Meropenem for Injection USP 1gm Technical Specification:

Product Name:Meropenem for Injection USP 1gm
Brand Name:MEROKEM
Strength:1gm, 2gm, 500mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.V. 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 & Anti-biotics, Carbapenem Antibiotic
Indication: Meropenem is used to used treat severe infections of the skin or stomach. Meropenem is also used to treat bacterial meningitis (infection that causes inflammation of the tissue that covers the brain and spinal cord).
Storage:Store Protected from moisture at a temperature not exceeding 30°C

GENERIC NAME OF MEDICINAL PRODUCT:

  • Meropenem for Injection USP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Meropenem for Injection USP 1gm
    Each vial contains:
    Meropenem (Sterile) USP
    to Anhydrous meropenem …………1000mg
    Sodium Carbonate (Sterile) USP
    Eq. to Sodium (as a buffer) ……………………90.2mg
    Sterile water for Injection BP….…………… 20ml

THERAPEUTIC INDICATION:

Meropenem is used to used treat severe infections of the skin or stomach. Meropenem is also used to treat bacterial meningitis (an infection that causes inflammation of the tissue that covers the brain and spinal cord).

DIRECTION OF USE:

The powder is to be reconstituted with 20ml of Sterile Water for Injections BP for IV use. Any unused portion must be discarded. The reconstituted solution should be used immediately after preparation. The prepared solution should be used only if it is clear.

CAUTION & WARNING:

CAUTION:  If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

FOR HUMAN USE ONLY.
(ULTRA-BROAD-SPECTRAM INJECTABLE ANTIBIOTICS)

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING:  It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.

Keep medicine out of reach of children.

*Not to be sold without sterile water for Injection.

STORAGE & DOSAGE:

STORAGE:  Store Protected from moisture at a temperature not exceeding 30°C.

Read enclosed leaflet before use.

DOSAGE:  As directed by Physician.

Why Taj Pharmaceuticals?

Discover the top reasons to choose Taj Pharmaceuticals for Meropenem for Injection. With a proven track record of quality, reliability, and affordability, Taj Pharmaceuticals delivers trusted and effective healthcare solutions for your critical needs. At Taj Pharmaceuticals, we prioritize patient well-being and safety above all else. Our Meropenem for Injection is manufactured in state-of-the-art facilities adhering to stringent quality standards, ensuring the highest level of purity and efficacy. Rest assured, you’re receiving a product you can trust. We understand that timely access to critical medications is crucial. Taj Pharmaceuticals is committed to a seamless supply chain, providing Meropenem for Injection when you need it most. Our global distribution network ensures that healthcare professionals and patients worldwide have access to this life-saving medication. In addition to our unwavering commitment to quality and accessibility, Taj Pharmaceuticals offers Meropenem for Injection at competitive prices. We believe that quality healthcare should be affordable, and our pricing reflects this dedication to making essential treatments accessible to all. Choose Taj Pharmaceuticals for Meropenem for Injection and experience peace of mind, quality, affordability, and global availability. Your health and well-being are our top priorities.

What is Meropenem for Injection and its uses:

Meropenem for Injection is a medication that belongs to the class of drugs known as carbapenem antibiotics. It is used to treat various bacterial infections in adults and children, typically in a hospital or clinical setting due to its intravenous (IV) administration. Here’s more information about Meropenem for Injection and its uses:

  • Bacterial Infections: Meropenem is primarily prescribed to treat a wide range of severe bacterial infections caused by susceptible bacteria. It is effective against both Gram-positive and Gram-negative bacteria. Some common infections it is used to treat include:
  • Septicemia: Meropenem can be used to treat septicemia (bloodstream infections) caused by susceptible bacteria.
  • Urinary Tract Infections: It may also be prescribed for complicated urinary tract infections.
  • Gynecological Infections: In certain cases, Meropenem may be used to treat gynecological infections.
  • Febrile Neutropenia: It is sometimes used in patients with febrile neutropenia, a condition where a person has a fever and a low white blood cell count, often seen in cancer patients undergoing chemotherapy.
  • Empiric Therapy: In some situations, where the causative bacteria are unknown, Meropenem may be used as empiric therapy until the specific bacteria and their susceptibility are determined.

