Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Insulin soluble human; Insulin isophane human
Sanofi
A10AD01
Insulin soluble human; Insulin isophane human
25unit/1ml ; 75unit/1ml
Suspension for injection
Subcutaneous
No Controlled Drug Status
VMP not recommended to prescribe - patient training required
BNF: 06010102; GTIN: 5013841202187
541559 Aqra d-dokument sħiħ541559 SAP-NR. (DMC): 541559 SCHRIFTGRÖSSE: 9 PUNKT DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM ERSTELLT AM: 24. APRIL 2018 / VERSION: 1 / MAC 541559 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. WHAT IS IN THIS LEAFLET 1. What Insuman Comb 25 is and what it is used for 2. What you need to know before you use Insuman Comb 25 3. How to use Insuman Comb 25 4. Possible side effects 5. How to store Insuman Comb 25 6. Contents of the pack and other information 1. WHAT INSUMAN COMB 25 IS AND WHAT IT IS USED FOR Insuman Comb 25 contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin. Insuman Comb 25 is an insulin preparation with a gradual onset and long duration of action. Insuman Comb 25 is used to reduce high blood sugar in patients with diabetes mellitus who need treatment with insulin. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INSUMAN COMB 25 DO NOT USE INSUMAN COMB 25 If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Insuman Comb 25 in cartridges is only suitable for injecting just under the skin using a reusable pen (see also section 3). Speak to your doctor if you need to inject your insulin by a
INSUMAN COMB 25 100 IU/ML SUSPENSION FOR INJECTION IN A CARTRIDGE Summary of Product Characteristics Updated 27-Jul-2017 | SANOFI 1. Name of the medicinal product Insuman Comb 25 100 IU/ml suspension for injection in a vial Insuman Comb 25 100 IU/ml suspension for injection in a cartridge Insuman Comb 25 SoloStar 100 IU/ml suspension for injection in a pre-filled pen 2. Qualitative and quantitative composition Insuman Comb 25 100 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. Insuman Comb 25 100 IU/ml in a cartridge, Insuman Comb 25 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 Comb 25 is a biphasic isophane insulin suspension consisting of 25% dissolved insulin and 75% crystalline protamine insulin. * 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 Comb 25 is injected subcutaneously 30 to 45 minutes before a meal. _Insuman Comb 25 SoloStar 100 IU Aqra d-dokument sħiħ