Gansulog

Each ml contains 100 IU Insulin Glargine (equivalent to 3.64 mg) in 3-mL cartridge.
*Insulin glargine is produced by recombinant DNA technology in Escherichia coli strain K12 substrain W3110.
Excipients/Inactive Ingredients: Metacresol, Glycerin, Zinc chloride, Hydrochloric acid, Sodium hydroxide, Water for injection.

ATC code: A10AE.
Pharmacology: Pharmacodynamics: Insulin acts via specific membrane-bound receptors on target tissues to regulate metabolism of carbohydrate, protein and fats. Target organs for insulin include the liver, skeletal muscle and adipose tissue.
Within the liver: insulin stimulates hepatic glycogen synthesis.
Pharmacokinetics: Onset of action: 3 to 4 hours.
Duration: 10.8 to > 24 hours.
Absorption: Slow.
Metabolism: Partially metabolized in the subcutaneous depot at the carboxyl terminus of the B chain to form two active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Time to peak, plasma: No pronounced peak; Excretion: Urine.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
However, there is a risk of malignant fibrous histiocytoma shown in a non-clinical study of Gansulog.

Treatment of diabetes mellitus type 1 and 2 in patients 18 years of age and older who require insulin.

Insulin glargine is a long-acting insulin administered by SC injection.
Recommended dose: Patients ≥ 18 years of age: Diabetes mellitus, type 1: SC dose: Initial dose: Approximately one-third to one-half of the total daily insulin requirement administered once daily.
Diabetes mellitus, type 2: SC dose: Initial basal insulin dose: 0.2 units/kg once daily; up to 10 units/day. Adjust dosage according to patient response.
Patients under 18 years of age: No data are available for patients under 18 years of age.
Special populations: Renal impairment: The safety and efficacy of Gansulog have not been established in Renal impairment population. No data are available. However, Insulin requirement may be reduced due to changes in insulin clearance or metabolism.
Hepatic impairment: The safety and efficacy of Gansulog have not been established in Hepatic impairment population. No data are available. However, Insulin requirement may be reduced due to changes in insulin clearance or metabolism.
Dosage adjustment: Dosage must be titrated to achieve glucose control and avoid hypoglycemia.
Administration: Insulin glargine should only be administered subcutaneously.
Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. Insulin glargine should be administered once daily at the same time each day. Do not dilute or mix insulin glargine with any other insulin formulation or solution.
Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.
Please bring Gansulog to room temperature before use and follow the injection steps described as follows: (1) Check the insulin to make sure it is clear and colorless. Do not use Gansulog if it is colored or cloudy, or if the patient sees particles in the solution.
(2) Gansulog should be used with GanleePen insulin delivery device only (the reusable pen), please read the GanleePen's medical device instruction manual before use.
(3) Gansulog is injected under the skin (subcutaneously) of the upper arm, thigh, or stomach area (abdomen). Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before the patient injects the dose. Injection sites must be rotated within a given injection area from one injection to the next.
(4) Pinch the skin of the injection site with the fingers and puncture the needle. After the pusher is pushed to the end, keep the needle under the skin for a few seconds to ensure that the correct dose is injected, then pull out the needle, and gently press the injection site with the sterile cotton ball for a few seconds, but do not rub the injection site to avoid damage to the subcutaneous tissue or cause the exudation of Gansulog.

Acute Toxicity: Pathogenesis: Acute hypoglycemia may result from excessive insulin dosage relative to food intake and/or energy expenditure, and numerous conditions may predispose to the development of insulin-induced hypoglycemia.
Hypoglycemia may result from overinsulinization, irregular eating patterns, increased physical activity, and/or decreased carbohydrate content of meals.
Manifestations: Hypoglycemia, is the principal Manifestations of acute insulin overdosage. Symptoms of moderate hypoglycemia include aggressiveness, drowsiness, confusion and autonomic symptoms. Severe hypoglycemia is associated with altered states of consciousness, including coma and seizures.
Fatalities have been reported following severe insulin-induced hypoglycemia.
Other complications include hypoglycemia, respiratory insufficiency/failure, pulmonary edema, congestive heart failure, hypertension, and cerebral edema.
Treatment: Mild hypoglycemia may be relieved by oral administration of carbohydrate-containing food or drink. Severe hypoglycemia requires treatment with glucagon or IV dextrose solution.
Patients unresponsive to or unable to receive glucagon should be given approximately 10-20 g of glucose as 20-50 mL of 50% dextrose injection IV. Higher or repeated dose of IV dextrose may be required in severe case, and subsequent continuous IV infusion of glucose at 5-10 g/hour may be necessary to maintain adequate blood glucose concentration until the patient is conscious and able to eat. The patient should be monitored closely until complete recovery is assured as hypoglycemia may recur.

Hypersensitivity to insulin glargine or any component of the formulation (listed in Description).

Severe, life-threatening allergic reactions, including anaphylaxis may occur. If hypersensitivity reactions occur, discontinue therapy.
Use with caution and monitor blood glucose closely in renal or hepatic impairment due to changes in insulin clearance metabolism.
Hypoglycemia is the most common adverse effect of insulin. Hypoglycemia may result from increased work or exercise without eating.
Insulin requirements may be altered during illness, emotional disturbances or other stressors. Instruct patients to use caution with ethanol; may increase risk of hypoglycemia. Insulin may produce hypokalemia which, if left untreated, may result in respiratory paralysis, ventricular arrhythmia and even death.
Insulin glargine is a clear solution, but it is NOT intended for IV or IM administration or via an insulin pump.
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia or hyperglycemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Patients should be advised to take precautions to avoid hypoglycemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycemia or have frequent episodes of hypoglycemia. It should be considered whether it is advisable to drive or use machines in these circumstances.

Pregnancy: Category C (insulin glargine).
Because insulin glargine has an increased affinity to the insulin-like growth factor (IGF-I) receptor, there are theoretical concerns that it may contribute to adverse events when used during pregnancy.
Women who are stable on insulin glargine prior to conception may continue it during pregnancy.
Lactation: All types of insulin may be used while breast-feeding.

Has primarily symptoms of hypoglycemia.
Cardiovascular: Hypertension, peripheral edema, retinal vascular disease, thrombophlebitis, traumatic haematoma.
Central nervous system: Depression, headache.
Endocrine & metabolic: Hypoglycemia (more common in Type I on combination regimens), sodium retention.
Gastrointestinal: Diarrhea, Nausea, Vomiting, Toothache.
Genitourinary: Urinary tract infection.
Immunologic: Antibody development (effect on therapy not reported).
Infection: Infection, influenza.
Local: Erythema at injection site, itching at injection site, localized edema, pain at injection site, swelling at injection site, extravasation, phlebitis.
Neuromuscular & skeletal: Arthralgia, back pain, limb pain.
Ophthalmic: Cataract retinopathy.
Respiratory: Bronchitis, cough, nasopharyngitis, pharyngitis (children & adolescents), rhinitis (children & adolescents), sinusitis, upper respiratory tract infection (more common in adults), oropharyngeal pain.
Miscellaneous: Accidental injury, chest pain.
Rare but important or life-threatening: Hyperglycemia, hypersensitivity reaction, hypertrophy at injection site, injection site reaction (including urticaria and inflammation), lipoatrophy at injection site, skin rash, weight gain.
Skin and subcutaneous tissue disorders: Frequency 'not known': Cutaneous amyloidosis.
Skin and subcutaneous tissue disorders: Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.

Metabolism/Transport Effects: None known. Avoid Concomitant Use: Avoid concomitant use of Insulin Glargine with any of the following: Macimorelin; Pioglitazone.
Increased Effect/Toxicity: Insulin Glargine may increase the levels/effects of Hypoglycemia-Associated Agents: Pioglitazone.
The levels/effects of Insulin Glargine may be increased by: Alpha-Lipoic Acid; Androgens; Antidiabetic Agents; Beta-Blockers; Dipeptidyl Peptidase-IV Inhibitors; Edetate Calcium Disodium; Edetate Disodium; Glucagon-Like Peptide-1 Agonists; Guanethidine; Herbs (Hypoglycemic Properties); Liraglutide; Metreleptin; Monoamine Oxidase Inhibitors; Pegvisomant; Pioglitazone; Pramlintide; Prothionamide; Quinolones; Salicylates; Selective Serotonin Reuptake Inhibitors; Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors.
Decreased Effect: Insulin Glargine may decrease the levels/effects of: Macimorelin.
The levels/effects of Insulin Glargine may be decreased by: Hyperglycemia-Associated Agents: Quinolones; Ritodrine; Thiazide and Thiazide-Like Diuretics.

Incompatibilities: Incompatible with: Insulin aspart, insulin detemir, insulin glulisine, insulin lispro, insulin NPH, insulin regular when mixed together in syringe.

Do not freeze.
Storage condition: 2°C-8°C, keep away from direct heat and light.
In-use cartridges, opened vial: Do not store in the refrigerator, store in the temperature not above 25°C and away from direct heat or direct light. The medicinal product may be stored for maximum of 4 weeks.
Shelf-life: 24 months.

Insulin Preparations

A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.

D