FrancophonIA/ELRC3.0 huggingface dataset:
English: Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml) During use or when carried as a spare: Store below 25°C.
Croatian: Actrapid bočica (40 internacionalnih jedinica/ml)/Actrapid bočica (100 internacionalnih jedinica/ml) Tijekom uporabe ili kad se lijek nosi kao rezervni: čuvati na temperaturi ispod 25°C.
English: Instructions on how to use Actrapid solution for injection in FlexPen.
Croatian: Upute za uporabu Actrapid otopine za injekciju u brizgalici FlexPen
English: Actrapid vials are for use with insulin syringes with a corresponding unit scale.
Croatian: Actrapid bočice koriste se s inzulinskim štrcaljkama s odgovarajućom jediničnom skalom.
English: ► There are no restrictions on treatment with Actrapid during breast-feeding.
Croatian: ► Nema ograničenja za liječenje lijekom Actrapid tijekom dojenja.
English: You must use the pen as described in the Instructions on how to use Actrapid InnoLet.
Croatian: Brizgalicom morate rukovati na način opisan u uputama za uporabu Actrapid InnoLet brizgalice.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution in a pre-filled multidose disposable pen made of polypropylene.
Croatian: Uložak (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem (brombutil/poliizopren) sadrži 3 ml otopine u jednokratnoj, višedoznoj napunjenoj brizgalici od polipropilena.
English: Actrapid InnoLet is a pre-filled disposable pen containing human insulin.
Croatian: Actrapid InnoLet je jednokratna napunjena brizgalica koja sadrži humani inzulin.
English: Actrapid FlexPen is a pre-filled disposable pen containing human insulin.
Croatian: Actrapid FlexPen je jednokratna napunjena brizgalica koja sadrži humani inzulin.
English: ► After each injection, be sure to remove and discard the needle and store Actrapid without the needle attached.
Croatian: ► Nakon svakog injiciranja iglu obavezno skinite i bacite u otpad te spremite Actrapid bez pričvršćene igle.
English: Solution for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Croatian: 1 x 3 ml uložak 5 x 3 ml uložaka 10 x 3 ml uložaka
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution.
Croatian: Uložak (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem (brombutil/poliizopren) sadrži 3 ml otopine.
English: Setting the dose • Always check that the push-button is fully depressed and the dose selector is set to 0.
Croatian: • Uvijek provjerite je li potisni gumb pritisnut do kraja, a izbornik doze postavljen na 0.
English: Then turn the vial and syringe upside down and draw up the prescribed dose of Actrapid.
Croatian: Zatim preokrenite bočicu i štrcaljku i navucite propisanu dozu lijeka Actrapid.
English: If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.
Croatian: Ako ste uzimali bilo koji od navedenih lijekova, obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUTEVI PRIMJENE LIJEKA
English: You must use the pen as described in the Instructions on how to use Actrapid FlexPen.
Croatian: Brizgalicom morate rukovati na način opisan u uputama za uporabu Actrapid FlexPen brizgalice.
English: 1 ml solution contains 40 international units insulin human* (equivalent to 1.4 mg).
Croatian: 1 ml otopine sadrži 40 internacionalnih jedinica humanog inzulina* (što odgovara 1,4 mg).
English: Actrapid vial (40 international units/ml)
Croatian: Actrapid bočica (40 internacionalnih jedinica/ml)
English: Remove the paper tab from a new disposable needle.
Croatian: B Otrgnite papirnatu naljepnicu s nove igle za jednokratnu uporabu.
English: ► Needles and Actrapid InnoLet must not be shared.
Croatian: ► Igle i Actrapid InnoLet ne smiju se dijeliti s drugim osobama.
English: zinc chloride, glycerol, metacresol, sodium hydroxide/hydrochloric acid for pH adjustment and water for injections
Croatian: POPIS POMOĆNIH TVARI cinkov klorid, glicerol, metakrezol, natrijev hidroksid/kloridnu kiselinu za podešavanje pH i vodu za injekcije.
