NITRONAL
Active substance: GLYCERYL TRINITRATE
View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nitronal 1 mg/ml solution for infusion
glyceryl trinitrate
Read all of this leaet carefully before you start taking this medicine. - Keep this leaet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Nitronal is and what it is used for 2. Before you take Nitronal 3. How to take Nitronal 4. Possible side effects 5. How to store Nitronal 6. Further information 1. WHAT NITRONAL IS AND WHAT IT IS USED FOR Nitronal contains glyceryl trinitrate (GTN). GTN belongs to a group of medicines called nitrates, which relax the muscle around blood vessels and make the hearts work easier. Nitronal is a medicine which is only used in hospitals. It is used in three conditions: - in heart failure - in angina - to lower the blood pressure during surgery. All patients given Nitronal are monitored very carefully. 2. BEFORE YOU TAKE NITRONAL Do not take Nitronal if you - are allergic (hypersensitive) to nitrates or any of the other ingredients of Nitronal (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. - are taking Viagra (sildenal) or similar products for the treatment of erectile dysfunction or hypertension of arterial lung vessels. If you take these products and Nitronal , a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. - are suffering from: - shock - severe anaemia - bleeding in the brain - low blood oxygen - severe blood loss - a certain heart disease called hypertrophic obstructive cardiomyopathy Nitronal is not intended for use in children. Take special care with Nitronal Before treatment with Nitronal , tell your doctor if you have any of these medical conditions: - severe liver disease - kidney disease - low body temperature - underactive thyroid Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines. Your doctor may need to take special care or change the dose. This is especially important for: - drugs which lower blood pressure - certain antidepressants (tricyclics). - pain killers which are similar to morphine (Nitronal may also affect these) - medicines for the treatment of erectile dysfunction or hypertension of arterial lung vessels (see Do not take Nitronal if you) Pregnancy and breast-feeding Tell your doctor if you are pregnant or breast-feeding. Nitronal should not be used during pregnancy or breast-feeding unless the doctor considers it essential. Driving and using machines Do not drive or operate any tools or machines until you know how Nitronal affects you.
223050025/7
Important information about some of the ingredients of Nitronal Nitronal contains 49 milligrams of glucose monohydrate per millilitre (ml). You should take this into account if you have diabetes mellitus. 3. HOW TO TAKE NITRONAL Dosage Nitronal will be given to you in hospital. Nitronal is always given slowly into the blood stream (intravenous administration). The usual dose for adults and the elderly depends on the condition: Heart failure: 10 to 100 micrograms per minute Angina: Initially 10 to 15 micrograms per minute, increasing until the angina is relieved Lowering blood pressure during surgery: 25 to 200 micrograms per minute If you take more Nitronal than you should Overdose is highly unlikely, as Nitronal will be given to you in hospital, but you might experience vomiting, restlessness, low blood pressure, fainting, a bluish tinge to the skin, coldness of the skin, difficulty breathing, slow heart rate, psychosis or methaemoglobinaemia (a blood disorder). If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nitronal can cause side effects, although not everybody gets them. You may get a headache or feel sick, dizzy or restless. You may sweat or ush, have low blood pressure, faster (or sometimes slower) heart rate or a pain in the chest or abdomen. If this happens, the doctor may give less Nitronal or stop the treatment. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE NITRONAL Keep out of the reach and sight of children. Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Nitronal . Nitronal should be stored unopened: do not store Nitronal above 25C. Keep the ampoules and vial in the outer carton and use before the expiry date printed on the ampoule or vial and carton. The expiry date refers to the last day of that month. The diluted solution, which should be used as soon as possible, is stable in the recommended infusion system for up to 24 hours. Nitronal is for single dose use only. Discard any unused contents. 6. FURTHER INFORMATION What Nitronal contains The active substance is glyceryl trinitrate (GTN). Nitronal contains 1 milligram (mg) per millilitre (ml) of GTN. Each 5 ml ampoule contains 5 mg of GTN, each 25 ml ampoule contains 25 mg GTN and each 50 ml vial contains 50 mg of GTN. The other ingredients are glucose monohydrate, water for injections, and dilute hydrochloric acid. What Nitronal looks like and contents of the pack Nitronal is a sterile, colourless solution for infusion. Nitronal is available as cartons of 10 amber glass ampoules containing 5 ml or 25 ml of solution, or single clear glass vials containing 50 ml of solution. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Merck Serono Limited Bedfont Cross, Stanwell Road, Feltham, Middlesex TW14 8NX. UK. Manufacturer: G. Pohl-Boskamp GmbH & Co. KG Kieler Strasse 11 25551 Hohenlockstedt Germany G. Pohl-Boskamp GmbH & Co. KG Kaddenbusch 11 25578 Dgeling Germany This leaet was last approved in February 2010. TW238320
