PACKAGE LEAFLET: INFORMATION FOR THE USER    szoooooitooo

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

Vancomycin

Read all of this leaflet carefully before you start using 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 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 are given Vancomycin

3.    How you are given Vancomycin

4.    Possible side effects

5.    How to store Vancomycin

6.    Further information

ASANDOZ

What Vancomycin is and what it is used for

Vancomycin belongs to a group of glycopeptide antibiotics which eliminate bacteria that cause many kinds of infections, including pneumonia and skin, bone and heart valve infections.

It is used to treat:

•    serious infections caused by vancomycin-sensitive bacteria which are resistant (insensitive) to many other antibiotics,

•    patients allergic to penicillins and cephalosporins.

Vancomycin can also be given to you at the time of some surgical procedures to prevent bacterial endocarditis (an infection of the heart) if you are at high risk of developing this and can not receive other types of antibiotics.

Your medicine is in the form of a powder for solution. Before use, it will be dissolved and diluted with an intravenous fluid that will be given to you slowly by a drip into your vein by a doctor or nurse.

Before you are given Vancomycin

Do not have Vancomycin if you:

•    are allergic (hypersensitive) to vancomycin.

Tell your doctor if you have had any problems with this medicine or any other in the past.

Take special care with Vancomycin

Before treatment with vancomycin, make sure that your doctor knows about your medical history, especially if you:

•    have kidney problems

•    have ear problems such as deafness

•    have low blood count

•    are pregnant, or planning to become pregnant

•    are breast-feeding

•    are elderly and over 60 years of age

•    are a premature infant or a child

•    are going to have surgery

In case you develop severe allergic reaction, your doctor will stop treatment with vancomycin and give you other appropriate treatment.

If you will be given the infusion too fast, you can get some side effects such as low blood pressure or a rash. Stopping the infusion usually results in a prompt cessation of these reactions.

Vancomycin must be used with caution in patients with kidney failure or in those who receive concomitant treatment with other substances toxic to kidney as the possibility of developing toxic effects is much higher. Serial tests of kidney function should be performed and the appropriate dose regimens adhered to in order to reduce this risk.

Deafness, transitory or permanent, which may be preceded by noises in the ears, can occur in

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patients with prior deafness, who have received excessive doses, or who receive concomitant treatment with another substance toxic to hearing. To reduce this risk, blood levels should be determined periodically and periodic testing of hearing function is recommended.

If you will receive vancomycin over a longer-term period, your blood will be tested at regular intervals. You should also be monitored because of possible superinfection (new infection occurring over the existing one) or severe, sometimes bloody diarrhoea (condition called pseudomembranous colitis).

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal remedies or vitamins and minerals, because some of them could have an interaction with vancomycin. Furthermore, do not take any new medicine without consulting your doctor.

The following can react with vancomycin if you take them at the same time, such as medicines for the treatment of:

•    infections caused by bacteria (streptomycin, neomycin, gentamicin, kanamycin, amikacin, bacitracin, tobramycin, polimyxin B, colistin),

•    tuberculosis (viomycin),

•    fungal infections (amphotericin B),

•    cancer (cisplatin), and:

•    medicines for muscle relaxation during anaesthesia,

•    anaesthetic agents (if you are going to have

general anaesthesia).

Your doctor may need to monitor your blood and adjust the dosage if vancomycin is given at the same time with other medicines.

Pregnancy and breast-feeding

Pregnancy

If you are, or think you may be, pregnant, tell your doctor. Vancomycin should be given during pregnancy only if clearly needed.

Breast-feeding

Tell your doctor if you are breast-feeding as Vancomycin passes into breast milk. Your doctor will decide, if vancomycin is clearly needed or if you must 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 operate machines.

How you are given Vancomycin

You will be given Vancomycin by medical staff while you are in hospital.

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

This is an extract from the Summary of Product Characteristics to assist in the administration of Vancomycin. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the medicinal product.

Dosage and method of administration

Vancomycin is administered via an intravenous infusion and not in the form of a bolus injection or intramuscularly.

Adults and adolescents above 12 years of age

The recommended daily intravenous dose is 2 g, divided into doses of 500 mg every 6 hours or 1000 mg every 12 hours.

Parenterally vancomycin shall only be administered as slow intravenous infusion (not more than 10 mg/min - over at least 60 min) which is sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1000 mg).

