Vancomycin Powder For Concentrate For Solution For Infusion 500 Mg
PATIENT INFORMATION LEAFLET
Vancomycin
Powder for concentrate for solution for infusion 500 mg and 1000 mg
Vancomycin hydrochloride
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Please see section 4.
What is in this leaflet:
1 .WhatVancomycin 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
How does the medicine work?
Vancomycin is an antibiotic. Antibiotics help your body fight infections. Vancomycin works by destroying certain bacteria that cause infections.
What is the medicine used for?
Vancomycin is used for the treatment of serious infections caused by certain bacteria.
2. BEFORE YOU USE VANCOMYCIN Do not use the medicine if
• You have had an allergic reaction such as a rash, itching, swelling or breathing difficulties after receiving this medicine or other antibiotics.
Warnings and precautions
Talk to your doctor before you are given this medicine if:
• You have kidney problems
• You are hard of hearing
• You have difficulties to urinate
• You are elderly
• You have been treated with other antibiotics (e.g aminoglycosides)
• If you are allergic to teicoplanin.
When receiving treatment with Vancomycin:
• your blood levels will be checked regularly. Your doctor may decide to adjust the dose on the basis of your blood levels
• your kidney and hearing functions should be tested periodically
• and if you develop severe diarrhoea, please contact your doctor
• if you experience ringing in the ears (tinnitus), please tell your doctor, nurse or other healthcare professional immediately, as this may be the onset of hearing loss.
Taking other medicines
Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Special precautions must be taken if you use Vancomycin together with:
• other medicines, which also can cause hearing, kidney or nervous system problems. Close observation is necessary if you receive certain medicines (aminoglycosides amphotericin B, genatmycin, streptomycin, neomycin, kanamycin, amikacin, tobramycin, viomycin, bacitracin, polymyxin B, colistin and cisplatin)
• anaesthetics. This may cause reddening of the skin, rashes or allergic reactions
• certain muscle relaxing medicines (such as succinylcholine).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines No effects on ability to drive and use machines have been observed.
3. HOW TO USE VANCOMYCIN
Always use this medicine exactly as your doctor has told you. Check with you doctor if you are not sure.
The medicine is given into a vein, usually in your arm, slowly over several hours. The doctor will decide the total duration of administration and at which rate you will be given the medicine. The amount of medicine in your blood will usually be measured at regular intervals.
The recommended dose is:
Adults:
500 mg intravenously every 6 hours or 1000 mg every 12 hours.
Children:
10 mg/kg, every 6 hours or 20 mg/kg every 12 hours.
Newborn children:
0-7 days old: Starting dose of 15 mg/kg with subsequent doses of 10 mg/kg every 12 hours.
7-30 days old: Starting dose of 15 mg/kg with subsequent doses of 10 mg/kg every 8 hours.
Patients with reduced kidney function: The starting dose should always be at least 15 mg/kg. The doctor will adjust the dose individually for you.
Patients with no kidney function:
The starting dose is 15 mg/kg followed by doses of 1.9 mg/kg body weight every 24 hours.
Do not tamper with the bag/bottle.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Vancomycin can cause side effects, although not everybody gets them.
The most common side effects are pain, redness and swelling at the site where the needle is inserted in the vein and allergy-like reactions. Therefore please tell your doctor or nurse immediately If you experience any of following serious side effects:
• any kind of an allergic reactions such as difficulty in breathing, rash, itching and flushing of the upper body ("red man syndrome") as these are commonly seen (may occur in 1 to 10 of 100 patients)
• any kind of serious rash, as this can be related to serious life-threatening skin diseases (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis), although these are very rare (may occur in less than 1 In 10,000 patients).
Common side effects (may occur in 1 to 10 in 100 patients):
Fall in blood pressure, breathing difficulties, wheezing, redness of the upper body and face, inflammation of the mucosa, hives, reduced kidney function, pain, redness and swelling at the site where the needle is inserted in the vein and pain and muscle spasms In the chest and back muscles.
Rare side effects (may occur in less than 1 to 10 in 10,000 patients):
Pain and muscle spasms in the chest and back, fever, chills, dizziness.
Changes in the blood picture which may increase the risk of infection and increase bleeding tendency, nausea, kidney inflammation, kidney failure, ringing in your ears (tinnitus) and allergic reactions.
Very rare side effects (may occur in less than 1 in 10,000 patients):
Difficulty in hearing, inflammation in the intestines, cardiac arrest, severe allergic skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) and inflammation of the blood vessels.
Not known (cannot be estimated from the available data):
Severe skin disease causing blisters (Linear IgA bullous dermatosis). If blisters occur, please tell your doctor.
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.
During or shortly after rapid infusion anaphylactic reactions may occur. The reactions cease when infusion is stopped.
If you experience ringing in the ears (tinnitus), please tell your doctor, nurse or other healthcare professional immediately, as this may be the onset of hearing loss.
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 Yellow card scheme:
Tel: Freephone 0808100 3352 Website: 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.
For healthcare professionals only, please see the section below.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medcines via wastewater. Ask your pharmacist how to trow away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION What Vancomycin contains
The active substance is vancomycin hydrochloride.
What Vancomycin looks like and contents of the pack
Vancomycin is available as a powder for solution for infusion, in 2 strengths.
500 mg and 1000 mg.
The medicine is a powder that has to be dissolved before you receive it.
Marketing Authorisation Holder and Manufacturer: Xellia Pharmaceuticals ApS, Dalslandsgade 11,2300 Copenhagen S, Denmark
This leaflet was last revised in August 2015
1922-1
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. Dilute the reconstituted solution with at least 100 ml sterile diluent (to 5 mg/ml), see below.
1000 mg:
Dissolve the content of the vial with 20 ml sterile water. Dilute the reconstituted solution with at least 200 ml sterile diluent (to 5 mg/ml), see below.
Suitable diluents are:
• Sodium Chloride 9 mg/ml (0.9%) Injection
• Glucose 50 mg/ml (5%) Injection
• Glucose 5% and NaCI 0.9%
• Ringer-Acetate.
The concentration of vancomycin in the prepared infusion fluid must not exceed 0.5% w/v (5 mg/ml).
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
The dose Is adjusted individually and according to kidney function. The usual dose Is:
Adults: 500 mg every 6 hours or 1000 mg every 12 hours given by slow intravenous infusion.
Children: 20 mg/kg body weight every 12 hours given by slow intravenous infusion.
Storage
Powder before opening: store below 25°C.
Reconstituted concentrate and diluted product: store in a refrigerator (2°C - 8°C) and use within 24 hours.
From a microbiological point of vie/y unless the method of reconstitution/dilutlon precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Vancomycin powder for infusion should not be used after the expiry date which is stated on the carton.
1 Pia 1922-1 Vancomcin 15-08-24, Format 150 x 420 mm, Font: Frutiger Condensed 7pt Black, Profile