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Zarzio 48 MU/0.5 mL

NAFDAC Reg. No. A6-100055 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Zarzio 48 MU/0.5 mL
NAFDAC number
A6-100055
Active ingredient
Filgrastim
Strength
48 MU/0.5 mL
Form
Solution for injection/infusion
Pack size
0.5 mL x 5's (in Pre-filled Syringes)
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
29 Aug 2022
Status
Active View on NAFDAC ↗
Registration valid to
28 Aug 2027
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Zarzio 48 MU/0.5 mL is on the NAFDAC register with an active registration (A6-100055). 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.

What Zarzio 48 MU/0.5 mL is used for

From the official U.S. FDA label for filgrastim, the active ingredient registered with NAFDAC.

What it is used for

RELEUKO is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever. ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). …

Possible side effects

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions ( 5.1 )] Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.2 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] Glomerulonephritis [see Warnings and Precautions ( 5.5 )] Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautious ( 5.6 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.7 )] Myelodysplastic Syndrome [see Warnings and Precautions ( 5.8 )] Acute Myeloid Leukemia [see Warnings and Precautions ( 5.8 )] Thrombocytopeni …

Do not use if

RELEUKO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see Warnings and Precautions ( 5.3 )]. Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products. ( 4 )

Warnings

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO in patients with ARDS. ( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO in patients with serious allergic reactions. ( 5.3 ) Fatal sickle cell crises: Discontinue RELEUKO if sickle cell crisis occurs. ( 5.4 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of RELEUKO if causality is likely. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim product use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes ( see Data ). …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Zarzio 48 MU/0.5 mL

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

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Zarzio 48 MU/0.5 mL

What is in Zarzio 48 MU/0.5 mL?

Zarzio 48 MU/0.5 mL contains Filgrastim (48 MU/0.5 mL), as solution for injection/infusion, according to its NAFDAC registration record.

Is Zarzio 48 MU/0.5 mL registered with NAFDAC?

Yes. Zarzio 48 MU/0.5 mL is listed on the NAFDAC register under registration number A6-100055, and its registration is active as of 27 October 2026.

Has Zarzio 48 MU/0.5 mL been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Zarzio 48 MU/0.5 mL in our automatically synced alert list.

How can I check that my pack of Zarzio 48 MU/0.5 mL is genuine?

Run a free authenticity scan with the NAFDAC number A6-100055, 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.

What is Zarzio 48 MU/0.5 mL used for?

RELEUKO is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever. ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation ch (Summarised from the official U.S. FDA label for filgrastim. Always follow your doctor or pharmacist.)

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