KAMRAB rabies immunoglobulin 150 IU/mL solution for injection vial

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Indlægsseddel Indlægsseddel (PIL)
27-08-2021
Produktets egenskaber Produktets egenskaber (SPC)
27-08-2021

Aktiv bestanddel:

rabies immunoglobulin, Quantity: 150 IU/mL

Tilgængelig fra:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Lægemiddelform:

Injection, solution

Sammensætning:

Excipient Ingredients: sodium hydroxide; glycine; water for injections

Indgivelsesvej:

Intramuscular

Enheder i pakken:

2 mL and 10 mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

KamRAB is rabies immunoglobulin indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal.,KamRAB should be administered concurrently with a full course of rabies vaccine.,? Do not administer additional (repeat) doses of KamRAB once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine.,? Do not administer KamRAB to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titre.

Produkt oversigt:

Visual Identification: Clear to slightly opalescent, colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2021-08-16

Indlægsseddel

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Produktets egenskaber

                                Product and Consumer Medicine Information Licence
-------------------------
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.	*
TERMS OF ACCESS	*
2.1  We grant to You a perpetual, non-exclusive, royalty-free,
world-wide, irrevocable and non-transferable licence to download,
store in cache, display, print and copy a single copy or part of a
single copy of a PI Document or CMI Document made available via Our
website.	*
2.2  If You wish to use any PI Document or CMI Document for purposes
other than those specified in clause 2.1 of this Licence, You must
seek the permission of the Sponsor.	*
2.3  We may remove a PI Document or CMI Document from Our website at
any time in Our sole discretion.	*
EXCLUSION OF LIABILITY	*
3.1  You acknowledge and agree that You are responsible for making
Your own enquiries to determine whether any PI Document or CMI
Document is accurate, up to date and fit for Your purposes.	*
3.2  The PI Document or CMI Document is provided to You for the
purpose of disseminating health information free of charge for the
benefit of the public.  This Licence and any PI Document or CMI
Document made available to You via Our website is not a substitute fo
                                
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