FrancophonIA/ELRC3.0 huggingface dataset:
English: It is unlikely that the antibody responses to treatment with Somatropin Biopartners are of clinical relevance.
Croatian: Odgovori protutijela na liječenje Somatropinom Biopartners najvjerojatnije nemaju kliničku važnost.
English: The solvent vial should be warmed to room temperature and the powder vial should be tapped and shaken to ensure the powder is moving freely.
Croatian: Bočicu s otapalom treba zagrijati na sobnu temperaturu, a bočicu s praškom kucnuti i protresti kako bi se provjerilo da se prašak slobodno miče.
English: Treatment should be discontinued if there is evidence of tumour
Croatian: Liječenje se mora prekinuti ako postoji dokaz (ponovnog) rasta tumora.
English: Therefore, in children weighing more than 40 kg the overall injection volume must be divided into equal parts between two injection sites, as more than 1 mL of suspension is required.
Croatian: Stoga u djece tjelesne težine veće od 40 kg ukupni volumen injekcije mora se jednoliko razdijeliti na dva mjesta injekcije, jer je potrebno više od 1 ml suspenzije.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza “Rok valjanosti”.
English: Side effects very commonly reported in adults (may affect more than 1 in 10 people) were tissue swelling due to fluid retention, mild increase in blood sugar and headache.
Croatian: Vrlo često zabilježene nuspojave u odraslih (mogu se javiti u više od 1 na 10 osoba) bile su otok tkiva zbog zadržavanja tekućine, blago povišenje šećera u krvi i glavobolja.
English: Growth hormone increases the extrathyroidal conversion of thyroxin (T4) to triiodothyronine (T3) and may unmask central hypothyroidism.
Croatian: Hormon rasta povećava ekstratiroidno pretvaranje tiroksina (T4) u trijodotironin (T3) i može otkriti prikriveni centralni hipotireoidizam.
English: • Somatropin must not be used when there is any evidence of tumour activity.
Croatian: • Somatropin se ne smije primijeniti kad postoji bilo kakav dokaz tumorske aktivnosti.
English: Common: Hypercortisolism (7.7%), hypothyroidism (2.2%), adrenal cortical insufficiency (3.3%), hypothyreosis secondary to TSH deficiency (2.6%), decreased free thyroxine (4.4%), increased blood TSH (2.2%)
Croatian: Često: hiperkortizolizam (7,7%), hipotireoidizam (2,2%), adrenalna kortikalna insuficijencija (3,3%), sekundarna hipotireoza zbog nedostatka TSH (2,6%), smanjeni slobodni tiroksin (4,4%), povišeni TSH u krvi (2,2%)
English: Long-term therapy in growth hormone-deficient patients increases bone mineral density.
Croatian: Dugotrajno liječenje bolesnika s nedostatkom hormona rasta povećava mineralnu gustoću kostiju.
English: Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency (GHD).
Croatian: Dijagnozu i terapiju ovim lijekom trebaju započeti i nadzirati liječnici s odgovarajućim iskustvom u dijagnozi i liječenju bolesnika s nedostatkom hormona rasta (NHR).
English: The adverse reactions most commonly reported were injection site related reactions, peripheral oedema, headache, myalgia, arthralgia, paraesthesia, hypothyroidism and decreased free thyroxine.
Croatian: Najčešće zabilježene nuspojave bile su reakcije na mjestu primjene injekcije, periferni edemi, glavobolja, mialgija, artralgija, parestezija, hipotireoidizam i snižen slobodni tiroksin.
English: Inject the entire contents of the syringe into the vial of powder, holding the syringe against the vial wall.
Croatian: Ubrizgajte cijeli sadržaj štrcaljke u bočicu s praškom, držeći štrcaljku uz stijenku bočice.
English: The swirling should only be stopped once the suspension appears uniform, white and all the powder on the bottom is dispersed.
Croatian: S mućkanjem treba prestati kad suspenzija izgledom postane jednolična, bijela i sav prašak s dna bude raspršen.
English: - You must have regular thyroid function tests as this medicine can affect the amount of thyroid
Croatian: - Morate redovito raditi pretrage funkcije štitne žlijezde, jer ovaj lijek može utjecati na količinu hormona štitne žlijezde u krvi.
English: Malignancies/tumours
Croatian: Zloćudne bolesti/tumori
English: Intracranial tumours must be inactive and antitumour therapy must be completed prior to the initiation of growth hormone therapy.
Croatian: Intrakranijalni tumori moraju biti neaktivni i antitumorska terapija mora biti završena prije početka terapije hormonom rasta.
English: Common: Back pain, pain in extremities, arthralgia, shoulder pain, musculoskeletal stiffness, bone pain, muscular weakness, sensation of heaviness, tendonitis, joint swelling, arthritis, musculosceletal pain, myalgia*
Croatian: Često: bol u leđima, bol u ekstremitetima, artralgija, bol u ramenu, mišićno-koštana ukočenost, bol u kostima, mišićna slabost, osjećaj težine, tendinitis, otok zglobova, artritis, mišićno-koštana bol, mialgija*
English: Scoliosis
Croatian: Skolioza
English: At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension.
Croatian: Za sada nema dovoljno dokaza na temelju kojih bi se mogle donositi kliničke odluke za bolesnike s prethodnom riješenom intrakranijalnom hipertenzijom.
English: An increasing sensitivity to growth hormone (expressed as change in IGF-I per growth hormone dose) over time may be observed, particularly in men.
Croatian: Tijekom vremena može se opaziti pojačana osjetljivost na hormon rasta (izražena kao promjena u IGF-I po dozi hormona rasta).
English: Because human growth hormone (hGH) may induce a state of insulin resistance and hyperglycaemia, patients treated with this medicinal product should be monitored for evidence of glucose intolerance.
Croatian: Budući da ljudski hormon rasta (hGH) može dovesti do inzulinske rezistencije i hiperglikemije, bolesnici liječeni ovim lijekom moraju se nadzirati zbog znakova intolerancije glukoze.
English: Paediatric patients with endocrine disorders, including GHD, may develop slipped capital femoral epiphyses more frequently.
Croatian: Pedijatrijski bolesnici s endokrinim poremećajima, uključujući NHR, mogu češće razviti skliznuće glave bedrene kosti.
English: Side effects very commonly reported (may affect more than 1 in 10 people) were injection site swelling and development of substances (antibodies) in the blood that bind to growth hormone.
Croatian: Vrlo često zabilježene nuspojave (mogu se javiti u više od 1 na 10 osoba) bile su otok na mjestu injekcije i razvoj tvari u krvi koje vežu hormon rasta i zovu se protutijela.
English: Patients taking insulin for diabetes mellitus should be carefully monitored during treatment with somatropin.
Croatian: Bolesnici koji uzimaju inzulin za šećernu bolest moraju se pažljivo pratiti tijekom liječenja somatropinom.
English: Tumours must be inactive and cancer therapy complete before you can start your treatment with growth hormone.
Croatian: Tumori moraju biti inaktivni i terapija raka mora biti završena prije nego što počnete liječenje hormonom rasta.
English: Therefore, if you weigh more than 40 kg the overall injection volume must be divided into equal parts between two injection sites, as more than 1 mL of suspension is required.
Croatian: Stoga, ako imate tjelesnu težinu veću od 40 kg ukupni volumen injekcije mora se jednoliko razdijeliti na dva mjesta injekcije, jer je potrebno više od 1 ml suspenzije.
English: Common: headache (4.4%), lethargy (1.1%), dizziness (2.6%) Rare: paraesthesia*
Croatian: Često: glavobolja (4,4%), letargija (1,1%), omaglica (2,6%) Rijetko: parestezija*
English: Your doctor may need to adjust the dose of Somatropin Biopartners or of the other medicines: - corticosteroids, such as cortisone or prednisolone: medicines to reduce inflammation or immune system activity, to prevent organ transplant rejection or to treat asthma - thyroxine: a medicine to treat reduced thyroid gland function - insulin: a medicine to lower blood sugar levels
Croatian: Liječnik će Vam možda trebati prilagoditi dozu Somatropina Biopartners ili drugog lijeka: - kortikosteroidi, kao što je kortizon ili prednizolon: lijekovi za smanjenje upale ili aktivnosti imunološkog sustava, za sprječavanje odbacivanja presađenog organa ili za liječenje astme - tiroksin: lijek za liječenje smanjene funkcije štitne žlijezde - inzulin: lijek za snižavanje razine šećera u krvi
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: What Somatropin Biopartners contains
Croatian: Što Somatropin Biopartners sadrži
English: When adverse reactions occurred, they tended to be transient and severity was generally mild to moderate.
Croatian: Kad su nastale nuspojave, pokazale su se prolaznima i po težini su općenito bile blage do umjerene.
