Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Insulin soluble human; Insulin isophane human
Sanofi
A10AD01
Insulin soluble human; Insulin isophane human
15unit/1ml ; 85unit/1ml
Suspension for injection
Subcutaneous
No Controlled Drug Status
VMP not recommended to prescribe - patient training required
BNF: 06010102; GTIN: 5000283654285
541552 Soma hati kamili541552 SAP-NR. (DMC): 541552 SCHRIFTGRÖSSE: 9 PUNKT DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM ERSTELLT AM: 03. MAI 2018 / VERSION: 3 / MAC 541552 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 15 is and what it is used for 2. What you need to know before you use Insuman Comb 15 3. How to use Insuman Comb 15 4. Possible side effects 5. How to store Insuman Comb 15 6. Contents of the pack and other information 1. WHAT INSUMAN COMB 15 IS AND WHAT IT IS USED FOR Insuman Comb 15 contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin. Insuman Comb 15 is an insulin preparation with a gradual onset and long duration of action. Insuman Comb 15 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 15 DO NOT USE INSUMAN COMB 15 If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Insuman Comb 15 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 an
OBJECT 1 INSUMAN COMB 15 100 IU/ML SUSPENSION FOR INJECTION IN A CARTRIDGE Summary of Product Characteristics Updated 13-Apr-2018 | SANOFI 1. Name of the medicinal product Insuman Comb 15 100 IU/ml suspension for injection in a cartridge 2. Qualitative and quantitative composition Insuman Comb 15 100 IU/ml in a cartridge Each ml contains 100 IU insulin human (equivalent to 3.5 mg). Each cartridge 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 15 is a biphasic isophane insulin suspension consisting of 15% dissolved insulin and 85% 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 15 is injected subcutaneously 30 to 45 minutes before a meal. _Secondary dose adjustment _ Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement. Dose adjustment may also be required, for example, if - the patient's weight changes, - the patient's life-style changes, - other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4). _Special populations _ Soma hati kamili