Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - simulect

Document Subject

Generated Narrative: MedicinalProductDefinition mp8922f58fa03c5bb0f5736b85deead4c0

identifier: http://ema.europa.eu/identifier/EU/1/98/084/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Simulect 20 mg powder and solvent for solution for injection or 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-8922f58fa03c5bb0f5736b85deead4c0

identifier: http://ema.europa.eu/identifier/EU/1/98/084/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - simulect

Attesters

What is in this leaflet

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

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, adolescents and children who are having a kidney transplant. Immunosuppressants reduce the body s response to anything that it sees as foreign which includes transplanted organs. The body s immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs.

You will only be given two doses of Simulect. These will be given in hospital, around the time of your transplant operation. Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely. You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.

Follow your doctor s instructions carefully. If you are unsure about anything, ask your doctor, nurse or pharmacist.

You must not be given Simulect

• if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6 under What Simulect contains . Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past.
• if you are pregnant or breast-feeding.

Warnings and precautions Talk to your doctor, nurse or pharmacist before you are given Simulect:

• if you have previously received a transplant that failed after only a short time or,
• if you have previously been in the operating theatre for a transplantation that in the end was not performed.

In this situation, you may have received Simulect. Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.

If you need to have a vaccination, seek your doctor s advice first.

Other medicines and Simulect Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Older patients (aged 65 years and over) Simulect can be given to older patients, but the information available is limited. Your doctor may discuss this with you before you are given Simulect.

Children and adolescents (aged 1 to 17 years) Simulect can be given to children and adolescents. The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.

Pregnancy and breast-feeding It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant. You must not be given Simulect if you are pregnant. You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect. If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.

You should also tell your doctor if you are breast-feeding. Simulect may harm your baby. You must not breast-feed after being given Simulect or up to 4 months after the second dose.

Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.

Driving and using machines There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.

Simulect contains sodium and potassium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium- free .

This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially potassium-free .

You will only be given Simulect if you are receiving a new kidney. Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20 30 minutes or as an intravenous injection using a syringe.

If you have experienced a severe allergic reaction to Simulect or if you had complications after your surgery such as graft loss, the second dose of Simulect should not be given to you.

The first dose is given just before the transplant operation, and the second dose 4 days after the operation.

Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection.

Usual dose for children and adolescents (aged 1 to 17 years)

• For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg.
• For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg.

If you are given too much Simulect An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer. Your doctor will watch out for any effects on your immune system and treat them if necessary.

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

Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine.

Sudden severe allergic reactions have been reported in patients treated with Simulect. If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, sneezing, wheezing or trouble breathing, severely decreased urine output, or fever and flu-like symptoms, tell your doctor or nurse immediately.

In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.

In children, the most commonly reported side effects were constipation, excessive growth of normal hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections.

Reporting of side effects If you get any side effects, talk to your doctor, nurse 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 this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C).

What Simulect contains

• The active substance is basiliximab. Each vial contains 20 mg of basiliximab.
• The other ingredients are potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine. What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 20 mg of basiliximab. It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections. This solvent is used to dissolve the powder before it is given to you.

Simulect is also available in vials with 10 mg basiliximab.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Novartis Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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