국가: 이스라엘
언어: 영어
출처: Ministry of Health
INSULIN GLARGINE
ELI LILLY ISRAEL LTD, ISRAEL
A10AE04
SOLUTION FOR INJECTION
INSULIN GLARGINE 100 U/ML
S.C
Required
LILLY FRANCE
INSULIN GLARGINE
Treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adults patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.
2020-11-30
I BASAKPN F 09 Page 1 of 9 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ACTIVE INGREDIENT AND ITS QUANTITY: Each pre-filled pen contains a 3 mL cartridge. Each 1 mL contains: 100 units (3.64 mg) of insulin glargine. INACTIVE INGREDIENTS AND ALLERGENS: see “Important information about some of the ingredients of this medicine” in section 2 and section 6 “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet. You may need to read it again. This leaflet contains concise information about the medicine. If you have any further questions, contact your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. FOR ADULTS: Note that the Ministry of Health has approved a one-time switch between an original medicine and a biosimilar medicine and vice versa. Your doctor will give you an explanation about the medicine and the meaning of this switch. Every switch of a biological medicine must be performed by the attending doctor. The brand name of the medicine that appears on the prescription must be identical to the brand name that appears on the package of the medicine dispensed to you by the pharmacy. In any case of doubt, refer to the pharmacist or attending doctor. FOR CHILDREN: Note that each time you receive the medicine at the pharmacy, it is important that you make sure that you receive the same medicine that was prescribed for you by your attending specialist. If the medicine you received looks different from that which you usually receive, or if the instructions for use have changed, please refer to the pharmacist immediately to make sure that you have received the correct medicine. Any switch or change in dosage of a medicine containing insulin glargine must be made by the attending specialist only. Please check that the brand name o 전체 문서 읽기
X BASAKPN F 09 Page 1 of 14 1. NAME OF THE MEDICINAL PRODUCT BASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 100 units of insulin glargine* (equivalent to 3.64 mg). Each pen contains 3 mL of solution for injection, equivalent to 300 units. * Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_ . For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear colorless solution. Basaglar is a biosimilar medicinal product that has been demonstrated to be similar in quality, safety and efficacy to the reference medicinal product Lantus. Please be aware of any differences in the indications between the biosimilar medicinal product and the reference medicinal product. Information regarding interchangeability can be found on the website of the Ministry of Health: https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Basaglar contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Basaglar 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, Basaglar 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 Basaglar and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). X BASAKPN F 09 Page 2 of 14 _Special population_ _Elderly population (≥65 years old) _ In the elderly, progressive deterioration of r 전체 문서 읽기