Patients requiring fluid restriction can receive a solution of 500 mg /50 ml or 1000 mg /100 ml. With these higher concentrations the risk for infusion related side effects can be increased.

For bacterial endocarditis, the generally accepted regimen is 1000 mg vancomycin intravenously every 12 hours for 4 weeks either alone or in combination with other antibiotics (gentamicin plus rifampin, gentamicin, streptomycin). Enterococcal endocarditis is treated for 6 weeks with vancomycin in combination with an aminoglycoside - according to national recommendations.

Peri-operative prophylaxis:

Adults receive 1000 mg vancomycin intravenously prior to surgery (prior to induction of anaesthesia) and depending on time and type of surgery, the dose of 1000 mg of vancomycin i.v. 12 hours postoperatively can be given.

Children one month to 12 years of age

The recommended intravenous dose is 10 mg/kg, every 6 hours or 20 mg/kg every 12 hours.

Infants and newborns

The recommended initial dose is 15 mg/kg, followed by 10 mg/kg every 12 hours during the first week of life and every 8 hours after that age and up to 1 month of age. Careful monitoring of serum concentration of vancomycin is recommended (see below).

Elderly patients:

Lower maintenance doses may be required due to the age-related reduction in renal function.

Obese patients:

Modification of the usual daily doses may be required.

Patients with hepatic insufficiency

There is no evidence that the dose has to be reduced in patients with hepatic insufficiency.

Patients with impaired renal function

The dose must be adjusted in patients with impaired renal function and the following nomogram can serve as guidance. Careful monitoring of serum concentration of vancomycin is recommended (see below).

Creatinine clearance (ml/s)

0,00    0,50    1,00    1,50    2,00

0    20    40    60    80    100    120

Creatinine clearance (ml/min)

Dosing nomogram for adults with impaired renal function

2000 _ 1800 E

1600 J

1400 S. 1200 | 1000 £ 800 > 600 ° 400    8

200 Z

In patients with mild or moderate renal failure, the starting dose must not be less than 15 mg/kg. In patients with severe renal failure, it is preferable to administer a maintenance dose between 250 mg and 1000 mg at a spacing of several days rather than administer lower daily doses.

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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,

•    the infection you have,

•    how well your kidneys are working,

•    your hearing ability

•    any other medicines you may be taking.

Adults and children above 12 years:

the usual dose is 2000 mg daily in two or four doses.

Children under 12 years:

will be given smaller doses, depending on their body weight.

Patients with impaired kidney function, the elderly and pre-term new-born infants:

the doctor will reduce the dose or extend the interval between two doses.

During 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.

How the treatment will be given 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, never in a muscle. Vancomycin will be diluted before being given to you, and will slowly flow 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.

If you are given more Vancomycin than you should

As this medicine will be given to you while you are in the hospital, it is unlikely that you will be given too much vancomycin. However, tell your doctor or nurse immediately if you have any concerns.

•    increase or decrease in some of the cells in the blood;

•    noises (e.g. hissing) in the ears;

•    feeling faint;

•    red or purple skin (possible signs of blood vessel inflammation);

•    nausea.

Very rare side effects (affect less than 1 user in 10,000):

Skin disorders resulting from an allergic reaction (multiple skin lesions, joint aches), cardiac arrest, or inflammation of the bowel which causes abdominal pain or bloody diarrhoea.

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor.

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How to store Vancomycin

Your doctor or nurse will ensure that Vancomycin is properly stored.

Keep out the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the vial label and the carton. Do not store above 25°C.

The stability of reconstituted solution is stated below in the additional information for health professionals.

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.

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Further information

What Vancomycin contains

- The active substance is vancomycin hydrochloride.

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.

Vancomycin 500 mg, powder for solution for infusion:

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

Vancomycin 1000 mg, powder for solution for infusion:

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

Stop taking the medicine immediately and

seek medical attention if signs of an allergic reaction occur:

•    hives; swelling of your face, lips, tongue, or throat; difficulty breathing or swallowing or dizziness.

If you think you have any of the following side effects or symptoms, tell your doctor as soon as possible:

Common side effects (affect 1 to 10 users in 100):

•    decrease in blood pressure; swelling, redness and pain along a vein;

•    breathlessness, a high pitched sound resulting from turbulent air flow in the upper airway;

•    generalized rash and mucosal inflammation, itching, itchy rash;

•    redness of the upper body and the face, pain and spasm of the chest and back muscles,

•    kidney problems which may be detected primarily by increased creatinine or urea concentrations in your blood.

