Zefei(gemcitabine hydrochloride  for injection)
gemcitabine hydrochloride  for injection

English name: Gemcitabine Hydrochloride for Injection.
Chinese Pinyin: Zhusheyong Yansuan Jixitabi.
The main ingredient of this product is gemcitabine hydrochloride.
Chemical name: (+) 2 ́-deoxy-2 ́, 2 ́- difluorocytidine monohydrochloride.


/upload/images/2017/10/10/4df5cb388c1a422cb59da29a9d9a7759.png
【Name】

Common Name: Gemcitabine Hydrochloride for Injection

Brand Name: ZeFei

English name: Gemcitabine Hydrochloride for Injection

Chinese Pinyin: Zhusheyong Yansuan Jixitabi

【Ingredients】

The main ingredient of this product is gemcitabine hydrochloride.

Chemical name: (+) 2 ́-deoxy-2 ́, 2 ́- difluorocytidine monohydrochloride.

Structural Formula: 

Molecular formula:  C9H11F2N3O4•HCl

Molecular weight:  299.70

Excipients: mannitol, sodium acetate

【Description】

This product is a white solid.

【Indications】

For the treatment of advanced non-small cell lung cancer, breast cancer and pancreatic cancer.

【Strength】 1.0g(Calculated on gemcitabine)
【Dosage and Administration】

The recommended dose of Gemcitabine for adult is 1000 mg/m2 as an intravenous infusion over 30 minutes once a week for three consecutive weeks, followed by a week of rest, repeated every four weeks. The dose is reduced accordingly according to the patient's toxicity.

Preparation method: Add at least 25 mL of 0.9% Sodium Chloride Injection to the vial (containing gemcitabine 1.0 g), the dilution yields a gemcitabine concentration of not more than 40 mg/mL, shake to dissolve. Prior to administration the

required amount of drug must be diluted with 0.9% Sodium Chloride Injection.

The prepared gemcitabine solution should be stored at room temperature and used within 24 hours. The gemcitabine solution should not be refrigerated to prevent crystal precipitation.

Geriatric Use: Older patients over the age of 65 can also be well tolerated. Although age has an effect on the clearance and half-life of gemcitabine, there is no evidence that older patients need to adjust the dose.

Pediatric Use: The safety and effectiveness of gemcitabine have not been established in pediatric patients.

2001: First-to-market generic drug in China

2004: Included in NRDL

2006: Designated as a National Key New Product by PRC Ministry of Science and Technology

2010: National Science and Technology Major Project

2013: Approval (powder injectable) from US FDA

2013: Second Prize for the Advancement of Science and Technology

2014: Gold Prize of the WIPO-SIPO Award for Chinese Outstanding Patented Invention & Industrial Design

2014: Included in the National Torch Program by PRC Ministry of Science and Technology