Document: Corvert solution for infusion ENG PL change

• Corvert solution for infusion PL
• Corvert solution for infusion ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Corvert 87 microgram/ml solution for infusion

(ibutilide)

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor/nurse or pharmacist.

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Corvert is and what it is used for

2. Before you take Corvert

3. How to take Corvert

4. Possible side effects

6. Further information

Corvert belongs to a group of medicines called antiarrhythmics that are used for the treatment of heart rhythm problems. These products prevent the heart from beating irregularly.

Corvert is used to restore specific heart rhythm disorders to normal heart beat .

Your doctor will ask you questions before giving you your medicine to make sure that it is suitable for you. If you do not understand any of the questions, ask your doctor to explain.

Do not use Corvert

• If you are allergic (hypersensitive) to ibutilide fumarate, or any of the other ingredients of Corvert.

• If you have certain types of heart rhythm problems such as

  • Increased heart rhythm (for example torsade de pointe)

  • Sick sinus syndrome

  • AV block

  • Prolonged QT interval

  • If you have suffered a heart attack within one month

  • If you have symptoms of heart failure

  • If you do not have enough potassium or magnesium in your blood

• If you are taking other medication against heart rhythm problems,

• If you have liver problems

Take special care with Corvert

Please tell your doctor or pharmacist if you suffer or have suffered from the following:

• Dysfunction of the left side of your heart whereby the amount of blood ejected by the heart is reduced (low left ventricular ejection fraction)

• Heart failure

Your doctor will monitor your cardiac rhythm during treatment and for at least 4 hours after treatment. If you previously have had particular types of heart rhythm disorders called ventricular arrhythmias you should be under observation for at least 24 hours following treatment with Covert.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

It is especially important to tell your doctor if you are taking any of the following:

• Certain other drugs that control heart rhythm. These must not be given together with Corvert or within 4 hours of treatment with Corvert.

• Certain drugs that act on the nervous system (thioridazine, chlorpromazine, levomepromazine, sulpride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol, drugs used for depression)

• certain antibiotics (erythromycin, pentamidine, fluoroquinolones)

• certain drugs that treat allergies (terfenadine, astemizole, mizolastine)

• certain drugs used for heart disorders (digoxin, bepridil)

• cisapride (used for stomach disorders)

• halofantrine (used to treat malaria)

Pregnancy and breast-feeding

Corvert should only be used in pregnant women if clearly necessary. Talk to your doctor if you are pregnant.

Breast-feeding is not recommended during treatment with Corvert. Talk to your doctor if you are breast-feeding.

Driving and using machines

The effects on the ability to drive and use machines have not been studied. This medicinal product will be given to you at a hospital, so it is not likely that you will drive or use machines right after treatment.

Corvert will be administered via infusion by trained staff. Your doctor will determine how much Covert you need to take. If you weigh 60 kg or more, the usual dose is 1 mg ibutilide fumarate (1 vial), and the administration takes at least 10 minutes. If you weigh less than 60 kg, the dose may need to be adjusted.

If the heart rhythm problem does not terminate within 10 minutes after the end of the initial infusion, a second dose may be administered.

Corvert is not recommended for use in children below 18.

If you have recently had heart surgery, your doctor may decide to give you a lower dose.

If you use more Corvert than you should

If you are given a higher dose that you should be getting, the clinician will provide you with the supportive therapy you need.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Corvert can cause side effects, although not everybody gets them.

Rhythm disorders are the most common and serious side-effects.

Patients with a history of heart failure or with a dysfunction of the left ventricle of the heart whereby the amount of blood ejected by the heart is reduced (low left ventricular ejection fraction), have a higher risk of developing serious rhythm disorders.

Common (occurs in more than 1 in 100 but less than 1 in 10 users) Different types of rhythm disorders with increased or decreased heart beat, low blood pressure, changes in your ECG.

Uncommon (occurs in more than 1 in 1000 but less than 1 in 100 users) Painful tightening of the chest (angina pectoris), ventricular fibrillation, atrial fibrillation, vasodilatation, high blood pressure, acute kidney failure.

5. HOW TO STORE CORVERT

Keep out of the reach and sight of children.

Do not use Corvert after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Unopened package:Do not store above 25^oC. Do not refrigerate or freeze. Store in the original package.

Opened package:Corvert as a single dose vial should be used only once and the admixture solution is chemically and physically stable for 24 hours at 25^oC. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 ^oC to 8 ^oC, unless dilution has taken place in controlled and validated aseptic conditions

6. FURTHER INFORMATION

What Corvert contains

• The active substance is Ibutulide 87 microgram/ml as ibutilide fumarate 100 microgram/ml.

• The other ingredients are: sodium acetate (granular trihydrate) 0.189 mg, sodium chloride 8.9 mg, sodium hydroxide solution 10%, hydrochloric acid solution 10% and water for injections.

What Corvert looks like and contents of the pack

Type I glass vial with rubber plug and aluminum cap, 10 ml pack size.

Marketing Authorisation Holder and Manufacturer

Tobe completed nationally

Manufacturer:

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs

Belgium

This leaflet was last approved on

9 June 2011

The following information is intended for medical or healthcare professionals only

Corvert may be given in the concentrated form or diluted. One vial of 10 ml may be diluted with 50 ml solution for infusion.

For post cardiac surgery patients, 5 ml may be diluted with 50 ml solution for infusion.

The following diluents are compatible with Corvert:

Glucose 50 mg/ml (5%) solution for infusion

Sodium Chloride 9 mg/ml (0,9%) solution for infusion

Admixtures of the solution are compatible with polyvinyl chloride bags (PVC) and polyolefin bags.

Allow the solution to obtain room temperature before infusion.

Any unused product or waste material should be disposed of in accordance with local requirements.