FrancophonIA/ELRC3.0 huggingface dataset:
English: Wounds on the legs (leg ulcers), and modification of liver function.
Croatian: Rijetke nuspojave (mogu se javiti kod do 1 na 1000 osoba): Rane na nogama (čirevi na nozi) i promjene u funkciji jetre.
English: and the usual dose is between 15 and 30 mg/kg b.w./day.
Croatian: Početna doza hidroksikarbamida je 15 mg/kg tjelesne težine bolesnika, a uobičajena doza je između 15 i 30 mg/kg tjelesne težine/na dan.
English: Siklos 100 mg film-coated tablets
Croatian: Siklos 100 mg filmom obložene tablete
English: Store below 30°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30°C.
English: Siklos 1000 mg film-coated tablets.
Croatian: Siklos 1000 mg filmom obložene tablete.
English: Amenorrhea General disorders and administration site conditions: Not known:
Croatian: Opći poremećaji i reakcije na mjestu primjene: Nepoznato:
English: Siklos 100 mg film-coated tablets.
Croatian: Siklos 100 mg filmom obložene tablete.
English: Suomi/Finland
Croatian: Suomi/Finland Addmedica
English: Siklos 100 mg film-coated tablets Each film-coated tablet contains 100 mg of hydroxycarbamide.
Croatian: Siklos 100 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 100 mg hidroksikarbamida.
English: Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.
Croatian: Ako tijekom uzimanja Siklosa osjetite omaglicu nemojte upravljati vozilima ili rukovati strojevima.
English: Off-white, capsule-shaped, film-coated tablet with triple scoring on both sides.
Croatian: Gotovo bijela filmom obložena tableta u obliku kapsule s tri ureza na obje strane.
English: Siklos 1000 mg film-coated tablets Each film-coated tablet contains 1,000 mg of hydroxycarbamide.
Croatian: Siklos 1000 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 1000 mg hidroksikarbamida.
English: Siklos 100 mg tablets hydroxycarbamide Oral use
Croatian: Siklos 100 mg tablete hidroksikarbamid Za primjenu kroz usta
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: OBLIK I SADRŽAJ 30 tableta
English: Cutaneous dryness Reproductive system and breast disorders: Very common: Oligospermia , azoospermia4 Not known:
Croatian: suhoća kože Poremećaji reproduktivnog sustava i dojki: Vrlo često:
English: Contents of the pack and other information What Siklos contains
Croatian: Sadržaj pakiranja i druge informacije
English: EU/1/07/397/002 60 tablets EU/1/07/397/003 90 tablets EU/1/07/397/004 120 tablets
Croatian: EU/1/07/397/004 120 tableta
English: Hydroxycarbamide is presumed to be a transspecies carcinogen.
Croatian: Hidroksikarbamid se smatra kancerogenim za različite vrste.
English: Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), and hair loss.
Croatian: Manje česte nuspojave (mogu se javiti kod do 1 na 100 osoba): Omaglica, mučnina, izbijanje crvenih promjena na koži koje svrbe (osip), crni nokti (melanonihija) i ispadanje kose.
English: Bleeding
Croatian: krvarenje
English: Siklos 1000 mg film-coated tablets hydroxycarbamide
Croatian: Siklos 1000 mg filmom obložene tablete hidroksikarbamid
English: Siklos 100 mg film-coated tablets hydroxycarbamide
Croatian: Siklos 100 mg filmom obložene tablete hidroksikarbamid
English: Siklos should be used with caution in patients with mild to moderate renal impairment (see section
Croatian: Kod bolesnika s blagim ili umjerenim oštećenjem bubrega terapiju Siklosom treba provoditi uz mjere opreza (vidjeti dio 4.2).
English: Each tablet contains 1,000 mg of hydroxycarbamide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 1000 mg hidroksikarbamida.
English: Each tablet contains 100 mg of hydroxycarbamide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 100 mg hidroksikarbamida.
English: Platelets
Croatian: Trombociti
English: If you get any side effects, talk to your doctor or, pharmacist or nurse.
