KOGENATE FS octocog alfa (bhk) 2000 IU powder for injection vial with diluent syringe

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Octocog alfa, Quantity: 2000 IU

제공처:

Bayer Australia Ltd

INN (International Name):

Octocog alfa,water for injections

약제 형태:

Injection, diluent for

구성:

Excipient Ingredients: water for injections

관리 경로:

Intravenous

패키지 단위:

5 mL (2000IU)

처방전 유형:

Not scheduled. Not considered by committee

치료 징후:

KOGENATE FS is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). It may also be used in patients with factor VIII inhibitors (neutralising antibodies) who continue to respond to infused factor VIII. KOGENATE FS does not contain Von Willebrand factor and hence is not indicated in von Willebrands disease.

제품 요약:

Visual Identification: Glass Syringe; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Registered

승인 날짜:

2009-08-26

환자 정보 전단

KOGENATE
®
FS with BIO-SET CMI
Page 1 of 7
KOGENATE
® FS
(with BIO-SET)
octocog alfa (bhk) (recombinant Factor VIII)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
KOGENATE FS
This leaflet does not contain all
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 taking
KOGENATE FS against the
benefits they expect it will have
for you.
KOGENATE FS should only be
used under medical supervision.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read
it again.
WHAT KOGENATE FS
IS USED FOR
KOGENATE FS will both help
to prevent and treat bleeding,
occurring either spontaneously
or due to injury, and bleeding
during emergency and surgical
procedures, by temporarily
providing additional Factor VIII.
BEFORE YOU USE
KOGENATE FS
_ _
_WHEN YOU MUST NOT USE IT _
Do not use KOGENATE FS if
you have an allergy to:
•
any medicine containing
octocog alfa (bhk)
(recombinant Factor VIII)
•
any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
As KOGENATE FS contains
trace amounts of mouse and
hamster proteins, a possibility
exists that patients treated with
this product may develop
hypersensitivity to these non-
human proteins. If you
experience any of these
symptoms, you should stop the
injection at once and seek
medical attention immediately.
DO NOT USE KOGENATE FS
AFTER THE EXPIRY DATE
(EXP)
PRINTED ON THE PACK.
The expiry date is printed on
the carton and vial after
“EXP” (e.g. 3 NOV 18 refers to
3 November 2018). If it has
expired return it to your
pharmacist for disposal.
DO NOT USE THIS MEDICINE IF THE
PACKAGING IS TORN OR SHOWS
SIGN

제품 특성 요약

130524 KOGENATE FS with BIO-SET PI Page 1 of 14
PRODUCT INFORMATION
KOGENATE
® FS
(WITH BIO-SET)
OCTOCOG ALFA (BHK) (RECOMBINANT FACTOR VIII)
NAME OF THE MEDICINE
KOGENATE FS is a sterile, stable, purified recombinant human
antihaemophilic Factor VIII
concentrate produced from genetically engineered baby hamster kidney
cells (bhk) containing a
cloned human Factor VIII gene. The name of the active ingredient in
KOGENATE FS is octocog
alfa (bhk).
DESCRIPTION
Octocog alfa (bhk) is a highly purified glycoprotein consisting of
multiple peptides including an
80 kDa and various extensions of the 90 kDa subunit. KOGENATE FS is
available in the
following dose strengths:
TABLE 1 Available dose strengths and approximate concentration of
reconstituted KOGENATE FS
KOGENATE FS dose strengths
Concentration of reconstituted KOGENATE FS
250 IU
~ 100 IU/mL
500 IU
~ 200 IU/mL
1000 IU
~ 400 IU/mL
2000 IU
~ 400 IU/mL
3000 IU
~ 600 IU/mL
Each vial of KOGENATE FS contains the labelled amount of octocog alfa
(bhk) [Factor VIII] in
International Units (IU). One IU, as defined by the World Health
Organisation standard for blood
coagulation Factor VIII, human, is approximately equal to the level of
Factor VIII activity found in
1.0 mL of fresh pooled human plasma.
One single-use vial with lyophilisate for injection or infusion
contains:
Active ingredient: octocog alfa (bhk) (nominal dose of 250, 500, 1000,
2000, or 3000 IU).
Excipients: sucrose, histidine, glycine, sodium chloride, calcium
chloride and polysorbate 80.
[Trace amounts of mouse and hamster protein are also present.]
One single-use prefilled diluent syringe for parenteral use contains:
Excipient: water for injections, 2.5 mL for 250, 500, 1000 IU; 5 mL
for 2000, 3000 IU.
PHARMACOLOGY
KOGENATE FS has the same biological activity as Factor VIII derived
from human plasma with
the exception that KOGENATE FS does not contain von Willebrand factor.
PHARMACOKINETICS
In 2 trials of single dose KOGENATE FS 50 IU/kg IV, involving 35
patients aged 12 to 59 years
with haemophilia A (Fact