Vancomycin 500 Mg Powder For Concentrate For Solution For Infusion
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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 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.
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 storeVancomycin
6. Contents of the pack and other 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
• inflammation of the lung
• blood poisoning
• soft tissue infection
Vancomycin can also be used before surgery to prevent possible infections.
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).
Warnings and precautions
Talk to your doctor before using Vancomycin 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.
Other medicines and Vancomycin
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
• 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 breast-feeding
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.
• As prevention before a surgery against bacterial infections
Adults receive 1000 mg prior to surgery and depending on time and type of surgery, the dose of 1000 mg of vancomycin can also be given 12 hours after the surgery.
• Children (1 month to 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.
• Infants up to a month
For infants 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 pseudo-allergic reactions when intravenous infusion of Vancomycin is carried out too fast.
Common side effects, may affect up to 1 in 10 people:
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, may affect up to 1 in 100 people:
Transient or persistent impairment of the hearing function.
Rare side effects, may affect up to 1 in 1,000 people:
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, may affect up to 1 in 10,000 people:
Severe skin reactions with life-threatening general symptoms (e. g. exfoliative dermatitis, Stevens-Johnson-syndrome, acute generalised exanthematous pustulosis or Lyell-syndrome), inflammation of blood vessels, often with skin rash (vasculitis), bacterial inflammation of the bowel (pseudomembranous colitis).
Not known: frequency cannot be estimated from the available data
Drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS) and necrosis in the kidney tissue.
Severe anaphylactoid reactions are possible during or short time after fast intravenous infusion. The reactions disappear after the infusion was stopped.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any side effects not listed in this leaflet.
5. How to store Vancomycin
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
The infusion concentrate should be stored at 2-8°C.
Do not use this medicine if you notice particulate matter or a discoloration of the solution for infusion.
Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6. Contents of the pack and other information What Vancomycin contains
The active substance is vancomycin hydrochloride. Each vial contains vancomycin hydrochloride corresponding to 500 mg vancomycin (equivalent to not less than 525 000 IU) as vancomycin hydrochloride
Each vial contains vancomycin hydrochloride corresponding to 1000 mg vancomycin (equivalent to not less than 1 050 000 IU) as vancomycin hydrochloride
The other excipients are sodium hydroxide, hydrochloric acid for pH adjustment.
What Vancomycin looks like and contents of the pack
This medicinal product is presented as a white or almost white powder for concentrate for solution for infusion.
Vancomycin is available in package with 1 glass vial with a rubber stopper and a flip-off cap. Marketing Authorisation Holder and Manufacturer:
Marketing authorisation holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer:
Agila Specialties Polska 10 Daniszewska St,
03-230 Warsaw Poland
This medicinal product is authorised in the Member Sattes of the EEA under the following names:
|
Austria |
Vancomycin FarmaPlus 500mg Pulver fur ein Konzentrat zur Herstellung einer Infusionslosung Vancomycin FarmaPlus 1000 mg Pulver fur ein Konzentrat zur Herstellung einer Infusionslosung |
|
Belgium |
Vancomycin FarmaPlus 500mg, poeder voor concentraat voor oplossing voor infusie Vancomycin FarmaPlus 1000 mg, poeder voor concentraat voor oplossing voor infusie |
|
Denmark |
Vancomycin FarmaPlus 500mg pulver til koncentrat til infusionsv^ske, oplosning Vancomycin FarmaPlus 1000 mg pulver til koncentrat til infusionsv^ske, oplosning |
|
Finland |
Vancomycin FarmaPlus 500mg kuiva-aine valikonsentraatiksi infuusionestetta varten, liuos Vancomycin FarmaPlus 1000 mg kuiva-aine valikonsentraatiksi infuusionestetta varten, liuos |
|
France |
Vancomycin FarmaPlus 500mg poudre pour solution a diluer pour solution pour perfusion Vancomycin FarmaPlus 1000 mg poudre pour solution a diluer pour solution pour perfusion |
|
Germany |
Vancomycin FarmaPlus 500mg Pulver fur ein Konzentrat zur Herstellung einer Infusionslosung Vancomycin FarmaPlus 1000 mg Pulver fur ein Konzentrat zur Herstellung einer Infusionslosung |
|
Greece |
Vancomycin FarmaPlus 500mg Kovrg yra tcukvo Sra^upa yra napaaKsup Vancomycin FarmaPlus 1000mg Kovrg yra tcukvo Sra^upa yra napaaKeu'n |
|
Ireland |
Vancomycin FarmaPlus 500mg powder for concentrate for solution for infusion Vancomycin FarmaPlus 1000mg powder for concentrate for solution for infusion |
|
Italy |
Vancomicina FarmaPlus |
|
Latvia |
Vancomycin FarmaPlus 500mg pulveris infuziju skrduma koncentrata pagatavosanai Vancomycin FarmaPlus 1000mg pulveris infuziju skrduma koncentrata pagatavosanai |
|
Lithuania |
Vancomycin FarmaPlus 500mg milteliai infuzinio tirpalo koncentratui Vancomycin FarmaPlus 1000mg milteliai infuzinio tirpalo koncentratui |
|
Norway |
Vancomycin FarmaPlus 500mg pulver til konsentrat til infusjonsv^ske, opplosning Vancomycin FarmaPlus 1000mg pulver til konsentrat til infusjonsv^ske, opplosning |
|
Poland |
Vancomycin FarmaPlus Vancomycin FarmaPlus |
|
Prtugal |
Vancomycin FarmaPlus 500mg po para concentrado para solu^ao para perfusao Vancomycin FarmaPlus 1000mg po po para concentrado para solu^ao para perfusao |
|
Romania |
Vancomicina FarmaPlus 500mg pulbere pentru concentrat pentru solutie perfuzabila Vancomicina FarmaPlus 1000mg pulbere pentru concentrat pentru solutie perfuzabila |
|
Slovakia |
Vancomycin FarmaPlus 500mg prasok na infuzny koncentrat Vancomycin FarmaPlus 1000mg prasok na infuzny koncentrat |
|
Slovenia |
Vankomicin FarmaPlus 500mg prasek za koncentrat za raztopino za infundiranje Vankomicin FarmaPlus 1000mg prasek za koncentrat za raztopino za infundiranje |
|
Spain |
Vancomycin FarmaPlus 500mg Polvo para concentrado para solucion para perfusion Vancomycin FarmaPlus 1000mg Polvo para concentrado para solucion para perfusion |
|
Sweden |
Vancomycin FarmaPlus 500mg pulver till koncentrat till infusionsvatska, losning Vancomycin FarmaPlus 1000 mg pulver till koncentrat till infusionsvatska, losning |
|
United Kingdom |
Vancomycin 500mg Powder for concentrate for solution for infusion Vancomycin 1000 mg Powder for concentrate for solution for infusion |
This leaflet was last revised: 03/2015
The following information is intended for medical or healthcare professionals only:
Vancomycin may be diluted with sterile water, 9 mg/ml sodium chloride or 50 mg/ml glucose. Vancomycin solutions are not compatible with solutions of betalactam antibiotics. The risk of precipitation increases with higher concentrations of vancomycin. To prevent precipitation, intravenous cannulae and catheters should be flushed with saline between administration of Vancomycin and these antibiotics. Vancomycin solutions must only be diluted to concentrations of 5 mg/ml or less.
Vancomycin is not licensed for administration as intravitreal injection. Precipitation has been observed following intravitreal injection of vancomycin and ceftazidim using separate syringes and needles for the treatment of endophthalmitis. The precipitate in the vitreous body dissolved completely but slowly over a period of 2 months, during which visual acuity also improved
The powder must be reconstituted and the resulting concentrate must then be diluted further prior to use.
Preparation of the infusion concentrate
Dissolve the contents of a 500 mg vancomycin vial in 10 ml of sterile water.
Dissolve the contents of a 1000 mg vancomycin vial in 20 ml of sterile water.
One ml of reconstituted solution contains 50 mg of vancomycin. pH=2.5 - 4.5.
To prevent precipitation due to the low pH of vancomycin hydrochloride in solution, all intravenous cannulae and catheters should be flushed with saline.
Appearance of the infusion concentrate Clear, colorless solution free from particles.
For storage conditions of the reconstituted medicinal product, see sections 5 Preparation of the solution for infusion
Vancomycin may be diluted with sterile water, 9 mg/ml sodium chloride or 50 mg/ml glucose.
Vial containing 500 mg vancomycin:
Dilute 10 ml of the infusion concentrate with 90 ml of 9 mg/ml sodium chloride or 50 mg/ml glucose, and administer as intravenous infusion. The solution for infusion contains 5 mg vancomycin/ml.
Vial containing 1000 mg vancomycin:
Dilute 20 ml of the infusion concentrate with 180 ml of 9 mg/ml sodium chloride or 50 mg/ml glucose, and administer as intravenous infusion. The solution for infusion contains 5 mg vancomycin/ml.
Appearance of solution for infusion
The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used is the solution is clear and free from particles.
The concentration of vancomycin in Solution for infusion should not exceed 5 mg/ml.
The desired dose should be administered slowly by intravenous infusion at a rate of no more than 10 mg/minute, for at least 60 minutes or even longer.
For storage conditions of the diluted medicinal product, see sections 5
Disposal
Vials are for single use only. Unused product must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
Vancomycin solutions are not compatible with solutions of penicillins or cephalosporins (betalactam antibiotics). The risk of precipitation increases with higher concentrations of vancomycin. To prevent precipitation, intravenous cannulae and catheters should be flushed with saline between administration of Vancomycin and these antibiotics. Vancomycin solutions must only be diluted to concentrations of 5 mg/ml or less.
Stability
Shelf life for reconstituted concentrate for solution for infusion:
Chemical and physical in-use stability has been demonstrated for 24 hours stored at 2-8°C.
Shelf life for prepared solution for infusion:
Chemical and physical in-use stability has been demonstrated for 12 hours stored at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the total in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions
Administration
Allergic shock (anaphylactic/anaphylactoid reactions) may occur during and immediately after rapid infusion of Vancomycin.
Rapid administration (i.e., over several minutes) can cause excessive hypotension (including shock, and, rarely, cardiac arrest), histamine-like response and maculopapular or erythematous rash ("red man's syndrome" or "red neck syndrome"). In case of serious acute hypersensitivity reactions (e.g. anaphylactic reaction), treatment with vancomycin should be discontinued immediately and the usual emergency measures have to be started.
Patients requiring fluid restriction may be treated with concentrations of up to 10 mg/ml. However, such concentrations involve a greater risk of infusion-related complications. The rate of infusion should under no circumstances exceed 10 mg/min.
Concomitant use of Vancomycin and anaesthetics increases the risk of flushing of the upper body and allergic shock. To reduce the risk of such reactions, Vancomycin should be administered for a period of 60 minutes prior to the anaesthetic.