Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: 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: 5000283652946
LEGENDE / LEGEND SAP-Nr. / Plant PM code: 541512 Sprachvariante / Country code: 103 Version: 1 Datum / Date: 13.04.2018 PE Abmessungen / Dimensions: 628 × 296 mm Schriftgröße / Font size: 10 Pt Zeilenabstand / Line spacing: 11 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 LANTUS® SOLOSTAR® 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN insulin glargine Talk to your doctor, pharmacist or nurse before using Lantus. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor. If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet). 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 (for example, adjustment to insulin dose, blood and urine tests): – 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 requi Đọc toàn bộ tài liệu
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 Đọc toàn bộ tài liệu