Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - mylotarg

Document Subject

Generated Narrative: MedicinalProductDefinition mp7cf956e7748c0ba411215481856f48ab

identifier: http://ema.europa.eu/identifier/EU/1/18/1277/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: MYLOTARG 5 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-7cf956e7748c0ba411215481856f48ab

identifier: http://ema.europa.eu/identifier/EU/1/18/1277/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - mylotarg

Attesters

What is in this leaflet

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

MYLOTARG contains the active substance gemtuzumab ozogamicin, an anticancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. This substance is delivered to cancer cells by the monoclonal antibody. A monoclonal antibody is a protein which recognises certain cancer cells.

MYLOTARG is used to treat a certain type of blood cancer called acute myeloid leukaemia (AML) in which the bone marrow makes abnormal white blood cells. MYLOTARG is intended for the treatment of AML for patients aged 15 years and above who have not tried other treatments. MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL).

MYLOTARG should not be given if you:

are allergic to gemtuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
When you first receive this medicine and during the course of treatment, tell your doctor or nurse if you: have or ever had liver problems: MYLOTARG may cause, during or after treatment, a potentially life-threatening condition called hepatic venoocclusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots which may lead to fluid retention, rapid weight gain, increased liver size (which may be painful), and ascites (excessive accumulation of fluid in the abdominal cavity).
allergic reaction: experience a high-pitched whistling sound during breathing (wheezing), difficult breathing, shortness of breath or cough with or without mucous, hives, itching, swelling, or feeling fever and chills (signs of an infusion related reaction) during or shortly after the MYLOTARG infusion. infection: have or think you have, an infection, develop chills or shivering, or feel warm, or have fever. Some infections may be serious and may be life-threatening. bleeding: have unusual bleeding, bleeding from your gums, bruising easily or getting nose bleeds on a regular basis.

anaemia: have headaches, feel tired, experience dizziness, or look pale .

infusion reaction: experience during or shortly after MYLOTARG infusion symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome).

Children and adolescents MYLOTARG must not to be used in children and adolescents under 15 years of age because limited data are available in this population.

Other medicines and MYLOTARG Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before you are given this medicine.

You must avoid becoming pregnant or fathering a child because of potential adverse effects on the child. Women must use 2 methods of effective contraception during treatment and for at least 7 months after the last dose of treatment. Men must use 2 methods of effective contraception during treatment and for at least 4 months after the last dose of treatment. Contact your doctor immediately if you or your partner becomes pregnant while taking this medicine.

Seek advice regarding fertility preservation before treatment.

If you need treatment with MYLOTARG, you must stop breast-feeding during treatment and for at least 1 month after treatment. Talk to your doctor.

Driving and using machines If you feel unusually tired, dizzy or have a headache (these are very common side effects of MYLOTARG) you should not drive or use machines.

MYLOTARG contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially sodium- free .

A doctor or nurse will give you MYLOTARG through a drip in your vein (intravenous infusion) gradually over 2 hours. Your doctor will decide on the correct dose. Your doctor or nurse may change your dose, interrupt, or completely stop treatment with MYLOTARG if you have certain side effects. Your doctor may lower your dose based on your response to treatment. Your doctor will do blood tests during the treatment to check for side effects and for response to treatment. Before you receive MYLOTARG, you will be given some medicines to help reduce symptoms such as fever and chills, known as infusion reactions, during or shortly after the MYLOTARG infusion.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of the side effects could be serious and may occur during or after treatment with MYLOTARG. Immediately contact your doctor or nurse if you experience any of the following serious side effects (see also section 2 What you need to know before you are given MYLOTARG ):

Liver problems Tell your doctor right away if you have rapid weight gain, feel pain in the upper right side of your abdomen, have accumulation of fluid causing abdominal swelling. Your doctor may do blood tests and find abnormalities in liver blood tests, which might be signs of a potentially life-threatening condition called venoocclusive liver disease.

Bleeding (signs of a low number of blood cells known as platelets) Tell your doctor right away if you bruise easily or get nose bleeds on a regular basis, or have black tarry stools, coughing up of blood, bloody sputum, feeling dizzy, fainting, or confusion.

Infections (signs of a low number of white blood cells known as neutrophils) Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening.

Complication known as tumour lysis syndrome Tell your doctor right away if you experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.

