160 mg/ml solution for injection, pre-filled syringe 
human normal immunoglobulin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Beriglobin is and what it is used for 
2. What you need to know before you take Beriglobin 
3. How to get Beriglobin 
4. Possible side effects 
5. How to store Beriglobin 
6. Contents of the packaging and other information 

1. What Beriglobin is and what it is used for

Beriglobin is an immunoglobulin preparation (immunoglobulin G). It contains antibodies against bacteria and viruses. Antibodies are part of the body’s defenses against infections.

You can get Beriglobin

  • as travel prophylaxis against an infectious liver disease ( Hepatitis A) when there are less than 2 weeks left until you can be exposed to infection.
  • as a preventive treatment for Hepatitis A, if you have been exposed to infection during the last 2 weeks.

Your doctor or nurse will give you Beriglobin as an injection into a muscle.

What you need to know before you take Beriglobin

Do not use Beriglobin

  • if you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).

Beriglobin must not be given into a blood vessel. Beriglobin must also not be given in a muscle if you have a sharp decrease in the number of platelets ( platelets ) in the blood or if you have any other bleeding disorder.

Warnings and cautions

Talk to your doctor or pharmacist before taking Beriglobin:

  • if you are deficient in IgA – antibody s. In rare cases, you may have an allergic reaction.
  • if you are receiving human normal immunoglobulin for the first time. Certain side effects may occur more frequently in those receiving human normal immunoglobulin for the first time.
  • if you have previously received other products for the treatment of the same symptoms.

If Beriglobin has been accidentally given into a blood vessel, you may develop a severe allergic reaction (anaphylactic shock ). In other rare cases, Beriglobin may cause a drop in blood pressure with an anaphylactic reaction, even in people who have previously tolerated treatment with human normal immunoglobulin.

If an allergic or anaphylactic reaction is suspected, the injection should be stopped immediately. Early symptoms of an allergic reaction may include dizziness, increased heart rate, palpitations, vomiting, cold sweats, feeling hot, hives, itching, and shortness of breath. If you experience any of these symptoms, notify the person giving you the injection immediately.

After receiving Beriglobin, the results of certain blood tests (serological tests) may be affected for some time. Tell your doctor that you are taking Beriglobin if you are going to have blood tests.

Measures to prevent the transmission of infectious agents

Beriglobin is produced from blood plasma (the liquid part of the blood). When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. These include:

  • careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded;
  • tests on each donation and on plasma pools for signs of viruses/infections,
  • the inclusion of steps in the manufacturing process of blood and plasma products that inactivate/secrete viruses.

Despite these measures, the risk of transmission of infection can not be completely ruled out when using drugs prepared from human blood or plasma. This also applies to infectious agents or infectious diseases of hitherto unknown origin.

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

Immunoglobulins have not been associated with the infectious diseases hepatitis A or parvovirus B19, possibly because the antibodies contained in the medicine protect against these infections.

When you are given Beriglobin, it is strongly recommended that the product name and batch number be registered to enable the tracking of the used product.

Other medicines and Beriglobin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or other vaccines.

Beriglobin may reduce the effect of vaccination with live attenuated viral vaccines such as measles, rubella, mumps, and chickenpox. After treatment with Beriglobin, 3 months should elapse before you are vaccinated with live attenuated virus vaccines. In the case of the measles vaccine, you may have to wait up to 1 year after treatment with Beriglobin. It is therefore important that the doctor performing the vaccination knows that you are being treated or have been treated with Beriglobin.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of Beriglobin during pregnancy and lactation has not been established in studies. Experience to date with immunoglobulin therapy does not indicate harmful effects during pregnancy or in the newborn. Immunoglobulins are excreted in breast milk and may help protect the newborn from certain infections.

Driving and using machines

The ability to drive or use machines may be impaired by certain side effects associated with Beriglobin. If you experience any side effects during treatment, wait until they pass before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Beriglobin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is next to “sodium-free”.

3. How to get Beriglobin

Beriglobin is given as an injection into a muscle. Beriglobin is injected by a doctor or nurse.

Your doctor will determine the dose in relation to your weight.

Usually, you have to lie down when you get an injection. If you get a larger volume, you will be injected in several places to divide the dose one.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Your doctor or nurse will monitor you when you receive an injection to see if you may experience any side effects.

Tell your doctor immediately if you get any of the following symptoms:

  • Difficulty breathing, pressure over the chest, swelling of the face and skin, feeling hot or hives ( urticaria ), drop in blood pressure. This can be a sign of a serious allergic reaction and can occur even if you have not had an allergic reaction during previous treatment. (This side effect occurs in an unknown number of users.)

Other side effects are

Very common (may affect more than 1 in 10 people).

  • Injection site pain.

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

  • Headache, fever.

Has been reported (occurs in an unknown number of users).

  • Fainting, dizziness.
  • Cramps in the trachea.
  • Rash.
  • Reactions in blood vessels, especially if the drug was accidentally injected into a blood vessel.
  • Nausea, vomiting.
  • Joint pain ( arthralgia ), back pain.
  • Swelling, redness, calluses, heat, itching, bruising, rash, and hives at the injection site.
  • Overindulge.
  • Feeling sick.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Beriglobin

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 carton or prefilled syringe after EXP. date. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze.

Once the package has been opened, its contents must be used immediately.

Beriglobin must not be mixed with other medicines.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is human normal immunoglobulin 160 mg/ml, of which immunoglobulin G constitutes at least 95%.
  • The other ingredients are glycine, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment ), and water for injections.

What the medicine looks like and the contents of the pack

Appearance:

Beriglobin is a clear solution. The color can vary from colorless, pale yellow to pale brown during the shelf life.

Pack sizes

Beriglobin is available in a pre-filled syringe of 2 ml.

Beriglobin is supplied in the following packages:

1 pre-filled syringe (graduated with headline = 0.1 ml) with 2 ml solution and an injection needle

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

D-35041 Marburg

Germany

Local representative :

CSL Behring AB

Box 712

182 17 Danderyd

Muhammad Nadeem

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