מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: 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: 5000283654650
LEGENDE / LEGEND SAP-Nr. / Plant PM code: 541524 Sprachvariante / Country code: 103 Version: 2 Datum / Date: 03.05.2018 UK Abmessungen / Dimensions: 628 × 296 mm Schriftgröße / Font size: 9 Pt Zeilenabstand / Line spacing: 10 Pt Seite / Page: 1/2 Druckbare Farben / Printing colours Pantone Reflex Blue C Technische Information / Technical information Kontur / Outline PACKAGE LEAFLET: INFORMATION FOR THE USER INSUMAN® BASAL SOLOSTAR® 100 IU/ML SUSPENSION FOR INJECTION IN A PRE-FILLED PEN insulin human 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 sugar level may increase (hyperglycaemia). – If you are not eating enough, your blood sugar level may become too low (hypoglycaemia). In most cases you will need a doctor. MAKE SURE THAT YOU CONTACT A DOCTOR EARLY. If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortn קרא את המסמך השלם
INSUMAN BASAL SOLOSTAR 100 IU/ML SUSPENSION FOR INJECTION IN A PRE FILLED PEN 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-fill קרא את המסמך השלם