FrancophonIA/ELRC3.0 huggingface dataset:
English: What Removab looks like and contents of the pack Removab is presented as a clear and colourless concentrate for solution for infusion in a pre-filled syringe with a cannula.
Croatian: Removab je bistri i bezbojni koncentrat za otopinu za infuziju u napunjenoj štrcaljki s cjevčicom.
English: • polyurethane, polyurethane silicon coated catheters
Croatian: • poliuretanom, poliuretanskim kateterima obloženim silikonom Uz to, potrebno je sljedeće:
English: Catumaxomab was administered as four intraperitoneal infusions with increased doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively (see section 4.2).
Croatian: Katumaksomab je primijenjen u četiri intraperitonealne infuzije s povećanjem doza od 10, 20, 50 i 150 mikrograma na dan 0, 3, 7 i 10 (vidjeti dio 4.2).
English: 50 micrograms on day 7
Croatian: 3. doza 50 mikrograma 7. dan
English: Hepatic impairment or portal vein thrombosis / obstruction Patients with hepatic impairment of a higher severity grade than moderate and / or with more than 70% of the liver metastasised and / or portal vein thrombosis / obstruction have not been investigated.
Croatian: U ispitivanja nisu uključivani bolesnici s oštećenjem funkcije jetre većeg stupnja od umjerenog i/ili s više od 70% tkiva jetre zahvaćenog metastazama i/ili trombozom/opstrukcijom portalne vene.
English: 10 micrograms pre-filled syringe
Croatian: 10 mikrograma napunjena štrcaljka
English: Patients with renal impairment of a higher severity grade than mild have not been investigated.
Croatian: U ispitivanja nisu uključivani bolesnici s oštećenjem funkcije bubrega većim od blagog.
English: Headache, dizziness.
Croatian: Glavobolja, vrtoglavica
English: Total volume of Removab concentrate for solution for infusion
Croatian: Ukupan volumen Removab koncentrata za otopinu za infuziju
English: oedema peripheral*, general physical health deterioration*, chest pain, influenza-like illness, malaise*, catheter site erythema.
Croatian: Bol, astenija*, sindrom sistemskog upalnog odgovora*, edem uključujući periferni edem*, opće fizičko pogoršanje zdravlja*, bol u prsima, bolest slična gripi, slabost*, eritem na mjestu katetera
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister: Removab 10 micrograms
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister: Removab 10 mikrograma
English: 150 micrograms on day 10
Croatian: 4. doza 150 mikrograma 10. dan
English: 50 micrograms pre-filled syringe
Croatian: 50 mikrograma napunjena štrcaljka
English: Median puncture-free survival (days) 95% CI for median (days) p-value (log-rank test)
Croatian: Medijan preživljenja bez punkcije (dani) 95% CI za medijan (dani) p-vrijednost (log-rank test)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister: Removab 50 micrograms
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister: Removab 50 mikrograma
English: • The pre-filled syringe cannula is inserted through the 50 ml syringe opening so that the cannula is immersed in the sodium chloride 9 mg/ml (0.9%) solution for injection (Figure 2).
Croatian: • Cjevčica napunjene štrcaljke umetne se kroz otvor štrcaljke od 50 ml tako da je cjevčica uronjena u 9 mg/ml (0,9%) otopinu natrijevog klorida za injekciju (Slika 2).
English: Sodium chloride 9 mg/ml (0.9%) solution for injection
Croatian: Natrijev klorid 9 mg/ml (0,9%) otopina za injekciju
English: Respiratory, thoracic and mediastinal disorders Common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: Removab dosing schedule comprises the following four intraperitoneal infusions: 1st dose
Croatian: Četiri infuzije Removaba za intraperitonealnu primjenu doziraju se na sljedeći način: 1. doza 10 mikrograma 0. dan
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton: Removab 50 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija: Removab 50 mikrograma
English: Removab must not be administered as a bolus or by any route other than intraperitoneally.
Croatian: Removab se ne smije primjenjivati u obliku bolusa ili nekim drugim načinom primjene osim u trbušnu šupljinu.
English: gastric disorder, ileus*, gastroesophageal reflux disease, dry mouth.
Croatian: flatulencija, želučani poremećaji, ileus *, gastroezofagealna refluksna bolest,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton: Removab 10 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija: Removab 10 mikrograma
English: Hypotension*, hypertension*, flushing.
Croatian: Hipotenzija*, hipertenzija*, crvenilo uz osjećaj vrućine
English: A pivotal, two-arm, randomised, open-label, phase II/III clinical trial in 258 patients with symptomatic malignant ascites due to EpCAM-positive carcinomas of whom 170 were randomised to catumaxomab treatment.
Croatian: Pivotalno, randomizirano, otvoreno kliničko ispitivanje u fazama II/III s dvije skupine ispitanika obuhvatilo je 258 bolesnika sa simptomatskim malignim ascitesom uzrokovanim
English: 50 ml Syringe
Croatian: štrcaljka od 50 ml
English: 3rd infusion 50 micrograms
Croatian: 3. infuzija 50 mikrograma
English: Median overall survival (days) 95% CI for median (days) p-value (log-rank test) Hazard ratio (HR) (Catumaxomab versus Catumaxomab + Prednisolone) 95% CI for HR
Croatian: 95% CI za medijan (dani) p-vrijednost (log-rank test) Omjer hazarda (HR) (katumaksomab naspram katumaksomab + prednizolon) 95% CI za HR
English: • The enclosed cannula is attached to the Removab pre-filled syringe.
Croatian: • Priložena se cjevčica pričvrsti na Removab napunjenu štrcaljku.
English: Common serious side effects (may affect up to 1 in 10 people): - Loss of appetite - Dehydration - Reduction in red blood cells (anaemia) - Decreased blood levels of calcium and sodium - A very fast heart beat - High or low blood pressure - Abdominal pain accompanied by difficulty or blockage passing stools, constipation - Shortness of breath - Accumulation of fluid around the lungs which cause chest pain and breathlessness - Inflammation of the bile ducts - Skin redness, rash - Very fast heartbeat, fever, shortness of breath, feeling faint or light-headed - Complex of reactions due to the release of mediators of inflammation - Worsening of general state of health, generally feeling unwell and weak - Fluid retention - Hypersensitivity
Croatian: Česte ozbiljne nuspojave (mogu se javiti u do 1 na 10 osoba): - Gubitak apetita - Dehidracija - Smanjenje broja crvenih krvnih stanica (anemija) - Smanjene razine kalcija i natrija u krvi - Ubrzani rad srca - Visoki ili niski krvni tlak - Bolovi u trbuhu popraćeni poteškoćama ili blokadom prolaska stolice, zatvor - Nedostatak zraka
English: Very common Abdominal pain*, nausea*, vomiting*, diarrhoea*.
Croatian: Bol u trbuhu*, mučnina*, povraćanje*, proljev*
English: infusion cycle consisting of 10, 20, 50 and 150 micrograms of catumaxomab in 8 patients with malignant ascites due to carcinoma (IP-CAT-AC-04)
Croatian: U ispitivanju izvedivosti kojim je procjenjivan drugi ciklus i.p. infuzija koji se sastojao od 10, 20, 50 i 150 mikrograma katumaksomaba u 8 bolesnika s malignim ascitesom zbog karcinoma (IP-CAT-AC04) adenozin deaminaza (ADA) bila je detektibilna u svim dostupnim uzorcima ascitesa i plazme pri probiru.
English: Uncommon Gastrointestinal haemorrhage*, intestinal obstruction*.
Croatian: Manje često Gastrointestinalno krvarenje*, crijevna opstrukcija*
English: sinus tachycardia.
Croatian: Tahikardija*, uključujući sinus tahikardiju
English: Uncommon Extravasation*, application site inflammation*.
Croatian: Manje često Ekstravazacija*, upala na mjestu primjene*
English: Anaemia*, lymphopenia, leukocytosis, neutrophilia.
