PACKAGE LEAFLET. Package leaflet: Information for the user. Vancomycin Hospira 1000 mg Powder for concentrate for solution for infusion.

Transcription

1 PACKAGE LEAFLET Package leaflet: Information for the user Vancomycin Hospira 500 mg Powder for concentrate for solution for infusion Vancomycin Hospira 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. - 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. See section 4. What is in this leaflet 1. What Vancomycin Hospira is and what it is used for 2. What you need to know before you use Vancomycin Hospira 3. How to use Vancomycin Hospira 4. Possible side effects 5. How to store Vancomycin Hospira 6. Contents of the pack and other information 1. What Vancomycin Hospira is and what it is used for Vancomycin Hospira contains the active substance vancomycin. Vancomycin belongs to the group of medicines that are called glycopeptide antibiotics. These medicines are used for the treatment of infections that are caused by bacteria. Intravenous use In intravenous use the Vancomycin Hospira powder is dissolved and diluted before it is then administered to you by your doctor as a slow infusion into a vein. Vancomycin Hospira is used for the treatment of severe infections that are caused by bacteria sensitive to vancomycin, that are resistant (insensitive) to many other antibiotics and in patients who have not responded to treatment with other antibiotics or tolerated other antibiotics poorly. It is used for the treatment of various severe infections of the endocardium or the heart valves, the blood, the lungs, the bones or soft tissues (skin, connective tissue, muscle). Oral use The Vancomycin Hospira powder may also be administered to you orally after dissolution (through the mouth or a stomach tube) for the treatment of certain severe inflammatory bowel conditions. 2. What you need to know before you use Vancomycin Hospira Do not use Vancomycin Hospira, 1

2 if you are allergic to vancomycin or any of the other ingredients of this medicine listed in section 6. Inform your doctor if you have ever had problems with this or any other medicine. Warnings and precautions Talk to your doctor or pharmacist before using Vancomycin Hospira: if you have kidney problems, if you are hard of hearing, if you are older than 60 years, if you are allergic to the antibiotic teicoplanin. During treatment with Vancomycin Hospira your blood values and your liver, kidney and hearing functions will be checked regularly. Your doctor may then adjust the dose. In order to prevent allergic reactions, you will be given Vancomycin Hospira slowly (maximum 10 mg/min) and sufficiently diluted, infused into a vein over at least 60 minutes. If the infusion is administered to you too quickly you may develop symptoms of a hypersensitivity reaction, such as a fall in blood pressure, reddening of the skin or skin rash. These reactions usually go away after the infusion has stopped. Administering it too fast may also cause pain and inflammation as well as a blood clot at the injection site. The infusion sites should also be changed regularly. If you already have hearing problems or are given other substances that damage hearing at the same time, you may have temporary or permanent hearing loss, which may be preceded by noises in the ears (tinnitus). Your doctor will therefore check your blood level and your hearing function at regular intervals. If you have kidney problems or are treated with other medicines that are harmful to the kidneys, the risk of harmful effects by Vancomycin Hospira is greatly increased. Your doctor will therefore carry out follow-up tests. If you are treated for an inflammatory bowel disease, you may also develop side effects of Vancomycin Hospira after oral ingestion (through the mouth or a stomach tube) that usually occur in intravenous administration. This must be particularly taken into account if your kidneys have only limited function. If you get severe, persistent diarrhoea during or after intravenous treatment, please tell your doctor at once, so that this can be treated as quickly as possible. Children and adolescents Vancomycin must be used with particular caution in infants and children, because their kidneys have not yet fully developed. The concentrations of vancomycin in the blood should therefore be monitored carefully. Other medicines and Vancomycin Hospira Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This is particularly important if you are taking/using one of the following medicines: Medicines for fungal infections (amphotericin B) Medicines for the treatment of bacterial infections (other antibiotics, such as aminoglycosides, streptomycin, neomycin, gentamicin, kanamycin, amikacin, bacitracin, tobramycin, polymyxin B, colistin) 2

