Patient Leaflet Updated 07-Dec-2021 | CSL Behring UK Limited
Berinert 500 & 1500 IU Powder and solvent for solution for injection / infusion
CSL Behring
Berinert® 500 IU
Powder and solvent for solution for injection / infusion
Berinert® 1500 IU
Powder and solvent for solution for injection
Human C1-esterase inhibitor
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 pack and other information
Berinert is presented as powder and solvent. The made-up solution of Berinert 500 IU is to be given by injection or infusion into a vein. Berinert 1500 IU may be given by slow injection only.
Berinert is made from human plasma (this is the liquid part of the blood). It contains the protein human C1-esterase inhibitor as active ingredient.
Berinert is used for the treatment and pre-procedure prevention of the hereditary angioedema type I and II (HAE, oedema = swelling).
HAE is a congenital disease of the vascular system. It is a non-allergic disease. HAE is caused by deficiency, absence or defective synthesis of C1-esterase inhibitor, an important protein.
The illness is characterised by the following symptoms:
Generally, all parts of the body can be affected.
The following sections contain information that your doctor should consider before you are given Berinert.
Please inform your doctor or pharmacist if you are allergic to any medicine or food.
Your doctor will consider carefully the benefit of treatment with Berinert compared with the risk of these complications.
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:
Manufacturers of these products 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, the AIDS virus), hepatitis B virus, hepatitis C virus (inflammation of the liver) and for the non-enveloped viruses hepatitis A (inflammation of the liver) and parvovirus B19.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived products.
It is strongly recommended that every time that Berinert is given, the date of administration, the batch number and the injected volume should be recorded.
No studies on the effects on the ability to drive and use machines have been performed.
Berinert 500 IU contains up to 49 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2.5 % of the recommended maximum daily dietary intake of sodium for an adult.
Berinert 1500 IU contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. .
Treatment should be started and supervised by a doctor who is experienced in the treatment of C1-esterase inhibitor deficiency.
Adults
Treatment of acute angioedema attacks:
20 IU per kilogram body weight (20 IU/kg b.w.).
Pre-procedure prevention of angioedema attacks:
1000 IU less than 6 hours prior to a medical, dental, or surgical procedure.
Treatment of acute angioedema attacks:
20 IU per kilogram body weight (20 IU/kg b.w.).
Pre-procedure prevention of angioedema attacks:
15 to 30 IU per kilogram body weight (15-30 IU/kg b.w.) less than 6 hours prior to a medical, dental, or surgical procedure. Dose should be selected taking into account clinical circumstances (e.g. type of procedure and disease severity).
No case of overdose has been reported.
Berinert is usually injected into a vein (intravenously) by your doctor or nurse. You or your carer might also administer Berinert as an injection, but only after receiving adequate training. If your doctor decides that you may be suitable for such home-treatment, he/she will give you detailed instructions. You will be required to keep a diary in order to document each treatment received at home and to bring it to each of your visits to the doctor. Regular review of your/your carer’s injection technique will be performed to ensure continued appropriate handling.
Without opening either vial, warm the Berinert powder and the solvent to room temperature. This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes. DO NOT expose the vials to direct heat. The vials must not be heated above body temperature (37°C).
Carefully remove the protective caps from the solvent vial and the product vial. Clean the exposed rubber stoppers of both vials with one alcohol swab each and allow them to dry. The solvent can now be transferred to the powder with the administration set (Mix2Vial) attached.
Please follow the instructions given below.
1. Open the Mix2Vial package by peeling off the lid. Do not remove the Mix2Vial from the blister package!
2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
3. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set.
4. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.
5. With one hand grasp the product-side of the Mix2Vial set and with the other hand, grasp the solvent-side and unscrew the set carefully into two pieces.
Discard the solvent vial with the blue Mix2Vial adapter attached.
6. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.
7. Draw air into an empty, sterile syringe. Use the syringe provided with the product. While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting. Inject air into the product vial.
8. While keeping the syringe plunger pressed, invert the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe.
Berinert 500 IU solution is to be administered by slow intravenous injection or infusion (4 ml/minute). Berinert 1500 IU solution is to be administered by slow intravenous injection only.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesired reactions with Berinert are rare.
The following side effects have been observed rarely (may affect up to 1 in 1000 people):
In very rare cases (may affect up to 1 in 10,000 people), hypersensitive reactions might progress as far as shock.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom:
or search for MHRA Yellow Card in the Google Play or Apple App Store
Malta:
The active substance is:
Human C1-esterase inhibitor (500/1500 IU/vial; after reconstitution with 10/3 ml water for injections 50/500 IU/ml)
See section “The following information is intended for healthcare professionals only” for further information.
The other ingredients are:
Glycine, sodium chloride, sodium citrate
See last paragraph of section 2. "Important information about some of the ingredients of Berinert".
Solvent: Water for injections
Berinert is presented as a white powder and is supplied with water for injections as solvent.
The made-up Berinert 500 IU solution should be colourless and clear. Berinert 1500 IU may be colourless and clear to slightly opalescent.
Box with 500/1500 IU contains:
1 vial with powder (500/1500 IU)
1 vial with 10 ml / 3 ml water for injections
1 filter transfer device 20/20
Administration set (inner box):
1 disposable 10 ml / 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 plaster
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in September 2021
4 Milton Road, Haywards Heath, West Sussex, RH16 1AH, UK
+44 (0)1444 447 400
+44 (0)1444 447 405
+44 (0)1444 447 402
http://www.cslbehring.co.uk
+44 (0)1444 447 403
+44 (0)1444 447 405