Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - respreeza

Document Subject

Generated Narrative: MedicinalProductDefinition mpa1d327760eabe9367684e5523c2c313b

identifier: http://ema.europa.eu/identifier/EU/1/15/1006/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Respreeza 1,000 mg powder and solvent 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-a1d327760eabe9367684e5523c2c313b

identifier: http://ema.europa.eu/identifier/EU/1/15/1006/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - respreeza

Attesters

What is in this leaflet:

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

What Respreeza is This medicine contains the active substance human alpha1-proteinase inhibitor, which is a normal component of the blood and is found in the lung. There, its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase. Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an alpha1-proteinase inhibitor deficiency). What Respreeza is used for This medicine is used in adults with known severe alpha1-proteinase inhibitor deficiency (an inherited condition also called alpha1 antitrypsin deficiency) who have developed a lung condition called emphysema. Emphysema develops when the lack of alpha1-proteinase inhibitor results in a condition in which neutrophil elastase is not being properly controlled, damaging the tiny air sacs in the lungs through which oxygen passes into the body. Because of this damage, the lungs do not work properly. Using this medicine regularly increases the blood and lung levels of alpha1-proteinase inhibitor, thus slowing the progression of emphysema.

Do NOT take Respreeza

if you are allergic to human alpha1-proteinase inhibitor or any of the other ingredients of this medicine (listed in section 6).

if you have been found to have a deficiency of certain blood proteins called immunoglobulin type A (IgA) and have developed antibodies against them. Warnings and precautions

Talk to your doctor or healthcare professional before using Respreeza. Information on allergic reactions: when slowing or stopping the infusion may be required? You may be allergic to human alpha1-proteinase inhibitor even if you have previously received human alpha1-proteinase inhibitors and had tolerated them well. In some cases, severe allergic reactions may occur. Your doctor will inform you about signs of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, face, or mouth) (see also section 4).

Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of this medicine. Depending on the nature and severity of the reaction, your doctor may decide whether to slow or stop the infusion completely and start the appropriate treatment.

In case of self-administration / home-treatment, stop the infusion immediately and contact your doctor or healthcare professional. Information on safety with respect to infections Respreeza is made from human blood plasma (this is the liquid part of the blood with the blood cells removed). Because blood can carry infections, when medicines are made from human blood or plasma certain measures are put in place to prevent these from being present in the medicine and passed on to patients. These include:

careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,

the testing of samples of donated blood and plasma to try to avoid use of material with signs of virus/infections,

the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses. The measures taken are considered effective for viruses such as human immunodeficiency virus (HIV), hepatitis A virus, hepatitis B virus, hepatitis C virus, and parvovirus B19 virus. However, despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived proteinase inhibitors.

It is strongly recommended that every time you receive a dose of Respreeza the name and batch number of the product are recorded in order to maintain a record of the batches used. Smoking Since tobacco smoke is an important risk factor for the development and progression of emphysema, you are strongly advised to stop smoking and avoid passive smoking. Children and adolescents This medicine is not for use in children or adolescents below 18 years of age. Other medicines and Respreeza

Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine. Since alpha1-proteinase inhibitor is a normal component of human blood, recommended dose of this medicine is not expected to cause harm to the developing foetus. However, as there is no information available regarding the safety of Respreeza use during pregnancy, if you are pregnant, this medicine should only be given to you with caution. It is unknown whether Respreeza passes into human milk. If you are breast-feeding, your doctor will discuss with you the risks and benefits of taking this medicine. There are no data concerning the effect on fertility but as alpha1-proteinase inhibitor is a normal component of human blood, no adverse effects on fertility are expected if you use Respreeza at the recommended dose. Driving and using machines Dizziness may occur after the administration of this medicine. If you experience dizziness, you should not drive or use machines until the dizziness has passed (see section 4). Respreeza contains sodium This medicinal product contains approximately 37 mg sodium per 1,000 mg Respreeza vial, 149 mg sodium per 4,000 mg Respreeza vial and 186 mg sodium per 5,000 mg Respreeza vial, equivalent to 1.9%, 7.4% and 9.3% respectively, of the WHO recommended maximum daily intake of 2 g sodium for an adult. Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet.

After reconstitution, Respreeza is given by infusion into a vein. A healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency will supervise the first infusions. Home treatment / Self-administration After the first infusions, you or your caregiver might also administer Respreeza, but only after receiving adequate training. If your doctor decides that you are suitable for such home-treatment / self- administration, he or she will instruct you in:

how to prepare and give this medicine (see the illustrated instructions at the end of this leaflet in Information for health-care professionals and for patients suitable for home-treatment / self- administration ),

how to keep the product sterile (aseptic infusion techniques),

how to keep a treatment diary,

how to identify side effects, including signs of allergic reactions, and measures to be taken in case such effects occur (see also section 2 and section 4). Your doctor or your healthcare professional will regularly review your / your caregiver s infusion technique to ensure continued appropriate handling. Dose The amount of Respreeza you are given is based on your body weight. The recommended dose is 60 mg per kg of body weight and should be administered once per week. The infusion solution is normally given over about 15 minutes (about 0.08 ml of solution per kg body weight each min). Your doctor will determine the appropriate infusion rate for you by taking into account your weight and your tolerability to infusion. If you use more Respreeza than you should Consequences of an overdose are unknown.

Tell your doctor or healthcare professional if you think you have used more Respreeza as you should. He or she will take the appropriate measures. If you forget to use Respreeza

Proceed with your next dose immediately and continue at regular intervals as advised by your doctor or healthcare professional.

Do not take a double dose to make up for a forgotten dose. If you stop using Respreeza

Do no stop using this medicine without consulting your doctor or healthcare professional. If treatment with Respreeza is stopped, your condition may worsen.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects may occur even if you previously received human alpha1-proteinase inhibitors and had tolerated them well. Some side effects may be serious: Uncommonly (may affect up to 1 in 100 people), allergic reactions have been observed. They may progress in some very rare cases (may affect up to 1 in 10,000 people) to severe allergic reactions even when you have shown no signs of allergy on previous infusions.

Tell your doctor or healthcare professional immediately if you notice any sign of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, face, or mouth) during the administration of Respreeza. Depending on the nature and severity of the reaction, your doctor or healthcare professional may decide whether to slow or stop the administration completely and give appropriate treatment for the reaction. In case of self-administration / home-treatment, stop the infusion immediately and contact your doctor or healthcare professional. The other side effects may include: Commonly (may affect up to 1 in 10 people) Dizziness, headache, shortness of breath (dyspnoea), nausea. Uncommonly (may affect up to 1 in 100 people) Altered sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (paraesthesia), flushing, hives (urticaria), scaly rash and rash all over the body, physical weakness (asthenia), infusion-site reactions (such as burning, stinging, pain, swelling or redness at the infusion site (haematoma)). Very rarely (may affect up to 1 in 10,000 people) Decreased sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (hypoaesthesia), excessive sweating (hyperhidrosis), itching, chest pain, chills, fever (pyrexia). Frequency not known (frequency cannot be estimated from the available data) Pain to the lymph glands (oval-shaped masses of tissue that are distributed throughout the body and which may be palpable for example in the armpit, groin or neck), swollen face, swollen eyes and lips. Reporting of side effects If you get any side effects, talk to your doctor or healthcare professional. 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 outer carton and the vial labels after EXP. The expiry date refers to the last day of that month. Do not store above 25 C. Do not freeze. After reconstitution, the solution should be used immediately. If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 C). Do not freeze the reconstituted solution.

What Respreeza contains The active substance is human alpha1-proteinase inhibitor. One vial contains approximately 1,mg, 4,000 mg or 5,000 mg of human alpha1-proteinase inhibitor. The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate and mannitol (see section 2). Solvent: Water for injections. What Respreeza looks like and contents of the pack This medicine is a white to off-white powder. After it has been reconstituted with water for injections, the solution should be clear, colourless to slightly yellow and free from visible particles. Presentations One pack contains: Respreeza 1,000 mg powder and solvent for solution for infusion:

1 single-use powder vial

1 solvent vial of 20 ml water for injections

1 transfer set 20/20 (Mix2Vial set) for reconstitution Respreeza 4,000 mg powder and solvent for solution for infusion:

1 single-use powder vial

1 solvent vial of 76 ml water for injections

1 transfer set 20/20 (Mix2Vial set) for reconstitution Administration set (inner box):

1 IV infusion set

1 butterfly set

3 alcohol swabs Respreeza 5,000 mg powder and solvent for solution for infusion:

1 single-use powder vial

1 solvent vial of 95 ml water for injections

1 transfer set 20/20 (Mix2Vial set) for reconstitution Administration set (inner box):

1 IV infusion set

1 butterfly set

3 alcohol swabs Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer CSL Behring GmbH Emil-von-Behring-Strasse D-35041 Marburg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien CSL Behring NV T l/Tel: +32 15 28 89 Lietuva CentralPharma Communications UAB Tel: +370 5 243 0

: +359 2 810 3Luxembourg/Luxemburg CSL Behring NV T l/Tel: +32 15 28 89 esk republika CSL Behring s.r.o. Tel: +420 702 137 Magyarorsz g CSL Behring Kft. Tel.: +36 1 213 4Danmark CSL Behring AB Tel: +46 8 544 966 Malta AM Mangion Ltd. Tel: +356 2397 6Deutschland CSL Behring GmbH Tel: +49 69 30584Nederland CSL Behring BV Tel: +31 85 111 96 Eesti CentralPharma Communications O Tel: +3726015Norge CSL Behring AB Tlf: +46 8 544 966
CSL Behring
: +30 210 7255 sterreich CSL Behring GmbH Tel: +43 1 80101 2Espa a CSL Behring S.A. Tel: +34 933 67 1Polska CSL Behring Sp. z.o.o. Tel.: +48 22 213 22 France CSL Behring SA T l: +33 1 53 58 54 Portugal CSL Behring Lda Tel: +351 21 782 62 Hrvatska Marti Farm d.o.o. Tel: +385 1 5588Rom nia Prisum Healthcare S.R.L. Tel: +40 21 322 01 Ireland CSL Behring GmbH Tel: +49 69 30517Slovenija EMMES BIOPHARMA GLOBAL s.r.o.- podru nica v Sloveniji Tel:+ 386 41 42 0 sland CSL Behring AB S mi: +46 8 544 966 Slovensk republika CSL Behring s.r.o. Tel: +421 911 653 Italia CSL Behring S.p.A. Tel: +39 02 34964 Suomi/Finland CSL Behring AB Puh/Tel: +46 8 544 966
CSL Behring
: +30 210 7255 Sverige CSL Behring AB Tel: +46 8 544 966 Latvija CentralPharma Communications SIA Tel: +371 6 7450United Kingdom (Northern Ireland) CSL Behring GmbH Tel: +49 69 30517This leaflet was last revised in MM/YYYY. Detailed information on this medicine is available on the European Medicines Agency web site: