Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Insulin glargine
Sanofi
A10AE04
Insulin glargine
100unit/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
VMP not recommended to prescribe - brands not bioequivalent
BNF: 06010102; GTIN: 5013011005082
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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.541502 SAP-NR. (DMC): 541502 SCHRIFTGRÖSSE: 9,5 PUNKT DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT 420 X 296 MM ERSTELLT AM: 17. APRIL 2018 / VERSION: 1 / MAC 541502 PACKAGE LEAFLET: INFORMATION FOR THE USER LANTUS® 100 UNITS/ML SOLUTION FOR INJECTION IN A CARTRIDGE insulin glargine WHAT IS IN THIS LEAFLET: 1. What Lantus is and what it is used for 2. What you need to know before you use Lantus 3. How to use Lantus 4. Possible side effects 5. How to store Lantus 6. Contents of the pack and other information 1. WHAT LANTUS IS AND WHAT IT IS USED FOR Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin. Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood- sugar-lowering action. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LANTUS DO NOT USE LANTUS If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Lantus 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 another method. Talk to your doctor, pharmacist or nurse Preberite celoten dokument
OBJECT 1 LANTUS 100 UNITS/ML SOLUTION FOR INJECTION IN A CARTRIDGE Summary of Product Characteristics Updated 06-Apr-2018 | SANOFI 1. Name of the medicinal product Lantus 100 units/ml solution for injection in a vial Lantus 100 units/ml solution for injection in a cartridge Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen 2. Qualitative and quantitative composition Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg). Lantus 100 units/ml solution for injection in a vial Each vial contains 5 ml of solution for injection, equivalent to 500 units, or 10 ml of solution for injection, equivalent to 1000 units. Lantus 100 units/ml solution for injection in a cartridge, Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen Each cartridge or pen contains 3 ml of solution for injection, equivalent to 300 units. *Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. Clear colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 4.2 Posology and method of administration Posology Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once daily at any time but at the same time each day. The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). _Special population _ _Elderly population (≥65 years old)_ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. _Renal impairmen Preberite celoten dokument