Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tepadina

Document Subject

Generated Narrative: MedicinalProductDefinition mp23483e68b180589da70be31f3872f1d0

identifier: http://ema.europa.eu/identifier/EU/1/10/622/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TEPADINA 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-23483e68b180589da70be31f3872f1d0

identifier: http://ema.europa.eu/identifier/EU/1/10/622/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tepadina

Attesters

What is in this leaflet

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

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

TEPADINA 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. TEPADINA can be used in adults and children and adolescents.

Do not use TEPADINA

• 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 TEPADINA 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.

TEPADINA may cause another type of cancer in the future. Your doctor will discuss this risk with you.

Other medicines and TEPADINA 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 TEPADINA. You must not use TEPADINA during pregnancy.

Both women and men using TEPADINA must use effective contraceptive methods during treatment. Men should not father a child while treated with TEPADINA 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 TEPADINA.

TEPADINA 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 adverse reactions of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines. If you are affected, do not drive or use machines.

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

How TEPADINA is given TEPADINA 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, TEPADINA can cause side effects, although not everybody gets them.

The most serious side effects of TEPADINA 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.

Side effects of TEPADINA may occur with certain frequencies, which are defined 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 (BUN increase)
• 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 TEPADINA 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.

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

What TEPADINA contains

• The active substance is thiotepa. One vial contains 15 mg thiotepa. After reconstitution, each mL contains 10 mg thiotepa (10 mg/mL).
• TEPADINA does not contain any other ingredients.

What TEPADINA looks like and contents of the pack TEPADINA is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa. Each carton contains 1 vial.

Marketing Authorisation Holder and Manufacturer
ADIENNE S.r.l. S.U.
Via Galileo Galilei, 20867 Caponago (MB) Italy
Tel: +39 02 40700adienne@adienne.com

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

Belgi /Belgique/Belgien Accord Healthcare bv T l/Tel: +32 51 79 40 Lietuva Accord Healthcare AB Tel: +46 8 624 00
Accord Healthcare Polska Sp. z o.o. Te .: +48 22 577 28 Luxembourg/Luxemburg Accord Healthcare bv T l/Tel: +32 51 79 40 esk republika Accord Healthcare Polska Sp. z o.o. Tel: +48 22 577 28 Magyarorsz g Accord Healthcare Polska Sp. z o.o. Tel.: +48 22 577 28 Danmark Accord Healthcare AB Tlf: + 46 8 624 00 Malta Accord Healthcare Ireland Ltd Tel: +44 (0) 208 901 3Deutschland Accord Healthcare GmbH Tel: +49 89 700 9951 0 Nederland Accord Healthcare B.V. Tel: +31 30 850 6Eesti Accord Healthcare AB Tel: +46 8 624 00 Norge Accord Healthcare AB Tlf: + 46 8 624 00
Accord Healthcare Italia Srl : + 39 02 943 23 sterreich Accord Healthcare GmbH Tel: +43 (0)662 424899-0

Espa a Accord Healthcare S.L.U. Tel: +34 93 301 00 Polska Accord Healthcare Polska Sp. z o.o. Tel.: +48 22 577 28 France Accord Healthcare France SAS T l: +33 (0)320 401 Portugal Accord Healthcare, Unipessoal Lda Tel: +351 214 697 Hrvatska
Accord Healthcare Polska Sp. z o.o. Tel: +48 22 577 28 Rom nia Accord Healthcare Polska Sp. z o.o. Tel: +48 22 577 28 Ireland Accord Healthcare Ireland Ltd Tel: +44 (0)1271 385Slovenija Accord Healthcare Polska Sp. z o.o. Tel: +48 22 577 28 sland Accord Healthcare AB S mi: + 46 8 624 00 Slovensk republika Accord Healthcare Polska Sp. z o.o. Tel: +48 22 577 28 Italia Accord Healthcare Italia Srl Tel: +39 02 943 23 Suomi/Finland Accord Healthcare Oy Puh/Tel: + 358 10 231 4
Accord Healthcare S.L.U. : + 34 93 301 00 Sverige Accord Healthcare AB Tel: + 46 8 624 00 Latvija Accord Healthcare AB Tel: +46 8 624 00 United Kingdom (Northern Ireland)
Accord-UK Ltd Tel: +44 (0)1271 385This leaflet was last revised in

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