FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol and/or corticosteroids) and a reduction of the infusion rate to 50% - 25% of the rate at which the previous reaction occurred.
Croatian: U slučaju opetovane umjerene reakcije na infuziju ili ponovnog pokretanja nakon teške jednokratne reakcije na infuziju, premedikacija se mora uzeti u obzir (antihistaminici i paracetamol i/ili kortikosteroidi) te smanjenje brzine infuzije na 50% - 25% brzine pri kojoj je došlo do prethodne reakcije.
English: Following 24 weeks of therapy, Naglazyme-treated patients experienced a 92 ± 40 m improvement in the distance walked in 12 minutes relative to placebo-treated patients (p = 0.025).
Croatian: Slijedeća 24 tjedna terapije, kod bolesnika liječenih lijekom Naglazyme su došlo je do poboljšanja od 92 ± 40 m u prehodanoj daljini u 12 minuta, u odnosu na one bolesnike koji su dobivali placebo (p =
English: For Naglazyme, no clinical data on exposed pregnancies are available.
Croatian: Nema dostupnih kliničkih podataka o izloženosti lijeku Naglazyme tijekom trudnoće.
English: In the Naglazyme clinical trials, IARs were usually manageable by interrupting or slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol), thus enabling the patient to continue treatment.
Croatian: U kliničkim ispitivanjima lijeka Naglazyme, reakcije na infuziju su se uglavnom mogle zbrinuti prestankom ili usporavanjem brzine infuzije te premedikacijom bolesnika antihistaminicima i/ili antipireticima (paracetamol) i time omogućavajući nastavak liječenja bolesnika.
English: The three clinical studies performed with Naglazyme focused on assessing the systemic manifestations of MPS VI such as endurance, joint mobility, joint pain and stiffness, upper airway obstruction, manual dexterity and visual acuity.
Croatian: Tri kliničke studije s lijekom Naglazyme su se usmjerile na procjenu sistemskih manifestacija MPS VI poput izdržljivosti, pokretnosti zglobova, bolova u zglobovima i ukočenosti, opstrukcije gornjih dišnih putova, manualnih vještina i oštrine vida.
English: Treated patients experienced a 5.7 stair per minute improvement in the 3 Minute Stair Climb relative to placebo-treated patients.
Croatian: Kod liječenih bolesnika primijećeno je poboljšanje od 5,7 stepenica u minuti u 3-minutnom testu uspinjanja stepenicama, naspram bolesnika koji su dobivali placebo.
English: PSURs The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Croatian: Nositelj odobrenja će nastaviti podnositi PSUR svake godine, do drugačije dogovorenog od strane CHMP-a.
English: - If you have a fever, or if you are having difficulty breathing before this medicine is given, talk with your doctor about delaying your Naglazyme infusion.
Croatian: Ako imate vrućicu, ili ako imate problema s disanjem, prije nego Vam da ovaj lijek,
English: MPS VI is a heterogeneous and multisystemic disorder characterized by the deficiency of N-acetylgalactoasamine 4-sulfatase, a lysosomal hydrolase which catalyses the hydrolysis of sulfate moiety of the glycosaminoglycan, dermatan sulfate.
Croatian: MPS VI je heterogeni i višesustavni poremećaj kojeg karakterizira deficijencija N-acetilgalaktozamin 4-sulfataze, lizosomalne hidrolaze koja katalizira hidrolizu sulfatne polovine glikozaminoglikana, dermatan sulfata.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir kod bolesnika koji su na kontroliranom unosu natrija.
English: Reactions of unknown frequency were reported post-marketing.
Croatian: Reakcije nepoznate učestalosti su prijavljene nakon stavljanja lijeka na tržište.
English: Management of infusion-associated reactions
Croatian: Zbrinjavanje reakcija vezanih za infuziju
English: The recommended dose regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours.
Croatian: Preporučeno doziranje galsulfaze je 1 mg/kg tjelesne težine primijenjen jednom tjedno u obliku intravenske infuzije tijekom 4 sata.
English: People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, which breaks down specific substances (glycosaminoglycans) in the body.
Croatian: Osobe oboljele od MPS VI bolesti imaju ili nisku razinu ili nemaju enzim koji se naziva N-acetilgalaktozamin 4-sulfataza koji razgrađuje određene tvari (glukozaminoglikane) u tijelu.
English: Final CSP Study Report: 31 July activities.
Croatian: izvještaj ispitivanja: 31. srpnja 2020.
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol should be considered and/or a reduction in the infusion rate to half the rate at which the reaction occurred.
Croatian: U slučaju blage ili umjerene reakcije na infuziju, mora se uzeti u obzir liječenje antihistaminicima i paracetamolom, i/ili smanjenje brzine infuzije na pola brzine pri kojoj je došlo do reakcije.
English: There have been post-marketing reports of patients treated with Naglazyme who experienced the onset or worsening of SCC requiring decompression surgery.
Croatian: Postoje izvješća nakon stavljanja lijeka u promet o bolesnicima liječenim lijekom Naglazyme u kojih se javila kompresija leđne/cervikalne moždine ili u kojih je nastupilo njeno pogoršanje i za koje je bila potrebna kirurška dekompresija.
English: Dyspnoea1, nasal congestion1
Croatian: Dispneja1, nosna kongestija1
English: Due to the small patient population, an adverse reaction in a single patient is classified as common.
Croatian: Uslijed malog broja bolesnika, nuspojave koje su se javile u jednog bolesnika su klasificirane kao česte.
English: Common symptoms of infusion reactions were pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm and arthralgia.
Croatian: Česti simptomi infuzijskih reakcija bili su svrbež, povraćanje, bol u abdomenu, mučnina, hipertenzija, glavobolja, bol u prsima, eritem, kašalj, hipotenzija, angioedem, respiratorni distres, tremor, konjunktivitis, malaksalost, bronhospazam i artralgija.
English: Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Croatian: Razrijeđene otopine: Dokazana kemijska i fizikalna stabilnost u primjeni je do 4 dana na sobnoj temperaturi (23°C - 27°C).
English: Subjects enrolled in the program will have urinary glycosaminoglycan and samples for total antibodies routinely collected as specified in the Schedule of Activities.
Croatian: Ispitanicima upisanima u program će se redovno prikupljati uzorci urinarnog glikozaminoglikana (GAG) i ukupnih antitijela kao što je navedeno u Rasporedu aktivnosti.
English: The solution must be diluted further before it can be infused.
Croatian: Otopina se mora dodatno razrijediti prije infuzije.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at room temperature (23C27C) during administration.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja odgovornost su korisnika i normalno ne bi smjeli biti dulji od 24 sata pri 2°C - 8°C, nakon kojih slijedi do 24 sata na sobnoj temperaturi (23°C - 27°C) tijekom primjene lijeka.
English: The following information is intended for medical or healthcare professionals only: Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Croatian: Naglazyme se ne smije miješati s drugim lijekovima u istoj infuziji, osim onih navedenih ispod.
English: Only clear and colourless solutions without visible particles should be used.
Croatian: Smiju se koristiti samo bistre i bezbojne otopine bez vidljivih čestica.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/324/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/05/324/001
English: Treatment with Naglazyme showed improvement, or lack of worsening, of facial dysmorphism.
Croatian: Liječenje Naglazymom pokazalo je poboljšanje odnosno nije bilo pogoršanja dismorfije lica.
English: Ear and labyrinth disorders
Croatian: Poremećaj uha i labirinta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg galsulfase.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaki ml otopine sadrži 1 mg galsulfaze.
English: One vial of 5 ml contains 5 mg galsulfase.
Croatian: Jedna bočica od 5 ml sadrži 5 mg galsulfaze.
English: EU/1/05/324/001 1 vial EU/1/05/324/002 6 vials
Croatian: EU/1/05/324/002 6 bočica
English: Other medicines and Naglazyme
Croatian: Drugi lijekovi i Naglazyme
English: Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Croatian: Galsulfaza je rekombinantni oblik humane N-acetilgalaktozamin 4-sulfataze i proizvedena je tehnologijom rekombinantne DNK na staničnoj kulturi jajnika kineskog hrčka (Chinese Hamster Ovary (CHO)).
English: If you are given more Naglazyme than you should Naglazyme is administered under the supervision of a nurse or doctor, he or she will check that the correct dose has been given and act accordingly if necessary.
Croatian: Ako ste dobili više Naglazyma nego što se trebali Naglazyme se primjenjuje pod nadzorom medicinske sestre ili liječnika.
English: The solution is to be visually inspected for particulate matter prior to use.
Croatian: Otopinu treba vizualno provjeriti da li u njoj ima čestica prije uporabe.
English: How this medicine works
Croatian: Kako ovaj lijek djeluje
English: The most common symptoms of infusion associated reactions include fever, chills, rash, hives and shortness of breath.
Croatian: Najčešći simptomi reakcija na infuziju uključuju vrućicu, zimicu, osip, koprivnjaču i nedostatak zraka.
English: Pain1, chest pain1, rigors1, malaise1, pyrexia
Croatian: Bol1, bol u prsima1, tresavica1, malaksalost1, pireksija
English: Serious adverse reactions included laryngeal edema, apnoea, pyrexia, urticaria, respiratory distress, angioedema, asthma and anaphylactoid reaction.
Croatian: Ozbiljne nuspojave su uključivale edem grkljana, apneju, pireksiju, urtikariju, respiratorni distres, angioedem, astmu i anafilaktoidnu reakciju.
English: • Decreased heart rate
Croatian: • Usporeni srčani ritam
English: Samples from those subjects who have a consistent increase in urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
Croatian: Uzorci prikupljeni od ispitanika kod kojih je konzistentni porast vrijednosti urinarnog GAG-a zajedno s visokim razinama antitijela procijenit će se i uzorci antitijela da se vidi imali li dokaza za postojanje neutralizirajućih aktivnosti.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Zbrinjavanje kompromitiranih dišnih putova
English: Special populations
Croatian: Starija populacija
English: A clear to slightly opalescent, and colourless to pale yellow solution.
Croatian: Bistra do lagano opalescentna i bezbojna do blijedo žuta otopina.
English: EXPIRY DATE
Croatian: Datum dospijeća
English: Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80
Croatian: natrijev klorid natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat polisorbat 80 voda za injekcije
English: Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”.
Croatian: Nuspojave prijavljene nakon stavljanja lijeka u promet su uključene, a kategorija njihove učestalosti je navedena kao ,,nepoznatoˮ.
English: The solution is to be mixed gently before infusion.
Croatian: Otopinu treba nježno promiješati prije infuzije.
English: - The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
Croatian: - Drugi(a)(e) sastojak(ci) su: natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, polisorbat 80, voda za injekcije.
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Croatian: Koncentrat za otopinu za infuziju mora biti razrijeđen s otopinom natrijeva klorida 9 mg/ml (0,9%) za infuziju korištenjem aseptične tehnike.
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: 1Reactions reported more frequently in the active arm of the placebo-controlled study than the placebo arm; frequency determined from 39 patients of the blinded Phase 3 study.
Croatian: 1Reakcije prijavljene češće u bolesnika koji su primali lijek u kliničkoj studiji u odnosu na bolesnike koji su primali placebo, učestalost je procijenjena na temelju 39 bolesnika u slijepoj studiji faze 3.
English: Preparation of the Naglazyme infusion (aseptic technique is to be used) The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.
Croatian: Mora se odrediti broj bočica koje treba razrijediti na temelju individualne težine bolesnika te ih izvaditi iz hladnjaka otprilike 20 minuta prije, kako bi im se dozvolilo da dostignu sobnu temperaturu.
English: Very common symptoms of these infusion reactions were pyrexia, chills/rigors, rash, urticaria and dyspnoea.
Croatian: Vrlo česti simptomi infuzijskih reakcija bili su pireksija, zimica/tresavica, osip, urtikarija, i dispneja.
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion associated reactions”).
Croatian: Nuspojave su uglavnom zabilježene tijekom primjene lijeka ili kratko nakon primjene lijeka, to su takozvane reakcije na infuziju.
