iMedi.co.uk

Vancomycin 500mg Powder For Solution For Infusion

Informations for option: Vancomycin 500mg Powder For Solution For Infusion, show other option
Document: leaflet MAH GENERIC_PL 25174-0013 change

&





PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER Vancomycin 500 mg Powder for Solution for Infusion Vancomycin 1 g

Powder 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 further questions, please ask your doctor or your 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.    WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR

2.    BEFORE YOU TAKE VANCOMYCIN

3.    HOW TO TAKE VANCOMYCIN

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE VANCOMYCIN

6.    FURTHER INFORMATION

1.    WHAT IS VANCOMYCIN AND WHAT IS IT USED FOR?

Vancomycin belongs to a group of medicines called antibiotics. Antibiotics help your body fight infections. Vancomycin works by destroying certain bacteria that cause infection.

Vancomycin infusion is often used to treat infections caused by bacteria called ‘staphylococci’ which may be difficult to cure using more common antibiotics like penicillin. Some of the infections it is used to treat are:

•    Bone infections

•    Pneumonia

•    Septicaemia (blood poisoning)

•    Soft tissue infections

Vancomycin is sometimes used during operations or dental procedures to prevent infections.

Vancomycin can also be given as a solution to drink to kill bacteria which cause severe diarrhoea.

If your doctor gives you this medicine for anything else, ask him or her if you have any questions about it.

2.    BEFORE YOU USE VANCOMYCIN

Vancomycin is not suitable for everyone.

Do not take Vancomycin:

•    If you are allergic to Vancomycin or any other ingredient of this medicine or if you have ever had an allergic reaction to any other antibiotic. Symptoms of an allergic reaction are rash, itching, swelling or breathing difficulties.

(See section 6 of this leaflet for a full list of ingredients).

•    If you have difficulty hearing.

•    If you have ever had kidney trouble.

Take special care with Vancomycin:

•    If you are about to have a general anaesthetic

• If you are taking other antibiotics that can affect your kidneys e.g. amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin or cisplatin

If any of the above apply to you, please talk to your doctor or pharmacist for advice if you have not already done so.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines. In particular tell your doctor if you are taking any other antibiotics.

Taking Vancomycin with food and drink:

Vancomycin can be given as an infusion or taken as a solution before, with or after food.

If Vancomycin is being taken as a solution to drink, a common flavouring syrup may be added to the solution to improve the taste.

Pregnancy and breast - feeding:

You should tell your doctor if you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should receive Vancomycin. Mothers who wish to breast-feed should discuss this with their doctor who will then advise you on what to do.

Driving or using machines:

Vancomycin has no known affect on your ability to drive and operate machinery.

3. HOW TO TAKE VANCOMYCIN

The dose of medicine given to you will depend on your age, the infection you have, how well your kidneys are working, if you have poor hearing and any other medicines you may be taking.

Usual doses - as infusion

Adults: 500mg every 6 hours or 1000mg

every 12 hours.

Children: 10mg for every kilogram of their body weight every 6 hours.

The Vancomycin solution must slowly go through a tube and needle from a bag or pump and into one of your veins. This is called an ‘intravenous infusion’. This will usually take at least one hour each time you get a dose.

Usual doses - orally by mouth Adults: 500mg a day, divided into more than one dose, for 7 to 10 days.

Children: 40mg for every kilogram of their body weight each day. This will be divided into 3 or 4 doses and given for 7 to 10 days.






Adults and children should not have more than 2 grams of Vancomycin by mouth each day.

Your doctor will only inject Vancomycin into a vein and not into a muscle.

Your doctor or nurse may take samples of your blood. The hospital's laboratory will measure the amount of Vancomycin in your blood. Your doctor may decide to change your dose to get the right amount in your blood. They may count your blood cells.

Your doctor may also test your kidneys and ears, especially if you are elderly. If you have difficulty hearing, your doctor may not want to give you an injection of Vancomycin.

Your doctor or nurse will take great care that the Vancomycin solution does not leak out of your vein when they are injecting it. Please tell then immediately if you have pain or swelling during the injection or later.

Elderly patients: Your doctor may need to prescribe a lower dose to those listed above.

Patients with kidney or liver problems: Your doctor may prescribe a lower dose.

If you take more Vancomycin than you should:

It is most unlikely that you will be given too much medicine by the nurse or doctor. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.

If you forget to take Vancomycin.

Your doctor or nurse know when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor.

If you stop taking Vancomycin

It is important that the course of treatment your doctor has prescribed is taken. You may start to feel better but it is important not to stop taking this medicine, until the doctor advises, otherwise your condition may get worse again.

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

4. POSSIBLE SIDE EFFECTS

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

Vancomycin is well tolerated by most patients and side effects are usually mild and go away.

Tell your doctor and stop taking Vancomycin

immediately if you experience any of the

following rare effects:

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

Other side effects include:

•    Kidney troubles, but this is rare.

•    Hearing difficulty - sometimes with

•    dizziness and ringing in the ears.

•    Low blood cell count - these may cause

•    symptoms such as chills and, occasionally, bruising.

•    Feeling sick

•    You are less likely to have side effects if you are given Vancomycin as a solution to drink because it usually passes through your stomach and intestines without getting into the rest of your body.

• If the Vancomycin solution is too strong or if it is injected too quickly it can cause your blood pressure to drop, difficulty breathing, rashes and itchiness, flushed skin and muscle pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE VANCOMYCIN

Keep out of the reach and sight of children.

The hospital will store the vials of Vancomycin at not above 25°C. The hospital should not use Vancomycin after the ‘Use Before' date shown on the carton and vial label. This product is for single use only and any out of date or unused vancomcyin should be returned to your doctor or pharmacist for disposal.

When Vancomycin powder has been dissolved in sterile diluting solution the hospital may store the solution in the refrigerator (2-8°C) for up to 24 hours.

Solutions of the parenteral powder intended for oral administration may be stored in a refrigerator (2°-8°C) for 24 hours.

Keep medicine out of reach and sight of children.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Vancomycin contains

The active ingredient is: Vancomycin Hydrochloride

A hospital pharmacist, nurse or doctor will have dissolved the Vancomycin injection powder, usually in either sterile sodium chloride solution or sterile dextrose solution.

What Vancomycin look likes and contents of the pack

Vancomycin Hydrochloride powder which looks like a whitish, porous cake.

A glass vial supplied to the hospital containing either 500 milligrams (mg) or 1000 milligrams. Each vial contains vancomycin 500 mg (equivalent to 500 000IU) or 1 g (equivalent to 1 000 000IU) as vancomycin hydrochloride.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Laboratorio Reig Jofre, Gran Capitan, 10 08970 Sant Joan Despi, Barcelona, Spain

Manufacturer:

Laboratorio Reig Jofre, Gran Capitan, 10 08970 Sant Joan Despi, Barcelona, Spain

Leaflet revision date: May 2015

B1YYYY-01


4