Adynovate

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Rurioctocog alfa pegol 1500 [iU];  ;  

Tilgængelig fra:

Takeda New Zealand Limited

Dosering:

1500 IU

Lægemiddelform:

Powder for injection with diluent

Sammensætning:

Active: Rurioctocog alfa pegol 1500 [iU]     Excipient: Calcium chloride dihydrate Glutathione Histidine Mannitol Polysorbate 80 Sodium chloride Trehalose dihydrate Trometamol Water for injection

Recept type:

General sale

Terapeutiske indikationer:

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.

Produkt oversigt:

Package - Contents - Shelf Life: Combination pack, 1 product vial + 1 diluent vial + BAXJECT III reconstitution device - 2 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months not refrigerated stored at or below 30°C protect from light. Do not return to the refrigerator 3 hours reconstituted stored at or below 30°C - Combination pack, 1 product vial + 1 diluent vial + BAXJECT II Hi-Flow reconstitution device - 2 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months not refrigerated stored at or below 30°C protect from light. Do not return to the refrigerator 3 hours reconstituted stored at or below 30°C - Combination pack, 1 product vial + 1 diluent vial + BAXJECT III reconstitution device - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months not refrigerated stored at or below 30°C protect from light. Do not return to the refrigerator 3 hours reconstituted stored at or below 30°C - Combination pack, 1 product vial + 1 diluent vial + BAXJECT II Hi-Flow reconstitution device - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 months not refrigerated stored at or below 30°C protect from light. Do not return to the refrigerator 3 hours reconstituted stored at or below 30°C - Vial, glass, Type 1, with butyl rubber stopper - drug product - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1, with chlorobutyl rubber stopper - diluent - 2 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1, with chlorobutyl rubber stopper - diluent - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisation dato:

2019-09-25

Indlægsseddel

ADYNOVATE
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ADYNOVATE?
ADYNOVATE contains the active ingredient rurioctocog alfa pegol.
ADYNOVATE is used in the management of bleeding episodes
in patients with haemophilia A (an inherited bleeding disorder caused
by lack of blood clotting factor VIII). ADYNOVATE does not
contain von Willebrand factor and is therefore not suitable for
treating von Willebrand's disease. For more information, see Section
1. Why am I using ADYNOVATE? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADYNOVATE?
Do not use if you have ever had an allergic reaction to ADYNOVATE,
octocog alfa (a medicine called ADVATE), or you are allergic
to mouse or hamster proteins or any of the ingredients listed at the
end of the CMI. Talk to your doctor if you have or have had any
other medical conditions, if you have had or at risk of any heart
problems, if you take any other medicines, or if you are pregnant or
plan to become pregnant or if you are breastfeeding or plan to
breastfeed. For more information, see Section 2. What should I know
before I use ADYNOVATE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or Haemophilia Treatment Centre if you are taking or
using any other medicines including any that you get without
a prescription from your pharmacy, supermarket, or health food shop.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN ADYNOVATE?
•
ADYNOVATE injection will be prepared and administered by a qualified
healthcare professional who is experienced in the care
of patients with haemophilia. Some individuals may be trained to use
ADYNOVATE at home.
•
Your doctor will decide on your dose of ADYNOVATE depending on your
condition and body weight.
•
The frequency of infusions you receive, and how long you will use
ADYNOVATE

Produktets egenskaber

NEW ZEALAND DATA SHEET
ADYNOVATE Data Sheet V4.0 CCDS7.0
Page 1
1 PRODUCT NAME
ADYNOVATE 250 IU powder for injection with diluent
ADYNOVATE 500 IU powder for injection with diluent
ADYNOVATE 750 IU powder for injection with diluent
ADYNOVATE 1000 IU powder for injection with diluent
ADYNOVATE 1500 IU powder for injection with diluent
ADYNOVATE 2000 IU powder for injection with diluent
ADYNOVATE 3000 IU powder for injection with diluent
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rurioctocog alfa pegol
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
International Units (IU) per vial for reconstitution with 5 mL or 2 mL
sterile water for injections.
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.
_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.
_Biological origin of the active substance _
ADYNOVATE [rurioctocog alfa pegol, Recombinant Coagulation Factor VIII
(rch), PEGylated] is a
full-length form of human coagulation factor VIII (parent molecule:
ADVATE [octocog alfa,
Recombinant Human Factor VIII (rch)] with an extended half-life.
ADYNOVATE is comprised of 2,332
amino acids [molecular weight (MW) 280kDa] covalently conjugated with
a polyethylene glycol
(PEG) reagent (MW 20kDa). The therapeutic activity of ADYNOVATE is
derived from ADVATE, which
is produced by recombinant DNA technology from a Chinese hamster ovary
cell line. The ADVATE
molecule is then covalently conjugated with the PEG reagent, which
targets lysine residues. The PEG
moiety is conjugated to the ADVATE molecule to increase the plasma
half-life through the reduction
of the LRP-1 receptor-mediated