Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Insulin glulisine, Quantity: 3.49 mg/mL
Sanofi-Aventis Australia Pty Ltd
Insulin glulisine
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; metacresol; polysorbate 20; trometamol; hydrochloric acid; sodium hydroxide
Subcutaneous
5 x SoloStar pen containing APIDRA 3mL cartridge, Patient Starter Pack: 1 pen with 1 x 3mL cartridge
(S4) Prescription Only Medicine
Apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.
Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2006-11-28
APIDRA ® _(A-PID-RA)_ _insulin glulisine (in-sue-lin glue-lee-seen)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Apidra. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. All medicines have risks and benefits. Your doctor has weighed the risks of you using Apidra against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT APIDRA IS USED FOR Apidra is used to reduce high blood sugar (glucose) levels in people with diabetes mellitus. Apidra is a modified insulin that is very similar to human insulin. It is a substitute for the insulin produced by the pancreas. Apidra is a short-acting insulin. Your doctor may tell you to use a long- acting insulin in combination with Apidra. Apidra is not addictive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY APIDRA HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU USE APIDRA _WHEN YOU MUST NOT USE_ _APIDRA_ DO NOT USE APIDRA: - IF YOU HAVE AN ALLERGY TO: • any medicine containing insulin • any of the ingredients contained in Apidra listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • redness, swelling, rash and itching at the injection site • rash, itching or hives on the skin • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body - IF YOU ARE EXPERIENCING LOW BLOOD SUGAR LEVELS (HYPOGLYCAEMIA - A "HYPO"). If you have a lot of hypos discuss appropriate treatment with your doctor. - AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If you use Apidra after the expiry date has passed, it may not work as well. If it has expired or is damaged, return it to your pharmacist for disposal. - IF THE PRODUCT APPEARS CLOUDY, DIS Read the complete document
apidra-ccdsv12-piv13-15feb21 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION – APIDRA (INSULIN GLULISINE) 1 NAME OF THE MEDICINE Insulin glulisine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Apidra contains 100 IU/mL (3.49 mg/mL) insulin glulisine. For full list of excipients, see Section 6.1, List of Excipients. 3 PHARMACEUTICAL FORM Solution for injection. Apidra is a sterile clear, colourless solution of insulin glulisine in vials and cartridges for use as an injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia. 4.2 DOSE AND METHOD OF ADMINISTRATION Apidra is a recombinant human insulin analogue that has been shown to be equipotent to human insulin. After subcutaneous administration it has a more rapid onset and a shorter duration of action than regular human insulin. Apidra is for single patient use only. Apidra should be given by injection within 15 minutes before or immediately after a meal. DOSE The dosage of Apidra should be individualised and determined based on the physician’s advice in accordance with the needs of the patient. Apidra should normally be used in regimens that include a longer-acting insulin or basal insulin analogue. Apidra should be administered by subcutaneous injection in the abdominal wall, the thigh or deltoid. As with all insulins, injection sites within an injection area (abdomen, thigh, deltoid) should be rotated from one injection to the next in order to reduce the risk of lipodystrophy and localised cutaneous amyloidosis. Do not inject into areas of lipodystrophy and localised apidra-ccdsv12-piv13-15feb21 Page 2 of 21 cutaneous amyloidosis. (see Section 4.4 Special warnings and precautions for use and 4.8 Adverse Effects (Undesirable Effects). As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by injection site, exercise and other variable Read the complete document