Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kanuma

Document Subject

Generated Narrative: MedicinalProductDefinition mped2ea7f84dcb14b5fa486093df321548

identifier: http://ema.europa.eu/identifier/EU/1/15/1033/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: KANUMA 2 mg/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-ed2ea7f84dcb14b5fa486093df321548

identifier: http://ema.europa.eu/identifier/EU/1/15/1033/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - kanuma

Attesters

What is in this leaflet

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

KANUMA contains the active substance sebelipase alfa. Sebelipase alfa is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats. It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).

LAL deficiency is a genetic disease that leads to liver damage, high blood cholesterol, and other complications due to a build-up of certain types of fats (cholesteryl esters and triglycerides).

How KANUMA works This medicine is an enzyme replacement therapy. This means that it replaces the missing or defective LAL enzyme in patients with LAL deficiency. This medicine works by lowering the build-up of fat that causes medical complications, including impaired growth, liver damage and heart complications. It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.

You must not be given KANUMA

• If you or your child has experienced life-threatening allergic reactions to sebelipase alfa that cannot be managed when you or your child receives the medicine again, or to egg or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If treated with KANUMA, you or your child may experience a side effect while you or your child is being given the medicine or during the hours following the infusion (see section 4). This is known as an infusion reaction which can sometimes be severe, and may include an

allergic reaction that could be life-threatening and require medical treatment. The first time that you or your child are given KANUMA you should be observed by a healthcare professional for 1 hour to watch for any signs of an infusion reaction. If you or your child experiences a severe infusion reaction like this, seek immediate medical attention. If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions. These medicines may include antihistamines, fever-reducing medicines and/or corticosteroids (a type of anti-inflammatory medicines). If the infusion reaction is severe, your doctor may stop KANUMA infusion and start giving you or your child appropriate medical treatment.

• The development of blood proteins against KANUMA, also called anti-drug antibodies, may occur during the treatment. Talk to your doctor if you experience decreased efficacy with KANUMA
• This medicine may contain egg proteins. If you or your child has an egg allergy or a history of allergies to eggs, tell your doctor or nurse (see You must not be given KANUMA).

Other medicines and KANUMA Tell your doctor if you or your child are using, have recently used or might use any other medicines.

Pregnancy There are no data from the use of sebelipase alfa in pregnant women. As a precautionary measure, you should not be given KANUMA if you are pregnant.

Breast-feeding It is not known whether sebelipase alfa passes into breast milk. Tell your doctor if you are breast- feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking KANUMA, considering the benefit of breast-feeding to the baby and the benefit of KANUMA to the mother.

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.

Driving and using machines KANUMA may have a minor influence on the ability to drive and use machines. Adverse effects of sebelipase alfa include dizziness which could affect the ability to drive or use machines.

KANUMA contains sodium
This medicine, when diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion for intravenous administration contains 33 mg sodium (main component of cooking/table salt) at the recommended dose. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult. Tell your doctor if you or your child is on a controlled sodium diet.

The dose you or your child receives is based on your or your child s body weight.

Infants (< 6 months of age) For patients who have signs and symptoms of the disease when they are infants, the recommended starting dose is 1 mg/kg or 3 mg/kg once weekly. Dose adjustments may be considered based on how well your child responds to treatment.

Children and adults The recommended dose is 1 mg per kg body weight once every other week through a drip into a vein. Dose adjustments may be considered based on how well you or your child responds to treatment.

Each infusion will take approximately 1 to 2 hours. You or your child may be monitored by your doctor or nurse for an additional hour after the infusion. KANUMA should be started at as young an age as possible and is intended for long-term use.

Your doctor or nurse will give KANUMA to you or your child by an infusion (drip) into a vein. The medicine will be diluted before being given to you or your child.

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

Side effects were seen while patients were being given the medicine or shortly after (infusion reactions). The most serious side effects may include an allergic reaction (seen very commonly [may affect more than 1 in 10 people] in infants younger than 6 months old, or commonly [may affect up to 1 in 10 people] in children and adults) with symptoms including difficulty breathing, rapid breathing, fast heartbeat, chest discomfort, mild swelling of eyelids, red eyes, runny nose, flushing, hives, itching, diarrhoea, paleness, wheezing, low blood oxygen, skin redness and irritability. If you or your child experiences symptoms like these, seek immediate medical attention. If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions. If the infusion reaction is severe, your doctor may stop the infusion of KANUMA in the vein and start giving appropriate medical treatment.

Very Common (may affect more than 1 in 10 people) side effects reported in infants (1 to 6 months old) are:
Hypersensitivity (irritability, agitation, vomiting, urticaria, eczema, pruritus, pallor and drug hypersensitivity), severe allergic reactions (anaphylactic reactions) Eyelid swelling Fast heartbeat Difficulty breathing Diarrhoea, vomiting Rash, raised rash Fever Decreased oxygen in the blood, blood pressure increased, rapid breathing, development of blood proteins

Very Common (may affect 1 in 10 people or more) side effects reported in children and adolescents (4 to 18 years old) and adults are: Hypersensitivity (chills, eczema, laryngeal oedema, nausea, pruritus and urticaria) Dizziness Stomach ache, diarrhoea Tiredness, fever

Common (may affect up to 1 in 10 people) side effects reported in children and adolescents (4 to 18 years old) and adults are:
Severe allergic reaction (anaphylactic reaction),
Fast heartbeat Skin redness, low blood pressure Shortness in breath Stomach bloating Rash, red swollen skin Chest discomfort, reaction at the infusion site

Frequency, type and severity of adverse reactions in children are similar to those in adults.

Reporting of side effects If you or your child gets any side effects, talk to your doctor. 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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C). Do not freeze. Do not shake. Store in the original package in order to protect from light.

For diluted solutions, immediate use is recommended. If not used immediately, the diluted solution may be stored up to 24 hours at 2 C to 8 C or up to 12 hours below 25 C.

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 KANUMA contains

• The active substance is sebelipase alfa. Each ml of concentrate contains 2 mg sebelipase alfa. Each vial contains 20 mg of sebelipase alfa in 10 ml.
• The other ingredients are sodium citrate (see section 2 under KANUMA contains sodium ), citric acid monohydrate, human serum albumin, and water for injections.

What KANUMA looks like and contents of the pack KANUMA is supplied as a concentrate for solution for infusion (sterile concentrate). It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.

Pack size: 1 vial containing 10 ml of concentrate.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France

Manufacturer: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom

Alexion Pharma International Operations Limited College Business and Technology Park Blanchardstown Road North

Dublin D15 RIreland

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

Belgi /Belgique/Belgien
Alexion Pharma Belgium
T l/Tel: +32 0 800 200 Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660

Te .: +359 24455Luxembourg/Luxemburg
Alexion Pharma Belgium
T l/Tel: +32 0 800 200 esk republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 Magyarorsz g
AstraZeneca Kft.
Tel.: +36 1 883 6Danmark
Alexion Pharma Nordics AB
Tlf: +46 0 8 557 727 Malta
Alexion Europe SAS
Tel: +353 1 800 882 Deutschland
Alexion Pharma Germany GmbH
Tel: +49 (0) 89 45 70 91 Nederland
Alexion Pharma Netherlands B.V.
Tel: +32 (0)2 548 36 Eesti
AstraZeneca
Tel: +372 6549 Norge
Alexion Pharma Nordics AB
Tlf: +46 (0)8 557 727
AstraZeneca A.E.
: +30 210 6871 sterreich
Alexion Pharma Austria GmbH
Tel: +41 44 457 40 Espa a
Alexion Pharma Spain, S.L.
Tel: +34 93 272 30 Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 France
Alexion Pharma France SAS
T l: +33 1 47 32 36 Portugal
Alexion Pharma Spain, S.L. - Sucursal em Portugal
Tel: +34 93 272 30 Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 Rom nia
AstraZeneca Pharma SRL
Tel: +40 21 317 60 Ireland
Alexion Europe SAS
Tel: +353 1 800 882 Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 sland
Alexion Pharma Nordics AB
S mi: +46 0 8 557 727 Slovensk republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7Italia
Alexion Pharma Italy srl
Tel: +39 02 7767 9Suomi/Finland
Alexion Pharma Nordics AB
Puh/Tel: +46 0 8 557 727
Alexion Europe SAS
: +357 22490Sverige
Alexion Pharma Nordics AB
Tel: +46 0 8 557 727 Latvija
SIA AstraZeneca Latvija
Tel: +371 67377United Kingdom (Northern Ireland)
Alexion Europe SAS
Tel: +44 (0) 800 028 4This leaflet was last revised in .

Other sources of information

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