GMP Certified / Octreotide Acetate Injection 100mcg/1ml

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 100mcg/1ml
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Octreotide Acetate Injection
Strength	100mcg/1ml
Packing	2*5 amps/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:
Octreotide Acetate Injection

Character:
This product is colorless and clear liquid.

Indications:
1. Emergency treatment of esophageal and gastric variceal bleeding due to cirrhosis, combined with special treatment (such as endoscopic sclerotherapy).
2. Relieve signs and symptoms associated with gastrointestinal and pancreatic endocrine tumors. There is sufficient evidence that octreotide is effective against the following tumors: carcinoid tumors with carcinoid syndrome; For VIP tumors, octreotide has an effective rate of about 50% for the following tumors.
(1) gastrinoma /Zollinger-Ellison syndrome (usually combined with selective H2 receptor antagonists, with antacids as appropriate).
(2) islet tumor (used to prevent hypoglycemia before islet tumor and maintain normal blood sugar).
(3) Growth hormone releasing factor tumor. Octreotide acetate treatment can only reduce symptoms and signs, but not cure.
3. Prevent postoperative complications of pancreas
4. In patients with acromegaly who have failed to be treated with surgery, radiation therapy or dopamine receptor agonists, symptoms can be controlled and the concentration of growth hormone and auxin mediators C can be reduced. This product is also recommended for patients with acromegaly who are unable or unwilling to undergo surgery, and for patients with intermittent periods when radiation therapy is not effective.

Adverse reactions:
The main adverse reactions of octreotide acetate were local and gastrointestinal reactions.
Local reactions after subcutaneous injection may include pain or needling, tingling, or burning at the injection site, with redness and swelling. These phenomena rarely last more than 15 minutes. If the solution is brought to room temperature before injection or the concentration of the solution is increased by reducing the amount of solvent, local discomfort can be reduced.
Gastrointestinal adverse reactions include loss of appetite, nausea, vomiting, spasmodic abdominal pain, bloating, abdominal pain, loose stools, diarrhea, and steatosis. Although the measured excretion of fecal fat may be increased, there is no evidence that long-term octreotide acetate treatment causes malabsorption leading to malnutrition. In rare cases, gastrointestinal adverse reactions may be similar to acute intestinal obstruction with progressive severe epigastrosis, abdominal tenderness, muscle tension, and abdominal distension. Avoiding eating before and after administration (that is, injecting between meals or while resting in the bedroom) can reduce the occurrence of gastrointestinal adverse reactions. Long-term use of octreotide acetate may lead to gallstone formation (see "Precautions").
Octreotide acetate can inhibit the secretion of growth hormone, glucagon and insulin, so this product may cause blood sugar regulation disorders. Because it can reduce postprandial glucose tolerance in patients, some long-term dosing can cause persistent hyperglycemia. Hypoglycemia was observed.
In rare cases, patients may experience hair loss and allergies.
Acute pancreatitis is rarely reported, but it usually appears within hours or days of starting treatment and may gradually disappear when the drug is stopped. Pancreatitis may also occur in patients with gallstones after long-term use of octreotide acetate.
Individual patients developed liver dysfunction, including: acute hepatitis without cholestasis, aminotransferase returned to normal after discontinuation; Slowly occurring hyperbilirubinemia was associated with increased alkaline phosphatase, γ-glutamyltransferase, and slightly elevated aminotransferase.

Pharmacology and toxicology:
Pharmacological action
Octreotide acetate is a synthetic octapeptide compound, which is a somatostatin analogue of tetradeceptide. Octreotide acetate has a pharmacological effect similar to that of natural hormones, but it has a stronger effect on inhibiting growth hormone, glucagon and insulin. Similar to somatostatin, octreotide acetate can also inhibit the LH response to GnRH, reduce visceral blood flow, and inhibit the secretion of 5-HT, gastrin, vasoactive intestinal peptide, chymosin, motilin, and glucagon.
Toxicological study
Genotoxicity: No genotoxicity has been observed in laboratory studies.
Reproductive toxicity: Octreotide acetate was given to rats and rabbits at a dose estimated by body surface area equivalent to 16 times of the highest dose for human use, and no effects on fertility and litter were observed.
Carcinogenicity: Mice were injected subcutaneously with octreotide acetate at a dose of up to 2mg/kg/ day (about 8 times of human exposure according to body surface area) for 85-89 weeks, and no carcinogenicity was found. When octreotide acetate was injected subcutaneously into rats, sarcoma and squamous cell tumor appeared at the injection site at the highest dose of 1.25mg/kg/ day (about 10 times the human exposure according to the body surface area), the incidence of males and females was 27% and 12%, respectively, and the incidence of solvent control group was 8% to 10%. The increased incidence of these tumors is likely related to the local irritation caused by repeated administration of the same subcutaneous site and the hypersensitivity of rats. Octreotide acetate was used continuously in humans for 5 years, and no tumor was observed at the injection site. At a dose of 1.25mg/kg/ day, the incidence of uterine adenomas in female animals was 15%, compared with 7% in the saline group and 0% in the solvent control group. The occurrence of uterine adenoma in female animals may be related to estrogen levels in older animals.

Storage:
Keep in a cold place (2 ~ 10ºC).