Croatian: Ako primijetite bilo koju od nuspojava, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Sodium stearyl fumarate Silicified microcrystalline cellulose Basic butylated methacrylate copolymer
Croatian: FARMACEUTSKI PODACI 6.1 Pomoćne tvari natrijev stearilfumarat celuloza, mikrokristalična, silificirana kopoli (butadien/ metakrilat), lužnati 6.2 Inkompatibilnosti Nije primjenjivo.
English: Breast-feeding
Croatian: OPIS NUSPOJAVA
English: Skin cancer has also been reported in patients receiving long-term hydroxycarbamide.
Croatian: Kod bolesnika koji su primali dugotrajnu terapiju hidroksikarbamidom zabilježena je i pojava raka kože.
English: Cytotoxic: handle tablets with care.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično : tabletama rukujte s oprezom.
English: Off-white oblong-shaped, film-coated tablet with half-scoring on both sides.
Croatian: Gotovo bijela ovalna filmom obložena tableta s razdjelnom linijom na obje strane Tableta se može razdijeliti na dva jednaka dijela.
English: You must not breast-feed while taking Siklos.
Croatian: Tijekom uzimanja Siklosa ne smijete dojiti.
English: powder: 2500 IU; solvent: 3.2 ml
Croatian: prašak: 2500 IU; otapalo: 3,2 ml
English: EU/1/12/775/001 NovoThirteen 2500 IU Powder and solvent for solution for injection
Croatian: EU/1/12/775/001 NovoThirteen 2500 IU
English: Intravenous use powder: vial (glass); solvent: vial (glass)
Croatian: Primjena u venu prašak: bočica (staklo); otapalo: bočica (staklo)
English: 1 powder vial + 1 solvent vial + 1 vial adapter
Croatian: 1 bočica s praškom + 1 bočica s otapalom + 1 nastavak za bočicu
English: 18 November 2013
Croatian: 18. listopada 2013.
English: September 2013 CMDh meeting
Croatian: rujan 2013. sastanak CMDh-a
English: Annex VI
Croatian: Prilog VI.
English: It was to be available as 200 mg capsules.
Croatian: Dostupan je kao kapsule od 200 mg.
English: The Committee had concerns over the quality of the medicine (in particular on the choice of the starting material to make the medicine and the presence of impurities).
Croatian: Povjerenstvo je bilo zabrinuto zbog kvalitete lijeka (posebice vezano uz odabir početnog materijala za izradu lijeka i prisutnost nečistoća).
English: In addition, the CHMP had concerns about the documentation submitted in support of the effectiveness and safety of the medicine.
Croatian: Nadalje, CHMP bio je zabrinut zbog dokumentacije dostavljene u prilog djelotvornosti i sigurnosti lijeka.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole AIDSCFM can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Holoclar dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: How far into the evaluation was the application when it was withdrawn?
Croatian: U kojoj je fazi bilo vrednovanje prijave kada je ista povučena?
English: In its letter notifying the Agency of the withdrawal of application, the applicant stated that it was withdrawing the application since it would require a further time extension to provide the responses to the CHMP's questions.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, podnositelj zahtjeva naveo je da povlači zahtjev budući da mu je potrebno dodatno dulje vrijeme kako bi dostavio odgovore na pitanja CHMP-a.
English: On 23 February 2015, Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ketoconazole AID-SCFM, for the treatment of Cushing's syndrome.
Croatian: Dana 23. veljače 2015. godine, Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare službeno je obavijestila Povjerenstvo za lijekove za humanu uporabu (CHMP) da želi povući svoju zahtjev za izdavanje odobrenja za stavljanje u promet lijeka Ketokonazol AID-SCFM, za terapiju Cushingovog sindroma.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio početnu dokumentaciju koju je proizvođač dostavio te je sastavilo popis pitanja.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Ketoconazole AID-SCFM was expected to be used to treat adults with Cushing's syndrome for whom surgery was not an option or had failed.
Croatian: Ketokonazol AID-SCFM trebao se koristiti u terapiji odraslih osoba s Cushingovim sindromom za koje kirurški zahvat nije mogućnost ili nije bio uspješan.
English: The active substance in Ketoconazole AID-SCFM, ketoconazole, blocks the activity of a group of enzymes involved in the production of cortisol by the adrenal glands, such as 17 alpha-hydroxylase or 11b-hydroxylase.
Croatian: Djelatna tvar lijeka Ketokonazol AID-SCFM, ketokonazol, inhibira djelovanje grupe enzima uključenih u stvaranje kortizola od strane nadbubrežnih žlijezdi, poput 17 alfa-hidroksilaze ili 11b-hidroksilaze.
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Croatian: Cuhingov sindrom je bolest okarakterozirana prekomjernom proizvodnjom hormona kortizola od strane nadbubrežnih žlijezdi, dvije žlijezde koje se nalaze iznad bubrega.
English: Blocking cortisol production will help to reduce cortisol levels in the body, thereby relieving the symptoms of the disease.
Croatian: Inhibirajući stvaranje kortizola pomaže pri smanjivanju koncentracije kortizola u tijelu, te se tako ublažavaju simptomi bolesti.
English: The company also cited commercial reasons, since another medicine containing ketoconazole for Cushing's syndrome was recently authorised in the EU.
Croatian: Tvrtka je također navela komercijalne razloge, budući da drugi lijekovi koji sadrže ketokonazol za terapiju Cushingovog sindroma su nedavno odobreni u EU.
English: Another medicine containing ketoconazole (Ketoconazole HRA) was recently approved in the EU to treat Cushing's syndrome.
Croatian: Drugi lijek koji sadrži ketokonazol (Ketokonazol HRA) nedavno je odobren u EU za liječenje Cushingovog sindroma.
English: The company had not yet responded to the questions at the time of the withdrawal.
Croatian: U trenutku povlačenja proizvođač još nije bilo dostavio svoje odgovore.
English: Because ketoconazole is a well-known substance and its use in Cushing's syndrome is well established, the applicant presented data from the published literature to support its application for Ketoconazole AID-SCFM.
Croatian: Budući da je ketokonazol dobro poznata tvar, te je njegova uporaba u terapiji Cushingovog sindroma dobro utvrđena, podnositelj zahtjeva dostavio je podatke iz objavljene literature kako bi podržao zahtjev za lijek Ketokonazol AID-SCFM.
English: What were the reasons given by the company for withdrawing the application?
Croatian: Koje je razloge za povlačenje prijave proizvođač naveo?
English: Ketoconazole can also block the production of other hormones produced by the adrenal gland which are often raised in Cushing's syndrome.
Croatian: Ketokonazol može također inhibirati stvaranje drugih hormona koje proizvodi nadbubrežna žlijezda, a koji su najčešće povišeni u slučaju Cushingovog sindroma.
English: Ketoconazole AID-SCFM was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 9 August 2012 for Cushing's syndrome.
Croatian: Ketokonazol AID-SCFM bio je označen kao lijek za liječenje rijetkih i teških bolesti dana 9. kolovoza 2012. za Cushingov sindrom.
English: Ketoconazole AID-SCFM is a medicine that contains the active substance ketoconazole.
Croatian: Ketokonazol AID-SCFM? je lijek koji sadrži djelatnu tvar ketokonazol.
English: Based on the initial review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Ketoconazole AID-SCFM could not have been approved for the treatment of Cushing's syndrome.
Croatian: Na temelju inicijalnog pregleda podataka, u trenutku povlačenja, CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Ketokonazol AID-SCFM za terapiju Cuhingovog sindroma.
English: What is Ketoconazole AID-SCFM?
Croatian: Što je Ketokonazol AID-SCFM?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Ketoconazole AID-SCFM did not outweigh its risks.
Croatian: Sukladno navedenome, u vrijeme povlačenja CHMP, zbog izostanka potvrde o učinkovitosti, smatrao je kako koristi lijeka Ketokonazol AID-SCFM ne nadmašuju s njim povezane rizike.
English: What was Ketoconazole AID-SCFM expected to be used for?
Croatian: Za što se Ketokonazol AID-SCFM trebao koristiti?
English: How is Ketoconazole AID-SCFM expected to work?
Croatian: Kako je Ketokonazol AID-SCFM trebao djelovati?
English: MA (EU) Number Name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: The average improvement was about 1.4 points.
Croatian: Prosječno poboljšanje bilo je približno 1,4 boda.
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen.
Croatian: Više informacija nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Privigen.
English: The patients had an average of 0.08 serious infections per year.
Croatian: Bolesnici su imali u prosjeku 0,08 ozbiljnih infekcija godišnje.
English: IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection.
Croatian: IgG se primjenjuje kao lijek od 1980-ih godina i ima širok spektar djelovanja protiv organizama koji mogu uzrokovati infekciju.
English: What is Privigen and what is it used for?
Croatian: Što je Privigen i za što se primjenjuje?
English: Privigen was given on two consecutive days.
Croatian: Lijek Privigen primjenjivao se dva uzastopna dana.
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Croatian: Sadržava imunoglobulin G (IgG) koji je vrsta protutijela.
English: What measures are being taken to ensure the safe and effective use of Privigen?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Privigen?
English: Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Croatian: Privigen je lijek koji se primjenjuje za potporu imunosnom sustavu (prirodna obrana tijela) u dviju glavnih skupina bolesnika:
English: Other information about Privigen
Croatian: Ostale informacije o lijeku Privigen
English: Since this is below the predefined threshold of one serious infection per year, this indicates that the medicine is effective as replacement therapy.
Croatian: Budući da je to manje od unaprijed utvrđene granične vrijednosti od jedne ozbiljne infekcije godišnje, to znači da je lijek učinkovit kao terapija nadomještanja.
English: As human normal immunoglobulin has been used to treat these diseases for a long time, and in accordance with current guidelines, only three small studies were needed to establish the effectiveness and safety of Privigen in patients.
Croatian: Budući da se ljudski normalni imunoglobulin odavno primjenjuje za liječenje ovih bolesti, u skladu s postojećim smjernicama bilo je potrebno provesti samo tri mala ispitivanja kako bi se utvrdila učinkovitost i sigurnost lijeka Privigen u bolesnika.
English: The European Medicines Agency concluded that Privigen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Privigen nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: The dose may need to be adjusted for patients depending on their response.
Croatian: Dozu će možda biti potrebno prilagoditi ovisno o odgovoru bolesnika.
English: The company that markets Privigen has made some changes in the way it is produced to reduce this risk and is performing a study to monitor the effect of the changes.
Croatian: Tvrtka koja lijek Privigen stavlja u promet uvela je određene promjene u načinu proizvodnje lijeka kako bi se smanjio taj rizik te provodi ispitivanje u cilju nadzora učinka tih promjena.
English: In this third study, 17 (61%) of the 28 patients responded to treatment with an improvement of at least one point on the disability scale.
Croatian: U tom trećem ispitivanju, 17 od 28 bolesnika (61 %) odgovorilo je na liječenje, uz poboljšanje od najmanje jednog boda na ljestvici onesposobljenosti.
English: Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Privigen pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The main measure of effectiveness was the number of serious bacterial infections over a year's treatment.
Croatian: Glavno mjerilo učinkovitosti bio je broj ozbiljnih bakterijskih infekcija tijekom jednogodišnjeg liječenja.
English: Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Croatian: Lijek Privigen dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 25. travnja 2008.
English: An overview of Privigen and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Privigen i zašto je odobren u EU-u
English: Privigen (human normal immunoglobulin)
Croatian: Privigen (normalni ljudski imunoglobulin)
English: The medicine is available as a solution for infusion (drip) into a vein.
Croatian: Lijek je dostupan kao otopina za infuziju (ukapavanje) u venu.
English: The most common side effects with Privigen (seen in more than 1 patient in 10) are headache, nausea, pain (including in the back, neck, limbs, joints and face), fever, chills and a flu-like illness.
Croatian: Najčešće nuspojave lijeka Privigen (opažene u više od 1 na 10 bolesnika) su glavobolja, mučnina, bol (u leđima, vratu, udovima, zglobovima i licu), vrućica, zimica i bolest slična gripi.
English: This confirmed that Privigen is effective in immunomodulation.
Croatian: Time je potvrđeno da je lijek Privigen učinkovit u imunomodulaciji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Privigen have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Privigen nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Privigen authorised in the EU?
Croatian: Zašto je lijek Privigen odobren u EU-u?
English: • Patients who are at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease).
Croatian: • bolesnika koji su izloženi riziku od infekcije jer nemaju dovoljno protutijela (koja se također nazivaju imunoglobulini, a to su bjelančevine u krvi koje pomažu tijelu u borbi protiv bolesti).
English: As for all medicines, data on the use of Privigen are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Privigen kontinuirano se prate.
English: The main measure of effectiveness was the number of patients who showed improvement of their disability, measured by a decrease on a 10point scale of disability in their arms and legs.
Croatian: Glavno mjerilo učinkovitosti bio je broj bolesnika kod kojih je došlo do ublažavanja onesposobljenosti, što se mjerilo smanjenjem onesposobljenosti u rukama i nogama na ljestvici od 10 bodova.
English: Privigen can only be obtained with a prescription and treatment for patients with a lack of antibodies should be started and monitored by a doctor experienced in treating such conditions.
Croatian: Privigen se izdaje samo na liječnički recept, a liječenje bolesnika s nedostatkom protutijela treba započeti i nadzirati liječnik s iskustvom u liječenju takvih stanja.
English: What are the risks associated with Privigen?
Croatian: Koji su rizici povezani s lijekom Privigen?
English: These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs.
Croatian: To su bolesnici s primarnom imunom trombocitopenijom (ITP), koji nemaju dovoljno trombocita (komponente u krvi koje potiču njezino zgrušavanje) i koji su izloženi visokom riziku od krvarenja; bolesnici s Guillain-Barréovim sindromom ili kroničnom upalnom demijelinizirajućom polineuropatijom (CIDP), upalnim poremećajima živaca koji uzrokuju slabost i utrnulost mišića; bolesnici koji imaju Kawasakijevu bolest, koja se uglavnom pojavljuje u djece i uzrokuje upalu krvnih žila; te bolesnici koji imaju multifokalnu motornu neuropatiju (MMN), tj. oštećenje živaca koje uzrokuje slabost ruku i nogu.
English: In the first study, Privigen was used in 80 patients with PID, with the medicine being infused every three or four weeks.
Croatian: U prvom ispitivanju lijek Privigen primijenjen je u 80 bolesnika s PID-om, pri čemu se lijek ukapavao svaka tri ili četiri tjedna.
English: For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Privigen pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Privigen works by restoring abnormally low IgG levels to their normal range in the blood.
Croatian: Privigen djeluje tako što omogućuje da abnormalno niske razine IgG-a u krvi opet postanu normalne.
English: The second study looked at using Privigen in 57 patients with ITP.
Croatian: U drugom ispitivanju proučavana je primjena lijeka Privigen u 57 bolesnika s ITP-om.
English: A third study examined the use of Privigen for immunomodulation in 28 patients with CIDP who were given Privigen every three weeks over a period of 24 weeks.
Croatian: U trećem ispitivanju ispitana je primjena lijeka Privigen za imunomodulaciju u 28 bolesnika s CIDP-om, koji su dobivali lijek Privigen svaka tri tjedna tijekom razdoblja od 24 tjedna.
English: Severe haemolysis has previously been reported to be slightly more frequent with Privigen than with some other products containing the same active substance.
Croatian: Prethodno je zabilježeno da se teška hemoliza javlja malo češće pri primjeni lijeka Privigen nego pri primjeni nekih drugih lijekova koji sadrže istu djelatnu tvar.
English: In this study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study.
Croatian: U tom ispitivanju broj trombocita u 46 od 57 bolesnika (81 %) iznosio je više od 50 milijuna trombocita po mililitru barem jednom tijekom ispitivanja.
English: The main measure of effectiveness was the highest blood platelet level that was achieved in the week after Privigen was given.
Croatian: Glavno mjerilo učinkovitosti bila je najviša razina trombocita u krvi postignuta u tjednu nakon primjene lijeka Privigen.
English: The medicine contains the active substance human normal immunoglobulin.
Croatian: Lijek sadržava djelatnu tvar ljudski normalni imunoglobulin.