Digoxin-specific Fab fragments
Consumer Medicine Information
What is in this leaflet?
Please read this leaflet carefully and keep it while being treated. Do not throw it away. You may want to read it again.
This leaflet answers some common questions about Digibind Injection. It does not contain all of the available information.
It does not take the place of talking to your doctor.
If you have any more questions about your medicine, ask your doctor.
All medicines have risks and benefits. Your doctor has weighed the expected benefits of you being given Digibind Injection against the risks this medicine could have for you.
If you have any concerns about being given this medicine, ask your doctor.
What is Digibind Injection used for?
Digibind Injection is an antidote used to treat life-threatening digoxin or digitoxin overdose.
Digibind Injection belongs to a group of medicines called the antigen binding fragments.
Digibind is a sterile freeze-dried powder of antigen binding fragments (Fab) obtained from antidigoxin antibodies raised in sheep.
The Fab fragments react with digoxin or digitoxin in the blood to prevent death from digoxin/digitoxin overdose.
Your doctor may have prescribed Digibind Injection for another reason.
Digibind Injection is not addictive.
Before you are given Digibind Injection
Digibind Injection should not be used if:
- the expiry date (EXP) printed on the pack has passed.
- the packaging is torn or shows signs of tampering
Tell your doctor if:
Where possible, tell your doctor if:
- you have ever had an allergic reaction to digoxin-specific Fab fragments or any of the ingredients listed toward the end of this leaflet.
- you are allergic to foods, dyes, preservatives or any other medicines.
- you have received Digibind Injection previously.
- you have ever had an allergic reaction to papain, chymopapain or other papaya extracts.
- you have previously received antibodies or Fab fragments obtained from sheep.
- you have kidney disease.
- you are taking any other medicines, including medicines you buy without a prescription.
- you are breastfeeding, pregnant or trying to become pregnant.
How Digibind Injection is given
Digibind Injection will be given under the supervision of a doctor.
Digibind is given into your vein after being made up with sterile water for injections.
Your doctor will decide what dose you will receive.
The dose varies depending on the amount of digoxin in your blood that needs to be neutralised and your body weight. The Product Information leaflet provided in the carton explains this information to your doctor.
What do I do if I receive too much? (Overdose)
As Digibind Injection is given to you under the supervision of your doctor, it is unlikely that you will receive too much. However, if you experience any side effects after being given Digibind Injection, tell your doctor immediately.
While you are being given Digibind Injection
Things to be careful of
Digibind Injection can lower the potassium levels in your blood. For this reason, the potassium levels in your blood should be closely monitored, particularly during the first few hours after Digibind Injection has been given.
What are the side effects?
Check with your doctor as soon as possible if you think you are experiencing any side effects or an allergic reaction after receiving Digibind Injection, even if the problem is not listed below.
Like other medicines, Digibind Injection can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
The most commonly reported side-effect is low potassium concentration.
In some cases, poor heart function may be worsened because the effects of digoxin has been neutralised.
Rarely, allergic reactions (eg. swelling at injection site, swelling of the face, rash) have occurred.
Tell your doctor immediately if you notice any of the following:
- Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could also be symptoms of an allergic reaction.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
How do I store Digibind Injection?
Keep this medicine where children cannot reach it, such as in a locked cupboard.
Digibind Injection should be stored in a fridge at 2 °C to 8 °C. Do not freeze. Protect from light.
Do not leave in a car, on window sill or in bathroom.
Keep Digibind Injection in its carton until time of use.
Return any unused or expired medicine to your pharmacist.
What does Digibind Injection look like
Your Digibind Injection is a powder for injection supplied in a vial within a carton. Each carton contains one vial.
Each vial is made up with sterile water for injections before use.
Each vial contains 38 mg of digoxin-specific Fab fragments plus 75 mg of sorbitol and 28 mg of sodium chloride. It contains no preservatives.
Your Digibind Injection is supplied by:
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia Victoria 3155
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
This leaflet was prepared on 21 January 2003.
The information provided applies only to: Digibind® Injection.
®Digibind is a registered trade mark of the GlaxoSmithKline group of companies.
Digibind Injection: AUST R 10963.
© 2003 GlaxoSmithKline
Published by MIMS August 2003