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Vancomycin 500 Mg Powder For Concentrate For Solution For Infusion

Informations for option: Vancomycin 500 Mg Powder For Concentrate For Solution For Infusion, show 2 options
Document: leaflet MAH GENERIC_PL 00057-1168 change

Package leaflet: Information for the patient Vancomycin 500 mg

powder for concentrate for solution for infusion Vancomycin 1000 mg

powder for concentrate for solution for infusion

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

-    If you have any further questions, ask your doctor, hospital pharmacist or nurse.

-    If you get any of the side effects, talk to your doctor, hospital pharmacist or nurse. This includes any possible effects not listed in this leaflet. See section 4.

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.

What is in this leaflet

1.    What Vancomycin is and what it is used for

2.    What you need to know before you use Vancomycin

3.    How to use Vancomycin

4.    Possible side effects

5.    How to store Vancomycin

6.    Contents of the pack and other 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?

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

2. What you need to know before you use Vancomycin Do not use Vancomycin

• If you are allergic to vancomycin or any of the other ingredients of this leaflet (listed in section 6).

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

Warnings and precautions

Talk to your doctor or hospital pharmacist before taking 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 the age of 60

Other medicines and Vancomycin

Tell your doctor or hospital pharmacist if you are taking or have recently taken or might take any other medicines.

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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or hospital pharmacist for advice before taking this medicine. Vancomycin should be given during pregnancy and breast-feeding only if clearly needed. The doctor may decide that you should stop breast-feeding.

Driving and using machines

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

3. How to 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 doctors instructions.

If you receive more Vancomycin than you should

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 medicine, ask your doctor or the other health care professionals.

4. Possible side effects

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

Vancomycin 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.

Common side effects (may affect up to 1 in 10 people):

-    Fall in blood pressure

-    Breathlessness, noisy breathing (a high pitched sound resulting from turbulent air flow in the upper airway)

-    Pain, redness and swelling at the site where the needle is inserted in the vein

-    Rash and inflammation of the lining of the mouth, itching, itching rash, hives

-    Kidney problems which may be detected primarily by blood tests

-    Redness of upper body and face, inflammation of a vein

Uncommon side effects (may affect up to 1 in 100 people):

Temporary or permanent loss of hearing

Rare side effects (may affect up to 1 in 1,000 people):

-    Anaphylactic reactions, allergic reactions

-    Increase or decrease in some of the white cells in the blood, decrease in platelets (blood cells responsible for blood clotting)

-    Ringing in your ears, dizziness

-    Blood vessel inflammation

-    Nausea (feeling sick)

-    Inflammation of the kidneys and kidney failure

-    Pain in the chest and back muscles

-    Fever, chills

Very rare side effects (may affect up to 1 in 10,000 people):

-    Sudden onset of severe allergic skin reaction with skin flaking blistering or peeling skin. This may be associated with a high fever and joints paints

-    Difficulty in hearing

-    Cardiac arrest

-    Inflammation of the bowel which causes abdominal pain and diarrhea, which may contain blood

If any of the side effects get serious, or if you experience side effects not listed in this leaflet, please tell your doctor or other health care professionals.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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

Your doctor will be responsible for storing the medicine.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and vial as EXP. The expiry date refers to the last day of that month.

Powder as packaged for sale:

Store below 25°C.

Keep the vial in the outer carton in order to protect from light..

The stability of the reconstituted concentrate and further diluted product is stated below in the additional information for medical or healthcare professionals.

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

6.    Contents of the pack and other information

What Vancomycin contains

The active substance is vancomycin.

Vancomycin 500 mg powder for concentrate for solution for infusion:

Each vial contains 500 mg vancomycin (as vancomycin hydrochloride) equivalent to 500,000 IU. Vancomycin 1000 mg powder for concentrate for solution for infusion:

Each vial contains 1000 mg vancomycin (as vancomycin hydrochloride) equivalent to 1,000,000 IU.

What Vancomycin looks like and contents of the pack

Vancomycin 500 mg powder for concentrate for solution for infusion:

- A white to cream coloured powder in a clear glass vial with a grey flip-off cap Pack size: 1 & 10 vials, and multipacks comprising 10 cartons, each containing 10 vials.

Not all pack sizes may be marketed.

Vancomycin 1000 mg powder for concentrate for solution for infusion:

- A white to cream coloured powder in a clear glass vial with a green flip-off cap Pack size: 1 & 10 vials, and multipacks comprising 10 cartons, each containing 10 vials Not all pack sizes may be marketed.

The medicine is a powder that has to be dissolved before you receive it. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom.

Manufacturer

Xellia Pharmaceuticals ApS .

Dalslandsgade 11.

2300 Copenhagen S.

Denmark.

This leaflet was last revised in 11/2015.

Ref: gxVN 2_0 UK

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 10mg/ml may be used; use of such higher concentrations may increase the 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:    10 mg/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.

Ref: gxVN 2_0 UK