3 Medicines that suppress the activity of the immune system (ciclosporin) Diuretic medicines (loop diuretics) Medicines for cancer (cisplatin) Anaesthetics (if you are given a general anaesthetic) Medicines to relax the muscles during anaesthesia (muscle relaxants) Oral contraceptives (the pill ) 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 or pharmacist for advice before taking this medicine. Pregnancy Vancomycin Hospira should be administered during pregnancy only if absolutely necessary. Your doctor will decide whether you should be given Vancomycin Hospira. Breast-feeding Tell your doctor if you are breast-feeding, because Vancomycin Hospira passes into breast milk. Your doctor will decide whether you must stop breast-feeding during treatment with Vancomycin Hospira. Driving and using machines No studies have been carried out on the effects on the ability to drive and the ability to use machines. Vancomycin Hospira contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free. 3. How to use Vancomycin Hospira Vancomycin Hospira will be administered to you by the doctor during your stay in hospital. Your doctor will decide how much of this medicine you should be given every day and how long the treatment should last. Your doctor will adjust the dose to your weight, age and kidney function. Intravenous use This medicine will firstly be dissolved and then sufficiently diluted before it is given to you. You will normally be given a slow drip infusion into a vein (maximum 10 mg/min). The infusion lasts at least 60 minutes. Patients with normal kidney function Adults and adolescents over 12 years The usual intravenous administration is 500 mg every 6 hours or 1,000 mg every 12 hours. Children from one month to 12 years Children are usually given 10 mg/kg body weight at intervals of 6 h. The daily dose is 40 mg/kg body weight. Newborn children (not premature babies) and infants A starting dose of 15 mg/kg and a maintenance dose of 10 mg/kg every 12 hours in the first week of life and every 8 hours up to the age of one month are recommended. 3

4 Patients with impaired kidney function and elderly patients The doctor will reduce the dose or lengthen the interval between two doses. Blood tests may be made during treatment. You may be asked to provide urine samples and hearing tests may be carried out to discover possible signs of side effects. Oral use For oral administration the contents of a vial are dissolved in water and given to you in part quantities to drink or administered with a stomach tube. The usual dose for adults is 500 mg to 2 g vancomycin daily in 3 or 4 partial administrations. Children are given 40 mg/kg body weight per day in 3 or 4 partial administrations. A daily dose of 2 g vancomycin should not be exceeded. Duration of treatment The duration of treatment depends on the severity and the course of your infection and may be several weeks. If you have been given more Vancomycin Hospira than you should have This medicine is administered to you by your doctor. It is unlikely that you will be given a dose that is too low or too high. Despite this, you should tell your doctor if you have concerns. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Events in connection with the infusion Low blood pressure, breathlessness, itching skin rash, reddening of the skin of the upper body, pain and cramps in the chest or back muscles may occur during or shortly after a rapid infusion. Vancomycin Hospira is administered very slowly (over at least 60 minutes) to reduce these reactions. Severe allergic reaction Swelling of the face or throat, breathing difficulties, feeling of weakness, itching skin or nettle rash. The consequences can be very serious. Therefore tell your doctor or nurse immediately. The infusion will then be stopped. Inflammation of the vein may occur. This can be reduced by slow infusion of diluted solutions and changing the infusion site. Common: may affect up to 1 in 10 people Decrease in blood pressure Breathlessness, laboured breathing Rare: may affect up to 1 in 1,000 people Reduced number of blood platelets Decreased or increased number of certain white blood cells (neutropenia, agranulocytosis, eosinophilia) 4

5 Severe allergic (anaphylactic) reactions Dizziness Temporary or lasting worsening of hearing function Hearing loss Vertigo Ringing in the ear (tinnitus) Cardiac arrest Inflammation of the veins Nausea Skin rashes (including exfoliative dermatitis) Severe allergic reaction of the skin (Stevens-Johnson syndrome) Nettle rash Itching Reddening of the skin of the upper body (red neck) Kidney failure Inflammation of kidney tissue Pain and cramps in chest and back muscles Drug fever Trembling Very rare: may affect up to 1 in 10,000 people Inflammation of the large bowel (pseudomembranous colitis) Watering eyes Inflammation of the blood vessels Not known: frequency cannot be estimated from the available data Hypersensitivity reactions Inflammation of the liver and jaundice Symptoms with blistering Severe allergic reaction of the skin with blistering (Lyell s syndrome) Autoimmune reaction of the skin (linear IgA bullous dermatitis) Chills Elevated liver enzyme values 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Vancomycin Hospira 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 label and the outer carton after EXP. The expiry date refers to the last day of that month. Store in the original pack to protect from light. Concentrate 5

6 Shelf life after reconstitution with water for injections: Chemical and physical stability were demonstrated for 14 days at 5 C and for 24 hours at 25 C. Solution for infusion Shelf life after dilution in 5% glucose solution; 0.9% sodium chloride solution; Ringer lactate solution or 3.3% glucose solution and 0.3% sodium chloride solution: Chemical and physical stability were demonstrated for 96 hours at 5 C and for 24 hours at 25 C. Oral solution The solution for oral use is to be used immediately after preparation. From a microbiological point of view the product should be used immediately. If it is not used immediately, the user is responsible for the period and the conditions of storage before use, which should not normally exceed 24 hours at 2 C to 8 C, unless reconstitution/dilution was performed under controlled and validated aseptic conditions. 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 Hospira contains The active substance is: vancomycin (as hydrochloride). The other ingredients are: hydrochloric acid and sodium hydroxide solution (to adjust the ph) Vancomycin Hospira 500 mg Powder for concentrate for solution for infusion: One 10 ml vial contains 500 mg (equivalent to 500,000 IU) vancomycin as hydrochloride. Vancomycin Hospira 1000 mg Powder for concentrate for solution for infusion: One 30 ml vial contains 1000 mg (equivalent to 1,000,000 IU) vancomycin as hydrochloride. What Vancomycin Hospira looks like and contents of the pack Vancomycin Hospira is a white to pale brown crystalline powder for concentrate for solution for infusion in a glass vial (type I, clear, colourless) with a rubber stopper and aluminium crimped cap with protective cap of polypropylene. Pack sizes: 1 vial containing 500 mg Vancomycin. 1 vial containing 1000 mg Vancomycin. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer <[To be completed nationally]> 6

7 This leaflet was last revised in <{month YYYY}>. <This medicinal product is authorised in the Member States of the EEA under the following names:> <To be completed nationally> The following information is intended for healthcare professionals only: Preparation Administration only after reconstitution and dilution of the powder. The reconstituted solution should be colourless, clear and free of visible particles. Solution for infusion Firstly the powder is dissolved in 10 ml (for 500mg) or 20ml (for 1000mg) water for injections. The vancomycin concentrate made in this way can be stored in the refrigerator for up to 14 days at 5 C or 24 hours at 25 C without significant loss of efficacy. Before administration to the patient the volume of concentrate should be further diluted to at least 100ml of dilution solution (for 500mg), or to at least 200 ml of dilution solution (for 1000mg). In patients whose volume intake must be managed restrictively the concentration of vancomycin in the final solution for infusion may increase to up to 10 mg/ml. The vancomycin concentrate may be further diluted with the following solutions for infusion: 5% glucose solution, 0.9% sodium chloride solution, Ringer Lactate solution, 3.3% glucose solution and 0.3% sodium chloride solution Oral solution The contents of one vial can be dissolved with 500 mg vancomycin in 30 ml water or with 1,000 mg vancomycin in 60 ml water. A taste corrector may be added to this preparation. Unused medicine or waste material must be disposed of in accordance with national requirements. Other information Therapeutic blood levels should be between 30 and 40 mg/l one hour after the end of the infusion, the trough levels between 5 and 10 mg/l. Regular checking of blood levels is indicated in longer periods of use, especially in patients with impaired renal function or impairment of hearing ability and in concomitant administration of ototoxic and/or nephrotoxic substances. Incompatibilities Incompatibilities occurred in the mixing of solutions of vancomycin with the following substances: Aminophylline; barbiturates; benzyl penicillins; chloramphenicol hydrogen succinate sodium salt, chlorothiazide sodium; dexamethasone-21-dihydrogenphosphate disodium salt; heparin sodium; hydrocortisone-21-hydrogen succinate sodium salt; methicillin sodium; sodium bicarbonate; nitrofurantoin sodium; Novobiocin sodium; phenytoin sodium; sulfadiazine sodium; sulfafurazole diethanolamine. 7

8 The preparations should be administered separately in the case of combination treatment of vancomycin with other antibiotics/chemotherapy agents. Vancomycin solutions have a low ph value ( ). When other injectable substances are added there may therefore be chemical or physical incompatibility, which may manifest by clouding of the solution or precipitation of the substances. Storage Concentrate Shelf life after reconstitution with water for injections: Chemical and physical stability were demonstrated for 14 days at 5 C and for 24 hours at 25 C. Solution for infusion Shelf life after dilution in 5% glucose solution; 0.9% sodium chloride solution; Ringer lactate solution or 3.3% glucose solution and 0.3% sodium chloride solution: Chemical and physical stability were demonstrated for 96 hours at 5 C and for 24 hours at 25 C. Oral solution The solution for oral use is to be used immediately after preparation. From a microbiological point of view the product should be used immediately. If it is not used immediately, the user is responsible for the period and the conditions of storage before use, which should not normally exceed 24 hours at 2 C to 8 C, unless the reconstitution/dilution was performed under controlled and validated aseptic conditions. 8