Albunorm 25%, 250 g/l, solution for infusion.

Presentation: Albunorm 25% is a hyperoncotic solution containing 250 g/l of total protein of which at least 96% is human albumin.
Indication: Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of
a colloid is appropriate. Dosage and Method of administration: The concentration of the albumin preparation, dosage and the
infusion-rate should be adjusted to the patient´s individual requirements. The dose required depends on the size of the patient, the
severity of trauma or illness and on continuing fluid and protein losses. If human albumin is to be administered, haemodynamic
performance should be monitored regularly. Data on the use of Albunorm 25% in children are limited; therefore, the product should
only be administered to these individuals if the benefits clearly outweigh potential risks. Human albumin can be directly administered
by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). The infusion rate Human albumin
should be adjusted according to the individual circumstances and the indication. In plasma exchange the infusion-rate should be
adjusted to the rate of removal. Contraindications: Hypersensitivity to albumin preparations or to any of the excipients. Special
warnings and precautions for use: Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of infusion.
In case of shock, medical treatment should be implemented. Albunorm 25% should be used with caution in conditions where
hypervolaemia or haemodilution could represent a special risk for the patient. Caution is advised in patients with severe traumatic
brain injury. The colloidosmotic effect of human albumin 200 or 250 g/l is approximately four times that of blood plasma, care must
be taken to assure adequate hydration of the patient. Circulatory overload and hyperhydration must be avoided. Electrolyte status
must be monitored and electrolyte balance maintained. Albunorm 25% must not be diluted with water for injections as this may

Complex function designed by nature

cause haemolysis in recipients. This medicinal product contains 7.2-8 mmol / 14.4-16 mmol sodium per one bottle of 50 ml /100 ml
albumin solution, attention must be paid in patients on a controlled sodium diet. This medicine contains maximum 1mmol potassi-
um per one bottle of 100 ml albumin solution, in patients with reduced kidney function or patients on a controlled potassium diet this
fact must be considered. Despite the standard measure to prevent infections resulting from the use of medicinal products prepared
from human blood or plasma, the possibility of transmitting infective agents cannot be totally excluded. The name and batch number
of the product should be record to maintain a link between the patient and the batch of the product. Fertility, pregnancy and
lactation: Use of Albunorm 25% in pregnancy has not been established in controlled clinical trials. However, clinical experience
suggests no harmful effects on the course of pregnancy, the fetus or neonates. Undesirable Effects: Mild reactions such as flush,
urticaria, fever, and nausea occur rarely and normally disappear rapidly after infusion rate is slowed down or stopped. Very rarely,
severe reactions such as shock may occur, in that case the infusion must be stopped and an appropriate treatment initiated.
Overdose: Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs, infusion must be stopped
and haemodynamic parameters of the patient should be monitored.

Marketing Authorization Number:

Albunorm 25% DKI1509300849B1

HARUS DENGAN RESEP DOKTER.

HANYA UNTUK TENAGA KESEHATAN

01/BRC/ALB/PM/IV/21

Marketed by:
PT. SATYA ABADI PHARMA
Ruko Bintaro Jaya Sektor IX, Blok H-6 & H-7
Kel. Pondok Pucung, Kec. Pondok Aren
Kota Tangerang Selatan 15229 Prov. Banten
Telp : (021) 74865990
www.sapharma.co.id
PT SATYA ABADI PHARMA
Albumin, a complex and multifunctional
molecule The oncotic power of albumin
Albumin is a multifunctional protein with a stable but flexible
counteract the hypovolaemia
and modifiable structure.
developed in cirrhotic patients10
The biological actions of albumin are related to its distribution,
molecular concentration, and complex structure.
Cirrhotic patients develop portal hypertension, associated with splanchnic arterial
vasodilatation, deterioration of cardiac function and consequent hypovolaemia.
Human albumin plays a major role as Albumin administration not only expands the plasma volume and increases
the main intravascular volume regulator cardiac preload and cardiac output but also induces vasoconstriction at splanchnic
microcirculation level, and, due to its antioxidant properties, plays a crucial role in
and has also homeostatic properties and transport functions.
the transport of physiologic substances and disposal of toxic substances.10
Its capacity to bind reactive oxygen species, metals, and bilirubin guarantees its antioxidant
Possible mechanism by which human albumin could exert beneficial effects in cirrhosis: 11
properties; and the endotoxin inactivation capacity supports its immunomodulatory function and
also its potential role as an endothelial stabilizer.

Human albumin is indicated for1 Evaluated in all relevant clinical settings CIRRHOSIS
Restoration and maintenance of circulating blood volume • Cardiac surgery2, 4, 5, 6, 8
where volume deficiency has been demonstrated, and • Sepsis and septic shock9
use of a colloid is appropriate. • Cirrhosis10, 11, 12, 13 O

N
P
RT
AL S IO
• Neonates, paediatrics2, 3 H Y PE RT E N
• Burns7 S
Endothelial stabilization VA PLA AL O Immunomodulation

n
RI

N
t io
SO N C
D I H N IC C T E ATI ma
LA BA L O C lam
N S Inf

Albumin exerts beneficial effects as

T IO
N T R A emia/
o t o x
End
Oncotic pressure

priming solution during cardiopulmonary

Endothelial stabilization
EF F
Capillary permeability E CT MIA
IVE A LAE
RTERIAL HYPOVO

bypass surgery8 A CT
IVAT
Ren
ION VA SYS
SO C ONSTRICTOR t em
in - an g
TE M

i o t en si n-al d o st er o n e sy
s
Oncotic pressure

Sym p at R
AS h et i c n er vo u s syst em HE S e
CIT A n t i d i u r et i c h o r m o n e OT G AN ailur
f
In cardiac surgery with CPB, haemodilution with reduction of albumin concentration ES OR gan
r
L l t io
and decrease in colloid oncotic pressure (COP) are the main factors associated with H YP
ON A
TRAE
BR A
CER E RFUSIO
N Mu
R E NA L E
P t hy
myocardial, pulmonary, intestinal, and cerebral oedema. The use of albumin in the M IA H YPERFUSION HY PO
l
ha o p a
Oncotic pressure En cep
prime can attenuate this deleterious effect and offer additional benefits. Capillary permeability
Ren al f ailu re

Number of platelets after CPB (No./µl) Postoperative bleeding in ICU after CPB (ml) Oncotic pressure Oncotic pressure
Immunomodulation
Antioxidant
Endothelial stabilization
200 000 P < 0.001 P < 0.001 P < 0.045
175 000
1 500 1 294
150 000 1 102
131 000 1 200
Pathophysiology of cirrhosis and its complications and the potential beneficial effects of albumin. This figure summarizes all the possible
100 000 900 mechanisms by which human albumin could exert its beneficial effects.
680 963
P = 0.045 819
600
50 000 References
1. Summary of product characteristics of albunorm®
300 520 2. Golab H et al. Relevance of colloid oncotic pressure regulation during neonatal and infant cardiopulmonary bypass: a prospective randomized study. Eur J Cardiothorac Surg 2011;
0 39(6): 886—891
Albumin + Ringer lactate 3. Akech S et al. Volume expansion with albumin compared to gelofusine in children with severe malaria: results of a controlled trial. PLoS Clin Trials. 2006 Sep; 1(5): e21.
0 4. Onorati F et al. Does priming implementation with low-dose albumin reduce postoperative bleeding following cardiopulmonary bypass? Int J Artif Organs 2003; 26 (3): 211-216
Ringer lactate 24 h 48 h 72 h 5. Rusell J et al. Albumin versus crystalloid for pump priming in cardiac surgery: meta-analysis of controlled trials. J Cardiothorac Vasc Anesth; 2004, 18(4): 429-437
Adapted from Onorati 2003 Adapted from Onorati 2003 6. Sedrakyan A. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest ; 2003, 123:1853–1857
7. Cochran A et al. Burn patient characteristics and outcomes following resuscitation with albumin. Burns; 2007, 33(1):25-30
Better preservation of platelet count4, 5, 8 Decreased need of blood transfusions and lower
8. Moret E et al. Albumin - Beyond fluid replacement in cardiopulmonary bypass surgery: why, how, and when? Semin Cardiothorac Vasc Anesth 2014; 18(3) 252–259
9. Caironi p et al. Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med 2014;370(15):1412-21
and colloid osmotic pressure.5, 8 postoperative blood loss.4, 8 10. Arroyo V, Fernandez J. Pathophysiological basis of albumin use in cirrhosis. Ann Hepatol 2011;10(1):S6-S14
11. Garcia-Martinez R et al. Albumin: Pathophysiologic basis of its role in the treatment of cirrhosis and its complications. Hepatology 2013;58(5):1836-1846
Albumin + Ringer lactate 12. Ortega R et al. Terlipressin therapy with and without albumin for patients with hepatorenal syndrome: results of a prospective, nonrandomized study. Hepatology 2002;36(4):941-948
13. Bernardi M et al. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology 2012;55(4):1172-1181
Ringer lactate