PATIENT INFORMATION LEAFLET

Vancomycin

Powder for solution for infusion 500 mg and 1 g

Vancomycin hydrochloride

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 or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1 .WhatVancomycin is and what it is used for

2.    Before you use Vancomycin

3.    How to use Vancomycin

4.    Possible side effects

5.    How to store Vancomycin

6.    Further information

1.    WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR

How does the medicine work?

Vancomycin is an antibiotic. Antibiotics help your body fight infections. Vancomycin works by destroying certain bacteria that cause infections.

What is the medicine used for?

Vancomycin is used for the treatment of serious infections caused by certain bacteria.

2.    BEFORE YOU USE VANCOMYCIN Do not use the medicine if:

•    You have had an allergic reaction such as a rash, itching, swelling or breathing difficulties after receiving this medicine or other antibiotics.

Talk to your doctor before you are given this medicine if:

•    You have kidney problems

•    You are hard of hearing.

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

Pregnancy and breast-feeding

•    You should tell your doctor ifyou are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should be given Vancomycin.

Ask your doctor or pharmacist for advice before taking any medicine.

3.    HOWTO USE VANCOMYCIN

The medicine is given into a vein, usually in your arm, slowly over several hours. The doctor will decide at which rate you will be given the medicine. The amount of medicine in your blood will usually be measured at regular intervals.

Do not tamper with the bag/bottle. Follow the doctor's instructions.

If you have any questions, ask your doctor.

4.    POSSIBLE SIDE EFFECTS

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

All medicines can cause allergic reactions, although serious allergic reactions (anaphylactic shock) are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, redness on the upper part of the body, rash or itching.

Very common side effects (may occur in more than

1    in 10 patients):

Fall in blood pressure, pain and muscle spasms in the chest and back. Pain, redness and swelling at the site where the needle is inserted in the vein.

Common side effects (may occur in less than 1 in 10 patients):

Difficulty in hearing.

Rare side effects (may occur in less than 1 in 1000 patients):

Anaphylactic shock.

Fever, chills, dizziness.

Reduction of white blood cells which may increase the risk of infection, reduction in platelets which may increase bleeding tendency.

Skin flaking.

Ringing in your ears.

If any of the side effects are troublesome or you experience side effects that are not mentioned above, tell your doctor. He/she will have more information on the medicine and will know what to do.

5.    HOWTO STORE VANCOMYCIN

Your doctor will be responsible for storing the medicine.

For healthcare professionals only, please see the next section.

This medicine will be kept out of the reach and sight of children.

6.    FURTHER INFORMATION

What Vancomycin contains:

The active ingredient is vancomycin hydrochloride.

Vancomycin is available as a powder for solution for infusion, in

2    strengths; 500 mg and 1 g.

The medicine is a powder that has to be dissolved before you receive it.

Marketing Authorisation Holder and Manufacturer:

Xellia Pharmaceuticals ApS Dalslandsgade 11 2300 Copenhagen S Denmark

This leaflet was last approved in August 2010

K1814-A

The following information is intended for medical or healthcare professionals only.

Preparation

500 mg:

Dissolve the content of the vial with 10 ml sterile water. Dilute the reconstituted solution with at least 100 ml sterile sodium chloride 0.9% w/v or glucose 5% w/v.

1    g:

Dissolve the content of the vial with 20 ml sterile water. Dilute the reconstituted solution with at least 200 ml sterile sodium chloride 0.9% w/v or glucose 5% w/v.

The concentration of vancomycin in the prepared infusion fluid must not exceed 0.5% w/v (5 mg/ml).

The infusion should not be mixed with other drugs.

Infusion

Must be given by slow intravenous infusion over at least 60 minutes at a maximum rate of 10 mg/min, equal to

2    ml/min of an infusion with a concentration of 5 mg/ml.

Dosage

The dose is adjusted individually and according to kidney function. The usual dose is:

Adults:

500 mg every 6 hours or 1 g every 12 hours given by slow intravenous infusion.

Children:

20 mg/kg body weight every 12 hours given by slow intravenous infusion.

Storage

Vancomycin powder for infusion should be stored below 25°C.

The reconstituted solution should be stored in a refrigerator (2°C - 8°C) and used within 24 hours.

The prepared infusion fluid should be used within 12 hours.

Vancomycin powder for infusion should not be used after the expiry date which is stated on the carton.

Rev 05/2011

a.