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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin 500 mg, Powder for solution for infusion Vancomycin 1000 mg, Powder for solution for infusion

Vancomycin

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

This medicine contains the active substance vancomycin, which is an antibiotic. Vancomycin is used to treat severe bacterial infections caused by bacteria resistant to other antibiotics and for patients who are allergic to beta-lactam antibiotics, e.g. penicillin:

-    inflammation of the inner heart membrane

-    infections of the bones and joints

-    inflammation of the lung

-    blood poisoning

-    soft tissue infection

Vancomycin can also be used before surgery to prevent possible infections.

2.    BEFORE YOU USE VANCOMYCIN

Do not use Vancomycin

-    If you are allergic (hypersensitive) to vancomycin.

Take special care with Vancomycin

You should inform your doctor, if you:

-    suffer or have suffered from an acute failure of the kidney as well as in case of impaired kidney function.

-    suffer from impaired hearing function or have previously experienced hearing loss.

-    are also taking medicinal products which can harm the ears (e.g. aminoglycoside antibiotics).

-    have previously had an allergic reaction to the medicinal substance teicoplanin, since then there is an increased risk of being allergic to Vancomycin as well.

-    suffer from severe persistent diarrhoea during or after treatment with Vancomycin. In this case contact your doctor immediately. Do not take any anti-diarrhoeic medicine without consulting your doctor.

Using other medicines

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

-    Medicines potentially harmful to kidney and hearing: If you simultaneously receive vancomycin and other medicinal products potentially harmful to kidney and hearing function (e. g. aminoglycoside antibiotics), this harmful effect can be increased. In such cases, a careful and regular control of the kidney and the hearing function is necessary.

-    Anaesthetics: The use of anaesthetics increases the risk of getting certain side effects of vancomycin like drop of blood pressure, skin erubescence, nettle rash and itching.

-    Muscle relaxants: If you simultaneously receive muscle relaxants (e.g. succinylcholine), their effect can be intensified or prolonged.

Pregnancy and lactation

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

Vancomycin crosses the placenta and there is a risk of toxicity for the ears and kidneys of the foetus. Therefore, if you are pregnant, your doctor should only give you vancomycin if clearly necessary and after careful consideration of benefits and risks.

Vancomycin passes into breast milk. Since the baby might be affected by this medicinal product, it should be used during breastfeeding only if other antibiotics have failed. You should discuss with your doctor the possibility of stopping breastfeeding.

Driving and using machines

Vancomycin has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE VANCOMYCIN

Administration:

Vancomycin is always administered by healthcare personnel. It will be given as an infusion (into a vein). Your doctor will inform you about the necessary duration and frequency of administration of Vancomycin.

Dosage:

•    Patients with normal kidney function , adults and children from 12 years

The usual dose is 500 mg every 6 hours or 1 g every 12 hours.

•    Children (under 12 years)

The usual daily dose is 40 mg/kg body weight, mostly in 4 single doses, that is 10 mg/kg body weight every 6 hours.

•    Sucklings and new-borns

For young sucklings and new-borns the doses can be lower.

0-7 days: Initial dose of 15 mg/kg body weight and maintenance doses of 10 mg/kg body weight every 12 hours.

7-30 days: Initial dose of 15 mg/kg body weight and maintenance doses of 10 mg/kg body weight every 8 hours.

• Premature babies and elderly patients

The dosage must be adjusted for premature babies because their kidneys are not fully functional yet.

In elderly people the dosage of vancomycin must be adapted because kidney function naturally decreases with age. This may require the monitoring of vancomycin levels in your blood.

Treatment duration

The treatment duration depends on severity of the infection as well as on the clinical and bacteriological progress.

If the administration of Vancomycin has been forgotten

A double dose must not be given to make up for a forgotten dose. A forgotten dose should only be given before the next regular dose if the time span between the administrations is still long enough.

If the treatment with Vancomycin is interrupted or untimely discontinued

Low dosage, irregular administration or premature therapy discontinuation can compromise the outcome of the therapy or lead to relapses, whose therapy is more difficult. Please follow the instructions of your doctor.

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

4. POSSIBLE SIDE EFFECTS

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

The most common side effects are pain, swelling and inflammation of veins at the infusion site and pseudoallergic reactions when intravenous infusion of Vancomycin is carried out too fast.

Common side effects, occurring in 1 to 10 out of 100 treated patients:

Drop of blood pressure, breathlessness (dyspnoea), wheezy breathing (stridor), acute rash (exanthema), mucous membrane inflammation, itching (pruritus), nettle rash (urticaria), impaired kidney function which is mainly recognisable by elevated creatinine or urea concentrations in your blood, inflammation of the veins (phlebitis), erubescence of the upper body („red neck“ or „red man syndrome“), pain and spasm of the chest or back muscles.

Uncommon side effects, occurring in 1 to 10 out of 1000 treated patients:

Transient or persistent impairment of the hearing function.

Rare side effects, occurring in 1 to 10 out of 10,000 treated patients:

Cardiac arrest, drop or elevation of the number of certain blood cells, ringing in the ears (tinnitus), feeling of dizziness or “spinning” (vertigo), feeling sick (nausea), skin disease with blebs (bullous dermatosis), inflammation of the kidneys (interstitial nephritis) and / or acute failure of the kidney, hypersensitivity (anaphylactoid) reactions with symptoms like drug fever and chills.

Very rare side effects, occurring in less than 1 out of 10,000 treated patients:

Severe skin reactions with life-threatening general symptoms (e. g. exfoliative dermatitis, Stevens-Johnson-syndrome or Lyell-syndrome), inflammation of blood vessels, often with skin rash (vasculitis), bacterial inflammation of the bowel (pseudomembranous colitis).

Side effects of unknown frequency and single reported cases:

Syndrome that may cause a rash, fever, inflammation of internal organs, and characteristic abnormalities of your blood (so called "DRESS"), sudden formation of pustules within large swollen areas (so called "AGEP"), acute kidney damage.

Severe anaphylactoid reactions are possible during or short time after fast intravenous infusion. The reactions disappear after the infusion was stopped.

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.

5. HOW TO STORE VANCOMYCIN

Keep out of the reach and sight of children.

Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.

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

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 substance is vancomycin. Each vial contains 500 mg or 1000 mg vancomycin (as vancomycin hydrochloride), respectively.

•    There are no other ingredients.

This leaflet was last revised in 03/2014

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

Mode of application and therapy duration

Parenterally vancomycin is to be administered as slow intravenous infusion (not more than 10 mg / min, as well single doses lower than 600 mg over at least 60 min) and in sufficient dilution (at least 100 ml per 500 mg or at least 200 ml per 1000 mg). Patients with limited fluid intake can also receive a solution of 500 mg / 50 ml or 1000 mg / 100 ml.

Preparation of the solution

Vancomycin 500 mg: The content of one vial is dissolved in 10 ml water for injections and further diluted with other solutions for infusion to 100-200 ml.

Vancomycin 1000 mg: The content of one vial is dissolved in 20 ml water for injections and further diluted with other solutions for infusion to 200-400 ml.

The vancomycin concentration should not exceed 2.5-5 mg/ml.

Compatibility with intravenous solutions

Vancomycin is compatible with water for injections, 5% glucose solution and physiological sodium chloride solution. Vancomycin solutions are basically administered separately, if the chemical and physical compatibility with another infusion solution is not proven.

Important incompatibilities

Vancomycin solutions have a low pH value, which can lead to chemical or physical instability after mixing with other substances. Every parenteral solution should therefore be checked visually for precipitation or changed colour prior to usage.

Combination therapy

In case of a combination therapy of vancomycin with other antibiotics / chemotherapeutics, the preparations should be administered separately.

Storage after reconstitution

Shelf-life of the prepared infusion solution

The chemical and physical stability of the prepared solution for infusion has been demonstrated for 96 hours at a temperature of 2-8°C. From a microbiological view, the prepared solution for infusion should be used immediately. If this advice is not followed, the user is responsible for storage conditions and storage duration. Storage may only exceed 24 hours if the preparation of the solution for infusion was drawn out under controlled and validated aseptic conditions.