ADYNOVATE rurioctocog alfa pegol (rch) 1500 IU powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

water for injections, Quantity: 5.4 mL

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 vial of drug powder (rurioctocog alfa pegol) and 1 vial of diluent (WFI) with 1 reconstitution system (Baxject II or Baxject III)

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

ADYNOVATE is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for:,? Control and prevention of bleeding episodes,? Routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? Perioperative management (surgical prophylaxis),ADYNOVATE is not indicated for the treatment of von Willebrand disease.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-01-29

Patient Information leaflet

ADYNOVATE
_Rurioctocog alfa pegol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START USING ADYNOVATE.
This leaflet answers some common
questions about ADYNOVATE. It
does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
ADYNOVATE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may wish to read it again.
WHAT IS ADYNOVATE
USED FOR
ADYNOVATE belongs to the group
of medicines called blood
coagulation factor VIII. It is used for
the treatment and prophylaxis of
bleeding in patients with haemophilia
A (congenital factor VIII deficiency).
ADYNOVATE does not contain von
Willebrand factor and is therefore not
suitable for use in von Willebrand's
disease.
ADYNOVATE contains the active
substance rurioctocog alfa pegol,
PEGylated human recombinant
coagulation factor VIII. The human
coagulation factor VIII is produced
by recombinant DNA technology and
has been modified chemically to
prolong its duration of action.
_HOW DOES ADYNOVATE_
_WORK_
Under normal physiological
condition, factor VIII is essential for
blood clotting and maintenance of a
bleeding episode.
Individuals with haemophilia A
disease, which is a hereditary
disorder of blood coagulation have a
low level of factor VIII in their blood
circulation. As a result of factor VIII
deficiency, the individual with this
disease may have a heavy bleeding
into joints, muscles or internal organs
either spontaneously or as a result of
accidental or surgical trauma.
ADYNOVATE is similar to plasma-
derived factor VIII. As it works in
the same way, it can be used as a
replacement therapy in patients with
haemophilia A.
BEFORE YOU ARE GIVEN
ADYNOVATE
_ADYNOVATE SHOULD NOT BE_
_GIVEN TO YOU IF:_
•
you are allergic (hypersensitive)
to mouse, hamster proteins or any
other ing

Summary of Product characteristics

ADYNOVATE PI V2.0 CCDS 6.0
Page
1
AUSTRALIAN PRODUCT INFORMATION
ADYNOVATE
® (RURIOCTOCOG ALFA PEGOL)
1
NAME OF THE MEDICINE
Rurioctocog alfa pegol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADYNOVATE 250, 500, 750, 1000, 1500, 2000 and 3000 International Units
(IU).
ADYNOVATE [rurioctocog alfa pegol, Recombinant Coagulation Factor VIII
(rch),
PEGylated] is supplied in single-use vials containing nominal
potencies of 250, 500, 750, 1000,
1500, 2000 or 3000 IU per vial with a diluent vial containing sterile
water for injections for
reconstitution to 2 mL or 5 mL.
The 5 mL diluent of water for injections is available for ADYNOVATE
250, 500, 750, 1000,
1500, 2000 or 3000 IU.
The 2 mL diluent of water for injections is available for ADYNOVATE
250, 500, 750, 1000 or
1500 IU.
The amounts of the inactive ingredients are constant in all strengths.
Excipient(s) with known effect
Each vial of ADYNOVATE contains 0.45 mmol (10 mg) sodium, see section
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for injection with diluent.
ADYNOVATE is formulated as a sterile, non-pyrogenic, white to
off-white, lyophilised
powder for intravenous injection after reconstitution with water for
injections.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
ADYNOVATE is a long-acting antihaemophilic factor (recombinant)
indicated in
haemophilia A (congenital factor VIII deficiency) patients for:
•
Control and prevention of bleeding episodes
•
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes
•
Perioperative management (surgical prophylaxis)
ADYNOVATE is not indicated for the treatment of von Willebrand
disease.
ADYNOVATE PI V2.0 CCDS 6.0
Page
2
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
Treatment with ADYNOVATE should be under the supervision of a
physician experienced in
the treatment of haemophilia.
TREATMENT MONITORING
During the course of treatment, appropriate determination of factor
VIII levels (by one-stage
clotting