Product Definition and Composition

اسپارتینا®^® is a pharmaceutical preparation containing tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, produced by CinnaGen Company under strict manufacturing standards. Spartina^® is manufactured as a sterile, preservative-free, pre-filled single-dose auto-injector for subcutaneous use only. Spartina^® is developed and produced at CinnaGen’s pharmaceutical facilities according to Good Manufacturing Practice (GMP) guidelines. It is intended exclusively for once-weekly subcutaneous administration in adult patients, using designated injection areas (abdomen, thigh, or upper arm), with site rotation recommended. The active pharmaceutical ingredient, tirzepatide, is synthesized in-house and formulated in a clear, colorless to slightly yellow solution. This guarantees a consistent and high-quality product suitable for healthcare professional prescription use.

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اسپارتینا®^® is designed to address the metabolic needs of adult patients with obesity, type 2 diabetes, or moderate-to-severe obstructive sleep apnea, when combined with lifestyle interventions.

Type 2 Diabetes Mellitus

To improve glycemic control in adults with type 2 diabetes, as an adjunct to diet and exercise

Weight Management

For chronic weight management in adults with obesity, or in those with overweight and at least one weight-related comorbid condition (e.g., cardiovascular disease, dyslipidemia, hypertension, OSA, type 2 diabetes mellitus) alongside a reduced-calorie diet and increased physical activity

Moderate-to-Severe OSA

For the treatment of moderate to severe obstructive sleep apnea in adults with obesity.

Dosing

Each Spartina^® auto-injector delivers one of the following dose strengths:

0 mg

مکانیسم اثر

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It exerts its clinical effects through:

Enhancement of glucose-dependent insulin secretion
Reduction of glucagon secretion
Delay of gastric emptying
Appetite regulation leading to reduced calorie intake
Weight loss through fat mass reduction while maintaining lean mass proportionally

Safety Profile Summary Contraindications:

Contraindications

Warnings and Precautions

پانکراتیت حاد Discontinue if suspected/confirmed
Hypoglycemia: Higher risk with insulin or sulfonylureas; dose adjustment may be needed
GI Effects: Nausea, vomiting, diarrhea → risk of dehydration/renal issues; ensure hydration
Caution in Severe GI Disease: Not studied in severe disorders (e.g. gastroparesis); use with caution
رتینوپاتی دیابتی Monitor patients with active/untreated retinopathy or macular edema
Anaesthesia Risk: Delayed gastric emptying may increase aspiration risk during procedures

How to Store Spartina^®

Keep Spartina^® refrigerated at 2-8°C and out of the sight and reach of children.
Protect the medication from direct sunlight.
اسپارتینا®^® is a single-dose product for one-time use only.
Do not shake the device.
Always check the expiry date before use.
Never heat or freeze the medication.
Store Spartina^® in its original package until use.

Injection Sites for Spartina^®

اسپارتینا®^® is administered via subcutaneous injection in the following areas:

The abdomen (at least 5 cm away from the belly button).
The back and sides of the upper arms (halfway between the elbow and shoulder).
The front of the thighs (approximately 5 cm above the knee and 5 cm below the groin).
Assistance from another person may be required if injecting into the upper arm.
Patients can use the same body area each week but should choose a different injection site within that area.
If insulin is also being injected, a different injection site should be selected for that injection.

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