Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin human
BIOCON SDN BHD
Insulin human
3 ml mL; 10 mL; 3 mL
BIOCON SDN BHD
_Consumer Medication Information Leaflet _ INSUGEN ® -R Human Insulin of Recombinant DNA origin, 100 IU/mL 1 | P a g e WHAT IS IN THIS LEAFLET: 1) What INSUGEN ® -R is and what it is used for? 2) How INSUGEN ® -R works? 3) Before you use INSUGEN ® -R 4) How to use INSUGEN ® -R? 5) While you are using INSUGEN ® -R 6) Side effects 7) Storage and Disposal of INSUGEN ® -R? 8) INSUGEN ® -R Description 9) Manufacturer and Product Registration Holder 10) Date of Revision 11) Serial Number 1) WHAT INSUGEN ® -R IS AND WHAT IT IS USED FOR? INSUGEN ® -R contains the active substance human insulin, which is used to treat diabetes. Diabetes mellitus is condition in which a person has high blood sugar, either because the pancreas does not produce enough insulin or the cells do not respond to the insulin that is produced; therefore, extra insulin is needed to lower your blood sugar levels. INSUGEN ® -R is a short/fast-acting insulin. 2) HOW INSUGEN ® -R WORKS? After administration of INSUGEN ® -R, it will start to lower your blood sugar in about half an hour, and the effect will last for approximately 6 hours. INSUGEN ® -R can be prescribed along with Intermediate acting insulin to control your blood sugar. Please consult your doctor before you change your insulin. 3) BEFORE YOU USE INSUGEN ® -R _When you must not use it _ If you are allergic (hypersensitive) to any of the ingredients in INSUGEN ® -R (see section 9 for list of ingredients). Watch out for the signs of allergy in section 6 (_Possible side effects_) or ask your doctor for clarification. If you experience symptoms of low blood sugar levels (hypoglycaemia), or a hypoglycaemic attack (symptom of low blood sugar). See section 7 (_What_ _to do _ _in an emergency_) to know more about hypoglycaemia. _Before you start to use it_ Inform your doctor if: You have any other medical conditions, such as infection, fever, kidney or liver problems. Some medical conditions can alter your insulin requirements and your doctor will suggest a change in dose Baca dokumen lengkap
D:\e drive\Jobs G Drive Data\HEALTH CARE\PACKAGING\INTERNATIONAL\MALAYSIA ARTWORKS\DUOPHARMA\MALAYSIA MFG\INSUGEN CARTRIDGE MALAYSIA MFG\221121 _DOSAGE_ _ELIMINATION_ _METABOLISM_ _DISTRIBUTION_ _ABSORPTION_ Non-Clinical data reveal 3 ML CARTRIDGE 3 ML CARTRIDGE SIZE : 170 x 230mm (±1mm) PAPER : From India Supply: 45 GSM ITC newsprint paper (40 GSM - 50 GSM) From Malaysia Supply: 50 GSM Woodfree Paper (45 GSM - 55 GSM) LEAFLET FOLDING SIZE : 170 x 29mm (±2mm) PHARMA CODE : FOLDING PATTERN TO BE SAME AS PER ATTACHED DWG. NO. 70M1163101 Insulin, Human of recombinant DNA Origin. For s.c. or i.v. use only. BIOCON MALAYSIA MASTER PROOF OF APPROVED PRINTED CARTRIDGE LEAFLET ART WORK INSUGEN ® -R 100 IU/ML, 3 ML FOR COLOUR COPY (FOR DUOPHARMA - MALAYSIA MFG.) ANNEXURE- 4 [Ref. No. : BM/QA/SOP/059] ARTWORK CODE: BM/XXXX/XX PANTONE 7624 C PANTONE 2035 C PANTONE 123 C BLACK C PANTONE 541 C COLOURS: 1 2 For the use of only a registered medical practitioner or hospital or laboratory For the use of only a registered medical practitioner or hospital or laboratory Insulin, Human of recombinant DNA Origin. For s.c. or i.v. use only. sympathomimetics Side _DOSAGE ADJUSTMENT_ SPECIAL WARNING AND PRECATIONS FOR USE). For subcutaneous or intravenous use. Intramuscular administrations are possible under guidance by a physician. INSUGEN®-R may also be administered intravenously, which should only be carried out by healthcare professionals. The intravenous use of INSUGEN®-R from cartridge should be an exception only in situations where vials are not available. In this case, INSUGEN®-R should be drawn into an insulin syringe, provided air is avoided, or infused with an infusion system. This procedure should only be carried out by healthcare professionals. Never use insugen-R, if the solution is not clear, colourless and aqueous or if it shows cloudiness or any suspended matter Do not refrigerate. Do not freeze. 42 days. direct sunlight. and NATURE AND CONTENT OF CONTAINER: DISPOSAL BM/XXXXX/XX PRODUCT REGISTRATION HOLDER AND MANUF Baca dokumen lengkap