Vancomycin 500 Mg Powder For Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vancomycin 500mg & 1000mg Powder for Concentrate for Solution for Infusion Vancomycin
Please 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 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 get serious, or you notice any side effects not listed in the leaflet please tell your doctor or pharmacist.
The name of your medicine is one of the following:
- Vancomycin 500 mg Powder for Concentrate for Solution for Infusion.
- Vancomycin 1000 mg Powder for Concentrate for Solution for Infusion.
In the rest of this leaflet your medicine is called Vancomycin._
In this leaflet:
1. What Vancomycin is and what it is used for
2. Before you take Vancomycin
3. How to take Vancomycin
4. Possible side effects
5. How to store Vancomycin
6. Further Information
1. 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 a nurse.
2. Before you take Vancomycin
The nurse or doctor giving you this medicine will ask some questions about you. They need the following information before you have this medicine for the first time.
Do not take Vancomycin
• If you are allergic to this medicine or any other glycopeptide antibiotics
Take special care with Vancomycin
Before your treatment starts, tell your nurse or doctor if you:
• have kidney problems
• have ear problems such as deafness
• have low blood count
• are pregnant, or planning to become pregnant
• are breastfeeding
• 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 like low blood pressure or 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 ears, can occur in 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 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 diarrhea (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, gentamycin, kanamycin, amikacin, bacitracin, tobramycin, polymixin 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
• If you are pregnant, or think you may be pregnant you must tell your doctor.
• If you are breast-feeding you must tell your doctor as small amounts of Vancomycin will be in the breast milk and may affect your baby.
Your doctor will advise you if you should have this medicine during pregnancy and breastfeeding.
Driving and using machines: There is no known effect on the ability to drive and use machinery while taking Vancomycin.
3. How to take Vancomycin
A doctor or a nurse will usually give you this medicine. Your doctor or nurse will give the correct dose for you into your vein. It will be given to you as a slow injection over at least 60 minutes or by a continuous infusion over a longer time (your doctor or nurse may call this an “IV” or “intravenous infusion” or “drip”). Your doctor will decide the amount (dose) of your medicine to give you. This will depend on a number of things. These things include how bad your infection is, the type of infection and the type of bacteria causing it and how healthy you are. Your doctor will also decide how long you need to take your medicine for. This will depend on how bad your infection is and how you respond to your medicine. The usual time is for at least 2 or 3 days after you are feeling better but can be as long as 3 weeks depending on the severity and type of infection. As this medicine is a powder, liquid must be added to make a solution before you receive it. Your doctor, nurse or pharmacist will normally do this for you. Adults and children 12 years and over: The usual dose is 500 milligrammes (500 mg) every 6 hours or 1 gram (1 g) every 12 hours. If you are elderly (over 65 years) your dose may be reduced depending on how good your kidney function is. Newborn and very young babies: An initial dose of 15mg per kg of bodyweight, followed by 10mg per kg of bodyweight every 12 hours in the first week of life and, every 8 hours up to one month old. The medicine will be given to you as an IV infusion (drip) which may take up to 60 minutes. Infants and children up to 12 years: The usual dose is 10 mg per kg of bodyweight every 6 hours. Patients with kidney problems: If you have severe kidney problems, your doctor may also take some blood tests to help calculate the correct dose for you. If you are receiving dialysis (blood treatment when your kidneys do not work properly), an initial dose of 15 mg per kg of bodyweight and blood tests will be taken to ensure you have enough in your blood. After the initial dose 1.9 mg per kg bodyweight every 24 hours to maintain therapeutic levels. In cases of severe kidney problems, a dose may be given every few days rather than daily.
Please read the other side of the leaflet.
If you take more Vancomycin than you should: A doctor or a nurse will usually give you this medicine. If you think you may have received too much medicine please tell your doctor or nurse at once.
If you forget to take Vancomycin: A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.
If you stop taking Vancomycin:It is very important to finish the course of treatment your doctor has prescribed, even if you start to feel better. If you do not finish the course of treatment, your infection may get worse again. If you have any further questions on the use of your medicine, ask your doctor, nurse or pharmacist.