English: What you need to know before you use Somatropin Biopartners
Croatian: Što morate znati prije nego počnete primjenjivati Somatropin Biopartners
English: Collect the following items before you begin: - supplied in the pack - Somatropin Biopartners vial containing active substance - Somatropin Biopartners vial containing 1.5 mL solvent for suspension for injection - not supplied in the pack - one sterile injection syringe with 19 (19G) or wider Gauge needle to withdraw the solvent - one sterile injection syringe with 26 Gauge (26G) needle for the injection
Croatian: Prikupite sljedeći pribor prije nego što počnete: - isporučeno u pakiranju - Somatropin Biopartners bočica koja sadrži djelatnu tvar - Somatropin Biopartners bočica koja sadrži 1,5 ml otapala za suspenziju za injekciju - nije isporučeno u pakiranju - jedna sterilna štrcaljka za injekciju s iglom od 19 Gaugea (19G) ili širom za izvlačenje otapala - jedna sterilna štrcaljka za injekciju s iglom od 26 Gaugea (26G) za injekciju - vatica natopljena alkoholom - suha gaza ili vatica - samoljepivi flaster - kutija za odlaganje uporabljenih štrcaljki i igala
English: Leukaemia
Croatian: Leukemija
English: A baseline scan is recommended in these patients before instituting growth hormone replacement therapy.
Croatian: Preporučuje se početna snimka u ovih bolesnika prije uvođenja nadomjesne terapije hormonom rasta.
English: Injecting the suspension
Croatian: Ubrizgavanje suspenzije
English: Withdrawing the suspension
Croatian: Izvlačenje suspenzije
English: The solvent is a clear, oily liquid.
Croatian: Otapalo je bistra, uljna tekućina.
English: Excessive glucocorticoid therapy will inhibit the growth-promoting effect of hGH.
Croatian: Prekomjerna terapija glukokortikoidima inhibirat će učinak hGH na poticanje rasta.
English: Remove the needle guard and fill the syringe with a volume of air equal to the required volume of the solvent for injection, making it easier to withdraw the solvent:
Croatian: Uklonite štitnik za iglu i napunite štrcaljku volumenom zraka koji je jednak potrebnom volumenu otapala za injekciju, što će olakšati izvlačenje otapala:
English: Other medicines and Somatropin Biopartners
Croatian: Drugi lijekovi i Somatropin Biopartners
English: Tap and shake the vial of powder to make sure the powder is moving freely.
Croatian: Kucnite po bočici s praškom i protresite je kako biste provjerili da se prašak slobodno miče.
English: Caution should be exercised when this medicinal product is administered to breast-feeding women.
Croatian: Potreban je oprez kad se ovaj lijek primjenjuje dojiljama.
English: Patients receiving concomitant glucocorticoid therapy should have their dose carefully adjusted.
Croatian: Bolesnicima koji istovremeno primaju terapiju glukokortikoidima moraju se pažljivo prilagoditi doze.
English: Solvent: Medium chain triglycerides.
Croatian: Otapalo: trigliceridi srednje duljine lanca.
English: Somatropin therapy has a beneficial effect on body composition in patients with -GHD, in that body fat stores are reduced and lean body mass is increased.
Croatian: Terapija somatropinom ima povoljan učinak na sastav tijela u bolesnika s NHR, na način da se smanjuju tjelesne zalihe masti, a povećava bezmasna tjelesna masa.
English: • Somatropin treatment must not be started in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure or similar conditions.
Croatian: • Liječenje Somatropinom ne smije se započeti u bolesnika s akutnom kritičnom bolešću zbog komplikacija nakon otvorene operacije srca ili abodimena, višestrukih traumatskih ozljeda ili u bolesnika s akutnim respiratornim zatajenjem ili slična stanja.
English: Common: Adrenal insufficiency, decreased free thyroxine, decreased free tri-iodothyronine, increased blood TSH, hypothyroidism*
Croatian: Često: adrenalna insuficijencija, smanjeni slobodni tiroksin, smanjeni slobodni trijodotironin, povišeni TSH u krvi, hipotireoidizam*
English: The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data):
Croatian: Učestalost niže navedenih nuspojava definirana je pomoću sljedeće konvencije: Vrlo često (≥1/10); često (≥1/100 i <1/10); rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Side effects were generally transient and mild to moderate.
Croatian: Nuspojave su općenito bile prolazne i blage do umjerene.
English: Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD).
Croatian: Somatropin Biopartners je indiciran za nadomjesnu terapiju endogenim hormonom rasta u odraslih s nedostatkom hormona rasta (NHR) koji je nastao u djetinjstvu ili odrasloj dobi.
English: Preparing the suspension
Croatian: Priprema suspenzije
English: Holding the needle against the inside vial wall, the entire contents of the syringe should be injected into the powder vial.
Croatian: Držeći iglu uz unutarnju stijenku bočice, potrebno je ubrizgati cijeli sadržaj štrcaljke u bočicu s praškom.
