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DBL™ Isethionate for Injection Pentamidine Isetionate (pen-TAM-i-deen eye-se-THIO-nate) Consumer Medicine Information What is in this leaflet is a need to consider pentamidine while you How DBL Pentamidine Isethionate are breast-feeding, your doctor will discuss for Injection is given This leaflet answers some common questions with you the benefits and risks of being about DBL Pentamidine Isethionate for given it. How much is given Injection. If you are not sure whether you should be Your doctor will decide what dose of It does not contain all the available given DBL Pentamidine Isethionate for pentamidine you will receive. This depends information. Injection, talk to your doctor or on your condition and other factors, such as It does not take the place of talking to your pharmacist. your weight. doctor or pharmacist. Before you are given it How is it given All medicines have risks and benefits. Your Tell your doctor or pharmacist if you have DBL Pentamidine Isethionate for Injection is doctor or pharmacist has weighed the risks of allergies to: given as a slow injection into a vein you being given DBL Pentamidine • any other medicines (intravenously) over a period of at least 60 Isethionate for Injection against the benefits minutes. DBL Pentamidine Isethionate for they expect it will have for you. • any other substances, such as foods, preservatives or dyes Injection must only be given by a doctor or If you have any concerns about taking this nurse. Tell your doctor or pharmacist if you have medicine, ask your doctor or pharmacist. Some patients develop sudden, severe low Keep this leaflet with the medicine. or have had any medical conditions, especially the following: pressure after a dose of pentamidine. You may need to read it again. Therefore, you should be lying down while • malnutrition you are being given pentamidine. Your blood What DBL Pentamidine Isethionate • high or low blood sugar levels pressure will be closely monitored. for injection is used for • problems How long it is given DBL Pentamidine Isethionate for Injection is • problems To treat Pneumocystis carinii pneumonia used to treat an infection called • heart problems (PCP), DBL Pentamidine Isethionate for Pneumocystis carinii pneumonia (PCP). This • blood pressure problems (high or low Injection is usually given once daily for 14 kind of pneumonia occurs commonly in blood pressure) days. patients whose immune system is not • low numbers of red blood cells, white To treat , DBL Pentamidine working normally, such as cancer patients, blood cells, or platelets. Isethionate for Injection may be given once, transplant patients, or patients with acquired twice or three times a week. immune deficiency syndrome (AIDS). If you have not told your doctor or pharmacist about any of the above, tell To treat , DBL Pentamidine DBL Pentamidine Isethionate for Injection them before you are given DBL Isethionate for Injection may be given either can also be used to treat other types of Pentamidine Isethionate for Injection. daily or on alternate days for a total of 7 to protozoal infections, such as Leishmaniasis 10 doses. and Trypanosomiasis. This medicine may cause serious reactions, sometimes leading to death, including: If you are given too much Your doctor may have prescribed DBL (overdose) Pentamidine Isethionate for Injection for • very low blood pressure, even after one another reason. dose As DBL Pentamidine Isethionate for Injection is given to you under the Ask your doctor if you have any questions • very low blood sugar supervision of your doctor, it is very about why this medicine has been • irregular heartbeat unlikely that you will receive too much. prescribed for you. • inflamed However, if you experience any severe side There is no evidence that DBL Pentamidine Taking other medicines effects after being given this medicine, tell Isethionate for Injection is addictive. Tell your doctor or pharmacist if you are your doctor immediately, telephone the This medicine is available only with a taking/using any other medicines, Poisons Information Centre (telephone 13 doctor’s prescription. including any that you buy without a 11 26) for advice, or go to the Accident prescription from your pharmacy, and Emergency department at your Before you are given DBL supermarket or health food shop. nearest hospital. Pentamidine Isethionate for injection Some medicines and pentamidine may You may need urgent medical attention. interfere with each other. These include: Symptoms of a pentamidine overdose may When you must not be given it include the side effects listed below in the You must not be given DBL Pentamidine • , a drug used to treat serious fungal infections ‘Side Effects’ section, but are usually of a Isethionate for Injection if you have an more severe nature. allergy to pentamidine. • antibiotics, such as gentamicin Symptoms of an allergic reaction to While you are being given DBL pentamidine may include: • , a drug used to treat certain Pentamidine Isethionate for Injection • shortness of breath, wheezing or types of cancer difficulty breathing • , a type of antibiotic Things you must do • swelling of the face, lips, tongue or other Medicines that are harmful to the liver, Tell any other doctors, dentists, and parts of the body kidneys or blood cells may also interfere pharmacists who are treating you that you are being given pentamidine. • rash, itching or hives on the skin. with pentamidine. These medicines may be affected by If you are about to be started on any new You should not be given DBL Pentamidine medicine, tell your doctor, dentist or Isethionate for Injection if you are pentamidine, or may affect how well it works. You may need different amounts of pharmacist that you are being given pregnant or intend to become pregnant. pentamidine. Pentamidine is not recommended for use your medicine, or you may need to take/use during . If there is a need to different medicines. Your doctor or If you plan to have surgery that needs a consider pentamidine during your pregnancy, pharmacist will advise you. general anaesthetic, tell your doctor or your doctor will discuss with you the benefits Your doctor and pharmacist may have more dentist that you are being given and risks of being given it. information on medicines to be careful with pentamidine. You should not be given DBL Pentamidine or avoid while being given pentamidine. If you become pregnant while being given Isethionate for Injection if you are breast- pentamidine, tell your doctor immediately. feeding or plan to breast-feed. Keep all of your doctor’s appointments so Pentamidine is not recommended while you that your progress can be checked. are breast-feeding, as it is not known whether Your doctor may do some tests (such as pentamidine passes into breast milk. If there blood and platelet counts, blood sugar, heart

DBL™ Pentamidine Isethionate for Injection Published by MIMS September 2021 1 rate, kidney and ) from These are very serious side effects. You may time to time to make sure the medicine is need urgent medical attention or working and to prevent unwanted side hospitalisation. effects. Other side effects not listed above may occur Things to be careful of in some patients. Be careful driving or operating machinery Tell your doctor or nurse if you notice until you know how DBL Pentamidine anything that is making you feel unwell. Isethionate for Injection affects you. Do not be alarmed by this list of possible Pentamidine may cause dizziness and light- side effects. headedness in some people. You may not experience any of them. Make sure you know how you react to Storage pentamidine before you drive a car, operate DBL Pentamidine Isethionate for Injection machinery, or do anything else that could be will generally be stored in the pharmacy or dangerous if you are dizzy or light-headed. If on the ward. The injection is kept in a cool this occurs do not drive. dry place, protected from light, where the If you drink , dizziness or light- temperature stays below 25°C. headedness may be worse. Product description Side effects What it looks like Tell your doctor or nurse as soon as DBL™ Pentamidine Isethionate for Injection possible if you do not feel well while you is a white or almost white powder. It must be are being given DBL Pentamidine dissolved and further diluted before it is Isethionate for Injection. given. This medicine helps most people with protozoal infections, but it may have Ingredients unwanted side effects in a few people. All Active ingredient: medicines can have side effects. Sometimes • pentamidine isetionate they are serious, most of the time they are There are no other ingredients. not. You may need medical treatment if you DBL Pentamidine Isethionate for Injection get some of the side effects. does not contain lactose, sucrose, gluten, Ask your doctor, pharmacist or nurse to tartrazine or any other azo dyes. answer any questions you may have. Sponsor Tell your doctor, pharmacist or nurse if you notice any of the following: Pfizer Australia Pty Ltd Sydney NSW • nausea and vomiting Toll Free Number: 1800 675 229 • taste disturbances, metallic taste www.pfizer.com.au • pain or redness at the injection site DBL Pentamidine Isethionate for Injection is • skin rash, redness, itching available in the following strength: • flushing in face 300 mg /vial AUST R 16260 • hair loss This leaflet was updated in July 2021 • hallucinations. These may be serious side effects. You may need urgent medical attention. If any of the following happen, tell your doctor or nurse immediately or, if you are not in a hospital, go to the Accident and Emergency department at your nearest hospital: • signs of an infection such as sore throat or fever • unusual bleeding or bruising • signs of high blood sugar, which may include increased urination, unusual thirst, tiredness • peeling of the skin • signs of low blood sugar, which may include trembling or shaking, light- headedness, irritability • dizziness or fainting, which may be signs of low blood pressure • slow, fast or irregular heart rate • pain in upper abdomen • less urine, change in the colour of your urine with swelling in your legs, ankles or feet • breathlessness, difficulty in breathing. • pain, swelling, redness, skin tenderness, warmth, sudden shortness of breath, chest pain (signs of blood clot) • fever, chills, headache and muscle pain (signs of Herxheimer reaction)

DBL™ Pentamidine Isethionate for Injection Published by MIMS September 2021 2