100 mg\/ml solution <\/p>\n\n\n\n
for injection Tranexamic acid Accord contains\u00a0tranexamic acid, which belongs to a group of medicines called hemostatics, and fibrinolysis inhibitors (medicines that stop bleeding).<\/p>\n\n\n\n Tranexamic acid Accord is used in adults and children over 1 year of age to prevent and treat bleeding due to\u00a0fibrinolysis, which means that the blood has difficulty clotting.<\/p>\n\n\n\n Specific uses include:<\/p>\n\n\n\n Tranexamic acid contained\u00a0in Tranexamic acid Accord may also be approved to treat other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions. Due to the risk of edema (fluid accumulation) in the brain and convulsions, use in the brain ( intrathecal and intraventricular injection or intracerebral application) is not recommended.<\/p>\n\n\n\n If you think any of the above applies to you, or if you are in any doubt, talk to your doctor before you are given Tranexamic acid Accord.<\/a><\/p>\n\n\n\n Tell your doctor if any of the following apply to you to help him or she decides if the Tranexamic acid Accord is right for you:<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines,\u00a0vitamins, minerals, herbal remedies, or dietary supplements.<\/p>\n\n\n\n In particular, tell the doctor if you are taking:<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n Tranexamic acid\u00a0is excreted in breast milk.\u00a0The use of Tranexamic acid Accord during breastfeeding is therefore not recommended.<\/p>\n\n\n\n No studies have been performed on the ability to drive and use machines.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure. Use for adults<\/strong><\/p>\n\n\n\n Use for children<\/strong><\/p>\n\n\n\n If Tranexamic acid Accord is given to children from 1 year of age, dose one is based on the child’s weight.<\/p>\n\n\n\n The doctor decides which dose is suitable and how long the child should be treated.<\/p>\n\n\n\n Use for the elderly<\/strong><\/p>\n\n\n\n No dose\u00a0reduction is\u00a0needed unless there are signs of\u00a0renal failure.<\/p>\n\n\n\n Use in patients with impaired renal function<\/strong><\/p>\n\n\n\n In case of impaired kidney function, the dose can be reduced. The doctor decides which dose you should receive based on a blood test.<\/p>\n\n\n\n Use in patients with impaired liver function<\/strong><\/p>\n\n\n\n No dose reduction is needed.<\/p>\n\n\n\n Mode of administration<\/strong><\/p>\n\n\n\n Tranexamic acid Accord should only be injected slowly into a blood vessel (vein). Tranexamic acid Accord must not be injected into a muscle.<\/a><\/p>\n\n\n\n If you receive more Tranexamic acid Accord than the recommended\u00a0dose, you may experience a temporary drop in blood pressure (you may feel faint or dizzy when you stand up).\u00a0Talk to your doctor or pharmacist immediately.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Side effects that have been reported with Tranexamic acid Accord<\/strong><\/p>\n\n\n\n The following side effects have been reported with other Tranexamic acid Accord:<\/p>\n\n\n\n If you experience any of the following side effects after receiving the medicine, contact your doctor immediately. If you are not in a hospital, you MUST SEE a hospital immediately. These side effects are rare but serious.<\/p>\n\n\n\n Other side effects that may occur are:<\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 users)<\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/p>\n\n\n\n Has been reported (occurring in an unknown number of users)<\/p>\n\n\n\n If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n This medicine does not require any special storage instructions.\u00a0Use before the expiry date which is stated on the carton and the ampoule label after Ex.dat\/EXP.\u00a0The expiration date is the last day of the specified month.\u00a0The doctor or nurse will check this before you receive an\u00a0injection.<\/p>\n\n\n\n Unopened ampoules have no special storage instructions.<\/a><\/p>\n\n\n\n The active substance is\u00a0tranexamic acid.<\/p>\n\n\n\n Each 5 ml solution contains 500 mg\u00a0tranexamic acid.<\/p>\n\n\n\n Each 10 ml solution contains 1,000 mg\u00a0tranexamic acid.<\/p>\n\n\n\n
tranexamic acid<\/a><\/p>\n\n\n\nWhat Tranexamic acid Accord is and what it is used for<\/h2>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before you use Tranexamic acid Accord<\/h2>\n\n\n\n
Do not use Tranexamic acid Accord<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Tranexamic acid Accord<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Tranexamic acid Accord<\/h2>\n\n\n\n
The usual\u00a0dose\u00a0is 500-1000 mg (5-10 ml) two to three times per day.<\/li>
The usual\u00a0dose\u00a0is 1,000 mg (10 ml) every 6 to 8 hours or up to 15 mg per kg of body weight.<\/li><\/ul>\n\n\n\nIf you use too much Tranexamic acid Accord <\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Tranexamic acid Accord<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n