Ertapenem for Injection 500mg (Erataj)

Ertapenem for Injection 500mg Technical Specification:

Product Name:Ertapenem for Injection 500mg
Brand Name:Erataj
Strength:1gm, 500mg
Dosage Form:Lyophilized Powder Injection (Sterile) *No-preservative
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V./I.M use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Carbapenem
Indication: Ertapenem injection is used to treat certain serious infections, including pneumonia and urinary tract, skin, pelvic, and stomach infections, that are caused by bacteria.
Storage:Store below 25°C. Protect from light and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ertapenem for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ertapenem for Injection 500mg
    Each vial Contains:
    (Sterile) Ertapenem Sodium
    Eq. to Anhydrous Ertapenem ……………500mg
    Excipients…………………………………………q. s
    Sterilised Water for Injection BP…………….10ml

THERAPEUTIC INDICATION:

Ertapenem injection is used to treat certain serious infections, including pneumonia and urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of infections following colorectal surgery.

Ertapenem is also used to prevent infection in people having certain types of surgery.

DIRECTION OF USE:

Use immediately after dissolving the contents.
For IV use: The reconstituted solution should be used within 6 hours of preparation if stored below 25°C or within 24 hours if stored under refrigeration (at 5°C). The solution of Erataj should not be frozen.
Refer package insert for reconstitution and administration.
For IM use: The reconstituted IM solution should be used within 1 hour of preparation.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible after dissolving the contents, please do not use the solution.
Improper storage may deteriorate the product.

Do not use solvent or infusion fluids containing dextrose for reconstitution or administration of ertapenem.
MUST BE RECONSTITUTED AND FURTHER DILUTED PRIOR TO USE.

DO NOT SKIP ANY DOSES AND FINISH THE FULL COURSE OF TREATMENT EVEN IF YOU FEEL BETTER.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

WARNING: It is dangerous to take this preparation except under medical supervision.
To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C, Protect from light and moisture. Do not freeze.

KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Use only after reading the directions on the package insert.

DOSAGE: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a standout choice for Ertapenem for Injection due to its unwavering commitment to quality and safety. The company’s rigorous quality control measures ensure that Ertapenem for Injection meets the highest industry standards, guaranteeing its safety and efficacy. With a proven track record of delivering reliable and effective medications globally, Taj Pharmaceuticals has earned the trust of healthcare providers and patients alike. Moreover, Taj Pharmaceuticals prioritizes research and development, continually optimizing its products for therapeutic efficacy. This dedication to innovation ensures that their medications, including Ertapenem for Injection, are designed to meet evolving healthcare needs. The company’s global presence and extensive distribution network make essential medications accessible to patients worldwide, promoting healthcare accessibility.

Affordability is another key facet of Taj Pharmaceuticals’ approach. They offer cost-effective solutions, ensuring that critical medications remain within reach for individuals without compromising on quality. The company’s customer-centric approach emphasizes exceptional service and support, fostering a positive healthcare experience for both healthcare professionals and patients. Furthermore, Taj Pharmaceuticals is committed to environmental responsibility, implementing sustainable manufacturing practices to minimize its ecological footprint. By choosing Taj Pharmaceuticals for Ertapenem for Injection, individuals are selecting a reliable healthcare partner dedicated to quality, safety, affordability, and customer satisfaction, with a mission to prioritize the health and well-being of patients.

What is Ertapenem for Injection And its uses:

Ertapenem for Injection, 1gm, is a medication that contains the active ingredient ertapenem. It belongs to a class of antibiotics known as carbapenems and is primarily used to treat a wide range of bacterial infections. Here’s an overview of Ertapenem for Injection and its uses:

  • Antibiotic Medication: Ertapenem is a powerful broadspectrum antibiotic. It is administered via intravenous (IV) or intramuscular (IM) injection to effectively target and combat various bacterial infections.
  • Bacterial Infections: Ertapenem for Injection is prescribed for the treatment of various bacterial infections, including but not limited to:
    Intraabdominal Infections: It is used to treat intraabdominal infections, such as appendicitis, peritonitis, and abscesses, often caused by a range of bacteria.
    Skin and Soft Tissue Infections: Ertapenem can be used to treat skin and soft tissue infections, including cellulitis, diabetic foot infections, and surgical site infections.
    Urinary Tract Infections: It may be prescribed for complicated urinary tract infections (UTIs) when other antibiotics are not effective.
    Community-acquired pneumonia: In some cases, Ertapenem can be used for the treatment of communityacquired pneumonia in adults.
    Gynecological Infections: It can also be employed in the management of gynecological infections like pelvic inflammatory disease (PID).
  • BroadSpectrum Activity: Ertapenem exhibits broadspectrum antibacterial activity against a wide range of Grampositive and Gramnegative bacteria, making it suitable for various types of infections.
  • Hospital and Healthcare-associated Infections: Ertapenem is sometimes used in hospital settings to treat infections that may be acquired during hospital stays or healthcare procedures.
  • Intravenous or Intramuscular Administration: Ertapenem for Injection is typically administered by a healthcare professional as an IV infusion or IM injection, ensuring rapid and effective delivery of the medication into the bloodstream.

