GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Voriconazole for Injection 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Voriconazole for Injection 200mg
a) Each vial contains:
Voriconazole USP………200mg
Excipients………………….q.s
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….20ml

THERAPEUTIC INDICATIONS:

Voriconazole injection is used to treat certain serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (including infections in the skin, stomach, kidney, bladder, and wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate or do not respond to other types of medicine.

DIRECTION OF USE:

For Intravenous Infusion after dilution.
Reconstitute with 10ml of Water for Injection USP to give a clear solution containing 10mg/ml.
Reconstituted solution should be immediately used after preparation.
For administration, the required volume of the reconstitution solution is added to a recommended compatible infusion solution to provide a final solution containing 0.5-5mg/ml.
For appropriate diluents and storage recommendation and dosage information, refer prescribing information.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Not for Bolus Injection.
Discard unused portion.
Must be further diluted before use.
Do not mix or administer as an infusion with other medical products.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENC
E Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at controlled room temperature 15°C to 30°C (59°F TO 86°F). Do not freeze. Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Voriconazole for Injection 200mg Technical Specification:

Product Name:Voriconazole for Injection
Brand Name:Ortrex
Strength:200mg/Vial
Dosage Form:Lyophilized Powder for Injection (No preservatives)
Packing:1 Sterile Single Dose Vial +1 WFI Tray
Route of Administration:For IV Infusion 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-Fungals (Triazoles)
Indication: Voriconazole injection is the class of medicines known as ‘antifungals’ used to treat a broad range of infections caused due to fungi and yeast.
Storage:Store at controlled room temperature 15°C to 30°C (59°F TO 86°F). Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Voriconazole for Injection 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Voriconazole for Injection 200mg
    a. Each vial contains:
    Voriconazole USP………200mg
    Excipients………………….q.s
    b This pack also contains:
    One FFS ampule of Sterile Water for Injection USP…….20ml

THERAPEUTIC INDICATIONS:

Voriconazole injection is used to treat certain serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (including infections in the skin, stomach, kidney, bladder, and wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate or do not respond to other types of medicine.

DIRECTION OF USE:

For Intravenous  Infusion after dilution.
Reconstitute with 10ml of Water for Injection USP to give a clear solution containing 10mg/ml.

Reconstituted solution should be immediately used after preparation.
For administration, the required volume of the reconstitution solution is added to a recommended compatible infusion solution to provide a final solution containing 0.5-5mg/ml.
For appropriate diluents and storage recommendation and dosage information, refer prescribing information.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Not for Bolus Injection.
Discard unused portion.
Must be further diluted before use.
Do not mix or administer as an infusion with other medical products.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at controlled room temperature 15°C to 30°C (59°F TO 86°F). Do not freeze.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

When choosing a pharmaceutical company for medications like Voriconazole for Injection, several critical factors should guide the decision-making process. Taj Pharmaceuticals, an Indian-based pharmaceutical company, is one potential option, but the selection should be based on a thorough evaluation of several key considerations. First and foremost, the quality and regulatory compliance of the pharmaceutical company are paramount. Ensuring that Taj Pharmaceuticals maintains stringent manufacturing standards and adheres to regulatory guidelines is essential, especially for medications like Voriconazole, which are used to treat severe fungal infections. High-quality manufacturing is vital for the effectiveness and safety of the medication. Voriconazole for Injection is a prescription medication primarily used to treat invasive fungal infections. Consequently, the choice of manufacturer should align with the recommendations and prescription provided by your healthcare provider. Given the seriousness of the conditions it treats, it is imperative to trust the quality and reliability of the manufacturer. Affordability and accessibility are significant considerations when evaluating pharmaceutical companies. Medication costs can vary, and understanding your budget and insurance coverage is essential in determining the most cost-effective option for obtaining Voriconazole for Injection. Reliability in medication supply is crucial, particularly for individuals who require this medication to combat life-threatening fungal infections. Ensuring that the chosen pharmaceutical company, such as Taj Pharmaceuticals, maintains a dependable supply chain is essential for timely access to Voriconazole when needed most. While patient reviews and feedback may not always be readily available for medications like Voriconazole, they can provide valuable insights into the experiences of individuals who have used a specific brand or manufacturer’s product. However, it’s essential to consider these insights in conjunction with guidance from healthcare providers. Ultimately, the decision regarding which pharmaceutical company to choose for Voriconazole for Injection should be made in consultation with your healthcare provider. They can consider your unique medical history, the specific fungal infection being treated, and your response to the medication when recommending a particular brand or manufacturer. When selecting a pharmaceutical company for Voriconazole for Injection, it’s crucial to weigh factors such as quality, prescription guidance, cost, accessibility, and consultation with healthcare providers. This comprehensive approach ensures that you receive the most appropriate and effective treatment for your specific fungal infection while prioritizing safety and efficacy.

What is Voriconazole for Injection and its uses?

Voriconazole for Injection is a medication used to treat serious fungal infections. It belongs to a class of drugs known as triazole antifungals and is particularly effective against a wide range of fungal species. Here’s an overview of Voriconazole for Injection and its uses:

Voriconazole for Injection: Voriconazole is the active ingredient in this medication. While it is available in various formulations, including tablets and oral suspension, the injectable form is used when intravenous administration is necessary for fast and efficient delivery of the medication.

Uses of Voriconazole for Injection:

  • Invasive Aspergillosis: Voriconazole is a first-line treatment for invasive aspergillosis, a fungal infection caused by the Aspergillus species. This condition typically affects individuals with weakened immune systems, such as those undergoing chemotherapy or organ transplantation.
  • Invasive Candidiasis: It is used to treat invasive candidiasis, which is caused by Candida species. Candidiasis can manifest as bloodstream infections (candidemia), deep-seated tissue infections, or infections in specific organs like the eye.
  • Serious Fungal Infections: Voriconazole for Injection may be prescribed for other serious fungal infections, including those caused by Scedosporium and Fusarium species. It is also used in cases of infections that do not respond to other antifungal medications.
  • Preventing Fungal Infections: In some situations, such as after stem cell or bone marrow transplantation, Voriconazole may be used as a preventive measure to reduce the risk of fungal infections.

Voriconazole works by inhibiting the growth and replication of fungal cells by interfering with their ability to produce ergosterol, a key component of fungal cell membranes. This disruption weakens the fungal cell walls, making them more susceptible to damage and destruction. It’s important to note that Voriconazole for Injection is typically administered in a healthcare setting, such as a hospital, under the supervision of a healthcare provider. The choice of antifungal medication and formulation, including injectable forms, is determined by the specific fungal infection, its severity, and individual patient factors. Treatment with Voriconazole should be closely monitored by a healthcare provider due to the potential for side effects and the need for dosage adjustments based on factors like liver function. Additionally, the duration of treatment can vary depending on the type and extent of the fungal infection. If you are prescribed Voriconazole for Injection, it’s essential to follow your healthcare provider’s recommendations and attend regular follow-up appointments to monitor treatment progress and address any concerns.

How do Voriconazole for Injection work?

Voriconazole for Injection is an antifungal medication that works by inhibiting the growth and replication of fungal cells. It belongs to a class of drugs known as triazole antifungals. Here’s how Voriconazole for Injection works:

  • Inhibition of Ergosterol Synthesis: Fungal cell membranes contain a vital component called ergosterol, which is analogous to cholesterol in human cell membranes. Ergosterol is crucial for maintaining the integrity and stability of fungal cell walls. Voriconazole interferes with the fungal cell’s ability to synthesize ergosterol, a process essential for fungal growth and survival.
  • Disruption of Fungal Cell Membranes: When Voriconazole inhibits ergosterol synthesis, it leads to a decrease in the production of ergosterol within the fungal cell membrane. This disruption weakens the fungal cell wall’s structure, making it more susceptible to damage and permeable to essential cellular components.
  • Cellular Damage and Death: With compromised cell membranes, fungal cells become vulnerable to various stresses, including osmotic pressure changes and the host’s immune responses. This vulnerability can result in cellular damage and ultimately lead to the death of the fungal cell.
  • Prevention of Fungal Replication: Voriconazole’s actions not only lead to the death of existing fungal cells but also prevent the replication of new fungal cells. This inhibits the growth and spread of the fungal infection within the body.

Voriconazole for Injection is effective against a wide range of fungal species, including Aspergillus, Candida, Scedosporium, Fusarium, and others. It is particularly valuable in the treatment of invasive fungal infections in individuals with compromised immune systems, such as those undergoing chemotherapy, organ transplantation, or with conditions like AIDS. The use of Voriconazole for Injection is typically guided by a healthcare provider, and the specific dosage and duration of treatment depend on factors such as the type and severity of the fungal infection, the patient’s overall health, and their response to the medication. Monitoring of liver function is often necessary during Voriconazole treatment, as the medication can affect liver enzymes. It’s crucial for individuals prescribed Voriconazole for Injection to follow their healthcare provider’s recommendations closely, including the prescribed dosage and administration schedule. Additionally, regular follow-up appointments are essential to monitor treatment progress, assess side effects, and make any necessary adjustments to the treatment plan.