Croatian: Anemija*, limfopenija, leukocitoza, neutrofilija Manje često Trombocitopenija*, koagulopatija*
English: It is important to tell your doctor if you have any of the following: - undrained fluid in your abdominal cavity - cold hands and feet, light headedness, difficulty passing urine, increased heart rate, and weakness (symptoms of low blood volume) - weight gain, weakness, shortness of breath and fluid retention (symptoms of low blood protein levels) - feeling dizzy and faint (symptoms of low blood pressure) - problems with your heart and circulation - kidney or liver problems - an infection.
Croatian: Važno je da obavijestite svog liječnika ako se na Vas odnosi nešto od sljedećeg: - imate nakupljenu tekućinu u trbušnoj šupljini - imate hladne ruke ili noge, blagu ošamućenost, poteškoće s mokrenjem, ubrzani rad srca,
English: Table 2 EpCAM expression in most relevant ascites causing cancer types
Croatian: Tablica 2 Izraženost EpCAM antigena pri sijelima raka koji uzrokuju stvaranje ascitesa Retrospektivni podaci iz ispitivanja
English: Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products.
Croatian: 4.2 Doziranje i način primjene Removab se mora primjenjivati pod nadzorom liječnika s iskustvom u primjeni antineoplastičnih lijekova.
English: The catheter for intraperitoneal administration should be placed under ultrasound guidance by a physician experienced in intraperitoneal administration procedures.
Croatian: Kateter za primjenu u trbušnu šupljinu trebao bi pod kontrolom ultrazvuka uvesti liječnik s iskustvom u postupku primjene lijeka u trbušnu šupljinu.
English: Hepatic impairment
Croatian: - Osjećaj vrtoglavice
English: Ear and labyrinth disorders Common
Croatian: Manje često Konvulzije* Poremećaji uha i labirinta Često
English: Hazard ratio (HR)
Croatian: Omjer hazarda (HR) (katumaksomab naspram katumaksomab + prednizolon)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe: Removab 50 micrograms
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Napunjena štrcaljka: Removab 50 mikrograma
English: Ascites drainage
Croatian: Evakuacija ascitesa
English: One pre-filled syringe contains 50 micrograms catumaxomab in 0.5 ml solution, corresponding to 0.1 mg/ml.
Croatian: Jedna napunjena štrcaljka sadrži 50 mikrograma katumaksomaba u 0,5 ml otopine, što odgovara 0,1 mg/ml.
English: One pre-filled syringe contains 10 micrograms catumaxomab in 0.1 ml solution, corresponding to 0.1 mg/ml.
Croatian: Jedna napunjena štrcaljka sadrži 10 mikrograma katumaksomaba u 0,1 ml otopine, što odgovara 0,1 mg/ml.
English: Constipation*, dyspepsia, abdominal distension, sub-ileus*, flatulence,
Croatian: Konstipacija*, dispepsija, bolovi zbog rastezanja trbušne stijenke, subileus*,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe: Removab 10 micrograms
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Napunjena štrcaljka: Removab 10 mikrograma
English: Time to first need for therapeutic ascites puncture Median time to first need for therapeutic ascites puncture (days)
Croatian: Vrijeme do prve potrebne terapijske punkcije ascitesa
English: Number of Removab pre-filled syringe(s)
Croatian: Broj Removab napunjenih štrcaljki
English: EXP
Croatian: antigen
English: infusions in doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively, in both groups.
Croatian: Katumaksomab je primjenjen u četiri 3-satne i.p. infuzije konstantne brzine u dozama od 10, 20, 50 i 150 mikrograma na dan 0, 3, 7 i 10, kod obje skupine ispitanika.
English: Intraperitoneal use only.” must be attached to the 50 ml syringe containing the diluted Removab solution for intraperitoneal infusion.
Croatian: mora se pričvrstiti na štrcaljku od 50 ml koja sadrži razrijeđenu otopinu Removaba za primjenu u trbušnu šupljinu.
English: Removab 10 micrograms concentrate for solution for infusion catumaxomab
Croatian: Removab 10 mikrograma koncentrat za otopinu za infuziju katumaksomab
English: Removab 50 micrograms concentrate for solution for infusion catumaxomab
Croatian: Removab 50 mikrograma koncentrat za otopinu za infuziju katumaksomab
English: Am Haag 6-7
Croatian: Am Haag 6-7 82166 Graefelfing
English: Uncommon serious side effects (may affect up to 1 in 100 people): - Lumps under the skin on the back of the legs that may become sores and leave scars - Inflammation and pain or burning and stinging in the area around the catheter - Reduction in number of blood platelets, blood clotting problems - Bleeding in the stomach or gut, shown by the vomiting of blood or the passage of red or black stools - Skin reaction, severe allergic skin reaction (dermatitis) - Fits - Lung problems including blood clot in the lungs - Low blood oxygen levels - Severe kidney problems - Extravasation (inadvertent leakage of administered medicinal product from the intraperitoneal catheter system into surrounding tissue)
Croatian: - Smanjenje broja trombocita, problemi sa zgrušavanjem krvi - Krvarenje u želucu ili crijevima, koje se očituje povraćanjem krvi ili crvenom ili crnom stolicom - Kožna reakcija, teška alergijska kožna reakcija (dermatitis) - Napadaji
English: Hazard ratio (HR) (Catumaxomab versus Catumaxomab + Prednisolone) 95% CI for HR
Croatian: Omjer hazarda (HR) 95% CI za HR
English: What Removab contains - The active substance is catumaxomab (50 micrograms in 0.5 ml, corresponding to 0.1 mg/ml).
Croatian: - Djelatna tvar je katumaksomab (50 mikrograma u 0,5 ml, što odgovara 0,1 mg/ml).
English: What Removab contains - The active substance is catumaxomab (10 micrograms in 0.1 ml, corresponding to 0.1 mg/ml).
Croatian: - Djelatna tvar je katumaksomab (10 mikrograma u 0,1 ml, što odgovara 0,1 mg/ml).
English: Intraperitoneal use only, after dilution.
Croatian: Samo za primjenu u trbušnu šupljinu, nakon razrjeđivanja.
English: Posology
Croatian: Katumaksomab
English: In one patient (0.1%) dyspnoea and in 3 patients (0.4%) hypotension was reported in CTCAE grade 4 intensity.
Croatian: Dispneja u jednog bolesnika (0,1%) i hipotenzija u 3 bolesnika (0,4%) prijavljeni su s intenzitetom CTCAE stupnja 4. Simptomi boli i pireksije mogu se ublažiti ili izbjeći premedikacijom (vidjeti dio 4.2 i 4.4).
English: Patients of nonCaucasian origin have not been included in these clinical studies.
Croatian: U ova klinička ispitivanja nisu bili uključeni drugi bolesnici osim bolesnika bijele rase.
English: Precautions to be taken before administering the medicinal product Before administration of Removab the concentrate for solution for infusion is diluted in sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Prije primjene Removaba koncentrat za otopinu za infuziju potrebno je razrijediti u 9 mg/ml (0,9%) otopini natrijevog klorida za injekciju.
English: (Part of the Outer Carton)
Croatian: (Tablica 4).
English: Proteinuria.
Croatian: Gušterača
English: Common side effects (may affect up to 1 in 10 people): - Pain - Reduction or increase in number of white blood cells - Decreased blood levels of potassium - Decreased blood protein levels - Increase of bilirubin in blood - Spinning sensation - Indigestion, stomach problems, heartburn, feeling bloated, passing wind, dry mouth - Flu-like symptoms - Dizziness or headache - Chest pain - Increased sweating - Infections - Increased protein levels in urine - Back pain, aching muscles and joints - Feeling anxious and having difficulty sleeping - Itchy rash or hives - Redness of the skin in the area around the catheter - Flushing - Cough
Croatian: - Povećane razine proteina u urinu - Bol u leđima, bol u mišićima i zglobovima - Osjećaj tjeskobe i poteškoće sa spavanjem - Osip koji svrbi ili koprivnjača - Crvenilo kože u području oko katetera
English: 3 Perfusion Tubing (1 mm inner diameter, 150 cm length) 5 Perfusion Lead
Croatian: 1 250 ml natrijevog klorida 9 mg/ml (0,9%) 2 Removab otopina za i.p. infuziju 3 Perfuzijske cijevi (1 mm unutrašnji promjer, 150 cm dužina) 4 Infuzijski ventil
English: • Sodium chloride 9 mg/ml (0.9%) solution for injection
Croatian: • 9 mg/ml (0,9%) otopina natrijevog klorida za injekciju • precizna perfuzijska pumpa
English: • The tip cap from the Removab pre-filled syringe is removed with the tip pointing up.
