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Prescribing Information

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Metalyse® 25 mg (TENECTEPLASE) is available for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage1

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Minute Matters

HRCT
  • Metalyse 25 mg for AIS
  • ThiNK Stroke
  • Clinical Trial Data
  • Dosing & Administration
  • Contraindications
  • Time is Brain

Metalyse 25 mg (tenecteplase) and Actilyse® (alteplase) have comparable contraindications, and special warnings and precautions for use1,2

Metalyse 25 mg is a genetically modified version of Actilyse. As such, the safety characteristics are similar for both treatments. See below to compare the contraindications, special warnings and precautions for use for both Metalyse 25 mg and Actilyse, and to view the adverse event profile for Metalyse 25 mg.1,2

On this page

  • Contraindications
  • Special warnings and precautions for use
  • Frequency of adverse reactions

Thrombolytic treatment requires adequate monitoring. Metalyse 25 mg should only be used with the involvement and follow-up of physicians trained and experienced in neurovascular care and the use of thrombolytic treatments, with the facilities to monitor that use.1

Metalyse 25 mg and Actilyse: contraindications for use

Please see the table below for a full list of contraindications of Actilyse and Metalyse 25 mg.

Metalyse® 25 mg (tenecteplase) packshot
Actilyse2Metalyse 25 mg1
Hypersensitivity to alteplase, arginine, phosphoric acid, or polysorbate 80Hypersensitivity to tenecteplase, arginine, concentrated phosphoric acid (E 338), polysorbate 20 (E 432), or to gentamicin (a trace residue from the manufacturing process)
Actilyse is contraindicated in cases where there is a high risk of haemorrhage such as:Metalyse 25 mg is contraindicated in situations associated with a higher risk of bleeding, including:
  • Significant bleeding disorder at present or within the past 6 months
  • Significant bleeding disorder at present or within the past 6 months
  • Patients receiving effective oral anticoagulant*
  • Patients receiving effective anticoagulation (e.g. vitamin K antagonists with INR > 1.7)† 
  • See special warnings and precautions of use subsection “Bleeding” below.
  • Known history of or suspected intracranial haemorrhage
  • Known history of or suspected intracranial haemorrhage
  • Symptoms suggestive of subarachnoid haemorrhage, even if CT-scan is normal
  • Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
  • Symptoms suggestive of subarachnoid haemorrhage, even if CT-scan is normal
  • Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques
  • Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques
  • Minor neurological deficit or symptoms rapidly improving before start of infusion
  • Acute ischaemic stroke without disabling neurological deficit, or symptoms rapidly improving before start of injection
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • Known haemorrhagic diathesis
  • Known haemorrhagic diathesis
  • Severe uncontrolled arterial hypertension
  • Severe uncontrolled arterial hypertension
  • Please see special warnings and precautions of use below
  • Major surgery or significant trauma in past 3 months
  • Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months
  • Evidence of intracranial haemorrhage (ICH) on the CT-scan
  • Recent trauma to the head or cranium
  • Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a noncompressible blood-vessel (e.g. subclavian or jugular vein puncture)
  • Please refer to the special warnings and precautions of use section below
  • Bacterial endocarditis, pericarditis
  • Bacterial endocarditis, pericarditis
  • Acute pancreatitis
  • Acute pancreatitis
  • Severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
  • Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
  • Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations
  • Active ulcerative gastro-intestinal disease
  • Known arterial aneurysm and/or arterial/venous malformation
  • Neoplasm with increased bleeding risk
  • Neoplasm with increased bleeding risk
  • Symptoms of ischaemic attack beginning more than 4.5 hours prior to infusion start or symptoms for which the onset time is unknown and could potentially be more than 4.5 hours ago
 
