DigiFab 40 mg/1 vial Powder for solution for infusion

DigiFab^®, 40 mg/vial, Powder for solution for infusion

(referred to as DigiFab^® hereafter in this leaflet).

digoxin immune Fab

DigiFab^® belongs to a group of medicines known as digitalis antitoxins. It is a preparation of protein fragments derived from antibodies produced in sheep. DigiFab^® binds and neutralises digoxin and other digoxin-like substances.

DigiFab^® solution is used to treat an overdose of digoxin and other digoxin-like substances, when stopping taking digoxin and other measures are not sufficient.

DigiFab^® solution is also used to treat poisoning resulting from other digoxin-like substances, called cardiac glycosides, that can be found in certain plants.

You should not be given DigiFab^® if you are allergic to DigiFab^® or to any of the other ingredients of DigiFab^® (for other ingredients see section 6 Other information).

Warnings and precautions. Before you are given DigiFab^® you should tell your doctor if:

• You are allergic to papaya extracts, to pineapple or to sheep proteins (sheep protein may be found in cheeses and some meats) are allergic to alpha-gal or have been diagnosed with alpha-gal syndrome.
• You are taking digoxin for heart problems. DigiFab^® neutralises digoxin and may cause a worsening of your heart condition).
• You have been treated previously with DigiFab^®. Repeat use of DigiFab^® may be associated with a severe allergic reaction.

If any of the above apply to you then talk to your doctor who will decide what to do.

Your doctor or nurse will usually give you DigiFab^® by infusion into a vein. The powder in each vial will be dissolved in sterile water and may be further diluted with sterile saline solution.

If you have further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, DigiFab^® can cause side effects, although not everybody gets them.

The following side effects are important and will require immediate action if you experience them. Tell your doctor or nurse immediately if you experience any of the following symptoms (you may need to stop DigiFab^®):

• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• allergic skin reactions such as rash, itchy skin, hives
• fever

The frequencies at which the above reactions occur are not stated.

The following side effects have also been reported:

Common, affecting up to 1 in 10 people:

• Allergic reaction
• Worsening of heart failure causing retention of fluid
• Chest pain
• Low blood pressure
• Changes in blood test results for potassium (this may affect how the heart works or cause tiredness, weakness or pins and needles)
• Severe kidney disease
• Light-headedness on standing
• Inflammation of vein at site of infusion
• Flu-like symptoms
• Headache, feeling confused, feeling tired
• Nausea, vomiting, diarrhoea or constipation, abdominal distension

Symptoms may occur up to 14 days after the infusion.

You will be given DigiFab^® in a hospital. The hospital will store the medicine correctly between 2 and 8°C. Not to be stored in a freezer.

After DigiFab^® has been made up, it should be used immediately.

DigiFab^® must not be used after the expiry date on the vial and outer carton. The hospital pharmacist will check this before he/she dispenses DigiFab^®.

All medicines should be kept out of the reach and sight of children.