Croatian: • Ukloni se zatvarač vrha s Removab napunjene štrcaljke pri čemu ona mora biti usmjerena vrhom prema gore.
English: Uncommon Renal failure acute*.
Croatian: Proteinurija Manje često Akutno zatajenje bubrega*
English: What Removab is and what it is used for What you need to know before you use Removab How to use Removab
Croatian: Što morate znati pije nego počnete primjenjivati Removab
English: Abdominal pain
Croatian: Sijelo antigen
English: Gastric
Croatian: prednizolon
English: Sodium citrate Citric acid monohydrate Polysorbate 80
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina hidrat polisorbat 80 voda za injekcije
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 10 micrograms of catumaxomab* in 0.1 ml solution, corresponding to 0.1 mg/ml.
Croatian: Jedna napunjena štrcaljka sadrži 10 mikrograma katumaksomaba* u 0,1 ml otopine, što odgovara 0,1 mg/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 50 micrograms of catumaxomab* in 0.5 ml solution, corresponding to 0.1 mg/ml.
Croatian: Jedna napunjena štrcaljka sadrži 50 mikrograma katumaksomaba* u 0,5 ml otopine, što odgovara 0,1 mg/ml.
English: Ovarian
Croatian: Jajnik
English: Subsequently, prior to each Removab administration 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection shall be infused to support distribution of the antibody in the abdominal cavity.
Croatian: ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju kako bi se pospješila raspodjela protutijela u trbušnoj šupljini.
English: Cancer Type
Croatian: NAZIV LIJEKA
English: NAME OF THE MEDICINAL PRODUCT Removab 50 micrograms concentrate for solution for infusion
Croatian: Removab 50 mikrograma koncentrat za otopinu za infuziju
English: NAME OF THE MEDICINAL PRODUCT Removab 10 micrograms concentrate for solution for infusion
Croatian: Removab 10 mikrograma koncentrat za otopinu za infuziju
English: National or local guidance should be taken into consideration.
Croatian: U obzir treba uzeti nacionalne ili lokalne smjernice.
English: If you miss an injection, you should have it as soon as possible.
Croatian: Ako propustite injekciju, morate je primiti što je prije moguće.
English: Do not stop taking Rocephin unless your doctor tells you to.
Croatian: Nemojte prestati primati Rocephin, osim ako Vam tako ne kaže liječnik.
English: Rocephin is usually given by a doctor or nurse.
Croatian: Rocephin obično daje liječnik ili medicinska sestra.
English: However, if it is almost time for your next injection, skip the missed injection.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću injekciju, preskočite propuštenu injekciju.
English: Talk to your doctor if you experience these symptoms.
Croatian: Obratite se svom liječniku ako primijetite bilo koji od tih simptoma.
English: The incidence appears to be lower with slow infusion (20 - 30 minutes).
Croatian: Čini se da je incidencija manja kod sporije infuzije (20-30 minuta).
English: There is no specific antidote.
Croatian: Nema specifičnog protulijeka.
English: The signs may include:
Croatian: Znakovi mogu uključivati:
English: The duration of therapy varies according to the course of the disease.
Croatian: Trajanje terapije varira ovisno o tijeku bolesti.
English: Acute otitis media
Croatian: Akutni otitis media
English: The number of days or weeks that you are given Rocephin depends on what sort of infection you have.
