100 mg/ml solution for injection -/infusion solution
tranexamic acid
What Statraxen is and what it is used for
Statraxen contains tranexamic acid, which is an anti-bleeding agent.
Statraxen is used in adults and children over 1 year of age to prevent and treat bleeding due to fibrinolysis, which means that the blood has difficulty clotting.
Specific uses include:
- 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 anti-clotting medicine.
Tranexamic acid contained in Statraxen may also be approved to treat 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.
What you need to know before you are given Statraxen
You should not be given Statraxen
- 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 problems with your kidneys
- if you have previously had convulsions.
Due to the risk of edema (swelling) of the brain and convulsions, use in the brain ( intrathecal and intraventricular injection or intracerebral use) is not recommended.
If you think any of the above apply to you, or if you are unsure about anything, talk to your doctor before you are given Statraxen.
Warnings and precautions
Tell your doctor if any of the following apply to you to help him or she decide if Statraxen is right for you:
- If you have had blood in your urine: Statraxen should not be given because of the risk of 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 ), Statraxen 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 been activated.
- If you have previously had convulsions, you should not be treated with Statraxen. The doctor must use the smallest possible dose to avoid convulsions during treatment with Statraxen.
- If you are on long-term treatment with Statraxen, any changes in color vision must be monitored, and if necessary, the treatment must be discontinued.
In case of continued long-term use of Statraxen, you should go for regular eye examinations (checking visual acuity, color vision, fundus, the field of vision, etc.).
In the case of eye changes, in particular diseases of the retina, the doctor must decide after consultation with a specialist whether long-term treatment with Statraxen is necessary in your case.
Other medicines and Statraxen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell the doctor if you are taking:
- other medicines to make the blood clot called antifibrinolytics
- medicines that prevent the formation of blood clots, so-called thrombolytic medicines
- birth control pills.
Pregnancy, breastfeeding, and fertility
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 receiving this medicine.
Tranexamic acid is excreted in breast milk. The use of Statraxen during breastfeeding is therefore not recommended. Women of childbearing potential should use effective contraception during treatment with Statraxen.
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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How you are given Statraxen
Use for adults
Statraxen will be given to you by slow injection or infusion into a blood vessel. The doctor decides which dose is right for you and how long you will be treated.
Use for children
For children from 1 year, dose one is based on the child’s weight. The doctor decides which dose is suitable and how long the child should be treated.
Use for the elderly
No dose reduction is needed unless there are signs of renal failure.
Uses for patients with impaired renal function
In case of impaired kidney function, the dose of tranexamic acid will be reduced about a blood test (serum creatinine value).
Use for patients with impaired liver function
No dose reduction is needed.
Mode of administration
Statrax should only be injected slowly into a blood vessel.
Statrax must not be injected into a muscle.
If you have been given too much Statraxen
If you receive more Statraxen than you should, you may experience a temporary drop in blood pressure.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 users)
- Stomach/intestinal problems (nausea, vomiting, diarrhea)
Uncommon (may affect up to 1 in 100 users)
- effects on the skin: rash
Has been reported (occurring in an unknown number of users)
- 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 Statraxen
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date which is stated on the carton after the Expiration date. The expiration date is the last day of the specified month.
After dilution:
Chemical-physical stability has been demonstrated for 24 hours at 2-8°C.
From a microbiological point of view, the diluted infusion solution should be used immediately. If not used immediately, in-use storage times and conditions before administration are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C. The cooled solution must then return to room temperature before administration.
The solution for injection/infusion can be mixed with sodium chloride (9 mg/ml), glucose
(50 mg/ml) and Ringer-Acetate solution for infusion .
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tranexamic acid.
- Other ingredients are hydrochloric acid, sodium hydroxide, and water for injections.
Appearance and package sizes of the medicine
Clear, colorless solution.
Glass ampoule 1×5 ml, 5×5 ml, 10×5 ml, 1×10 ml, 5×10 ml, 10×10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
CampusPharma AB
Karl Gustavsgatan 1A
411 25 Gothenburg
Manufacturer
Labianca Pharmaceuticals, SLU
Casanova, 27-31
08757 Corbera de Llobregat
Barcelona
Spain
Industria Farmaceutica Galenica Senese Srl
Via Cassia Nord 351
53014 Monteroni d’Arbia (Siena)
Italy