223050025/7
Nitronal 1 mg/ml solution for infusion
glyceryl trinitrate
Read all of this leaet carefully before you start taking this medicine. - Keep this leaet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Nitronal is and what it is used for 2. Before you take Nitronal 3. How to take Nitronal 4. Possible side effects 5. How to store Nitronal 6. Further information 1. WHAT NITRONAL IS AND WHAT IT IS USED FOR Nitronal contains glyceryl trinitrate (GTN). GTN belongs to a group of medicines called nitrates, which relax the muscle around blood vessels and make the hearts work easier. Nitronal is a medicine which is only used in hospitals. It is used in three conditions: - in heart failure - in angina - to lower the blood pressure during surgery. All patients given Nitronal are monitored very carefully. 2. BEFORE YOU TAKE NITRONAL Do not take Nitronal if you - are allergic (hypersensitive) to nitrates or any of the other ingredients of Nitronal (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. - are taking Viagra (sildenal) or similar products for the treatment of erectile dysfunction or hypertension of arterial lung vessels. If you take these products and Nitronal , a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. - are suffering from: - shock - severe anaemia - bleeding in the brain - low blood oxygen - severe blood loss - a certain heart disease called hypertrophic obstructive cardiomyopathy Nitronal is not intended for use in children. Take special care with Nitronal Before treatment with Nitronal , tell your doctor if you have any of these medical conditions: - severe liver disease - kidney disease - low body temperature - underactive thyroid Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines. Your doctor may need to take special care or change the dose. This is especially important for: - drugs which lower blood pressure - certain antidepressants (tricyclics). - pain killers which are similar to morphine (Nitronal may also affect these) - medicines for the treatment of erectile dysfunction or hypertension of arterial lung vessels (see Do not take Nitronal if you) Pregnancy and breast-feeding Tell your doctor if you are pregnant or breast-feeding. Nitronal should not be used during pregnancy or breast-feeding unless the doctor considers it essential. Driving and using machines Do not drive or operate any tools or machines until you know how Nitronal affects you.
223050025/7
Important information about some of the ingredients of Nitronal Nitronal contains 49 milligrams of glucose monohydrate per millilitre (ml). You should take this into account if you have diabetes mellitus. 3. HOW TO TAKE NITRONAL Dosage Nitronal will be given to you in hospital. Nitronal is always given slowly into the blood stream (intravenous administration). The usual dose for adults and the elderly depends on the condition: Heart failure: 10 to 100 micrograms per minute Angina: Initially 10 to 15 micrograms per minute, increasing until the angina is relieved Lowering blood pressure during surgery: 25 to 200 micrograms per minute If you take more Nitronal than you should Overdose is highly unlikely, as Nitronal will be given to you in hospital, but you might experience vomiting, restlessness, low blood pressure, fainting, a bluish tinge to the skin, coldness of the skin, difficulty breathing, slow heart rate, psychosis or methaemoglobinaemia (a blood disorder). If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nitronal can cause side effects, although not everybody gets them. You may get a headache or feel sick, dizzy or restless. You may sweat or ush, have low blood pressure, faster (or sometimes slower) heart rate or a pain in the chest or abdomen. If this happens, the doctor may give less Nitronal or stop the treatment. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE NITRONAL Keep out of the reach and sight of children. Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Nitronal . Nitronal should be stored unopened: do not store Nitronal above 25C. Keep the ampoules and vial in the outer carton and use before the expiry date printed on the ampoule or vial and carton. The expiry date refers to the last day of that month. The diluted solution, which should be used as soon as possible, is stable in the recommended infusion system for up to 24 hours. Nitronal is for single dose use only. Discard any unused contents. 6. FURTHER INFORMATION What Nitronal contains The active substance is glyceryl trinitrate (GTN). Nitronal contains 1 milligram (mg) per millilitre (ml) of GTN. Each 5 ml ampoule contains 5 mg of GTN, each 25 ml ampoule contains 25 mg GTN and each 50 ml vial contains 50 mg of GTN. The other ingredients are glucose monohydrate, water for injections, and dilute hydrochloric acid. What Nitronal looks like and contents of the pack Nitronal is a sterile, colourless solution for infusion. Nitronal is available as cartons of 10 amber glass ampoules containing 5 ml or 25 ml of solution, or single clear glass vials containing 50 ml of solution. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Merck Serono Limited Bedfont Cross, Stanwell Road, Feltham, Middlesex TW14 8NX. UK. Manufacturer: G. Pohl-Boskamp GmbH & Co. KG Kieler Strasse 11 25551 Hohenlockstedt Germany G. Pohl-Boskamp GmbH & Co. KG Kaddenbusch 11 25578 Dgeling Germany This leaet was last approved in February 2010. TW238320
223050025/7
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
