NAME OF THE MEDICINAL PRODUCT Apidra Insulin Vial
Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg). Again, Apidra 100 Units/ml solution for injection in a vial Each vial contains 10 ml of solution for injection, equivalent to 1000 Units. Also, Apidra 100 Units/ml solution for injection in a cartridge Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units. Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Each pen contains 3 ml of solution for injection, equivalent to 300 Units. Insulin glulisine is produced by recombinant DNA technology in Escherichia coli. For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Apidra 100 Units/ml solution for injection in a vial Solution for injection in a vial. To add, Apidra 100 Units/ml solution for injection in a cartridge Solution for injection in a cartridge. Again, Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Solution for injection in a pre-filled pen. Clear, colourless, aqueous solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, are treatment with insulin is require.
4.2 Posology and method of administration Posology The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents. The dose of Apidra should be individually adjusted.
Diabetes Mellitus Type I or II
Indicated to improve glycemic control in adults and children with diabetes mellitus
- Equipotent to regular human insulin (ie, elicits same glucose lowering effects on unit per unit basis) when administered IV
- Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin
- Dosage must is individualize; blood glucose monitoring is essential in all patients receiving insulin therapy
- Total daily insulin requirement may vary and is usually between 0.5-1 unit/kg/day
- Insulin requirements may be alter during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs
- Administer within 15 minutes before a meal or within 20 minutes after starting a meal
- When administering by SC injection, insulin glulisine should generally be use in regimens with an intermediate- or long-acting insulin
- Administered by SC injection in the abdominal wall, thigh, or upper arm
- Injection sites should rotate within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy
Summary of the safety profile
Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Tabulated list of adverse reactions
The following relates adverse reactions from clinical studies are below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions is present in order of decreasing seriousness.
|MedDRA Organ system classes||Very common||Common||Uncommon||Rare||Unknown|
|Metabolism and nutrition disorders||Hypoglycaemia||Hyperglycaemia (potentially leading to Diabetic ketoacidosis(1))|
|Skin and subcutaneous tissue disorders||Injection site reactions
Local hypersensitivity reactions
|General disorders and administration site conditions||Systemic hypersensitivity reactions|
|(1) Again, Apidra 100 Units/ml solution for injection in a vial: Most of the cases relates to handling errors or pump system failure when Apidra is use with CSII.|
Generic Name: insulin glulisine (IN su lin GLOO lis een)
Brand Name: Apidra, Apidra OptiClik Cartridge, Apidra SoloStar Pen. Apidra Insulin Vial
Medically reviewed by Drugs.com on Nov 2, 2017 – Written by Cerner Multum
What is insulin glulisine?
Again, Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glulisine is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Apidra Insulin Vial
Also, Insulin glulisine is used to improve blood sugar control in adults and children with diabetes mellitus. Insulin glulisine is used to treat type 1 or type 2 diabetes in adults, and type 1 diabetes children who are at least 4 years old.
Insulin glulisine may also be use for purposes not listed in this medication guide Apidra Insulin Vial.
Never share an injection pen or syringe with another person, even if the needle has been changed.
Before taking this medicine
Therefore, Insulin glulisine is not approve for use by anyone younger than 4 years old, and should not be use to treat type 2 diabetes in a child of any age.
To make sure insulin glulisine is safe for you, tell your doctor if you have:
- liver or kidney disease;
- low levels of potassium in your blood (hypokalemia); or
- diabetic ketoacidosis (call your doctor for treatment).
You can trust the safety and effectiveness of your generic medicines. It is very important to take your medicines as prescribed by your physician. As the Food and Drug Administration (FDA) the federal agency charge with overseeing the safety, effectiveness and quality of the drug supply tells us, “not taking your medicine as prescribe by a doctor or instructed by a pharmacist could lead to your disease getting worse, hospitalization, even death.”
“Safety of Medicines” is the first principle list in the AAM Code of Business Ethics. But, Every member company pledges to “conform to high standards of quality, safety and efficacy as determined by regulatory authorities in each economy in which they operate.” Also, This commitment to quality, therefore safety and efficacy applies regardless of where medicines are manufactured.
Apidra Insulin Vial Online
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