100 mg/ml solution for injection/infusion
tranexamic acid
What Tranexamic acid Stragen is and what it is used for
Tranexamic acid Stragen contains tranexamic acid, which belongs to a group of drugs called antihemorrhagic; fibrinolysis inhibitors, and amino acids .
Tranexamic acid Stragen is used in adults and children over 1 year of age to prevent and treat bleeding caused by fibrinolysis, which means that the blood has difficulty clotting.
Specific areas of use include the following:
- Heavy menstruation in women
- Bleeding in the stomach/intestines
- Bleeding in the urinary tract after prostate surgery or surgical procedures affecting the urinary tract
- Ear, nose, or throat surgery
- Heart/vascular surgery, abdominal surgery, or gynecological surgery
- Bleeding after you have been treated with another medicine to dissolve blood clots.
Tranexamic acid found in Tranexamic acid Stragen may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you are given tranexamic acid Stragen
Do not use Tranexamic acid Stragen
- if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).
- if you have a disease that causes you to get blood clots.
- if you have a disease called ‘consumptive coagulopathy’, where the blood throughout the body begins to form blood clots.
- if you have severely impaired kidney function (risk of the medicine accumulating).
- if you have previously had convulsions.
Due to the risk of cerebral edema and convulsions, Tranexamic acid Stragen must not be used in the brain ( intrathecal and intraventricular injection or intracerebral application).
If you think that any of the above apply to you, or if you are not sure, talk to your doctor before you are given Tranexamic acid Stragen.
Warnings and precautions
Tell your doctor if any of the following apply to you, to help him or she decide if Tranexamic acid Stragen is right for you:
- If you have had blood in your urine (Tranexamic acid Stragen can cause flow obstruction in the urethra).
- If you have an increased risk of blood clots.
- If you have severe clotting or bleeding throughout your body (disseminated intravascular coagulation ), Tranexamic acid Stragen may not be suitable for you, unless you have acute severe bleeding and blood tests have shown that the process that inhibits the blood’s ability to clot ( fibrinolysis ) has activated.
- If you have had seizures in the past, you should not be treated with Tranexamic acid Stragen. The doctor must use the smallest possible dose to avoid convulsions when treated with Tranexamic acid Stragen.
- If you are on long-term treatment with Tranexamic acid Stragen, any changes in color vision should be monitored, and if necessary, the treatment should be discontinued. If you are treated with tranexamic acid for a long time, you should have regular eye examinations (checking visual acuity, color vision, fundus, the field of vision, etc.). In the case of eye changes, especially diseases of the retina, the doctor must consult with a specialist and then decide whether long-term treatment with tranexamic acid is necessary in your particular case.
Other medicines and Tranexamic acid Stragen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines, vitamins, minerals, natural remedies, or dietary supplements.
In particular, you should inform your doctor if you are taking:
- other medicines to increase the coagulation capacity of the blood, so-called antifibrinolytic agents
- medicines that prevent the formation of blood clots, so-called thrombolytic medicines
- birth control pills.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, consult your doctor before you are given Tranexamic acid Stragen. Tranexamic acid is excreted in breast milk. Use of Tranexamic acid Stragen during breastfeeding is therefore not recommended.
Driving ability and use of machinery
No studies have been performed on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How Tranexamic acid Stragen is given
Use in adults
Tranexamic acid Stragen is given as a slow injection or infusion into a vein. The doctor decides which dose is right for you and how long you will be treated.
Use for children
Tranexamic acid Stragen solution for injection/infusion can be given to children over 1 year of age, and the dose is then based on the child’s weight. The doctor decides which dose is suitable and how long the child should be treated.
Use in the elderly
No dose reduction is necessary unless there are signs of renal failure.
Use for patients with impaired kidney function
If you have impaired kidney function, the dose of tranexamic acid is reduced based on the results of a blood test (serum creatinine level).
Use in patients with impaired liver function
No dose reduction is necessary.
Method of administration
Tranexamic acid Stragen should only be injected slowly into a vein.
Tranexamic acid Stragen must not be administered into a muscle.
If you have received more Tranexamic acid Stragen than the recommended dose en
If you are treated with a larger amount of Tranexamic acid Stragen than the recommended dose en you may experience a temporary drop in blood pressure. Contact a doctor or pharmacist immediately if this occurs.
Additional dosing information intended for healthcare professionals can be found at the end of this leaflet.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for Tranexamic acid Stragen:
Common side effects (affects up to 1 in 10 users)
Uncommon side effects (affects up to 1 in 100 users)
- skin related problems: rash
Frequency not known (cannot be estimated from available data)
- malaise with low blood pressure, especially if the injection has been given too quickly
- blood clots
- effects on the nervous system: convulsions
- effects on the eyes: vision changes including impaired color vision
- effect on the immune system: allergic reactions
How to store Tranexamic acid Stragen
Store out of sight and reach of children.
Use before the expiry date stated on the label and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
The medicine must be used immediately after opening the package. Any remaining medication must be discarded.
Do not use this medicine if you notice visible changes that indicate a deterioration in quality, such as discoloration or sedimentation.
Contents of the packaging and other information
Contents declaration
- The active substance is tranexamic acid. One ml of solution for injection/infusion contains 100 mg of tranexamic acid. One ampoule with 5 ml solution for injection contains 500 mg of tranexamic acid . One ampoule with 10 ml solution for injection contains 1,000 mg of tranexamic acid .
- Other ingredients are water for injections and hydrochloric acid (for pH adjustment).
Appearance and package sizes of the medicine
Tranexamic acid Stragen is a clear, colorless solution for intravenous use packaged in clear glass ampoules (type I).
Tranexamic acid Stragen is available in the following pack sizes:
- Packaging of 5 ampoules with 5 ml of solution each
- Packaging of 5 ampoules with 10 ml of solution each
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Stragen Nordic A/S
Helsingørsgade 8C
DK-3400 Hillerød,
Denmark
Phone: +45 4810 8810
E-mail: info@stragen.dk
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstr. 18
D-31028 Gronau, Germany