Vancomycin 1000 Mg Powder For Concentrate For Solution For Infusion
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Kxxxx-A |
GB/IE V003 |
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Size |
148x420 mm |
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Smallest Font Size |
8 pt. |
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Version 3 |
10-10-2015 11:01 |
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Holger Clas |
+49 6172 686 6161 |
Colors:
• black
Package leaflet: Information for the user
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 using 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. This includes any possible side effects not listed in this leaflet. See section 4.
The name of this medicine is Vancomycin 500 mg/1000 mg powder for solution for infusion, called Vancomycin Infusion in the rest of the leaflet.
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 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 qive 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 infusion is and what it is used for
2. What you need to know before you use Vancomycin infusion
3. Howto use Vancomycin infusion
4. Possible side effects
5. Howto store Vancomycin infusion
6. Contents of the pack and other information
1. What Vancomycin infusion is and what it is used for
How does the medicine work?
Vancomycin infusion contains the active ingredient vancomycin, as vancomycin hydrochloride, which is an antibiotic. Antibiotics help your body fight infections. Vancomycin infusion works by eliminating certain bacteria that cause infections.
What is the medicine used for?
Vancomycin infusion 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 infusion
Do not use Vancomycin infusion
• If you are allergic (hypersensitive) to Vancomycin infusion
• 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 our doctor before using Vancomycin infusion:
• 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 infusion
Tell your doctor if you are taking, have recently taken or might take any other medicines.
The following medicine may interact with Vancomycin infusion:
• 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 pharmacist for advice before using this medicine.
Vancomycin infusion should be given during pregnancy and breast-feeding only if clearly needed. The doctor may decide that you should stop breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Vancomycin infusion has no or very little effect on your ability to drive and use machines.
3. How to use Vancomycin infusion
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 recommended dose 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 doctor's instructions.
If you receive too much Vancomycin infusion
Your doctor monitors the amount of Vancomycin infusion you receive.
If blood tests and other tests show that you have too much in your body, the amount of Vancomycin infusion 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.
V003
K-xxxx
The following information is intended for 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 infusion should be stored below 25°C. Keep the vial in the outer carton in order to protect from light.
Vancomycin 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.
very common:
may affect more than 1 in 10 people common:
may affect up to 1 in 10 people uncommon:
may affect up to 1 in 100 people rare:
may affect up to 1 in 1,000 people very rare:
may affect up to 1 in 10,000 people not known:
frequency cannot be estimated from the available data_
Common side effects:
■ 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:
Temporary or permanent loss of hearing
Rare side effects:
■ 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:
• 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.
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.
For UK - You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL- Dublin 2;
Tel:+353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vancomycin infusion
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
6. Contents of the pack and other information
What Vancomycin infusion 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 infusion 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 dear glass vial with a grey flip-off cap.
Pack size: 1 vial, 10 x 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, 10 x 1 vial.
The medicine is a powder that has to be dissolved before you receive it.
Marketing Authorisation Holder:
Fresenius Kabi Limited Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT,UK
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S, Denmark
This medicinal product is authorised in the Member States under the following names:
Belgium and The Netherlands: Vancomycin infusione Fresenius Kabi 1000 mg poeder voor concentraat voor oplossing voor infusie; Vancomycin infusione Fresenius Kabi 500 mg poeder voor concentraat voor oplossing voor infusie
Bulgaria: Vancomycin infusion Kabi 1000 mg powder for concentrate for solution for infusion; Vancomycin infusion Kabi 500 mg powder for concentrate for solution for infusion Czech Republic and Slovakia:
Vancomycin infusion Kabi 1000 mg; Vancomycin infusion Kabi 500 mg Denmark: Vancomycin infusion Fresenius Kabi
Estonia and Poland: Vancomycin infusion Kabi 1000 mg; Vancomycin infusion Kabi 500 mg
France: Vancomycin infusione Kabi 1000 mg, poudre pour solution pour perfusion ; Vancomycin infusione Kabi 500 mg, poudre pour solution pour perfusion Germany and Luxembourg:
Vancomycin infusion Kabi 1 g Pulver zur Herstellung eines Konzentrats fur eine Infusionslosung; Vancomycin infusion Kabi 500 mg Pulver zur Herstellung eines Konzentrats fur eine Infusionslosung
Greece: Vancomycin infusion/Kabi 1000mg, xdvig yia ttukv6 BidAupa yia TTapaoxEufj SiaAupaTog npog eyxuan; Vancomycin infusion/Kabi 500mg, xovig yia ttukv6 BidAupa yia napacKeufj BiaAuparog npog Eyxuaq Hungary: Vancomycin infusion Kabi 1000 mg por oldatos infuziohoz valo koncentratumhoz; Vancomycin infusion Kabi 500 mg por oldatos infuziohoz valo koncentratumhoz
Iceland: Vancomycin infusion 1000 mg stofn fyrir innrennslisbykkni, lausn; Vancomycin infusion 500 mg stofn fyrir innrennslisbykkni, lausn Ireland and United Kingdom:
Vancomycin infusion 1000 mg powder for concentrate for solution for infusion; Vancomycin infusion 500 mg powder for concentrate for solution for infusion Latvia: Vancomycin infusion Kabi 1000 mg pulveris infuziju skTduma koncentrata pagatavoSanai; Vancomycin infusion Kabi 500 mg pulveris infuziju skTduma koncentrata pagatavosanai Lithuania: Vancomycin infusion Kabi 1000 mg milteliai infuzinio tirpalo koncentratui; Vancomycin infusion Kabi 500 mg milteliai infuzinio tirpalo koncentratui
Norway: Vancomycin infusion Fresenius Kabi 1 g pulver til konsentrat til infusjonsvaeske, opplesning; Vancomycin infusion Fresenius Kabi 500 mg pulver til konsentrat til infusjonsvaeske, opplesning Portugal: Vancomicina Kabi Romania: Vancomicina Kabi 1000 mg pulbere pentru concentrat pentru solutie perfuzabila; Vancomicina Kabi 500 mg pulbere pentru concentrat pentru solujie perfuzabila
Slovenia: Vankomicin Kabi 1 g prasek za koncentrat za raztopino za infundiranje; Vankomicin Kabi 500 mg prasek za koncentrat za raztopino za infundiranje Spain: Vancomicina Kabi 1g polvo para concentrado para solucion para perfusion EFG; Vancomicina Kabi 500mg polvo para concentrado para solucion para perfusion EFG Sweden: Vancomycin infusion Fresenius Kabi 1 g, pulver till koncentrat till infusionsvatska, losning; Vancomycin infusion Fresenius Kabi 500 mg, pulver till koncentrat till infusionsvatska, losning