It’s important to note that Meropenem is a powerful antibiotic and should only be used under the guidance of a healthcare professional. The choice of this antibiotic is based on the type of infection, the suspected or identified bacteria, and the patient’s medical history. As with all antibiotics, it’s important to complete the full course of treatment even if you start feeling better before the medication is finished. Stopping antibiotics prematurely can lead to antibiotic resistance and recurrence of the infection. Always follow your healthcare provider’s instructions when taking Meropenem for Injection.

How Does Meropenem for Injection Work?

Meropenem for Injection works as a potent antibiotic by interfering with the growth and reproduction of susceptible bacteria. It belongs to the class of antibiotics known as carbapenems, which are broad-spectrum antibiotics effective against a wide range of both Gram-positive and Gram-negative bacteria. Here’s how Meropenem works:

  • Inhibition of Cell Wall Synthesis: Meropenem primarily targets the bacterial cell wall, which is a crucial structural component for the survival and integrity of bacteria. It inhibits the synthesis of the bacterial cell wall by binding to specific proteins called penicillin-binding proteins (PBPs) located on the surface of bacterial cells. This action disrupts the formation of the cell wall and weakens the bacterial cell’s structural integrity.
  • Cell Lysis: As a result of Meropenem’s interference with cell wall synthesis, the bacterial cell becomes structurally unstable. Without a properly formed cell wall, the cell becomes more susceptible to the internal osmotic pressure, causing it to swell and eventually burst. This process is known as cell lysis.
  • Bacterial Death: The disruption of the bacterial cell wall and subsequent lysis ultimately leads to bacterial death. When the bacterial cells are unable to maintain their structural integrity, they cannot survive or replicate. This is the mechanism by which Meropenem effectively eliminates susceptible bacteria.
  • Broad-Spectrum Activity: Meropenem’s broad-spectrum activity means that it is effective against a wide variety of bacteria, including those that are resistant to other commonly used antibiotics. It is used in the treatment of serious infections where the causative bacteria may not be known or where multiple types of bacteria are suspected.

It’s important to note that Meropenem is administered intravenously (IV) and is typically used for severe bacterial infections that do not respond to other antibiotics or when the precise identity of the infecting bacteria is uncertain. The choice to use Meropenem is made by healthcare professionals based on factors such as the type of infection, bacterial susceptibility, and the patient’s medical history. Additionally, Meropenem should be used cautiously to minimize the risk of antibiotic resistance and to ensure it is effective in treating bacterial infections.

Benefits and Side Effects of Meropenem for Injection:

Meropenem for Injection is a potent antibiotic used to treat a variety of bacterial infections. Like all medications, it comes with both benefits and potential side effects. Here, we’ll outline the benefits and common side effects of Meropenem for Injection:

Benefits:

  • Broad-spectrum Antibiotic: Meropenem is a broad-spectrum antibiotic, which means it is effective against a wide range of both Gram-positive and Gram-negative bacteria. This versatility makes it valuable in treating infections when the exact bacterial species is unknown or when multiple types of bacteria are involved.
  • Effective Against Resistant Bacteria: Meropenem is often used to treat infections caused by bacteria that are resistant to other antibiotics. It is considered a carbapenem antibiotic, which tends to have a lower likelihood of resistance compared to some other antibiotic classes.
  • Treatment of Severe Infections: Meropenem is particularly useful for treating severe and life-threatening infections, such as hospital acquired pneumonia, septicemia, and intraabdominal infections.
  • Rapid Onset of Action: Meropenem starts working quickly, often within hours, to control the growth of bacteria and alleviate symptoms of infection.

Common Side Effects:

  • Nausea and Vomiting: Gastrointestinal upset, including nausea and vomiting, can occur with Meropenem use. Taking the medication with food or adjusting the dosing schedule may help alleviate these symptoms.
  • Diarrhea: Diarrhea is another common side effect. If it becomes severe or persistent, it should be reported to a healthcare provider.
  • Injection Site Reactions: Since Meropenem is administered through intravenous (IV) injection, it may cause pain, redness, or swelling at the injection site.
  • Headache: Some individuals may experience headaches while taking Meropenem.
  • Skin Rash: Skin rashes or itching are possible side effects, though they are less common.
  • Changes in Laboratory Test Results: Meropenem can affect blood and liver function test results. Your healthcare provider will monitor these values during treatment.

Serious Side Effects (Less Common):

While less common, some individuals may experience more serious side effects, including:
Severe allergic reactions (e.g., hives, difficulty breathing, swelling of the face, lips, tongue, or throat).
Seizures: Meropenem can lower the seizure threshold, so it should be used with caution in individuals with a history of seizures.
Clostridium difficile-associated diarrhea: This can occur after antibiotic use and may be severe.