Infusion reactions Medicines of this type (monoclonal antibodies) can cause infusion reactions such as a rash, shortness of breath, difficulty breathing, a tight chest, chills or fever, back pain.

Side effects include:

Very common (may affect more than 1 in 10 people):

Infections (including serious infections)

Reduced number of blood platelets (cells that help blood to clot)

Reduced number of white blood cells which may result in general weakness and a tendency to develop infections

Reduced number of red blood cells (anaemia) which may result in fatigue and shortness of breath

High blood sugar

Decreased appetite

Headache

Rapid heartbeat

Bleeding

Low blood pressure

High blood pressure

Shortness of breath

Vomiting

Diarrhoea

Pain in the abdomen

Feeling sick (nausea)

Mouth inflammation

Constipation

Abnormalities in liver blood tests (which can be indicators of liver injury)

Skin rash

Fever

Oedema (excess fluid in body tissue, causing swelling of the hands and feet)

Fatigue

Chills

Changes in the levels of different enzymes in the blood (may show in your blood tests)

Prolonged clotting time (which may result in prolonged bleeding)

High level of uric acid in the blood

Common (may affect up to 1 in 10 people):

Signs of an infusion reaction, such as a rash, shortness of breath, difficulty breathing, a tight chest, chills or fever, back pain during or after MYLOTARG infusion

Signs of an enlarged liver (hepatomegaly), such as an enlarged belly

Abnormal liver function

Excessive accumulation of fluid in the abdomen/stomach

Indigestion

Inflammation of the oesophagus (swallowing tube)

Liver venoocclusive disease (VOD), which includes signs of enlarged liver, pain in the upper right belly, yellowing of the skin and the whites of the eyes, accumulation of fluid in the abdomen, weight gain, abnormal liver blood tests

Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)

Redness of the skin

Itchy skin

Organ failure

Uncommon (may affect up to 1 in 100 people):

Liver failure

Budd-Chiari syndrome, which includes pain in the upper right part of the belly, an abnormally large liver, and/or accumulation of fluid in the belly associated with blood clots in the liver. Symptoms may also include feeling sick (nausea) and/or vomiting.

Frequency unknown (frequency cannot be estimated from the available data):

Interstitial pneumonia (inflammation of the lungs causing coughing and difficulty breathing)

Inflammation of the bowel in association with low white blood cell counts

Inflammation of the urinary bladder resulting in bleeding from the bladder

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.

MYLOTARG will be stored by the health professionals at the hospital or clinic.

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 vial label and carton after EXP. The expiry date refers to the last day of that month.

Unopened vial: Store in a refrigerator (2 C 8 C). Do not freeze. Store the vial in the original carton to protect from light.

Reconstituted and diluted solution: Protect the reconstituted and diluted MYLOTARG solutions from light. The solutions should be used immediately. Do not freeze the reconstituted or diluted solution.

If not used immediately:

Following reconstitution, the original vial may be stored up to 16 hours in a refrigerator (2 C 8 C) or up to 3 hours at room temperature (below 30 C).

The diluted solution may be stored up to 18 hours in a refrigerator (2 C 8 C) and up to 6 hours at room temperature (below 30 C). The allowed time at room temperature (below 30 C) includes the time required for preparation of the diluted solution, equilibration, if needed, and administration. The maximum time from preparation of the diluted solution through administration should not exceed hours.

Do not use this medicine if you notice any particulate matter or discolouration prior to administration.

Do not throw away any medicines via wastewater or household waste. Ask your doctor how to throw away medicines you no longer use. These measures will help protect the environment.

What MYLOTARG contains

The active substance is gemtuzumab ozogamicin.

One vial contains 5 mg gemtuzumab ozogamicin.

After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.

The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous. See section 2, MYLOTARG contains sodium .

What MYLOTARG looks like and contents of the pack

MYLOTARG is a powder for concentrate for solution for infusion. It is supplied as white to off-white cake or powder.

Each carton contains 1 amber glass vial, with rubber stopper and crimp seal with flip-off cap.

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium

Manufacturer

Pfizer Service Company BV Hoge Wei 1930, Zaventem Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4
,

.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel: +36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055 51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer Tel: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550-520
Pfizer . . (Cyprus Branch) : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: + 371 670 35 This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: