\n\n40 mg powder for solution for injection \/ infusion
esomeprazole (in the form of sodium salt)<\/p>\n\n\n\n
Esomeprazole Accord contains a medicine called esomeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced in the stomach.
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Esomeprazole Accord is used for short-term treatment of certain conditions that can not be treated orally. It is used to treat the following conditions:
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Adults<\/strong><\/p>\n\n\n\n Children and adolescents 1\u201118 years<\/strong><\/p>\n\n\n\n Esomeprazole contained in the Esomeprazole Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions. You must not be given esomeprazole if you are taking any of the above medicines. If you are not sure, talk to your doctor or nurse before taking this medicine. <\/p>\n\n\n\n Talk to your doctor or nurse before giving Esomeprazole Accord: Esomeprazole may mask symptoms of other diseases. Therefore, if any of the following occur before or after you receive esomeprazole, talk to your doctor straight away: Ingestion of proton pump inhibitors such as Esomeprazole may slightly increase the risk of fractures in the hip and wrists and spine, especially if taken for more than a year. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis ). If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Esomeprazole Accord. Also remember to mention any other side effects, such as joint pain.<\/p>\n\n\n\n Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines. You should do this because esomeprazole may affect the way some medicines work and because some medicines may affect esomeprazole. You must not be given Esomeprazole if you are taking any medicine containing nelfinavir (used to treat HIV – infection ). Tell your doctor or nurse if you are taking any of the following medicines:<\/p>\n\n\n\n If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can be given Esomeprazole Accord during that time. It is not known whether esomeprazole passes into breast milk or not. You must therefore not be given esomeprazole if you are breast-feeding.<\/p>\n\n\n\n Esomeprazole is unlikely to affect your ability to drive or use other tools or machines. However, side effects such as dizziness and visual disturbances may occur in less common cases. (see section 4). If you are affected, do not drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is almost “sodium-free”. Esomeprazole can be given to children and adolescents aged 1\u201118 years as well as to adults including the elderly. Getting Esomeprazole Accord<\/strong> Use for adults<\/strong><\/em><\/p>\n\n\n\n Children and young people<\/em><\/strong><\/p>\n\n\n\n If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you think you have been given too much esomeprazole, talk to your doctor immediately.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop taking esomeprazole and contact your doctor immediately:<\/strong><\/p>\n\n\n\n These side effects are rare and may affect up to 1 in 1,000 people. Other side effects include: Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people)<\/strong><\/p>\n\n\n\n Has been reported (occurs in an unknown number of people)<\/strong><\/p>\n\n\n\n In very rare cases, esomeprazole can affect the white blood cells, leading to a weakened immune system. If you get an infection with symptoms, such as fever and severe general malaise, or fever with symptoms of local infection, such as pain in the neck, throat, or mouth or difficulty throwing water, you must contact your doctor as soon as possible, so that on white blood cells ( agranulocytosis ) can be ruled out by a blood test. You must provide information about your medication on such an occasion. Keep this medicine out of the sight and reach of children. The doctor and the hospital pharmacy are responsible for ensuring that the Esopremazole Accord is stored and delivered correctly. Do not use this medicine after the expiry date which is stated on the carton or vial. The expiration date is the last day of the specified month. Do not store above 25 \u00b0 C. Keep the vial in the outer carton to protect it from light. However, the vials can be stored without an outer carton in normal indoor light for up to 24 hours. Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 12 hours at 25 \u00b0 C. From a microbiological point of view, the drug should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 12 hours at 2-8 \u00b0 C, unless reconstitution has taken place under controlled and validated aseptic conditions. Do not use this medicine if you notice that the medicine has deteriorated, eg if the porous cake has collapsed and the reconstituted solution contains small particles. 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.<\/p>\n\n\n\n Esomeprazole Accord contains the active substance esomeprazole sodium. Each vial of powder for solution for injection\/infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole. The other ingredients are disodium edetate and sodium hydroxide. For further information on the sodium content, see section 2.<\/p>\n\n\n\n Esomeprazole Accord is a white to off-white, porous cake or powder. This is mixed into a solution before it is given to you. Esomeprazole Accord is available in 6 ml clear glass type I vials according to the European Pharmacopoeia, sealed with a gray bromobutyl rubber stopper and a purple aluminum detachable seal. Pack sizes:<\/p>\n\n\n\n 1 vial<\/p>\n\n\n\n 10 vials<\/p>\n\n\n\n 50 vials Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong> Accord Healthcare BV<\/p>\n\n\n\n Winthontlaan 200<\/p>\n\n\n\n 3526 KV Utrecht<\/p>\n\n\n\n Netherlands Manufacturer<\/strong> Accord Healthcare Limited<\/p>\n\n\n\n Sage House,<\/p>\n\n\n\n 319 Pinner Road,<\/p>\n\n\n\n North Harrow,<\/p>\n\n\n\n Middlesex, HA1 4HF,<\/p>\n\n\n\n UK Wessling Hungary Kft.<\/p>\n\n\n\n Foot out 56<\/p>\n\n\n\n 1047 Budapest<\/p>\n\n\n\n Hungary Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n ul. Lutomierska 50,95-200 Pabianice, Poland<\/p>\n\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" 40 mg powder for solution for injection \/ infusion
<\/p>\n\n\n\n2. What you need to know before you are given Esomeprazole Accord<\/h2>\n\n\n\n
You should not be given Esomeprazole Accord<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and Esomeprazole Accord<\/h2>\n\n\n\n
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<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nEsomeprazole Accord contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to take Esomeprazole Accord<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you are given too much Esomeprazole Accord<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Esomeprazole Accord<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
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<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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