  • Seizure at onset of stroke
  • Please refer to special warnings and precautions for use below
  • Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
  • Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
  • Patients with any history of prior stroke and concomitant diabetes
  • Patients with any history of prior stroke and concomitant diabetes
  • Prior stroke within the last 3 months
  • Prior stroke within the last 3 months
  • Platelet count of below 100,000/mm3
  • Platelet count of below 100,000/mm3
  • Systolic blood pressure >185 mm Hg or diastolic BP > 110 mm Hg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP to these limits
  • Systolic blood pressure > 185 mm Hg or diastolic BP > 110 mm Hg, or when BP cannot be reduced below these limits by careful management
  • Blood glucose <50 mg/dl or >400 mg/dl (<2.8 mm or >22 mm)
  • Blood glucose <50 mg/dl (see special warnings and precautions for use below) or >400 mg/dl (<2.8 mM or >22.2 mM)
  • Manifest or recent severe or dangerous bleeding
 
Actilyse is contraindicated for the treatment of acute ischaemic stroke in children and adolescents under 16 years of ageMetalyse 25 mg is not recommended for use in children below 18 years of age (see warnings below)

*  The use of Actilyse may be considered when dosing or time since the last intake of anticoagulant treatment makes residual efficacy unlikely confirmed by appropriate test(s) of anticoagulant activity for the product(s) concerned showing no clinically relevant activity on the coagulation system.2

†  The use of Metalyse 25 mg may be considered when appropriate test(s) show no clinically relevant activity on the coagulation system.1

Metalyse 25 mg and Actilyse: special warnings and precautions for use

Please see the table below for a full list of special warnings and precautions for use for each treatment, as detailed in their respective Summary of Product Characteristics.1,2 

Needle entering stopper of Metalyse® 25 mg (tenecteplase) vial
Actilyse2Metalyse 25 mg1

Traceability


In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recordedIn order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded

Thrombolytic/fibrinolytic treatment requires adequate monitoring. Actilyse should only be used under the responsibility and follow-up of physicians trained and experienced in the use of neurovascular care and in the use of thrombolytic treatments and with the facilities to monitor that use

It is recommended that when Actilyse is administered standard resuscitation equipment and pharmacotherapy is available in all circumstances

Thrombolytic treatment requires adequate monitoring. Treatment must be performed under the responsibility and follow-up of physicians trained and experienced in neurovascular care and the use of thrombolytic treatments, with the facilities to monitor that use
For the verification of treatment indication remote diagnostic measures may be considered as appropriateFor the verification of treatment indication remote diagnostic measures may be considered as appropriate
The appropriate pack size of Actilyse product should be chosen carefully and in accordance with the intended use. The 2 mg vial of Actilyse is not indicated for use in acute ischaemic stroke (due to risk of massive under-dosing). Only 10 mg, 20 mg or 50 mg vials are indicated for use in acute ischaemic strokeThe appropriate presentation of Metalyse product should be chosen carefully and in line with the indication. The 50 mg vial of Metalyse is not intended for use in acute ischaemic stroke. The 25 mg presentation of Metalyse is only intended for use in acute ischaemic stroke

