natgillin/translations-raw huggingface dataset:
On the adjusted 10 point INCAT (Inflammatory Neuropathy Cause and Treatment) scale a clinically meaningful improvement of at least 1-point from baseline to treatment week 25 was observed in 17 out of 28 patients.
[Uzrok i liječenje upalne neuropatije]) od 10 točaka, klinički značajno poboljšanje od barem 1 točke od početka liječenja do 25. tjedna uočeno je u 17 od 28 bolesnika.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
On day 3 patients could receive a second dose of 1 g/ kg bw, for patients with a platelet count of < 50×109 / l on day 3 this second dose was mandatory.
Treći dan bolesnici su mogli primiti drugu dozu od 1 g/kg TT, a za bolesnike s brojem trombocita od <50 x 109/1 treći dan je druga doza bila obavezna.
The scheduled dose of 1 g/kg bw per infusion was closely adhered to in all patients (median 2 g IgG/kg bw).
Strogo se pridržavalo dogovorene doze od 1 g/kg TT po infuziji za sve bolesnike (medijan 2 g IgG/kg TT).
Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Najniže razine potrebno je mjeriti i procijeniti ovisno o kliničkom odgovoru bolesnika.
Starting dose: 2 g/kg given over 2-5 consecutive days.
Početna doza: 2 g/kg tijekom 2-5 uzastopnih dana.
Some published studies pertaining to hyperprolinaemia have shown that longterm, high doses of L-proline have effects on brain development in very young rats.
visoke doze L-prolina imaju utjecaj na razvoj mozga u vrlo mladih štakora.
Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Privigen 100 mg/ml otopina za infuziju Ljudski normalni imunoglobulin (i.v.Ig)
Symptoms typically appear within 1 to 6 hours following treatment.
Simptomi se obično javljaju unutar 1 do 6 sati nakon liječenja.
IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern.
Intravenski globulini nisu indicirani kod bolesnika sa selektivnim nedostatkom IgA, kada je nedostatak IgA jedini poremećaj.
IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Primatelje i.v.Ig terapije nužno je pratiti kako bi se uočili klinički znakovi i simptomi hemolize
Information on safety with respect to infections Privigen is made from human blood plasma (this is the liquid part of the blood).
Privigen se dobiva iz ljudske plazme (to je tekući dio krvi).
Three to six months are required after the initiation of therapy for equilibration to occur.
Za uspostavljanje ravnoteže, potrebno je 3 do 6 mjeseci od početka liječenja.
• You are overweight, are elderly, have diabetes, have been bedridden for a long time, have high blood pressure, have low blood volume (hypovolaemia), have problems with your blood vessels (vascular diseases), have an increased tendency for blood clotting (thrombophilia or thrombotic episodes) or have a disease or a condition which causes your blood to thicken (hyperviscous blood).
• Prekomjerne ste težine, starija ste osoba, imate šećernu bolest, prikovani ste za krevet već dulje vrijeme, imate visoki krvni tlak, nizak volumen krvi (hipovolemija), probleme s krvnim žilama (vaskularna bolest), povećanu sklonost stvaranju ugrušaka (trombofilija ili trombotičke epizode) ili imate bolest ili stanje koje uzrokuje povećanje gustoće krvi (hiperviskozna krv).
The following table shows an overview of the ADRs observed in the six clinical studies categorized according the MedDRA System Organ Class (SOC), Preferred Term Level (PT) and frequency.
Tablica u nastavku pokazuje pregled nuspojava zabilježenih u 6 kliničkih ispitivanja kategoriziranih prema MedDRA klasifikaciji organskih sustava, razini preporučenog pojma i učestalosti.
Isolated cases of haemolysis-related renal dysfunction/renal failure or disseminated intravascular coagulation and death have occurred.
Opisani su izolirani slučajevi disfunkcije/zatajenja bubrega povezanog s hemolizom ili diseminirane intravaskularne koagulacije i smrti.
If insufficient treatment effect is seen after 6 months, the treatment should be discontinued.
Nakon svakog ciklusa potrebno je procijeniti terapijski učinak; ako se terapijski učinak ne opazi nakon 6 mjeseci, liječenje treba prekinuti.
There are 5 groups: Patients who do not have enough blood platelets (primary immune thrombocytopenia (ITP) and who are at high risk of bleeding or will have surgery in the near future.
Postoji 5 skupina: bolesnici koji nemaju dovoljno trombocita (primarna imunološka trombocitopenija (ITP)) te koji su pod povećanim rizikom od krvarenja ili koji će se uskoro podvrgnuti kirurškom zahvatu. bolesnici s Guillain-Barréovim sindromom.
The dosage interval when steady state has been reached varies from 3 to 4 weeks.
Nakon postizanja stanja dinamičke ravnoteže interval doziranja varira od 3 do 4 tjedna.
In patients at risk, the use of IVIg products that do not contain sucrose should therefore be considered.
Stoga, u rizičnih bolesnika treba razmotriti primjenu i.v.Ig lijekova koji ne sadrže saharozu.
A second dose in subjects with platelet counts ≥ 50×109 /l after the first dose provided a relevant additional benefit in terms of higher and longer-lasting increases in platelet counts compared to a single dose.
Druga doza kod ispitanika s brojem trombocita ≥50x109/1 nakon prve doze pružila je relevantnu dodatnu korist u smislu većeg i dužeg rasta broja trombocita u usporedbi s pojedinačnom dozom.
• chest pain, chest discomfort, painful respiration due to transfusion related lung injury (TRALI) Tell your doctor or healthcare professional immediately if you have any of the above symptoms.
• bol u prsištu, nelagoda u prsištu, bolno disanje zbog akutne ozljede pluća povezane s transfuzijom Ako imate jedan od gore navedenih simptoma, odmah obavijestite svog liječnika ili zdravstvenog radnika.
In subjects with platelet counts < 50×109 / l after the first dose, 30% showed a platelet response of ≥ 50×109 / l after the mandatory second dose.
Kod bolesnika s brojem trombocita <50x109/1 nakon prve doze, 30% ih je pokazalo odgovor trombocita od ≥50x109/1 nakon obavezne druge doze.
Muscle strength as measured by the MRC (Medical Research Council) Score improved in all patients by 6.9 points (95% confidence interval [4.11, 9.75], in previously treated patients by 6.1 points (95% confidence interval [2.72, 9.44]) and in untreated patients by 7.7 points (95% confidence interval [2.89, 12.44]).
Medical Research Council [Vijeće za medicinska istraživanja]) poboljšala se u svih bolesnika za 6,9 bodova (interval pouzdanosti 95% [4,11; 9,75], u prethodno liječenih bolesnika za 6,1 bodova (interval pouzdanosti 95% [2,72; 9,44] te u neliječenih bolesnika za 7,7 bodova (interval pouzdanosti 95% [2,89; 12,44]).
Rarely human normal immunoglobulins including Privigen may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Rijetko se događa da normalni ljudski imunoglobulini uključujući Privigen izazivaju nagli pad krvnog tlaka i, u izoliranim slučajevima, anafilaktički šok, čak kada u bolesnika nije zabilježena preosjetljivost na taj lijek pri prijašnjim primjenama.
In the first CIDP study, a prospective multicenter open label trial (Privigen impact on mobility and autonomy PRIMA study), 28 patients (13 subjects who have previously received IVIG and 15 subjects not) were treated with a Privigen loading dose of 2g/kg bw given over 2-5 days followed by 6 maintenance doses of 1g/kg bw over 1-2 days every three weeks.
U prvom ispitivanju KUDP, prospektivnom multicentričnom otvorenom ispitivanju (PRIMAPrivigen impact on mobility and autonomy study), 28 bolesnika (njih 13 koji su prethodno primali i.v.Ig i 15 koji nisu) liječeni su udarnom dozom Privigena od 2 g/kg TT davanoj tijekom 2-5 dana nakon čega slijedi šest doza održavanja od 1 g/kg TT tijekom 1 do 2 dana svaka tri tjedna.
Symptoms typically appear within 1 to 6 hours after receiving treatment.
Simptomi se obično javljaju unutar 1 do 6 sati nakon primitka terapije.
Because the solution contains no preservative, Privigen should be infused as soon as possible.
Budući da otopina ne sadrži konzervanse, Privigen treba primijeniti infuzijom što je prije moguće.
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Ravnoteža između intra- i ekstravaskularnih odjeljaka se postiže nakon približno tri do pet dana.
In the case of measles, this impairment may persist for up to 1 year.
U slučaju morbila, to umanjivanje djelotvornosti cjepiva može potrajati do jedne godine.
There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including stroke), pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients.
Postoje klinički podaci koji potvrđuju povezanost i.v.Ig primjene i tromboembolijskih događaja kao što su infarkt miokarda, cerebralni krvožilni događaj (uključujući i moždani udar), plućna embolija i duboka venska tromboza za koje se smatra da su povezani s relativnim povećanjem viskoznosti krvi zbog visokog dotoka imunoglobulina u rizičnih bolesnika.
In the pivotal PID study, 80 patients were enrolled and treated with Privigen.
U pivotalnom ispitivanju PID-a bilo je uključeno 80 bolesnika koji su se liječili Privigenom.
Routine laboratory tests may commonly reveal changes to liver functions (hyperbilirubinaemia) as well as changes in blood count (e.g. Coombs' (direct) test positive), increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase).
Rutinski laboratorijski testovi mogu obično otkriti promjene funkcije jetre (hiperbilirubinemija) kao i promjene u krvnoj slici (npr. Pozitivni (direktni) Coombs-ov test) , povišenu alanin aminotransferazu, povišenu aspartat aminotransferazu), povišenu laktat dehidrogenazu u krvi.
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Imunoglobulini se izlučuju u majčino mlijeko i mogu pridonijeti zaštiti novorođenčeta od patogena koji u organizam ulaze preko sluznica.
What Privigen is used for
Za što se Privigen koristi
Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl.
Pleocitoza do nekoliko tisuća stanica po mm3, pretežno granulocitne loze, i povišene razine proteina do nekoliko stotina mg/dl su često prisutni u cerebrospinalnoj tekućini.
Privigen 100 mg/ml solution for infusion
Privigen 100 mg/ml otopina za infuziju
Myalgia (including muscle spasms, musculoskeletal stiffness, musculoskeletal pain)
Mialgija (uključujući grčeve mišića, mišićnokoštanu ukočenost, mišićno-koštanu bol)
Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactoid reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
U rijetkim slučajevima, ljudski normalni imunoglobulini mogu uzrokovati pad krvnog tlaka s anafilaktoidnom reakcijom, čak i u bolesnika koji su već podnosili liječenje ljudskim normalnim imunoglobulinom.
Chronic inflammatory demyelinating polyneuropathy (CIDP)* The recommended starting dose is 2 g/kg bw divided over 2 to 5 consecutive days followed by maintenance doses of 1 g/kg bw over 1 to 2 consecutive days every 3 weeks.
Kronična upalna demijelinizirajuća polineuropatija (KUDP)* Preporučena početna doza je 2 g/kg TT podijeljena tijekom 2 do 5 uzastopnih dana nakon čega slijedi doza održavanja od 1 g/kg TT tijekom 1 do 2 uzastopna dana svaka 3 tjedna.
Patients may experience effects, such as dizziness or nausea, during treatment with Privigen that might affect the ability to drive and use machines.
Bolesnici tijekom liječenja lijekom Privigen mogu primijetiti nuspojave poput omaglice ili mučnine koje mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Multifocal Motor Neuropathy (MMN)
Multifokalna motorička neuropatija (MMN)
In the PID extension study, 55 patients were enrolled and treated with Privigen.
U nastavku ispitivanja PID-a bilo je uključeno 55 bolesnika koji su se liječili Privigenom.
Human normal immunoglobulin should be infused intravenously at an initial infusion rate of 0.3 ml/kg bw/hr for approximately 30 min.
Ljudski normalni imunoglobulin treba primijeniti intravenskom infuzijom pri početnoj brzini infuzije od 0,3 ml/kg TT po satu tijekom približno 30 minuta.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Usprkos tim mjerama, kada se primjenjuju lijekovi iz krvi ili plazme ne može se u potpunosti isključiti mogućnost prijenosa infekcije.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
1038 infusions were administered, 272 (in 16 patients) in the 3-week schedule and 766 (in 64 patients) in the 4-week schedule.
bolesnika) u 3-tjednom rasporedu i 766 (kod 64 bolesnika) u 4-tjednom rasporedu.
Certain adverse reactions may occur more frequently: - in case of high rate of infusion, - in patients with hypogammaglobulinaemia or agammaglobulinaemia, with or without IgA deficiency, - in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
- u bolesnika s hipogamaglobulinemijom ili agamaglobulinemijom, sa ili bez nedostatka IgA - u bolesnika koji prvi put primaju ljudski normalni imunoglobulin ili, rijetko, pri promjeni ljudskog normalnog imunoglobulina, ili kada je prošao duži vremenski interval od prethodne infuzije.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Postoje ohrabrujuća klinička iskustva o tome kako se imunoglobulinima ne prenosi hepatitis A ili parvovirus B19, a također se pretpostavlja da protutijela pridonose obrani od virusa.
Decreased haemoglobin (including decreased red blood cell count, decreased haematocrit), Coombs` (direct) test positive, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase
Sniženi hemoglobin (uključujući sniženi broj crvenih krvnih stanica, sniženi hematokrit), pozitivni Coombsov (direktni) test, povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišena razina laktat dehidrogenaze u krvi
Subjects all with IVIg pretreatment of at least 8 weeks and with an IVIg-dependence confirmed by clinically evident deterioration during an IVIg withdrawal phase of up to 12 weeks, received a Privigen loading dose of 2 g/kg bw followed by up to 4 Privigen maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks.
Bolesnici prethodno liječeni i.v.Ig-om tijekom najmanje 8 tjedana i s i.v.Ig ovisnošću potvrđenom očitim kliničkim pogoršavanjem tijekom faze ustezanja primjene i.v.Ig-a do 12 tjedana primili su udarnu dozu Privigena od 2 g/kg TT, a potom i do četiri doze održavanja Privigena od 1 g/kg TT svaka 3. tjedna do 13. tjedna.
You will recognize TRALI by severe difficulty in breathing (respiratory distress), abnormally low level of oxygen in the blood (hypoxemia), normal heart function (left ventricular function) and increased body temperature (fever).
Akutnu ozljedu pluća povezanu s transfuzijom prepoznat će te po teškim poteškoćama u disanju (respiratorni distres), abnormalno niskoj razini kisika u krvi (hipoksemija), normalnom radu srca (funkcija lijeve klijetke) i povišenoj tjelesnoj temperaturi (vrućica).
IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Pokazano je da i.v.Ig lijekovi prolaze posteljicu, i to povećano nakon trećeg tromjesečja.
There are no data on pharmacokinetic properties in paediatric patients with CIDP.
Nema podataka o farmakokinetičkim svojstvima u pedijatrijskih bolesnika s
Such side effects may occur even if you have previously received human immunoglobulins and tolerated them well.
Nuspojave se mogu javiti čak i ako ste prije primali humane imunoglobuline i ako ste ih dobro podnosili.
Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration.
Hemolitička anemija se može razviti nakon i.v.Ig terapije zbog olakšane sekvestracije eritrocita.
Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Nositelj odobrenja za stavljanje lijeka u promet: CSL Behring GmbH
Aseptic meningitis
Aseptički memingitis
CSL Behring GmbH, D-35041 Marburg, Germany
CSL Behring GmbH, D-35041 Marburg, Njemačka
If dilution prior to infusion is desired, Privigen may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5%).
Kad je prije infuzije potrebno razrjeđenje, Privigen se može razrijediti s 5%-tnom otopinom glukoze na konačnu koncentraciju od 50 mg/ml (5%).
Transfusion related acute lung injury
Akutna ozljeda pluća povezana s transfuzijom
Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, patients with diseases which increase blood viscosity).
Potreban je oprez u propisivanju i primjeni infuzije i.v.Ig-a u pretilih bolesnika i u bolesnika s postojećim čimbenicima rizika za trombotične događaje (poodmakla životna dob, hipertenzija, šećerna bolest, anamneza krvožilnih bolesti ili trombotičnih epizoda, bolesnici sa stečenim ili nasljednim trombofiličnim poremećajem, bolesnici s produljenim razdobljima imobilizacije, bolesnici s teškom hipovolemijom te bolesnici s bolestima koje povećavaju viskoznost krvi).
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella.
Primjena imunoglobulina može umanjiti djelotvornost cjepiva koja sadrže žive atenuirane viruse kao što su to morbili, rubela, parotitis i varičela u razdoblju od najmanje 6 tjedana do 3 mjeseca.
1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml or 40 g/400 ml), 3 vials (10 g/100 ml or 20 g/200 ml).
1 bočica (2,5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml ili 40 g/400 ml), 3 bočice (10 g/100 ml ili 20 g/200 ml).
The dose required to achieve a trough level of 5 to 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month.
Doza potrebna za postizanje najniže razine od 5-6 g/l iznosi 0,2-0,8 g/kg tjelesne težine/mjesec.
Tell your doctor prior to treatment.
Prije liječenja obavijestite svog liječnika.
Additional measures of CIDP improvement were an increase in R-ODS (Rasch-built Overall Disability Scale) score of ≥ 4 points, a mean grip strength increase of ≥ 8 kPa, or an MRC sum score increase of ≥ 3 points.
od ≥ 4 boda, srednja vrijednost povećanja snage hvata od ≥ 8 kPa ili povećanje MRC ukupnog rezultata za ≥ 3 boda.
It is strongly recommended that every time Privigen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Preporučuje se pri svakoj primjeni Privigenom zabilježiti naziv i broj serije lijeka, u svrhu praćenja povezanosti između bolesnika i serije lijeka.
The duration of treatment beyond 25 weeks should be subject to the physician's discretion based upon the patient response and maintenance response in the long-term.
Na liječniku je da odluči želi li nastaviti liječenje dulje od 25 tjedna na temelju bolesnikova odgovora i održavanja postignutog odgovora na dulje vrijeme.
Patients with an acquired immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4 g/l.
bolesnici sa stečenom imunodeficijencijom (SID) s teškim ili ponavljajućim infekcijama, onih u kojih antimikrobno liječenje nije bilo učinkovito te s dokazanim nedostatkom stvaranja specifičnog antitijela ili s koncentracijom IgG-a u serumu <4 g/l.
Aseptic meningitis syndrome has been reported to occur in association with IVIg treatment.
Sindrom aseptičnog meningitisa (AMS) Sindrom aseptičnog meningitisa prijavljen je u vezi s liječenjem i.v.Ig-om.
Because the solution contains no preservative, Privigen should be infused immediately.
S obzirom da otopina ne sadrži konzervanse, Privigen treba odmah primijeniti infuzijom.
Privigen comes as a ready-to-use solution in single-use vials.
Privigen se isporučuje kao otopina spremna za uporabu u bočicama za jednokratnu uporabu.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin including Privigen.
Kod primjene normalnog ljudskog imunoglobulina uključujući Privigen zabilježene su slučajevi reverzibilnog aseptičkog meningitisa i rijetki slučajevi prolaznih kožnih reakcija (uključujući kožni eritemski lupus - učestalost nepoznata).
IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis.
Hemolitička anemija i.v.Ig lijekovi mogu sadržavati protutijela na krvne grupe koja mogu reagirati kao hemolizini i in vivo dovesti do oblaganja eritrocita imunoglobulinom uzrokujući tako pozitivnu direktnu antiglobulinsku reakciju (Coombsov test) i rijetko hemolizu.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Prema kliničkim iskustvima s primjenom imunoglobulina ne treba očekivati štetne učinke tijekom trudnoće na fetus ili na novorođenče.
The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) given once, followed by at least 0.2 g/kg bw every 3 to 4 weeks.
Preporučena početna doza iznosi 0,4-0,8 g/kg tjelesne težine (TT) jednokratno, a zatim svaka 3 do 4 tjedna treba primijeniti dozu od najmanje 0,2 g/kg TT.
Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
Emil-von-Behring-Strasse 76 D-35041 Marburg
In PID patients who have tolerated the infusion rate of 4.8 ml/kg bw/hr well, the rate may be further increased gradually to a maximum of 7.2 ml/kg bw/hr.
U PID bolesnika koji su dobro podnijeli brzinu infuzije od 4,8 ml/kg TT/sat, brzina infuzije se može postupno povećati na najviše 7,2 ml/kg TT/sat.
0.2 - 0.4 g/kg bw every 3 to 4 weeks
0,2 - 0,4 g/kg TT svaka 3 do 4 tjedna
EU/1/08/446/001 5 g/50 ml EU/1/08/446/002 10 g/100 ml EU/1/08/446/003 20 g/200 ml EU/1/08/446/004 2.5 g/25 ml EU/1/08/446/005 10 g/100 ml (3 vial pack size) EU/1/08/446/006 20 g/200 ml (3 vial pack size) EU/1/08/446/007 40 g/400 ml
EU/1/08/446/001 5 g/50 ml EU/1/08/446/002 10 g/100 ml EU/1/08/446/003 20 g/200 ml EU/1/08/446/004 2,5 g/25 ml EU/1/08/446/005 10 g/100 ml (pakiranje od 3 bočice) EU/1/08/446/006 20 g/200 ml (pakiranje od 3 bočice) EU/1/08/446/007 40 g/400 ml