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Nyumbani / Registered in Nigeria / Actilyse Powder

Actilyse Powder

NAFDAC Reg. No. A6-0592 · Drug

Registered with NAFDAC. Registration activeAs of 1 November 2026 · synced automatically from official sources.
Product
Actilyse Powder
NAFDAC number
A6-0592
Active ingredient
Alteplase
Strength
50 mg
Form
Powder for injection
Pack size
1 x 1's
Manufacturer
Not listed
Applicant (holder)
Fensyl MHP Consulting Limited
Approved
20 Dec 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
20 Dec 2025
WHO alerts
None found
Community reports
None
Times checked
0

About the medicine: Alteplase: uses, dosage and brands worldwide

What we found

  • Actilyse Powder is on the NAFDAC register with an active registration (A6-0592). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

How to use Actilyse Powder

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

How to take it and how often

Cathflo ® Activase ® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. • Patients weighing ≥30 kg: 2 mg in 2 mL • Patients weighing

Children
  • A total of 432 subjects under age 17 have received Cathflo Activase in the three trials
  • Rates of serious adverse events were similar in the pediatric and adult patients, as were the rates of catheter function restoration
Older adults

In 312 patients enrolled who were age 65 years and over, no incidents of intracranial hemorrhage (ICH), embolic events, or major bleeding events were observed. One hundred three of these patients were age 75 years and over, and 12 were age 85 years and over. The effect of Alteplase on common age-related comorbidities has not been studied. …

Talk to a doctor first if

Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).

Medicines it may not mix with

The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.

Warnings

None.

Possible side effects

The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label: Bleeding Hypersensitivity In the clinical trials, the most serious adverse events reported after treatment were sepsis (see PRECAUTIONS, Infections ), gastrointestinal bleeding, and venous thrombosis. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Pregnancy and breastfeeding

Pregnancy Alteplase has been shown to have an embryocidal effect due to an increased postimplantation loss rate in rabbits when administered intravenously during organogenesis at a dose (3 mg/kg) approximately 50 times human exposure (based on AUC) at the dose for restoration of function to occluded CVADs. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-01-20.

Label for alteplase, the active ingredient registered with NAFDAC.

Check your pack of Actilyse Powder

Add the expiry date on your pack for a full Trust Score.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

About Actilyse Powder

What is in Actilyse Powder?

Actilyse Powder contains Alteplase (50 mg), as powder for injection, according to its NAFDAC registration record.

Is Actilyse Powder registered with NAFDAC?

Yes. Actilyse Powder is listed on the NAFDAC register under registration number A6-0592, and its registration is active as of 1 November 2026.

Has Actilyse Powder been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Actilyse Powder in our automatically synced alert list.

How can I check that my pack of Actilyse Powder is genuine?

Run a free authenticity scan with the NAFDAC number A6-0592, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

How do I take Actilyse Powder?

Follow your prescription or the leaflet in your pack. The official label says: Cathflo ® Activase ® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. • Patients weighing ≥30 kg: 2 mg in 2 mL • Patients weighing…

What is Actilyse Powder used for?

Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. (Summarised from the official U.S. FDA label for alteplase. Always follow your doctor or pharmacist.)

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