ZUTECTRA 500 IU Injectable solution

Зміст інструкції

1. Zutectra 500 IU injectable solution in pre-filled syringe
   1. What is Zutectra and what is it 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
   7. How to administer Zutectra injection yourself or with the help of an assistant

Zutectra 500 IU injectable solution in pre-filled syringe

Human anti-hepatitis B immunoglobulin

Read this leaflet carefully before using this medicine as it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their
symptoms are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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
• 7. How to administer Zutectra yourself or with the help of an assistant

1. What is Zutectra and what is it used for

What is Zutectra
Zutectra contains antibodies against the hepatitis B virus, which constitute the body's defense substances
to protect against hepatitis B. Hepatitis B is an inflammation of the liver caused by the
hepatitis B virus.

What is Zutectra used for
Zutectra is used in the prevention of hepatitis B reinfection in adults who have had a
liver transplant at least 1 week prior, for liver failure caused by hepatitis B.

2. What you need to know before you use Zutectra

Do not use Zutectra
if you are allergic to human immunoglobulins or to any of the other ingredients of this
medicinal product (listed in section 6). In particular, in very rare cases of immunoglobulin A (IgA) deficiency with antibodies directed against IgA in the blood. This can lead to a
serious allergic reaction (anaphylaxis).
An allergic reaction may manifest with sudden shortness of breath, difficulty breathing, increased
heart rate, swelling of the eyelids, face, lips, throat or tongue, skin rash or
itching.
Zutectra is intended for subcutaneous injection (under the skin) only. Injection into a vein
or blood vessel can cause anaphylactic shock.

Warnings and precautions
Before treatment, tell your doctor or healthcare professional
if you have been told that you have antibodies against IgA type immunoglobulins in your blood. This
is a very rare condition and can cause allergic reactions.

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

You will be monitored during and shortly after the first injection of Zutectra, to
ensure that no reaction occurs. If you have an allergic reaction to Zutectra, the injection
will be immediately stopped. Immediately inform your doctor or healthcare professional if you notice the
appearance of any reaction during the injection of Zutectra.

If you are HBsAg-positiveyou will not receive Zutectra, as you would not benefit from it. Your doctor
will explain this situation to you.

For your safety, the level of antibodies will be checked periodically.

Possible interference with blood testsZutectra may alter the results of certain blood
tests (serological tests). Before any blood test, tell your doctor about the
treatment with Zutectra.

Information on the starting material of Zutectra and the possibility of transmitting infectious
agents
Zutectra is made from human blood plasma (the liquid part of blood).
When medicines are derived from human blood or plasma, measures are taken
to prevent infections that can be transmitted to patients. These include

• careful selection of blood and plasma donors, to ensure that those at risk of carrying infections are excluded, and
• testing of each donation and plasma pools, to exclude signs of viruses/infections. Manufacturers of these medicines also include steps in the processing of blood or plasma that can inactivate or remove viruses. Despite these precautions, when medicines prepared from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely eliminated. This applies even to unknown or emerging viruses and other types of infection.

The precautions taken are considered effective for enveloped viruses, such as human immunodeficiency
virus (HIV), hepatitis B and hepatitis C, and for the non-enveloped hepatitis A virus.
The precautions taken may have limited value against non-enveloped viruses, such as parvovirus B19
(causative agent of Erythema Infectiosum or Fifth Disease).
Immunoglobulins like Zutectra have not been associated with hepatitis A and parvovirus
B19 infections, possibly because the antibodies against these infections contained in the product are protective.
It is important to record the batch number of Zutectra. Therefore, each time you receive a new
pack of Zutectra, notethe date and batch number(indicated on the pack after “Lot”) and
keep this information in a safe place, for example in 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 may reduce the effectiveness of some vaccines (measles, rubella, mumps, varicella) for a period
of up to 3 months.
It may be necessary to wait at least 3 months after the last injection of Zutectra before you can have
a vaccination with live attenuated vaccines.
Before any vaccination, tell your doctor about your treatment with Zutectra.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before using this medicine.

Driving and operating machinery
Zutectra does not or has negligible effect on the ability to drive and operate machinery.

3. How to use Zutectra

Zutectra is intended for subcutaneous injection (under the skin)only. The contents of each pre-filled syringe must be used only once. Do not inject into a blood vessel.
In most cases, the doctor or nurse will administer the injection. However, if your antibody levels are sufficient and you have a fixed-dose regimen, you or a person assisting you may administer the injection at home, after adequate training (see below).
It is strongly recommended to use the treatment diary to record Zutectra injections. The
doctor will explain how to use it.
The dose can be personalised and adjusted from 500 IU up to 1,000 IU (in exceptional cases up to

• 1,500 IU) weekly or every two weeks. The dose will depend on your clinical condition. The doctor will regularly check your condition and tell you how much and how often to use Zutectra.

Injection performed by yourself or with the help of an assistant
You can self-inject Zutectra without the help of a doctor if you have received adequate training. If
you self-inject Zutectra, read the instructions in the paragraph “How
to perform a Zutectra injection by yourself or with the help of an assistant” carefully.
Zutectra should be brought to room temperature (approximately 23 °C-27 °C) before use.

If you use more Zutectra than you should
The consequences of an overdose are not known. However, if you have used a higher dose of Zutectra
than prescribed, seek medical advice immediately from your doctor, healthcare professional or
pharmacist.

If you forget to use Zutectra
Do not take a double dose to make up for a missed injection. Contact your doctor for
dose management. The doctor will tell you how much and how often to use Zutectra.

Make sure you use Zutectra as prescribed and according to your doctor's instructions, to avoid the
risk of hepatitis B re-infection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects observed with Zutectra were of mild to moderate nature.
In very rare cases, normal human immunoglobulins can cause a severe allergic reaction.

If you notice any of the following effects, stop the injection and inform your doctor immediately:
skin rash,
itching,
wheezing,
difficulty breathing,
swelling of the eyelids, face, lips, throat or tongue,
low blood pressure, rapid pulse

This could be a severe allergic reaction (anaphylactic shock).
If you experience any adverse event after the injection, consult your doctor immediately.
The following side effects have been reported with Zutectra:
Common(may affect less than 1 in 10 people):
injection site reactions: pain, urticaria at the injection site, hematoma (accumulation of
blood in the tissues under the skin), redness of the skin (erythema)

Uncommon(may affect less than 1 in 100 people):
headache
pain in the upper abdomen (from the chest to the navel)

In addition, the following reactions have been reported only once:
fatigue (tiredness)
high blood pressure (hypertension)
inflammation of the nose and throat (nasopharyngitis)
muscle spasms
allergic reactions (hypersensitivity)
irregular heartbeat (palpitations), heart disorders
itching, skin rash
pain in mouth and throat

With other preparations based on human immunoglobulins, the following additional
symptoms have been reported:
chills
headache
dizziness
fever
vomiting
mild allergic reactions
nausea (urgent need to vomit)
joint pain
low blood pressure
moderate back pain
injection site reactions: swelling, irritation, redness, hardening of the skin,
local heat, itching, bruises and rashes.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
healthcare professional. You can also report side effects directly through the national reporting
system listed in Annex V. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Zutectra

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 packaging, on the blister and
on the label of the pre-filled syringe after Exp./EXP. The expiry date refers to the last
day of that month.
Store and transport in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled
syringe in the outer packaging to protect the medicine 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 in suspension.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Once the injection is finished, immediately dispose of all needles, syringes and empty glass containers
in the sharps container that has been provided to you.

6. Contents of the pack and other information

What Zutectra contains
The active substanceis human anti-hepatitis B immunoglobulin, 500 IU/mL.
Zutectra contains 150 mg/mL of human plasma proteins, of which at least 96 % are
immunoglobulin G (IgG). The maximum content of immunoglobulin A (IgA) is

• 6,000 micrograms/mL. The other ingredientsare glycine and water for injections.

Description of the appearance of Zutectra and contents of the pack
Zutectra is presented as an injectable solution in pre-filled syringes (500 IU/mL - pack of
five in a blister). The colour of the solution may vary from clear to opalescent and from colourless to
pale yellow.
1 pre-filled syringe of 1 mL of Zutectra contains 500 IU. Zutectra is supplied in a pack
containing 5 pre-filled syringes, each in a blister.

Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstrasse 5
D-63303 Dreieich
Germany
Tel.: + 49 6103 801–0
Fax: + 49 6103 801–150
E-mail: [email protected]
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Infarama BV
Ringlaan 39
B-1853 Strombeek-Bever
Tél/Tel: +32 11 31 26 16

Lietuva
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0

България
МЕДИС ФАРМА БЪЛГАРИЯ ЕООД
1700 София
Ул. Проф. Атанас Иширков 31, офис 6
T: +359 2 427 49 58

Luxembourg/Luxemburg
Biotest AG
Landsteinerstr. 5
D-63303 Dreieich
Tél/Tel: + 49 6103 801-0

Česká republika
Reg-Pharm spol.s.r.o.
Fialková 45
CZ-10600 Praha 10
Tel: + 420 2 7265 4004

Magyarország
Biotest Hungaria Kft.
Torbágy u. 15/A
H-2045 Törökbálint
Tel.: + 36 23 511 311

Danmark
Unimedic Pharma AB
Box 6216
S-102 34 Stockholm
Tlf:+ 46 10 130 99 80

Malta
Rodel Ltd
55, Ravina
Triq ir-Russett
MT-Kappara SGN 4432
Tel: + 356 27 386221

Deutschland
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0

Nederland
Infarama BV
Ringlaan 39
B-1853 Strombeek-Bever
Tel: +32 11 31 26 16

Eesti
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0

Norge
Unimedic Pharma AB
Box 6216
S-102 34 Stockholm
Tlf:+ 46 10 130 99 80

Ελλάδα
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Τηλ: + 49 6103 801-0

Österreich
Biotest Austria GmbH
Einsiedlergasse 58
A-1050 Wien
Tel: + 43 1 545 15 61-0

España
Biotest Medical, S.L.U.
C/ Frederic Mompou, 5 – 6º 3ª A
E-08960 Sant Just Desvern
Barcelona
Tel: +34 935 952 661

Polska
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0

France
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tél: 00800 98832872

Portugal
SPCare Especialidades Farmacêuticas, Lda
Rua Luciano Cordeiro, nº 123, 1º dto.
P-1050 139 Lisboa
Tel: + 351 21 193 14 20

Hrvatska
Medis Adria d.o.o.
Buzinska cesta 58
10010 Zagreb - Buzin
T: +385 1 2303 446

România
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0

Ireland
Aquilant Pharmaceuticals
21 Fonthill Business Park
Fonthill Road
Clondalkin
IRL-Dublin 22
Tel: + 353 1 404 8344

Slovenija
MEDIS, d.o.o.
Brnčičeva 1,
SI-1231 Ljubljana-Črnuče,
Tel: +386 1 589 69 00

Slovenská republika
Reg-Pharm spol.s.r.o.
Fialková 45
CZ-10600 Praha 10
Tel: + 420 2 7265 4004

Italia
Biotest Italia S.r.l.
Via Leonardo da Vinci 43
I-20090 Trezzano sul Naviglio
Tel: + 39 02 4844 291

Ísland
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Sími: + 49 6103 801-0

Suomi/Finland
Unimedic Pharma AB
Box 6216
S-102 34 Stockholm
Puh/Tel: + 46 10 130 99 80

Κύπρος
ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ ΛΤΔ
Γ. ΚΡΑΝΙΔΙΩΤΗ
Τ. Θ. 22578 1522 ΛΕΥΚΩΣΙΑ
Κ Υ Π Ρ Ο Σ
Τηλ: + 357 22 611 038

Sverige
Unimedic Pharma AB
Box 6216
S-102 34 Stockholm
Tel: + 46 10 130 99 80

Latvija
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0

United Kingdom (Northern Ireland)
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Tel: + 49 6103 801-0
More detailed information on this medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu.

7. How to administer Zutectra injection yourself or with the help of an assistant

The following instructions explain how to self-inject Zutectra. Read these instructions carefully and follow them step by step. The doctor, or an assistant, will illustrate the self-administration procedure to you.
Do not attempt to self-inject until you are sure you understand how to prepare the solution for injection and how to administer the injection.

General information:
Keep syringes and the disposal unit out of reach of children; if possible, keep the supply locked up.
Try to administer the injection at the same time each day. This will make it easier to remember to administer the injection.
Check the dose carefully.
Before use, the solution should be brought to room temperature (approximately 23 °C-27 °C).
Remove each pre-filled syringe from the package only when you are ready for the injection. Once the protective cap has been removed from the pre-filled syringe, administer the injection immediately.
The color of the solution may vary from clear to opalescent and from colorless to pale yellow. Do not use solutions that are cloudy or contain deposits.
This medicine should not be mixed with others.

Before the injection:

• 1.Wash your hands. It is important that your hands and the objects you use are as clean as possible.
• 2.Gather everything you need in advance. Choose a clean surface on which to place all the objects to be used:

two alcohol-soaked swabs,
a pre-filled syringe of Zutectra,
a needle suitable for subcutaneous injection.
Note that swabs and needles are not included in the package and must be obtained separately.
Make sure you have your treatment diary and a sharps container for disposing of waste readily available.

• 3.Before preparing the injection, decide where to inject. Inject Zutectra into the layer of fatty tissue between the skin and the muscle (approximately 8-12 mm under the skin). The best areas to administer the injection are those where the skin is less adherent and softer, such as on the abdomen, arm, thigh or buttocks, and away from joints, nerves and bones.

Important:do not inject into areas with bumps, bruises, nodules, pain or on an area with altered color, indentations, scabs, or where the skin is broken. Talk to your doctor or healthcare provider and inform them if you have these or other unusual conditions. Rotate the injection site each time. If some areas are difficult to reach, find someone who can help you administer the injection.

• 4.Preparation of the pre-filled syringe of Zutectra:

Remove the pre-filled syringe from the package.

Examine the solution carefully. It must
appear clear and without particles. If the solution
shows color changes, is cloudy or contains
particles, discard it and take another pre-filled
syringe.
Remove the protective cap from the
syringe.

Remove the needle from the sterile package and attach
it to the syringe.

• 5.Removing any air bubbles present in the pre-filled syringe.

Hold the syringe with the needle pointing upwards
and gently tap with your fingers to move the air to
the tip of the syringe.
Gently press the plunger of the syringe to
expel the air bubbles.

Injection

• 1.Choose the area where to inject and record it in the therapy diary. Also record the date and lot number (see “Information on the Zutectra starting material and the possibility of transmission of

Abdomen (stomach): do not use points less than
2.5 cm from the navel. Avoid using the belt area, as
friction can cause irritation of the injection site. Avoid
surgical scars.
These are the best points to use for
self-injection.

Thighs: use the central and outer areas, where it is
possible to lift the tissues with your fingers. Usually, the
areas richest in fatty tissue are those furthest from the
knee and closest to the groin.
Arms: use the back of the arm.
Using this site, it is difficult to lift the skin
with your fingers and administer the Zutectra self-injection.
If, however, you choose this point, try to lift the
tissues by resting your arm on the back of a
chair or against the wall. It is, however, easier
to get help from someone if you want to use this
area.
Buttocks: use the areas where it is possible to lift the
tissues with your fingers. It is more difficult to
administer the self-injection in this area. Stand in front
of the mirror to locate the point better or
ask an assistant to administer the injection.

It is important to rotate the injection site each time.In this way, the skin will remain
more supple and the medicine will be absorbed more evenly. Start by administering the injection in one
point, then use all the other points in subsequent times, then return to the first point used and
start rotating again. It is useful to always note where you administer the injection to avoid problems.
The figure below illustrates the administration on the thigh as an example:

• 2.Rub the area to be injected with an alcohol-soaked swab. Let it air dry.

• 3.Gently lift the skin around the disinfected injection site and insert the needle into the skin with a quick, firm movement, at an angle of 45-90 degrees. Inject under the skin as shown by the doctor or nurse.
• 4.Inject the liquid by gently pressing the plunger of the syringe. Inject all the solution slowly, until the syringe is empty.

• 5.Then, immediately withdraw the needle and release the skin.

• 6.Clean the injection site by rubbing with circular movements with the alcohol-soaked swab.

Disposal of all used items
Once the injection is finished, immediately dispose of all needles and empty glass containers in a
sharps container.