ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Octocog alfa, Quantity: 4000 IU

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1 vial with advate (octocog alfa (rch)) 4000 IU powder and 1 vial of diluent (WFI) with a drug delivery system (Baxject II or Baxject III)

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

Advate is indicated for use in haemophilia A for prevention and control of haemorrhagic episodes. Patients with haemophilia A may be treated with Advate as perioperative management. Advate is not indicated in von Willebrand's disease.

Product summary:

Visual Identification: ; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-07-16

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Summary of Product characteristics

Product and Consumer Medicine Information Licence
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ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
DOCUMENTS ("LICENCE")
PARTIES
YOU or YOUR means any legal person or entity who accesses or downloads
a PI Document or CMI Document from Our website
and
US, WE or OUR means the COMMONWEALTH OF AUSTRALIA as represented by
the THERAPEUTIC GOODS ADMINISTRATION ABN 40 939 406 804 of 136
Narrabundah Lane, Symonston ACT 2609, Australia.
OPERATIVE PROVISIONS *
NATURE OF AGREEMENT *
1.1  This Licence specifies the terms and conditions of Your access
and use of PI Documents and CMI Documents made available to the
general public by Us via Our website. *
1.2  You acknowledge and agree that accessing PI Documents or CMI
Documents in accordance with this Licence is beneficial to You because
it provides You with product information about therapeutic goods and
is beneficial to Us because it assists Us in our portfolio
responsibilities. *
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