NOVOEIGHT 500 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TUROCTOCOG ALFA

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

B02BD02

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

TUROCTOCOG ALFA 500 IU / 4 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic area:

COAGULATION FACTOR VIII

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).NovoEight can be used for all age groups.

Authorization date:

2020-08-31

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor's prescription only
NOVOEIGHT
® 500 IU
NOVOEIGHT
® 1000 IU
NOVOEIGHT
® 2000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT: TUROCTOCOG ALFA
Inactive ingredients and allergens in this medicine: See section 2
under
"
Important
information about some of this medicine's ingredients
"
and section 6
"
Additional information
"
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
NovoEight is used to treat and prevent bleeding episodes in patients
with haemophilia A
(inborn factor VIII deficiency) and can be used for all age groups.
THERAPEUTIC GROUP: antihaemorrhagics, blood coagulation factor VIII.
NovoEight contains the active substance turoctocog alfa, human
coagulation factor VIII.
Factor VIII is a protein naturally found in the blood that helps it to
clot.
In patients with haemophilia A, factor VIII is missing or not working
properly. NovoEight
replaces this faulty or missing ‘factor VIII’ and helps blood to
form clots at the site of
bleeding.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active substance or to any of the
other ingredients this
medicine contains (listed in section 6
"
Additional information
"
).
•
you are allergic to hamster proteins.
Do not use NovoEight if either of the above applies to you. If you are
not sure, consult your
doctor before using this medicine.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
TALK TO YOUR DOCTOR BEFORE USING NOVOEIGHT.
There is a rare chance that you may experience an anaphylactic
reaction (a severe, sudden
aller

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
NovoEight
®
500 IU
NovoEight
®
1000 IU
NovoEight
®
2000 IU
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoEight 500 IU.
Each powder vial contains nominally 500 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 125 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 1000 IU.
Each powder vial contains nominally 1000 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 250 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 2000 IU.
Each powder vial contains nominally 2000 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 500 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
The potency (IU) is determined using the European Pharmacopoeia (Ph.
Eur) chromogenic assay. The
specific activity of NovoEight is approximately 8,300 IU/mg protein.
Turoctocog alfa (human coagulation factor VIII (rDNA)) is a purified
protein that has 1,445 amino
acids with an approximate molecular mass of 166 kDA. It is produced by
recombinant DNA
technology in Chinese hamster ovary (CHO) cells, and prepared without
the addition of any human or
animal derived protein in the cell culture process, purification or
final formulation.
Turoctocog alfa is a B-domain truncated recombinant human coagulation
factor VIII (B-domain
consists of 21 amino acids of the wild type B-domain) without any
other modifications in the amino
acid sequence.
Excipient with known effect:
The medicinal product contains 30.5 mg sodium per reconstituted vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or slightly yellow powder or friable mass.
Clear and colourless solution for injection.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenita