FrancophonIA/ELRC3.0 huggingface dataset:
English: Specific for the complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections indications treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours) for up to 14 days.
Slovenian: 1, pozitiven test za Clostridioides Značilno za indikacije zapletene okužbe v trebušni votlini, akutni pielonefritis in zapletene okužbe sečil, zdravljene z zdravilom Zerbaxa (1 g/0,5 g intravensko na 8 ur) do 14 dni.
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia**
Slovenian: Bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem**
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia
Slovenian: Bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem
English: In clinical studies, there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Slovenian: Pri bolnikih, pri katerih je v kliničnih študijah med zdravljenjem prišlo do pozitivnega DAGT, ni bilo dokazov o hemolizi.
English: How to store Zerbaxa
Slovenian: Shranjevanje zdravila Zerbaxa
English: Hepatic impairment
Slovenian: Psihiatrične motnje nespečnost
English: 1, anxiety Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol
English: Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Slovenian: Gramnegativne bakterije Escherichia coli Klebsiella pneumoniae
English: Zerbaxa 1 g / 0.5 g powder for concentrate for solution for infusion ceftolozane / tazobactam
Slovenian: Zerbaxa 1 g / 0,5 g prašek za koncentrat za raztopino za infundiranje ceftolozan / tazobaktam
English: A decline in renal function has been seen in patients receiving ceftolozane/tazobactam.
Slovenian: Pri bolnikih, ki so prejemali ceftolozan/tazobaktam, so opazili zmanjšano delovanje ledvic.
English: 1, renal failure
Slovenian: 1, odpoved ledvic
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftolozane/tazobactam (see section 4.8).
Slovenian: Pri uporabi ceftolozana/tazobaktama so poročali o kolitisu in psevdomembranskem kolitisu, povezanima z antibiotikom (glejte poglavje 4.8).
English: Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis*
Slovenian: Enterobacterales zapletene okužbe v trebušni votlini* zapletene okužbe sečil* akutni pielonefritis*
English: Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis* Hospital-acquired pneumonia, including ventilator-associated pneumonia**
Slovenian: P. aeruginosa zapletene okužbe v trebušni votlini* zapletene okužbe sečil* akutni pielonefritis* bolnišnična pljučnica, vključno s pljučnico, povezano z umetnim predihavanjem**
English: Hyperglycaemia hypomagnesaemia hypophosphataemia
Slovenian: Presnovne in prehranske motnje hipokaliemija hiperglikemija hipomagneziemija hipofosfatemija
English: For preparation of the 1.5 g ceftolozane / 0.75 g tazobactam dose: Withdraw the entire contents from one reconstituted vial (approximately 11.4 mL per vial) and 5.7 mL from a second reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 1,5 mg ceftolozana/0,75 g tazobaktama: Z brizgo izvlecite celotno vsebino ene rekonstituirane viale (približno 11,4 ml na vialo) in 5,7 ml iz druge rekonstituirane viale in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: Tazobactam is a beta-lactam structurally related to penicillins.
Slovenian: Tazobaktam je betalaktam, po zgradbi soroden penicilinom.
English: Candidiasis including oropharyngeal and vulvovaginal Clostridioides difficile colitis fungal urinary tract infection Clostridioides difficile infection
Slovenian: Infekcijske in parazitske bolezni kolitis zaradi Clostridioides difficile kandidoza, vključno z orofaringealno in vulvovaginalno
English: No dose adjustment is recommended for ceftolozane/tazobactam in subjects with hepatic impairment (see section 4.2).
Slovenian: Pri bolnikih z okvaro jeter prilagoditev odmerka ceftolozana/tazobaktama ni potrebna (glejte poglavje 4.2).
English: Dyspnoea
Slovenian: Odmerek
English: For preparation of the 2 g ceftolozane / 1 g tazobactam dose: Withdraw the entire contents from two reconstituted vials (approximately 11.4 mL per vial) using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 2 g ceftolozana/1 g tazobaktama: Z brizgo izvlecite celotno vsebino iz dveh rekonstituiranih vial (približno 11,4 ml na vialo) in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: Zerbaxa was evaluated in Phase 3 comparator-controlled clinical trials of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis), which included a total of 1,015 patients, treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
Slovenian: V preskušanja je bilo vključenih skupaj 1.015 bolnikov, ki so se do 14 dni zdravili z zdravilom Zerbaxa (1 g/0,5 g intravensko na 8 ur, prilagojeno delovanju ledvic, če je bilo potrebno).
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - Hypersensitivity to any cephalosporin antibacterial agent; - Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).
Slovenian: - Huda preobčutljivost (npr. anafilaktična reakcija, huda kožna reakcija) na katero koli drugo vrsto betalaktamskih antibiotikov (npr. na peniciline ali karbapeneme).
English: In addition tazobactam does not inhibit the following types of beta-lactamase:
Slovenian: Tazobaktam ne zavira vseh encimov skupine A. Prav tako tazobaktam ne zavira naslednjih tipov betalaktamaz:
English: For preparation of the 1 g ceftolozane / 0.5 g tazobactam dose: Withdraw the entire contents (approximately 11.4 mL) of the reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 1 g ceftolozana/0,5 g tazobaktama: Z brizgo izvlecite celotno vsebino rekonstituirane viale (približno 11,4 ml) in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: For preparation of the 250 mg ceftolozane / 125 mg tazobactam dose: Withdraw 2.9 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 250 mg ceftolozana/125 mg tazobaktama: 2,9 ml vsebine izvlecite iz rekonstituirane viale in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: For preparation of the 300 mg ceftolozane / 150 mg tazobactam dose: Withdraw 3.5 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 300 mg ceftolozana/150 mg tazobaktama: 3,5 ml vsebine izvlecite iz rekonstituirane viale in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: Zerbaxa was evaluated in a Phase 3 comparator-controlled clinical trial of hospital-acquired pneumonia, including ventilator-associated pneumonia, which included a total of 361 patients, treated with Zerbaxa (2 g / 1 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
Slovenian: Preskušanje je zajelo 361 bolnikov, ki so do 14 dni prejemali zdravilo Zerbaxa (2 g/1 g intravensko na 8 ur, prilagojeno delovanju ledvic, če je bilo treba).
English: Peri/postnatal development was impaired (reduced pup weights, increase in stillbirths, increase in pup mortality) concurrent with maternal toxicity after intraperitoneal administration of tazobactam in the rat.
Slovenian: Po intraperitonealni uporabi tazobaktama pri podganah so poleg toksičnih učinkov pri samicah - materah opažali prizadetost peri- in postnatalnega razvoja (manjša telesna masa mladičev, več mrtvoskotenosti, večja umrljivost mladičev).
English: For preparation of the 500 mg ceftolozane / 250 mg tazobactam dose: Withdraw 5.7 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 500 mg ceftolozana/250 mg tazobaktama: 5,7 ml vsebine izvlecite iz rekonstituirane viale in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: Complicated urinary tract infections
Slovenian: Zapletene okužbe sečil Akutni pielonefritis
English: For preparation of the 100 mg ceftolozane / 50 mg tazobactam dose: Withdraw 1.2 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Slovenian: Za pripravo odmerka 100 mg ceftolozana/50 mg tazobaktama: 1,2 ml vsebine izvlecite iz rekonstituirane viale in jo dodajte v infuzijsko vrečko, ki vsebuje 100 ml 0,9 % natrijevega klorida za injiciranje (fiziološke raztopine) ali 5 % glukoze za injiciranje.
English: Nausea
Slovenian: Občutljivi
English: Complicated intra-abdominal infections
Slovenian: Zapletene okužbe sečil
English: Sodium chloride Arginine
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid arginin citronska kislina, brezvodna
English: No dose adjustment of ceftolozane/tazobactam is recommended for hospital-acquired pneumonia, including ventilatorassociated pneumonia patients with augmented renal clearance.
Slovenian: Pri bolnikih z bolnišnično pljučnico, vključno s pljučnico, povezano z umetnim predihavanjem, ki imajo povečan očistek kreatinina odmerka ceftolozana/tazobaktama ni treba prilagoditi.
English: This summary was last updated in 07-2014.
Slovenian: Povzetek je bil nazadnje posodobljen 07-2014.
English: The full EPAR for Ratiograstim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ratiograstim je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ratiograstim on 15 September 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ratiograstim, veljavno po vsej Evropski uniji, izdala 15. septembra 2008.
