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Tenecteplase

تنکتپلاز

⚠ Unverified

🩸 Blood And Blood Forming OrgansTissue plasminogen activator (thrombolytic)

🤰 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) BLA103909 ATC B01AD11

Market / country: 🇺🇸 USA

TNKase (US)

🧮 Dose calculator

Disease / regimen

Acute ischaemic stroke (thrombolysis) · Regimen source: FDA TNKase · 2.1, Table 1

• IV bolus over 5 seconds. Monitor and control blood pressure during and after. FDA TNKase · 2.1

Formulation

Age *

Weight (kg) *

Enter age and weight.

🛡️ Safety & information

Contraindications

⛔ Active internal bleeding; intracranial or intraspinal surgery or trauma within 2 months; bleeding diathesis; severe uncontrolled hypertension; intracranial lesion (neoplasm, AVM, aneurysm). Stroke: active intracranial haemorrhage. STEMI: history of intracranial haemorrhage. FDA TNKase · 4

Warnings

• Bleeding (including intracranial); cholesterol embolisation; reperfusion arrhythmias. FDA TNKase · 5

Formulations

25 mg or 50 mg vial; 5 mg/mL after reconstitution — powder for injection 🇺🇸 USA FDA TNKase · 3 FDA TNKase · 2.3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA TNKase · 8.1
“Risk Summary There are risks to the mother and fetus from acute ST elevation myocardial infarction and acute ischemic stroke, which are medical emergencies in pregnancy and can be fatal if left untreated (see Clinical Considerations ).”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA TNKase · 8.2
“Risk Summary There are no data on the presence of tenecteplase in either human or animal milk, the effects on the breastfed infant, or the effect on milk production.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA TNKase · 8.4
“The safety and effectiveness of TNKase 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 TNKase · 8.5
“Of the total number of TNKase-treated patients within 0-3 hours in Trial 1 for acute ischemic stroke (AIS), 426 (72%) were 65 years of age and older, and 290 (49%) were 75 years of age and older [see Clinical Studies (14.1) ].”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA103909
DailyMed (FDA label)FDA TNKase
MedlinePlus (NIH)Tenecteplase Injection
WHO ATC/DDDB01AD11
Darooyab (Iran)Tenecteplase

🇮🇷 Registered in Iran Darooyab · G-1899/Tenecteplase

Dosage forms with Iranian generic codes, per Darooyab.

51682 · TENECTEPLASE 50 MG POWDER FOR INJECTION · پودر تزریقی تنکتپلاس 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 TNKase · 3 FDA TNKase · 2.3 FDA TNKase · 2.1, Table 1 FDA TNKase · 2.1 FDA TNKase · 2.2, Table 2 FDA TNKase · 2.2 FDA TNKase · 2.5 FDA TNKase · 4 FDA TNKase · 5 FDA TNKase · SPL approval / marketing category FDA TNKase · 8.1 FDA TNKase · 8.2 FDA TNKase · 8.4 FDA TNKase · 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-1899/Tenecteplase
Clinical review⚠ Unverified

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