Vancomycin 500 Mg Powder For Concentrate For Solution For Infusion
Patient information leaflet.
Vancomycin 500 mg
Powder for concentrate for solution for infusion Vancomycin 1000 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible
side 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 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.
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 medicine (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 pharmacist before using Vancomycin if you:
• have kidney problems
• are hard of hearing.
• are pregnant or planning to become pregnant
• are breast-feeding
• are elderly, over the age of 60.
Injection site pain, inflammation of the vein wall and blood clotting can occur and is occasionally severe, slow administration also reduces these side effects.
If you suffer from kidney failure or receive concomitant treatment with other substances toxic to kidney the possibility of developing toxic effects is much higher.
Your doctor may perform several tests to see if your kidneys and liver are working properly.
If you are elderly or have kidney problems your doctor may also perform regular tests on your hearing and measure the amount of vancomycin in your blood.
Deafness transitory or permanent, which may be preceded by noises in ears, can occur in patients with prior deafness, who have received excessive doses, or who receive treatment with another substance toxic to hearing. To reduce this risk, blood levels should be checked periodically and periodic testing of hearing functions is recommended.
Prolonged use of Vancomycin powder may result in the overgrowth of resistant organisms; your doctor will monitor this.
Other medicines and Vancomycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are also taking any of the following, as they 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)
• Allergic to another antibiotic called teicoplanin you may also be allergic to vancomycin.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be planning to have a baby, ask your doctor or 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 are given too much Vancomycin
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 product, 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.
Vancomycin may cause serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as liver or blood cells (DRESS syndrome). Symptoms include skin rash, fever, swollen glands that do not go away, swelling of your lip and tongue, yellowing of your skin or the whites of the eyes, unusual bruising or bleeding, severe fatigue or weakness, unexpected muscle pain or frequent infections.
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
• Pain and spasm of the chest and back muscles
Uncommon side effects (may affect up to 1 in 100 people)
• Temporary or permanent loss of hearing
Rare side effects (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
• Fever, chills
• Diarrhoea
Very Rare side effects (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
• Cardiac arrest
• Inflammation of the bowel which causes abdominal pain and diarrhea, which may contain blood
• Inflammation of the blood vessels
Not known (frequency cannot be estimated from the available data)
• Overgrowth of resistant organisms (bacteria or fungi)
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
Your doctor will be responsible for storing the medicine.
Keep out of the reach and sight of children.
Do not use Vancomycin 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.
Do not throw away any medicines via wastewater or household waste. Ask your phamacist how to throw away medicines you no longer use. These measures will help protect the enviroment.
6. Contents of the pack and other information
What Vancomycin contains:
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 vial.
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 vial.
The medicine is a powder that has to be dissolved before you receive it.
Marketing Authorisation Holder:
Teva UK Limited Brampton Road,
Hampden Park,
Eastbourne,
East Sussex,
BN22 9AG
Manufacturer
Axellia Pharmaceuticals ApS Dalslandsgade 11 2300 Copenhagen S Denmark
OR*
Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
This medicinal product is authorised in the Member States under the following names: Belgium: Vamysin, poeder voor concentraat voor oplossing voor infusie.
Denmark: Vancomycin Teva
France: Vancomycine Xellia poudre pour solution a diluer pour solution pour perfusion. Germany: Vanco-ratiopharm Pulver zur Herstellung einer Infusionslosung.
Luxembourg: Vamysin poudre pour solution a diluer pour solution pour perfusion.
The Netherlands: Vancomycine Teva poeder voor concentraat voor oplossing voor infusie.
Romania: Vancomicina Teva Pharma pulbere pentru concentrat pentru solufie perfuzabila. United Kingdom: Vancomycin Powder for concentrate for solution for infusion
This leaflet was last revised in 03/2015.
* Only the actual site of batch release will appear on the printed version of the leaflet
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.