FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop using Mircera if you develop these symptoms and contact your doctor or seek medical attention immediately, see also section 2.
Croatian: Prestanite primjenjivati lijek Mircera u slučaju nastanka tih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Croatian: Prije injiciranja pričekajte da napunjena štrcaljka poprimi sobnu temperaturu.
English: The solution is clear, colourless to slightly yellowish and free of visible particles.
Croatian: Otopina je bistra, bezbojna do blago žućkasta i bez vidljivih čestica.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous or intravenous use Read the package leaflet before use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za supkutanu ili intravensku primjenu Prije uporabe pročitajte uputu o lijeku
English: Pre-filled syringe 360 micrograms contains 0.6 ml solution.
Croatian: Napunjena štrcaljka od 360 mikrograma koja sadrži 0,6 ml otopine.
English: Follow the recommendations of your healthcare professional about how you should inject MIRCERA.
Croatian: Slijedite preporuke koje Vam je za injiciranje lijeka MIRCERA dao zdravstveni radnik.
English: MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe
Croatian: MIRCERA 30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 40 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 50 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 60 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 75 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 100 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 120 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 150 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 200 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki MIRCERA 360 mikrograma/0,6 ml otopina za injekciju u napunjenoj štrcaljki
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.8).
Croatian: Prijavljene su teške kožne nuspojave, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne (vidjeti dio 4.8).
English: During treatment with MIRCERA
Croatian: Tijekom liječenja lijekom MIRCERA
English: No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenom funkcijom jetre nije potrebno prilagođavati početnu dozu niti mijenjati smjernice za prilagodbu doze (vidjeti dio 5.2).
English: During the study, platelet counts below 100 x 109/l were observed yearly in 1.5% to 3.0% of patients treated with MIRCERA and 1.6% to 2.5% of patients treated with other ESAs.'
Croatian: Tijekom ispitivanja, broj trombocita niži od 100 x 109/l opažen je svake godine u 1,5% - 3,0% bolesnika liječenih lijekom MIRCERA te u 1,6% - 2,5% bolesnika koji su primali druge lijekove za stimulaciju eritropoeze.
English: • If you are not currently treated with an ESA If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms for every kilogram of your body weight to be administered under the skin once every month as a single injection.
Croatian: Ako niste na dijalizi preporučena početna doza lijeka MIRCERA iznosi 1,2 mikrograma po kilogramu tjelesne težine, primijenjeno jednom injekcijom pod kožu jedanput mjesečno.
English: Insert the needle of the pre-filled syringe into the cleaned venous port.
Croatian: Uvedite iglu napunjene štrcaljke u očišćeni otvor za injekciju na venskoj liniji.
English: Attach the needle to the syringe by pushing it firmly onto the syringe.
Croatian: Pričvrstite iglu na štrcaljku čvrsto je pritišćući na štrcaljku.
English: If a dose adjustment is required to maintain the target haemoglobin concentration above 10 g/dl (6.21 mmol/l), the monthly dose may be increased by approximately 25%.
Croatian: Ako je za održavanje ciljne koncentracije hemoglobina iznad 10 g/dl (6,21 mmol/l) potrebna prilagodba doze, mjesečna se doza može povećati za otprilike 25%.
English: Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
Croatian: Nakon supkutane primjene u bolesnika s kroničnom bolesti bubrega koji nisu bili na dijalizi, maksimalne koncentracije metoksi polietilenglikol-epoetina beta u serumu opažene su 95 sati (medijan) nakon primjene.
English: Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 micrograms contain 0.3 ml solution.
Croatian: Napunjene štrcaljke od 30, 40, 50, 60, 75, 100, 120, 150, 200 i 250 mikrograma koje sadrže 0,3 ml otopine.
English: You may inject MIRCERA into the upper arm, thigh or abdomen, except around the navel (belly button).
Croatian: Lijek MIRCERA možete injicirati u nadlakticu, bedro ili trbuh, osim područja oko pupka.