Haemorrhages/Bleeding


The most common complication encountered during Actilyse therapy is bleeding. The concomitant use of other active substances affecting coagulation or platelet function may contribute to bleedingThe most common complication encountered during Metalyse 25 mg therapy is bleeding. The concomitant use of other active substances affecting coagulation or platelet function (e.g. heparin) may contribute to bleeding
As fibrin is lysed during Actilyse therapy, bleeding from recent puncture sites may occur. Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including those following catheter insertion, arterial and venous puncture cutdown and needle puncture)As fibrin is lysed during Metalyse 25 mg therapy, bleeding from recent puncture site may occur. Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites and needle puncture sites)
The use of rigid catheters, intramuscular injections and non-essential handling of the patient should be avoided during treatment with ActilyseThe use of rigid catheters as well as intramuscular injections and non-essential handling of the patient should be avoided during treatment with Metalyse 25 mg
If a potentially dangerous haemorrhage occurs, in particular cerebral haemorrhage, the fibrinolytic therapy must be discontinued, and concomitant heparin administration should be terminated immediately. In general, however, it is not necessary to replace the coagulation factors because of the short half-life and the minimal effect on the systemic coagulation factors. Most patients who have bleeding can be managed by interruption of thrombolytic and anticoagulant therapy, volume replacement, and manual pressure applied to an incompetent vesselShould serious bleeding occur, in particular cerebral haemorrhage, concomitant heparin administration should be terminated immediately
Protamine should be considered if heparin has been administered within 4 hours of the onset of bleeding. In the few patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated. Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration. A target fibrinogen level of 1 g/l is desirable with cryoprecipitate infusion. Antifibrinolytic agents are available as a last alternativeAdministration of protamine should be considered if heparin has been administered within 4 hours before the onset of bleeding. In the few patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated. Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration. A target fibrinogen level of 1 g/l is desirable with cryoprecipitate infusion. Antifibrinolytic agents are available as a last alternative
The risk of intracranial haemorrhage is increased in elderly patients, therefore in these patients the risk/benefit evaluation should be carried out carefullyMetalyse should be administered with caution in the elderly (> 80 years) due to a higher bleeding risk
As with all thrombolytic agents, the expected therapeutic benefit should be weighed up particularly carefully against the possible risk, especially in patients with:In the following conditions, the risk of Metalyse 25 mg therapy may be increased and should be weighed against the anticipated benefits:
  • Small recent traumas, such as biopsies, puncture of major vessels, intramuscular injections, cardiac massage for resuscitation
  • Recent intramuscular injection or small recent traumas, puncture of major vessels
  • Conditions with an increased risk of haemorrhage which are not mentioned in Contraindications
 
  • Patients receiving oral anticoagulant treatment: The use of Actilyse may be considered when dosing or time since the last intake of anticoagulant treatment makes residual efficacy unlikely confirmed by appropriate test(s) of anticoagulant activity for the product(s) concerned showing no clinically relevant activity on the coagulation system
  • Patients receiving oral anticoagulants: The use of Metalyse 25 mg may be considered when appropriate test(s) show no clinically relevant activity on the coagulation system
  • Please refer to contraindications section above
  • Prolonged (> 2 minutes) or traumatic cardiopulmonary resuscitation or cardiac massage.
lntracerebral haemorrhage represents the major adverse reaction in the treatment of acute ischaemic stroke (up to 15% of patients without any increase of overall mortality and without any relevant increase in overall mortality and severe disability combined, i.e. modified Rankin scale [mRS] score of 5 and 6)Intracerebral haemorrhage represents the major adverse reaction in the treatment of acute ischaemic stroke (up to 19% of patients without any increase of overall morbidity or mortality)
Patients with acute ischaemic stroke treated with Actilyse have a markedly increased risk of intracranial haemorrhage as the bleeding occurs predominantly into the infarcted area.
This applies in the following cases:
Risk of intracranial haemorrhage in patients with acute ischaemic stroke may be increased with the use of Metalyse 25 mg.

This applies in particular in the following cases:
  • all situations listed in Contraindications and in general all situations involving a high risk of haemorrhage
 
  • as time to treatment from onset of stroke symptoms increases, net clinical benefit decreases. Therefore, the administration of Actilyse should not be delayed
  • late time to treatment from last known well. Therefore, the administration of Metalyse 25 mg should not be delayed
  • patients pre-treated with acetyl salicylic acid may have a greater risk of intracerebral haemorrhage, particularly if Actilyse treatment is delayed
  • patients pre-treated with acetylsalicylic acid (ASA) may have a greater risk of intracerebral haemorrhage and/or mortality, particularly if Metalyse 25 mg treatment is delayed
  • compared to younger patients, patients of advanced age (over 80 years) may have a somewhat poorer outcome independent of treatment. They are also more likely to have more severe strokes, which are associated with a higher absolute risk of intracerebral haemorrhage when thrombolysed compared with milder strokes when thrombolysed or with non-thrombolysed patients. Although available data indicate that the net benefit of Actilyse in patients over 80 years is smaller compared with younger patients, Actilyse can be used in patients over 80 years on an individual benefit-risk basis. Patients of advanced age should be selected very carefully considering both the general health and the neurological status
  • compared to younger patients, patients of advanced age (over 80 years) may have a somewhat poorer outcome independent of treatment and may have an increased risk of intracerebral haemorrhage when thrombolysed. In general, the benefit-risk of thrombolysis in patients of advanced age remains positive. Thrombolysis in AIS patients should be evaluated on individual benefit-risk basis
  • In patients with very mild stroke, the risks outweigh the expected benefit
 
