FrancophonIA/ELRC3.0 huggingface dataset:
English: Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Croatian: 2 komore najmanje dva od šest segmenata stijenke klijetke nisu mogla ocijeniti) i kod kojih je utvrđena bolest koronarnih arterija ili se sumnja na nju, kako bi omogućio opacifikaciju srčanih komora i bolje ocrtavanje endokardijalne granice lijeve klijetke pri mirovanju i pod opterećenjem.
English: Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code: V08DA04
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: ultrazvučno kontrastno sredstvo, mikrosfere fosfolipida,
English: Gas and solvent for dispersion for injection/infusion 1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
Croatian: 1 x 1,5 ml jednodozna bočica 4 x 1,5 ml jednodozne bočice
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
Croatian: Svaki ml sadrži najviše 6,4 x 109 lipidnih mjehurića koji sadrže perflutren, s prosječnim promjerom u rasponu od 1,1-2,5 mikrometara.
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Croatian: Luminity 150 mikrolitara/ml plin i otapalo za disperziju za injekciju/infuziju perflutren
English: Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained with noncontrast echocardiography is not optimal.
Croatian: (začepljenjem krvnih žila koje opskrbljuju srčani mišić) ili sumnjom na takvu bolest, kada slika dobivena nekontrastnom ehokardiografijom nije optimalna.
English: Nervous system disorders Common: Headache
Croatian: Poremećaji živčanog sustava Često: glavobolja Manje često: omaglica, disgeuzija
English: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride
Croatian: 1,2-dipalmitoil-sn-glicero-3-fosfatidilkolin (DPPC) 1,2-dipalmitoil-sn-glicero-3-fosfatidilna kiselina, mononatrijeva sol (DPPA) N-(metoksipolietilenglikol 5000 karbamoil)-1,2-dipalmitoil-sn-glicero-3fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE) natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev klorid propilenglikol glicerol voda za injekcije
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion
Croatian: Luminity 150 mikrolitara/ml plin i otapalo za disperziju za injekciju/infuziju
English: Intravenous use Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Croatian: Preporučena doza putem intravenske infuzije je 1,3 ml disperzije koja se dodaje u 50 ml 9 mg/ml (0,9%) otopine natrijevog klorida ili 50 mg/ml (5%) otopine glukoze za injekciju.
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm).
Croatian: Svaki ml sadrži najviše 6,4 x 109 lipidnih mikrosfera koje sadrže perflutren, sa srednjim promjerom u rasponu od 1,1-2,5 mikrometara (μm).
English: Luminity is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion (drip solution) after being diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Croatian: Luminity se zatim daje u venu bilo kao ‘bolus' injekcija (koja se daje odjednom) ili kao infuzija (otopina za kapanje) nakon razrjeđivanja s 9 mg/ml (0,9%) otopinom natrijevog klorida ili 50 mg/ml
English: - Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Croatian: - Luminity se može razrijediti s 9 mg/ml (0,9%) otopinom natrijevog klorida za injekciju ili 50 mg/ml (5%) otopinom glukoze za injekciju.
English: Rare: Dyspepsia Not known: Tongue disorder
Croatian: Nepoznato: poremećaj jezika
English: Excipients: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
Croatian: Pomoćne tvari: 1,2-dipalmitoil-sn-glicero-3-fosfatidilkolin (DPPC), 1,2-dipalmitoil-sn-glicero-3fosfatidilna kiselina, mononatrijeva sol (DPPA), N-(metoksipolietilenglikol 5000 karbamoil)-1,2-dipalmitoil-sn-glicero-3fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol, voda za injekcije
English: Luminity has not been specifically studied in elderly patients.
Croatian: Stariji bolesnici Luminity nije posebno ispitivan u starijih bolesnika.
English: Luminity has not been specifically studied in patients with hepatic impairment.
Croatian: Luminity nije posebno ispitivan u bolesnika s oštećenjem bubrega.
English: Store in a refrigerator (2°C - 8°C) For storage conditions after activation of the medicinal product, see section 6.3.
Croatian: Čuvati u hladnjaku (2°C - 8°C)
English: Uncommon: Pruritus, increased sweating Rare: Rash, urticaria, erythema, erythematous rash
Croatian: Rijetko: osip, urtikarija, eritem, eritematozni osip
English: Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arrest, decreased oxygenation, hypoxia, Gastrointestinal disorders Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting,
Croatian: Rijetko: respiratorni distres, kašalj, suho grlo Nepoznato: respiratorni arest, smanjena oksigenacija, hipoksija
English: Do not use Luminity after the expiry date which is stated on the carton and label after EXP. Before activation (shaking), store in a refrigerator (2°C - 8°C).