English: Somatropin Biopartners has given rise to the formation of antibodies in approximately 4% of adult patients.
Croatian: Somatropin Biopartners izazvao je stvaranje protutijela u približno 4% odraslih bolesnika.
English: Common: Conjunctivitis, visual acuity reduced
Croatian: Često: konjunktivitis, smanjena oštrina vida
English: - 0.7 mL in a 1 mL graduated syringe for Somatropin Biopartners 10 mg - 1.2 mL in a 2 mL graduated syringe for Somatropin Biopartners 20 mg
Croatian: - 0,7 ml u graduiranoj štrcaljki od 1 ml za Somatropin Biopartners 10 mg - 1,2 ml u graduiranoj štrcaljki od 2 ml za Somatropin Biopartners 20 mg
English: Somatropin promotes cellular protein synthesis and nitrogen retention.
Croatian: Somatropin potiče sintezu staničnih proteina i zadržavanje dušika.
English: Somatropin Biopartners is not recommended in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti Somatropin Biopartners u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Thyroid function should therefore be closely monitored in all patients.
Croatian: Stoga se u svih bolesnika mora pažljivo pratiti funkcija štitne žlijezde.
English: Paediatric population (below 2 years of age) Somatropin Biopartners should not be used in infants below the age of 2 years.
Croatian: Somatropin Biopartners ne smije se primjenjivati u dojenčadi mlađe od 2 godine.
English: Somatropin Biopartners has given rise to the formation of antibodies in approximately 33% of the paediatric patients.
Croatian: Somatropin Biopartners doveo je do razvoja protutijela u približno 33% pedijatrijskih bolesnika.
English: The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data):
Croatian: Učesatlost niže navedenih nuspojava definirana je pomoću sljedeće konvencije: Vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The maximum retrievable amount of somatropin in one vial of suspension is 20 mg which is sufficient for administration in children of up to 40 kg bodyweight.
Croatian: Maksimalna količina somatropina koja se može izvući iz jedne bočice suspenzije je 20 mg, što je dovoljno za primjenu u djece tjelesne težine do 40 kg.
English: Fatty tissue under the skin can shrink at the site of injection on repeated administration at the same site.
Croatian: Potkožno masno tkivo može se stisnuti na mjestu primjene injekcije kad se ponavlja primjena na isto mjesto.
English: General disorders and administration site conditions Very common: injection site swelling (30.8%)
Croatian: Vrlo često: otok na mjestu injekcije (30,8%)
English: Only stop swirling the vial once the suspension appears uniform, white and all the powder on the bottom is dispersed.
Croatian: S mućkanjem kružnim pokretima treba prestati kad suspenzija izgledom postane jednolična, bijela i sav prašak s dna bude raspršen.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: 10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: 4 vials of 20 mg powder
Croatian: 4 bočice s 20 mg praška
English: - 0.4 mL in a 1 mL graduated syringe for Somatropin Biopartners 2 mg - 0.6 mL in a 1 mL graduated syringe for Somatropin Biopartners 4 mg - 0.9 mL in a 1 mL graduated syringe for Somatropin Biopartners 7 mg
Croatian: - 0,4 ml u graduiranoj štrcaljki od 1 ml za Somatropin Biopartners 2 mg - 0,6 ml u graduiranoj štrcaljki od 1 ml za Somatropin Biopartners 4 mg - 0,9 ml u graduiranoj štrcaljki od 1 ml za Somatropin Biopartners 7 mg
English: Turn the vial upside down, with the syringe in and place the tip of the needle in the suspension as shown in figure 9.
Croatian: Okrenite bočicu s uvedenom štrcaljkom naopako i postavite vršak igle u suspenziju kako je prikazano na slici 9.
English: Long term carcinogenicity studies with Somatropin Biopartners have not been conducted.
Croatian: Nisu provedena dugotrajna ispitivanja kancerogenosti Somatropina Biopartners.
English: Important information about some of the ingredients of Somatropin Biopartners
Croatian: Važne informacije o nekim sastojcima Somatropina Biopartners
English: Uncommon, may affect up to 1 in 100 people - enlargement of the male breast
Croatian: Manje često, mogu se javiti u do 1 na 100 osoba - povećanje dojki kod muškaraca
English: The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 6-month controlled clinical study with 151 adult patients with GHD of adult or childhood-onset and in a 6-month extension study.
Croatian: Opažene su sljedeće nuspojave tijekom liječenja Somatropinom Biopartners u 6-mjesečnom kontroliranom kliničkom ispitivanju u 151 odraslih bolesnika s NHR nastalim u odrasloj dobi ili djetinjstvu i u 6-mjesečnom produžetku ispitivanja.