Croatian: Broj dana ili tjedana tijekom kojih ćete primati Rocephin ovisi o vrsti infekcije koju imate.
English: Package leaflet: Information for the Patient
Croatian: Uputa o lijeku: Informacija za bolesnika
English: Treatment of overdose should be symptomatic.
Croatian: Liječenje predoziranja treba biti simptomatsko.
English: Do not take a double dose (two injections at the same time) to make up for a missed dose.
Croatian: Nemojte primiti dvostruku dozu (dvije injekcije odjednom) kako biste nadoknadili propuštenu dozu.
English: Patients should be cautious when driving or operating machinery.
Croatian: Bolesnici moraju biti oprezni kada upravljaju vozilom ili rade sa strojevima.
English: You may be given a different dose to the usual dose.
Croatian: Možda ćete primiti dozu drugačiju od uobičajene.
English: In older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.
Croatian: U starijih osoba u dobi iznad 75 godina prosječan poluvijek eliminacije obično je dvostruko ili trostruko dulji nego u mladih odraslih osoba.
English: • Blood or sugar in your urine.
Croatian: • krv ili šećer u mokraći
English: If you feel dizzy, do not drive or use any tools or machines.
Croatian: Ako osjetite omaglicu, nemojte voziti niti rukovati alatima i strojevima.
English: The risk of precipitate formation is increased in immobilized or dehydrated patients.
Croatian: Rizik od nastanka precipitata povećan je u imobiliziranih ili dehidriranih bolesnika.
English: The doses recommended in the tables below are the generally recommended doses in these indications.
Croatian: Doze preporučene u sljedećim tablicama su doze koje se općenito preporučuju u navedenim indikacijama.
English: The possibility of sensitisation should be taken into account.
Croatian: U obzir treba uzeti i mogućnost senzitizacije.
English: During childhood, the half-life is lower than in neonates or adults.
Croatian: U djetinjstvu je poluvijek kraći nego u novorođenčadi ili odraslih.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji lijeka prije primjene, vidjeti dio 6.6.
English: If you need a blood or urine test
Croatian: Ako morate obaviti pretrage krvi ili mokraće
English: Your doctor will decide the correct dose of Rocephin for you.
Croatian: Liječnik će odrediti točnu dozu lijeka Rocephin za Vas.
English: • The baby is premature.
Croatian: • ako je rođeno prerano
English: Penetration is greatest when the meninges are inflamed.
Croatian: Penetracija je najveća kada su moždane ovojnice upaljene.
English: Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:
Croatian: Rezistencija bakterija na ceftriakson može biti posljedica jednoga ili više sljedećih mehanizama:
English: Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Croatian: Treba uzeti u obzir službene preporuke o primjerenoj uporabi antibiotika.
English: If you are given Rocephin for a long time, you may need to have regular blood tests.
Croatian: Ako dugotrajno primate Rocephin, možda ćete redovito morati obavljati krvne pretrage.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Croatian: Budući da je te nuspojave dobrovoljno prijavila populacija neodređene veličine, nije moguće pouzdano odrediti njihovu učestalost, pa ih se stoga svrstava u kategoriju 'nepoznato'.
English: Newborn babies (0-14 days)
Croatian: Novorođenčad (0-14 dana)
English: • Rocephin may interfere with some types of blood glucose tests - please check with your doctor.
Croatian: • Rocephin može utjecati na neke vrste testova za utvrđivanje šećera u krvi - molimo provjerite sa svojim liječnikom.
English: Caution should be particularly considered in the paediatric population.
Croatian: Osobit oprez potreban je u pedijatrijskoj populaciji.
English: If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.
Croatian: Ako slučajno primite dozu veću od propisane, obratite se svom liječniku ili se odmah javite u najbližu bolnicu.
English: It works by killing bacteria that cause infections.
Croatian: Djeluje tako da uništava bakterije koje uzrokuju infekcije.
English: Inherently resistant organisms
Croatian: Inherentno rezistentni organizmi
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Osobito je važno da kažete liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova: