis regimen for adults:

Vials
INVANZ is a sterile lyophilized powder in a vial containing 1.046u00a0g ertapenem sodium equivalent to 1u00a0g ertapenem for intravenous infusion or for intramuscular injection.

Vial 1 gram. ()

No data

Known hypersensitivity to product components or anaphylactic reactions to u03b2-lactams. ()
Due to the use of lidocaine HCl as a diluent, INVANZ administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. ()

No data

Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving u03b2-lactams. ()
Seizures and other central nervous system adverse experiences have been reported during treatment. ()
Co-administration of INVANZ with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ()
Clostridium difficile
Caution should be taken when administering INVANZ intramuscularly to avoid inadvertent injection into a blood vessel. ()

The following are described in greater detail in the Warnings and Precautions section.
Adults:
The most common adverse reactions (u22655%) in patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. ()
In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials. ()
Pediatrics:
Adverse reactions in this population were comparable to adults. The most common adverse reactions (u22655%) in pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain. ()
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.

No data

Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended. ()
The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials 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 u226430 mL/min/1.73 m. (, , )

No specific information is available on the treatment of overdosage with INVANZ. Intentional overdosing of INVANZ is unlikely. Intravenous administration of INVANZ at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of INVANZ in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.
In the event of an overdose, INVANZ should be discontinued and general supportive treatment given until renal elimination takes place.
INVANZ can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

INVANZ (Ertapenem for Injection) is a sterile, synthetic, parenteral, 1-u03b2 methyl-carbapenem that is structurally related to beta-lactam antibiotics.
Chemically, INVANZ is described as [4-[3(3*,5*),4u03b1,5u03b2,6u03b2(*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is CHNOSNa, and its structural formula is:
Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran.
INVANZ is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6.0 mEq).
Each vial of INVANZ contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.

No data

No data

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No data

Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions may require immediate treatment. Advise patients to report any previous hypersensitivity reactions to INVANZ, other beta-lactams or other allergens.
Patients should be counseled to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with INVANZ. If treatment with INVANZ is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.
Patients should be counseled that antibacterial drugs including INVANZ should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When INVANZ is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by INVANZ or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

MERCK & CO., INC.,
By: Laboratoires Merck Sharp & Dohme-ChibretClermont Ferrand Cedex 9, 63963, France
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk0826-i-2002r024

10 Single dose vials 1 g
NDC 0006-3843-71
FOR INSTRUCTIONS ON RECONSTITUTIONAND DILUTION and USUAL DOSAGE:
See accompanying circular.
Each vial contains 1.046 grams ertapenemsodium, equiv. to 1 gram ertapenem.
INVANZn (ertapenem sodium) IV/IM
FOR INTRAVENOUS ORINTRAMUSCULAR USERx only
Inactive ingredients: 175 mg sodiumbicarbonate and sodium hydroxide toadjust pH to 7.5.
Solutions range from colorless to paleyellow. Variations of color within thisrange do not affect the potency of theproduct.
Do not store lyophilized powder above25u00b0C (77u00b0F).
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
By: Laboratoires Merck Sharp & Dohme-ChibretClermont Ferrand Cedex 9, 63963, France
Formulated in France.

PRINCIPAL DISPLAY PANEL - Single Dose ADD-Vantage Vial Label 1 g
Single dose ADD-Vantagen- vial1 g
Rx only
INVANZ
No. 3845
Each vial contains 1.046 grams ertapenem sodium, equiv. to 1 gram ertapenem.
FOR I.V. USE ONLY
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC., Whitehouse Station, NJ 08889, USA
By: Laboratoires Merck Sharp & Dohme-ChibretClermont Ferrand Cedex 9, 63963, FranceFormulated in France.
510176V190112-13845

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Ertapenem Sodium (Invanz)

Trade Name : INVANZ

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Ertapenem Sodium (Invanz)

Trade Name : INVANZ

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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CONTACT US

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