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Alteplase

آلتپلاز (اکتیلیز)

⚠ Unverified

🩸 Blood And Blood Forming OrgansThrombolytic (tPA)

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA103172 ATC B01AD02

Market / country: 🇺🇸 USA

Activase (US)

🧮 Dose calculator

Disease / regimen

Acute ischaemic stroke (thrombolysis) · Regimen source: FDA Activase · 2.1 FDA Activase · 2

• 10% of the total as a bolus over 1 min, the rest infused over 60 min. Only after excluding haemorrhage and checking contraindications. FDA Activase · 2 FDA Activase · 4.1

Formulation

Age *

Weight (kg) *

Enter age and weight.

🛡️ Safety & information

Contraindications

⛔ Active internal bleeding; recent intracranial or intraspinal surgery or serious head trauma; intracranial conditions raising bleeding risk; bleeding diathesis; severe uncontrolled hypertension. Stroke: intracranial or subarachnoid haemorrhage. MI and PE: recent stroke. FDA Activase · 4

Formulations

50 mg vial (1 mg/mL after reconstitution with 50 mL) — powder for injection 🇺🇸 USA FDA Activase · 3
100 mg vial (1 mg/mL after reconstitution with 100 mL) — powder for injection 🇺🇸 USA FDA Activase · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Activase · 8.1
“Risk Summary Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Activase · 8.2
“Risk Summary There are no data on the presence of alteplase in human milk, the effects on the breastfed infant, or the effects on milk production.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Activase · 8.4
“Safety and effectiveness of Activase in pediatric patients have not been established.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Activase · 8.5
“Acute Ischemic Stroke In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA103172
DailyMed (FDA label)FDA Activase
MedlinePlus (NIH)Alteplase Injection
WHO ATC/DDDB01AD02
Darooyab (Iran)Alteplase

🇮🇷 Registered in Iran Darooyab · G-1517/Alteplase

Dosage forms with Iranian generic codes, per Darooyab.

11407 · ALTEPLASE 10MG VIAL · ویال آلتپلاز ۱۰ میلی‌گرم
22174 · ALTEPLASE 20MG VIAL · ویال آلتپلاز ۲۰ میلی‌گرم
05775 · ALTEPLASE 50MG VIAL · ویال آلتپلاز ۵۰ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Activase · 3 FDA Activase · 2.1 FDA Activase · 2 FDA Activase · 4.1 FDA Activase · 2.3 FDA Activase · 2.2, Table 1 FDA Activase · 4 FDA Activase · SPL approval / marketing category FDA Activase · 8.1 FDA Activase · 8.2 FDA Activase · 8.4 FDA Activase · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-1517/Alteplase
Clinical review⚠ Unverified

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