GMP Certified / Palonosetron Hydrochloride Injection 0.25mg/5ml

• Quality Standard: USP, Bp
• Factory Certified: GMP
• Ctd Status: Available
• Transport Package: Sea Transportation
• Specification: 0.25mg/5ml
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description
 

Generic name	Palonosetron Hydrochloride Injection
Strength	0.25mg/5ml
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:
Palonosetron Hydrochloride Injection

Character:
This product is a colorless clear liquid.

Indications:
Prevent acute nausea and vomiting caused by moderate and severe emetic chemotherapy.

Adverse reactions:
The main symptoms are headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia. Rare adverse reactions are described in the drug instructions.
According to foreign clinical studies, 1374 adult patients participated in the clinical study of palonosetron for the prevention of nausea and vomiting caused by moderate or severe emetic chemotherapy. The results showed that the incidence and severity of adverse reactions caused by palonosetron were similar to ondansetron or dolasetron.

Pharmacology and toxicology:
Pharmacological action
Palonosetron is a selective antagonist of 5-HT3 receptor with strong affinity, with no affinity or low affinity to other receptors. The 5-HT3 receptor is located in the central and surrounding vagus nerve endings of the emetic chemotherapeutic receptor in the final region of the medulla oblongata. Chemotherapy agents stimulate the release of 5-HT by small intestinal pheochromotropic cells, which in turn activate the 5-HT3 receptor of the vagafferent nerve, producing the vomiting reflex.
Toxicological study
carcinogenicity
In a 104-week carcinogenicity study of CD-1 mice, animals were treated with 10, 30 and 60mg/kg/ day of palonosetron orally, and Palonosetron showed no carcinogenicity. The systemic exposure (plasma AUC) of palonosetron produced by the highest experimental dose was 150-289 times the recommended exposure (AUC=29.8ng/h/ml) after intravenous administration of 0.25mg palonosetron in humans. In the carcinogenicity study of SD rats at 104 weeks, male and female rats were orally given 15, 30, and 60 mg/kg/d and 15, 45, and 90 mg/kg/d palonosetron, respectively. The highest dose produced a systemic exposure to Palonosetron (plasma AUC) of 137-308 times the recommended dose exposure for humans. Palonosetron administration resulted in an increased incidence of benign adrenal pheochromocytoma and mixed benign and malignant pheochromocytoma in male rats, pancreatic islet cell adenomas, mixed adenomas and sarcomas, and pituitary tumors, and in female rats hepatocellular adenomas and sarcomas. The incidence of thyroid C-cell adenomas, mixed adenomas and sarcomas has increased.
mutagenicity
The bacterial Ames test, Chinese hamster ovarian cell mutagenicity test, in vitro hepatocyte disordered DNA synthesis (UDS) test or micronucleus test in mice showed no mutagenicity. However, palonosetron had chromosomal aberrations on Chinese hamster ovary cells.
Reproductive toxicity
The oral dose of 60mg/kg (about 1894 times of the recommended intravenous dose based on body surface area) had no effect on the fertility and fecundity of both male and female rats.

Storage:
Dark, sealed, not more than 30ºC store.