It’s important to remember that the benefits of Meropenem often outweigh the risks when it is used to treat severe bacterial infections. However, it should only be used under the guidance of a healthcare provider who can assess its appropriateness for your specific condition and monitor for side effects. If you experience any concerning side effects while taking Meropenem, it’s crucial to contact your healthcare provider promptly.

Frequently Asked Questions About Meropenem for Injection:

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

  1. What is Meropenem for Injection used to treat?

Meropenem for Injection is used to treat a variety of bacterial infections, including severe infections of the respiratory tract, urinary tract, skin and soft tissues, intraabdominal infections, septicemia (bloodstream infections), and more.

  1. How is Meropenem for Injection administered?

Meropenem is administered through intravenous (IV) injection, typically in a hospital or clinical setting. It is not available in oral form.

  1. Is Meropenem for Injection effective against all types of bacteria?

Meropenem is effective against a broad spectrum of bacteria, including both Gram-positive and gram-negative bacteria. However, it may not work against bacteria that are specifically resistant to carbapenem antibiotics.

  1. How long does a Meropenem infusion take?

The duration of each Meropenem infusion can vary but typically takes around 15 to 30 minutes. Your healthcare provider will determine the exact timing based on your condition and the dosage prescribed.

  1. Are there any potential side effects of Meropenem for Injection?

Common side effects include nausea, vomiting, diarrhea, headache, and injection site reactions. More serious side effects are rare but can include severe allergic reactions, seizures, and Clostridium difficile-associated diarrhea.

  1. Can Meropenem be used during pregnancy or breastfeeding?

Meropenem should be used during pregnancy only if clearly needed, as its safety during pregnancy has not been fully established. It is typically not recommended during breastfeeding.

  1. Is it possible to develop antibiotic resistance with Meropenem use?

Overuse or inappropriate use of antibiotics can contribute to antibiotic resistance. To minimize the risk of resistance, Meropenem should only be used when prescribed by a healthcare professional for bacterial infections that warrant its use.

  1. Can Meropenem interact with other medications?

Some medications may interact with Meropenem, potentially affecting its effectiveness or causing side effects. Inform your healthcare provider about all medications and supplements you are taking.

  1. What should I do if I miss a dose of Meropenem for Injection?

It’s important to receive Meropenem as prescribed by your healthcare provider. If you miss a dose, contact your healthcare team for guidance on how to proceed.

  1. How should Meropenem for Injection be stored?

Meropenem should be stored according to the instructions provided by the healthcare facility. Generally, it should be stored at room temperature and protected from light.

These are general FAQs about Meropenem for Injection, but individual experiences and circumstances may vary. Always consult with your healthcare provider or pharmacist for specific information and guidance related to your treatment with Meropenem.

As Meropenem for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Meropenem 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

Meropenem 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 Meropenem 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) Meropenem for Injection USP 1gm
(B) Meropenem for Injection USP 2gm
(C) Meropenem for Injection USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Meropenem for Injection USP 1g
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………1000mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) ……………………90.2mg
B. Sterile water for Injection BP….…………… 20ml


2. Meropenem for Injection USP 2gm
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………2gm
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) ……………………180.4mg
B. Sterile water for Injection BP….…………… 30ml

3. Meropenem for Injection USP 500mg
A. Each vial contains:
Meropenem (Sterile) USP
Eq. to Anhydrous meropenem …………500mg
Sodium Carbonate (Sterile) USP
Eq. to Sodium (as buffer) …………………45.1mg
B. Sterile water for Injection BP ………….… 10ml

THERAPEUTIC INDICATIONS:

Meropenem is used to used treat severe infections of the skin or stomach. Meropenem is also used to treat bacterial meningitis (infection that causes inflammation of the tissue that covers the brain and spinal cord).

DIRECTION OF USE:

The powder to be reconstituted with 20ml of Sterile Water for Injections BP for IV use.
Any unused portion must be discarded.
The reconstituted solution should be use immediately after preparation.
The prepared solution should be used only, if it is clear.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FOR HUMAN USE ONLY.
(ULTRA-BROAD-SPECTRAM INJECTABLE ANTIBIOTICS)
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.
Keep medicine out of reach of children.
*Not to be sold without sterile water for Injection.

STORAGE & DOSAGE:

STORAGE: Store Protected from moisture at a temperature not exceeding 30°C.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.