English: Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Croatian: Pročišćena galsulfaza, rekombinirani oblik ljudske N-acetilgalaktozamin 4-sulfataze je glikoprotein molekularne težine od otprilike 56 kD.
English: Paresthesia
Croatian: Parestezija
English: The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Croatian: Bistar do lagano opalescentan i bezbojan do blijedo žut koncentrat ne smije sadržavati vidljive čestice.
English: • Low blood-oxygen
Croatian: • Niska razina kisika u krvi
English: One ml of Naglazyme contains 1 mg galsulfase.
Croatian: Jedan ml Naglazyme-a sadrži 1 mg galsulfaze.
English: • Poor hearing
Croatian: • Oslabljeni sluh
English: Naglazyme is supplied as a concentrate for solution for infusion.
Croatian: Naglazyme je dostupan kao koncentrat za otopinu za infuziju.
English: Spinal or cervical cord compression
Croatian: Kompresija leđne/cervikalne moždine
English: A brief update will be submitted as part of the Annual Reassessments.
Croatian: Kratko upoznavanje s najnovijim podacima će se predati u sklopu Godišnjih reevaluacija.
English: The reactions are listed following the MedDRA frequency convention.
Croatian: Nuspojave su navedene prema MedDRA dogovorenoj učestalosti.
English: Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Croatian: Galsulfaza je rekombinantna ljudska N-acetilgalaktozamin 4-sulfataza proizvedena na genetski modificiranim stanicama jajnika kineskog hrčka (engl.
English: Angioeodema1, rash1, urticaria, pruritus Very Common Erythema
Croatian: Angioedem1, osip1, urtikarija, svrbež
English: • Cloudy eyes
Croatian: • Upala oka
English: Diluted solutions:
Croatian: Razrijeđene otopine:
English: Before dilution, each vial is to be inspected for particulate matter and discolouration.
Croatian: Prije razrjeđivanja, svaka bočica mora biti provjerena da li u njoj ima čestica i da li se boja promijenila.
English: The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Volumen Naglazyme se polako dodaje u natrij-kloridnu otopinu 9 mg/ml (0,9%) za infuziju.
English: Overall, one case of sleep apnoea was experienced from all clinical studies.
Croatian: Sveukupno, tijekom svih kliničkih ispitivanja zabilježen je jedan slučaj apneje u snu.
English: 5 years of age will be treated with the 1 mg/kg dose for at least one year.
Croatian: Procijeniti sigurnost i djelotvornost Naglazyme kod 10 pacijenata mlađih od 5 godina koji će biti liječeni dozom od 1mg/kg najmanje godinu dana.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA Naglazyme 1 mg/ml koncentrat za otopinu za infuziju galsulfaza
English: Patients who present with an acute febrile or respiratory illness may need to have their Naglazyme infusions delayed.
Croatian: Možda će trebati odgoditi infuziju lijeka Naglazyme u bolesnika s akutnom febrilnom ili respiratornom bolešću.
English: In patients who have experienced allergic reactions during infusion with Naglazyme, caution should be exercised upon rechallenge; appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) should be available during infusions.
Croatian: Odgovarajuće uvježbano osoblje i oprema za oživljavanje (uključujući adrenalin) moraju biti dostupni tijekom infuzije.
English: A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added.
Croatian: Iz infuzijske vrećice od 250 ml mora se izvući i odstraniti volumen 0,9% otopine natrijeva klorida (9 mg/ml) za infuziju jednak ukupnom volumenu Naglazyme-a koji će biti dodan.
English: • Pain (including ear, abdominal, joint, chest pain)
Croatian: • Bol (uključujući bol u uhu, trbuhu,
English: The most common adverse reactions were pyrexia, rash, pruritus, urticaria, chills/rigors, nausea, headache, abdominal pain, vomiting and dypsnoea.
Croatian: Najčešće nuspojave bile su pireksija, osip, svrbež, urtikarija, zimica/tresavica, mučnina, glavobolja, bol u abdomenu, povraćanje i dispneja.
English: NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Croatian: NAZIV GOTOVOG LIJEKA Naglazyme 1 mg/ml koncentrat za otopinu za infuziju galsulfaza
English: Marketing Authorization Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Croatian: BioMarin International Limited Shanbally, Ringaskiddy
English: • Tingling
Croatian: • Trnci
English: • Inflammation of the eye
Croatian: • Zamućenje vida
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima
English: • Wheezing • Skin redness
Croatian: • Piskanje • Crvenilo kože
English: 6.6 Special precautions for disposal and other handling Each vial of Naglazyme is intended for single use only.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Svaka bočica
English: The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.
Croatian: Bistra do lagano opalescentna i bezbojna do blijedo žuta otopina ne smije sadržavati vidljive čestice.
English: • Increased heart rate
Croatian: • Ubrzani srčani ritam
English: Ear pain1, hearing impaired1
Croatian: Bol u uhu1, poremećaj sluha1
English: Pallor
Croatian: Bljedilo
English: Table 1: Frequency of adverse drug reactions with Naglazyme
Croatian: Tablica 1: Učestalost nuspojava uzrokovanih lijekom Naglazyme MedDRA
English: • Bulging belly button
Croatian: • Ispupčenje pupka
English: Anaphylaxis, shock
Croatian: Poremećaji imunološkog sustava Anafilaksija, šok
English: For single use only Any unused solution should be discarded
Croatian: Neiskorištenu otopinu potrebno je zbrinuti.
English: What Naglazyme contains
Croatian: Što Naglazyme sadrži
English: • Skin paleness
Croatian: • Grlobolja
English: Nervous system disorders
Croatian: Krvožilni poremećaji
English: MedDRA
Croatian: Dojenje
English: Abdominal pain1, umbilical hernia1, vomiting, nausea
Croatian: Često Edem larinksa, hipoksija, tahipneja Nepoznato Poremećaji probavnog sustava Bol u trbuhu1, umbilikalna hernija1, povraćanje, mučnina
English: Areflexia1, headache
Croatian: Poremećaji živčanog sustava Arefleksija1, glavobolja
English: What is Taxespira and what is it used for?
Croatian: Što je Taxespira i za što se koristi
English: EMA/13030/2016 EMEA/H/C/003925
Croatian: EU/1/15/1017/003
English: • breast cancer.
Croatian: • krvni ugrušci.
English: Taxespira docetaxel
Croatian: Doksorubicin
English: The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Croatian: Docetaksel pripada skupini antitumorskih lijekova, koji se nazivaju taksani.
English: Taxespira is used with cisplatin and 5-fluorouracil.
Croatian: Kombinacija s cisplatinom i 5-fluoruracilom
English: The full EPAR and risk management plan summary for Taxespira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu .
English: • non-small-cell lung cancer.
Croatian: Karcinom nemalih stanica pluća
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Croatian: Ako se pojave kristali, otopina se ne smije primijeniti i mora se baciti.
English: Taxespira is available as a concentrate for solution for infusion (drip) into a vein and is given as a onehour infusion every three weeks.
Croatian: Docetaksel se primjenjuje u obliku jednosatne infuzije svaka tri tjedna.
English: Previously known as Docetaxel Hospira UK Limited.
Croatian: Hospira UK Limited Horizon,
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Ova Uputa o lijeku je dostupna na svim EU/EEA jezicima na internetskoj stranici Europske agencije za lijekove.
English: Taxespira is used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Croatian: Docetaksel se može primjenjivati samo na odjelima specijaliziranim za primjenu citotoksične kemoterapije i to isključivo pod nadzorom liječnika kvalificiranog za primjenu antitumorske kemoterapije (vidjeti dio 6.6).
English: For practical information about using Taxespira, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili bolničkom ljekarniku.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: Hospira Deutschland GmbH Tel: + 49 (0) 89 43 77 77 0
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Hospira UK Limited on 28 August 2015.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Hospira UK Limited
English: For more information on generic medicines, see the question-and-answer document here.
Croatian: Za dodatne informacije pogledajte uputu o lijeku.
English: What measures are being taken to ensure the safe and effective use of Taxespira?
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA