ALBUMEX 20 albumin (human) 2g/10mL injection vial

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Albumin, Quantity: 0.2 g/mL

Pieejams no:

CSL Behring Australia Pty Ltd

Zāļu forma:

Injection, intravenous infusion

Kompozīcija:

Excipient Ingredients: water for injections; sodium; octanoate

Ievadīšanas:

Intravenous

Ārstēšanas norādes:

INDICATIONS AS AT 27 JANUARY 2000: Hypoproteinaemia in the acutely ill patient: Albumex 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy. Shock: Albumex 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4-5% human albumin is preferred when available. Burns: Extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins, resulting in hypovolaemic shock and circulatory failure. Inititally (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. Large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of Albumex 20 are required to maintain adequate plasma volume and colloid osmotic pressure. Adult respiratory distress syndrome

Produktu pārskats:

Visual Identification: A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.; Container Type: Vial; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

1991-11-04

Lietošanas instrukcija

Albumex 20 AU CMI 13.00
Page 1 of 3
ALBUMEX
® 20
Human albumin, solution for intravenous infusion.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Albumex
®
20. It does not
contain all the available
information about Albumex
®
20.
It does not take the place of
talking to your doctor.
All medicines have benefits and
risks. Your doctor has weighed
the benefits that Albumex
®
20
will have for you against the
risks.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR. FOLLOW YOUR
DOCTOR’S ADVICE EVEN IF IT IS
DIFFERENT FROM WHAT THIS LEAFLET
SAYS.
PLEASE READ THIS LEAFLET
CAREFULLY AND KEEP IT FOR
FUTURE REFERENCE.
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.
WHAT ALBUMEX
® 20 IS
USED FOR
Albumex
®
20 may be used:
•
in an acutely ill patient
when the amount of protein
in their blood is low
(hypoproteinaemia)
•
to replace fluid in the blood
vessels due to acute loss of
blood or plasma (plasma is
the non-cellular part of the
blood)
•
to treat extensive burns
•
to treat a serious lung
condition (respiratory
distress syndrome)
•
in procedures where the
patient’s blood is purified
(haemodialysis)
•
in procedures where the
patient’s plasma is replaced
(plasma exchange).
The main functions of
Albumex
®
20 are to replace and
retain fluid in the blood vessels
and to carry other chemicals
through the blood stream.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ALBUMEX
® 20 HAS BEEN
PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
ALBUMEX
® 20
WHEN YOU MUST NOT
TAKE IT
DO NOT TAKE ALBUMEX
® 20 IF
YOU ARE ALLERGIC TO:
•
human albumin
•
any of the ingredients listed
at the end of this leaflet.
BEFORE YOU ARE GIVEN
IT
TELL YOUR DOCTOR IF YOU:
•
are allergic to any other
food or medicine
•
have any other medical
conditions such as a history
of heart or kidney disease,
low blood pressure

Produkta apraksts

Albumex 20 AU PI 13.00
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
ALBUMEX
® 20
(HUMAN ALBUMIN) – SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Human albumin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Albumin 20% (200 g/L)
It is a sterile, preservative-free 20% w/v human albumin solution. It
has a nominal osmolality
of 130 mOsm/kg, is hypotonic and the pH is 6.7 to 7.3. It is
hyperoncotic and hypo-osmotic
compared to human serum.
Albumex
®
20 is manufactured from human plasma collected by Australian Red Cross
Lifeblood. It is prepared using predominantly chromatographic
techniques.
The composition of Albumex
®
20 is as follows:
Human Albumin
200 g/L
Sodium
48–100 mmol/L
Octanoate
32 mmol/L
Albumex
®
20 also contains Water for Injections.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
Albumex
®
20 is a clear, slightly viscous liquid; it is almost colourless,
yellow, amber or
green.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HYPOPROTEINAEMIA IN THE ACUTELY ILL PATIENT
Albumex
®
20 is administered when there are existing or anticipated clinical
problems or
complications from reduced oncotic pressure, and/or as an adjunct to
diuretic therapy.
Albumex 20 AU PI 13.00
Page 2 of 14
SHOCK
Albumex
®
20 may be used for the resuscitation of patients in shock due to acute
loss of blood
or plasma, but 4–5% human albumin is preferred when available.
BURNS
Extensive burns are followed by sequential shifts in the distribution
of body water, salt and
proteins, resulting in hypovolaemic shock and circulatory failure.
Initially (during the first 24 hours) there is an increased vascular
permeability leading to loss
of water and proteins into the extravascular compartment, and
haemoconcentration. Large
volumes of crystalloid solutions should be infused to restore the
constricted intravascular
fluid space, and smaller amounts of Albumex
®
20 are required to maintain adequate plasma
volume and colloid osmotic pressure.
ADULT RESPIRATORY DISTRESS SYNDROME
The clinical syndrome is characte