4. Possible side- effects
Like all medicines, Vancomycin can cause side effects, although not everybody gets them. 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, redeness and pain along a vein;
• breathlessness, a high pitched sound resulting from turbulent air flow in the upper airway;
• generalised 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;
• increase or decrease in some of the cells in the blood;
• noises (e.g.) hissing in 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.
5. How to store Vancomycin
Your doctor, nurse or pharmacist will usually store your medicine for you. Keep your medicine out of the reach and sight of children. Do not use your medicine after the expiry date (EXP) given on the carton and the label on the glass container (vial). The expiry date is the last day of the month written on the packaging. Store below 25°C. Keep the vial in the outer carton to protect from light.
Vancomycin 500mg: Once the powder has been made into a liquid solution for injection, it should be used immediately or within 24 hours if it is kept in the fridge (ie 2-8oC).
Vancomycin 1000mg: The product should be used immediately.
Only use the solution if it is clear and contains no particles or specks of powder and there has been no colour change. Give any leftover medicine to your doctor, nurse or pharmacist. Do not put it down the drain or in the dustbin. If you do this, it will help protect the environment.
6. Further Information
What Vancomycin contains: The active medicine is Vancomycin. The other ingredient is hydrochloric acid.Each glass container will contain either 500 mg (equivalent to 525,000 IU) or 1000mg (equivalent to 1,050,000 IU) of vancomycin (as hydrochloride).
What Vancomycin looks like and contents of the pack: Vancomycin is a powder for concentrate for solution for infusion. This means liquid must be added to make a solution and more liquid must be added to dilute the solution before it can be given to you intravenously (by infusion).Normally your doctor, nurse or pharmacist will prepare your medicine before it is given to you. Each pack contains 1, 5 or 20 vials (glass containers). Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit.115, 1065 Nicosia, Cyprus.
Manufacturer: Demo S.A., 21st km National Road Athens, Lamia, 14568, Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Vancomycin Noridem 500 mg / 1 g Powder for Concentrate for Solution for Infusion Ireland: Vancomycin Noridem 500 mg / 1 g Powder for Concentrate for Solution for Infusion Germany: Vancomycin Noridem 500 mg / 1000 mg Pulver zur Herstellung einer Infusionslosung Austria: Vancomycin Noridem 500 mg / 1000 mg Pulver zur Herstellung einer Infusionslosung Greece: Vancomycin Noridem 500 mg / 1 g Powder for Concentrate for Solution for Infusion Spain: Vancomycin Noridem 500 mg / 1 g Powder for Concentrate for Solution for Infusion
This leaflet was last approved in December 2010.
The following information is intended for healthcare professionals only and includes
further instruction on preparation and administration of the product:_
Special precautions for disposal and other handling
The powder must be reconstituted and the resulting concentrate must then be diluted prior to use.
Preparation of the reconstituted concentrate: At the time of use, the content of each 500 mg vial is dissolved in 10 ml Water for Injections PhEur. or the content of each 1 g vial is dissolved in 20 ml Water for Injections Ph. Eur. One ml of reconstituted solution contains 50 mg of vancomycin. For storage conditions of the reconstituted medicinal product, see section 5. Preparation of final diluted Solution for Infusion Reconstituted solutions containing 50 mg/ml of vancomycin should be further diluted depending on the method of administration. Suitable diluents are:
5% Glucose Injection (50 mg/ml) or 0.9% Sodium Chloride Injection (9 mg/ml).
Intermittent infusion: 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. Continuous infusion: This should be used only if treatment with an intermittent infusion is not possible. Dilute 1 g to 2 g of dissolved vancomycin in a sufficient amount of the above suitable diluent and administer it in the form of a drip infusion, so that the patient will receive the prescribed daily dose in 24 hours. For storage conditions of the diluted medicinal product, see section 5.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. After reconstitution/dilution: Vancomycin 500mg: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage items and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8° C. Vancomycin 1000mg: From a microbiological and physicochemical point of view, the product should be used immediately.
Disposal: Vials are for single use only. Unused product or waste material must be discarded in accordance with local requirements
.If this leaflet is difficult to see or read please contact the following address for help: Fannin Limited, Fannin House, South County Business Park, Leopardstown,
Dublin 18, Ireland Tel +353-1-2907000