SUMMARY OF THE PRODUCT CHARACTERISTICS

1.1

NAME OF THE MEDICINAL PRODUCT

Albuminativ 40 g/l, solution for infusion 1.2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Albuminativ is a solution containing 40 g/L of total protein of which at least 96% is human albumin. Each 00 ml contains !0 g of human albumin Albuminativ 40 g/l is isooncotic to normal plasma. E"cipients # $otassium %o&ium ma". 0.4 mmol/L '4 mmol/L

(or a full list of e"cipients, see 6.'. 1.3 PHARMACEUTICAL FORM

%olution for infusion )he solution shoul& be clear or slightl* opalescent. 1.4 1.5 CLINICAL PARTICULARS Therape !"# "$%"#a!"&$'

+estoration an& maintenance of circulating bloo& volume where volume &eficienc* has been &emonstrate&, an& use of a colloi&, such as albumin, is appropriate. )he choice of albumin rather than artificial colloi& will &epen& on the clinical situation of the in&ivi&ual patient, base& on official recommen&ations. 1.( P&'&)&*+ a$% ,e!h&% &- a%,"$"'!ra!"&$

)he &osage an& the infusion,rate shoul& be a&-uste& to the patient.s in&ivi&ual re/uirements. Posology )he &ose re/uire& &epen&s on the si0e of the patient, the severit* of trauma or illness an& on continuing flui& an& protein losses. 1easures of a&e/uac* of circulating volume an& not plasma albumin levels shoul& be use& to &etermine the &ose re/uire&. 2f human albumin is to be a&ministere&, haemo&*namic performance shoul& be monitore& regularl*. )his ma* inclu&e# arterial bloo& pressure an& pulse rate central venous pressure pulmonar* arter* we&ge pressure urine output

'

electrol*te haematocrite/haemoglobin 3see section 4.44 Method of administration 5uman Albumin can be &irectl* a&ministere& b* the intravenous route. )he infusion rate shoul& be a&-uste& accor&ing to the in&ivi&ual circumstances an& the in&ication. 2n plasma e"change the infusion,rate shoul& be a&-uste& to the rate of removal. 1.. C&$!ra"$%"#a!"&$'

5*persensitivit* to albumin preparations or to an* of the e"cipients. 1./ Spe#"a) 0ar$"$*' a$% pre#a !"&$' -&r 'e

2f allergic or anaph*lactic,t*pe reactions occur, the infusion shoul& be stoppe& imme&iatel* an& appropriate treatment institute&. 2n case of shoc6, the current me&ical stan&ar&s for shoc6, treatment shoul& be observe&. Albumin shoul& be use& with caution in con&itions where h*pervolaemia an& its conse/uences or haemo&ilution coul& represent a special ris6 for the patient. E"amples of such con&itions are# , , , , , , , 7ecompensate& car&iac insufficienc* 5*pertension 8esophageal varices $ulmonar* oe&ema 5aemorrhagic &iathesis %evere anaemia +enal an& post,renal anuria

!0,! % human albumin solutions 3such as Albuminativ !00 g/l4 are relativel* low in electrol*tes compare& to the 4, % human albumin solutions 3such as Albuminativ 40 g/l4. 9hen albumin is given, the electrol*te status of the patients shoul& be monitore& 3see section 4.!4 an& appropriate steps ta6en to restore or maintain the electrol*te balance. Albumin solutions must not be &ilute& with water for in-ections as this ma* cause haemol*sis in recipients. 2f comparativel* large volumes are to be replace&, controls of coagulation an& haematocrit are necessar*. :are must be ta6en to ensure a&e/uate substitution of other bloo& constituents 3coagulation factors, electrol*tes, platelets, an& er*throc*tes4. 5*pervolaemia ma* occur if the &osage an& rate of infusion are not a&-uste& to the patient.s circulator* situation. At the first clinical signs of car&iovascular overloa& 3hea&ache, &*spnoea, -ugular vein congestion4, or increase& bloo& pressure, raise& venous pressure an& pulmonar* oe&ema, the infusion is to be stoppe& imme&iatel*.

)his me&icinal pro&uct contains '4. mmol so&ium per '00 mL. )o be ta6en into consi&eration b* patients on a controlle& so&ium &iet )his me&icine contains less than ' mmol potassium per '00 mL, i.e. essentiall* ;potassium, free.. %tan&ar& measure to prevent infections resulting from the use of me&icinal pro&ucts prepare& from human bloo& or plasma inclu&e selection of &onors, screening of in&ivi&ual &onations an& plasma pools for specific mar6ers of infection an& the inclusion of effective manufacturing steps for the inactivation/removal of viruses. 7espite this, when me&icinal pro&ucts prepare& from human bloo& or plasma are a&ministere&, the possibilit* of transmitting infective agents cannot be totall* e"clu&e&. )his also applies to un6nown or emerging viruses an& other pathogens. )here are no reports of virus transmissions with albumin manufacture& to European $harmacopeia specifications b* establishe& processes. 2t is strongl* recommen&e& that ever* time that Albuminativ is a&ministere& to a patient, the name an& batch number of the pro&uct are recor&e& in or&er to maintain a lin6 between the patient an& the batch of the pro&uct. 1.1 I$!era#!"&$ 0"!h &!her ,e%"#"$a) pr&% #!' a$% &!her -&r,' &- "$!era#!"&$

<o specific interactions of human albumin with other me&icinal pro&ucts are 6nown. 1.12 Pre*$a$#+ a$% )a#!a!"&$

)he safet* of Albuminativ for use in human pregnanc* has not been establishe& in controlle& clinical trials. 5owever, clinical e"perience with albumin suggests that no harmful effects on the course of pregnanc*, or on the foetus an& the neonate are to be e"pecte&. <o animal repro&uction stu&ies have been con&ucte& with Albuminativ 40 g/l. 5uman albumin is a normal constituent of human bloo&. 1.11 E--e#!' &$ a3")"!+ !& %r"4e a$% 'e ,a#h"$e'

<o effects on abilit* to &rive an& use machines have been observe&. 1.12 U$%e'"ra3)e e--e#!'

A&verse reactions for Albuminativ 40 g/l are rare. )hese reactions normall* &isappear rapi&l* when the infusion rate is slowe& &own or the infusion is stoppe&. 2n case of severe reactions, the infusion shoul& be stoppe& an& an appropriate treatment shoul& be initiate&. )he following a&verse reactions have been observe& for Albuminativ 40 g/l &uring the postmar6eting phase. =er* common 3>'/'04? common 3>'/'00, @'/'04? uncommon 3>'/',000, @'/'004? rare 3>'/'0,000, @'/',0004? ver* rare 3@'/'0,0004, inclu&ing isolate& reports. S+'!e, Or*a$ C)a'' Immune system disorders Psychiatric disorders Rare Ver+ rare

anaph*lactic reaction anaph*lactic shoc6 h*persensitivit* confusional state

S+'!e, Or*a$ C)a'' Nervous system disorders Cardiac disorders Vascular disorders Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders Skin and su cutaneous tissue disorders

Rare

Ver+ rare hea&ache tach*car&ia bra&*car&ia

h*potension

h*pertension flushing &*spnoea nausea urticaria angioe&ema rash er*thematosus h*perhi&rosis $*re"ia chills

General disorders and administration site conditions (or information on viral safet* see 4.4. 1.13 O4er%&'e

5*pervolaemia ma* occur if the &osage an& rate of infusion are too high. At the first clinical signs of car&iovascular overloa& 3hea&ache, &*spnoea, -ugular vein congestion4, or increase& bloo& pressure, raise& central venous pressure an& pulmonar* oe&ema, the infusion shoul& be stoppe& imme&iatel* an& the patient.s haemo&*namic parameters carefull* monitore&. 1.14 1.15 PHARMACOLO5ICAL PROPERTIES Phar,a#&%+$a,"# pr&per!"e'

$harmacotherapeutic group# $lasma substitutes an& plasma protein fractions, A): co&e# B0 AA0' 5uman albumin accounts /uantitativel* for more than half of the total protein in the plasma an& represents about '0% of the protein s*nthesis activit* of the liver. $h*sico,chemical &ata# Albuminativ 40 g/l is mil&l* h*pooncotic to normal plasma. )he most important ph*siological functions of albumin result from its contribution to oncotic pressure of the bloo& an& transport function. Albumin stabilises circulating bloo& volume an& is a carrier of hormones, en0*mes, me&icinal pro&ucts an& to"ins. 1.1( Phar,a#&6"$e!"# pr&per!"e'

Cn&er normal con&itions, the total e"changeable albumin pool is 4, g/6g bo&* weight, of which 40,4 % is present intravascularl* an& ,60% in the e"travascular space. 2ncrease&

capillar* permeabilit* will alter albumin 6inetics an& abnormal &istribution ma* occur in con&itions such as severe burns or septic shoc6. Cn&er normal con&itions, the average half,life of albumin is about '9 &a*s. )he balance between s*nthesis an& brea6&own is normall* achieve& b* fee& bac6 regulation. Elimination is pre&ominantl* intracellular an& &ue to l*sosome proteases. 2n health* sub-ects, less than '0% of infuse& albumin leaves the intravascular compartment &uring the first ! hours following infusion. )here is consi&erable in&ivi&ual variation in the effect on plasma volume. 2n some patients the plasma volume can remain increase& for some hours. 5owever, in criticall* ill patients, albumin can lea6 out of the vascular space in substantial amounts at an unpre&ictable rate. 1.1. Pre#)"$"#a) 'a-e!+ %a!a

5uman albumin is a normal constituent of human plasma an& acts li6e ph*siological albumin. 2n animals, single &ose to"icit* testing is of little relevance an& &oes not permit the evaluation of to"ic or lethal &oses or of a &ose,effect relationship. +epeate& &ose to"icit* testing is impracticable &ue to the &evelopment of antibo&ies to heterologous protein in animal mo&els. )o &ate, human albumin has not been reporte& to be associate& with embr*o,foetal to"icit*, oncogenic or mutagenic potential. <o signs of acute to"icit* have been &escribe& in animal mo&els. 1.1/ 1.11 PHARMACEUTICAL PARTICULARS L"'! &- e7#"p"e$!'

%o&ium capr*late %o&ium chlori&e %o&ium 5*&ro"i&e or 5*&rochloric aci& 3&ilute4 to p5 D.0 9ater for in-ections !lectrolytes" %o&ium '4 mmol/l $otassium ma"imum 0.4 mmol/l 1.22 I$#&,pa!"3")"!"e'

Albuminativ 40 g/l must not be mi"e& with other me&icinal pro&ucts, whole bloo& an& pac6e& re& cells. 1.21 A *ears. 1.22 Spe#"a) pre#a !"&$' -&r '!&ra*e She)-8)"-e

7o not store above ! :. 7o not free0e.

Eeep the container in the outer carton in or&er to protect from light. 1.23 Na! re a$% #&$!e$! &- #&$!a"$er

00 ml of solution in infusion bottle 3t*pe 22 glass4 with stopper 3bromobut*l rubber4 an& seale& with a pull,off cap. $ac6 of ', $ac6s of '! 1.24 Spe#"a) pre#a !"&$' -&r %"'p&'a) a$% &!her ha$%)"$*

)he solution can be &irectl* a&ministere& b* the intravenous route. Albumin solutions must not be &ilute& with water for in-ections as this ma* cause haemol*sis in recipients. 2f large volumes are a&ministere&, the pro&uct shoul& be warme& to room or bo&* temperature before use. 7o not use solutions that are clou&* or have &eposits. )his ma* in&icate that the protein is unstable or that the solution has become contaminate&. 8nce the container has been opene&, the contents shoul& be use& imme&iatel*. An* unuse& pro&uct or waste material shoul& be &ispose& of in accor&ance with local re/uirements. 1.25 MAR9ETIN5 AUTHORISATION HOLDER

@ Fto be complete& nationall*G> 1.2( MAR9ETIN5 AUTHORISATION NUM:ER;S<

@ Fto be complete& nationall*G> 1.2. DATE OF FIRST AUTHORISATION=RENE>AL OF THE AUTHORISATION

'99',06,0D / !0'0,0',0' 1.2/ DATE OF REVISION OF THE TE?T

!0'0,0!,'H