English: MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 40 micrograms/0.3 ml solution for injection in pre-filled syringe 50 micrograms/0.3 ml solution for injection in pre-filled syringe 60 micrograms/0.3 ml solution for injection in pre-filled syringe 75 micrograms/0.3 ml solution for injection in pre-filled syringe 100 micrograms/0.3 ml solution for injection in pre-filled syringe 120 micrograms/0.3 ml solution for injection in pre-filled syringe 150 micrograms/0.3 ml solution for injection in pre-filled syringe 200 micrograms/0.3 ml solution for injection in pre-filled syringe 250 micrograms/0.3 ml solution for injection in pre-filled syringe 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: 30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 40 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 50 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 60 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 75 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 100 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 120 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 150 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 200 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 360 mikrograma/0,6 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: Table 2: Adverse reactions attributed to the treatment with MIRCERA in CKD patients .
Croatian: Tablica 2: Nuspojave pripisane liječenju lijekom MIRCERA zabilježene u bolesnika s kroničnom bolesti bubrega.
English: A slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
Croatian: U sklopu kliničkih ispitivanja uočen je neznatan pad broja trombocita, koji je ostao unutar granica normale.
English: Intravenous route:
Croatian: Primjena u venu:
English: · Do not try to replace the shield on the needle.
Croatian: • Nemojte pokušati zamijeniti zaštitni pokrov na igli.
English: (b) Tabulated list of adverse reactions
Croatian: (b) Tablični prikaz nuspojava
English: Patients not currently treated with an erythropoiesis stimulating agent (ESA): In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended starting dose in patients not on dialysis is 1.2 microgram/kg body weight, administered once every month as a single subcutaneous injection.
Croatian: Kako bi se razina hemoglobina povećala na vrijednosti iznad 10 g/dl (6,21 mmol/l), preporučena početna doza za bolesnike koji nisu na dijalizi iznosi 1,2 mikrograma/kg tjelesne težine, primijenjena jedanput mjesečno, kao jedna supkutana injekcija.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava manje često trombocitopenija*
English: It can be injected subcutaneously in the abdomen, arm or thigh.
Croatian: Može se dati supkutano u trbuh, nadlakticu ili bedro.
English: A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Subcutaneous route:
Croatian: Potkožna primjena:
English: If the rate of rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) over a month or if the haemoglobin level is increasing and approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25%.
Croatian: Ako je mjesečni porast razine hemoglobina veći od 2 g/dl (1,24 mmol/l) ili ako se povećava i približava razini od 12 g/dl (7,45 mmol/l), dozu treba smanjiti za otprilike 25%.
English: Alternatively, a starting dose of 0.6 microgram/kg bodyweight may be administered once every two weeks as a single intravenous or subcutaneous injection in patients on dialysis or not on dialysis.
Croatian: Alternativno, dijalizirani i nedijalizirani bolesnici mogu primiti početnu dozu od 0,6 mikrograma/kg tjelesne težine, jedanput svaka dva tjedna jednom intravenskom ili supkutanom injekcijom.
English: If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Croatian: Ako se razina hemoglobina nastavi povećavati, terapiju treba prekinuti dok se razina hemoglobina ne počne smanjivati.
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Croatian: Prijavljene su ozbiljne kožne reakcije, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezane s liječenjem epoetinom.
English: Wipe off the venous port of the hemodialysis as instructed by your healthcare provider
Croatian: Obrišite otvor za injekciju na venskoj liniji za hemodijalizu sukladno uputama zdravstvenog radnika.
English: Dispose of the syringe
Croatian: Bacite štrcaljku
English: MIRCERA has no or negligible influence on the ability to drive and use machines.
Croatian: MIRCERA ne utječe na sposobnost upravljanja vozilima i rada sa strojevima ili je taj utjecaj zanemariv.
English: • If you are a patient with chronic kidney disease and anemia treated with an ESA and are also a cancer patient you should be aware that ESAs, might have a negative impact on your condition.
Croatian: • Ako imate kroničnu bolest bubrega i liječite se lijekom za stimulaciju eritropoeze, a bolujete i od karcinoma, budite svjesni da bi lijekovi za stimulaciju eritropoeze mogli imati negativan utjecaj na Vaše stanje.
English: Throw away used syringes in a puncture-resistant container.
Croatian: Upotrijebljene štrcaljke bacite u neprobojni spremnik.
English: During clinical studies patients had a slight decrease in their platelet blood counts.
Croatian: Tijekom kliničkih ispitivanja u bolesnika je primijećen blagi pad broja trombocita.
English: Slovenská republika Roche Slovensko, s.r.o.
Croatian: Česká republika Roche s. r. o.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije manje često tromboza krvožilnog pristupa
English: · Do not warm up the syringe in any other way.
Croatian: • Štrcaljku ne smijete grijati ni na
English: Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Croatian: Smiju se primijeniti samo bistre, bezbojne do žućkaste otopine koje ne sadrže vidljive čestice.
English: If you have developed PRCA, your MIRCERA treatment will be discontinued.
Croatian: Ako se u Vas razvila izolirana aplazija crvene krvne loze, liječenje lijekom MIRCERA će se prekinuti.
English: Grasp the syringe and the rubber tip cap firmly and remove the rubber tip cap from the syringe (bend and pull).
Croatian: Čvrsto uhvatite štrcaljku i gumeni zatvarač vrha te skinite gumeni zatvarač vrha sa štrcaljke (savinite i povucite).
English: Tap the syringe gently to bring any bubbles to the top.
Croatian: Lagano prstom kucnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
English: Remove the pre-filled syringe from the venous port WITHOUT releasing the plunger.
Croatian: Izvadite napunjenu štrcaljku iz otvora za injekciju na venskoj liniji, ali pritom NE otpuštajte klip.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Croatian: Emil-Barell-Strasse 1
English: How to use MIRCERA
Croatian: Kako primjenjivati lijek MIRCERA
English: The solution is clear and colourless to slightly yellowish.
Croatian: Otopina je bistra i bezbojna do blago žućkasta.
English: As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting.
Croatian: Kao i kod ostalih lijekova za stimulaciju eritropoeze, nakon puštanja lijeka u promet zabilježeni su slučajevi tromboze, uključujući plućnu emboliju.
English: Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles
Croatian: Jedno pakiranje sadrži 3 napunjene štrcaljke s 0,3 ml otopine i 3 igle
English: How to store MIRCERA
Croatian: Kako čuvati lijek MIRCERA
English: · Do not pull on the plunger.
Croatian: • Nemojte vući klip.
English: Dispose of the syringe: · Throw away used syringes in a sharps/ puncture-resistant container.
Croatian: • Upotrijebljene štrcaljke bacite u spremnik za oštre predmete/neprobojan spremnik.
English: Tell your doctor if you are breast-feeding or intend to breast-feed.
Croatian: Obavijestite liječnika ako dojite ili namjeravate dojiti.
English: Nervous system disorders
Croatian: Potisnik klipa
English: Step 4.
Croatian: PRILOG III.
English: In clinical trials, an increased risk of death, serious cardiovascular events including thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l) (see section 4.8).
Croatian: Koncentracija hemoglobina: U bolesnika s kroničnom bolesti bubrega, koncentracija hemoglobina se treba održavati tako da ne prijeđe gornju granicu ciljne koncentracije hemoglobina preporučene u dijelu 4.2. U kliničkim ispitivanjima primijećen je povećan rizik od smrti, ozbiljnih kardiovaskularnih događaja uključujući trombozu ili cerebrovaskularnih događaja uključujući moždani udar, kada je ciljna razina hemoglobina, postignuta primjenom LSE, bila viša od 12 g/dl (7,5 mmol/l) (vidjeti dio 4.8).
English: Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been reported, frequency unknown.
Croatian: Prijavljena je izolirana aplazija crvene krvne loze (PRCA) prouzročena neutralizirajućim antieritropoetinskim antitijelima, nepoznate učestalosti.
English: • The active substance is methoxy polyethylene glycol-epoetin beta.
Croatian: • Djelatna tvar je metoksi polietilenglikol-epoetin beta.
English: Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
Croatian: Bolesnici koji se trenutno liječe lijekovima za stimulaciju eritropoeze (LSE): Bolesnici koji se već liječe s LSE mogu prijeći na lijek MIRCERA i primati je jedanput mjesečno u obliku jedne intravenske ili supkutane injekcije.
English: Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F).
Croatian: Štrcaljku uvijek čuvajte u hladnjaku na temperaturi od 2 - 8°C.
