ZALTRAP I.V. CONCENTRATED FOR PREPARING SOLUTIONS FOR INFUSION 200 mg/8 ml

Active ingredient: One mL of concentrated solution contains 25 mg aflibercept. One vial containing 8 mL of concentrated solution contains 200 mg aflibercept. Aflibercept is produced by recombinant DNA technology in the Chinese hamster ovary (CHO) K 1 mammalian cell expression system.

Excipients: Sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injection.

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

ZALTRAP contains aflibercept as the active ingredient. Aflibercept is produced by recombinant DNA technology in the Chinese hamster ovary (CHO) K 1 mammalian cell expression system. Aflibercept is a protein that works by preventing the formation of new blood vessels within the tumor. The tumor needs nutrients and oxygen from the blood to grow. Aflibercept stops or slows tumor growth by blocking the growth of blood vessels.

ZALTRAP concentrate is a clear, colorless or pale yellow solution. 1 box contains 1 glass vial containing concentrated solution.

ZALTRAP is a medicine used to treat advanced cancer of the colon or rectum (parts of the large intestine) in adults. It is given together with other medicines used in cancer treatment, including ‘5-fluorouracil’, ‘folinic acid’ and ‘irinotecan’.

ZALTRAP will be given to you by a doctor or nurse experienced in chemotherapy (cancer treatment). It will be given by drip (‘infusion’) into one of your veins (‘intravenous’). ZALTRAP should not be injected into the eye as it can cause serious harm.

This medication must be diluted before administration. Practical information regarding the administration of ZALTRAP for doctors, nurses and pharmacists is also provided in this leaflet.

Instructions for proper use and dosage/frequency of administration

The recommended dose for ZALTRAP is 4 mg for every kilogram of your body weight. Your doctor will decide the dose that is right for you.

Your treatment will continue as long as your doctor thinks the treatment is beneficial for you and the side effects are acceptable.

Like all medicines, side effects may occur in people who are sensitive to the ingredients contained in ZALTRAP.

Side effects seen when ZALTRAP is administered with chemotherapy are listed below.

Side effects are listed as shown in the following categories:

If any of the following occur, stop using ZALTRAP and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital:

These are all very serious side effects. You may need emergency medical attention or hospitalization.

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.