Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - topotecan

Document Subject

Generated Narrative: MedicinalProductDefinition mpc70f3196826e850a6889cb4c778ecf4a

identifier: http://ema.europa.eu/identifier/EU/1/10/633/001 – Single pack

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Topotecan Hospira 4 mg/4 ml 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-c70f3196826e850a6889cb4c778ecf4a

identifier: http://ema.europa.eu/identifier/EU/1/10/633/001 – Single pack

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - topotecan

Attesters

What is in this leaflet:

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

Topotecan Hospira helps to destroy tumours. A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.

Topotecan Hospira is used to treat:

ovarian cancer or small cell lung cancer that has come back after chemotherapy.

advanced cervical cancer if surgery or radiotherapy treatment is not possible. When treating cervical cancer, Topotecan Hospira is combined with another medicine called cisplatin.

Your doctor will decide with you whether Topotecan Hospira therapy is better than further treatment with your initial chemotherapy.

You should not receive Topotecan Hospira:

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

if you are breast-feeding

if your blood cell counts are too low. Your doctor will tell you whether this is the case, based on the results of your last blood test.

Tell your doctor if any of these applies to you.

Warnings and precautions
Before you are given this medicine your doctor needs to know:

if you have any kidney or liver problems. Your dose of Topotecan Hospira may need to be adjusted.

if you are pregnant or plan to become pregnant. See section Pregnancy and breast-feeding
below.

if you plan to father a child. See section Pregnancy and breast-feeding below.

Tell your doctor if any of these applies to you.

Other medicines and Topotecan Hospira
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription.

Remember to tell your doctor if you start to take any other medicines while you are on Topotecan Hospira.

Pregnancy and breast-feeding Topotecan is not recommended for pregnant women. It may harm a baby conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice. Do not try to become pregnant until a doctor advises you it is safe to do so.

Male patients who wish to father a child should ask their doctor for family planning advice or treatment. If your partner becomes pregnant during your treatment, tell your doctor immediately.

Do not breast-feed if you are being treated with topotecan. Do not restart breast-feeding until the doctor tells you it is safe to do so.

Driving and using machines Topotecan can make people feel tired. If you feel tired or weak, do not drive or use machines.

Topotecan Hospira contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free . If your doctor uses a solution of common salt to dilute Topotecan Hospira, the dose of sodium received would be larger.

The dose of topotecan you are given will be worked out by your doctor, based on:

your body size (surface area measured in square metres)

the results of blood tests carried out before treatment

the disease being treated.

The usual dose

Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day. You will have treatment once a day for 5 days. This pattern of treatment will normally be repeated every 3 weeks.

Cervical cancer: 0.75 mg per square metre of body surface area per day. You will have treatment once a day for 3 days. This pattern of treatment will normally be repeated every 3 weeks. When treating cervical cancer, Topotecan Hospira is combined with another medicine, called cisplatin. Your doctor will determine the correct dose of cisplatin.

The treatment may vary, depending on the results of your regular blood tests.

How topotecan is given A doctor or nurse will administer topotecan as an infusion into your arm lasting about 30 minutes.

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

Serious side effects: tell your doctor

These very common side effects may affect more than 1 in 10 people treated with Topotecan Hospira:

• Signs of infection: Topotecan may reduce the number of white blood cells and lower your resistance to infection. This can even be life threatening. Signs include:

fever

serious deterioration of your general condition

local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).

Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis)

This rare side effect may affect up to 1 in 1,000 people treated with Topotecan Hospira:

Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage. Signs include:

difficulty breathing

cough

fever

Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.

Very common side effects
These may affect more than 1 in 10 people treated with Topotecan Hospira:

Feeling generally weak and tired (temporary anaemia). In some cases you may need a blood transfusion.

Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood. This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to more severe bleeding (haemorrhage). Talk to your doctor for advice on how to minimise the risk of bleeding.

Weight loss and loss of appetite (anorexia); tiredness; weakness.

Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.

Inflammation and ulcers of the mouth, tongue or gums.

High body temperature (fever).

Hair loss.

Common side effects
These may affect up to 1 in 10 people treated with Topotecan Hospira:

Allergic or hypersensitivity reactions (including rash).

Yellow skin.

Feeling unwell.

Itching sensation.

Rare side effects
These may affect up to 1 in 1,000 people treated with Topotecan Hospira:

Severe allergic or anaphylactic reactions.

Swelling caused by fluid build-up (angioedema).

Mild pain and inflammation at the site of injection.

Itchy rash (or hives).

Side effects with frequency not known
The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):

Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).

Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).

If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Topotecan Hospira. Those effects are described in the cisplatin patient leaflet.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 Topotecan Hospira after the expiry date stated on the vial and carton after EXP.

Store in a refrigerator (2 C-8 C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

This medicine is for single use only. After opening, the product should be used immediately. If not used immediately, Topotecan Hospira can be used for up to 24 hours when stored in the fridge (protected from light) or at room temperature (in normal daylight conditions).

If visible particles are observed, the medicine should not be administered.

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 Topotecan Hospira contains The active substance in Topotecan Hospira is topotecan (as hydrochloride). 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). Each 4 ml vial of concentrate contains 4 mg topotecan (as hydrochloride).

The other ingredients are: tartaric acid (E334), water for injections and hydrochloric acid (E507) or sodium hydroxide (to adjust the pH of the solution).

What Topotecan Hospira looks like and the contents of the pack Topotecan Hospira is a clear, yellow or yellow-green concentrate for solution for infusion supplied in clear glass vials, each containing 4 ml concentrate. Topotecan Hospira is available in two pack sizes, containing either 1 vial or 5 vials. Not all pack sizes may be marketed.

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 Drugsales Ltd Tel: +356 21419070/1/2 Danmark 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 T l: +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) Tel: +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 website of the European Medicines Agency