Benefits of Voriconazole for Injection:

  • Effective Treatment: Voriconazole for Injection is highly effective in treating serious fungal infections, including invasive aspergillosis and candidiasis. It is considered a first-line treatment for these conditions, particularly in individuals with compromised immune systems.
  • Broad-Spectrum Antifungal: Voriconazole has a broad spectrum of activity, which means it can target and treat a wide range of fungal species, making it suitable for various fungal infections.
  • Fusarium and Scedosporium Infections: Voriconazole is one of the few antifungal medications effective against Fusarium and Scedosporium species, which are notoriously difficult to treat with other antifungal agents.
  • Preventive Use: In some cases, Voriconazole may be used prophylactically to prevent fungal infections in individuals at high risk, such as those undergoing stem cell or bone marrow transplantation.
  • Intravenous Administration: The injectable form of Voriconazole is particularly useful when a patient cannot take the medication orally or when fast and efficient delivery of the drug is necessary.

Common Side Effects of Voriconazole for Injection:

  • Visual Disturbances: Voriconazole can cause visual disturbances, such as changes in vision, blurred vision, and photophobia (sensitivity to light). These effects are usually reversible upon discontinuation of the medication.
  • Nausea and Vomiting: Gastrointestinal symptoms like nausea and vomiting are relatively common side effects of Voriconazole. Taking the medication with food or adjusting the dosage timing can help alleviate these symptoms.
  • Liver Function Changes: Voriconazole can affect liver enzymes, leading to changes in liver function tests. Regular monitoring of liver function is often necessary during treatment.
  • Skin Rash: Some individuals may develop skin rashes while taking Voriconazole. These rashes are usually mild, but severe skin reactions can occur in rare cases.
  • Central Nervous System Effects: Voriconazole may cause central nervous system (CNS) side effects, including hallucinations, confusion, and changes in mental status. These effects are more common in individuals with preexisting CNS conditions.
  • Photosensitivity: Voriconazole can make the skin more sensitive to sunlight, leading to an increased risk of sunburn. Patients should take precautions, such as wearing protective clothing and sunscreen, while outdoors.
  • Other Possible Side Effects: Voriconazole may also be associated with other side effects, including fever, headache, and abnormal liver function tests.

It’s important to note that individual responses to medications can vary, and not everyone will experience these side effects. Voriconazole for Injection is typically prescribed for serious fungal infections, and the potential benefits of effectively treating these infections often outweigh the risks of side effects. Healthcare providers closely monitor patients receiving Voriconazole, especially those on long-term treatment, to manage and address any side effects promptly. Patients should report any unusual or severe side effects to their healthcare provider. The decision to use Voriconazole for Injection should be made in consultation with a healthcare provider who can assess the specific fungal infection, overall health, and potential risks and benefits of treatment.

Frequently Asked Questions About Voriconazole for Injection:

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

  1. What is Voriconazole for Injection, and what is it used for?

Voriconazole for Injection is a medication used to treat serious fungal infections, including invasive aspergillosis, invasive candidiasis, and infections caused by Fusarium and Scedosporium species.

  1. How does Voriconazole for Injection work?

Voriconazole works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. This disruption weakens the fungal cell wall, making it more susceptible to damage and ultimately leading to fungal cell death.

  1. When is Voriconazole for Injection prescribed?

Voriconazole for Injection is prescribed when fast and efficient administration is required, or when a patient cannot take the medication orally. It is typically used for serious fungal infections that do not respond to other antifungal agents.

  1. What are the common side effects of Voriconazole for Injection?

Common side effects may include visual disturbances, nausea, vomiting, changes in liver function tests, skin rashes, and central nervous system effects such as hallucinations or confusion. Patients should report any side effects to their healthcare provider.

  1. Can Voriconazole for Injection be used in children and adolescents?

Voriconazole can be used in pediatric populations, but dosing and administration should be carefully determined by a healthcare provider based on the child’s age, weight, and specific condition.

  1. How should Voriconazole for Injection be administered?

Voriconazole for Injection is typically administered intravenously by a healthcare provider. The dosage and duration of treatment will be determined by the specific fungal infection and individual patient factors.

  1. Is it safe to take Voriconazole for Injection during pregnancy or while breastfeeding?

The use of Voriconazole during pregnancy or breastfeeding should be discussed with a healthcare provider, as the benefits and risks need to be carefully evaluated for each individual.

  1. Are there any drug interactions with Voriconazole for Injection?

Voriconazole can interact with several medications, including certain antifungals, antibiotics, and drugs that affect liver enzymes. Patients should inform their healthcare provider about all medications and supplements they are taking.

  1. How should Voriconazole for Injection be stored?

Voriconazole for Injection should be stored as directed by the manufacturer or healthcare provider. It is typically stored at room temperature and protected from light.

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

Patients should follow their healthcare provider’s instructions regarding the dosing schedule. If a dose is missed, it should be administered as soon as possible, but patients should not double up on doses to make up for a missed one.

These FAQs provide general information about Voriconazole for Injection, but individual responses to the medication can vary. Patients should consult with their healthcare provider for personalized guidance and information based on their specific medical condition and treatment plan.

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

Voriconazole 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 Voriconazole 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