Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - thiotepa

Document Subject

Generated Narrative: MedicinalProductDefinition mpf26848c5b2f5c977d1dab0f1db6d241e

identifier: http://ema.europa.eu/identifier/EU/1/21/1536/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Thiotepa Riemser 15 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

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f26848c5b2f5c977d1dab0f1db6d241e

identifier: http://ema.europa.eu/identifier/EU/1/21/1536/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - thiotepa

Attesters

What is in this leaflet

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

Thiotepa Riemser contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.

Thiotepa Riemser is used to prepare patients for bone marrow transplantation. It works by destroying bone marrow cells. This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells. Thiotepa Riemser can be used in adults and children and adolescents.

Do not use Thiotepa Riemser

• if you are allergic to thiotepa,
• if you are pregnant or think you may be pregnant,
• if you are breast-feeding,
• if you are receiving yellow fever vaccination, live virus and bacterial vaccines.

Warning and precautions You should tell your doctor if you have:

• liver or kidney problems,
• heart or lung problems,
• seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).

Because Thiotepa Riemser destroys bone marrow cells responsible for producing blood cells, regular blood tests will be taken during treatment to check your blood cell counts.

In order to prevent and manage infections, you will be given anti-infectives.

Thiotepa Riemser may cause another type of cancer in the future. Your doctor will discuss this risk with you. Other medicines and Thiotepa Riemser Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility You must tell your doctor if you are pregnant or you think you may be pregnant before you receive Thiotepa Riemser. You must not use Thiotepa Riemser during pregnancy.

Both women and men using Thiotepa Riemser must use effective contraceptive methods during treatment. Men should not father a child while treated and during the year after cessation of treatment.

It is not known whether this medicinal product is excreted in breast milk. As a precautionary measure, women must not breast-feed during treatment with Thiotepa Riemser.

Thiotepa Riemser can impair male and female fertility. Male patients should seek advice for sperm preservation before therapy is started.

Driving and using machines It is likely that certain side effects of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines. If you notice such side effects, do not drive or use machines.

Your doctor will calculate the dose according to your body surface or weight and your disease.

How Thiotepa Riemser is given Thiotepa Riemser is administered by a qualified healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial. Each infusion will last 2 - 4 hours.

Frequency of administration You will receive your infusions every 12 or 24 hours. The duration of treatment can last up to 5 days. Frequency of administration and duration of treatment depend on your disease.

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

The most serious side effects of Thiotepa Riemser therapy or the transplant procedure may include

• decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
• infection
• liver disorders including blocking of a liver vein
• the graft attacks your body (graft versus host disease)
• respiratory complications Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.

Other side effects of Thiotepa Riemser, which may occur with certain frequencies, are listed as follows:

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

• increased susceptibility to infection
• whole-body inflammatory state (sepsis)
• decreased counts of white blood cells, platelets and red blood cells (anaemia)
• the transplanted cells attack your body (graft versus host disease)
• dizziness, headache, blurred vision
• uncontrolled shaking of the body (convulsion)
• sensation of tingling, pricking or numbness (paraesthesia)
• partial loss of movement
• cardiac arrest
• nausea, vomiting, diarrhoea
• inflammation of the mucosa of the mouth (mucositis)
• irritated stomach, gullet, intestine
• inflammation of the colon
• anorexia, decreased appetite
• high glucose in the blood
• skin rash, itching, shedding
• skin colour disorder (do not confuse with jaundice - see below)
• redness of the skin (erythema)
• hair loss
• back and abdominal pain, pain
• muscle and joint pain
• abnormal electrical activity in the heart (arrhythmia)
• inflammation of lung tissue
• enlarged liver
• altered organ function
• blocking of a liver vein (veno-occlusive disease, VOD)
• yellowing of the skin and eyes (jaundice)
• hearing impaired
• lymphatic obstruction
• high blood pressure
• increased liver, renal and digestive enzymes
• abnormal blood electrolytes
• weight gain
• fever, general weakness, chills
• bleeding (haemorrhage)
• nasal bleeding
• general swelling due to fluid retention (oedema)
• pain or inflammation at the injection site
• eye infection (conjunctivitis)
• decreased sperm cell count
• vaginal bleeding
• absence of menstrual periods (amenorrhea)
• memory loss
• delaying in weight and height increase
• bladder disfunction
• underproduction of testosterone
• insufficient production of thyroid hormone
• deficient activity of the pituitary gland
• confusional state

Common side effects (may affect up to 1 in 10 people)

• anxiety, confusion
• abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm)
• creatinine elevated
• allergic reactions
• occlusion of a blood vessel (embolism)
• heart rhythm disorder
• heart inability
• cardiovascular inability
• oxygen deficiency
• fluid accumulation in the lungs (pulmonary oedema)
• pulmonary bleeding
• respiratory arrest
• blood in the urine (haematuria) and moderate renal insufficiency
• inflammation of the urinary bladder
• discomfort in urination and decrease in urine output (disuria and oliguria)
• increase in the amount of nitrogen components in the blood stream
• cataract
• inability of the liver
• cerebral haemorrhage
• cough
• constipation and upset stomach
• obstruction of the bowel
• perforation of stomach
• changes in muscle tone
• gross lack of coordination of muscle movements
• bruises due to a low platelet count
• menopausal symptoms
• cancer (second primary malignancies)
• abnormal brain function
• male and female infertility

Uncommon side effects (may affect up to 1 in 100 people)

• inflammation and exfoliation of the skin (erythrodermic psoriasis)
• delirium, nervousness, hallucination, agitation
• gastrointestinal ulcer
• inflammation of the muscular tissue of the heart (myocarditis)
• abnormal heart condition (cardiomyopathy)

Not known (frequency cannot be estimated from the available data)

• increased blood pressure in the arteries (blood vessels) of the lungs (pulmonary arterial hypertension)
• severe skin damage (e.g. severe lesions, bullae, etc.) potentially involving the full body surface which can be even life-threatening
• damage to a component of the brain (the so-called white matter) which can be even life- threatening (leukoencephalopathy)

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

Store and transport refrigerated (2 C 8 C). Do not freeze.

After reconstitution the product is stable for 8 hours when stored at 2 C 8 C.

After dilution the product is stable for 24 hours when stored at 2 C 8 C and for 4 hours when stored at 25 C. From a microbiological point of view, the product should be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements.

What Thiotepa Riemser contains

Thiotepa Riemser 15 mg powder for concentrate for solution for infusion

• The active substance is thiotepa. One vial contains 15 mg thiotepa. After reconstitution, each mL contains 10 mg thiotepa (10 mg/mL).

Thiotepa Riemser 100 mg powder for concentrate for solution for infusion

• The active substance is thiotepa. One vial contains 100 mg thiotepa. After reconstitution, each mL contains 10 mg thiotepa (10 mg/mL).

• Thiotepa Riemser does not contain any other ingredients.

What Thiotepa Riemser looks like and contents of the pack

Thiotepa Riemser 15 mg powder for concentrate for solution for infusion Thiotepa Riemser is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.

Thiotepa Riemser 100 mg powder for concentrate for solution for infusion Thiotepa Riemser is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.

Each carton contains 1 vial.

Marketing Authorisation Holder
Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-14199 Berlin
Germany

Manufacturer HWI pharma services GmbH Stra burger Str. 77767 Appenweier Germany

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

Belgi /Belgique/Belgien Eurocept Pharmaceuticals Pays-Bas/Nederland/Niederlande T l/Tel: +31 35 528 8info@eurocept.nl

Lietuva UAB ARMILA Lietuva Tel: +370 (0) 5 2777info@armila.com

Thrive Pharma Ltd.

Te .: +359 2 878 05 office@thrivepharmabg.com

Luxembourg/Luxemburg Eurocept Pharmaceuticals Pays-Bas/Nederland/Niederlande T l/Tel: +31 35 528 8info@eurocept.nl

esk republika LERAM pharmaceuticals s.r.o. esk republika Tel: +420 513 035 info@leram-pharma.cz Magyarorsz g SANATIS Europe Kft. Magyarorsz g Tel.: +36 (0) 23 367 office@sanatis.hu Danmark Abacus Medicine A/S Danmark Tlf: +44 (0) 203 630 1amps-medinfo@abacusmedicine.com
Malta Esteve Pharmaceuticals GmbH
Il- ermanja Tel: +49 (0) 30 338427-0 info.germany@esteve.com

Deutschland Esteve Pharmaceuticals GmbH Deutschland Tel: +49 (0) 30 338427-0 info.germany@esteve.com

Nederland Eurocept Pharmaceuticals Nederland Tel: +31 35 528 8info@eurocept.nl

Eesti AUXILIA Pharma O
Eesti Tel: +372 605 00 info@auxiliapharma.eu

Norge Abacus Medicine A/S Danmark Tlf: +44 (0) 203 630 1amps-medinfo@abacusmedicine.com

Esteve Pharmaceuticals GmbH

: +49 (0) 30 338427-0 info.germany@esteve.com

sterreich AGEA Pharma GmbH sterreich Tel: +43 (0) 1 336 01 office@ageapharma.com

Espa a Esteve Pharmaceuticals, S.A. Espa a Tel: +34 93 446 60 Polska COPHARMA JOSEPH RAKOTO Polska Tel.: +48 691 702 joseph.rakoto@copharma.pl

France Esteve Pharmaceuticals S.A.S France T l: +33 1 42 31 07 contact-france@esteve.com

Portugal Esteve Pharmaceuticals Laborat rio Farmac utico, Limitada
Portugal Tel: +34 93 446 60 Hrvatska MEDIS Adria d.o.o. Hrvatska Tel: +385 1 2303 info@medisadria.hr Rom nia Esteve Pharmaceuticals GmbH Germania Tel: +49 (0) 30 338427-0 info.germany@esteve.com

Ireland Esteve Pharmaceuticals GmbH
Germany Tel: +49 (0) 30 338427-0 info.germany@esteve.com Slovenija MEDIS d.o.o. Slovenija Tel: +386 (0) 1 589 69 info@medis.si

sland Abacus Medicine A/S Danm rk S mi: +44 (0) 203 630 1amps-medinfo@abacusmedicine.com

Slovensk republika LERAM pharmaceuticals s.r.o. esk republika Tel: +420 513 035 info@leram-pharma.cz Italia Esteve Pharmaceuticals S.r.l.
Italia info.italy@esteve.com

Suomi/Finland Abacus Medicine A/S Tanska Puh/Tel: +44 (0) 203 630 1amps-medinfo@abacusmedicine.com

MA Pharmaceuticals Trading Ltd.

: +357 25 587regulatory@mapharmagroup.com Sverige Abacus Medicine A/S Danmark Tel: +44 (0) 203 630 1amps-medinfo@abacusmedicine.com

Latvija Auxilia Pharma O
Estija Tel: +372 605 00 info@auxiliapharma.eu United Kingdom (Northern Ireland) Esteve Pharmaceuticals GmbH
Germany Tel: +49 (0) 30 338427-0 info.germany@esteve.com

This leaflet was last revised in {MM/YYYY}.

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