English: This means that Ratiograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Slovenian: To pomeni, da je podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebujejo enako zdravilno učinkovino (t.i. „referenčno zdravilo“).
English: During the first 21-day chemotherapy cycle, patients treated with either Ratiograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Slovenian: Med prvim 21-dnevnim ciklom kemoterapije so imeli bolniki, zdravljeni bodisi z zdravilom Ratiograstim ali Neupogen, hudo nevtropenijo v povprečju 1,1 dan, v primerjavi s 3,8 dneva pri tistih, ki so prejemali placebo.
English: This is a summary of the European public assessment report (EPAR) for Ratiograstim.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ratiograstim.
English: What measures are being taken to ensure the safe and effective use of Ratiograstim?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ratiograstim?
English: How it is given, the dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Slovenian: Način dajanja zdravila, odmerek in trajanje zdravljenja so odvisni od vzroka za uporabo zdravila, bolnikove telesne mase in odziva na zdravljenje.
English: Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim.
Slovenian: Filgrastim se izdeluje z metodo, imenovano „tehnologija rekombinantne DNK“: pri kateri se v bakterijo vstavi gen (DNK), s katerim lahko tvori filgrastim.
English: The most common side effect with Ratiograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Slovenian: Najpogostejši neželeni učinek zdravila Ratiograstim (opažen pri več kot 1 bolniku od 10) je mišičnoskeletna bolečina (bolečina v mišicah in kosteh).
English: For more information about treatment with Ratiograstim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ratiograstim preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: To study the safety of Ratiograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Slovenian: Za proučitev varnosti zdravila Ratiograstim sta bili izvedeni še dve študiji pri bolnikih s pljučnim rakom in z neHodgkinovim limfomom.
English: The active substance in Ratiograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Slovenian: Zdravilna učinkovina v zdravilu Ratiograstim, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (granulocyte colony stimulating factor - G CSF).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ratiograstim.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: A risk management plan has been developed to ensure that Ratiograstim is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ratiograstim je bil pripravljen načrt obvladovanja tveganj.
English: Ratiograstim is used to stimulate the production of white blood cells in the following situations:
Slovenian: Zdravilo Ratiograstim se uporablja za spodbujanje tvorbe belih krvničk v naslednjih primerih:
English: Ratiograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Slovenian: Zdravilo Ratiograstim se običajno daje v specializiranem zdravstvenem centru, vendar pa si ga lahko bolniki, ki ga prejemajo s podkožno injekcijo, dajejo tudi sami, pod pogojem, da so bili ustrezno usposobljeni.
English: Ratiograstim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Slovenian: Zdravilo Ratiograstim se lahko uporablja tudi pri bolnikih, ki bi naj darovali matične celice za presaditev, za sproščanje teh celic iz kostnega mozga.
English: The Committee recommended that Ratiograstim be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Ratiograstim izda dovoljenje za promet.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Ratiograstim is being used for.
Slovenian: Pri več kot 1 bolniku od 10 se lahko pojavijo tudi drugi neželeni učinki, odvisno od zdravstvenega stanja, zaradi katerega se zdravilo Ratiograstim uporablja.
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da so njegove koristi, kot pri zdravilu Neupogen, večje od z njim povezanih tveganj.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ratiograstim, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Ratiograstim was compared with Neupogen and with placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Slovenian: Zdravilo Ratiograstim so primerjali z zdravilom Neupogen in placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, ki je vključevala 348 bolnic z rakom dojke.
English: Treatment with Ratiograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Slovenian: Zdravljenje z zdraviloma Ratiograstim in Neupogen je privedlo do podobnega skrajšanja trajanja hude nevtropenije.
English: It contains the active substance filgrastim.
Slovenian: Vsebuje zdravilno učinkovino filgrastim.
English: The study looked at the duration of severe neutropenia during the patients' first cycle of cytotoxic chemotherapy.
Slovenian: Študija je proučevala trajanje hude nevtropenije med prvim ciklom citotoksične kemoterapije, ki ga je prejel bolnik.
English: What benefit has Ratiograstim shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ratiograstim izkazalo med študijami?
English: Ratiograstim is given by injection under the skin or infusion into a vein.
