PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION
Active substance: PANTOPRAZOLE SODIUM SESQUIHYDRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
D02195
4.Possible side effects
Like all medicines, Pantoprazole 40mg powder for solution for injection can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data). If you get any of the following side effects, tell your doctor immediately, or contact the casualty department at your nearest hospital: Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulty in breathing, allergic facial swelling (Quinckes oedema/angioedema), severe dizziness with very fast heartbeat and heavy sweating. Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome), Lyell Syndrome, Erythema multiforme) and sensitivity to light. Other serious conditions (frequency not known): yellowing of the skin or the whites of your eyes (severe damage to liver cells, jaundice) or fever, rash and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys). Other side effects are: Common (affects 1 to 10 users in 100): inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected. Uncommon (affects 1 to 10 users in 1,000) headache; dizziness; diarrhoea; feeling sick; vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash; exanthema, eruption; itching; feeling weak; exhausted or generally unwell; sleep disorders. Taking a proton pump inhibitor like Pantoprazole 40mg powder for solution for injection, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis). Rare (affects 1 to 10 users in 10,000) disturbances in vision such as blurred vision; hives; pain in the joints, muscle pains; weight changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions, depression; breast enlargement in males. Very rare (affects less than 1 user in 10,000) disorientation Not known (frequency cannot be estimated from the available data) hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood. If you are on Pantoprazole 40mg powder for solution for injection for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. Side effects identified through blood tests: Uncommon (affects 1 to 10 users in 1,000) an increase in liver enzymes Rare (affect 1 to 10 users in 10,000) an increase in bilirubin; increased fats in the blood.
Pantoprazole 40 mg powder for solution for injection Pantoprazole
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist. If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pantoprazole 40 mg powder for solution for injection is and what it is used for 2. Before you use Pantoprazole 40 mg powder for solution for injection 3. How to use Pantoprazole 40 mg powder for solution for injection 4. Possible side effects 5. How to store Pantoprazole 40 mg powder for solution for injection 6. Further information
cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered. Taking other medicines Pantoprazole injections may influence the effectiveness of other medicines, so tell your doctor if you are taking: Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole may stop these and other medicines from working properly. Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks. Atazanavir (used to treat HIV infection). Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant or think you may be pregnant, or if you are breast-feeding you should not be given this medicine unless your doctor considers the benefit for you greater than the potential risk for your unborn child or baby. Ask your doctor or pharmacist for advice before taking any medicine Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines. Important information about some of the ingredients of Pantoprazole 40 mg powder for solution for injection This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially sodium-free.
Very rare (affects less than 1 user in 10,000) a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in white cells in your blood which may lead to more frequent infections. If any of the side effects get serious or if you notice any side effects not listed in the leaflet, please tell your doctor or nurse.
5.How to store Pantoprazole 40mg powder for solution for injection
Keep out of the reach and sight of children. Do not use Pantoprazole 40 mg powder for solution for injection after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of the month. Do not store above 25C. Keep the vial in the outer carton in order to protect from light. After reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Do not use Pantoprazole 40 mg powder for solution for injection if you notice that the visual appearance has changed (e.g. if cloudiness or precipitation is observed). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
1.What Pantoprazole 40mg powder for solution for injection is and what it is used for
Pantoprazole 40mg powder for solution for injection is a selective proton pump inhibitor, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections as soon as your doctor sees fit. Pantoprazole 40mg powder for solution for injection is used for treating: Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. Stomach and duodenal ulcers Zollinger-Ellison syndrome and other conditions producing too much acid in your stomach.