Croatian: Prije aktivacije (miješanja) čuvati u hladnjaku (2°C - 8°C).
English: The product consists of lipid encapsulated perflutren microspheres.
Croatian: ATK oznaka: V08DA04 Proizvod se sastoji od mikrosfera perflutrena inkapsuliranih lipidom.
English: • abdominal pain, diarrhoea, nausea (feeling sick), vomiting,
Croatian: • poteškoće s disanjem, nadražaj grla, • bol u trbuhu, proljev, mučnina, povraćanje,
English: • breathing problems, cough, dry throat, difficulty in swallowing,
Croatian: • periferna hladnoća, • tegobe s disanjem, kašalj, suho grlo, poteškoće s gutanjem,
English: - The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Croatian: - fosfatidilna kiselina, mononatrijeva sol (DPPA), N-(metoksipolietilenglikol 5000 karbamoil)-1,2dipalmitoil-sn-glicero-3-fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol i voda za injekcije.
English: Patients with Cardiac Shunts
Croatian: Bolesnici sa srčanim spojevima (šantovima)
English: • numbness of the face,
Croatian: • oticanje oka,
English: Hepatic impairment Pharmacokinetics has not been specifically studied in the hepatic disease patients.
Croatian: Oštećenje jetre Farmakokinetika nije posebno ispitivana u bolesnika s bolešću jetre.
English: Gas and solvent for dispersion for injection/infusion Colourless, uniformly clear to translucent liquid.
Croatian: Bezbojna, jednolično bistra do prozirna tekućina.
English: Bolus intravenous injection using non-linear contrast imaging technique at rest and stress: The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement.
Croatian: Intravenska bolus injekcija uz korištenje osnovne tehnike snimanja pri mirovanju: Preporučena doza je 10 mikrolitara disperzije/kg sporom intravenskom bolus injekcijom, nakon čega slijedi bolus od 10 ml 9 mg/ml (0,9%) otopine natrijevog klorida ili 50 mg/ml (5%) otopine glukoze za injekciju.
English: • joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness
Croatian: • osip, crvenilo kože, • bol u zglobovima, bol u boku (bokovima), bol u vratu, mišićni grč, vrućica, ukočenost mišića • te poremećeni elektrokardiogram.
English: • fatigue,
Croatian: • Omaglica,
English: • feeling faint,
Croatian: • osjećaj nesvjestice,
English: Patients on mechanical ventilation
Croatian: Primjena i postupak mehaničke aktivacije
English: Lantheus EU Limited Rocktwist House Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Croatian: Clare V14 FW97 Irska
English: Uncommon: Dyspnoea, Throat Irritation
Croatian: Manje često: dispneja, nadražaj grla
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Uncommon: Dizziness, dysgeusia
Croatian: Rijetko: pireksija, tresavica
English: • peripheral coldness,
Croatian: • utrnulost lica,
English: • back pain, chest pain,
Croatian: • pojačano znojenje, • bol u leđima, bol u prsištu,
English: Pregnancy and breast-feeding
Croatian: prsišta i sredoprsja
English: • and abnormal vision.
Croatian: • te poremećeni vid.
English: Uncommon: Chest Pain, fatigue, feeling hot, injection site pain Rare: Pyrexia, rigors
Croatian: Manje često: bol u prsištu, umor, osjećaj vrućine, bol na mjestu primjene injekcije
English: Vascular disorders
Croatian: Poremećaji imunološkog sustava
English: Glycerol
Croatian: RMP-a.
English: The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose.
Croatian: Preporučena je doza 500 mg jedanput mjesečno, uz jednu dodatnu dozu od 500 mg dva tjedna nakon primjene prve doze.
English: The full EPAR for Fulvestrant Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Fulvestrant Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.
Croatian: Fulvestrant Mylan je antiestrogenski lijek koji se koristi za liječenje uznapredovalog ili metastatskog raka dojke (raka koji se proširio na druge dijelove tijela) u žena nakon menopauze koje pate od raka dojke s pozitivnim estrogenskim receptorima koje prethodno nisu bile liječene endokrinom terapijom ili koje su doživjele relaps bolesti nakon antiestrogenskog liječenja.
English: This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Faslodex.
Croatian: To znači da Fulvestrant Mylan sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Faslodex.
English: Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg).
Croatian: Fulvestrant Mylan izdaje se samo na liječnički recept i dostupan je kao otopina za injekciju u napunjenoj štrcaljki (250 mg).
English: Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Fulvestrant Mylan generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Fulvestrant Mylan is a ‘generic medicine'.
Croatian: Fulvestrant Mylan je „generički lijek”.
English: There was no need for ‘bioequivalence' studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nije bilo potrebe za ispitivanjima bioekvivalencije kako bi se istražilo apsorbira li se Fulvestrant Mylan na sličan način kao referentni lijek radi proizvodnje jednake razine djelatne tvari u krvi.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da je lijek Fulvestrant Mylan usporediv s lijekom Faslodex.
English: As for every medicine, the company provided studies on the quality of Fulvestrant Mylan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Fulvestrant Mylan.
English: This is because the composition of Fulvestrant Mylan is the same as the reference medicine and when given by injection into the muscle, the active substance in both products is expected to be absorbed in the same way.
Croatian: Razlog tome jest to što je sastav lijeka Fulvestrant Mylan isti kao sastav referentnog lijeka i kada se primjenjuje injekcijom u mišić, očekuje se da će se djelatna tvar u oba lijeka apsorbirati na isti način.
English: This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Fulvestrant Mylan.
English: It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall.
Croatian: On blokira receptore za estrogen na stanicama i smanjuje broj estrogenskih receptora.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni lijek, Faslodex, te ih ne treba ponavljati za lijek Fulvestrant Mylan.
English: What measures are being taken to ensure the safe and effective use of Fulvestrant Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fulvestrant Mylan?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulvestrant Mylan have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Fulvestrant Mylan nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Fulvestrant Mylan
Croatian: Ostale informacije o lijeku Fulvestrant Mylan
English: For more information about treatment with Fulvestrant Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Fulvestrant Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The Agency recommended that Fulvestrant Mylan be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Fulvestrant Mylan u promet u EU-u.
English: The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen.
Croatian: Djelatna tvar u lijeku Fulvestrant Mylan jest fulvestrant, antiestrogen.
English: It is not intended to provide practical advice on how to use Fulvestrant Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Fulvestrant Mylan.
English: What is Fulvestrant Mylan and what is it used for?
Croatian: Što je Fulvestrant Mylan i za što se koristi?
English: For practical information about using Fulvestrant Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Fulvestrant Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for Faslodex, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Faslodex.
English: Fulvestrant Mylan contains the active substance fulvestrant.
Croatian: Fulvestrant Mylan sadrži djelatnu tvar fulvestrant.
English: What are the benefits and risks of Fulvestrant Mylan?
Croatian: Koje su koristi i rizici od lijeka Fulvestrant Mylan?
English: Why is Fulvestrant Mylan approved?
Croatian: Zašto je lijek Fulvestrant Mylan odobren?
English: Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells.
Croatian: Vezivanje hormona estrogena na ciljeve (receptore) stanica raka potiče rast većine vrsta raka dojke.
English: How is Fulvestrant Mylan used?
Croatian: Kako se Fulvestrant Mylan koristi?
English: How has Fulvestrant Mylan been studied?
Croatian: Kako je Fulvestrant Mylan ispitivan?
English: How does Fulvestrant Mylan work?
Croatian: Kako djeluje Fulvestrant Mylan?
English: Solution for injection Subcutaneous use pre-filled syringe 1 pre-filled syringe
Croatian: Veličina pakovanja napunjena štrcaljka 1 napunjena štrcaljka
English: Such medicines include:
Croatian: Takvi lijekovi uključuju:
English: Case reports of efficacy are also available in literature.
Croatian: U literaturi su također dostupna izvješća o djelotvornosti.
English: The frequencies are not known (cannot be estimated from the available data).
Croatian: Učestalosti nisu poznate (ne može se procijeniti iz dostupnih podataka).
English: It is also well absorbed by the oral route.
Croatian: Također se dobro apsorbira peroralnim putem.
English: Lower doses (<1 mg/kg) may be needed.
Croatian: Mogu biti potrebne manje doze (<1 mg/kg).
English: When indicated, the frequency is based on a very small sample size.
Croatian: Kada je navedena, učestalost se temelji na vrlo maloj veličini uzorka.
English: A second dose may be given after one hour if required.
