GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Voriconazole for Injection 200mg (Ortrex)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Voriconazole for Injection 200mg
Each vial contains:
Voriconazole USP……………….200mg
Excipient…………………………………. q. s

b) Water for Injection I.P. ………10ml

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 etc.

DIRECTION OF USE:

Reconstituted with 10ml of Water for Injection

Reconstituted solution should be use immediately after preparation

To be diluted prior to Intravenous administration.

CAUTION & WARNING:

CAUTION: If any particle is visible dosowing the content please do not use the solution. Ask for replacement.

FLIP-OFF SEALS PROVIDED FOR TAMPER EVIDENCE

Warning: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store Below 25°C Protect from light. Do not freeze.

Head enclosed leaflet before reconstitution and use.

KEEP OUT OF REACH OF CHILDREN

Dosage: As directed by Physician

Voriconazole for Injection Technical Specification:

Product Name:Voriconazole for Injection
Brand Name:Ortrex
Strength:200mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Vial + WFI tray
Route of Administration:For I.V Infusion 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:Ani-fungal
Indication: Voriconazole injection (triazoles) is used to treat certain serious fungal or yeast infections.
Storage:Store Below 25°C Protect from light. Do not freeze

Exporters of Voriconazole for Injection 200mg in India

Taj Pharma is one of the fastest growing manufacturers of Voriconazole for Injection exports it across the globe. By adhering the strict norms of regulatory guidelines, we formulate the medicine in a complete hygienic and sterile environment. This sets us apart from other manufacturers and supplier of Voriconazole injection.

Being a WHO and GMP certified company, we never compromise with the quality of product we manufacture and export. Voriconazole for Injection is one of the best antifungal medicines that is injected intravenously to treat fungal infection in patients.

How does Voriconazole for Injection Work?

Voriconazole 200mg Injection is a member of the class of drugs known as antifungals. It inhibits fungal development and is used to treat a range of fungal illnesses. It eliminates fungus by disintegrating the fungal cell membrane.

How Voriconazole for Injection I.V. should be Given?

A doctor or a nurse is in charge of administering the injection. Do not administer the injection yourself. Even if your symptoms go away after a few days, continue taking the injection until your prescription is filled to get the greatest benefits. If you skip doses, you run the risk of developing infections that are resistant to subsequent treatment and the infection may return if you discontinue therapy too soon.

Dosage

A single-dose vial of Voriconazole for injection contains a sterile lyophilized powder containing 200 mg of Voriconazole in addition to other ingredient. The exact dose of the medicine should be decided by the authorized healthcare provider or a doctor.

Side Effects

Some of the frequent undesired effects include:

  • Rash
  • Nausea
  • Vomiting
  • Headache
  • Feeling lightheaded
  • Swelling of the lips
  • Difficulty breathing or swallowing

If this happens, get immediate assistance. Even these are typically not significant; you should still consult your doctor if you suspect a severe allergic response.

Precautions

  • Keep below precautionary measures in mind when planning to inject Voriconazole for Injection I.V:
  • If you are pregnant or think you might be pregnant, don’t take it until your doctor instructs you to.
  • If you have ever experienced kidney issues, heart failure, or liver issues, yellowing of skin, consult the doctor before taking it (jaundice).
  • You might not be a good candidate for this drug. Your doctor might want to perform a blood test to evaluate your liver if your course of therapy lasts more than a month.
  • Avoid using machinery or driving until it is safe to do so since the medication may cause you to feel lightheaded or dizzy.
  • It is dangerous to drink alcohol when using Voriconazole 200mg Injection.
  • Voriconazole 200mg Injection may induce uncomfortable light sensitivity or blurred vision, which may make it unsafe for you to operate a motor vehicle.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Voriconazole for Injection 200mg (Ortrex)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Voriconazole for Injection 200mg
    Each vial contains:
    Voriconazole USP……………….200mg
    Excipient…………………………………. q. sb) Water for Injection I.P. ………10ml

THERAPEUTIC INDICATION:

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 etc.

DIRECTION OF USE:

Reconstituted with 20ml of Water for Injection

Reconstituted solution should be use immediately after preparation

To be diluted prior to Intravenous administration.

CAUTION & SCHEDULE:

CAUTION: If any particle is visible dosowing the content please do not use the solution. Ask for replacement

FLIP-OFF SEALS PROVIDED FOR TAMPER EVIDENCE

Warning: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store Below 25°C Protect from light. Do not freeze

Head enclosed leaflet before reconstitution and use

KEEP OUT OF REACH OF CHILDREN

Dosage: As directed by Physician

Voriconazole for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Free Sale Certificate (FSC)
  • Stability Data (Accelerated stability / Long term stability / Zone 4b)
  • Method of Analysis (MOA)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)

Voriconazole for Injection Export Market

Taj Pharma is one of the trusted companies that is known to manufacture and export Voriconazole 200mg for Injection in different geographical locations such as:

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

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

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

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

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

Manufacturing Standard Operating Procedure:

Other Large Volume Parenterals (LVPs):

Other Dry Powder Injections:

Other Liquid Injections: