VANCOMYCIN 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Patient leaflet - VANCOMYCIN 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Vancomycin 500 mg powder for concentrate for solution for infusion

Vancomycin

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.

The following shaded information whose content has been agreed upon by the CHMP (for recent antibiotics SPC’s harmonisation procedure) could be added at the discretion of each Member States’ decision:

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

Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections.

Vancomycin powder is made into a solution for infusion.

Vancomycin is used in in all age groups by infusion for the treatment of the following serious infections:

– Infections of the skin and tissues below the skin.
– Infections of bone and joints.
– An infection of the lungs called „pneumonia“.
– Infection of the inside lining of the heart (endocarditis) and to prevent endocarditis in patients at

risk when undergoing major surgical procedures.

2. what you need to know before you use vancomycindo not use vancomycinif you are allergic to vancomycin or any of the other ingredients of this leaflet (listed in section 6).

Warnings and precautions

Serious side effects that may lead to loss of vision have been reported following the injection of vancomycin in the eyes. Vancomycin is not authorised for use in the eyes.

Talk to your doctor or hospital pharmacist before taking Vancomycin if:

– You suffered a previous allergic reaction to teicoplanin because this could mean you are also allergic to vancomycin.
– You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking vancomycin.
– You have a hearing disorder, especially if you are elderly (you may need hearing tests during treatment).
– You have kidney disorder (you will need to have your blood and kidneys tested during treatment).
– You are receiving vancomycin by infusion for the treatment of the diarrhoea associated to Clostridium difficile infection instead of orally.

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Stop using vancomycin and seek medical attention immediately if you notice any of the symptoms described in section 4.

Talk to your doctor or hospital pharmacist or nurse during treatment with Vancomycin if:

– You are receiving vancomycin for a long time (you may need to have your blood, hepatic and kidneys tested during treatment).
– You develop any skin reaction during the treatment.
– You develop severe or prolonged diarrhoea during or after using vancomycin, consult your doctor immediately. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

Children

Vancomycin will be used with particular care in premature infants and young infants, because their kidneys are not fully developed and they may accumulare vancomycin in the blood. This age group may need blood tests for controlling vancomycin levels in blood.

Concomitant administration of vancomycin and anaesthetic agents has been associated with skin redness (erythema) and allergic reactions in children. Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, nonsteroidal anti-inflammatory agents (NSAIDs, e.g. ibuprofen) or amphotericin B (medicine for fungal infection) can increase the risk of kidney damage and therefore more frequent blood and renal test may be necessary.

Other medicines and Vancomycin

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

Special care is needed if you are taking/using other medicines as some could interact with vancomycin.

The following medicine may interact with Vancomycin:

Anaesthetic agents
Medicine for muscle relaxation
Other antibiotics that can affect your kidneys (e.g. streptomycin, neomycin, gentamicin, kanamycin, amikacin, tobramycin, polymixin B, piperacillin/tazobactam, colistin and bacitracin)
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

You will be given Vancomycin by medical staff while you are in hospital. Your doctor will decide how much of this medicine you should receive each day and how long the treatment will last.

Dosage

The dose given to you will depend on:

– your age,
– your weight,
– the infection you have,
– how well your kidneys are working,
– your hearing ability,
– any other medicines you may be taking.

Intravenous administration

Adults and adolescents (from 12 years and older)

The dosage will be calculated according to your body weight. The usual infusion dose is 15 to 20 mg for each kg of body weight. It is usually given every 8 to 12 hours. In some cases, your doctor may decide to give an initial dose of up to 30 mg for each kg of body weight. The maximum daily dose should not exceed 2 g.

Use in children

Children aged from one month to less than 12 years of age

The dosage will be calculated according to your body weight. The usual infusion dose is 10 to 15 mg for each kg of body weight. It is usually given every 6 hours.

Preterm and term newborn infants (from 0 to 27 days)

The dosage will be calculated according to post-menstrual age (time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age).

The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose.

Method of administration

Intravenous infusion means that the medicinal product flows from an infusion bottle or bag through a tube to one of your blood vessels and into your body. Your doctor, or nurse, will always give vancomycin into your blood and not in the muscle.

Vancomycin will be given into your vein for at least 60 minutes.

Duration of treatment

The length of treatment depends on the infection you have and may last a number of weeks.

The duration of the therapy may be different depending on the individual response to treatment for every patient.

During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.

4. possible side effects

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

Stop using vancomycin and seek medical attention immediately if you notice any of the following symptoms:

– Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
– Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
– A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis).

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)
– 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):

– Decrease in white blood cells, red blood cells and platelets (blood cells responsible for blood

clotting)

– Increase in some of the white cells in the blood
– Loss of balance, 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 joint pains
– Cardiac arrest
– Inflammation of the bowel which causes abdominal pain and diarrhoea, which may contain blood

Not known (frequency cannot be estimated from the available data):

– Being sick (throwing up), diarrhoea
– Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine
– Rash with swelling or pain behind the ears, in the neck, groin, under the chin and armpits (swollen lymph nodes), abnormal blood and liver function tests
– Rash with blisters and fever

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 the national reporting system listed in Appendix V. 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 informationwhat vancomycin containsthe active substance is vancomycin.

Vancomycin 500 mg powder for concentrate for solution for infusion:

Each vial contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin.

Vancomycin 1000 mg powder for concentrate for solution for infusion:

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

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.