It’s important to note that Ertapenem for Injection should only be prescribed by a healthcare provider who has carefully considered the type of infection, the causative bacteria, and the patient’s overall health. The duration of treatment and dosage will vary depending on the specific infection being treated. Ertapenem works by inhibiting the formation of bacterial cell walls, ultimately leading to the death of susceptible bacteria. Its broad spectrum of activity makes it a valuable choice in the treatment of various bacterial infections. As with all antibiotics, it should be used with caution and only as prescribed by a healthcare provider to minimize the development of antibiotic resistance and potential side effects.

How Does Ertapenem for Injection Work?

Ertapenem for Injection works as a potent antibiotic by disrupting the growth and survival of susceptible bacteria. It belongs to the carbapenem class of antibiotics, which are known for their broad-spectrum activity against a wide range of Gram-positive and Gram-negative bacteria. Here’s how Ertapenem works:

  • Inhibition of Cell Wall Synthesis: Bacterial cells have a protective outer layer called the cell wall, which gives them structural integrity and shape. Ertapenem interferes with the synthesis of the bacterial cell wall by inhibiting an enzyme called penicillin-binding protein (PBP). PBPs are crucial for cross-linking the components of the cell wall. When Ertapenem binds to PBPs, it disrupts the formation of these cross-links.
  • Weakening the Cell Wall: As a result of the inhibition of PBP activity, the bacterial cell wall becomes weak and structurally compromised. This makes the bacterial cell more susceptible to osmotic pressure changes and external stresses.
  • Cell Lysis and Death: Without a stable and intact cell wall, the bacterial cell becomes unable to maintain its shape and withstand osmotic pressure. This ultimately leads to cell lysis, where the cell membrane ruptures, causing the release of cellular contents. Bacterial cell lysis results in the death of the bacterium.
  • Broad-Spectrum Activity: Ertapenem’s mechanism of action makes it effective against a wide range of bacteria, including both Gram-positive (e.g., Streptococcus and Staphylococcus) and Gram-negative (e.g., Escherichia coli and Klebsiella) species. It is particularly valuable in treating infections caused by multidrug-resistant bacteria.

Ertapenem for Injection is typically administered intravenously (IV) or intramuscularly (IM) to ensure rapid and reliable delivery into the bloodstream. Once in the bloodstream, it can effectively target and combat bacterial infections throughout the body. It’s important to note that Ertapenem is a prescription antibiotic and should only be used under the guidance of a healthcare provider. The choice of Ertapenem as a treatment depends on the specific infection, the suspected or identified bacteria causing the infection, and the patient’s medical history and condition. Antibiotics should be taken as prescribed and for the entire course of treatment to ensure the complete eradication of the infection and to minimize the risk of antibiotic resistance.

Benefits of Ertapenem for Injection:

  • Broad-Spectrum Antibiotic: Ertapenem is effective against a wide range of both Gram-positive and Gram-negative bacteria. This broad-spectrum activity makes it a valuable choice for treating various types of bacterial infections.
  • Treatment of Complicated Infections: Ertapenem is particularly useful in treating complicated infections, including intra-abdominal infections, skin and soft tissue infections, urinary tract infections, and gynecological infections. It is also employed in the management of hospital and healthcare-associated infections.
  • Multidrug-Resistant Bacteria: Ertapenem can be effective against bacteria that have become resistant to other antibiotics. This makes it an important option when dealing with infections caused by multidrug-resistant pathogens.
  • Convenient Administration: Ertapenem can be administered intravenously (IV) or intramuscularly (IM) by healthcare professionals, providing flexibility in the method of delivery based on the patient’s condition and clinical setting.

Common Side Effects of Ertapenem for Injection:

  • Gastrointestinal Symptoms: Common side effects may include nausea, vomiting, diarrhea, and abdominal pain. These gastrointestinal symptoms can usually be managed with supportive care.
  • Injection Site Reactions: For intramuscular administration, patients may experience injection site reactions, such as pain, swelling, or redness at the injection site.
  • Headache: Some individuals may experience headaches while receiving Ertapenem treatment.
  • Rash and Allergic Reactions: Although less common, skin rashes and allergic reactions are possible side effects. Severe allergic reactions, while rare, should be reported immediately to a healthcare provider.
  • Changes in Liver Enzymes: Ertapenem can affect liver function and may lead to elevated liver enzyme levels in some patients. Regular monitoring of liver function is typically recommended.
  • Diarrhea Associated with Clostridium difficile: In some cases, Ertapenem treatment may lead to diarrhea associated with Clostridium difficile infection, a potentially severe condition. It should be promptly reported to a healthcare provider.
  • Central Nervous System Effects: Some patients may experience central nervous system (CNS) effects, such as confusion or seizures, although these are rare.
  • Hypersensitivity Reactions: Allergic reactions, including severe hypersensitivity reactions, may occur. These can manifest as skin rash, fever, or other allergic symptoms and require immediate medical attention.

