Ozempic Semaglutide Injection

Brand Name:诺和泰 ®(Ozempic®)
Generic Name: Semaglutide
Strength: 1.34 mg/mL, 1.5 mL per pre-filled pen; delivers doses of 0.25 mg and 0.5 mg, 1 pen per box
Manufacturer: Novo Nordisk A/S (Denmark)
Marketing Authorization Holder: Novo Nordisk Pharma AG
Approval Date in China: April 27, 2021
Registration Number: 国药准字SJ20210015
Storage: Before first use: Store at 2–8°C, protected from light, do not freeze. After first use: Store below 30°C or refrigerated (2–8°C), use within 6 weeks. Keep the pen cap on to shield from light. Refer to the full package insert for detailed storage specifications.

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1. Indications and Usage
Type 2 Diabetes Mellitus: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Cardiovascular Risk Reduction: Reduces the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death, in adults with type 2 diabetes and established cardiovascular disease.
2. Dosage and Administration
Route of Administration: Subcutaneous injection ONLY. Do not administer intravenously or intramuscularly.
Dosage: The starting dose is 0.25 mg once weekly for 4 weeks. The dose should then be increased to 0.5 mg once weekly. If additional glycemic control is needed, the dose may be increased to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose.
Administration: Can be administered at any time of day, with or without meals. If a dose is missed, it can be administered within 5 days of the scheduled day; if more than 5 days have passed, skip the missed dose.
Injection Sites: Select injection sites in the abdomen, thigh, or upper arm. Rotate injection sites weekly.
3. Mechanism of Action
GLP-1 Receptor Agonism: Semaglutide is a GLP-1 receptor agonist that mimics the action of the endogenous hormone GLP-1.
Glucose-Dependent Insulin Secretion: It stimulates glucose-dependent insulin secretion from pancreatic beta cells.
Gastric Emptying: It suppresses glucagon secretion and delays gastric emptying, which contributes to improved glycemic control and weight reduction.
4. Safety and Warnings
Thyroid C-cell Tumors: Semaglutide increases thyroid C-cell tumor risk in rodents. It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Pancreatitis: Acute pancreatitis, including fatal and non-fatal cases, has been reported. The drug should be discontinued if pancreatitis is suspected.
Hypoglycemia: The risk of hypoglycemia increases when used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.
Gallbladder Disease: Reports of cholelithiasis and cholecystitis have been received.
Acute Kidney Injury: Acute kidney injury has been reported, often secondary to severe gastrointestinal reactions leading to dehydration.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Nausea, vomiting, diarrhea, abdominal pain, and constipation.
Clinical Research Highlights: Clinical trials have demonstrated significant improvements in glycated hemoglobin (HbA1c), body weight reduction, and a proven reduction in cardiovascular events in high-risk patients.
6. Drug Interactions
Oral Medications: Semaglutide delays gastric emptying and may affect the absorption of concurrently administered oral medications.
Sulfonylureas: Dose reduction of sulfonylureas should be considered when initiating semaglutide to mitigate hypoglycemia risk.
Warfarin: International Normalized Ratio (INR) should be monitored when used concomitantly with warfarin.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Semaglutide. Excipients include disodium phosphate dihydrate, phenol, propylene glycol, and water for injection.
Appearance: Clear, colorless liquid.
Packaging: Pre-filled pens (e.g., 2 mg/1.5 mL, 4 mg/3 mL).
Storage: Unopened pens must be stored in a refrigerator at 2°C to 8°C and protected from light. Do not freeze.

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