Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
insulin glargine (UNII: 2ZM8CX04RZ) (insulin glargine - UNII:2ZM8CX04RZ)
TYA Pharmaceuticals
insulin glargine
insulin glargine 100 [iU] in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Important Limitations of Use: - LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition. LANTUS is contraindicated - In patients with hypersensitivity to LANTUS or one of its excipients [See ]. Warnings and Precautions (5.4) Pregnancy Category C: Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m . In rabbits, doses of 0.072 mg/kg/day, which is approx
NDC:64725-2220-1 in a VIAL, GLASS of 10 INJECTION, SOLUTIONS LANTUS solution for injection 100 units per mL (U-100) is available as: Needles are not included in the packs. BD Ultra-Fine™ needles to be used in conjunction with SoloStar are sold separately and are manufactured by BD. 1 LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen. Unopened Vial/ SoloStar disposable insulin device: Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial: Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) SoloStar disposable insulin device: The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened. These storage conditions are summarized in the following table: Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. LANTUS must only be used if the solution is clear and colorless with no particles visible. Mixing and diluting: LANTUS must NOT be diluted or mixed with any other insulin or solution [S . ee ] Warnings and Precautions (5.2) The syringes must not contain any other medicinal product or residue. Vial: : If SoloStar disposable insulin device, malfunctions, LANTUS may be drawn from the cartridge system or from SoloStar into a U-100 syringe and injected. SoloStar
New Drug Application
LANTUS- INSULIN GLARGINE INJECTION, SOLUTION TYA PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANTUS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANTUS. LANTUS (INSULIN GLARGINE [RDNA ORIGIN] INJECTION) SOLUTION FOR SUBCUTANEOUS INJECTION INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Warnings and Precautions ( ) 5.8 10/2013 INDICATIONS AND USAGE LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ( ) 1 Important Limitations of Use: Not recommended for treating diabetic ketoacidosis. Use intravenous, short-acting insulin instead. DOSAGE AND ADMINISTRATION Individualize dose based on the type of diabetes and whether the patient is insulin-naïve ( , , ) 2.12.22.3 Administer subcutaneously once daily at any time of day, but at the same time every day. ( ) 2.1 Rotate injection sites within an injection area (abdomen, thigh, or deltoid) to reduce the risk of lipodystrophy. ( ) 2.1 Converting from other insulin therapies may require adjustment of timing and dose of LANTUS. Closely monitor glucoses especially upon converting to LANTUS and during the initial weeks thereafter. ( ) 2.3 DOSAGE FORMS AND STRENGTHS Solution for injection 100 units/mL (U-100) in 10 mL vials 3 mL SoloStar disposable insulin device ( ) 3 CONTRAINDICATIONS In patients with hypersensitivity to LANTUS or one of its excipients ( ) 4 WARNINGS AND PRECAUTIONS Dose adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision ( ) 5.1 Administration: Do not dilute or mix with any other insulin or solution. Do not administer subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur ( ) 5.2 Do not share reusable or disposable insulin devices or needles between patients ( ) 5.2 Hypoglycemia: Læs hele dokumentet