Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Human insulin (recombinant dna origin)
PCO Manufacturing Ltd.
A10AD; A10AD01
Human insulin (recombinant dna origin)
Suspension for injection
Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting; insulin (human)
2023-05-19
PACKAGE LEAFLET: INFORMATION FOR THE USER HUMULIN ® M3 KWIKPEN ® (MIXTURE 3) 100 IU/ML SUSPENSION FOR INJECTION (Insulin human) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 Humulin M3 KwikPen is and what it is used for 2. What you need to know before you use Humulin M3 KwikPen 3. How to use Humulin M3 KwikPen 4. Possible side effects 5. How to store Humulin M3 KwikPen 6. Contents of the pack and other information 1. WHAT HUMULIN M3 KWIKPEN IS AND WHAT IT IS USED FOR Humulin M3 KwikPen is a pre-filled pen containing the active substance human insulin, which is used to treat diabetes. You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood (blood sugar). Humulin M3 is used to control glucose in the long term. It is a premixed suspension of rapid and long acting insulin. Its action is prolonged by the inclusion of protamine sulfate in the suspension. Your doctor may tell you to use Humulin M3 KwikPen as well as a longer-acting insulin. Each kind of insulin comes with its own patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin. Each type of insulin has a different colour and symbol on the pack and the pen so that you can easily tell the difference. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMULIN M3 KWIKPEN HUMULIN M3 IN PRE-FILLED PEN IS ONLY SUITABLE FOR INJECTING JUST UNDER THE SKIN. SPEAK TO YOUR DOCTOR IF YOU NEED TO INJECT YOU Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 22 May 2023 CRN00DGMV Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Humulin M3 KwikPen (mixture 3) 100 IU/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 IU insulin human (produced in E. coli by recombinant DNA technology). One pre-filled pen contains 3 ml equivalent to 300 IU of biphasic isophane insulin – 30 % soluble insulin / 70 % isophane insulin. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM A suspension for injection in a pre-filled pen. _Product imported from Czech Republic:_ Humulin M3 is a sterile suspension of human insulin in the proportion of 30 % soluble insulin to 70 % isophane insulin. 4 CLINICAL PARTICULARS As per PA2276/006/002 5 PHARMACOLOGICAL PROPERTIES As per PA2276/006/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS m-cresol glycerol phenol protamine sulfate dibasic sodium phosphate zinc oxide water for injections. The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide. 6.2 INCOMPATIBILITIES Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE _Unused pre-filled pens_ Health Products Regulatory Authority 22 May 2023 CRN00DGMV Page 2 of 3 Store in a refrigerator (2° C – 8° C). Do not freeze. Do not expose to excessive heat or direct sunlight. _After first use_ Store below 30° C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached. 6.5 NATURE AND CONTENTS OF CONTAINER 3 ml suspension in a cartridge (type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber) in a pre-filled pen. Pack size of 5. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Do not reuse needles. Dispose o Olvassa el a teljes dokumentumot