6.Further Information
What Pantoprazole 40 mg powder for solution for injection contains The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate) The other ingredients are: - mannitol, - sodium citrate dihydrate - sodium hydroxide for pH adjustment What Pantoprazole 40 mg powder for solution for injection looks like and contents of the pack Pantoprazole 40 mg powder for solution for injection is a white or almost white uniform porous cake. It comes in packs of 1, 5, 10 and 20 glass vials. Not all packs may be marketed. Marketing Authorisation Holder: Martindale Pharmaceuticals Limited, Bampton Road, Harold Hill, Romford, Essex, United Kingdom. RM3 8UG. Manufacturers: Laboratorios Alcal Farma, S.L Carretera M-300 Km 29,920 Apartado de correos 37 28802 Alcal de Henares (Madrid) Tel: 0034 91 889 06 00 Fax: 0034 91 889 05 02 Valdepharm Parc Industriel dincarville - BP 606 27106 val de Reuil Cedex France Tel: 0033 232 25 70 70 Fax: 0033 232 25 70 26 This leaflet was last approved in April 2012 PL 00156/0338
3.How to use Pantoprazole 40mg powder for solution for injection
Your doctor or nurse will administer the daily dose to you as an injection into a vein over a period of 2-15 minutes. The usual dose is: For gastric ulcers, duodenal ulcers and reflux oesophagitis One vial (40 mg pantoprazole) a day. For the long-term treatment of ZollingerEllison syndrome and other conditions in which too much stomach acid is produced. Two vials (80 mg pantoprazole) a day. Your doctor may later adjust the dose depending on the amount of stomach acid you produce. If you are prescribed more than two vials (80mg) a day, the injections will be in two equal doses. Your doctor may prescribe a temporary dose of more than four vials (160mg) a day. If your stomach acid level needs to be controlled rapidly, a starting dose of 160 mg (four vials) should be enough to lower the amount of stomach acid sufficiently. Special patient groups: If you have severe liver problems the daily injection should be only 20 mg (half a vial). Children (under 18 years). These injections are not recommended for use in children. If you use more Pantoprazole 40 mg powder for solution for injection than you should These doses are carefully checked by your nurse or doctor so an overdose is extremely unlikely. There are no known symptoms of overdose. If you have any further questions on the use of this product ask your doctor or nurse. Continued overleaf
2.Before you use Pantoprazole 40mg powder for solution for injection
Do not use Pantoprazole 40mg powder for solution for injection If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole 40 mg powder for solution for injection (see section 6). If you are allergic to medicines containing other proton pump inhibitors. Take special care with Pantoprazole 40 mg powder for solution for injection. If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently. In case of a rise of liver enzymes the treatment should be stopped. If you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice. Tell your doctor immediately if you notice any of the following symptoms: an unintentional weight loss repeated vomiting difficulty in swallowing vomiting blood you look pale and feel weak (anaemia) you notice blood in your stools severe and/or persistent diarrhoea, as pantoprazole has been associated with a small increase in infectious diarrhoea. Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of TECHNICAL PRESCRIBING INFORMATION
D02195
Pantoprazole 40 mg powder for solution for injection
The following information is intended for medical or healthcare staff only: A ready-to-use intravenous solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into the vial containing the lyophilised powder. The solution may either be administered directly or after mixing it with 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. Glass or plastic containers should be used for dilution. Pantoprazole 40 mg, powder for solution for injection should not be prepared or mixed with solvents other than those stated. After reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. The medicine should be administered intravenously over 2 15 minutes. The content of the vial is for single intravenous use only. Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) must be discarded.
PL 00156/0338
D02195
D02195
D02195
4.Possible side effects
Like all medicines, Pantoprazole 40mg powder for solution for injection can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data). If you get any of the following side effects, tell your doctor immediately, or contact the casualty department at your nearest hospital: Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulty in breathing, allergic facial swelling (Quinckes oedema/angioedema), severe dizziness with very fast heartbeat and heavy sweating. Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome), Lyell Syndrome, Erythema multiforme) and sensitivity to light. Other serious conditions (frequency not known): yellowing of the skin or the whites of your eyes (severe damage to liver cells, jaundice) or fever, rash and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys). Other side effects are: Common (affects 1 to 10 users in 100): inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected. Uncommon (affects 1 to 10 users in 1,000) headache; dizziness; diarrhoea; feeling sick; vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash; exanthema, eruption; itching; feeling weak; exhausted or generally unwell; sleep disorders. Taking a proton pump inhibitor like Pantoprazole 40mg powder for solution for injection, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis). Rare (affects 1 to 10 users in 10,000) disturbances in vision such as blurred vision; hives; pain in the joints, muscle pains; weight changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions, depression; breast enlargement in males. Very rare (affects less than 1 user in 10,000) disorientation Not known (frequency cannot be estimated from the available data) hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood. If you are on Pantoprazole 40mg powder for solution for injection for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. Side effects identified through blood tests: Uncommon (affects 1 to 10 users in 1,000) an increase in liver enzymes Rare (affect 1 to 10 users in 10,000) an increase in bilirubin; increased fats in the blood.
Pantoprazole 40 mg powder for solution for injection Pantoprazole
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist. If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pantoprazole 40 mg powder for solution for injection is and what it is used for 2. Before you use Pantoprazole 40 mg powder for solution for injection 3. How to use Pantoprazole 40 mg powder for solution for injection 4. Possible side effects 5. How to store Pantoprazole 40 mg powder for solution for injection 6. Further information
cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered. Taking other medicines Pantoprazole injections may influence the effectiveness of other medicines, so tell your doctor if you are taking: Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole may stop these and other medicines from working properly. Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks. Atazanavir (used to treat HIV infection). Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant or think you may be pregnant, or if you are breast-feeding you should not be given this medicine unless your doctor considers the benefit for you greater than the potential risk for your unborn child or baby. Ask your doctor or pharmacist for advice before taking any medicine Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines. Important information about some of the ingredients of Pantoprazole 40 mg powder for solution for injection This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially sodium-free.
Very rare (affects less than 1 user in 10,000) a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in white cells in your blood which may lead to more frequent infections. If any of the side effects get serious or if you notice any side effects not listed in the leaflet, please tell your doctor or nurse.
5.How to store Pantoprazole 40mg powder for solution for injection
Keep out of the reach and sight of children. Do not use Pantoprazole 40 mg powder for solution for injection after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of the month. Do not store above 25C. Keep the vial in the outer carton in order to protect from light. After reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Do not use Pantoprazole 40 mg powder for solution for injection if you notice that the visual appearance has changed (e.g. if cloudiness or precipitation is observed). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
1.What Pantoprazole 40mg powder for solution for injection is and what it is used for
Pantoprazole 40mg powder for solution for injection is a selective proton pump inhibitor, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections as soon as your doctor sees fit. Pantoprazole 40mg powder for solution for injection is used for treating: Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. Stomach and duodenal ulcers Zollinger-Ellison syndrome and other conditions producing too much acid in your stomach.
6.Further Information
What Pantoprazole 40 mg powder for solution for injection contains The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate) The other ingredients are: - mannitol, - sodium citrate dihydrate - sodium hydroxide for pH adjustment What Pantoprazole 40 mg powder for solution for injection looks like and contents of the pack Pantoprazole 40 mg powder for solution for injection is a white or almost white uniform porous cake. It comes in packs of 1, 5, 10 and 20 glass vials. Not all packs may be marketed. Marketing Authorisation Holder: Martindale Pharmaceuticals Limited, Bampton Road, Harold Hill, Romford, Essex, United Kingdom. RM3 8UG. Manufacturers: Laboratorios Alcal Farma, S.L Carretera M-300 Km 29,920 Apartado de correos 37 28802 Alcal de Henares (Madrid) Tel: 0034 91 889 06 00 Fax: 0034 91 889 05 02 Valdepharm Parc Industriel dincarville - BP 606 27106 val de Reuil Cedex France Tel: 0033 232 25 70 70 Fax: 0033 232 25 70 26 This leaflet was last approved in April 2012 PL 00156/0338
3.How to use Pantoprazole 40mg powder for solution for injection
Your doctor or nurse will administer the daily dose to you as an injection into a vein over a period of 2-15 minutes. The usual dose is: For gastric ulcers, duodenal ulcers and reflux oesophagitis One vial (40 mg pantoprazole) a day. For the long-term treatment of ZollingerEllison syndrome and other conditions in which too much stomach acid is produced. Two vials (80 mg pantoprazole) a day. Your doctor may later adjust the dose depending on the amount of stomach acid you produce. If you are prescribed more than two vials (80mg) a day, the injections will be in two equal doses. Your doctor may prescribe a temporary dose of more than four vials (160mg) a day. If your stomach acid level needs to be controlled rapidly, a starting dose of 160 mg (four vials) should be enough to lower the amount of stomach acid sufficiently. Special patient groups: If you have severe liver problems the daily injection should be only 20 mg (half a vial). Children (under 18 years). These injections are not recommended for use in children. If you use more Pantoprazole 40 mg powder for solution for injection than you should These doses are carefully checked by your nurse or doctor so an overdose is extremely unlikely. There are no known symptoms of overdose. If you have any further questions on the use of this product ask your doctor or nurse. Continued overleaf
2.Before you use Pantoprazole 40mg powder for solution for injection
Do not use Pantoprazole 40mg powder for solution for injection If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole 40 mg powder for solution for injection (see section 6). If you are allergic to medicines containing other proton pump inhibitors. Take special care with Pantoprazole 40 mg powder for solution for injection. If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently. In case of a rise of liver enzymes the treatment should be stopped. If you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice. Tell your doctor immediately if you notice any of the following symptoms: an unintentional weight loss repeated vomiting difficulty in swallowing vomiting blood you look pale and feel weak (anaemia) you notice blood in your stools severe and/or persistent diarrhoea, as pantoprazole has been associated with a small increase in infectious diarrhoea. Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of TECHNICAL PRESCRIBING INFORMATION
D02195
Pantoprazole 40 mg powder for solution for injection
The following information is intended for medical or healthcare staff only: A ready-to-use intravenous solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into the vial containing the lyophilised powder. The solution may either be administered directly or after mixing it with 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. Glass or plastic containers should be used for dilution. Pantoprazole 40 mg, powder for solution for injection should not be prepared or mixed with solvents other than those stated. After reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. The medicine should be administered intravenously over 2 15 minutes. The content of the vial is for single intravenous use only. Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) must be discarded.
PL 00156/0338
D02195
D02195
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.