Uncommon side effects (affect 1 to 10 users in 1,000):

•    temporary or permanent loss of hearing.

Rare side effects (affect 1 to 10 users in 10,000):

•    anaphylactic reactions, allergic reactions;

•    drug fever, chills,

•    increased or reduced (sometimes severely decreased) urine output, or traces of blood in urine;

There are no other ingredients.

What Vancomycin looks like and contents of the pack

Vancomycin is a white or almost white freeze-dried powder for solution for intravenous infusion. It must be first dissolved in water for injection and further diluted in an appropriate diluent prior to use.

This medicine is supplied in colourless glass vials closed with rubber closures and sealed with aluminium and plastic flip off caps. This medicine is available in two strengths: 500 mg and 1000 mg.

Vancomycin is packed in carton boxes. Each box can contain 1,5, 10 or 100 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley Camberley, Surrey, GU16 7SR, UK

Manufacturer:

Lek Pharmaceuticals d.d., Verovskova 57 1526 Ljubljana, Slovenia. or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany

This leaflet was last approved in 04/2014

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Patients with anuria (with practically no renal function) should receive a dose of 15 mg/kg body weight until the therapeutic serum concentration is reached. The maintenance doses are 1.9 mg/kg body weight per 24 hours. In order to facilitate the procedure, adult patients with strongly impaired renal function may obtain a maintenance dose of 250 - 1000 mg at intervals of several days instead of a daily dose.

Preparation of infusion solution

For a 500 mg dose, dissolve 500 mg of vancomycin in 10 ml of water for injections For a 1000 mg dose, dissolve 1000 mg of vancomycin in 20 ml of water for injections.

One ml of reconstituted solution contains 50 mg of vancomycin. Solution prepared aseptically in this manner may be stored for 24 hours at 25°C or for 96 hours in a refrigerator at between 2°C and 8°C. After reconstitution, this solution should be further diluted.

The suitable diluents for further dilution are:

-    5% Glucose Injection or

-    0.9% Sodium Chloride Injection or

-    5% Glucose Injection with 0.9% Sodium Chloride Injection.

Intermittent infusion: Reconstituted solution containing 500 mg of vancomycin (50 mg/ml) must be diluted further with at least 100 ml of the above diluent (to 5mg/ml).

Reconstituted solution containing 1000 mg vancomycin (50 mg/ml) must be diluted further with at least 200 ml of the above diluent (to 5mg/ml).

The concentration of vancomycin in solution for infusion should not exceed 5 mg/ml.

Stability of diluted solutions

Vancomycin reconstituted solution (50 mg/ml), further diluted with 5% glucose or 0.9% sodium chloride (5mg/ml) may be stored in a refrigerator for 48 hours, or at 25°C for 24 hours without significant loss of potency. Solutions diluted with a combination of 5% glucose and 0.9% sodium chloride may be stored in a refrigerator (2°C - 8°C) for 48 hours or at 25°C for 24 hours.

From a microbiological point of view the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

If not used immediately, in - use storage times and conditions are the responsibility of the user.

Appearance of reconstituted solution

After reconstitution the solution is clear and colorless to slightly yellowish brown without visible particles. Appearance of diluted solution

After dilution the solution is clear and colorless without visible particles.

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

Monitoring of serum concentrations

The serum concentration of vancomycin should be monitored at the second day of treatment immediately prior to the next dose, and one hour post infusion. Therapeutic vancomycin blood levels should be between 30 and 40 mg/l (maximum 50 mg/l) one hour after the end of the infusion, the minimum level (short prior to the next administration) between 5 and 10 mg/l.

The concentrations should normally be monitored twice or three times per week.

Incompatibilities

The solution of vancomycin has a low pH value. In combination with other substances, it may become physically or chemically unstable.

Vancomycin solution should not be mixed with other solutions, with exceptions of those whose compatibility has been reliably verified.

Combination therapy:

In case of combination therapy of vancomycin with other antibiotic or chemotherapeutic agent, the preparations should be administered separately.

Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between administration of these antibiotics.

It is also recommended to dilute solutions of vancomycin to 5 mg/ml or less.

Disposal

Vials are for single use only. Unused medicinal product must be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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