국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Insulin isophane human
Sanofi
A10AC01
Insulin isophane human
100unit/1ml
Suspension for injection
Subcutaneous
No Controlled Drug Status
VMP not recommended to prescribe - patient training required
BNF: 06010102; GTIN: 5013841202149
541554 전체 문서 읽기541554 SAP-NR. (DMC): 541554 SCHRIFTGRÖSSE: 9 PUNKT DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM ERSTELLT AM: 18. APRIL 2018 / VERSION: 1 / MAC 541554 PACKAGE LEAFLET: INFORMATION FOR THE USER INSUMAN® BASAL 100 IU/ML SUSPENSION FOR INJECTION IN A CARTRIDGE insulin human READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THE INSTRUCTIONS FOR USING THE INSULIN PEN ARE PROVIDED WITH YOUR INSULIN PEN. REFER TO THEM BEFORE USING YOUR MEDICINE. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, pharmacist or nurse. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor. If you are allergic to this medicine or to animal insulins, talk to your doctor. Special patient groups If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose. Travel Before travelling, consult your doctor. You may need to talk about – the availability of your insulin in the country you are visiting, – supplies of insulin, needles etc., – correct storage of your insulin while travelling, – timing of meals and insulin administration while travelling, – the possible effects of changing to different time zones, – possible new health risks in the countries to be visited, – what you should do in emergency situations when you feel unwell or become ill. Illnesses and injuries In the following situations, the management of your diabetes may require a lot of care: – If you are ill or have a major injury then your blood sug
INSUMAN BASAL 100 IU/ML SUSPENSION FOR INJECTION IN A CARTRIDGE Summary of Product Characteristics Updated 27-Jul-2017 | SANOFI 1. Name of the medicinal product Insuman Basal 100 IU/ml suspension for injection in a vial Insuman Basal 100 IU/ml suspension for injection in a cartridge Insuman Basal SoloStar 100 IU/ml suspension for injection in a pre-filled pen 2. Qualitative and quantitative composition Insuman Basal 100 IU/ml in a vial Each ml contains 100 IU insulin human (equivalent to 3.5 mg). Each vial contains 5 ml of suspension for injection, equivalent to 500 IU insulin, or 10 ml of suspension for injection, equivalent to 1000 IU insulin. Insuman Basal 100 IU/ml in a cartridge, Insuman Basal SoloStar 100 IU/ml in a pre-filled pen Each ml contains 100 IU insulin human (equivalent to 3.5 mg). Each cartridge or pen contains 3 ml of suspension for injection, equivalent to 300 IU insulin. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin * . Insuman Basal is an isophane insulin suspension. * Human insulin is produced by recombinant DNA technology in _Escherichia coli_. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Suspension for injection. After resuspension, milky-white suspension. 4. Clinical particulars 4.1 Therapeutic indications Diabetes mellitus where treatment with insulin is required. 4.2 Posology and method of administration Posology The desired blood glucose levels, the insulin preparations to be used and the insulin dose regimen (doses and timings) must be determined individually and adjusted to suit the patient's diet, physical activity and life-style. _Daily doses and timing of administration _ There are no fixed rules for insulin dose regimen. However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day. The basal metabolic requirement is 40% to 60% of the total daily requirement. Insuman Basal is injected subcutaneously 45 to 60 minutes before a meal. _Insuman Basal SoloStar 100 IU/ml in a pre-filled pen_ SoloSt 전체 문서 읽기