Basic Information
ACTILYSE TREATMENT-SET 50 mg/vial
INJECTION, POWDER, FOR SOLUTION
Regulatory Information
SIN02340P
October 3, 1988
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
May 30, 2025
XB01AD02
Company Information
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Active Ingredients
Strength: 50 mg/vial
Detailed Information
Contraindications
**4.3 Contraindications** ACTILYSE is contraindicated in - patients with known hypersensitivity to the active substance alteplase or to any of the excipients - cases where there is a high risk of haemorrhage such as: - significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis - patients receiving effective oral anticoagulants treatment, e.g. warfarin sodium (INR> 1.3) (please see section Special warnings and precautions, subsection “Bleeding” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) - history or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage - severe uncontrolled arterial hypertension - major surgery or significant trauma in the past 10 days (this includes any trauma associated with the current acute myocardial infarction), recent trauma to head or cranium - prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes), obstetrical delivery, within the past 10 days, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture) - severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis - bacterial endocarditis, pericarditis - acute pancreatitis - documented ulcerative gastro-intestinal disease during the last 3 months - arterial aneurysms, arterial/venous malformations - neoplasm with increased bleeding risk In the indication of acute myocardial the following contraindications apply in addition: - Haemorrhagic stroke or stroke of unknown origin at any time - Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 4.5 hours In the indication of acute massive pulmonary embolism the following contraindications apply in addition: - Haemorrhagic stroke or stroke of unknown origin at any time - Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 4.5 hours In the indication acute ischaemic stroke the following contraindications apply in addition: - symptoms of ischaemic attack began more than 4.5 hours prior to infusion start or when time of symptom onset is unknown - symptoms of acute ischaemic stroke that were either rapidly improving or only minor before start of infusion - severe stroke as assessed clinically (e.g. NIHSS > 25) and/or by appropriate imaging techniques - seizure at the onset of stroke - history of previous stroke or serious head-trauma within three months - a combination of previous stroke and diabetes mellitus - administration of heparin within 48 hours preceding the onset of stroke with an elevated activated partial thromboplastin time (aPTT) at presentation - platelet count of less than 100,000 / mm3 - systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, or aggressive management (IV medication) necessary to reduce blood pressure to these limits - blood glucose < 50 mg/dL or > 400 mg/dL (< 2.8 mmol/L or > 22.2 mmol/L) - children under 16 years of age (for children ≥ 16 years of age see section Special warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
Indication Information
**4.1 Therapeutic indications** 1. **Thrombolytic treatment in acute myocardial infarction.** - 90 minutes (accelerated) dose regimen (see section 4.2 Posology and administration): for patients in whom treatment can be started within 6 hours of symptom onset; - 3 hours dose regimen (see section 4.2 Posology and administration): for patients in whom treatment can be started between 6 – 12 hours after symptom onset. ACTILYSE has proven to reduce 30-day-mortality in patients with acute myocardial infarction. 2. **Thrombolytic treatment in acute massive pulmonary embolism with haemodynamic instability.** The diagnosis should be confirmed whenever possible by objective means such as pulmonary angiography or non-invasive procedures such as lung scanning. There are no clinical trials on mortality and late morbidity related to pulmonary embolism. 3. **Thrombolytic treatment of acute ischaemic stroke** Treatment must be started as early as possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage). The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.