All the Active Ingredient Drugs
Thrombolytic Agent. Alteplase 20 mg/vial, 50 mg/Vial. VIAL. (pwdr.+ solvent for sol. for inject./
infus.): 1 + 1 vial of solvent. Dosage
must be ajust. individ according to pt.
med. cond.
Acute MI: In adults for the lysis of thrombi
obstruct. coron. arteries, the reduction of
infarct size, the improve. of ventr. func., the
reduction of the incidence of congest.
heart fail., reduct. of mortality assoc. with
AMI. Tmt. should be initiated as soon as
possible after the onset of AMI sympt.
Acute Massive Pulmon. embol. with
hemodynamic deprivation.: Management
of acute massive pulmonary embolism
(PE) in adults: For the lysis of acute pulm.
emboli, defined as obstruct. of blood flow
to a lobe or multiple segments of the lung,
For the lysis of pulmon. emboli
accompanied by unstable hemodynamics
e.g. fail.to maintain blood pressure
without supportive measures.
The diagnosis should be confirmed by
objective means, such as pulmon.
angiography or noninvasive procedures
such as lung scanning.For fibrinolytic
treatment of acute ischaemic stroke Tmt.
must be started as early as possible within
4.5 hrs. after onset of stroke sympt.and
after exclusion of intracr. haemorrhage by
appropriate imaging techniques (e.g.
cranial CT or other diag. imaging method
sensitive for the presence of
haemorrhage). The tmt. effect is timedependent;
therefore earlier tmt. incr. the
probability of a favourable outcome.
C/I: Hypersens. High risk cases of
haemorrhage such e.g.: Signific. bleed.
disor. at present or within the past 6
mnths. Known haemorrhage.diathesis.
Pts. receiving effective oral anticoag.
tmt., e.g. warfarin sodium (INR>1.3). Manifest or recent severe or dangerous bleed. Known hist. of or suspected intracran.
haemorrhage. Suspected subarachnoid
haemorrhage/condition after subarachnoid haemorrhage from aneurysm. Any history of CNS damage (i.e. neoplasm, aneurysm, intracran./spinal surg.). Recent (less than 10 days) traumatic external heart massage,
obstetrical delivery, recent puncture of a
non-compressible blood-vessel (e.g.
subclavian or jugular vein puncture).
Severe uncontrol.arterial hypertens.
Bact. endocarditis, pericarditis. Acute
pancreatitis. Documented ulcerative GI
dis. during the last 3 mnths., oesophageal varices, arterial-aneurysm, arterial/venous malformations.
Neoplasm with incr. bleed.risk. Severe liver dis., includ. hep. fail., cirrhosis, portal hypertension (oesophageal varices) and active hepatitis. Major surg. or signific. trauma in past 3 mnths.
Addit. contraind. in acute massive pulmonary embolism, MI, acute ischaemic stroke: see lit.
Acute ischaemic stroke in child. under 16 yrs old.
