PATIENT INFORMATION LEAFLET 333333-A

Vancomycin 500 mg

Powder for concentrate for solution for infusion Vancomycin 1000 mg

Powder for concentrate for solution for infusion

Vancomycin

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 nas 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.

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

•    dosage

•    schedules

•    duration of treatment

Consequently, to preserve the efficacy of this drug:

1    - Use antibiotics only when prescribed.

2    - Strictly follow the prescription.

3    - Do not re-use an antibiotic without medical prescription, even if you want to

treat a similar illness.

4    - Never give your antibiotic to another person; maybe it is not adapted to

her/his illness.

5    - After completion of treatment, return all unused drugs to your chemist's shop

to ensure they will be disposed of correctly.

In this leaflet:

1.    What Vancomycin 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 contains the active ingredient vancomycin, as vancomycin hydrochloride, which is an antibiotic. Antibiotics help your body fight infections. Vancomycin works by eliminating certain bacteria that cause infections.

What is the medicine used for?

Vancornycin is used for the treatment of serious infections caused by certain bacteria, such as infections of the bones, lung tissue infection^ skin and muscle (soft tissue) infection, infection in the heart

2.    BEFORE YOU USE VANCOMYCIN Do not use Vancomycin

•    If you are allergic (hypersensitive) to vancomycin

•    If you have had an allergic reaction such as a rash, itching, swelling or breathing difficulties after receiving this medicine

Take special care with Vancomycin

•    If you have kidney problems

•    If you are hard of hearing

•    If you are pregnant or planning to become pregnant

•    If you are breast-feeding

•    If you are elderly, over tne age of 60

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

The following medicine may interact with Vancomycin:

•    Anaesthetic agents

•    Medicine for muscle relaxation

•    Medicines for infections caused by bacteria (e.g polymixin B, colistin, bacitracin, aminoglycosides)

•    Medicine for fungal infection (amphotericin B)

•    Medicine for tuberculosis (viomycin)

•    Medicine for cancer (cisplatin)

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Vancomycin should be given during pregnancy and breast-feeding only if clearly needed.

The doctor may decide that you should stop breast-feeding.

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

Driving and using machines

Vancomycin has no or very little effect on your ability to drive and use machines.

3.    HOWTO USE VANCOMYCIN

This medicine will always be administered by a healthcare professional.

Your doctor will decide at which rate and how long you will be given the medicine.

The amount of medicine in your blood will usually be measured at regular intervals. Your doctor may also do blood tests to check your kidneys and tests checking your ears, especially if you are elderly.

• The medicine is given into a vein, usually in your arm, slowly over at least one hour

Dosage in adults and children above 12 years by infusion:

The usual dosage is 2000 mg daily in two or four doses or will be calculated depending on the body weight.

Dosage in children under 12 years and newborn infants by infusion:

The dosages will be calculated depending on their body weight.

Dosage in patients with impaired kidney function and the elderly by infusion:

The dosage may be reduced depending on how well the kidneys function.

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

If you receive too much Vancomycin

Your doctor monitors the amount of Vancomycin you receive. If blood tests and other tests show that you have too much in your body, the amount of Vancomycin will be reduced or treatment may be interrupted or stopped. The level remaining in your blood will be lowered.

If you have any further questions on the use of this product, ask your doctor or the other health care professionals.

4.    POSSIBLE SIDE EFFECTS

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

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 for injection. Dilute the reconstituted solution with at least 100 ml Sodium Chloride 9 mg/ml (0.9%) Injection, Glucose 50 mg/ml (5%) Injection, Sodium Chloride 9 mg/ml (0.9 %) and Glucose 50 mg/ml (5%) Injection or Ringer acetate Injection.

1000 mg:

Dissolve the content of the vial with 20 ml sterile water for injection. Dilute the reconstituted solution with at least 200 ml Sodium Chloride 9 mg/ml (0.9%) Injection, Glucose 50 mg/ml (5%) Injection, Sodium Chloride

9    mg/ml (0.9 %) and Glucose

50 mg/ml (5%) Injection or Ringer acetate Injection.

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

In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used; use of such higher concentrations may increase tne risk of infusion-related events.

Before administration, the reconstituted and diluted solutions should be inspected visually for particulate matter and discoloration. Only clear, and colourless solution free from particles should be used.

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

Intravenous use:

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 or 30 to 40 mg/ kg/day in 2 to 4 daily administrations.

Children: lOmg/kg body weight every 6 hours given by slow intravenous infusion.

Storage

Vancomycin powder for concentrate for solution for infusion should be stored below 25°C. Keep the vial in the outer carton in order to protect from light.

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

Reconstituted concentrate:

The reconstituted concentrate should be further diluted immediately after reconstitution.

Diluted product:

From a microbiological and physicochemical point of view, the product should be used immediately.

Rev. 11/2013

7 Pia: 333333-A Vancomycin 13-11-14, Font: Frutiger 57 Condensed 7,5pt, Format: 150 x 320 mm, Black Profile