Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Galcanezumab
ZUELLIG PHARMA SDN BHD
Galcanezumab
1 ml
ELI LILLY AND COMPANY
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PONTEVIA 120MG SOLUTION FOR INJECTION IN PRE-FILLED PEN PONTEVIA 120MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Galcanezumab 120 mg WHAT IS IN THIS LEAFLET 1. What Pontevia is used for 2. How Pontevia works 3. Before you use Pontevia 4. How to use Pontevia 5. While you are using it 6. Side effects 7. Storage and Disposal of Pontevia 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT PONTEVIA IS USED FOR Pontevia is a prescription medicine used to prevent migraine in adult patients who have at least 4 migraines days per month. HOW PONTEVIA WORKS Pontevia contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased levels of CGRP. Pontevia can reduce the frequency of migraine headache and improve your quality of life. It starts working in about a week. BEFORE YOU USE PONTEVIA - _When you must not use it _ If you are allergic to galcanezumab or any of the other ingredients of this medicine (see PRODUCT DESCRIPTION section). - _Before you start to use it _ Talk to your doctor, nurse or pharmacist before using Pontevia. Pontevia can potentially cause serious allergic reactions. You must look out for signs of these reactions while you are using Pontevia (see SIDE EFFECTS ). _Children _ _and _ _adolescents: _ Pontevia should not be given to children and adolescents under 18 years of age because it has not been studied in this age group. _Pregnancy and lactation_ : If you are a woman able to have children, you are advised to avoid becoming pregnant while using Pontevia. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of Pontevia in pregnancy as the effects of this medicine in pregnant women are not known. If you are breast-feeding or are planning to breast- সম্পূর্ণ নথি পড়ুন
Pontevia 120mg Pre- Pen and Syringe USPI August 2022 Page 1 of 13 HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PONTEVIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PONTEVIA. PONTEVIA (GALCANEZUMAB) INJECTION, FOR SUBCUTANEOUS USE -------- -------------------- INDICATIONS AND USAGE --------------------------- PONTEVIA is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month. (1.1) ------------------------DOSAGE AND ADMINISTRATION----------------------- • For subcutaneous use only. (2.1, 2.2, 2.3) • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose. (2.1) • Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. (2.3) ----------------------DOSAGE FORMS AND STRENGTHS--------------------- • Injection: 120 mg/mL solution in a single-dose prefilled pen (3) • Injection: 120 mg/mL solution in a single-dose prefilled syringe (3) ------------------------------- CONTRAINDICATIONS ------------------------------ PONTEVIA is contraindicated in patients with serious hypersensitivity to galcanezumab or to any of the excipients. (4) ------------------------ WARNINGS AND PRECAUTIONS ----------------------- Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported (see section 6.3). If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated (see section 4). Patients should be informed on the possibility of a delayed onset hypersensitivity reaction and instructed to contact their physician. ------------------------------- ADVERSE REACTIONS------------------------------ The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in PONTEVIA clinical studies were injection site reactions. (6.1) REVISED: 23 AUG 2022 FULL PRESCRIBING INFO সম্পূর্ণ নথি পড়ুন