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Generated Narrative: Bundle TEST PURPOSES ONLY - zutectra

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Generated Narrative: MedicinalProductDefinition mp73960cef65d43cea9c4f68f4818ce9c6

identifier: http://ema.europa.eu/identifier/EU/1/09/600/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Zutectra 500 IU solution for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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-	Country	Jurisdiction	Language
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Document Content

Generated Narrative: Composition composition-en-73960cef65d43cea9c4f68f4818ce9c6

identifier: http://ema.europa.eu/identifier/EU/1/09/600/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - zutectra

Attesters

7. How to inject Zutectra by yourself or by caregiver

What is in this leaflet:

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

What Zutectra is

Zutectra contains antibodies against the hepatitis B virus which are the body's own defensive substances to protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus.

What Zutectra is used for

Zutectra is used to prevent re-infection of hepatitis B in adults who have had a liver transplant at least 1 week ago because they had liver failure caused by hepatitis B.

Do not use Zutectra

• if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6). In particular, in very rare cases of insufficient amount of immunoglobulin A (IgA), when you have antibodies against IgA in your blood. This might lead to severe allergic reaction (anaphylaxis). An allergic reaction may include sudden wheeziness, difficulty in breathing, fast pulse, swelling of the eyelids, face, lips, throat or tongue, rash or itching.

Zutectra is for subcutaneous (under the skin) injection only. Injection into a vein or a blood vessel may result in allergic shock.

Warnings and precautions

Please tell your doctor or healthcare professional prior to treatment

• if you have been told that you have antibodies against immunoglobulins of the type IgA in your blood. This is very rare and may result in allergic reactions.

You may be allergic to immunoglobulins (antibodies) without knowing it, even if you have tolerated previous treatments with human immunoglobulins. Particularly if you do not have enough immunoglobulins of the type IgA in your blood, allergic reactions such as a sudden fall in blood pressure or shock may occur.

You will be carefully observed during and shortly after the 1st injection with Zutectra to make sure that you do not suffer from a reaction. If you have an allergic reaction to Zutectra, the injection will be stopped immediately. Please tell your doctor or healthcare professional immediately if you notice any reactions during your injection with Zutectra.

If you are HBs antigen positive you will not receive Zutectra since there is no benefit in administering this medicine to you. Your doctor will be able to explain this to you.

For your own safety you will be monitored for antibody levels regularly.

Possible interference with blood tests Zutectra might affect the results of certain blood tests (serological tests). Please tell your doctor about your treatment with Zutectra prior to any blood test.

Information on the starting material of Zutectra and the possibility of transmission of infectious agents:

The starting material or what Zutectra is made from is human blood plasma (this is the liquid part of the blood). When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include

• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
• the testing of each donation and pools of plasma for signs of virus/infections.
  Manufacturers of these medicines also include steps in the processing of the blood or plasma that can inactivate or remove viruses. 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.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19 virus (causative agent of Ringel rubella).

Immunoglobulins like Zutectra have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.

It is important to keep a record of the batch number of your Zutectra. So, every time you get a new package of Zutectra, note down the date and the batch number (which is on the packaging after "Lot") and keep this information in a safe place, for example your treatment diary (see section 3).

Other medicines and Zutectra Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.

Vaccinations Zutectra can reduce the effectiveness of some vaccines (measles, rubella, mumps, chicken pox) for a period of up to 3 months.

You may have to wait at least 3 months after the last injection of Zutectra before you can have live attenuated vaccines.

Please tell your doctor about your treatment with Zutectra prior to any vaccination.

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.

Driving and using machines Zutectra has no or negligible effects on your ability to drive or use machines.

Zutectra is intended for subcutaneous (under the skin) injection. The content of one pre-filled syringe is intended for use once only. Do not inject into a blood vessel.

In most cases you will be given the injection by your doctor or nurse. However, if your antibody levels are sufficient and you have a fixed dose regimen, you or your caregiver may be trained to carry out the injection at home (see below).

For the documentation of your injections of Zutectra it is strongly recommended to use the treatment diary. Your doctor will explain you how to use it.

The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) weekly or fortnightly. The dose will depend on your condition. Your doctor will regularly check your condition and tell you how much and how often you need to use Zutectra.

Injecting by yourself or by caregiver You can inject Zutectra yourself without the help of your doctor, if they have trained you to do this. If you are administering Zutectra yourself, please read instructions in the section How to inject Zutectra by yourself or by caregiver carefully.

Zutectra must be brought to room temperature (approx. 23 C-27 C) before use.

If you use more Zutectra than you should Consequences of an overdose are not known. However, if you have used more than the prescribed dose of Zutectra, contact your doctor, healthcare professional or pharmacist straight away for advice.

If you forget to use Zutectra Do not take a double dose to make up for a forgotten injection. Talk to your doctor about managing the dose. Your doctor will tell you how much and how often you need to use Zutectra.

Make sure you use Zutectra as prescribed and as instructed by your doctor to avoid the risk of a hepatitis B re-infection.

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

Most side effects observed with Zutectra were mild to moderate in nature. In very rare cases human normal immunoglobulins may cause a serious allergic reaction.

If you notice any of the following effects stop the injection and tell your doctor immediately:

• rash,
• itching,
• wheezing,
• difficulty in breathing,
• swelling of the eyelids, face, lips, throat or tongue,
• low blood pressure, fast pulse

This can be an allergic reaction or a serious allergic reaction (anaphylactic shock).

In case of any adverse event after the injection speak to your doctor immediately.

The following side effects have been reported with Zutectra:

Common (may affect up to 1 in 10 people):

• injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema).

Uncommon (may affect up to 1 in 100 people):

• headache
• upper abdominal pain (from your chest to the belly button)

Furthermore, the following reactions have been reported once only:

• tiredness (fatigue)
• high blood pressure (hypertension)
• inflammation of the nose and throat (nasopharyngitis)
• muscle spasm
• allergic reactions (hypersensitivity)
• abnormal heartbeat (palpitations), cardiac discomfort
• itching (pruritus), rash
• pain in the mouth and throat

With other human immunoglobulin preparations, the following additional symptoms have been reported:

• chills
• headache
• dizziness
• fever
• vomiting
• mild allergic reactions
• nausea (urge to vomit)
• joint pain
• low blood pressure
• moderate low back pain
• injection site reactions: swelling, soreness, redness, hardening of the skin, local heat, itching, bruising and rash.

Reporting of side effects If you get any side effects, talk to your doctor, healthcare professional 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 outer carton, the blister and the pre-filled syringe label after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2 C-8 C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

Once the protective cap has been removed from the pre-filled syringe, the solution should be administered immediately.

Do not use Zutectra if you notice that the solution is cloudy or contains particles.

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.
Once the injection has been completed, dispose of all needles, syringes and empty glass containers without delay in a container intended for sharp objects you were provided with.

What Zutectra contains

• The active substance is human hepatitis B immunoglobulin 500 IU/mL.
• Zutectra contains 150 mg/mL of human plasma protein of which at least 96 % is immunoglobulin G (IgG). The maximum immunoglobulin A (IgA) content is 6,000 micrograms/mL.
• The other ingredients are glycine and water for injections.

What Zutectra looks like and the contents of the pack

Zutectra is presented as a solution for injection provided in pre-filled syringes (500 IU/mL - pack size of 5 in a blister). The colour of the solution can vary from clear to opalescent and colourless to pale yellow.

One pre-filled syringe of 1 mL Zutectra contains 500 IU. Zutectra is supplied in a pack size containing 5 pre-filled syringes each in a blister pack.

Marketing Authorisation Holder and Manufacturer

Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany Tel.: + 49 6103 801-0 Fax: + 49 6103 801-Email: mail@biotest.com

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

Belgi /Belgique/Belgien, Nederland Ireland Twinpharma BV Trasmolenlaan 5 NL-3447 GZ Woerden T l/Tel +31 348 71 24 Aquilant Pharmaceuticals 21 Fonthill Business Park Fonthill Road Clondalkin IRL-Dublin Tel: + 353 1 404 8

1700
. . 31, 6 T: +359 2 427 49 Italia Grifols Italia S.p.A. Via Torino, I-56010 Vicopisano - Pisa Tel: +39 050 8755 esk republika, Slovensk republika Reg-Pharm spol.s.r.o. Fialkov CZ-10600 Praha Tel: + 420 2 7265 4
&
.
. . 22578 1522

: + 357 22 611 Danmark, sland, Norge, Suomi/Finland, Sverige
Grifols Nordic AB Tel: + 46 8 441 89 Email: infonordic@grifols.com

Magyarorsz g Biotest Hungaria Kft. Torb gy u. 15/A H-2045 T r kb lint Tel.: + 36 23 511 Deutschland, Eesti, , Latvija, Lietuva, Luxembourg/Luxemburg, Polska, Rom nia, United Kingdom (Northern Ireland)
Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel: + 49 6103 801-0

Malta Rodel Ltd 55, Ravina Triq ir-Russett MT-Kappara SGN 4Tel: + 356 27 386Espa a Grifols Movaco, S.A. Tel.: +34 93 571 02 sterreich Biotest Austria GmbH Einsiedlergasse A-1050 Wien Tel: + 43 1 545 15 61-0

France Grifols France 24 Rue de Prony F-75017 Paris
T l: +33 (0) 1 53530Portugal Grifols Portugal, Lda. Tel: +351 219 255 Hrvatska Medis Adria d.o.o. Buzinska cesta 10010 Zagreb - Buzin T: +385 1 2303 Slovenija MEDIS, d.o.o.
Brn i eva 1,
SI-1231 Ljubljana- rnu e,
Tel: +386 1 589 69 This leaflet was last revised in

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