COMPOSITION :
Tranxa® Injection 250 mg/5 ml, each ml contains : Tranexamic acid 50 mg.
DESCRIPTIONS :
Tranxa® contains Tranexamic acid as active ingredient available in injection 250 mg/5 ml.
INDICATIONS :
- For local fibrinolysis such as epistaxis, prostatectomy, cervical conization
- Hereditary angioneurotic edema
- Abnormal bleeding after surgery in general
- Bleeding after dental surgery in people with haemophilia
- Menorrhagia
DOSAGE AND ADMINISTRATIONS :
A day 1 – 2 ampoules (5 – 10 ml) is injected intravenously or intramuscularly, divided into 1 – 2 doses. At the time or after surgery, if needed can be given intravenously as much as 2 – 10 ampoules (10 – 50 ml) by drip infusion.
The dose of Tranxa® must be adjusted according to the condition of each patient according to the age or clinical condition.
CONTRAINDICATIONS :
- Patients receiving thrombin therapy.
- Patients with a history of hypersensitivity to any of the ingredients of this product.
WARNINGS AND PRECAUTIONS :
- Careful use in renal insufficiency patients because of the risk of accumulation.
- Guidelines for patients/patients with severe renal insufficiency.
| Creatinine serum | Dosage (IV) | Dosage frequency |
| 120 – 250 μmol/l | 15 mg/kgBW | 2 × daily |
| 250 – 500 μmol/l | 15 mg/kgBW | Every 24 hours |
| > 500 μmol/l | 7.5 mg/kgBW | Every 24 hours |
- Tranexamic acid is not indicated in hematuria caused by the renal parenchyma, in this condition fibrin deposition often occurs and may worsen the disease.
- Tranexamic acid is used in pregnant women only if it is clearly needed.
- Careful use in breastfeeding mothers to avoid risk to the baby.
- Patients with thrombosis (for example, cerebral thrombosis, myocardial infarction or thrombophlebitis, etc.) and in patients at high risk of thrombosis (Tranexamic acid can stabilize thrombosis).
- Patients receiving coagulopathy therapy (concomitant administration with Heparin and others) (Tranexamic acid can stabilize thrombosis).
- Postoperative patients, who are lying for long periods, as well as patients undergoing asthma. (venous thrombosis appears to occur in these patients and Tranexamic acid can stabilize thrombosis. Pulmonary embolism has been reported in relation to the end of the patient’s lying period or astriksi termination).
- Patients with renal failure (blood concentration can be increased).
- Patients with a history of hypersensitivity to any of the ingredients of this product.
- Caution for intravenous administration : In intravenous administration, the drug is injected slowly. (Symptoms such as nausea, chest discomfort, palpitations and decreased blood pressure are rare). If given intravenously, it is recommended to inject it slowly as well as administration/injection with calcium preparations (10 ml /1 – 2 minutes).
- Caution for intramuscular administration : In intramuscular administration, several things need to be considered to avoid damage to tissues, nerves and others :
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- Drug injections must be done carefully to avoid contact with nerves.
- If repeated injections are needed, the injection site should be replaced (for example, an alternative between the right arm and the left arm). Special attention needs to be given when the drug is administered to premature babies, newborns, nursing infants and children).
- If at the time of injection it causes pain or if blood flows into the syringe, remove the needle as quickly as possible and inject it in another place.
- Attention when opening the ampoule : To avoid contamination with foreign objects, before opening the ampoule, ampoules can be wiped using swab alcohol.
- Retinal degeneration because Tranexamic acid has been reported after high-dose and long-term administration in dogs.
PRESENTATION :
Tranxa® Injection 250 mg/5 ml Box, 5 ampoules @ 5 ml Reg. No. DKL0302333143A1
STORAGE :
STORE BELOW 30oC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia