FrancophonIA/ELRC3.0 huggingface dataset:
English: - Worsening of a condition called myasthenia gravis, a rare disease which causes muscle
Croatian: svrbež, gubitak teka ili bol u trbuhu (manje često). - pogoršanje stanja koje se naziva miastenija gravis, rijetke bolesti koja uzrokuje slabost mišića
English: The affinity of telithromycin for the 50S ribosomal subunits of organisms susceptible to erythromycin A is 10-fold higher than that of erythromycin A.
Croatian: Afinitet telitromicina za ribosomsku podjedinicu 50S u mikroorganizmima osjetljivima na eritromicin
English: Absorption
Croatian: Distribucija
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Aventis Pharma S.A.
Croatian: Aventis Pharma S.A.
English: Each film-coated tablet contains 400 mg of telithromycin.
Croatian: TVARI Jedna filmom obložena tableta sadrži 400 mg telitromicina.
English: Colchicine intoxication, including fatal cases, has been reported in patients treated with colchicine and strong CYP 3A4 inhibitors.
Croatian: U bolesnika liječenih kolhicinom i snažnim inhibitorima CYP3A4 prijavljena je intoksikacija kolhicinom, uključujući slučajeve sa smrtnim ishodom.
English: Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg. At steady-state AUC is approximately 1.5 fold increased compared to the single dose.
Croatian: Prosječna najniža koncentracija u plazmi u stanju dinamičke ravnoteže iznosi između 0,04 i 0,07 mg/l i postiže se za 3 do 4 dana uz primjenu doze telitromicina od 800 mg jedanput na dan.
English: Cholestatic jaundice
Croatian: Kolhicin
English: Due to a potential to increase the QT interval, Ketek should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, or bradycardia (<50 bpm), during concomitant administration of Ketek with QT interval prolonging agents, or in patients concomitantly treated with potent CYP 3A4 inhibitors such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole) (see sections 4.3 and 4.5).
Croatian: Oprez je potreban i kada se Ketek primjenjuje istodobno s lijekovima koji produljuju QT-interval kao i u bolesnika koji se istodobno liječe snažnim inhiborima CYP3A4 kao što su inhibitori proteaze i azolni antimikotici (npr. ketokonazol, flukonazol) (vidjeti dio 4.3 i 4.5).
English: Concomitant administration with ergot alkaloid derivatives (such as ergotamine and
Croatian: Istodobna primjena derivata ergot alkaloida (kao što su ergotamin i dihidroergotamin) (vidjeti dio 4.5).
English: - if you have had a liver disease (hepatitis and/or jaundice) while taking Ketek in the past.
Croatian: - ako ste imali neku bolest jetre (hepatitis i/ili žuticu) tijekom ranijeg uzimanja lijeka Ketek. - ako uzimate druge lijekove koji mogu produljiti QT-interval na elektrokardiogramu (EKG-u),
English: -Hepatic impairment
Croatian: Oštećenje bubrega
English: Sanofi Malta Ltd. Tel: +356 21493022
Croatian: Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400
English: Pregnancy, breast-feeding and fertility
Croatian: Ciklosporin, takrolimus, sirolimus
English: Uncommon (may affect up to 1 in 100 people) or rare side effects (may affect up to 1 in 1,000 people) - constipation, loss of appetite (anorexia) - inflammation in the mouth, fungal infection in the mouth (Candida infection)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba): - poremećaj osjeta mirisa, grčevi mišića.
English: Telithromycin does not induce expression of macrolide-lincosamide-streptogramin B (MLSB)
Croatian: Telitromicin in vitro ne inducira ekspresiju rezistencije na makrolide, linkozamide i streptogramin B (MLSB-tip rezistencije) u mikroorganizmima Staphylococcus aureus, Streptococcus pneumoniae i Streptococcus pyogenes.
English: - if you are taking certain medicinal products to control the blood level of cholesterol or other lipids like simvastatin, lovastatin, or atorvastatin, as the side effects of these medicinal products could be increased.
Croatian: • ergotamin ili dihidroergotamin (tablete ili inhalator za liječenje migrene) - ako uzimate određene lijekove za kontrolu razine kolesterola ili drugih lipida u krvi, kao što su simvastatin, lovastatin ili atorvastatinom, jer se mogu pojačati nuspojave tih lijekova. - ako Vi ili netko u Vašoj obitelji ima poremećaj na elektrokardiogramu (EKG) pod nazivom "sindrom produljenog QT-intervala".
English: Blood and the lymphatic system disorders
Croatian: Poremećaji reproduktivnog sustava i dojki vaginalna infekcija kandidom
English: Due to limited experience in patients with decreased metabolic capacity of the liver, Ketek should be used with caution in patients with hepatic impairment (see also section 4.4).
Croatian: Ketek se mora primjenjivati uz oprez u bolesnika s oštećenom jetrenom funkcijom (vidjeti također dio 4.4).
English: Eczema
Croatian: Dojenje
English: Haemophilus influenzae
Croatian: Poremećaji oka diplopija
English: Diarrhoea, nausea and dizziness were the most commonly reported adverse reactions in phase III clinical trials.
Croatian: Najčešće prijavljene nuspojave u fazi III kliničkih ispitivanja bile su proljev, mučnina i omaglica.
English: Slovenija sanofi-aventis d.o.o.
Croatian: Nederland sanofi-aventis Netherlands B.V.
English: 5.2 Pharmacokinetic properties
Croatian: 5.3 Neklinički podaci o sigurnosti primjene
English: Streptococcus pneumoniae
Croatian: Telitromicin je polusintetski derivat eritromicina
English: Erythema multiforme
Croatian: Mehanizam rezistencije
English: Avastin has been authorised in the EU since 12 January 2005.
Croatian: Avastin je odobren za primjenu u EU-u od 12. siječnja 2005.
English: The full European Public Assessment Report for Avastin can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije (EPAR) za lijek Avastin dostupno je na internet stranici Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measures of effectiveness were overall survival (how long the patients lived) and progression-free survival (how long the patients lived without their disease getting worse).
Croatian: Glavne mjere djelotvornosti bilo je ukupna stopa preživljenja (koliko dugo su bolesnici živjeli) i preživljenje bez progresije (koliko su dugo bolesnici živjeli bez pogoršanja bolesti).
English: What is Avastin?
Croatian: Što je Avastin?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili Vam je potrebno više informacija, obratite se liječniku koji Vam propisuje terapiju.
English: The applicant requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva zatražio je preispitivanje mišljenja.
English: Although there was an improvement in progression-free survival, it could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours.
Croatian: Iako je zabilježeno poboljšanje u preživljenju bez progresije, isto se ne može smatrati klinički relevantnim zbog ograničenja u metodama dostupnima za mjerenje veličine tumora mozga.
English: In addition, there was no benefit in terms of overall survival.
Croatian: Nadalje, nisu zabilježene koristi u smislu cjelokupne stope preživljenja.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje su posljedice ovog odbijanja za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: Refusal of a change to the marketing authorisation for Avastin (bevacizumab) EMA/577647/2014
Croatian: Odbijanje izmjene odobrenja za stavljanje u promet lijeka Avastin (bevacizumab) EMA/577647/2014
English: There are no consequences on the use of Avastin in its authorised indications.
Croatian: Nema posljedica za primjenu lijeka Avastin u njegovim odobrenim indikacijama.
English: The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer).
Croatian: Izmjena se odnosila na proširenje indikacije kako bi se dodalo liječenje glioblastoma (agresivnog tipa raka mozga).
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein).
Croatian: Dostupan je kao koncentrat za otopinu za infuziju (drip u venu).
English: By attaching to VEGF, Avastin stops cancer cells from developing their own blood supply and starves them of oxygen and nutrients, helping to slow down the growth of the cancer.
Croatian: Vezivanjem na VEGF, Avastin sprječava tumorske stanice od razvoja vlastite opskrbe krvlju te im uskraćuje kisik i hranjive tvari, što pomaže pri usporavanju rasta karcinoma.
English: The company informed the CHMP that there are no consequences for patients with glioblastoma receiving Avastin in clinical trials: patients will continue to receive Avastin in the on-going and future clinical trials.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike s glioblastomom koji primaju terapiju lijekom Avastin u kliničkim ispitivanjima: bolesnici će nastaviti primati Avastin u trenutnim i budućim kliničkim ispitivanjima.
English: What is happening with Avastin for treatment of other cancers?
Croatian: Kakve posljedice ishod ovog postupka ima na Avastin za liječenje drugih karcinoma?
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 September 2014.
Croatian: Nakon razmatranja razloga za ovaj zahtjev, CHMP je ponovno ispitao prvotno mišljenje te je potvrdio odbijanje odobrenja za stavljanje lijeka u promet dana 22. rujna 2014.
English: Refusal of a change to the marketing authorisation for Avastin (bevacizumab)
Croatian: Odbijanje izmjene odobrenja za stavljanje u promet lijeka Avastin (bevacizumab)
English: The company presented the results from one main study with Avastin involving 921 patients with newly diagnosed glioblastoma.
Croatian: Tvrtka je dostavila rezultate jednog glavnog ispitivanja provedenog s lijekom Avastin koje je obuhvatilo 921 bolesnika s novodijagnosticiranim glioblastomom.
English: On 22 May 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Avastin.
Croatian: Dana 22. svibnja 2014., Odbor za lijekove za humanu uporabu (CHMP) usvojio je negativno mišljenje kojim se preporuča odbijanje izmjene odobrenja za stavljanje u promet lijeka Avastin.
English: What was Avastin expected to be used for?
Croatian: Za što se Avastin trebao koristiti?
English: How is Avastin expected to work?
Croatian: Kako je Avastin trebao djelovati?
English: During the re-examination, the CHMP looked again at the data from the company and confirmed its opinion that the benefits of Avastin had not been sufficiently demonstrated in newly diagnosed glioblastoma.
Croatian: Tijekom ponovnog pregleda, CHMP je ponovno preispitao podatke koje je tvrtka dostavila i potvrdio je svoje mišljenje da koristi lijeka Avastin nisu dokazane u dostatnoj mjeri u slučaju novodijagnosticiranog glioblastoma.
English: At the time of the initial recommendation the CHMP noted that the effectiveness of Avastin in combination with radiotherapy and temozolomide had not been sufficiently demonstrated.
Croatian: U trenutku prvotne preporuke, CHMP je naglasio da djelotvornost lijeka Avastin u kombinaciji s radioterapijom i temozolomidom nije u dostatnoj mjeri dokazana.
English: It is used, in combination with other chemotherapy medicines (medicines to treat cancer), to treat certain types of the following cancers: cancer of the colon or rectum (large intestine); breast cancer; lung cancer; kidney cancer; cancer of the ovary; cancer of the fallopian tube or the peritoneum (the membrane lining the abdomen).
Croatian: Avastin se koristi za liječenje odraslih osoba sa sljedećim tipovima raka u kombinaciji s drugim citostaticima: karcinom kolona ili rektuma (debelog crijeva); karcinom dojke; karcinom pluća; karcinom bubrega; karcinom jajnika; karcinom jajovoda ili peritoneuma (membranske ovojnice abdomena).
English: Avastin was also expected to be used to treat adult patients with newly diagnosed glioblastoma in combination with radiotherapy (treatment with radiation) and temozolomide (another cancer medicine).
Croatian: Avastin se trebao koristiti za liječenje odraslih bolesnika s novodijagnosticiranim glioblastomom u kombinaciji s radioterapijom (liječenjem zračenjem) i temozolomidom (drugim citostatikom).
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Avastin in the treatment of newly diagnosed glioblastoma did not outweigh its risks.
Croatian: Stoga je u tom trenutku CHMP bio mišljenja da koristi lijeka Avastin u liječenju novodijagnosticiranog glioblastoma ne nadmašuju njegove rizike.
English: What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Croatian: Koji su glavni razlozi za zabrinutost CHMP-a koji su rezultirali odbijanjem izmjene odobrenja za stavljanje lika u promet?
English: In the study, patients received Avastin or placebo (a dummy treatment) in addition to treatment with radiotherapy and temozolomide.
Croatian: U ispitivanju, bolesnici su primili Avastin ili placebo (liječenje bez djelatne tvari) uz liječenje radioterapijom i temozolomidom.
English: Avastin is a cancer medicine that contains the active substance bevacizumab.
Croatian: Avastin je citostatik koji sadrži djelatnu tvar bevacizumab.
English: Therefore, the CHMP maintained its previous recommendation that the change to the marketing authorisation be refused.
Croatian: Stoga je CHMP zadržao svoju prethodnu preporuku za odbijanje izmjene odobrenja za stavljanje lijeka u promet.
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein), that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that
Croatian: Djelatna tvar Avastin, bevacizumab, je protutijelo (tip bjelančevine) koji je dizajniran za prepoznavanje i vezivanje na krvožilni endotelni čimbenik rasta (VEGF), bjelančevina koja cirkulira u krvi i potiče rast krvnih žila.
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Croatian: CHMP je stoga preporučio odbijanje izmjene odobrenja za stavljanje lijeka u promet.
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens
Croatian: --1 Svinjski cirkovirus tipa 2 subjedinični antigena ORF2 ≥ 4.5 log2 ELISA jed.* * Titar protutijela utvrđen in vivo testom potencije na pilićima
English: Packaging Content Package size
Croatian: Pakovanje Sadržaj Veličina pakovanja
English: MA (EU) number
Croatian: EU broj
English: Intravenous use bag (ethylene vinyl acetate)
Croatian: Intravenska primjena vrećica (etilenvinilacetat)
English: EU/1/18/1299/001 YESCARTA
Croatian: EU/1/18/1299/001 YESCARTA 0,4 x 1082 x 108 stanica
English: 22014 Incheon REPUBLIC OF KOREA
Croatian: 22014 Incheon REPUBLIKA KOREJA
English: Herzuma is not recommended for anyone under the age of 18 years.
Croatian: Herzuma se ne preporučuje osobama mlađima od 18 godina.
English:  Risk Management Plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: The patient who missed the dose should not wait until the next planned cycle.
Croatian: Bolesnik koji je propustio primiti dozu ne smije čekati sljedeći planirani ciklus.
English: WestEnd Office Building B torony Hungary
Croatian: WestEnd Office Building B torony Mađarska
English: Do not stop using this medicine without talking to your doctor first.
Croatian: Nemojte prestati primati ovaj lijek ako o tome prethodno niste razgovarali sa svojim liječnikom.
English:  you have ever had any other treatment for cancer.
Croatian: • Ako ste nekada primali bilo koju drugu terapiju za rak.
English: Other medicines and Herzuma
Croatian: Drugi lijekovi i Herzuma
English: Trastuzumab can cause breathing difficulties, especially when it is first given.
Croatian: Trastuzumab može izazvati poteškoće u disanju, osobito prilikom prve primjene.
English: Biotech Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
Croatian: Biotec Services International Limited Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend
English: Date of first authorisation: 9 February 2018 Date of latest renewal:
Croatian: Datum prvog odobrenja: 9. veljače 2018.
English: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, UNITED KINGDOM
Croatian: Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, UJEDINJENO KRALJEVSTVO
English: Store in a refrigerator (2ºC - 8ºC).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Herzuma should only be given by a doctor or nurse.
Croatian: Lijek Herzuma smije primijeniti samo liječnik ili medicinska sestra.
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: U ovom dijelu, za prikaz nuspojava prema učestalosti korišteni su sljedeći kriteriji: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Herzuma may also be given once a week for metastatic breast cancer.
Croatian: Herzuma se također može davati jednom tjedno za metastatski rak dojke.
English: Median follow-up 12 months*
Croatian: Medijan praćenja 12 mjeseci*
English: What Herzuma is and what it is used for
Croatian: Što je Herzuma i za što se koristi
English: Overall response rate, %
Croatian: Stopa ukupnog odgovora na liječenje,%
English: Herzuma is given as an intravenous infusion (“drip”) directly into your veins.
Croatian: Herzuma se primjenjuje intravenskom infuzijom („drip“) direktno u venu.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with trastuzumab.
Croatian: Ti lijekovi (ili neki drugi antraciklini) mogu oštetiti srčani mišić i povećati rizik od srčanih problema pri primjeni trastuzumaba.
English: Herzuma is not genotoxic.
Croatian: Lijek Herzuma nije genotoksičan.
English: What Herzuma looks like and contents of the pack
Croatian: Kako Herzuma izgleda i sadržaj pakiranja
English:  you suffer from breathlessness, especially if you are currently using a taxane.
Croatian: • Ako imate nedostatak zraka, osobito ako trenutno primate taksan.
English: 20 Academy -ro 51 beon-gil Yeonsu-gu
Croatian: CELLTRION INC., 20 Academy-ro 51 beon-gil Yeonsu-gu
English: • Your doctor will advise you of the risks and benefits of taking Herzuma during pregnancy.
Croatian: • Liječnik će Vam objasniti rizike i koristi primjene lijeka Herzuma tijekom trudnoće.
English: This medicinal product must not be diluted with glucose solutions since these cause aggregation of the protein.
Croatian: Lijek se ne smije razrjeđivati otopinama glukoze jer izazivaju agregaciju proteina.
English: What Herzuma contains
Croatian: Što Herzuma sadrži
English: Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
Croatian: Bridgend Industrial Estate Bridgend, CF31 3RT Ujedinjeno Kraljevstvo
English: The dose of Herzuma depends on your body weight.
Croatian: Potrebna doza lijeka Herzuma ovisi o Vašoj tjelesnoj težini.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herzuma treatment.
Croatian: Ako se pojave znakovi zatajenja srca (srce nedostatno pumpa krv), možda ćete srčanu funkciju kontrolirati češće (svakih šest do osam tjedana), a možda ćete primati terapiju za zatajenje srca ili ćete morati prekinuti liječenje lijekom Herzuma.
English: Herzuma may affect your ability to drive a car or operate machines.
Croatian: Herzuma može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: When Herzuma binds to HER2 it stops the growth of such cells and causes them to die.
Croatian: Kada se Herzuma veže na HER2, zaustavlja rast tih stanica i uzrokuje njihovo odumiranje.
English: Observation N= 1697***
Croatian: Opservacija N = 1697***
English: * defined as absence of any invasive cancer both in the breast and axillary nodes
Croatian: * definiran kao izostanak invazivnoga raka i u dojci i u aksilarnim čvorovima
English: Instructions for reconstitution and dilution:
Croatian: Upute za rekonstituciju i razrjeđivanje:
English: For storage conditions after reconstitution of the medicinal product, see section 6.3 and 6.6.
Croatian: Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3 i 6.6.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Croatian: Rezultati tih simulacija ukazuju da će najmanje 95% bolesnika postići koncentracije < 1 µg/ml (približno 3% vrijednosti Cmin,ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
English: Therefore, these patients should not be treated with Herzuma (see section 4.3).
Croatian: Te se bolesnike zato ne smije liječiti lijekom Herzuma (vidjeti dio 4.3).
English: Overexpression of HER2 is observed in 20% - 30% of primary breast cancers.
Croatian: Povećana ekspresija HER2 uočena je u 20%-30% primarnih karcinoma dojke.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6 - 8 weeks).
Croatian: Bolesnicima koji razviju asimptomatsku disfunkciju srca mogli bi koristiti češći pregledi (primjerice, svakih 6 - 8 tjedana).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trastuzumab, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za trastuzumab, znanstveni zaključci CHMP-a su sljedeći:
English: Administration in combination with an aromatase inhibitor
Croatian: Primjena u kombinaciji s inhibitorom aromataze
English: Other side effects that have been reported with Herzuma use (frequency cannot be estimated from the available data):
Croatian: Ostale nuspojave koje su uočene pri primjeni lijeka Herzuma (učestalost se ne može procijeniti iz dostupnih podataka):
English: If you receive Herzuma in combination with chemotherapy, some of them may also be due to the chemotherapy.
Croatian: Ako primate lijek Herzuma u kombinaciji s kemoterapijom, neke od njih mogu biti i posljedica primljene kemoterapije.
English: It should not be administered as an intravenous push or bolus.
Croatian: Ne smije se primijeniti kao intravenska injekcija ili bolus.
English: No long-term animal studies have been performed to establish the carcinogenic potential of Herzuma, or to determine its effects on fertility in males.
Croatian: Nisu provedena dugoročna ispitivanja na životinjama s ciljem utvrđivanja kancerogenog potencijala lijeka Herzuma ili njegovih učinaka na plodnost muškaraca.
English: Herzuma loading dose should be administered as a 90-minute intravenous infusion.
Croatian: Udarnu dozu lijeka Herzuma potrebno je primijeniti u 90-minutnoj intravenskoj infuziji.
English: It may take up to 7 months for Herzuma to be removed from your body.
Croatian: Može biti potrebno i do 7 mjeseci da se Herzuma ukloni iz Vašeg tijela.
English:  Keep this leaflet.
Croatian: • Sačuvajte ovu uputu.