Veyvondi

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

vonicog alfa

זמין מ:

Baxalta Innovations GmbH

קוד ATC:

B02BD10

INN (שם בינלאומי):

vonicog alfa

קבוצה תרפויטית:

Antihemorrhagics

איזור תרפויטי:

von Willebrand Diseases

סממני תרפויטית:

Veyvondi is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the- Treatment of haemorrhage and surgical bleeding- Prevention of surgical bleeding.Veyvondi should not be used in the treatment of Haemophilia A.

leaflet_short:

Revision: 8

מצב אישור:

Authorised

תאריך אישור:

2018-08-31

עלון מידע

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VEYVONDI 650 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VEYVONDI 1300 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
vonicog alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What VEYVONDI is and what it is used for
2.
What you need to know before you use VEYVONDI
3.
How to use VEYVONDI
4.
Possible side effects
5.
How to store VEYVONDI
6.
Contents of the pack and other information
1.
WHAT VEYVONDI IS AND WHAT IT IS USED FOR
VEYVONDI contains the active substance vonicog alfa, which is a
recombinant human von
Willebrand factor (rVWF). It behaves in the same way as natural human
von Willebrand factor (VWF)
in the body. VWF is the carrier molecule for coagulation factor VIII
and is involved in blood clotting
making platelets stick to wounds and so helps to form a blood clot.
Lack of VWF increases the
tendency to bleed.
VEYVONDI is used to prevent and treat bleeding episodes, including
bleeding during surgery, in adult
patients (aged 18 years and older) with von Willebrand disease. It is
used when treatment with another
medicine, desmopressin, is not effective or cannot be given.
Von Willebrand disease is an inherited bleeding disorder caused by the
lack or an insufficient amount
of von Willebrand factor. In patients with the disease the blood does
not clot normally leading to a
prolonged bleeding time. Administration of von Willebrand factor (VWF)
allows for correction of von
Willebrand factor deficiency.
2.
WHAT YOU NEED TO KNOW B

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VEYVONDI 650 IU powder and solvent for solution for injection
VEYVONDI 1300 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VEYVONDI 650 IU powder and solvent for solution for injection
Each vial of powder contains nominally 650 International Units (IU)
vonicog alfa.
After reconstitution with the 5 mL solvent provided, VEYVONDI contains
approximately 130 IU/mL
vonicog alfa.
VEYVONDI 1300 IU powder and solvent for solution for injection
Each vial of powder contains nominally 1300 International Units (IU)
vonicog alfa.
After reconstitution with the 10 mL solvent provided, VEYVONDI
contains approximately 130 IU/mL
vonicog alfa.
The specific activity of VEYVONDI is approximately 110 IU VWF:RCo/mg
protein.
The potency of VWF (IU) is measured using the European Pharmacopeia
ristocetin cofactor activity
assay (VWF: RCo). The ristocetin cofactor activity of recombinant
human von Willebrand factor was
determined against the International Standard for von Willebrand
factor concentrate (WHO).
Vonicog alfa is a purified recombinant human von Willebrand factor
(rVWF). It is manufactured by
recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO)
cell line without the
addition of any exogenous human-or animal-derived protein in the cell
culture process, purification or
final formulation.
The product contains only trace amounts of human recombinant
coagulation factor VIII (≤ 0.01 IU
FVIII / IU VWF: RCo) as determined using the European Pharmacopoeia
chromogenic assay for
factor VIII (FVIII).
Excipient with known effect
Each 650 IU powder vial contains 5.2 mg sodium.
Each 1300 IU powder vial contains 10.4 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is a white to off-white lyophilized powder
The solvent is a clear and colourless solution.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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