Croatian: Ako je potrebno, može se dati drugu dozu nakon jednog sata.
English: These features resolve generally within 2-12 hours of the injection.
Croatian: Ove osobitosti općenito nestaju unutar 2-12 sati nakon injekcije.
English: This discolouration is expected and will disappear after the treatment has ended
Croatian: Ova promjena boje je očekivana i nestat će nakon što liječenje završi.
English: Alternative treatment options should be considered.
Croatian: Trebalo bi razmotriti druge moguće načine liječenja.
English: Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016
Croatian: Datum posljednje obnove odobrenja: 8. veljače 2016.
English: Usually, treatment should not exceed one day.
Croatian: Obično, liječenje ne bi trebalo trajati dulje od jednog dana.
English: Treatment does not usually exceed one day.
Croatian: Liječenje obično ne traje dulje od jednog dana.
English: Keep the ampoule in the original package in order to protect from light.
Croatian: Ampulu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: One-month repeated dose toxicity in dogs showed no macroscopic toxic effects.
Croatian: Toksičnost jednomjesečnih ponovljenih doza u pasa nije pokazala makroskopske učinke.
English: Protective measures against exposure to light should be taken.
Croatian: Potrebno je poduzeti zaštitne mjere protiv izlaganja svjetlu.
English: After opening or dilution: From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product must be used immediately.
Croatian: Nakon otvaranja ili razrjeđivanja: S mikrobiološkog stajališta, osim u slučaju kada metoda otvaranja/ razrjeđivanja isključuje rizik od mikrobiološke kontaminacije, lijek se mora odmah primijeniti.
English: This medicine will help your haemoglobin return to normal and restore the transport of oxygen in the blood.
Croatian: Ovaj lijek će pomoći da se hemoglobin vrati u normalu i ponovo uspostavi prijenos kisika u krvi.
English: However, the risk is limited as the medicinal product is intended for acute administration only in emergency situations at hospital.
Croatian: Međutim, rizik je ograničen jer je lijek namijenjen za akutnu primjenu samo u hitnim situacijama u bolnici.
English: In rats, increased resorption rates have been observed.
Croatian: U štakora su primijećene povećane brzine resorpcije.
English: It must not be administered by subcutaneous or intrathecal injection.
Croatian: Lijek se ne smije primjenjivati supkutanom ili intratekalnom injekcijom.
English: Pharmacotherapeutic group: All other therapeutic products, antidotes, ATC code: V03AB17
Croatian: Farmakoterapijska skupina: svi drugi terapijski pripravci, protuotrovi, ATK oznaka: V03AB17
English: Before any administration, it is recommended to inspect the parenteral solutions to verify that they are free of particles.
Croatian: Prije bilo kakve primjene, preporučuje se pregledati parenteralne otopine i provjeriti da ne sadrže nikakve čestice.
English: There is no experience in patients with severe hepatic impairment.
Croatian: Nema iskustva u bolesnika s teškim oštećenjem jetre.
English: In rats and rabbits, teratogenic effects have been reported, with foetal and maternal toxicity.
Croatian: U štakora i kunića prijavljeni su teratogeni učinci uz fetalnu i materinsku toksičnost.
English: The clinical consequence is not known.
Croatian: Kliničke posljedice nisu poznate.
English: The clinical consequences of the inhibition are not known.
Croatian: Nisu poznate kliničke posljedice inhibicije.
English: Both infants had complex medical circumstances and methylthioninium chloride was only partially responsible.
Croatian: Oba dojenčeta imala su složene medicinske okolnosti i metiltioninijev klorid je bio samo djelomično odgovoran.
English: • Deficiency in NADPH (nicotinamide adenine dinucleotide phosphate) reductase.
Croatian: • Manjak NADPH (nikotinamid adenin dinukleotid fosfat) reduktaze.
English: Reported in infants only
Croatian: Prijavljeno samo kod dojenčadi
English: Other medicines and Methylthioninium chloride Proveblue Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Methylthioninium chloride Proveblue Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti uzimali bilo koje druge lijekove.
English: Use immediately on opening.
Croatian: Primijeniti odmah nakon otvaranja.
English: The patient should be maintained under observation, the methaemoglobin level should be monitored and appropriate supportive measures taken as necessary.
Croatian: Bolesnika treba zadržati na promatranju, potrebno je pratiti razinu methemoglobina i po potrebi poduzimati odgovarajuće potporne mjere.