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Fosfomycin Sodium for Injection 4g (Fositaj)
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Fosfomycin Sodium for Injection 4g
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Fosfomycin Sodium for Injection 4g
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Fosfomycin Sodium for Injection 4g
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Fosfomycin Sodium for Injection 4g
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Fosfomycin Sodium for Injection 4g
-
Fosfomycin Sodium for Injection 4g
-
Fosfomycin Sodium for Injection 4g
-
Fosfomycin Sodium for Injection 4g
-
Fosfomycin Sodium for Injection 4g
Fosfomycin Sodium for Injection 4g Technical Specification:
| Product Name: | Fosfomycin Sodium for Injection 4g |
| Brand Name: | Fositaj |
| Strength: | 500mg, 1g, 2g, 4g, 8g, 10g |
| Dosage Form: | Lyophilized Dry Powder for Injection (Sterile) *Preservative-free |
| Packing: | 1 Vial + WFI in a 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: | Anti-bacterial, Urological Products & broad spectrum bactericidal, Antibiotic |
| Indication: | Fosfomycin Injection is an antibiotic medicine used to treat bacterial infections in your body. |
| Storage: | Before Reconstitution- Store below 25°C. Protect from light and moisture.
After Reconstitution- Final Infusion can be stored up to 24 hours at room temperature or in a refrigerator 2°C to 8°C. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Fosfomycin Sodium for Injection 4g
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Fosfomycin Sodium for Injection 4g
a)Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin …………………4g
Excipients……………………………q.s.
b)Sterile Water for Injection USP……100ml
THERAPEUTIC INDICATIONS:
Fosfomycin Injection is an antibiotic medicine used to treat bacterial infections in your body. It is effective in some infections of the urinary tract, lungs (e.g., Pneumonia), bones, brain (e.g., Meningitis).
DIRECTION OF USE:
Use immediately After preparation.
After reconstitution each ml contains 40 mg Fosfomycin.
For method of reconstitution, storage, administration, dosage and indication: Refer to the enclose package insert.
CAUTION & WARNING:
CAUTION: Do not use the injection If the contents are not clear or contains visible particulate matter after reconstitution.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
STORAGE & DOSAGE:
Storage:
Before Reconstitution– Store below 25°C. Protect from light.
After Reconstitution– Final Infusion that has been produced under aseptic conditions can be stored up to 24 hours at room temperature or in a refrigerator (at 2-8°C), If protected from light. Discard unused portion.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Use only after reading the directions on the pack insert.
Dosage: As directed by Physician.
Why Taj Pharmaceuticals?
Choose Taj Pharmaceuticals for Fosfomycin Sodium for Injection and benefit from our decades of pharmaceutical expertise. We are dedicated to delivering the highest standards of safety and efficacy in every dose, ensuring that your patients receive the best care possible. Our state-of-the-art manufacturing facilities and rigorous quality control processes guarantee the purity and potency of each Fosfomycin Sodium vial. Whether you’re a healthcare provider seeking a trusted partner or a patient in need of reliable treatment, Taj Pharmaceuticals is here to provide you with the quality and peace of mind you deserve. Your well-being is our top priority. Unlocking the Power of Fosfomycin Sodium: Taj Pharmaceuticals leads the way in delivering excellence in pharmaceuticals. With a rich history of quality and cutting-edge research, we offer Fosfomycin Sodium for Injection that meets the highest standards of efficacy and safety. Our dedication to patient care extends to the production process, where rigorous quality control ensures each batch is consistently reliable. Taj Pharmaceuticals is your partner in fighting bacterial infections with Fosfomycin Sodium, backed by decades of experience and a commitment to advancing healthcare. Choose Taj Pharmaceuticals for Fosfomycin Sodium for Injection and experience the difference in quality, trust, and innovation in pharmaceuticals.
What is Fosfomycin Sodium for Injection and its uses:
Fosfomycin Sodium for Injection is a medication used to treat bacterial infections, particularly those caused by susceptible strains of bacteria. It contains the active ingredient fosfomycin, which is an antibiotic with a broad spectrum of activity against various types of bacteria. This medication is typically administered intravenously (through an IV) and is prescribed by healthcare professionals.
Uses of Fosfomycin Sodium for Injection:
- Urinary Tract Infections (UTIs): Fosfomycin Sodium is commonly used to treat uncomplicated urinary tract infections, such as cystitis. It is effective against a range of bacteria commonly responsible for UTIs, including Escherichia coli (E. coli).
- Intra-abdominal Infections: It may be used as part of the treatment regimen for intra-abdominal infections, including peritonitis, when caused by susceptible bacteria.
- Respiratory Tract Infections: In some cases, healthcare providers may prescribe Fosfomycin Sodium for the treatment of respiratory tract infections caused by susceptible bacteria.
- Bone and Joint Infections: It can be considered for the treatment of bone and joint infections when the causative bacteria are susceptible to fosfomycin.
- Skin and Soft Tissue Infections: Fosfomycin Sodium may be used to treat certain skin and soft tissue infections when appropriate.
- Other Infections: In some situations, healthcare providers may use Fosfomycin Sodium for the treatment of other bacterial infections if it is deemed suitable and effective.
It’s important to note that the choice of antibiotic, including Fosfomycin Sodium, should be guided by the specific type of infection, the identity of the causative bacteria, and their susceptibility to the medication. Antibiotics should be used under the supervision of a healthcare professional, and the prescribed dosage and duration of treatment should be followed carefully to ensure the best possible outcome and to prevent the development of antibiotic resistance. As with any medication, Fosfomycin Sodium for Injection may have potential side effects and interactions with other drugs. Patients should discuss any concerns or questions about its use with their healthcare provider.
How does Fosfomycin Sodium for Injection work?
Fosfomycin Sodium for Injection is an antibiotic medication that works by interfering with the formation of bacterial cell walls. Here’s how it works:
- Inhibition of Cell Wall Synthesis: Bacterial cells have a protective outer layer called the cell wall, which provides structural support and helps maintain cell integrity. The cell wall is composed of peptidoglycan, a complex molecule.
- Inhibition of Enzymes: Fosfomycin, the active ingredient in Fosfomycin Sodium, enters bacterial cells and interferes with the early stages of peptidoglycan synthesis. It specifically inhibits an enzyme called MurA, which is essential for the formation of a key component of the peptidoglycan layer.
- Weakening of the Cell Wall: Without the proper formation of peptidoglycan, the bacterial cell wall becomes structurally unstable. This leads to a weakening of the cell wall and compromises the integrity of the bacterial cell.
- Cell Lysis and Death: As a consequence of the weakened cell wall, the internal pressure of the bacterial cell becomes unbalanced. Eventually, this pressure differential causes the cell to rupture, leading to cell lysis (bursting) and bacterial cell death.
It’s important to note that Fosfomycin Sodium primarily targets the cell wall synthesis in bacteria, which is a unique mechanism of action compared to many other antibiotics. This makes it effective against a wide range of bacteria, including both Gram-positive and Gram-negative bacteria. Fosfomycin is often used to treat uncomplicated urinary tract infections (UTIs), as it can achieve high concentrations in the urinary tract, where many UTIs occur. However, its use for other types of bacterial infections is determined by the specific bacterial strain’s susceptibility to fosfomycin and the judgment of healthcare professionals.
Benefits and Side Effects of Fosfomycin Sodium for Injection:
Fosfomycin Sodium for Injection is an antibiotic medication used to treat bacterial infections. Like all medications, it has potential benefits and side effects. Here’s an overview:
Benefits:
- Effective Against Various Bacteria: Fosfomycin Sodium has a broad spectrum of activity, making it effective against both Gram-positive and Gram-negative bacteria. It is commonly used for treating uncomplicated urinary tract infections (UTIs) caused by susceptible bacteria, including Escherichia coli (E. coli).
- Single-Dose Option: Fosfomycin Sodium is available as a single-dose regimen for certain infections. This can be convenient for patients who prefer a shorter treatment duration.
- Alternative Treatment: It can serve as an alternative antibiotic for patients who may have allergies or adverse reactions to other antibiotics commonly used to treat bacterial infections.
Side Effects:
- Gastrointestinal Upset: Nausea, vomiting, diarrhea, and abdominal pain are common side effects of Fosfomycin Sodium. These symptoms are generally mild and transient.
- Allergic Reactions: While rare, some individuals may experience allergic reactions to Fosfomycin Sodium, which can manifest as skin rash, itching, swelling, or difficulty breathing. Seek immediate medical attention if any signs of an allergic reaction occur.
- Liver Function Abnormalities: In some cases, the medication may cause elevated liver enzymes and liver function abnormalities, although this is relatively uncommon.
- Renal Effects: Fosfomycin Sodium can affect kidney function, but severe kidney problems are rare. Patients with preexisting kidney issues should be monitored closely during treatment.
- Digestive System Disruption: Like other antibiotics, Fosfomycin Sodium can disrupt the balance of beneficial and harmful bacteria in the digestive tract, potentially leading to secondary infections such as Clostridium difficile-associated diarrhea.
- Infusion-Related Reactions: Intravenous administration of Fosfomycin Sodium may rarely cause infusion-related reactions, including fever, chills, and discomfort at the injection site.
- Hypersensitivity Reactions: Severe hypersensitivity reactions, although rare, can occur and may require discontinuation of the medication.
- Resistance: Overuse or improper use of antibiotics can lead to bacterial resistance. Therefore, Fosfomycin Sodium should be used judiciously and only when indicated.
It’s essential to take Fosfomycin Sodium as prescribed by a healthcare provider and to complete the full course of treatment, even if symptoms improve before the medication is finished. If you experience any concerning side effects or have questions about the medication, consult your healthcare provider. Additionally, inform your healthcare provider about any other medications you are taking to check for potential drug interactions. Fosfomycin Sodium should be used under the guidance and supervision of a healthcare professional to ensure its safe and effective use.
Frequently Asked Questions About Fosfomycin Sodium for Injection:
Certainly! Here are some frequently asked questions (FAQs) about Fosfomycin Sodium for Injection:
- What is Fosfomycin Sodium for Injection used to treat?
Fosfomycin Sodium for Injection is primarily used to treat bacterial infections, including uncomplicated urinary tract infections (UTIs) and other infections caused by susceptible bacteria.
- How does Fosfomycin Sodium for Injection work?
It interferes with the formation of bacterial cell walls, leading to the weakening and eventual rupture of bacterial cells, which results in bacterial cell death.
- Is Fosfomycin Sodium for Injection effective against a wide range of bacteria?
Yes, it has a broad spectrum of activity and is effective against both Gram-positive and gram-negative bacteria.
- What are the common side effects of Fosfomycin Sodium for Injection?
Common side effects may include nausea, vomiting, diarrhea, abdominal pain, and infusion related reactions. Less common side effects can include liver function abnormalities and allergic reactions.
- How is Fosfomycin Sodium for Injection administered?
It is typically administered as an intravenous (IV) infusion in a healthcare setting. The dosage and duration of treatment depend on the specific infection and patient’s condition.
- Can Fosfomycin Sodium for Injection be used during pregnancy or breastfeeding?
It should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks, and under the supervision of a healthcare provider.
- Are there any drug interactions with Fosfomycin Sodium for Injection?
It may interact with certain medications, so it’s important to inform your healthcare provider about all the medications you are taking.
- Is it available in oral form as well?
Yes, Fosfomycin is available in oral form for certain infections, but the injectable form may be preferred in severe cases or when oral administration is not feasible.
- Can Fosfomycin Sodium for Injection be used for all types of bacterial infections?
Its use is determined by the specific bacterial strain’s susceptibility to Fosfomycin and the judgment of healthcare professionals. It is typically used for specific types of infections, such as UTIs.
- How long does the treatment with Fosfomycin Sodium for Injection typically last?
The duration of treatment varies depending on the type and severity of the infection. It may be a single dose treatment for some uncomplicated UTIs or longer for other types of infections.
- Can it be used in children and elderly patients?
Fosfomycin Sodium for Injection may be used in both pediatric and elderly populations, but dosages and treatment duration may be adjusted based on individual patient factors.
Patients should consult with a healthcare provider for personalized information and guidance regarding the use of Fosfomycin Sodium for Injection and any specific questions or concerns they may have about its use and potential side effects.
As Fosfomycin Sodium for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Fosfomycin Sodium 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
Fosfomycin Sodium 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 Fosfomycin Sodium 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
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Fosfomycin Sodium for Injection 1g
C. Fosfomycin Sodium for Injection 2g
D. Fosfomycin Sodium for Injection 4g
E. Fosfomycin Sodium for Injection 8g
F. Fosfomycin Sodium for Injection 10g
QUALITATIVE AND QUANTITATIVE COMPOSITION:
i. Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………500mg
Excipients……………………………q.s.
ii. Sterile Water for Injection USP……12.5ml
B. Fosfomycin Sodium for Injection 1g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………1gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……25ml
C. Fosfomycin Sodium for Injection 2g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………2gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……50ml
D. Fosfomycin Sodium for Injection 4g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………4gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……100ml
E. Fosfomycin Sodium for Injection 8g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………8gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……200ml
F. Fosfomycin Sodium for Injection 10g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………10gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……250ml
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
After reconstitution each ml contains 40 mg Fosfomycin.
For method of reconstitution, storage, administration, dosage and indication: Refer to the enclose package insert.
CAUTION & WARNING:
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
STORAGE & DOSAGE:
Before Reconstitution- Store below 25°C. Protect from light.
After Reconstitution- Final Infusion that has been produced under aseptic conditions can be stored up to 24 hours at room temperature or in a refrigerator (at 2-8°C), If protected from light.
Discard unused portion.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Use only after reading the directions on the pack insert.
Dosage: As directed by Physician.