Frequently Asked Questions About Ertapenem for Injection:

Certainly, here are some frequently asked questions (FAQs) about Ertapenem for Injection:

  • What is Ertapenem for Injection?

Ertapenem for Injection is a prescription antibiotic medication that contains the active ingredient ertapenem. It is used to treat a wide range of bacterial infections.

  • How does Ertapenem work?

Ertapenem works by inhibiting the synthesis of the bacterial cell wall, leading to the weakening and eventual death of susceptible bacteria. It is effective against both Gram-positive and Gram-negative bacteria.

  • What types of bacterial infections can Ertapenem be used to treat?

Ertapenem is used to treat a variety of infections, including complicated intraabdominal infections, skin and soft tissue infections, urinary tract infections, gynecological infections, and certain respiratory tract infections.

  • Is Ertapenem effective against drug-resistant bacteria?

Yes, Ertapenem is known for its effectiveness against some multidrug-resistant bacteria, making it a valuable option in cases where other antibiotics may not work.

  • How is Ertapenem for Injection administered?

Ertapenem can be administered either intravenously (IV) or intramuscularly (IM) by a healthcare professional, depending on the patient’s condition and the clinical setting.

  • What should I do if I miss a dose of Ertapenem?

If you miss a dose of Ertapenem, contact your healthcare provider or nurse as soon as possible to discuss the best course of action. It may be necessary to adjust the dosing schedule.

  • Are there any potential side effects of Ertapenem for Injection?

Yes, Ertapenem may have side effects, including gastrointestinal symptoms (nausea, vomiting, diarrhea), headache, injection site reactions, skin rash, and, in rare cases, allergic reactions. Always inform your healthcare provider of any unusual symptoms.

  • Can Ertapenem cause antibiotic resistance?

The development of antibiotic resistance is a concern with any antibiotic. To minimize this risk, Ertapenem should be used as prescribed by a healthcare provider and only for the duration recommended.

  • Is it safe to use Ertapenem during pregnancy or while breastfeeding?

Ertapenem should be used during pregnancy or breastfeeding only if the potential benefits outweigh the potential risks. Consult with your healthcare provider for guidance.

  • Can I drink alcohol while taking Ertapenem?

It’s generally advisable to avoid alcohol while taking antibiotics, including Ertapenem. Alcohol can interact with medications and potentially affect their efficacy.

As Ertapenem for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Ertapenem for Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Ertapenem for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Ertapenem for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ertapenem for Injection 1gm
B) Ertapenem for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ertapenem for Injection 1gm
a) Each vial Contains:
(Sterile) Ertapenem Sodium
Eq. to Anhydrous Ertapenem ……...……1gm
Excipients…………………………………………q. s
b) Sterilised Water for Injection BP…………….10ml

B) Ertapenem for Injection 500mg
a) Each vial Contains:
(Sterile) Ertapenem Sodium
Eq. to Anhydrous Ertapenem ……500mg
Excipients…………………………………….…q. s
b) Sterilised Water for Injection BP…………...10ml


THERAPEUTIC INDICATIONS:

Ertapenem injection is used to treat certain serious infections, including pneumonia and urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of infections following colorectal surgery.
Ertapenem is also used to prevent infection in people having certain types of surgery.

DIRECTION OF USE:

Use immediately after dissolving the contents.
For IV use:
The reconstituted solution should be used within 6 hours of preparation if stored below 25°C or within 24 hours if stored under refrigeration (at 5°C). Solution of Erataj should not be frozen. Refer package insert for reconstitution and administration.
For IM use:
The reconstituted IM solution should be used within 1 hour of preparation.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible after dissolving the contents, please do not use the solution.
Improper storage may be deteriorated the product.
Do not use solvent or infusion fluids containing dextrose for reconstitution or administration of ertapenem.
MUST BE RECONSTITUTED AND FURTHER DILUTED PRIOR TO USE.
DO NOT SKIP ANY DOSES AND FINISH THE FULL COURSE OF TREATMENT EVEN IF YOU FEEL BETTER.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except under medical supervision.
To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE & DOSAGE:

STORAGE: Store below 25°C, Protect from light and moisture. Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Use only after reading the directions on the pack insert.
DOSAGE: As directed by Physician.

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