English: Insert the needle straight through the centre of the vial's rubber stopper into the suspension.
Croatian: Uvedite iglu ravno kroz sredinu gumenog čepa na bočici u suspenziju.
English: These patients should be counselled on risks before initiating therapy.
Croatian: Prije početka terapije ovi bolesnici moraju biti obaviješteni o rizicima.
English: Dosage reductions may be necessary: - in patients above 60 years of age - in patients who develop long lasting tissue swelling caused by fluid retention or who develop abnormal sensations such as prickling, tingling and itchiness - to avoid the development of carpal tunnel syndrome, where the nerve running through the wrist
Croatian: Sniženje doze može biti potrebno: - u bolesnika starijih od 60 godina - u bolesnika koji razviju dugotrajni otok tkiva prouzročen zadržavanjem tekućine ili koji razviju abnormalne senzacije kao što su bockanje, trnci i svrbež - da bi se izbjegao razvoj sindroma karpalnog kanala, gdje dolazi do pritiska na živac koji prolazi kroz zapešće (živac medijanus), što dovodi do utrnulosti i bola u šaci - nakon primjene lijeka tijekom produljenog vremenskog razdoblja, osobito u muškaraca.
English: Common: Impaired fasting glucose, hyperlipidaemia, increased blood insulin, increased blood cholesterol, decreased blood sodium, increased blood triglycerides, increased blood glucose, increased or decreased HDL, increased LDL
Croatian: Često: oštećenje tolerancije glukoze natašte, hiperlipidemija, povišen inzulin u krvi, povišen kolesterol u krvi, sniženi natrij u krvi, povišeni trigliceridi u krvi, povišena glukoza u krvi, povišen ili snižen HDL, povišen LDL
English: Common: Decreased or increased white blood cell count, increased glycosylated haemoglobin, decreased haemoglobin
Croatian: Često: smanjeni ili povećani broj bijelih krvnih stanica, povećani glikozilirani hemoglobin, sniženi hemoglobin
English: Somatropin Biopartners is not recommended during pregnancy.
Croatian: Ne preporučuje se koristiti Somatropin Biopartners tijekom trudnoće.
English: Clean the injection site with an unused alcohol swab.
Croatian: Očistite mjesto za injekciju pomoću nove vatice natopljene alkoholom.
English: IGF-I SDS in the range of +1 to +2
Croatian: IGF-I SDS u rasponu od +1 do +2
English: Somatropin Biopartners is indicated in children and adolescents aged 2 to 18 years for long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Croatian: Somatropin Biopartners je indiciran u djece i adolescenata u dobi od 2 do 18 godina za dugotrajno liječenje zastoja u rastu zbog nedovoljnog izlučivanja endogenog hormona rasta.
English: The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 12-month controlled comparative clinical study in 178 treatment naïve children with growth failure due to insufficient secretion of endogenous growth hormone and in a dose finding study.
Croatian: Opažene su sljedeće nuspojave tijekom liječenja Somatropinom Biopartners u 12-mjesečnom kontroliranom usporednom kliničkom ispitivanju u 178 djece koja prethodno nisu bila liječena i imaju zastoj u rastu zbog nedostatnog lučenja endogenog hormona rasta i u ispitivanju pronalaženja doze.
English: After reconstitution the medicinal product should be used immediately before the suspension settles.
Croatian: Nakon rekonstitucije, lijek treba primijeniti odmah prije nego što se suspenzija slegne.
English: Adults with childhood-onset of GHD
Croatian: Odrasli s NHR nastalim u djetinjstvu
English: After reconstitution the injection should be administered immediately.
Croatian: Nakon rekonstitucije, injekcija se mora treba odmah primijeniti.
English: General disorders and administration site conditions Very common: Oedema peripheral, oedema (local and generalised)* Common: Fatigue, pain, asthenia, face oedema, local swelling, oedema, thirst, malaise, chest pain, increased weight, injection site pain
Croatian: Vrlo često: periferni edemi, edemi (lokalni i generalizirani)* Često: umor, bol, astenija, edem lica, lokalni otok, edemi, žeđ, malaksalost, bol u prsištu, povećana tjelesna težina, bol na mjestu injekcije
English: In patients with an already manifest diabetes mellitus, the anti-diabetic therapy might require adjustment when somatropin treatment is initiated.
Croatian: U bolesnika s već manifestnom šećernom bolešću moguća je prilagodba antidijabetičke terapije prilikom započinjanja terapije somatropinom.