国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NITROGLYCERINE 400 µg/dosis
Ayrton Saunders (Ireland) Limited 8a Sandyford Business Centre Blackthorn Avenue, Sandyford - DUBLIN 18 (IERLAND)
C01DA02
NITROGLYCERINE 400 µg/dosis
Spray voor sublinguaal gebruik
ETHANOL ; NORFLURAAN ; PEPERMUNTOLIE,
Sublinguaal gebruik
Glyceryl Trinitrate
Hulpstoffen: ETHANOL; NORFLURAAN; PEPERMUNTOLIE;
1998-12-14
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER GLYTRIN, 400 MICROGRAM PER DOSIS, SUBLINGUALE SPRAY Glyceryl Trinitrate 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Glytrin is and what it is used for 2. What you need to know before you use Glytrin 3. How to use Glytrin 4. Possible side effects 5. How to store Glytrin 6. Contents of the pack and other information 1. WHAT GLYTRIN IS AND WHAT IT IS USED FOR Your medicine is called Glytrin. It is a sublingual (under the tongue) aerosol spray that contains the active ingredient glyceryl trinitrate. Glyceryl trinitrate belongs to a group of medicines called nitrates that relax the muscle walls of the blood vessels and reduce the workload of the heart. Glytrin is used to treat angina at the onset of an attack. It is also used for the prevention of angina, which can be brought on from physical effort, emotional stress, and exposure to cold, etc. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYTRIN DO NOT USE GLYTRIN AND TALK TO YOUR DOCTOR: • If you are ALLERGIC to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6). • If you have severe LOW BLOOD PRESSURE. • If you have SHOCK caused by low blood pressure. • If you have severe ANAEMIA . • If you have CONSTRICTIVE PERICARDITIS (a heart condition). • If you have an extremely LOW HEART RATE . • If you have GLUCOSE-6-PHOSPHATE-DEHYDROGENASE DEFICIENCY (an inherited enzyme deficiency, mainly affecting men). • If you have a BRAIN TRAUMA or CEREBRAL HAEMORRHAGE (bra 阅读完整的文件
Glytrin_NL_SPC_FEB 2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glytrin, 400 microgram per dosis, sublinguale spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glyceryl Trinitrate: 400 micrograms per metered dose Excipient(s) with known effect Ethanol (alcohol) – 7.5 mg per spray. For the full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Sublingual spray, solution. (Sublingual spray) 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute angina pectoris. Prevention of inducible angina (e.g. physical effort, emotional stress, exposure to cold). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Oromucosal Dosage _Adults including the elderly _ At the onset of an attack, one or two metered doses (400 to 800 micrograms glyceryl trinitrate) to be sprayed under the tongue for the relief of anginal pain while breath is held. No more than three doses are recommended at any one time. For the prevention of inducible angina (e.g. physical effort, emotional stress, exposure to cold), one or two 400 microgram metered doses sprayed under the tongue within 2 – 3 minutes of the event starting. _Paediatric population _ Glytrin should not be used in children and adolescents under 18 years. Method of administration Before using Glytrin for the first time, the patient should check that the spray is working by pressing the pump button a few times until it produces a fine mist of liquid. The patient should practice aiming the spray onto a tissue or similar item so that they will be able to aim it correctly under the tongue when they need to use it. If the patient does not need to use Glytrin very often, the spray should be checked regularly to see that it still works properly. During application the patient should rest, ideally in the sitting position. The canister should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should be Glytrin_NL_SPC_FEB 2021 Page 2 of 6 sprayed under the tongue and th 阅读完整的文件