Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin human
BIOCON SDN BHD
Insulin human
10ml mL; 3ml mL
Biocon Biologics Limited
_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 used for 2) How INSUGEN ® -R works 3) Before you use INSUGEN ® -R 4) How to use INSUGEN ® -R 5) While you are using it 6) Side effects 7) Storage and disposal of INSUGEN ® -R 8) Product description 9) Manufacturer and Product Registration Holder 10) Date of revision 11) Serial number 1) WHAT INSUGEN ® -R 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 long 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. You are pregnant, planning a pregnancy or breast- Đọc toàn bộ tài liệu
PANTONE 123 C BLACK PANTONE 2035 C PANTONE 7624 C D:\Jobs G Drive Data\HEALTH CARE\PACKAGING\INTERNATIONAL\MALAYSIA ARTWORKS\DUOPHARMA\INDIA MFG\INSUGEN VIAL INDIA MFG BBIL\180123 BIOCON FORMULATIONS MASTER PROOF OF APPROVED PRINTED VIAL LEAFLET ART WORK INSUGEN ® -R 100 IU/ML, 10 ML FOR COLOUR COPY (FOR MALAYSIA INDIA MFG BBL) ANNEXURE-4 [REF. NO. : S2/BF/QA/SOP/0018] ARTWORK CODE: BF2128/XX may help to reduce or prevent these reactions. General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin. Most reactionsare transitory and disappear during continued treatment. Uncommon - Oedema Oedema may occur upon initiation of insulin therapy. These symptoms are usually of transitory nature. Immune system disorders Uncommon - Urticaria, rash. Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, and angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting /loss of consciousness. Generalised hypersensitivity reactions are potentially life-threatening. OVERDOSE A specific overdose of insulin cannot be defined. However, hypoglycaemia may develop over sequential stages: · Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. · Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a medical professional. Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrate is recommended for t Đọc toàn bộ tài liệu