500 IU powder and solvent for solution for injection or infusion 
C1-esterase inhibitor, human

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 about it.

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

1. What Berinert is and what it is used for

What is Berinert?

Berinert consists of a powder and a diluent, which are prepared into a finished solution. The solution is then given as an injection or infusion into a vein.

Berinert is made from human plasma (the liquid part of the blood). It contains the human protein et C1 esterase inhibitor as an active ingredient.

What is Berinert used for?

Berinert is used to treat, and prevent surgery, edema that occurs in hereditary angioedema type I or II (HAE, edema = swelling). HAE is a congenital disease of the blood vessels. It is a non-allergic disease. HAE is caused by a lack, absence of, or a defective synthesis of C1 esterase inhibitors, which is an important protein. The disease is characterized by the following symptoms:

  • sudden swelling of hands and feet
  • sudden swelling of the face with a feeling of tension
  • eyelid swelling, lip swelling, possible swelling of the trachea with difficulty breathing
  • swollen tongue
  • colic pains in the stomach

In general, all parts of the body can be affected.

Berinert may also be approved for the treatment of other diseases not mentioned here. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Berinert

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The following sections contain information that your doctor should consider before taking Berinert.

Do not use Berinert:

  • if you are allergic to the C1-esterase inhibitor protein or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor or pharmacist if you are allergic to any medicine or to any food.

Warnings and cautions

Talk to your doctor or pharmacist before using Berinert:

  • if you have had allergic reactions to Berinert before. If your doctor advises you to, you should take antihistamines and corticosteroids for prevention
  • in case of an allergic or anaphylactic reaction (a severe allergic reaction that causes great difficulty in breathing or dizziness). Berinert should be discontinued immediately (ie discontinue the infusion ).
  • if your trachea swells (laryngeal edema). You should then be closely monitored with emergency care nearby
  • during use outside the approved range of use and dosage (eg Capillary Leak Syndrome (CLS). See section 4. “Possible side effects”.

Your doctor will carefully consider the benefits of treatment with Berinert compared to the risk of the above complications.

Virus security

When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes:

  • a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded, and
  • testing of individual donations and plasma pools for signs of virus/infection.

Manufacturers of these products also include steps in the handling of blood and plasma that can inactivate or secrete any viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to unknown or new viruses and other types of infection.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV which causes AIDS ), hepatitis B, hepatitis C virus ( inflammation of the liver), and against non-enveloped viruses such as hepatitis ( inflammation of the liver) and parvovirus B19.

Your doctor may suggest vaccination against hepatitis A and B if you are regularly / repeatedly treated with human plasma-derived preparations.

It is strongly recommended that the date of administration, batch number, and injected volume be recorded each time you receive Berinert.

Other drugs and Berinert

  • Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
  • Berinert should not be mixed with other medicinal products and diluents in the syringe/infusion set

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.
  • Berinert should only be given during pregnancy and breast-feeding if your doctor considers it necessary

Driving and using machines

No studies on the ability to drive and use machines have been performed.

Berinert contains sodium

Berinert contains up to 486 mg sodium (approximately 21 mmol) per 100 ml. This should be considered if you have been prescribed a low-salt diet.

3. How to use Berinert

Treatment should be initiated and supervised by a physician experienced in the management of C1-esterase inhibitor deficiency.

Dosage

Adults

For the treatment of acute angioedema attacks:

20 IU per kilogram body weight (20 IU / kg body weight). IU = IE (International Units)

Preventive treatment of angioedema attacks before surgery:

1000 IU less than 6 hours before medical, dental, or surgical procedure.

Children and young people

For the treatment of acute angioedema attacks:

20 IU per kilogram body weight (20 IU / kg body weight).

Preventive treatment of angioedema attacks before surgery:

15 to 30 IU per kilogram body weight (15-30 IU / kg body weight) less than 6 hours before medical, dental, or surgical procedure. Dose one should be chosen taking into account clinical conditions (eg type of procedure and severity of the disease).

If you use more Berinert than you should


Preparation and method of administration

Berinert is usually injected into a vein ( intravenously ) by your doctor or nurse. You or your assistant can also administer Berinert as an injection, but only after appropriate training has been completed. If your doctor decides that home treatment may be appropriate for you, he/she will give you detailed instructions. You will be asked to keep a diary to document each treatment you receive at home and to take it with you to your doctor’s visits. Your or your assistant’s injection technique will be reviewed periodically to ensure continued proper handling.

General instructions

  • The powder must be dissolved and withdrawn from the vial under aseptic conditions. Use the syringe that comes with the product.
  • The reconstituted solution should be colorless and clear. After filtration or assignment (see below), the solution should be inspected visually for particulate matter or discoloration prior to administration.
  • Do not use the solution if it is cloudy or if it contains flakes or particles.
  • Any unused product or waste material should be disposed of in accordance with local requirements.

Preparation

Without opening the vials, warm the Berinert powder and solution to room temperature. This can be done either by leaving the vials at room temperature for about 1 hour or by holding them in your hand for a few minutes. DO NOT expose the vials to direct heat. The vials should not be warmed above body temperature (37 ° C).

Carefully remove the protective caps from the vials. Clean the rubber stoppers on both vials with an alcohol swab and allow to dry. The solvent can now be transferred to the powder using the administration set (Mix2Vial). Follow the instructions below.


1
1. Open the Mix2Vial package by pulling off the closure. Do not remove Mix2Vial from the package!

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2. Place the bottle with liquid on a flat, clean surface and hold the bottle firmly. Take the package with the Mix2Vial set and press the blue part straight down on the cork of the liquid bottle.

3
Carefully remove the package from the Mix2Vial set by grasping the edge from above and pulling straight up . Make sure that only the packaging is removed, not the Mix2Vial set.

4
4. Place the powder bottle on a flat, firm surface. Invert the liquid bottle with the attached Mix2Vial set and press the transparent adapter straight down onto the powder bottle stopper. The liquid will automatically flow over to the powder bottle.

5
5. Grasp the part of the Mix2Vial set where the powder bottle sits with one hand and the part of the Mix2Vial set where the liquid bottle sits with the other hand and unscrew the set into 2 parts.Discard the liquid bottle with the blue part attached.

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6. Carefully rotate the powder bottle until the powder is completely dissolved. Do not shake the bottle.

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7. Inhale air into an empty, sterile syringe. Use the syringe that comes with the product. While the powder bottle is upright, the syringe is connected to the Luer-lock fitting on the Mix2Vial part.Inject air into the bottle.

Filling the syringe and administration


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8. With the syringe plunger depressed, turn the bottle (together with the set and syringe ) upside down. Withdraw the solution into the syringe by slowly returning the plunger.

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9. Once all the solution has been transferred to the syringe, grasp the syringe firmly (hold the syringe with the plunger down) and disconnect the Mix2Vial set from the syringe.

Administration

The solution should be given by slow intravenous (iv) injection or infusion (4 ml/minute).

4. Possible side effects

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

Contact your doctor immediately

  • if any of the side effects occur, or
  • if you notice any side effects not mentioned in this information

Side effects of Berinert are rare.

The following side effects have been reported rarely (affects less than 1 user in 1,000):

  • There is an increased risk of blood clots forming during prophylactic treatment or treatment for Capillary Leak Syndrome (when fluid from the small blood vessels flows out into tissue one) for example during or after heart surgery with blood circulation outside the body. See section 2. ” Warnings and Precautions “.
  • Elevated body temperature and burning and stinging sensation where the injection was given.
  • Hypersensitivity or allergic reactions (such as irregular heartbeat, faster heartbeat, drop in blood pressure, reddening of the skin, itching, difficulty breathing, headache, dizziness, nausea).

In very rare cases (less than 1 in 10,000 patients or in rare cases) hypersensitivity reactions have developed into shock.

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. 

5. How to store Berinert

  • 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 label and carton. The expiration date is the last day of the specified month.
  • Do not store above 30 ° C.
  • Do not freeze.
  • Keep the vial in the outer carton. Sensitive to light.
  • Berinert does not contain any preservative, so the reconstituted solution should be used immediately.
  • If the reconstituted solution is not used immediately, it must be used within 8 hours and should only be stored in the vial.

6. Contents of the packaging and other information

Content declaration

The active substance is :

C1 esterase inhibitor, human (500 IU / vial; after reconstitution 50 IU / ml). See section “The following information is intended for healthcare professionals only” for further information.

Other ingredients are:

Glycine, sodium chloride, sodium citrate

See the last paragraph in section 2. “Berinert contains sodium”.

Diluent: Water for injections

What the medicine looks like and the contents of the pack

Berinert is available as a white powder and is supplied with water for injections as a diluent. The reconstituted solution should be colorless and clear.

Packaging

Carton with 500 IU contains:

1 vial of powder (500 IU)

1 vial with 10 ml water for injections

1 transfer set with filter 20/20

Accessories for administration (inner packaging):

1 disposable syringe 10 ml

1 injection set

2 alcohol dryers

1 patch

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

This medicinal product is authorized under the European Economic Area under the names:

Berinert 500 Belgium, Cyprus, Greece, Luxembourg, Poland, Germany
Berinert 500, 500 IU Powder and solvent for solution for injection/infusion Bulgaria
Berinert Denmark, Italy, Portugal
Berinert 500 IU, injection/infusion solution and liuotin, liuosta varten Finland
Berinert 500 UI, powder and solvent forsolution injectable / perfusion France
Berinated 500 IU powder and liquid for solution for injection/infusion Norway
Berinert 500 UI, powder and solventinjectable / sprayable solution Romania
Berinert 500 IU Slovakia, Czech Republic
Berinert 500 ie prašek in vehikel zainjection / infusion raztopino Slovenia
Berinert 500 UI Polvo for solution injectable and for perfusion Spain
Berinert 500 IU powder and solventfor solution for injection/infusion UK
Berinert 500 IU, powder and liquid to solution for injection/infusion
Berinert 500 NE for old ageoldatos injekcióhoz vagy infusiohoz Hungary
Berinert 500 IU powder and solvents for the manufacture of injection or infusion solution

Muhammad Nadeem

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