Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - saphnelo

Document Subject

Generated Narrative: MedicinalProductDefinition mp44b9456eb2913b31231c4ec15c3a0e75

identifier: http://ema.europa.eu/identifier/EU/1/21/1623/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Saphnelo 300 mg 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

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-44b9456eb2913b31231c4ec15c3a0e75

identifier: http://ema.europa.eu/identifier/EU/1/21/1623/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - saphnelo

Attesters

What is in this leaflet

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

What Saphnelo is Saphnelo contains the active substance anifrolumab, a monoclonal antibody (a type of specialised protein that attaches to a specific target in the body). What Saphnelo is used for Saphnelo is used to treat moderate to severe lupus (systemic lupus erythematosus, SLE) in adults whose disease is not well controlled by standard therapies ( oral corticosteroids , immunosuppressants and/or antimalarials ). You will be given Saphnelo as well as your standard therapy for lupus. Lupus is a disease in which the system that fights infections (the immune system) attacks your own cells and tissues. This causes inflammation and organ damage. It can affect almost any organ in the body, including skin, joints, kidneys, brain and other organs. It can cause pain, rashes, swelling in joints, fevers and make you feel very tired or weak. How Saphnelo works People with lupus have high levels of proteins called type I interferons which stimulate the activity of the immune system. Anifrolumab attaches to a target (receptor) that these proteins act on, stopping them from working. Blocking their action in this way can reduce the inflammation in your body that causes the signs of lupus. The benefits of using Saphnelo Saphnelo may help to reduce your lupus disease activity and reduce the number of lupus flares you have. If you are taking medicines called oral corticosteroids , using Saphnelo may also allow your doctor to reduce the daily dose of oral corticosteroids that is needed to help control your lupus.

You should not be given Saphnelo

if you are allergic to anifrolumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor or nurse if you are not sure. Warnings and precautions Talk to your doctor or nurse before you are given Saphnelo:

if you think you have had an allergic reaction to this medicine at any time (see below under Look out for signs of serious allergic reactions and infections ).

if you get an infection or have symptoms of an infection (see below under Look out for signs of serious allergic reactions and infections ).

if you have a long-term infection or if you have an infection that keeps coming back.

if your lupus affects your kidneys or nervous system.

if you have, or have had, cancer.

if you have recently had an immunisation (vaccine) or plan to have one. You should not be given certain types of vaccines ( live or live attenuated vaccines) while being treated with this medicine.

if you are receiving another biologic medicinal product (such as belimumab for your lupus). If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given Saphnelo. Look out for signs of serious allergic reactions and infections Saphnelo may cause serious allergic reactions (anaphylaxis) see section 4. Get medical attention immediately if you think you may be having a serious allergic reaction. Signs may include:

swelling of your face, tongue, or mouth

breathing difficulties

feeling faint, dizzy or lightheaded (due to a drop in blood pressure). You may be more at risk of getting an infection when you are being treated with Saphnelo. Tell your doctor or nurse as soon as possible if you notice signs of any possible infection, including:

fever or flu-like symptoms

muscle aches

cough or feeling short of breath (these may be signs of an infection in your airways, see section 4)

burning when you urinate or passing urine more often than usual

diarrhoea or stomach pain

red skin rash that can cause pain and burning (this may be a sign of shingles, see section 4). Children and adolescents Do not give this medicine to children and adolescents less than 18 years of age because it has not been studied in this age group. Other medicines and Saphnelo

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using this medicine. If you are not sure, talk to your doctor or nurse before and during treatment with Saphnelo. Pregnancy and Breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy It is not known if Saphnelo can harm your unborn baby.

Before you start treatment with Saphnelo, tell your doctor if you are pregnant or think you may be pregnant. Your doctor will decide if you can be given this medicine.

Talk to your doctor if you plan to become pregnant while being treated with this medicine.

If you become pregnant while being treated with Saphnelo, tell your doctor. They will discuss with you whether you should stop treatment with this medicine. Breast-feeding

Before you start treatment with Saphnelo, tell your doctor if you are breast-feeding. It is not known whether this medicine is passed into breast milk. Your doctor will discuss with you whether you should stop treatment with this medicine while you are breast-feeding, or if you should stop breast-feeding. Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.

A nurse or doctor will give you Saphnelo.

The recommended dose is 300 mg.

It is given through a drip into a vein (intravenous infusion) over 30 minutes.

It is given every 4 weeks. If you miss an appointment to get Saphnelo call your doctor as soon as possible to make another appointment. Stopping treatment with Saphnelo Your doctor will decide if you need to stop being treated with this medicine. 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. Serious allergic reactions: Serious allergic reactions (anaphylaxis) are uncommon (may affect up to 1 in 100 people). Get medical attention immediately, or go to the nearest emergency department, if you get any of the following signs of a serious allergic reaction:

swelling of your face, tongue, or mouth

breathing difficulties

feeling faint, dizzy or lightheaded (due to a drop in blood pressure). Other side effects: Tell your doctor or nurse if you get any of the following side effects. Very common (may affect more than 1 in 10 people)

infections of the nose or throat

chest infection (bronchitis) Common (may affect up to 1 in 10 people)

infections of the sinuses or lungs

shingles (herpes zoster) - a red skin rash that can cause pain and burning

allergic (hypersensitivity) reactions

infusion reactions - can happen at the time of the infusion or shortly after; symptoms may include headache, feeling sick (nausea), being sick (vomiting), feeling very tired or weak (fatigue) and feeling dizzy 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.

The doctor, nurse or pharmacist is responsible for storing this medicine. The storage details are as follows:

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.

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 C 8 C).

Do not freeze or shake.

Store in the original package to protect from light.

What Saphnelo contains

The active substance is anifrolumab. Each vial contains 300 mg anifrolumab.

The other ingredients are histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate, polysorbate 80 and water for injections. What Saphnelo looks like and contents of the pack Saphnelo is supplied as a clear to opalescent, colourless to slightly yellow concentrate solution. Saphnelo is available in packs containing 1 vial. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: