500 IU solution for injection, solution in a pre-filled syringe
Human hepatitis B immunoglobulin
What Zutectra is and what it is used for
What Zutectra is
Zutectra contains antibodies against the hepatitis B virus, which are the body’s defense 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 a re-infection with hepatitis B in adults who have had a liver transplant at least 1 week before due to liver failure caused by hepatitis B.
What you need to know before you use Zutectra
Do not use Zutectra
- if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6). Especially in very rare cases with an insufficient amount of immunoglobulin A ( IgA ), when you have antibodies against IgA in your blood. This can lead to a severe allergic reaction ( anaphylaxis ).
An allergic reaction may include sudden wheezing and wheezing, difficulty breathing, rapid pulse, swelling of the eyelids, face, lips, throat, or tongue, rash, or itching.
Zutectra is only intended for subcutaneous injection ( injection under the skin). Injection into a vein or blood vessel can lead to allergic shock.
Warnings and precautions
Tell the doctor or healthcare professional before treatment
- if you know that you have antibodies against immunoglobulins of the IgA type in your blood. This is very rare and can lead to allergic reactions.
You may be allergic to immunoglobulins ( antibodies ) without knowing it, even if you have previously tolerated treatments with human immunoglobulins. Especially if you do not have enough immunoglobulins of the IgA type in your blood, allergic reactions such as a sudden drop in blood pressure or shock may occur.
You will be closely observed during and soon after the 1st injection of Zutectra to make sure you do not react. If you have an allergic reaction to Zutectra, stop the injection immediately. Tell your doctor or healthcare professional immediately if you notice any reactions during injection with Zutectra.
If you are HBs antigen positive, you will not receive Zutectra because you will not benefit from the medicine. The doctor can explain this to you.
For your safety, antibody levels are checked regularly.
Possible influence on blood samples
Zutectra can affect the results of some blood tests (blood serum tests). Tell the doctor that you are being treated with Zutectra before having any blood tests.
Information on the source material of Zutectra and the risk of transmission of infectious agents:
The source material or what Zutectra is made from is human blood plasma (the liquid part of the blood).
When medicines are made from human blood plasma, certain measures are taken to prevent infection from being passed on to patients. These include:
- careful selection of blood and plasma donors to ensure that those at risk of being carriers of infection are excluded and
- testing each donation and plasma pool for signs of viruses/infections.
Manufacturers of these drugs also take steps when processing the blood or plasma to neutralize or remove viruses. Despite these measures, the risk of transmission of infection cannot be completely excluded when medicinal products made from human blood or human plasma are administered. This also applies to hitherto unknown and new viruses or other types of infection.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus, and for non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19 (which causes the fifth disease).
Immunoglobulins such as Zutectra have not been associated with infection by hepatitis A or parvovirus B19, possibly because the antibodies against these infections found in the medicine have a protective effect.
You must record the batch number of Zutectra. Each time you receive a new pack of Zutrecta, you should therefore write down the date and batch number (which can be found on the pack after “Batch”) and save 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 can reduce the effectiveness of certain vaccines (measles, rubella, mumps, chicken pox) for a period of up to 3 months.
You may need to wait at least 3 months after the last injection of Zutectra before you can receive live attenuated vaccines.
Tell the doctor that you are receiving treatment with Zutectra before any vaccination.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult a doctor or healthcare professional before using this medicine.
Driving ability and use of machinery
Zutectra has no or negligible effect on the ability to drive and use machines.
How to use Zutectra
Zutectra is intended for subcutaneous (under the skin) injection. The contents of a pre-filled syringe are for single use only. Do not inject into a blood vessel.
In most cases, you will receive an injection from the doctor or nurse. If your antibody levels are satisfactory and you have a fixed dosage, however, you or your caregiver can be trained to give the injection at home (see below).
It is strongly recommended that you use the treatment diary to be able to document your injections with Zutectra. The doctor explains how to use it.
The dose can be determined individually and adjusted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) once a week or every two weeks. Does one depend on your illness? The doctor will check your condition regularly and tell you how much and how often you must use Zutectra.
Inject yourself or receive an injection from a healthcare provider
You can inject Zutectra yourself without the help of a doctor if you have been trained on how to do it. If you administer Zutectra yourself, read the instructions in the section “How you or a caregiver inject Zutectra” carefully.
Zutectra must reach room temperature (approximately 23-27ºC) before use.
If you have used too much Zutectra
The consequences of an overdose are not known, but if you have used more than the prescribed dose of Zutectra, contact your doctor, healthcare professional, or pharmacist immediately for advice.
If you forget to use Zutectra
Do not take a double dose to make up for a missed injection. Talk to the doctor about how to handle dose one. The doctor will tell you how much and how often you must use Zutectra.
Use Zutectra as prescribed and as directed by your doctor to avoid the risk of re-infection with hepatitis B.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects seen with Zutectra were mild to moderate. In very rare cases, human normal immunoglobulins can cause a severe allergic reaction.
If you notice any of the following side effects, stop the injection and contact your doctor immediately:
- rash
- itching,
- wheezing and wheezing
- breathing problems
- swelling of the eyelids, face, lips, throat, or tongue
- low blood pressure, fast pulse
This can be an allergic reaction or a severe allergic reaction (anaphylactic shock ).
If you experience any side effects after the injection, contact your doctor immediately.
The following side effects have been reported with Zutectra:
Common (may affect up to 1 in 10 users):
- reactions at the injection site: pain, hives ( urticaria ) at the injection site, hematoma (accumulation of blood in the tissue under the skin), redness of the skin ( erythema ).
Uncommon (may affect up to 1 in 100 users):
- headache
- pain in the upper part of the abdomen (from the chest down to the navel)
In addition, the following reactions have been reported only once:
- fatigue (exhaustion)
- high blood pressure ( hypertension )
- inflammation of the nose and throat ( nasopharyngitis )
- muscle spasms
- allergic reactions (hypersensitivity)
- abnormal heartbeats (palpitations), heart discomfort
- itching ( pruritus ), rash
- pain in the mouth and throat
With other human immunoglobulins, the following additional symptoms have been reported:
- overindulge
- headache
- dizziness
- fever
- vomiting
- mild allergic reactions
- nausea (need to vomit)
- joint pain
- low blood pressure
- moderate pain in the lumbar/lower back
- reactions at the injection site: swelling, tenderness, redness, hardness of the skin, local heat, itching, bruising, and rash.
How to store Zutectra
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the outer carton, on the blister, and on the pre-filled syringe after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 °C-8 °C). Do not freeze. Store the pre-filled syringe in the outer carton. Light sensitive.
The solution should be administered immediately after removing the tip cap from the pre-filled syringe.
Do not use Zutectra if you notice that the solution is cloudy or contains particles.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment. When the injection is finished, immediately dispose of all needles, syringes, and empty glass containers in the sharps container provided to you.
Contents of the packaging and other information
Contents declaration
- The active substance is human hepatitis B immunoglobulin 500 IU/ml.
- Zutectra contains 150 mg/ml human plasma protein of which at least 96% is immunoglobulin G (IgG). The maximum content of immunoglobulin A ( IgA ) is 6,000 micrograms/ml.
- Other ingredients are glycine and water for injections.
Appearance and package sizes of the medicine
Zutectra is a solution for injection in a pre-filled syringe (500 IU/ml – pack size of 5 in a blister). The color of the solution can vary from clear to opalescent and colorless to pale yellow.
A pre-filled syringe of 1 ml Zutectra contains 500 IU. Zutectra comes in a pack size of 5 pre-filled syringes in a blister pack.
Biotest Pharma GmbH
Landsteinerstrasse 5
D-63303 Dreieich
Germany
Tel.: + 49 6103 801-0
Fax: + 49 6103 801-150
Email: mail@biotest.com
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