natgillin/translations-raw huggingface dataset:
Prefilled syringes 30, 50, 75 micrograms are available in pack size of 1 or 3 pre-filled syringe(s).
Napunjene štrcaljke od 30, 50 i 75 mikrograma dostupne su u veličini pakiranja od 1 ili 3 napunjene štrcaljke.
Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap (bromobutyl rubber) and a needle 27G1/2.
Napunjena štrcaljka (staklo tipa I) s laminiranim čepom klipa (brombutil guma) i zatvaračem vrha (brombutil guma) te jedna igla 27G1/2.
In case PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
Ako se dijagnosticira PRCA, terapija lijekom MIRCERA mora se prekinuti, a bolesnike se ne smije prebaciti na liječenje nekim drugim LSE.
Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
Liječnik će Vas redovito slati na krvne pretrage kako bi uz pomoć izmjerenih vrijednosti razine hemoglobina pratio kako se Vaša anemija odgovara na liječenje.
Remove the needle shield and prepare for injection
Korak 5. Skinite zaštitni pokrov igle i pripremite se za injekciju
If you are advised to inject MIRCERA under your skin, please administer your dose as described below.
Ako Vam je zdravstveni radnik savjetovao da lijek MIRCERA injicirate pod kožu, molimo primijenite dozu na način opisan u nastavku.
You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room temperature not above 30 °C for a single period of one month.
MIRCERA napunjenu štrcaljku možete izvaditi iz hladnjaka i čuvati je na sobnoj temperaturi do 30°C u trajanju do mjesec dana.
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
U ispitivanju jednokratne doze, farmakokinetika metoksi polietilenglikol-epoetina beta nakon intravenske primjene bila je slična u bolesnika s teškim oštećenjem funkcije jetre i u zdravih ispitanika (vidjeti dio 4.2).
If you forget to use MIRCERA
Ako ste zaboravili primiti lijek MIRCERA
Perform the injection
Korak 6. Primijenite injekciju
To remove air bubbles from the prefilled syringe, hold the syringe with the needle pointing up.
Da biste uklonili mjehuriće zraka iz napunjene štrcaljke, držite štrcaljku iglom okrenutom prema gore.
Pulmonary embolism*
rijetko plućna embolija*
Package leaflet: Information for the user
Uputa o lijeku: Informacije za korisnika MIRCERA
Previous weekly epoetin intravenous or subcutaneous dose (IU/week)
Prethodna tjedna doza epoetina intravenski ili supkutano (i.j./tjedan)
· Do not remove the needle shield that protects the needle.
• Nemojte skinuti pokrov za iglu koji štiti iglu.
It did not induce a proliferative response in non-haematological tumor cell lines in vitro.
Lijek in vitro nije poticao proliferaciju staničnih linija nehematoloških tumora.
One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk.
Jedno ispitivanje na životinjama pokazalo je da se metoksi polietilenglikol-epoetin beta izlučuje u mlijeko ženki.
In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see section 4.2 and 5.1).
U bolesnika sa slabim hemoglobinskim odgovorom na epoetine potrebno je razmotriti druga moguća objašnjenja slabog odgovora (vidjeti dijelove 4.2 i 5.1).
Break the seal of the needle, using a twisting motion, and remove the needle cap as pictured.
Prelomite spoj igle kružnim pokretom i uklonite zatvarač igle kako je prikazano na slici.
The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
Prvu injekciju treba primijeniti u planiranom terminu sljedeće doze darbepoetina alfa ili epoetina.
Patients with hepatic impairment
Bolesnici s oštećenom funkcijom jetre
You will not receive another ESA and your doctor will treat you for this condition.
Nećete dobivati drugi lijek za stimulaciju eritropoeze, a liječnik će Vam propisati terapiju za ovo stanje.
Do not use MIRCERA
Nemojte primati lijek MIRCERA
STORAGE Keep the syringe and the puncture-resistant/ sharps container out of the reach of children.
Čuvajte štrcaljku i neprobojan spremnik/spremnik za oštre predmete izvan dohvata djece.
Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.
U usporedbi s eritropoetinom, pokazuje različitu aktivnost na razini receptora koju karakterizira sporija asocijacija i brža disocijacija s receptora, smanjena specifična aktivnost in vitro i povećana aktivnost in vivo te dulji poluvijek.
MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2.
MIRCERA je dostupna u napunjenim štrcaljkama s laminiranim čepom klipa i zatvaračem vrha te s jednom iglom 27G1/2.
· Never pull on or handle the syringe by its plunger.
• Nikada nemojte štrcaljku vući za klip niti rukovati njome držeći je za klip.
Before treatment with MIRCERA
Prije liječenja lijekom MIRCERA
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Fluktuaciju hemoglobina treba rješavati korekcijom doze, uzimajući u obzir da je ciljni raspon hemoglobina od 10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l).
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous or intravenous use Read the package leaflet before use Do not shake
NAČIN I PUT(EVI) PRIMJENE LIJEKA Za supkutanu ili intravensku primjenu Prije uporabe pročitajte uputu o lijeku Ne tresti
In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group.
U ispitivanju sigurnosti nakon dobivanja odobrenja, u kojem se ispitivala sigurnost lijeka kod dugoročne izloženosti (do 8,4 godine), početni broj trombocita niži od 100 x 109/l bio je prisutan u 2,1% bolesnika u skupini liječenoj lijekom MIRCERA i u 2,4% bolesnika u skupini koja je primala druge lijekove za stimulaciju eritropoeze.
The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
Farmakokinetika metoksi polietilenglikol-epoetina beta je ispitivana u zdravih dobrovoljnih ispitanika te anemičnih bolesnika s kroničnom bolesti bubrega na dijalizi i onih koji nisu na dijalizi.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Preživljenje i napredovanje tumora ispitivani su u pet velikih kontroliranih studija koje su uključivale ukupno 2833 bolesnika.
The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours.
Poluvrijeme eliminacije metoksi polietilenglikol-epoetina beta nakon intravenske primjene iznosi 134 sata.
Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Nakon supkutane primjene u bolesnika s kroničnom bolesti bubrega na dijalizi, maksimalne koncentracije metoksi polietilenglikol-epoetina beta u serumu opažene su 72 sata (medijan vrijednosti) nakon primjene.
Caution should be exercised with escalation of MIRCERA doses in patients with chronic renal failure.
Potreban je oprez prilikom povećanja doza lijeka MIRCERA u bolesnika s kroničnim zatajenjem bubrega.
Keep the pre-filled syringe in the outer carton in order to protect from light
Napunjenu štrcaljku čuvajte u vanjskom pakiranju radi zaštite od svjetlosti
Prefilled syringes 40, 60, 100, 120, 150, 200, 250 and 360 micrograms are available in pack size of 1 pre-filled syringe.
Napunjene štrcaljke od 40, 60, 100, 120, 150, 200, 250 i 360 mikrograma dostupne su u veličini pakiranja od 1 napunjene štrcaljke.
• hot flush
• naleti vrućine
Misuse of MIRCERA by healthy people may lead to an excessive increase in haemoglobin.
Zlouporaba lijeka MIRCERA u zdravih osoba može dovesti do prekomjernog povećanja razine hemoglobina što može uzrokovati po život opasne kardiovaskularne komplikacije.
MIRCERA should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.45 mmol/l).
Lijek MIRCERA treba davati supkutano ili intravenski da bi se razina hemoglobina povećala na razinu koja nije viša od 12 g/dl (7,45 mmol/l).
As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting (see section 4.4).
Kao i kod ostalih LSE, nakon puštanja lijeka u promet zabilježeni su slučajevi tromboze, uključujući plućnu emboliju (vidjeti dio 4.4).
· Do not inject areas that could be irritated by a belt or waistband.
• Nemojte injicirati lijek na područja koja bi mogao nadražiti remen ili elastični pojas.
In patients with a poor haemoglobin response to MIRCERA, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
U bolesnika sa slabim hemoglobinskim odgovorom na lijek MIRCERA potrebno je razmotriti druga moguća objašnjenja slabog odgovora (vidjeti dijelove 4.4 i 5.1).
Roche Pharma AG Emil-Barrell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil-Barrell-Strasse 1 D-79639 Grenzach-Wyhlen Njemačka
One pre-filled syringe contains: 30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 ml and 360 micrograms in 0.6 ml.
Jedna napunjena štrcaljka sadrži 30, 40, 50, 60, 75, 100, 120, 150, 200 ili 250 mikrograma u 0,3 ml otopine i 360 mikrograma u 0,6 ml otopine.
Each pre-filled syringe contains 0.3 ml or 0.6 ml.
Jedna napunjena štrcaljka sadrži 0,3 ml ili 0,6 ml otopine.
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with all ESAs, including MIRCERA.
Izolirana aplazija crvene krvne loze prouzročena antieritropoetinskim antitijelima zabilježena je uz sve LSE, uključujući lijek MIRCERA.
Hypersensitivity reactions, including cases of anaphylactic reaction and serious skin rashes including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in association with epoetin treatement.
Prijavljivane su reakcije preosjetljivosti, uključujući slučajeve anafilaktičke reakcije i ozbiljne kožne osipe, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezani s liječenjem epoetinom.
Fully insert the needle into the skin in a quick, “dart-like” motion.
Ubodite iglu do kraja u kožu brzim pokretom, poput strelice.
Stop using Mircera if you develop these symptoms and contact your doctor or seek medical attention immediately, see also section 2.
Prestanite primjenjivati lijek Mircera u slučaju nastanka tih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
Allow the pre-filled syringe to reach room temperature before injecting.
Prije injiciranja pričekajte da napunjena štrcaljka poprimi sobnu temperaturu.
The solution is clear, colourless to slightly yellowish and free of visible particles.
Otopina je bistra, bezbojna do blago žućkasta i bez vidljivih čestica.
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous or intravenous use Read the package leaflet before use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Za supkutanu ili intravensku primjenu Prije uporabe pročitajte uputu o lijeku
Pre-filled syringe 360 micrograms contains 0.6 ml solution.
Napunjena štrcaljka od 360 mikrograma koja sadrži 0,6 ml otopine.
Follow the recommendations of your healthcare professional about how you should inject MIRCERA.
Slijedite preporuke koje Vam je za injiciranje lijeka MIRCERA dao zdravstveni radnik.
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
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
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).
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).
During treatment with MIRCERA
Tijekom liječenja lijekom MIRCERA
No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
U bolesnika s oštećenom funkcijom jetre nije potrebno prilagođavati početnu dozu niti mijenjati smjernice za prilagodbu doze (vidjeti dio 5.2).
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.'
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.
• 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.
Ako niste na dijalizi preporučena početna doza lijeka MIRCERA iznosi 1,2 mikrograma po kilogramu tjelesne težine, primijenjeno jednom injekcijom pod kožu jedanput mjesečno.
Insert the needle of the pre-filled syringe into the cleaned venous port.
Uvedite iglu napunjene štrcaljke u očišćeni otvor za injekciju na venskoj liniji.
Attach the needle to the syringe by pushing it firmly onto the syringe.
Pričvrstite iglu na štrcaljku čvrsto je pritišćući na štrcaljku.
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%.
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%.
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.
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.
Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 micrograms contain 0.3 ml solution.
Napunjene štrcaljke od 30, 40, 50, 60, 75, 100, 120, 150, 200 i 250 mikrograma koje sadrže 0,3 ml otopine.
You may inject MIRCERA into the upper arm, thigh or abdomen, except around the navel (belly button).
Lijek MIRCERA možete injicirati u nadlakticu, bedro ili trbuh, osim područja oko pupka.
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
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
Table 2: Adverse reactions attributed to the treatment with MIRCERA in CKD patients .
Tablica 2: Nuspojave pripisane liječenju lijekom MIRCERA zabilježene u bolesnika s kroničnom bolesti bubrega.
A slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
U sklopu kliničkih ispitivanja uočen je neznatan pad broja trombocita, koji je ostao unutar granica normale.
Intravenous route:
Primjena u venu:
· Do not try to replace the shield on the needle.
• Nemojte pokušati zamijeniti zaštitni pokrov na igli.
(b) Tabulated list of adverse reactions
(b) Tablični prikaz nuspojava
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.
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.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava manje često trombocitopenija*
It can be injected subcutaneously in the abdomen, arm or thigh.
Može se dati supkutano u trbuh, nadlakticu ili bedro.
A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Subcutaneous route:
Potkožna primjena:
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%.
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%.
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.
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.
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.
Ako se razina hemoglobina nastavi povećavati, terapiju treba prekinuti dok se razina hemoglobina ne počne smanjivati.
Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Prijavljene su ozbiljne kožne reakcije, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezane s liječenjem epoetinom.
Wipe off the venous port of the hemodialysis as instructed by your healthcare provider
Obrišite otvor za injekciju na venskoj liniji za hemodijalizu sukladno uputama zdravstvenog radnika.
Dispose of the syringe
Bacite štrcaljku
MIRCERA has no or negligible influence on the ability to drive and use machines.
MIRCERA ne utječe na sposobnost upravljanja vozilima i rada sa strojevima ili je taj utjecaj zanemariv.
• 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.
• 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.
Throw away used syringes in a puncture-resistant container.
Upotrijebljene štrcaljke bacite u neprobojni spremnik.
During clinical studies patients had a slight decrease in their platelet blood counts.
Tijekom kliničkih ispitivanja u bolesnika je primijećen blagi pad broja trombocita.
Slovenská republika Roche Slovensko, s.r.o.
Česká republika Roche s. r. o.
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne komplikacije manje često tromboza krvožilnog pristupa
· Do not warm up the syringe in any other way.
• Štrcaljku ne smijete grijati ni na
Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Smiju se primijeniti samo bistre, bezbojne do žućkaste otopine koje ne sadrže vidljive čestice.
If you have developed PRCA, your MIRCERA treatment will be discontinued.
Ako se u Vas razvila izolirana aplazija crvene krvne loze, liječenje lijekom MIRCERA će se prekinuti.
Grasp the syringe and the rubber tip cap firmly and remove the rubber tip cap from the syringe (bend and pull).
Čvrsto uhvatite štrcaljku i gumeni zatvarač vrha te skinite gumeni zatvarač vrha sa štrcaljke (savinite i povucite).
Tap the syringe gently to bring any bubbles to the top.
Lagano prstom kucnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
Remove the pre-filled syringe from the venous port WITHOUT releasing the plunger.
Izvadite napunjenu štrcaljku iz otvora za injekciju na venskoj liniji, ali pritom NE otpuštajte klip.
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Emil-Barell-Strasse 1
How to use MIRCERA
Kako primjenjivati lijek MIRCERA
The solution is clear and colourless to slightly yellowish.
Otopina je bistra i bezbojna do blago žućkasta.