Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**DOSAGE AND ADMINISTRATION** Reconstitute the contents of one vial with 10 mL of physiological saline and inject intravenously. Preferably instill as an admixture with physiological saline or glucose injection. \[Thrombotic-occulsive diseases\] ♦ Cerebral thrombosis: Administer 60,000 international units once a day for about 7 days. ♦ Peripheral arterial-venous occlusion: Administer 60,000 to 240,000 international units on first day of treatment followed by tapered doses for about 7 days.
INTRAVENOUS
Medical Information
**INDICATIONS** Treatment of the following thrombotic-occlusive diseases: ♦ Cerebral thrombosis (within 5 days after the onset of symptoms, and without hemorrhage detectable by computed tomography) ♦ Peripheral arterial-venous occlusion (within 10 days after the onset of symptoms)
**(2) Contraindications** 1. Patients for whom hemostatic management is difficult: intracranial hemorrhage, hemoptysis, retroperitoneal hemorrhage and the like. 2. Patients having undergone intracranial or spinal surgery or with such injury (in the last 2 months). 3. Patients with aneurysm. 4. Patients with serious disturbances of consciousness. **(3) Contraindications as a general rule** This product is contraindicated in the following patients, as a general rule. If essential, however, it can be administered with caution. 1. Patients with atrial fibrillation (particularly with mitral stenosis), patients with infective endocarditis, patients with old myocardial infarction, and patients with a prosthetic valve. 2. Patients with neurological signs and symptoms of stroke which became complete instantaneously.
B01AD04
urokinase
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.
Active Ingredients
Documents
Package Inserts
1.4.3 Proposed PI.pdf
Approved: October 3, 2016