FrancophonIA/ELRC3.0 huggingface dataset:
English: • 1 vial containing the solvent (the clear liquid)
Croatian: • 1 bočicu koja sadrži otapalo (bistra tekućina)
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in a pre-filled pen Follitropin alfa
Croatian: GONAL-f 450 IU/0,75 ml (33 mikrograma/0,75 ml) otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: This side effect is common (may affect up to 1 in 10 people).
Croatian: Ta je nuspojava česta (mogu se javiti u manje od 1 na 10 osoba).
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of GONAL-f and lutropin alfa.
Croatian: • Kada se postigne odgovarajući odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili od 5000 IU do 10 000 IU hCG 24 do 48 sati nakon posljednje injekcije lijeka GONAL-f i lutropina alfa.
English: • Abdominal pain • Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
Croatian: • Bol u abdomenu • Mučnina, povraćanje, proljev, grčevi u trbuhu i nadutost
English: If you do not see a tiny drop(s) of fluid at or near the tip the first time you use a new pen: 1.
Croatian: Ako ne ugledate kapljicu (kapljice) tekućine na vrhu ili blizu vrha igle kad prvi put koristite napunjenu brizgalicu: 1. Pažljivo okrenite gumb za podešavanje doze u smjeru kazaljke na satu sve dok se na prozorčiću za prikaz doze ne pojavi 25.
English: if"0", injection complete if not "0", need second injection Inject this amount ..........using new pen
Croatian: ako "0", injekcija je potpuna ako nije"0",potrebna je druga injekcija Ubrizgajte ovu količinu.......... pomoću nove brizgalice
English: Subcutaneous use.
Croatian: Spontani pobačaj
English: Contains: One pre-filled syringe of solvent contains: 0.75 mL water for injections, benzyl alcohol
Croatian: Sadrži: Svaka napunjena štrcaljka otapala sadrži: 0,75 ml vode za injekciju, benzilni alkohol 0,9%.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/032 1 vial of powder for solution for injection.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/032 1 bočica s praškom za otopinu za injekciju.
English: 20 injection needles
Croatian: 1 višedozna napunjena brizgalica 20 igala za injekciju
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/033 solution for injection in pre-filled pen.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/033 otopina za injekciju u napunjenoj brizgalici.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 900 IU/1,5 ml (66 μg/1,5 ml) otopina za injekciju u napunjenoj brizgalici. folitropin alfa s.c.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Discard any unused solution.
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/021 1 vial of powder for solution for injection.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/021 1 bočica s praškom za otopinu za injekciju.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/033
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/033
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/034 solution for injection in pre-filled pen.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/034 otopina za injekciju u napunjenoj brizgalici.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL/vial
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 ml/bočica
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/034
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/034
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/005 1 vial of powder for solution for injection.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/005 1 bočica s praškom za otopinu za injekciju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/035 solution for injection in pre-filled pen.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/035 otopina za injekciju u napunjenoj brizgalici.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/031
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/031
English: Do not use this medicine after the expiry date which is stated on the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici iza oznake
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last GONAL-f injection.
Croatian: • Kada se postigne odgovarajući odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG“ (r-hCG, hCG dobiven u laboratoriju posebnom DNA tehnikom) ili od 5000 IU do 10 000 IU hCG 24 do 48 sati nakon posljednje injekcije lijeka GONAL-f.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 450 IU/0,75 ml (33 μg/0,75 ml) otopina za injekciju u napunjenoj brizgalici. folitropin alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/031 1 vial of powder for solution for injection.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/031 1 bočica s praškom za otopinu za injekciju.
English: Tap the reservoir holder gently.
Croatian: Tapkajte držač spremnika lagano prstom.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/035
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/001/035
English: Powder
Croatian: ŠTRCALJKI
English: • The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Croatian: • Drugi sastojci su: saharoza, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GONAL-f 300 IU/0,5 ml (22 μg/0,5 ml) otopina za injekciju u napunjenoj brizgalici. folitropin alfa.
English: 1 vial of powder for solution for injection.
Croatian: 1 bočica s praškom za otopinu za injekciju.
English: • Recap the pen.
Croatian: • Vratite zatvarač na brizgalicu.
English: Storing the GONAL-f pre-filled pen.
Croatian: 7.4. Čuvanje napunjene brizgalice lijeka GONAL-f OPREZ:
English: • GONAL-f is supplied in packs of 1 vial of powder with 1 pre-filled syringe of solvent and
Croatian: • GONAL-f je dostupan u pakiranju od 1 bočice s praškom s 1 napunjenom štrcaljkom s otapalom i 4 štrcaljke za jednokratnu uporabu za primjenu lijeka graduiranih u internacionalnim jedinicama (IU FSH)
English: Plunger piston
Croatian: Zatvarač brizgalice
English: Look closely at the tip of the needle for tiny drop(s) of fluid
Croatian: Pažljivo pogledajte vidi li se kapljica (kapljice) tekućine na vršku igle
English: Talk to your doctor immediately,
Croatian: Odmah se obratite svom liječniku
English: • You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have treatment for cancer, then there is still a chance you could become pregnant).
Croatian: • u postmenopauzi ste tj.imate najmanje 50 godina i Vaša zadnja menstruacija je bila prije više od jedne godine (ako su vaše menstruacije prestale zato što ste se liječili od karcinoma, tada još uvijek postoji šansa da možete ostati trudni).
English: EU/1/07/439/003 (50 tablets) EU/1/07/439/004 (150 tablets) EU/1/07/439/005 (50 x 1 tablets)
Croatian: EU/1/07/439/003 (50 tableta) EU/1/07/439/004 (150 tableta) EU/1/07/439/005 (50 x 1 tableta)
English: EU/1/07/439/001 (100 capsules) EU/1/07/439/002 (300 capsules) EU/1/07/439/006 (100 x 1 capsules)
Croatian: EU/1/07/439/001 (100 kapsula) EU/1/07/439/002 (300 kapsula) EU/1/07/439/006 (100 x 1 kapsula)
English: • if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na mofetilmikofenolat, mikofenolnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Patients taking Mycophenolate mofetil Teva should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Croatian: Kod bolesnika koji uzimaju Mikofenolat mofetil Teva trebalo bi raditi kompletnu krvnu sliku jedanput tjedno tijekom prvog mjeseca, dva puta mjesečno tijekom drugog i trećeg mjeseca liječenja, a zatim jedanput mjesečno tijekom prve godine.
English: It is recommended, however, to administer Mycophenolate mofetil Teva at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Croatian: Preporučuje se, međutim, primjena Mikofenolat mofetila Teva barem jedan sat prije odnosno tri sata nakon uzimanja sevelamera da bi se umanjio utjecaj na apsorpciju MPA.
English: • For 6°weeks after you stop taking Mycophenolate mofetil Teva.
Croatian: • razdoblje od 6 tjedana nakon što prestanete uzimati Mikofenolat mofetil Teva.
English: If neutropenia develops (absolute neutrophil count <°1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
Croatian: Ako se pojavi neutropenija (apsolutni broj neutrofila < 1,3 x 103/µl), možda će biti primjereno privremeno ili potpuno prekinuti primjenu Mikofenolat mofetila Teva.
English: Medicinal products that interfere with enterohepatic circulation (e.g. cholestyramine, ciclosporin A, antibiotics)
Croatian: Lijekovi koji se uključuju u enterohepatičnu cirkulaciju (npr. kolestiramin, ciklosporin A, antibiotici)
English: What Mycophenolate mofetil Teva is and what it is used for
Croatian: Što je Mikofenolat mofetil Teva i za što se koristi
English: • proliferation of the lymphatic tissue, including malignant tumours
Croatian: • pojačano stvaranje limfnog tkiva, uključujući zloćudne tumore
English: The MAH shall ensure that in each MS where Mycophenolate mofetil Teva is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Mycophenolate mofetil Teva are provided with the following educational package:
Croatian: Nositelj odobrenja pobrinut će se da u svim državama članicama u kojima se Mikofenolat mofetil Teva nalazi na tržištu, svi zdravstveni radnici i bolesnici za koje se očekuje da će propisivati, izdavati ili primjenjivati Mikofenolat mofetil Teva dobiju sljedeći paket edukacijskih materijala:
English: • low/high blood pressure, widening of blood vessels
Croatian: • nizak/visoki krvni tlak, proširenje krvnih žila
English: The usual way to take Mycophenolate mofetil Teva is as follows:
Croatian: Uobičajeni način uzimanja Mikofenolat mofetila Teva je sljedeći:
English: It is recommended to monitor MPA exposure levels and to adjust Mycophenolate mofetil Teva doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Croatian: Preporučuje se praćenje razina izloženosti MPA-u i prilagođavanje doze Mikofenolat mofetila Teva prema njima radi zadržavanja kliničke djelotvornosti pri istodobnoj primjeni rifampicina.
English: Mycophenolate mofetil Teva is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Croatian: Mikofenolat mofetil Teva je inhibitor inozin monofosfat dehidrogenaze (IMPDH).
English: Contents of the pack and other information What Mycophenolate mofetil Teva contains
Croatian: Sadržaj pakiranja i druge informacije Što Mikofenolat mofetil Teva sadrži
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner`s syndrome or uterine agenesis.
Croatian: • rođeni ste s jednim od sljedećih rijetkih urođenih stanja koja onemogućuju trudnoću: XY genotip,
English: Pregnancy, contraception and breast-feeding Contraception in women taking Mycophenolate mofetil Teva
Croatian: Trudnoća, kontracepcija i dojenje Kontracepcija u žena koje uzimaju Mikofenolat mofetil Teva
English: • high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate in the blood
Croatian: • previsoka kiselost tijela • visoka razina kalija u krvi, niska razina kalija, magnezija, kalcija i/ili fosfata u krvi
English: Patients receiving Mycophenolate mofetil Teva should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Croatian: Bolesnike koji primaju Mikofenolat mofetil Teva potrebno je uputiti da odmah prijave bilo koji znak infekcije, neočekivanu pojavu modrica, krvarenje ili bilo koju drugu manifestaciju depresije koštane srži.
English: If you take more Mycophenolate mofetil Teva than you should
Croatian: Ako uzmete više Mikofenolat mofetila Teva nego što ste trebali
English: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Croatian: Ozbiljne po život opasne infekcije, uključujući meningitis, endokarditis, tuberkulozu i atipičnu mikobakterijsku infekciju.
English: If you are a woman who could become pregnant you must use an effective method of contraception with Mycophenolate mofetil Teva.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, uz Mikofenolat mofetil Teva morate koristiti učinkovitu metodu kontracepcije.
English: Mycophenolate mofetil Teva should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Croatian: Mikofenolat mofetil Teva se nesmije koristiti u djece i adolescenata (od 2 do 18 godina) s presađenim srcem ili jetrom.
English: How to store Mycophenolate mofetil Teva Contents of the pack and other information
Croatian: Kako čuvati Mikofenolat mofetil Teva Sadržaj pakiranja i druge informacije
English: Before starting Mycophenolate mofetil Teva treatment, women of childbearing potential must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Croatian: Prije početka liječenja lijekom Mikofenolat mofetil Teva, žene reproduktivne dobi moraju imati dva negativna nalaza testova na trudnoću provedenih na uzorku seruma ili mokraće, čija je osjetljivost najmanje 25 mIU/ml, kako bi se isključila mogućnost nehotičnog izlaganja embrija mikofenolatu.
English: The educational materials should be implemented within four months after completion of this procedure and shall contain the following key elements:
Croatian: Edukacijske materijale potrebno je implementirati unutar četiri mjeseca nakon završetka ovog postupka, a moraju sadržavati sljedeće ključne elemente: Treba izraditi zasebne vodiče za zdravstvene radnike i bolesnike.
English: However, keep taking Mycophenolate mofetil Teva until you see him or her.
Croatian: Međutim, nastavite uzimati Mikofenolat mofetil Teva sve dok ga ne posjetite.
English: • Malformations of the fingers (e.g. polydactyly, syndactyly);
Croatian: • malformacije prstiju (npr. polidaktilija, sindaktilija);
English: What Mycophenolate mofetil Teva is and what it is used for What you need to know before you take Mycophenolate mofetil Teva How to take Mycophenolate mofetil Teva Possible side effects
Croatian: Što je Mikofenolat mofetil Teva i za što se koristi Što morate znati prije nego počnete uzimati Mikofenolat mofetil Teva Kako uzimati Mikofenolat mofetil Teva
English: Mycophenolate mofetil Teva should not be used at all in children under 2 years old.
Croatian: Mikofenolat mofetil Teva se nesmije koristiti u djece ispod 2 godine.
English: The Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Nositelj odobrenja mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskog programa i upitnika za praćenje trudnoće, uključujući medije komunikacije,
English: • if you are planning to become pregnant, or if you get pregnant while taking Mycophenolate mofetil
Croatian: - ako planirate trudnoću ili ako zatrudnite tijekom uzimanja Mikofenolat mofetila Teva.
English: Mycophenolate mofetil Teva reduces your body's defence mechanism.
Croatian: Mikofenolat mofetil Teva oslabljuje obrambeni mehanizam Vašeg tijela.
English: Therefore you should limit your exposure to sunlight and ultraviolet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Croatian: Zato prilikom izlaganja sunčevu svjetlu i ultraljubičastim (UV) zrakama nosite odgovarajuću zaštitnu odjeću i upotrebljavajte kremu za zaštitu od Sunca s visokim zaštitnim faktorom.
English: Mycophenolate mofetil Teva is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Croatian: Mikofenolat mofetil Teva se koristi u djece i adolescenata (od 2 do 18 godina) radi sprječavanje tijela da odbaci presađeni bubreg.
English: As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90°days after you stop taking Mycophenolate mofetil Teva.
Croatian: Vi ili Vaša partnerica koristite pouzdanu kontracepciju tijekom liječenja i još 90 dana nakon što prestanete uzimati Mikofenolat mofetil Teva.
English: • feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling anxious, abnormal thinking, difficulty in sleeping
Croatian: • osjećaj nemira, abnormalne misli, percepcija i razine svijesti, depresija, osjećaj tjeskobe, abnormalno razmišljanje, teškoće sa spavanjem
English: Mycophenolate mofetil Teva should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Croatian: Mikofenolat mofetil Teva ne smije se davati bolesnicima s preosjetljivošću na mofetilmikofenolat, mikofenolnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Croatian: Takve infekcije uključuju reaktivaciju latentnih virusa, poput reaktivacije hepatitisa B ili hepatitisa C i infekcije uzrokovane polioma virusima (nefropatija povezana s BK virusom i progresivna multifokalna leukoencefalopatija (PML) povezana s JC virusom).
English: Stopping your treatment with Mycophenolate mofetil Teva may increase the chance of rejection of your transplanted organ.
Croatian: Prekid liječenja Mikofenolat mofetilom Teva može povećati mogućnost da tijelo odbaci presađeni organ.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Talk to your doctor or pharmacist before taking Mycophenolate mofetil Teva.
Croatian: razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Mikofenolat mofetil Teva.
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive Mycophenolate mofetil Teva.
Croatian: Te promjene kod krvnih pretraga mogu predstavljati „pomak u lijevo“ zrelosti neutrofila koji se, kod imunosuprimiranih bolesnika poput onih koji primaju Mikofenolat mofetil Teva, može pogrešno interpretirati kao znak infekcije.
English: Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Croatian: Blijedoljubičasta, ovalna, filmom obložena tableta s utisnutom oznakom "M500" na jednoj strani i bez oznake na drugoj strani.
English: Other adverse reactions:
Croatian: Druge nuspojave:
English: Patients should be advised that during treatment with Mycophenolate mofetil Teva, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Croatian: Bolesnike treba upozoriti da će tijekom liječenja Mikofenolat mofetilom Teva cijepljenje možda biti manje djelotvorno te da treba izbjegavati primjenu živog atenuiranog cjepiva (vidjeti dio 4.5).
English: Treatment with Mycophenolate mofetil Teva should be initiated and maintained by appropriately qualified transplant specialists.
Croatian: Liječenje Mikofenolat mofetilom Teva trebaju započeti i voditi liječnici specijalisti odgovarajuće kvalificirani u području transplantacijske medicine.
English: What you need to know before you take Mycophenolate mofetil Teva
Croatian: Što morate znati prije nego počnete uzimati Mikofenolat mofetil Teva
English: Hypersensitivity reactions to Mycophenolate mofetil Teva have been observed (see section 4.8).
Croatian: Primijećene su reakcije preosjetljivosti na Mikofenolat mofetil Teva (vidjeti dio 4.8).
English: If neutropenia develops, dosing with Mycophenolate mofetil Teva should be interrupted or the dose reduced (see section 4.4).
Croatian: Ako se pojavi neutropenija, treba prekinuti primjenu Mikofenolat mofetila Teva ili smanjiti dozu (vidjeti dio 4.4).
English: Do not stop taking Mycophenolate mofetil Teva because you feel better.
Croatian: Nemojte prestati uzimati Mikofenolat mofetil Teva čak i ako se osjećate bolje.
English: Medicinal product subject to restricted medical prescription.
Croatian: Lijek se izdaje na ograničeni recept
English: Other medicines and Mycophenolate mofetil Teva
Croatian: Drugi lijekovi i Mikofenolat mofetil Teva
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte (mogu javiti u manje od 1 na 100 osoba)
English: It will explain that although this guide is very important it does not provide full information on mycophenolate mofetil and that the SmPC (healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read carefully.
Croatian: Objasnit će se i da taj vodič, iako je vrlo važan, ne sadrži sve informacije o mofetilmikofenolatu i da se stoga mora pažljivo pročitati i
English: Mycophenolate mofetil Teva is a medicine that is used to suppress immune activity.
Croatian: Mikofenolat mofetil Teva je lijek za suprimiranje imunološke aktivnosti.
English: What Mycophenolate mofetil Teva looks like and contents of the pack
Croatian: Kako Mikofenolat mofetil Teva izgleda i sadržaj pakiranja
English: Patients receiving Mycophenolate mofetil Teva should be monitored for neutropenia, which may be related to Mycophenolate mofetil Teva itself, concomitant medicinal products, viral infections, or some combination of these causes.
Croatian: Bolesnike koji primaju Mikofenolat mofetil Teva treba pažljivo nadzirati kako bi se opazili znakovi neutropenije, koju može izazvati sam Mikofenolat mofetil Teva, lijekovi koji se istodobno primjenjuju, virusne infekcije ili kombinacija tih uzroka.
English: Mean plasma MPAG AUC (0-12°h) was 2-3-fold higher than in post-transplant patients without delayed graft function.
Croatian: Srednji AUC (0-12 h) MPAG-a u plazmi bio je 2-3 puta veći nego kod bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presatka.