Kogenate FS

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Octocog alfa 1000 [iU]

Available from:

Bayer New Zealand Limited

INN (International Name):

Octocog alfa 1000 IU

Dosage:

1000 IU

Pharmaceutical form:

Injection with diluent

Composition:

Active: Octocog alfa 1000 [iU] Excipient: Calcium chloride dihydrate Glycine Histidine Polysorbate 80 Sodium chloride Sucrose Water for injection Water for injection

Units in package:

Combination pack, vial + diluent syringe, 1000 IU

Class:

General sale

Prescription type:

General sale

Manufactured by:

Bayer Healthcare LLC

Therapeutic indications:

KOGENATE FS is indicated in congenital Factor VIII deficiency (haemophilia A) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

Product summary:

Package - Contents - Shelf Life: Combination pack, vial + diluent syringe - 1000 IU - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Single excursion of up to 6 months at or below 30°C. 3 hours reconstituted stored at or below 25°C - Syringe, glass, prefilled; diluent WFI - 2.5 mL - 48 months from date of manufacture stored at or below 25°C. 30°C if from Bayer - Vial, glass, prefilled; diluent WFI - 2.5 mL - 48 months from date of manufacture stored at or below 25°C - Vial, glass, powder for injection; options on overseal - Aluminium, BIO-SET & MEDI-MOP - 1000 IU - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Single excursion of up to 6 months at or below 30°C.

Authorization date:

1998-08-18

Patient Information leaflet

KOGENATE
®
FS with vial adapter CMI
Page 1 of 6
KOGENATE
® FS
(with vial adapter)
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

Summary of Product characteristics

1902 KOGENATE
Page 1 of 13
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
KOGENATE® FS (with vial adapter) octocog alfa (bhk) 250 IU Injection
with diluent
KOGENATE® FS (with vial adapter) octocog alfa (bhk) 500 IU Injection
with diluent
KOGENATE® FS (with vial adapter) octocog alfa (bhk) 1000 IU Injection
with diluent
KOGENATE® FS (with vial adapter) octocog alfa (bhk) 2000 IU Injection
with diluent
KOGENATE® FS (with vial adapter) octocog alfa (bhk) 3000 IU Injection
with diluent
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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:
250, 500, 1000 IU: One vial with lyophilised powder contains 58 mg
glycine, 4.4 mg sodium chloride,
0.7 mg calcium chloride, 8 mg histidine, 200 µg polysorbate 80 and 28
mg sucrose.
2000, 3000 IU: One vial with lyophilised powder contains 110 mg
glycine, 8.6 mg sodium chloride,
1.3 mg calcium chloride, 15.2 mg histidine, 400 µg polysorbate 80 and
52 mg sucrose.
For the full list of Excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection with diluent
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
KOGENATE FS is indicated in congenital Factor VIII deficiency
(haemophilia A) for the treatment and
prophylaxis of bleeding in untreated and previously treated patients