  • Patients with very severe stroke are at higher risk for intracerebral haemorrhage and death, and should not be treated
 
  • Patients with extensive infarctions are at greater risk of poor outcome including severe haemorrhage and death. In such patients, the benefit/risk ratio should be thoroughly considered
 

Treatment must not be initiated later than 4.5 hours after the onset of symptoms because of unfavourable benefit/risk ratio mainly based on the following:

  • positive treatment effects decrease over time
  • particularly in patients with prior ASA treatment the mortality rate increases
  • increased risk of symptomatic haemorrhage
 

Thrombo-embolism


 

The use of Metalyse can increase the risk of thrombo-embolic events in patients with existing thrombi, e.g. left heart thrombus (mitral stenosis or atrial fibrillation, etc).

Blood pressure monitoring


BP monitoring during treatment administration and up to 24 hours seems justified; an intravenous antihypertensive therapy is also recommended if systolic BP >180 mm Hg or diastolic BP >105 mm HgBP monitoring during the first 24 hours after Metalyse 25 mg treatment  is necessary; intravenous antihypertensive therapy is recommended if systolic BP >180 mm Hg or diastolic BP >105 mm Hg

Special groups at reduced benefit/risk

The therapeutic benefit is reduced in patients that had a prior stroke or in those with known uncontrolled diabetes, thus the benefit/risk ratio is considered less favourable, but still positive in these patients


The benefit/risk ratio of Metalyse 25 mg administration should be thoroughly considered in AIS patients with the following conditions:

  • The benefit/risk ratio of thrombolytic therapy is considered less favourable in patients who have had a prior stroke or in those with known uncontrolled diabetes, but still positive in these patients.
  • Seizure at the onset of stroke. (Thrombolytic therapy in these patients should only be considered when there is no suspicion of a stroke mimic or significant head trauma).
  • In patients initially presenting with blood glucose < 50 mg/dL, thrombolysis may be considered after correction to normal blood glucose values, if the diagnosis of AIS persists, (please refer to contraindications section above)
In stroke patients the likelihood of good outcomes decreases with longer time to treatment from onset of symptoms, increasing age, increasing stroke severity and increased levels of blood glucose on admission while the likelihood of severe disability and death or symptomatic intracranial bleedings increases, independently from treatmentIn stroke patients the likelihood of a favourable outcome decreases with longer time from onset of symptoms to thrombolytic treatment, increasing age, increasing stroke severity and increased levels of blood glucose on admission while the likelihood of severe disability and death or symptomatic intracranial bleeding increases, independently of treatment

Drugs affecting coagulation/platelet function


Due to an increased haemorrhagic risk, treatment with platelet aggregation inhibitors should not be initiated within the first 24 hours following thrombolysis with Actilyse

Not included in the special warnings section in the summary of product characteristics but in section 4.5, interactions with other medicinal products

Medicinal products that affect coagulation or those that alter platelet function may increase the risk of bleeding (when administered prior to, during or after tenecteplase therapy). These products should be avoided in the first 24 hours after Metalyse treatment for acute ischaemic stroke. Please refer to the summary of product characteristics for further information regarding to pre-treatment with these substances. Not an exhaustive list of interactions with other medicinal products.

Cerebral oedema


Reperfusion of the ischaemic area may induce cerebral oedema in the infarcted zoneReperfusion of the ischaemic area may induce cerebral oedema in the infarcted zone

Hypersensitivity/re-administration

Immune-mediated hypersensitivity reactions associated with the administration of Actilyse can be caused by the active substance alteplase or any of the excipientsImmune-mediated hypersensitivity reactions associated with the administration of Metalyse 25 mg can be caused by the active substance tenecteplase, gentamicin (a trace residue from the manufacturing process) or any of the excipients

No sustained antibody formation to the recombinant human tissue-type plasminogen activator molecule has been observed after treatment. There is no systematic experience with re-administration of Actilyse

There is also a risk of hypersensitivity reactions mediated through a non-immunological mechanism

No sustained antibody formation to the tenecteplase molecule has been observed after treatment. However, there is no systematic experience with re-administration of Metalyse 25 mg. There is also a risk of hypersensitivity reactions mediated through a non-immunological mechanism

Angio-oedema represents the most common hypersensitivity reaction reported with Actilyse. This risk may be enhanced in the indication acute ischaemic stroke and/or by concomitant treatment with angiotensin-converting-enzyme (ACE) inhibitors. Patients treated for any authorised indication should be monitored for angio-oedema during and for up to 24 hours after infusion


Angio-oedema represents the most common hypersensitivity reaction reported with Metalyse 25 mg. This risk may be enhanced in the indication acute ischaemic stroke and/or by concomitant treatment with ACE inhibitors. Patients treated with Metalyse 25 mg should be monitored for angioedema during and for up to 24 hours after administration
If a severe hypersensitivity reaction (e.g. angio-oedema) occurs, the infusion should be discontinued, and appropriate treatment promptly initiated. This may include intubationIf a severe hypersensitivity reaction (e.g. angio-oedema) occurs, appropriate treatment should be promptly initiated. This may include intubation

Paediatric population


There is limited experience with the use of Actilyse in children and adolescents. When Actilyse is considered for the treatment of acute ischaemic stroke in carefully selected adolescents ≥16 years of age the benefit should be weighed carefully against the risks on an individual basis and discussed with the patient and parent/guardian as appropriate. Adolescents ≥16 years of age should be treated according to the instruction in the label for the adult population after imaging by appropriate techniques to rule out stroke mimics and confirming arterial occlusion corresponding to the neurological deficitSafety and efficacy data in children below 18 years of age are not available for Metalyse 25 mg. Therefore, Metalyse 25 mg is not recommended for use in children below 18 years of age
 This medicine contains 2.0 mg of polysorbate 20 in each 25 mg vial. Polysorbates may cause allergic reactions.

Pregnancy


There is a limited amount of data from the use of alteplase in pregnant women

Non-clinical studies performed with alteplase in doses higher than human doses exhibited fetal immaturity and/or embryotoxicity, secondary to the known pharmacological activity of the drug. Alteplase is not considered to be teratogenic

In cases of an acute life-threatening disease the benefit has to be evaluated against the potential risk

There is a limited amount of data from the use of Metalyse 25 mg in pregnant women

Non-clinical data performed with tenecteplase have shown bleeding with secondary mortality of dams due to the known pharmacological activity of the active substance and in a few cases abortion and resorption of the foetus occurred (effects only have been observed with repeated dose administration). Tenecteplase is not considered to be teratogenic

The benefit of treatment must be evaluated against the potential risks during pregnancy

Breast-feeding

It is unknown whether alteplase is excreted into human milk and there is insufficient information on the excretion of alteplase in animal milk

Caution should be exercised when Actilyse is used for a nursing woman and a decision must be made whether breast-feeding should be discontinued for the first 24 hours after use of Actilyse

It is unknown whether tenecteplase is excreted in human milk

Caution should be exercised when Metalyse 25 mg is administered to a nursing woman and a decision must be made whether breast-feeding should be discontinued within the first 24 hours after administration of Metalyse 25 mg

Summary of Metalyse 25 mg safety profile

Haemorrhage is the most common adverse event associated with the use of Metalyse 25 mg. The type of haemorrhage can be superficial at the injection site or internal at any site or body cavity.1

Intracerebral haemorrhage represents the major adverse reaction in the treatment of AIS (up to 19% of patients without any increase of overall morbidity or mortality).1

The risk of intracranial haemorrhage in patients with AIS may be increased with the use of Metalyse 25 mg.1

A comprehensive list of known adverse reactions can be found in the table below, and in the Summary of Product Characteristics for Metalyse 25 mg.1

Doctor in blue scrubs holding clipboard beside hospital bed
Summary of Product Characteristics

Known adverse reactions for Metalyse 25 mg1

System organ classAdverse reactionFrequency grouping
Immune system disordersAnaphylactoid reaction‡Rare
Nervous system disordersIntracranial haemorrhage§Very common
Eye disordersEye haemorrhageUncommon
Cardiac disordersPericardial haemorrhageRare
Vascular disordersHaemorrhageVery common
Embolism (thrombotic embolisation)Rare
Respirator, thoracic and mediastinal disordersEpistaxisCommon
Pulmonary haemorrhageRare
Gastrointestinal disordersGastrointestinal haemorrhage¶Common
Retroperitoneal haemorrhageǁUncommon
Nausea, vomitingNot known
Skin and subcutaneous tissue disordersEcchymosisCommon
Renal and urinary disordersUrogenital haemorrhage**Common
General disorders and administration site conditionsInjection site haemorrhageCommon
Puncture site haemorrhageCommon
InvestigationsBlood pressure decreasedRare
Body temperature increasedNot known
Injury, poisoning and procedural complicationsFat embolism††Not known
Surgical and medical proceduresTransfusionNot known

Frequency groupings are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), and not known (cannot be estimated from the available data).1

  • ‡ 

    Includes rash, urticaria, bronchospasm, and laryngeal oedema. 1
  • § 

    Examples include cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage. This includes associated symptoms such as somnolence, aphasia, hemiparesis, or convulsion. 1
  • ¶ 

    Such as gastric haemorrhage, gastric ulcer haemorrhage, rectal haemorrhage, haematemesis, melaena, or mouth haemorrhage. 1
  • ǁ 

    Such as retroperitoneal haematoma. 1
  • ** 

    Such as haematuria, haemorrhage urinary tract. 1
  • †† 

    May lead to corresponding consequences in the organs concerned. 1

Learn more about Metalyse 25 mg

Metalyse® 25 mg (tenecteplase) packshot

Clinical Trial Data

Metalyse 25 mg has a clinically relevant non-inferior efficacy and safety profile vs Actilyse.3–5

Learn more
Needle entering stopper of Metalyse® 25 mg (tenecteplase) vial

Dosing & Administration

With a single IV bolus and no requirement for an IV infusion pump, Metalyse 25 mg is simpler and quicker to administer than Actilyse.1,2

Learn more

Metalyse 25 mg is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.1

Actilyse is indicated for the fibrinolytic 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.2

Abbreviations

ACE: angiotensin-converting-enzyme, AIS: acute ischaemic stroke, ASA: acetylsalicylic acid, BP: blood pressure, CT: computerised tomography, ICH: intracranial haemorrhage, IV: intravenous, mRS: modified Rankin Scale, NIHSS: National Institutes of Health Stroke Scale.

References

  1. Metalyse® 25 mg (tenecteplase) Summary of Product Characteristics.
  2. Actilyse® (alteplase) Summary of Product Characteristics.
  3. Menon BK, et al. Lancet. 2022;400:161–169.
  4. Campbell BCV, et al. N Engl J Med. 2018;378:1573–1582.
  5. Muir K, et al. Lancet Neurol. 2024;23:1087–1096.

PC-GB-110817 V3 September 2025

Reporting adverse events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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