GMP Certified / Voriconazole for Injection 200mg

• Customization: Available
• Quality Standard: USP, Bp
• Factory Certified: GMP
• Model NO.: injection
• Ctd Status: Available
• Transport Package: Sea Transportation
• Specification: 200mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description
 

Generic name	Voriconazole for injection
Strength	200mg
Standard	BP
Shelf life	2 years
Packing form	1 vial/box

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Voriconazole for injection

Character:
This product is white or white powder.

Indications:
This product is a broad spectrum triazole antifungal drug with the following indications: treatment of invasive aspergillosis. For the treatment of severe invasive infections caused by fluconazol-resistant candida bacteria (including Candida claris). Treat severe infections caused by Actinomyces pedis and Fusarium. This product should be used primarily for the treatment of progressive, potentially life-threatening infections in immunodeficient patients.

Pharmacology and toxicology:
The mechanism of action of Voriconazole is inhibition of 14α-sterol demethylation mediated by cytochrome P450 in fungi, thereby inhibiting ergosterol biosynthesis. Voriconazole showed broad-spectrum antifungal activity in vitro. This product has antibacterial action against Candida genus (including fluconazole-resistant Candida Crassus, Candida glabra and Candida albicans resistant strains) and bactericidal action against all Aspergillus species tested. In addition, Voriconazole has bactericidal effects in vitro against other pathogenic fungi, including genera that are less sensitive to existing antifungals, such as Actinomyces pedis and Fusarium.
Animal experiments showed that the minimum inhibitory concentration of voriconazole was related to its curative effect. However, in clinical studies, there was no correlation between the minimum inhibitory concentration and clinical efficacy, and there appeared to be no correlation between the blood concentration of the drug and clinical efficacy. This is a characteristic of pyrrole antifungals.
microbiology
Clinical trials showed that Voriconazole was effective against Aspergillus genus, including aflatus, fumigus, Aspergillus terreus, Aspergillus Niger and Aspergillus nidus.  The genera of actinomyces pedis, which include cladomyces apicalis and Cladomyces polymyces and Fusarium have clinical efficacy (improvement or cure, see clinical experience section later).
Other fungal infections that are effectively treated (usually cured or improved) by Voriconazole include Streptospora, Blastomyces dermatitis, Blastomyces capitis, Mycospora, Coccidioides, Coccidioides macrospora, Coronium, Cryptococcus neoformans, Omphalus coracorhynchus, Echinomyces Acanthoides, Pigmentoides, Maduroides, Penicillium, and Penicillium, respectively. These include penicillium Maniffer, Trichophyllus, Scopularium brevis, and Trichomyces, including Trichomyces albus.
In vitro, Voriconazole was observed to have antibacterial effects on the following clinically isolated fungi, including Acarispora, Streptospora, bipolar, Cladophialophora, Cladophialophora spp. Voriconazole at 0.05-2μg/ml inhibited most strains.
In vitro studies have shown that Voriconazole has antibacterial effects on Curvularia and Sporotrichum, but its clinical significance is unclear.
Prior to treatment, specimens should be collected for fungal culture and other relevant laboratory tests (serological and histopathological) should be performed to isolate and identify the pathogenic bacteria. Antiinfective therapy must be performed before culture and other laboratory results are available, but once the results are available, the medication regimen should be adjusted accordingly.
Clinical strains with reduced susceptibility to voriconazole have been identified. However, the increase of the minimum inhibitory concentration value does not necessarily lead to clinical treatment failure, and there are also clinically effective infections caused by other pyrrole drug resistant strains. Due to the complexity of patients enrolled in clinical trials, it is difficult to determine the relationship between in vitro antimicrobial activity and clinical treatment outcomes. The critical concentration of voriconazole in susceptibility tests has not been established.
Drug resistance
The in vitro resistance of Candida, Aspergillus, Actinomyces pedis and Fusarium to voriconazole has not been studied enough. At present, the development of resistance of various fungi in the Voriconazole antimicrobial spectrum is not known.
Fungi that are less sensitive to fluconazole and itraconazole may also be less sensitive to voriconazole, suggesting that cross-resistance may exist in these pyrroles. The relationship between cross-resistance and clinical outcomes has not been fully established. If the isolates in clinical cases present cross-resistance, alternative antifungal therapy may be required.
Preclinical safety data
Toxicity studies of repeated administration suggest that the target organ of voriconazole is the liver. Similar to other antifungals, the plasma exposure to hepatotoxicity in experimental animals is equivalent to that achieved in humans with therapeutic doses. Experiments in rats, mice and dogs have found that voriconazole can also induce minor adrenal lesions. Other routine studies of safety pharmacology, reproductive toxicity, and potential carcinogenicity have not found specific harm to humans from voriconazole.
Reproductive studies have shown that when the total body exposure of voriconazole is equivalent to the exposure of human therapeutic dose, it has teratogenic effect on rats and embryonic toxicity on rabbits. In pre - and post-delivery studies, rats given exposure lower than that achieved with human therapeutic doses have prolonged gestation and prolonged delivery, resulting in dystostoic death of the mother, and reduced perinatal survival of the pups. Similar to other pyrrole antifungals, voriconazole is likely to affect delivery by a specie-specific mechanism, including lowering estradiol levels.

Storage:
Keep away from light and sealed.
Store the diluted solution at 2 ° C to 8 ° C for no more than 24 hours (in the refrigerator).
This product is a closed sterile powder. Therefore, from a microbiological point of view, it must be used immediately after dilution. If not immediately given intravenously, unless diluted in a sterile environment, it should be stored at a temperature of 2 ° C to 8 ° C for no more than 24 hours.
At 2 ° C to 8 ° C, the chemical and physical properties of the product remain stable within 24 hours.