BERIPLEX P/N human prothrombin complex 1000 IU powder for injection vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

water for injections, Quantity: 40 mL

Inapatikana kutoka:

CSL Behring Australia Pty Ltd

INN (Jina la Kimataifa):

Factor II,Factor IX,Factor VII,Factor X,Protein C,Protein S,water for injections

Dawa fomu:

Injection, solution

Tungo:

Excipient Ingredients:

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

Single vial: 1 x 1000

Dawa ya aina:

Not scheduled. Not considered by committee

Matibabu dalili:

Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.

Bidhaa muhtasari:

Visual Identification: Clear, colourless fluid; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2015-08-05

Taarifa za kipeperushi

Beriplex P/N AU CMI 6.00
Page 1 of 4
BERIPLEX
® P/N
Human prothrombin complex
CONSUMER MEDICINE INFORMATION
250 IU: AUST R 156330
500 IU: AUST R 156459
1000 IU: AUST R 228338
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Beriplex
®
P/N.
The leaflet does not contain all
the available information.
It does not take the place of
talking to your doctor.
All medicines have benefits and
risks. Your doctor has weighed
the benefits that Beriplex
®
P/N
will have for you against the
risks.
If you have any concerns about
taking this medicine, ask your
doctor. Follow your doctor’s
advice even if it is different
from what this leaflet says.
Keep this leaflet with the
medicine. You may need to read
it again.
The information in this leaflet is
subject to change. Please check
with your doctor whether there
is any new information about
this medicine that you should
know since you were last treated
with this medicine.
WHAT BERIPLEX
® P/N
IS USED FOR
Beriplex
®
P/N is used to treat
bleeding conditions that may be
caused when you are taking a
blood thinner (e.g. warfarin) and
unexpected bleeding occurs.
The coagulation factors called
factor II, factor VII, factor IX
and factor X together make up
the prothrombin complex. The
factors are made in the liver
when your body has enough
vitamin K.
Medicines, like warfarin, which
are used to thin the blood (also
called vitamin K antagonists, or
anticoagulants) prevent blood
clotting and may work by
stopping the liver from making
coagulation factors.
If you do not have enough
vitamin K, or you have been
treated with medicines which
are used to thin the blood, you
may be at risk of bleeding and
haemorrhage.
Ask your doctor if you have any
questions about why
Beriplex
®
P/N has been
prescribed for you.
HOW BERIPLEX
® P/N
WORKS
Beriplex
®
P/N works by
replacing the coagulation
(clotting) factors your body
needs.
Beriplex
®
P/N belongs to a
group of medicines called
prothrombin complex products,
which are made from human
blood.
BEFORE YOU ARE GIVEN
BERIPLEX
®

Tabia za bidhaa

Beriplex P/N AU PI 6.00
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
BERIPLEX
®
P/N
(HUMAN PROTHROMBIN COMPLEX)
1
NAME OF THE MEDICINE
Human prothrombin complex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Beriplex
®
P/N is presented as a powder, containing human prothrombin complex, in
packs of
250 IU, 500 IU and 1000 IU factor IX, for reconstitution with a vial
of diluent.
P/N refers to the virus inactivation and removal steps of
pasteurisation and nanofiltration
(virus filtration).
The product contains the following IU of the human coagulation factors
in
TABLE 1.
TABLE 1: ACTIVE INGREDIENT COMPOSITION
NAME OF THE
INGREDIENTS
CONTENT AFTER
RECONSTITUTION
(IU/ML)
BERIPLEX
® P/N 250
CONTENT PER VIAL
(IU)
BERIPLEX
® P/N 500
CONTENT PER VIAL
(IU)
BERIPLEX
® P/N 1000
CONTENT PER VIAL
(IU)
ACTIVE INGREDIENTS
Human
coagulation
factor II
20–48
200–480
400–960
800–1920
Human
coagulation
factor VII
10–25
100–250
200–500
400–1000
Human
coagulation
factor IX
20–31
200–310
400–620
800–1240
Human
coagulation
factor X
22–60
220–600
440–1200
880–2400
OTHER ACTIVE INGREDIENTS
Protein C
15–45
150–450
300–900
600–1800
Protein S
12–38
120–380
240–760
480–1520
The total protein content is 6–14 mg/mL of reconstituted solution.
Beriplex P/N AU PI 6.00
Page 2 of 22
The specific activity of factor IX is 2.5 IU per mg total protein.
The activities of all coagulation factors as well as protein C and S
(antigen) have been tested
according to the current valid international WHO Standards.
Beriplex
®
P/N contains up to 343 mg sodium (approximately 15 mmol) and up to 200
IU
heparin per 100 mL reconstituted solution.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection
Powder: white or slightly coloured powder or friable solid
Diluent (Water for Injections): clear, colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment and perioperative prophylaxis of bleedings in acquired
deficiency of th