Monday, March 28, 2011

Transamin

TRANSAMIN®
Antiplasminic Agent

COMPOSITION :
TRANSAMIN® 250 capsule, each capsule contains :
Tranexamic Acid ...........................................................................250 mg
TRANSAMIN® 500 film-coated tablet, each tablet contains :
Tranexamic Acid ...........................................................................500 mg
TRANSAMIN® 250 injection, each ml injection contains :
Tranexamic Acid ...........................................................................50 mg
TRANSAMIN® 500 injection, each ml injection contains :
Tranexamic Acid ...........................................................................100 mg

ACTIONS :
Tranexamic Acid dissolves in water at 25ÂșC in a concentration of about 11%, and is slightly soluble in methanol, ethanol and benzene, very slightly soluble in ether and aceton.
Fibrinolysis. degradation of fibrin in physiological or pathological state, is relating to the outbreak, development and cure of morbid phenomenon, including reactions in vivo caused by plasmin such as the influence on vascular permeability and coagulation factors.
Tranexamic Acid inhibits plasmin activity and shows anti hemorrhagic, antiinflammatory and anti allergic effects.

PREPARATIONS :
TRANSAMIN® 250 capsule:An orange and cream colored capsule, each capsule contains 250 mg of Tranexamic Acid.
TRANSAMIN® 500 film-coated tablet:A white colored tablet, each tablet contains 500 mg of Tranexamic Acid.
TRANSAMIN® 250 injection:Colorless and clear injectable solution, each ml contains 50 mg of Tranexamic Acid.
TRANSAMIN® 500 injection:Colorless and clear injectable solution, each ml contains 100 mg of Tranexamic Acid.
Chemical name:Trans-4-aminomethycyclohexanecarboxylic acid (AMCHA)

FARMACOLOGICAL ACTIONS :
  1. Antiplasminic activity
    • TRANSAMIN® inhibits both actions of plasminogen activator and plasmin.
    • Antiplasminic activity of TRANSAMIN® Is proven by various measurements in vitro, and by determination of plasmin activity in the blood and local activity after administering to the human body as well
  2. Hemostatic activity
    • TRANSAMIN® prevents degradation of fibrin, degeneration of platelet, increase of vascular fragility and splitting of coagulation factors.
    • These effects are clinically proved by reduction of bleeding amount, shortening of bleeding time and bleeding period in days.
  3. Anti allergic and antiinflammatory activities
    • Plasmin produces kinin and other active peptides which cause allergy and inflammatory diseases, and TRANSAMIN® improves inflammatory symptoms by inhibiting their production. 
INDICATIONS :
  1. Bleeding after systemic fibrinolysis as leukimia. hypoplastic anemia, purpura or abnormal bleeding during operation.
  2. Abnormal bleeding after local fibrinolysis such as bloody sputum and hemoptysis in pulmonary tuberculosis, genital bleeding, renal bleeding, or abnormal bleeding during/ after prostate operation.
  3. Erythema, sweeling and itching in eczema or similar diseases, urticaria, toxic exanthema and drug eruption.
  4. Pharyngodynia, flare, hyperemia in tonsilitis and pharyngolaryngitis.
  5. Stomatodynia and buccal mucosal aphtha in stomatitis.

CONTRAINDICATION :
Tranexamic Acid is contraindicated in patients with a history of thromboembolic.

SIDE EFFECTS :
Gastrointestinal disturbances, nausea, vomiting, anorexia, exanthema, and headache may occur in oral administration. These symptoms disappear by reducing the dose or discontinuing the administration.

DOSAGE AND ADMINISTRATION :
TRANSAMIN® 250 capsule :
Usual oral dose for adults is 1-2 capsules, 3-4 times a day.
TRANSAMIN® 500 film-coated tablet:
Usual oral dose for adults is ½-1 tablet, 3-4 times a day.
TRANSAMIN® 250 injection and TRANSAMIN® 500 injection :
For adults, 250 mg to 500 mg/day of Tranexamic Acid is usually administered intravenously or intramuscularly in one to three divided doses.
Dosage of TRANSAMIN® should be individualized in accordance with the patient's age and clinical condition.

PRECAUTIONS :
  1. When administered intravenously, it is advisable to inject as slowly as in the case of Calcium preparations (10 ml/1-2 minutes).
  2. Should be used with caution in patients with impaired renal function because of its accumulation risk.
  3. Should be used with caution in hematuria patients (especially In haemophilia) because upper urinary tract damage has been reported in several cases.
  4. Long-term therapy in hereditary angioneurotic oedema regular patients must be followed by eye examinations and liver function test.
  5. Should be used with caution in pregnant and lactation women because of its teratogenic and antifibrinolytic effects in neonates. 
STORAGE :
Store in a cool and dry place, protect from light.

SUPPLIED AND REGISTRATION NUMBER :
TRANSAMIN®250 capsule : Box of 10 strips @ 10 capsules/DKL7818811101A1
TRANSAMIN® 500 film-coated tablet : Box of 10 strips @ 10 tablets /DKL9318811217A1
TRANSAMIN® 250 injection : Box of 10 ampoules @ 5ml /DKL7818811043A1
TRANSAMIN® 500 injection : Box of 10 ampoules @ 5ml /DKL0118811043B1

ON MEDICAL PRESCRIPTION ONLY


Manufactured by:
PT Otto Pharmaceutical Industries
BANDUNG-INDONESIA

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