English: Attach the needle to the syringe
Croatian: Korak 4. Pričvrstite iglu na štrcaljku
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
English: If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your doctor about when to use the next doses.
Croatian: Ako propustite dozu lijeka MIRCERA, propuštenu dozu treba primijeniti čim se sjetite.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 75 mikrograma
English: INFORMATION IN BRAILLE mircera 120 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 120 mcg
English: Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.
Croatian: • Zdravi ljudi ne smiju uzimati lijek MIRCERA, jer bi to moglo pretjerano povisiti razinu hemoglobina i prouzročiti probleme sa srcem i krvnim žilama koji mogu biti opasni po život.
English: If signs and symptoms suggestive of these reactions appear, Mircera should be withdrawn immediately and an alternative treatement considered.If the patient has developed a severe cutaneous skin reaction such as SJS orTEN due to the use of Mircera, treatment with ESA must not be restarted in this patient at any time.
Croatian: U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prekinuti primjenu lijeka Mircera i razmisliti o zamjenskom liječenju.
English: INFORMATION IN BRAILLE mircera 75 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 75 mcg
English: • A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with erythropoiesis stimulating agents (ESAs), including MIRCERA.
Croatian: • U nekih bolesnika liječenih lijekovima za stimulaciju eritropoeze, uključujući i lijek MIRCERA, primijećeno je stanje koje se naziva izolirana aplazija crvene krvne loze (smanjeno ili zaustavljeno stvaranje crvenih krvnih stanica) zbog protutijela na eritropoetin.
English: Throw away the needle shield in the punctureresistant container or sharps container.
Croatian: Bacite zaštitni pokrov igle u neprobojni spremnik ili spremnik za oštre predmete.
English: INFORMATION IN BRAILLE mircera 360 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 360 mcg
English: IMPORTANT INFORMATION · Only use MIRCERA pre-filled syringeif you have been prescribed with this · medication.
Croatian: • Koristite MIRCERA napunjenu štrcaljku samo ako Vam je propisana.
English: • hypersensitivity (allergic reaction that can cause unusual wheezing or difficulty in breathing;
Croatian: • preosjetljivost (alergijska reakcija koja može uzrokovati neuobičajeno piskanje ili poteškoće pri disanju, oticanje jezika, lica ili ždrijela, ili otekline oko mjesta uboda, osjećaj ošamućenosti,
English: Each pack contains a pre-filled syringe of 0.6 ml and a needle
Croatian: Jedno pakiranje sadrži napunjenu štrcaljku s 0,6 ml otopine i iglu
English: There have been reports of platelet counts below the normal range (thrombocytopenia) in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi broja trombocita ispod normalnih vrijednosti (trombocitopenija).
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 360 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 360 mikrograma napunjena štrcaljka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 30 mikrograma
English: MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 833 micrograms/ml.
Croatian: MIRCERA 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 250 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 833 mikrograma/ml.
English: • pulmonary embolism.
Croatian: • plućna embolija (krvni ugrušci u plućima)
English: INFORMATION IN BRAILLE mircera 200 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 200 mcg
English: MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micgrograms/ml
Croatian: MIRCERA 200 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 200 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 667 mikrograma/ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 360 mcg/0.6 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 360 mcg/0,6 ml
English: INFORMATION IN BRAILLE mircera 150 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 150 mcg
English: Immediately throw away the needle cap in the sharps/ puncture-resistant container or sharps container.
Croatian: Odmah bacite zatvarač igle u spremnik za oštre predmete ili neprobojan spremnik.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 75 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 75 mikrograma
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 75 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 75 mcg/0,3 ml
English: Each pack contains a pre-filled syringe of 0.3 ml and a needle
Croatian: Jedno pakiranje sadrži napunjenu štrcaljku s 0,3 ml otopine i iglu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 50 mikrograma
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 360 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 360 mikrograma
English: MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ml.
Croatian: MIRCERA 150 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 150 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 500 mikrograma/ml.
English: INFORMATION IN BRAILLE mircera 250 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 250 mcg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 120 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 120 mikrograma napunjena štrcaljka
English: MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ml.
Croatian: MIRCERA 50 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 167 mikrograma/ml.