Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cresemba

Document Subject

Generated Narrative: MedicinalProductDefinition mp061484b9147260e88c643074459451f5

identifier: http://ema.europa.eu/identifier/EU/1/15/1036/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CRESEMBA 200 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-061484b9147260e88c643074459451f5

identifier: http://ema.europa.eu/identifier/EU/1/15/1036/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cresemba

Attesters

What is in this leaflet

1. What Cresemba is and what it is used for
2. What you need to know before you use Cresemba
3. How to use Cresemba
4. Possible side effects
5. How to store Cresemba
6. Contents of the pack and other information

What Cresemba is Cresemba is an anti-fungal medicine that contains the active substance isavuconazole. How Cresemba works Isavuconazole works by killing or stopping the growth of the fungus, which causes the infection. What Cresemba is used for Cresemba is used in adults to treat the following fungal infections:

invasive aspergillosis, caused by a fungus in the Aspergillus group;

mucormycosis, caused by a fungus belonging to the Mucorales group in patients for whom a treatment with amphotericin B is not appropriate.

Do not use Cresemba:

if you are allergic to isavuconazole or any of the other ingredients of this medicine (listed in section 6),

if you have a heart beat problem called familial short QT syndrome ,

if you are using any of the following medicines:

ketoconazole, used for fungal infections,

high doses of ritonavir (more than 200 mg every 12 hours), used for HIV,

rifampicin, rifabutin, used for tuberculosis,

carbamazepine, used for epilepsy,

barbiturate medicines like phenobarbital, used for epilepsy and sleep disorders,

phenytoin, used for epilepsy,

St John s wort, a herbal medicine used for depression,

efavirenz, etravirine, used for HIV,

nafcillin, used for bacterial infections. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Cresemba:

if you have had an allergic reaction to other azole anti-fungal treatments in the past, such as ketoconazole, fluconazole, itraconazole, voriconazole or posaconazole,

if you are suffering from severe liver disease. Your doctor should monitor you for possible side effects. Look out for side effects Stop using Cresemba and tell your doctor straight away if you notice any of the following side effects:

sudden wheezing, difficulty breathing, swelling of the face, lips, mouth or tongue, severe itching, sweating, dizziness or fainting, fast heartbeat or pounding in the chest these may be signs of a severe allergic reaction (anaphylaxis). Problems while having Cresemba as drip into a vein Tell your doctor straight away if you notice any of the following side effects:

low blood pressure, feel short of breath, nausea, dizziness, headache, tingling your doctor may decide to stop the infusion. Changes in your liver function Cresemba can sometimes affect your liver function. Your doctor may carry out blood tests while you are taking this medicine. Skin problems Tell your doctor straight away if you get severe blistering of the skin, mouth, eyes or genitals. Children and adolescents Cresemba should not be used in children or adolescents younger than 18 years because there is no information on use in this age group. Other medicines and Cresemba Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines may affect the way Cresemba works or Cresemba may affect the way they work, if they are taken at the same time. In particular, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines:

ketoconazole, used for fungal infections,

high doses of ritonavir (more than 200 mg every 12 hours), used for HIV,

rifampicin, rifabutin, used for tuberculosis,

carbamazepine, used for epilepsy,

barbiturate medicines like phenobarbital, used for epilepsy and sleep disorders,

phenytoin, used for epilepsy,

St John s wort, a herbal medicine used for depression,

efavirenz, etravirine, used for HIV,

nafcillin, used for bacterial infections. Unless your doctor tells you otherwise, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines:

rufinamide or other medicines which decrease the QT interval on the heart tracing (ECG),

aprepitant, used to prevent nausea and vomiting by cancer treatment,

prednisone, used for rheumatoid arthritis,

pioglitazone, used for diabetes. Tell your doctor or pharmacist if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines are still having the desired effect:

ciclosporin, tacrolimus and sirolimus, used to prevent rejection of a transplant,

cyclophosphamide, used for cancer,

digoxin, used to treat heart failure or an uneven heart beat,

colchicine, used for gout attack,

dabigatran etexilate, used to stop blood clots after hip or knee replacement surgery,

clarithromycin, used for bacterial infections,

saquinavir, fosamprenavir, indinavir, nevirapine, lopinavir/ritonavir combination, used for HIV,

alfentanil, fentanyl, used against strong pain,

vincristine, vinblastine, used for cancer,

mycophenolate mofetil (MMF), used in transplant patients,

midazolam, used for severe insomnia and stress,

bupropion, used for depression,

metformin, used for diabetes,

daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan, used for different sorts of cancer. 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 using this medicine. Do not take Cresemba if you are pregnant, unless your doctor tells you otherwise. This is because it is not known if it may affect or harm your unborn baby. Do not breast-feed if you are taking Cresemba. Driving and using machines Cresemba may make you feel confused, tired or sleepy. It can also make you pass out. Therefore, be very careful when driving or operating machines.

