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).
Method of administrationBerinert is to be reconstituted according to section 6.6. The reconstituted solution should be colourless and clear to slightly opalescent. The solution is to be administered by slow i.v. injection.
Home treatment and self-administrationThere are limited data on the use of this medicinal product in home treatment or self-administration. Potential risks associated with home treatment are related to the administration itself as well as the handling of adverse drug reactions, particularly hypersensitivity. The decision on the use of home treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.
Virus safetyStandard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.The measures taken are considered effective for enveloped viruses such as HIV, HBV, HCV and for the non-enveloped viruses HAV and parvovirus B19.Appropriate vaccination (hepatitis A and B) should be generally considered for patients in regular/repeated receipt of human plasma-derived products.It is strongly recommended that every time Berinert is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
PregnancyThere are limited amount of data that indicate no increased risk from the use of Berinert in pregnant women. Berinert is a physiological component of human plasma. Therefore, no studies on reproduction and developmental toxicity have been performed in animals and no adverse effects on fertility, pre- and postnatal development are expected in humans. Therefore, Berinert should be given to a pregnant woman only if clearly needed.
BreastfeedingIt is unknown whether Berinert is excreted in human milk, but due to its high molecular weight, the transfer of Berinert into breast milk seems unlikely. However, breastfeeding is questionable in women suffering from hereditary angioedema. A decision must be made whether to discontinue breastfeeding or to discontinue the Berinert therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
FertilityBerinert is a physiological component of human plasma. Therefore, no studies on reproduction and developmental toxicity have been performed in animals and no adverse effects on fertility, pre- and postnatal development are expected in humans.
|1/100 to < 1/10
|1/1,000 to < 1/100
|1/10,000 to < 1/1,000
|1/10,000 (including reported single cases)
|Development of thrombosis*
|General disorders and administration site conditions
|Rise in temperature, reactions at the injection side
|Immune system disorders
|Allergic or anaphylactic-type reactions (e.g. tachycardia, hyper- or hypotension, flushing, hives, dyspnoea, headache, dizziness, nausea)
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the UK Yellow Card Scheme.Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store
Powder:GlycineSodium chlorideSodium citrate
Solvent:Water for injections
Powder (1500 IU) in a vial (Type I glass) with a stopper (bromobutyl rubber), blue seal (aluminium) and orange flip-off cap (plastic).
3 ml of solvent in a vial (Type I glass) with a stopper (chlorobutyl or bromobutyl rubber), blue seal (aluminium) and orange flip-off cap (plastic).
1 vial with powder
1 solvent vial (3 ml)
1 filter transfer device 20/20
Administration set (inner box):
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
Not all pack sizes may be marketed.
Method of administration
General instructions- The solution should be colourless and clear to slightly opalescent. - After filtering/withdrawal (see below) reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.- Do not use solutions that are cloudy or have deposits.- Reconstitution and withdrawal must be carried out under aseptic conditions. Use the syringe provided with the product.
ReconstitutionBring the solvent to room temperature. Ensure product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
|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.
Withdrawal and application
|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.