English: Draw into the syringe the same amount of air as the dose of intermediate- or long-acting insulin.
Croatian: Navucite u štrcaljku količinu zraka koja je jednaka dozi srednjedugodjelujućeg ili dugodjelujućeg inzulina.
English: You can carry it with you and keep it at room temperature (below 25ºC) for up to 4 weeks.
Croatian: Lijek možete nositi uza se i čuvati na sobnoj temperaturi (ispod 25°C) najviše 4 tjedna.
English: 1 ml solution contains 100 IU insulin human (equivalent to 3.5 mg),
Croatian: 1 ml otopine sadrži 100 IU humanog inzulina (što odgovara 3,5 mg),
English: You can carry it with you and keep it at room temperature (below 25ºC) for up to 6 weeks.
Croatian: Lijek možete nositi uza se i čuvati na sobnoj temperaturi (ispod 25°C) najviše 6 tjedana.
English: Actrapid is a fast-acting insulin.
Croatian: Actrapid je brzodjelujući inzulin.
English: 1 ml solution contains 40 IU insulin human (equivalent to 1.4 mg),
Croatian: 1 ml otopine sadrži 40 IU humanog inzulina (što odgovara 1,4 mg),
English: Actrapid vial (100 international units/ml)
Croatian: Actrapid bočica (100 internacionalnih jedinica/ml)
English: How to inject Actrapid
Croatian: Kako injicirati Actrapid
English: Actrapid is presented as a solution for injection.
Croatian: Actrapid je otopina za injekciju.
English: Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra, bezbojna i vodena.
English: Actrapid is administered by injection under the skin (subcutaneously).
Croatian: Actrapid je namijenjen injiciranju pod kožu (supkutano).
English: It may affect less than 1 in 10,000 people.
Croatian: Može se javiti u manje od 1 na 10 000 osoba.
English: Making the injection
Croatian: Otopina za injekciju
English: ► Needles and Actrapid Penfill must not be shared.
Croatian: ► Igle i Actrapid Penfill ne smiju se dijeliti s drugim osobama.
English: During use or when carried as a spare: The product can be stored for a maximum of 4 weeks.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: lijek se može čuvati najviše 4 tjedna.
English: Read carefully the Instructions on how to use Actrapid FlexPen included in this package leaflet.
Croatian: Pažljivo pročitajte upute za uporabu Actrapid FlexPen brizgalice u ovoj Uputi o lijeku.
English: 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg).
Croatian: 1 ml otopine sadrži 100 internacionalnih jedinica humanog inzulina* (što odgovara 3,5 mg).
English: Read the following instructions carefully before using your FlexPen.
Croatian: Prije uporabe brizgalice FlexPen pozorno pročitajte ove upute.
English: Insulins and analogues for injection, fast-acting, insulin (human).
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti: inzulini i analozi za injiciranje brzog djelovanja, inzulin (humani).
English: ► Needles and Actrapid FlexPen must not be shared.
Croatian: ► Igle i Actrapid FlexPen ne smiju se dijeliti s drugim osobama.
English: How to handle Actrapid FlexPen
Croatian: Kako rukovati brizgalicom Actrapid FlexPen
English: Monitoring of blood glucose is necessary during the insulin infusion.
Croatian: Tijekom infuzije inzulina nužno je praćenje razine glukoze u krvi.
English: The following substances may increase the patient's insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Croatian: oralni kontraceptivi, tiazidi, glukokortikoidi, hormoni štitnjače, simpatomimetici, hormon rasta i danazol.
English: May affect less than 1 in 100 people.
Croatian: Manje česte nuspojave Mogu se javiti u manje od 1 na 100 osoba.
English: Preparing your Actrapid FlexPen Check the name and coloured label of your pen to make sure that it contains the correct type of insulin.
Croatian: Provjerite naziv i boju naljepnice na brizgalici kako biste bili sigurni da sadrži odgovarajuću vrstu inzulina.