Slovenian: Zdravilo Ratiograstim se daje z injekcijo pod kožo ali infuzijo v veno.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Slovenian: • za zmanjšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvničk) in ob pojavu febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri bolnikih, ki jih zdravijo s kemoterapijo (zdravljenje raka), ki je citotoksična (ubija celice);
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Slovenian: • za povišanje ravni nevtrofilcev in zmanjšanje tveganja okužb pri bolnikih z nevtropenijo z anamnezo hudih, ponavljajočih se okužb;
English: The CHMP decided that, in accordance with EU requirements, Ratiograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Ratiograstim po kakovosti, varnosti in učinkovitosti primerljivo z zdravilom Neupogen.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
Slovenian: • za zmanjšanje trajanja nevtropenije pri bolnikih, ki prejemajo zdravljenje za uničenje celic kostnega mozga pred njegovo presaditvijo (kot npr. pri nekaterih bolnikih z levkemijo), pri katerih obstaja tveganje za dolgotrajno, hudo obliko nevtropenije;
English: The replacement acts in same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.
Slovenian: Nadomestek deluje na enak način kot naravni granulocitne kolonije stimulirajoči faktor, in sicer tako, da spodbudi kostni mozeg k tvorjenju več belih krvničk.
English: Ratiograstim is a solution for injection or for infusion (drip into a vein).
Slovenian: Zdravilo Ratiograstim je raztopina za injiciranje ali infundiranje (dajanje v veno).
English: Other information about Ratiograstim
Slovenian: Druge informacije o zdravilu Ratiograstim
English: What is the risk associated with Ratiograstim?
Slovenian: Kakšna tveganja so povezana z zdravilom Ratiograstim?
English: Ratiograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Slovenian: Zdravilo Ratiograstim so proučevali, da bi dokazali, da je podobno referenčnemu zdravilu Neupogen.
English: infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Slovenian: • za zdravljenje trdovratne nevtropenije pri bolnikih z napredovalo okužbo z virusom humane imunske pomanjkljivosti (HIV), za zmanjšanje bakterijskih okužb, kadar ostale vrste zdravljenja niso primerne.
English: Why has Ratiograstim been approved?
Slovenian: Zakaj je bilo zdravilo Ratiograstim odobreno?
English: How has Ratiograstim been studied?
Slovenian: Kako je bilo zdravilo Ratiograstim raziskano?
English: Ratiograstim is a ‘biosimilar' medicine.
Slovenian: Zdravilo Ratiograstim je podobno biološko zdravilo.
English: Therefore, the effectiveness of Ratiograstim was shown to be equivalent to that of Neupogen.
Slovenian: Tako je bilo dokazano, da je zdravilo Ratiograstim enako učinkovito kot zdravilo Neupogen.
English: The reference medicine for Ratiograstim is Neupogen.
Slovenian: Referenčno zdravilo za zdravilo Ratiograstim je zdravilo Neupogen.
English: What is Ratiograstim used for?
Slovenian: Za kaj se zdravilo Ratiograstim uporablja?
English: What is Ratiograstim?
Slovenian: Kaj je zdravilo Ratiograstim?
English: How is Ratiograstim used?
Slovenian: Kako se zdravilo Ratiograstim uporablja?
English: How does Ratiograstim work?
Slovenian: Kako zdravilo Ratiograstim deluje?
English: This summary was last updated in 05-2013.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2013.
English: In children, these side effects are seen in between 1 and 10 patients in 100.
Slovenian: Pri otrocih se ti neželeni učinki pojavljajo pri 1 do 10 bolnikih od 100.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NutropinAq on on 16 February 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom NutropinAq, veljavno po vsej Evropski uniji, odobrila dne 16. februarja 2001.
English: The main measures in the studies in children were the speed of growth during the study and the height at the end of the study.
Slovenian: Glavni merili v študijah pri otrocih sta bili hitrost rasti med samo študijo in telesna višina ob koncu študije.
English: The full EPAR for NutropinAq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NutropinAq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: NutropinAq is used to treat the following groups of children:
Slovenian: Zdravilo NutropinAq se uporablja za zdravljenje naslednjih skupin otrok:
English: EPAR summary for the public somatropin
Slovenian: Povzetek EPAR za javnost somatropin
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Slovenian: Do pomanjkanja lahko pride v odrasli dobi ali otroštvu, mora pa biti pred pričetkom zdravljenja potrjeno s preiskavami.