GMP Certified / Pantoprazole Sodium for Injection 40mg

• Quality Standard: USP, Bp
• Packing: 1 Vial+1 AMP/Box
• Factory Certified: GMP
• Ctd: Available
• Transport Package: Carton
• Specification: 40mg
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Generic Name	Pantoprazole Sodium for injection
Strength	40mg
Packing	1 vial+1 amp / box
Origin	China

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:
Pantoprazole Sodium for injection

Character:
 This product is white or white like loose mass or powder..

Indications:
It is suitable for duodenal ulcer, gastric ulcer, acute gastric mucosal disease, compound gastric ulcer and other acute upper gastrointestinal bleeding.

Taboo:
1, allergic to this product is prohibited;
2. Prohibited for pregnant and lactating women.

Drug interaction:
It has a low affinity with liver cytochrome P450 enzyme and has a phase II metabolic pathway, so it interacts less with other drugs metabolized by cytochrome P450 enzyme system than omeprazole and Lansoprazole.

Pharmacology and toxicology
Pharmacological action
Pantoprazole is a proton pump inhibitor that inhibits the final step in gastric acid production by covalently binding to two sites of the H+-K+ ATPase system in gastric parietal cells. The effect is dose-dependent and inhibits both basal and stimulated gastric acid secretion. The combination of this product with H+-K+ ATPase can cause its anti-gastric acid secretion for more than 24 hours.
Toxicological study
Genotoxicity: Pantoprazole human lymphocyte chromosome aberration test, Chinese hamster ovary cell /HGPRT forward mutation test and one of the second mouse micronucleus test results were positive, while rat liver DNA covalent binding test results were difficult to determine. Ames test, rat hepatocyte extra-programmed DNA synthesis test (UDS), AS52/GPT mammalian cell forward gene mutation test, mouse lymphoma L5178Y cell thymine kinase mutation test and in vivo rat bone marrow cell chromosome aberration test were negative.
Reproductive toxicity: Oral administration of Pantoprazole 500mg/kg/d(98 times the clinical recommended oral dose according to body surface area) in male rats and oral administration of Pantoprazole 450mg/kg/d (88 times the clinical recommended oral dose according to body surface area) in female rats showed no significant abnormalities in fertility and reproductive behavior.
The intravenous administration of pantoprazole 20mg/kg/d in rats (4 times the clinical recommended oral dose based on body surface area) and 15mg/kg/d in rabbits (6 times the clinical recommended oral dose based on body surface area) did not cause significant damage to fertility and litter. Pantoprazole and its metabolites can be secreted from rabbit milk.
Carcinogenicity: When pantoprazole was administered orally for 24 consecutive months, dose-dependent intestinal pheochromoid cell proliferation and benign and malignant neuroendocrine cell tumors were observed in the gastric fundus of SD rats. At doses of 50 and 200mg/kg/ day (10 and 40 times the clinically recommended oral dose based on body surface area), benign squamous cell papillomas and malignant squamous cell carcinomas appeared in the anterior stomach. Pantoprazole also caused gastrointestinal tumors in a very small number of rats, including occasional duodenal adenocarcinoma at a dose of 50mg/kg/ day, and benign polyps and adenocarcinomas at the fundus of the stomach at a dose of 200mg/kg/ day. When Pantoprazole was administered at a dose of 0.5-200 mg/kg/ day, hepatocellular adenoma and liver cancer were dose-dependent in rats, and 200mg/kg/ day also increased the incidence of thyroid cystic cell tumor and cystic cell carcinoma. Hepatocellular adenomas and hepatocellular carcinoma were also occasionally observed in 6 - and 12-month toxicity studies in SD rats.
Fischer344 rats were given pantoprazole 5-50mg/kg/d orally for 24 consecutive menstrual periods (1-10 times the clinically recommended oral dose based on body surface area), and intestinal pheochromoid cell hyperplasia and benign and malignant neuroendocrine cell tumors appeared in the gastric floor in a dose-dependent manner. However, the dose selection in this trial was insufficient to support an adequate evaluation of Pantoprazole's potential carcinogenicity.
In B6C3F1 mice, 5-150mg/kg/d of pantoprazole was given orally for 24 consecutive periods (0.5-15 times of the recommended oral dose according to the body surface area), and the gastrogastrogastro-intestinal chromomaffin cell proliferation was also observed. The incidence of hepatocellular adenoma and liver cancer increased in female mice at 150mg/kg/ day.
The results of carcinogenicity studies in rodents above suggest that this product has certain carcinogenicity, but the relevance of this result to the clinic is not clear.

Storage:
Keep in a cool place (no more than 20 ° C).