English: Small amounts of air may collect in the needle and cartridge during normal use.
Croatian: U igli i ulošku se tijekom uobičajene primjene mogu nakupiti male količine zraka.
English: ► If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.
Croatian: ► ako ste alergični na humani inzulin ili neki drugi sastojak ovog lijeka, vidjeti dio 6. ► ako sumnjate da počinje hipoglikemija (niska razina šećera u krvi), vidjeti Sažetak ozbiljnih i vrlo čestih nuspojava u dijelu 4. ► u inzulinskim infuzijskim pumpama.
English: Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml) Intravenous use
Croatian: Actrapid bočica (40 internacionalnih jedinica/ml)/Actrapid bočica (100 internacionalnih jedinica/ml)
English: Each prefilled pen contains 300 IU of human insulin in 3 ml solution for injection.
Croatian: Jedna napunjena brizgalica sadrži 300 IU humanog inzulina u 3 ml otopine za injekciju.
English: Read carefully the Instructions on how to use Actrapid InnoLet included in this package leaflet.
Croatian: Pažljivo pročitajte upute za uporabu Actrapid InnoLet brizgalice u ovoj Uputi o lijeku.
English: • Always prime InnoLet before you inject.
Croatian: • Uvijek provjerite protok kroz brizgalicu InnoLet prije injiciranja.
English: Before using Actrapid
Croatian: Prije primjene lijeka Actrapid
English: Paediatric population Actrapid can be used in children and adolescents.
Croatian: Primjena u djece i adolescenata Actrapid se može primjenjivati u djece i adolescenata.
English: ► Actrapid FlexPen is only suitable for injecting under the skin.
Croatian: ► Actrapid FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: Actrapid InnoLet is only suitable for subcutaneous injections.
Croatian: Actrapid InnoLet je prikladan samo za potkožne injekcije.
English: Actrapid Penfill EU/1/02/230/005 EU/1/02/230/006 EU/1/02/230/007
Croatian: EU/1/02/230/005 EU/1/02/230/006 EU/1/02/230/007
English: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Croatian: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danska
English: Solution for injection 1 vial of 10 ml 5 vials of 10 ml
Croatian: 1 bočica od 10 ml 5 bočica od 10 ml
English: ► Actrapid InnoLet is only suitable for injecting under the skin.
Croatian: ► Actrapid InnoLet je prikladan samo za ubrizgavanje pod kožu.
English: ► Needles and syringes must not be shared.
Croatian: ► Igle i štrcaljke ne smiju se dijeliti s drugim osobama.
English: Actrapid FlexPen is only suitable for subcutaneous injections.
Croatian: Actrapid FlexPen je prikladan samo za potkožne injekcije.
English: ► Actrapid Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: ► Actrapid Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: Actrapid Penfill is only suitable for subcutaneous injections from a reusable pen.
Croatian: Actrapid Penfill je prikladan samo za potkožne injekcije iz brizgalice za višekratnu uporabu.
English: Actrapid FlexPen 100 international units/ml solution for injection in pre-filled pen.
Croatian: Actrapid FlexPen 100 internacionalnih jedinica/ml otopina za injekciju u napunjenoj brizgalici.
English: Actrapid InnoLet is only suitable for injecting under the skin.
Croatian: Actrapid InnoLet je prikladan samo za ubrizgavanje pod kožu.
English: Actrapid InnoLet EU/1/02/230/010 EU/1/02/230/011 EU/1/02/230/012
Croatian: EU/1/02/230/010 EU/1/02/230/011 EU/1/02/230/012
English: Actrapid FlexPen is only suitable for injecting under the skin.
Croatian: Actrapid FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: EXP/ During use or when carried as a spare: Use within 6 weeks
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: upotrijebiti unutar 6 tjedana.
English: EXP/ During use or when carried as a spare: Use within 4 weeks
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: upotrijebiti unutar 4 tjedna.
English: Actrapid FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Croatian: Actrapid FlexPen je napunjena brizgalica namijenjena uporabi s jednokratnim iglama NovoFine ili NovoTwist duljine do 8 mm.
English: Actrapid Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: Actrapid Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: Actrapid FlexPen EU/1/02/230/013 EU/1/02/230/014 EU/1/02/230/015
Croatian: EU/1/02/230/013 EU/1/02/230/014 EU/1/02/230/015
English: Actrapid FlexPen 100 IU/ml Solution for injection Insulin human SC
Croatian: Actrapid FlexPen 100 IU/ml Otopina za injekciju humani inzulin s.c.
English: How to take Actrapid
Croatian: Kako primijeniti Actrapid
English: Each vial contains 1,000 IU of human insulin in 10 ml solution for injection.
Croatian: 1000 IU humanog inzulina u 10 ml otopine za injekciju.
English: Each vial contains 400 IU of human insulin in 10 ml solution for injection.
Croatian: 400 IU humanog inzulina u 10 ml otopine za injekciju.
English: Actrapid 40 IU/ml Solution for injection Insulin human
Croatian: Actrapid 40 IU/ml Otopina za injekciju humani inzulin
English: Actrapid 40 IU/ml Solution for injection Insulin human SC, IV
Croatian: Actrapid 40 IU/ml Otopina za injekciju humani inzulin s.c., i.v.
English: May affect less than 1 in 10,000 people.
Croatian: Vrlo rijetke nuspojave Mogu se javiti u manje od 1 na 10 000 osoba.
English: Actrapid InnoLet 100 international units/ml solution for injection in pre-filled pen.
Croatian: Actrapid InnoLet 100 internacionalnih jedinica/ml otopina za injekciju u napunjenoj brizgalici.
English: Always make sure that a drop appears at the needle tip before you inject.
Croatian: Prije injiciranja uvijek provjerite je li se na vrhu igle pojavila kapljica.
English: How to store Actrapid
Croatian: Kako primjenjivati Actrapid
English: Actrapid vial, Penfill and FlexPen:
Croatian: Actrapid bočica, Penfill i FlexPen: Novo Nordisk A/S
English: Actrapid FlexPen 100 IU/ml Solution for injection in pre-filled pen Insulin human
Croatian: Actrapid FlexPen 100 IU/ml Otopina za injekciju u napunjenoj brizgalici humani inzulin
English: Actrapid 100 IU/ml Solution for injection Insulin human SC, IV
Croatian: Actrapid 100 IU/ml Otopina za injekciju humani inzulin s.c., i.v.
English: Actrapid 100 IU/ml Solution for injection Insulin human
Croatian: Actrapid 100 IU/ml Otopina za injekciju humani inzulin
English: Actrapid Penfill 100 international units/ml solution for injection in cartridge.
Croatian: Actrapid Penfill 100 internacionalnih jedinica/ml otopina za injekciju u ulošku.
English: Actrapid 40 international units/ml solution for injection in vial.
Croatian: Actrapid 40 internacionalnih jedinica/ml otopina za injekciju u bočici.
English: Denmark Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet Actrapid InnoLet:
English: Each cartridge contains 300 IU of human insulin in 3 ml solution for injection.
Croatian: 300 IU humanog inzulina u 3 ml otopine za injekciju.
English: Actrapid InnoLet 100 IU/ml Solution for injection in pre-filled pen Insulin human
Croatian: Actrapid InnoLet 100 IU/ml Otopina za injekciju u napunjenoj brizgalici humani inzulin
English: EU/1/02/230/003 1 vial of 10 ml EU/1/02/230/004 5 vials of 10 ml
Croatian: EU/1/02/230/004 5 bočica od 10 ml
English: Actrapid Penfill 100 IU/ml Solution for injection Insulin human SC
Croatian: Actrapid Penfill 100 IU/ml Otopina za injekciju humani inzulin s.c.
English: Actrapid InnoLet 100 IU/ml Solution for injection Insulin human SC
Croatian: Actrapid InnoLet 100 IU/ml Otopina za injekciju humani inzulin s.c.
English: Package leaflet: Information for the user Actrapid FlexPen 100 IU/ml (international units/ml) solution for injection in pre-filled pen human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actrapid FlexPen 100 IU/ml (internacionalnih jedinica/ml) otopina za injekciju u napunjenoj brizgalici humani inzulin
English: Package leaflet: Information for the user Actrapid 40 IU/ml (international units/ml) solution for injection in vial human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actrapid 40 IU/ml (internacionalnih jedinica/ml) otopina za injekciju u bočici humani inzulin
English: Actrapid Penfill 100 IU/ml Solution for injection in cartridge Insulin human
Croatian: Actrapid Penfill 100 IU/ml Otopina za injekciju u ulošku humani inzulin
English: Actrapid 100 international units/ml solution for injection in vial.
Croatian: Actrapid 100 internacionalnih jedinica/ml otopina za injekciju u bočici.
English: EU/1/02/230/013 1 pen of 3 ml EU/1/02/230/014 5 pens of 3 ml EU/1/02/230/015 10 pens of 3 ml
Croatian: EU/1/02/230/014 5 brizgalica od 3 ml
English: Package leaflet: Information for the user Actrapid InnoLet 100 IU/ml (international units/ml) solution for injection in pre-filled pen human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actrapid InnoLet 100 IU/ml (internacionalnih jedinica/ml) otopina za injekciju u napunjenoj brizgalici humani inzulin
English: EU/1/02/230/001 1 vial of 10 ml EU/1/02/230/002 5 vials of 10 ml
Croatian: EU/1/02/230/002 5 bočica od 10 ml
English: EU/1/02/230/010 1 pen of 3 ml EU/1/02/230/011 5 pens of 3 ml EU/1/02/230/012 10 pens of 3 ml
Croatian: EU/1/02/230/011 5 brizgalica od 3 ml
English: Package leaflet: Information for the user Actrapid Penfill 100 IU/ml (international units/ml) solution for injection in cartridge human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actrapid Penfill 100 IU/ml (internacionalnih jedinica/ml) otopina za injekciju u ulošku humani inzulin
English: Package leaflet: Information for the user Actrapid 100 IU/ml (international units/ml) solution for injection in vial human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actrapid 100 IU/ml (internacionalnih jedinica/ml) otopina za injekciju u bočici humani inzulin
English: EU/1/02/230/016 5 packs of 1 x 10 ml vial
Croatian: EU/1/02/230/012 10 brizgalica od 3 ml
English: EU/1/02/230/017 5 packs of 1 x 10 ml vial
Croatian: EU/1/02/230/015 10 brizgalica od 3 ml
English: What is Fanaptum?
Croatian: Što je Fanaptum?
English: What consequences does this refusal have for patients in clinical trials?
Croatian: Koje posljedice ima ovo odbijanje zahtjeva za bolesnike u kliničkim ispitivanjima?
English: 10 November 2017 EMA/729957/2017 EMEA/H/C/004149
Croatian: EMA/729957/2017 EMEA/H/C/004149
English: The company presented the results of 2 main studies of 4 and 26 weeks' duration.
Croatian: Tvrtka je predstavila rezultate dvaju glavnih ispitivanja koja su trajala 4, odnosno 26 tjedana.
English: It measured the time until the patient's symptoms came back (first relapse).
Croatian: Mjerilo se vrijeme do ponovne pojave simptoma u bolesnika (prvi relaps).
English: Refusal of the marketing authorisation for Fanaptum (iloperidone) EMA/729957/2017
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Fanaptum (iloperidon) EMA/729957/2017
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Croatian: Shizofrenija je mentalna bolest koja se očituje nizom simptoma, uključujući nesuvislo razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnjičavost i iluzije (pogrešna vjerovanja).
English: The company that applied for authorisation is Vanda Pharmaceuticals Ltd.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Vanda Pharmaceuticals Ltd.
English: By blocking these receptors, iloperidone is expected to normalise the activity of the brain and reduce the symptoms of the disease.
Croatian: Očekuje se da će blokiranjem tih receptora iloperidon normalizirati aktivnost mozga i smanjiti simptome bolesti.
English: Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Croatian: Neurotransmiteri su tvari koje živčane stanice upotrebljavaju za komunikaciju sa susjednim stanicama.
English: The way it works is unclear, but it is thought to attach to certain receptors (targets) for neurotransmitters on nerve cells in the brain.
Croatian: Način na koji djeluje nije poznat, ali smatra se da se veže na određene receptore (mete) za neurotransmitere na živčanim stanicama u mozgu.
English: Iloperidone is thought to block receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin), which play a role in schizophrenia.
Croatian: Smatra se da iloperidon blokira receptore za neurotransmitere dopamin i 5-hidroksitriptamin (također poznat kao serotonin), koji igraju ulogu u shizofreniji.
English: What was Fanaptum expected to be used for?
Croatian: Za što se Fanaptum trebao koristiti?
English: The Committee considered that this risk was significant despite the measures proposed by the company to minimise it.
Croatian: Odbor smatra da je rizik značajan unatoč mjerama za smanjenje rizika koje je predložila tvrtka.
English: The company informed the CHMP that there are no ongoing clinical studies with Fanaptum in the EU at the present time.
Croatian: Tvrtka je obavijestila CHMP da se trenutačno ne provode klinička ispitivanja lijeka Fanaptum u EU-u.
English: In this study, the main measure of effectiveness was the change in the patients' symptoms after 4 weeks, assessed using a standard scale for schizophrenia.
Croatian: U tom je ispitivanju glavno mjerilo djelotvornosti bila promjena simptoma u bolesnika nakon 4 tjedna, koja je procijenjena na temelju standardne ljestvice za shizofreniju.
English: The measures included restricting use to patients whose treatment with another antipsychotic did not work or was no longer tolerated, and prohibiting use in patients who cannot effectively break down the medicine or are taking certain other medicines.
Croatian: Mjere su uključivale ograničenu primjenu u bolesnika čija terapija drugim antipsihoticima nije bila djelotvorna ili je bolesnik više nije mogao podnositi te zabranu primjene u bolesnika čiji organizam ne može djelotvorno razgraditi lijek i u onih koji uzimaju neke druge lijekove.
English: Fanaptum was expected to be used to treat schizophrenia in adults.
Croatian: Fanaptum se trebao koristiti za liječenje shizofrenije u odraslih.
English: In terms of safety, the CHMP was concerned about the medicine's effects on the heart: Fanaptum causes QT prolongation, a change in the heart's electrical activity which can cause a life-threatening abnormality of heart rhythm.
Croatian: U pogledu sigurnosti, CHMP je izrazio zabrinutost u vezi utjecaja lijeka na srce: Fanaptum uzrokuje produljenje QT intervala, promjenu u električnoj aktivnosti srca koja može uzrokovati abnormalnost srčanog ritma opasnu za život.
English: At the time of the initial recommendation, the CHMP considered that the effectiveness of Fanaptum in studies was modest.
Croatian: U vrijeme prve preporuke CHMP je smatrao da je učinkovitost lijeka Fanaptum u ispitivanjima bila skromna.
English: How does Fanaptum work?
Croatian: Kako djeluje Fanaptum?
English: The CHMP also noted that the medicine starts to have its effects after 2 to 3 weeks of treatment, which is a concern when treating sudden (acute) episodes of schizophrenia.
Croatian: CHMP je također utvrdio da lijek počinje djelovati tek nakon 2 do 3 tjedna terapije, što nije sigurno za liječenje iznenadnih (akutnih) epizoda shizofrenije.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Croatian: Nakon razmatranja razloga za ovaj zahtjev, CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet dana 9. studenoga 2017.