Concentrate for Dispersion for Infusion Amphotericin B Lipid Complex
Read all of this leaflet carefully before you start using this medicinebecause it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctoror nurse. This medicine has been prescribed for youonly. Do not pass it on to others. It may harm them, even if their symptoms are the same asyours. If you get any side effects, talk toyour doctoror nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is inthis leaflet: 1. What ABELCET LIPID COMPLEXis and what it is used for 2. What you need to know before you use ABELCET LIPID COMPLEX 3. How to use ABELCET LIPID COMPLEX 4. Possible side effects 5. How to store ABELCET LIPID COMPLEX 6. Contents of the pack and otherinformation
1. What ABELCET LIPID COMPLEXis and what it is used for
Abelcet LipidComplexis a medicine to treat severe fungal infections such as blood infection with candida, aspergillus, cryptococcus, fusarium, zygomycetes, blastomycetes or coccidiodes, or cryptococcal meningitis (inflammation of the brain). Fungi are common and are found throughout nature but do not normally cause infections. However, under certain circumstances, for instance, when the body’s immune system is not working properly, a few types of fungi can infect humans. Abelcet Lipid Complex is used to treat fungalinfections in children aged 1 month to 16 years of age.
2. What you need to know before you use ABELCET LIPID COMPLEX
Do not use ABELCET LIPID COMPLEX If you are allergic to amphotericin B or any of the other ingredients of this medicine(listed in section6). Warnings and precautions Talk to your doctor or nurse before using ABELCET LIPID COMPLEX.
Your doctor may need to monitor you carefully and do some extra tests while you are being treated with ABELCET LIPID COMPLEX,particularly if you have had previous problems with your kidneys or liver. If you have a kidney problem, your doctor will perform a blood test at least once a week to check how your kidneys are working while you are receiving ABELCET LIPID COMPLEX. Children Do not give this medicine tochildren less than 1 month of age because there are no data to support its use. Other medicinesandABELCET LIPID COMPLEX Tell your doctor if you are taking, have recently taken or might takeany other medicines, including medicines obtained without a prescription.
ABELCET LIPID COMPLEXmay interact with drugs which can affect your kidney function other drugs such as zidovudine (used to treat HIV infection) or ciclosporin (a drug tosuppress your immune system). Amphotericin B has been reported to interact with the following drugs: drugs to treat cancer corticosteroids and corticotrophin (ACTH) (drugs given to treat a variety of conditions such as allergies and hormone imbalances) digitalis glycosides (used to treat heart conditions) flucytosine (used to treat fungal infections) muscle relaxants. Pregnancy, breast-feedingand fertility 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 You should avoid driving a vehicle or operating machinery after treatment with Abelcet Lipid Complexas the side effects of Abelcet Lipid Complexcould affect your ability to drive safely. Important information about some of the ingredients of ABELCET LIPID COMPLEX This medicinal product contains 0.156mmol(or 3.6mg) sodium per mL.This represents3.12mmol (or 71.8mg)sodium per 20mL vial. To be taken into consideration by patients on a controlled sodium diet.
3. How to use ABELCET LIPID COMPLEX
Method and route of administration ABELCET LIPID COMPLEXmust be diluted with a dextrose (sugar) solution before use. ABELCET LIPID COMPLEXmust be administered as an infusion to the vein. This will be given by a drip into a vein in your arm over about 2 hours.
Dosage and frequency of administration ABELCET LIPID COMPLEXwill normally be given to you by your doctor or by a nurse. The recommended daily dose is 5.0mg of ABELCET LIPID COMPLEXfor every kg of your body weight, given as a single infusion. A test dose of 1mg is given initially to see if you are sensitive to any of the ingredients. The number of days over which you will be treated depends on many factors, but will probably be at least 14days. No change in dose is required for children, elderly people and those suffering from kidney or liver disease. If you stop using ABELCET LIPID COMPLEX It is important that you follow your doctor’s instructions and receive all the medicationprescribed for you even if you feel better. If you usemore ABELCET LIPID COMPLEXthan you should You should tell your doctor immediately if you think you received too much ABELCET LIPID COMPLEX. You may experience side effects as listed in section 4 “Possible side effects”.You doctor may need to check your heart and breathing rates, your kidney andliver function, your blood cell counts or the level of potassium in your body. If you forget to useABELCET LIPID COMPLEX Do not take a double dose tomake up for a forgotten dose. You should tell your doctor immediately, he/she will decide when you should be given your next dose of ABELCET LIPID COMPLEX.
If you have any further questions on the use of this medicine, ask your doctor or nurse
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon allergic reactions (may affect 1 to 10 people in 1000) Seek medical help immediatelyif you have any of the following symptoms of a serious allergic reaction: difficulty breathing and/or feeling dizzy or faint severe itching of the skin or raised lumps on the skin swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
You should also seek urgent medical help if you have any of the following serious side effects: severe chest pain (heart attack) or difficulty breathing encephalopathy (a disease of the brain, which may cause you to become confused or behave strangely, and/or feel drowsy).
You may experience chills, fever, nausea (feeling sick), vomiting (beingsick), rash, itching, muscle pain, abdominal pain,convulsions (fits), chest pain, or low blood oxygen levels and blue lips and skin, although this will probably only occur during the infusion or in the first 2 days of treatment. Your nurse or doctor may be able to arrange some simple treatment to help control these side effects. ABELCET LIPID COMPLEXmay affect your kidney, liver or blood. Your doctor will check for these and other unwanted effects by carrying out appropriate tests, for example checking the level of potassium in your body. Very common side effects(may affectmore than 1 in10 people) Chills, fever, increased levels of a substance called creatinine in the blood. Common side effects(may affectup to 1 in 10 people) Increased heart rate, irregular heartbeat, low or high blood pressure, low blood platelets(which can lead to an increased risk of bleeding), breathing problems, asthma, nausea(feeling sick), vomiting(being sick), headache, shaking, kidneyproblems (signs include tiredness and passing less urine), kidneyfunction tests abnormal, increased ordecreased blood potassium levels(which can makeyou feel tired, confused, and have muscle weakness or cramps or make yourheart beat abnormally), decreased blood magnesium levels (which can give you“pins and needles”, muscular pains, weakness or spasms), liver function tests abnormal, rash Uncommon side effects(may affect up to 1 in 100 people) Injection site reactions, convulsions(fits), neuropathy (nerve disease) The following side effects have also been reported with the use of ABELCET LIPID COMPLEXbut it is not known how often they occur: Widespread flaking or scaling of theskin, excessive thirst and the production of large amounts of weak (watery) urine
Side effects in children and adolescents are similar to those observed in adults. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcardor search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ABELCET LIPID COMPLEX
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 labelafter EXP. Storein a refrigerator (2°C -8°C). Do not freeze. Keep vial in the outer carton.
6. Contents of the pack and other information What ABELCET LIPID COMPLEXcontains the active substance is Amphotericin B. the other ingredients are L-α-dimyristoylphosphatidylcholine (DMPC),L-αdimyristoylphosphatidylglycerol(sodium and ammonium salts)(DMPG), sodium chloride (common salt)and water for injection. What ABELCET LIPID COMPLEXlooks like and contents of the pack ABELCET LIPID COMPLEXis supplied as a yellow concentrate for suspension for infusion. Each vial contains 5mgAmphotericin B perml. Vials of 10ml contain 50 mg amphotericin B. Vials of 20 ml contain 100 mg amphotericin B. Vials are packaged in cartons of 10 vials. Not all pack sizes may be marketed. Marketing Authorisation Holder Teva Pharma B.V. Swensweg 5 2031 GA Haarlem The Netherlands
Manufacturer AndersonBrecon (UK) Limited, Wye Valley Business Park, Hay-on-Wye Hereford, HR3 5PG, UK. Or
Teva PharmaceuticalsEurope B.V. Swensweg 5 2031 GA Haarlem The Netherlands
Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath, K32 YD60
It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. We will not accept any liability for any wrong or incomplete information, nor will we accept any responsibility for the consequences arising out of the usage of the information.