Cresemba will be given to you by a doctor or nurse. Starting dose for the first two days (48 hours) The recommended dose is one vial every 8 hours. Usual dose after the first two days This is started 12 to 24 hours after your last starting dose. The recommended dose is one vial once a day. You will be given this dose until your doctor tells you otherwise. The duration of treatment with Cresemba may be longer than 6 months if your doctor considers this necessary. The vial will be given as a drip into a vein by your doctor or nurse. If you use more Cresemba than you should If you think you have been given too much Cresemba, talk to your doctor or nurse straight away. You may have more side effects such as:

headache, feeling dizzy, restless or sleepy,

tingling, reduced sense of touch or sensation in the mouth,

problems being aware of things, hot flushes, anxiety, joint pain,

changes in the way things taste, dry mouth, diarrhoea, vomiting,

feeling your heart beat, faster heart rate, being more sensitive to light. If you forget to use Cresemba As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However, tell your doctor or nurse if you think that a dose has been forgotten. If you stop using Cresemba Cresemba treatment will continue for as long as your doctor tells you. This is to make sure that the fungal infection has gone. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Cresemba and tell your doctor straight away if you notice any of the following side effects:

a severe allergic reaction (anaphylaxis) such as sudden wheezing, breathing problems, swelling of the face, lips, mouth or tongue, severe itching, sweating, dizziness or fainting, fast heartbeat or pounding in the chest. Tell your doctor straight away if you notice any of the following side effects:

severe blistering of the skin, mouth, eyes or genitals. Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Common: may affect up to 1 in 10 people

low potassium in your blood,

decreased appetite,

hallucinations (delirium),

headache,

sleepiness,

inflamed veins that could lead to blood clots,

shortness of breath or sudden and severe difficulty breathing,

feeling sick (nausea), being sick (vomiting), diarrhoea, stomach pain,

changes in blood tests of liver function,

rash, itching,

kidney failure (symptoms could include swelling of legs),

chest pain, feeling tired or sleepy,

problems where the injection was given. Uncommon: may affect up to 1 in 100 people

reduced white blood cells - can increase your risk of infection and fever,

reduced blood cells called platelets - can increase your risk for bleeding or bruising,

reduced red blood cells - can make you feel weak or short of breath or make your skin pale,

severe reduction in blood cells - can make you feel weak, cause bruising or make infections more likely,

rash, swelling of your lips, mouth, tongue or throat with difficulty breathing (hypersensitivity),

low blood sugar levels,

low blood levels of magnesium,

low levels in the blood of a protein called albumin ,

not getting the right goodness from your diet (malnutrition),

depression, difficulty sleeping,

seizure, fainting or feeling faint, dizziness,

sensation of tingling, tickling, or pricking of the skin (paraesthesia),

altered mental state (encephalopathy),

changes in taste (dysgeusia),

feeling of spinning or being dizzy (vertigo),

heart beat problems - may be too fast or uneven, or extra heart beats this may show in your heart tracing (electrocardiogram or ECG),

problems with the blood circulation,

low blood pressure,

wheezing, very fast breathing, coughing up blood or blood-stained sputum, nose bleeding,

indigestion,

constipation,

feeling bloated (abdominal distension),

enlarged liver,

inflammation of the liver,

problems with the skin, red or purple spots on the skin (petechiae), inflamed skin (dermatitis), hair loss,

back pain,

swelling of the extremities,

feeling weak, very tired, or sleepy or generally out of sorts (malaise). Side effects with frequency not known:

anaphylaxis (a severe allergic reaction). 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.

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 after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C to 8 C). Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Cresemba contains

The active substance is isavuconazole. Each vial contains 372.6 mg isavuconazonium sulfate, corresponding to 200 mg isavuconazole.

The other ingredients (excipients) are mannitol (E421) and sulfuric acid. What Cresemba looks like and contents of the pack Cresemba 200 mg is presented in a single use glass vial as a powder for concentrate for solution for infusion. Marketing Authorisation Holder: Basilea Pharmaceutica Deutschland GmbH Marie-Curie-Strasse 8 79539 L rrach Germany Manufacturer: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth A91 P9KD Ireland Almac Pharma Services Limited Seagoe Industrial Estate Craigavon, Co. Armagh BT63 5UA United Kingdom (Northern Ireland) For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Pfizer SA/NV Tel/T l: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514 ,
.: +359 2 970 4Luxembourg/Luxemburg Pfizer SA/NV T l/Tel: +32 (0)2 554 62 esk republika Pfizer s.r.o. Tel: +420-283-004-Magyarorsz g Pfizer Kft. Tel.: + 36 1 488 37 Danmark Unimedic Pharma AB Tlf: +46 (0) 10-130 99 Malta Vivian Corporation Ltd. Tel: +35621 344Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Nederland Pfizer bv Tel: +31 (0)800 63 34 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7Norge Unimedic Pharma AB Tlf: +46 (0) 10-130 99
Pfizer A.E. : +30 210 67 85 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0 Espa a Pfizer S.L. Tel: +34 91 490 99 Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 France Pfizer T l: +33 (0)1 58 07 34 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Rom nia Pfizer Rom nia S.R.L. Tel: +40 (0) 21 20 728 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) +44 (0)1304 616Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 sland Unimedic Pharma AB S mi: +46 (0) 10-130 99 Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: +421-2-3355 5Italia Pfizer S.r.l. Tel: +39 06 33 18 Suomi/Finland Unimedic Pharma AB Puh/Tel: +46 (0) 10-130 99
Pfizer . . (CYPRUS BRANCH) : +357 22 817Sverige Unimedic Pharma AB Tel: +46 (0) 10-130 99 Latvija Pfizer Luxembourg SARL fili le Latvij Tel: +371 670 35 United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: