FrancophonIA/ELRC3.0 huggingface dataset:
English: Interruption or early stopping of treatment with this medicine may impair the success of the therapy.
Slovenian: Prekinitev ali predčasna ustavitev zdravljenja s tem zdravilom lahko ogrozi uspeh zdravljenja.
English: Reconstitution and dilution should be performed using aseptic techniques to ensure the sterility of the prepared suspension.
Slovenian: Rekonstitucija in redčenje morata potekati z aseptičnimi tehnikami, da se zagotovi sterilnost pripravljene suspenzije.
English: The suspension should appear uniform and white.
Slovenian: Suspenzija mora biti enotnega in belega videza.
English: In rabbits and monkeys no adverse effects were observed.
Slovenian: Pri kuncih in opicah niso opazili neželenih učinkov.
English: - Your doctor may check the level of sugar in your urine or blood since it may be affected by this
Slovenian: - Vaš zdravnik bo morda preverjal raven sladkorja v urinu ali krvi, saj lahko to zdravilo nanjo
English: The blood levels of IGF-I require regular monitoring so that they can be kept within the normal range for your age and gender.
Slovenian: Ravni rastnega dejavnika IGF-I v krvi je treba redno spremljati, da se jih lahko vzdržuje v razponu, normalnem za vašo starost in spol.
English: Wash your hands thoroughly with soap and water and dry them with a clean towel before preparing your injection.
Slovenian: Temeljito si umijte roke z milom in vodo, nato pa si jih pred pripravo injekcije osušite s čisto brisačo.
English: Benign intracranial hypertension
Slovenian: Benigna intrakranialna hipertenzija
English: Your doctor may decide upon a lower starting dose.
Slovenian: Vaš zdravnik se lahko odloči zmanjšati začetni odmerek.
English: • Somatropin must not be used for growth promotion in children with closed epiphyses.
Slovenian: • Somatropina se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami.
English: Do not touch the needle or allow it to come into contact with any surface prior to the injection.
Slovenian: Igle se ne dotikajte in ne dovolite, da pride pred injiciranjem v stik s katero koli površino.
English: D-72764 Reutlingen Germany
Slovenian: D-72764 Reutlingen Nemčija
English: Children below 2 years of age
Slovenian: Otroci, stari manj kot 2 leti
English: The dose may be reduced in steps of 0.5 mg at a time.
Slovenian: Odmerek se lahko naenkrat zmanjša v korakih po 0,5 mg.
English: These patients should be counselled on risks before initiating therapy.
Slovenian: Tem bolnikom je treba pred uvedbo zdravljenja svetovati glede teh tveganj.
English: Slowly withdraw the suspension.
Slovenian: Počasi izvlecite suspenzijo.
English: (the median nerve) becomes squeezed, resulting in hand numbness and pain - following use of the medicine over an extended period of time, particularly in men.
Slovenian: (mediani živec) stisne, kar povzroči omrtvelost in bolečino dlani - po dalj časa trajajoči uporabi zdravila, zlasti pri moških
English: It has 191 amino acid residues and a molecular weight of 22,125 Daltons.
Slovenian: Ima 191 aminokislinskih ostankov in molekulsko maso 22.125 daltonov.
English: figure 3b
Slovenian: Slika 3a
English: This medicine is used once a week.
Slovenian: To zdravilo se daje enkrat na teden.
English: Number of injections per dose
Slovenian: Število injekcij na odmerek
English: Remove the carton from the refrigerator.
Slovenian: Škatlo vzemite iz hladilnika.
English: Progression of scoliosis can occur in patients who experience rapid growth.
Slovenian: Napredovanje skolioze se lahko pojavi pri bolnikih, ki hitro rastejo.
English: Pack sizes:
Slovenian: Velikost pakiranja:
English: If you miss a dose, contact your doctor who will help establish a new dosing schedule.
Slovenian: Če izpustite odmerek, se obrnite na svojega zdravnika, ki vam bo pomagal določiti nov načrt odmerjanja.
English: Inadequate treatment of hypothyroidism may prevent optimal response to somatropin.
Slovenian: Neustrezno zdravljenje hipotiroidizma lahko prepreči optimalni odziv na somatropin.
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Slovenian: Vendar pa ni dokazov o večji pojavnosti levkemije pri prejemnikih rastnega hormona brez dejavnikov nagnjenosti.
English: - Inform the doctor if you begin to limp during treatment.
Slovenian: - Obvestite svojega zdravnika, če začnete med zdravljenjem šepati.
English: IGF-I SDS
Slovenian: SDS IGF-I
English: Additional reports based on published information for daily growth hormone treatments are listed with asterisks.
Slovenian: Dodatna poročila, ki temeljijo na objavljenih informacijah za vsakodnevno zdravljenje z rastnim hormonom, so označena z zvezdico.
English: This medicince is injected once a week.
Slovenian: To zdravilo se injicira enkrat na teden.
English: After the injection, growth hormone is slowly released into your body over a period of about a week.
Slovenian: Po injiciranju se rastni hormon počasi sprošča v telo, kar traja približno en teden.
English: Young adult patients with closed epiphyses who have previously been treated as children for GHD should be re-evaluated for GHD using the criteria for adult patients (see section 4.1) before replacement therapy is commenced at the doses recommended for adults.
Slovenian: Mlade odrasle bolnike z zaprtimi epifizami, ki so se predhodno kot otroci zdravili zaradi GHD, je treba ponovno oceniti za GHD s kriteriji za odrasle bolnike (glejte poglavje 4.1), preden se začne nadomestno zdravljenje z odmerki, priporočenimi za odrasle.
English: The most prominent effect of somatropin in children is the stimulation of the growth plates of long bones.
Slovenian: Najbolj poudarjen učinek somatropina pri otrocih je, da stimulira rastne plošče dolgih kosti.
English: In order to reach the defined treatment goal, men may need lower growth hormone doses than women.
Slovenian: Za dosego opredeljenega cilja zdravljenja utegnejo moški potrebovati manjše odmerke rastnega hormona od žensk.
English: Generally, 2 mg once a week for all patients apart from female patients receiving oral oestrogen therapy who should receive 3 mg once a week.
Slovenian: Na splošno je začetni odmerek 2 mg enkrat na teden za vse bolnike, razen za ženske, ki prejemajo peroralno estrogensko terapijo, ki naj prejmejo 3 mg enkrat na teden.
English: Do not inject this medicine yourself unless you have received training and you understand the procedure.
Slovenian: Tega zdravila si ne injicirajte, če o tem niste bili ustrezno poučeni in če ne razumete postopka.
English: +1.5 mg (female on oral oestrogen) +1.0 mg (all other patients)
Slovenian: +1,5 mg (ženske, ki dobivajo peroralni estrogen) +1,0 mg (vsi drugi bolniki)
English: Detailed information on how to administer this medicinal product is provided in section 3 of the patient leaflet.
Slovenian: Podrobne informacije o dajanju tega zdravila najdete v poglavju 3 navodila za bolnika.
English: Thyroxine replacement therapy may therefore need to be initiated or adjusted.
Slovenian: Morda bo treba uvesti ali prilagoditi nadomestno zdravljenje s tiroksinom.
English: The recommended weekly dose in children (i.e. 0.5 mg/kg/week) should not be exceeded as there is limited experience with higher doses in this patient group.
Slovenian: Priporočenega tedenskega odmerka za otroke (tj. 0,5 mg/kg/teden) ni dovoljeno prekoračiti, saj je izkušenj z višjimi odmerki pri tej skupini bolnikov malo.
English: Experience with somatropin treatment in patients above 60 years of age is limited.
Slovenian: Izkušenj z zdravljenjem bolnikov, starejših od 60 let, je malo.
English: -0.5 mg (all patients) IGF-I = insulin-like growth factor-I, SDS = standard deviation score.
Slovenian: -0,5 mg (vsi bolniki) IGF-I = insulinu podobni rastni dejavnik-I, SDS = standardni odklon.
English: With the exception of injection site related reactions and the formation of antibodies to rhGH which were reported more frequently in children than in adults the safety profile of Somatropin Biopartners is similar for children and adults.
Slovenian: Z izjemo reakcij na mestu injiciranja in nastajanjem protiteles proti rhGH, o katerih so pogosteje poročali pri otrocih kot pri odraslih, je profil varnosti zdravila Somatropin Biopartners za otroke in odrasle podoben.
English: Remove the protective caps from the top of both vials as seen in figure 3a.
Slovenian: Odstranite zaščitni zaporki z obeh vial, kot je prikazano na sliki 3a.
English: - If you have had a tumour your doctor will examine you before and regularly during treatment.
Slovenian: - Če ste imeli tumor, vas bo zdravnik pregledal pred zdravljenjem in jih nato med zdravljenjem redno pregledovati.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 ºC - 8 ºC).
English: Vials and solvent required for preparation of one dose*
Slovenian: Viale in vehikel, potrebni za pripravo enega odmerka*
English: This medicine should not be used in infants below the age of 2 years.
Slovenian: Tega zdravila ne uporabljajte pri dojenčkih, starih manj kot 2 leti.
English: Due to the prolonged-release characteristics of this medicinal product peak levels of growth hormone can be expected approximately 15 hours after injection, see section 5.2.
Slovenian: Zaradi podaljšanega sproščanja tega zdravila se pričakovane najvišje ravni rastnega hormona pojavijo približno 15 ur po injiciranju, glejte poglavje 5.2.
English: If the symptoms leading to the dose reduction disappear, at the judgment of the physician, the dose may be maintained at the decreased level or increased according to the dose adjustment scheme described above.
Slovenian: Če simptomi, zaradi katerih je bil odmerek zmanjšan, izginejo, je mogoče odmerek po presoji zdravnika ohraniti na zmanjšani ravni ali pa ga povečati v skladu z zgoraj opisano shemo prilagajanja odmerka.
English: In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Slovenian: Ob upoštevanju tega ni verjetno, da bi bilo potrebno nadaljevanje nadomestnega zdravljenja s somatropinom pri ženskah s pomanjkanjem rastnega hormona v tretjem trimesečju nosečnosti.
English: In women taking oral oestrogens, a higher dose of somatropin may be required to achieve the treatment goal, see section 4.2.
Slovenian: Pri ženskah, ki jemljejo peroralne estrogene, bodo morda potrebni višji odmerki somatropina, da se doseže cilj zdravljenja, glejte poglavje 4.2.
English: Some patients may develop antibodies to rhGH.
Slovenian: Pri nekaterih bolnikih se lahko razvijejo protitelesa proti rhGH.
English: If you are injecting this medicine yourself you will be shown how to prepare and give the injection.
Slovenian: Če si zdravilo injicirate sami, vam bodo pokazali, kako si ga pravilno pripravite in injicirate.
English: Similar results were achieved for all other parameters assessed including height SDS (standard deviation score), bone maturation, IGF-I and IGF BP-3.
Slovenian: Podobne rezultate so dosegli za vse druge ocenjene parametre, vključno s standardnim odklonom (SDS, Standard Deviation Score), zrelostjo kosti, IGF-I in IGF BP-3.
English: In particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Slovenian: Svojega zdravnika še zlasti obvestite, če jemljete ali ste pred kratkim jemali katero od spodaj navedenih zdravil.
English: Initially, patients should have their IGF-I levels assessed at 3- to 4-weekly intervals until IGF-I SDS is in the target range of -0.5 to +1.5.
Slovenian: Na začetku je treba pri bolnikih oceniti ravni IGF-I v 3- do 4-tedenskih intervalih, dokler ni SDS IGF-I v ciljnem razponu od -0,5 do +1,5.
English: Side effects were generally transient and mild to moderate.
Slovenian: Neželeni učinki so bili na splošno prehodni in blagi do zmerni.
English: Conversion from patient body weight to dose, number of vials, total injection volume and number of injections in paediatric patients
Slovenian: Pretvorba s telesne mase bolnika v odmerek, število vial, skupni volumen injiciranja in število injekcij pri pediatričnih bolnikih
English: If the symptom reappears after the dose increase, then the dose should be maintained at the previous lower dose.
Slovenian: Če se simptomi po povečanju odmerka ponovno pojavijo, je treba ohraniti prejšnji nižji odmerek.
English: Few patients discontinued treatment due to injections site reactions.
Slovenian: Nekaj bolnikov je zdravljenje prekinilo zaradi reakcij na mestu injiciranja.
English: Injection volume (mL)
Slovenian: Volumen injekcije (ml)
English: Inject the medicine as instructed by your doctor who will also tell you what dose to use and how to inject this dose with the vials you have been prescribed.
Slovenian: Zdravilo si injicirajte po navodilih zdravnika, ki vam bo povedal tudi, kolikšen odmerek morate uporabiti in kako si morate ta odmerek injicirati z vialami, ki so vam bile predpisane.
English: At present, there is insufficient evidence to guide clinical decision-making in patients with resolved intracranial hypertension.
Slovenian: Trenutno ni dovolj dokazov za vodenje kliničnega odločanja pri bolnikih z odpravljeno intrakranialno hipertenzijo.
English: Few patients discontinued treatment due to injections site reactions, see section 4.8.
Slovenian: Nekaj bolnikov je zdravljenje prekinilo zaradi reakcij na mestu injiciranja, glejte poglavje 4.8.
English: When it stimulates the growth of cells in the long bones of the legs and spine, it causes an increase in height.
Slovenian: S spodbujanjem rasti celic v dolgih kosteh nog in v hrbtenici povzroči povečanje telesne višine.
English: Then continue to fill the syringe with the correct volume of suspension as advised by your doctor.
Slovenian: Nato injekcijsko brizgo polnite naprej, da dosežete pravilno količino suspenzije, kot vam je svetoval vaš zdravnik.
English: These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.
Slovenian: Ti bolniki naj opravijo en dinamični test, s katerim se bodisi dokaže bodisi izključi GHD.
English: Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: After removal of the protective caps from the top of both vials the rubber stoppers should be cleaned with an alcohol swab.
Slovenian: Po odstranitvi zaščitnih zapork z obeh vial je treba gumijasta zamaška očistiti z alkoholno blazinico.
English: Insulin sensitivity
Slovenian: Preobčutljivost na insulin
English: No accumulation of hGH following multiple dosing of this medicinal product has been observed.
Slovenian: Kopičenja hGH po večkratnem odmerjanju tega zdravila niso opazili.
English: Animal studies with this medicinal product are not sufficient to fully assess the reproductive toxicity potential.
Slovenian: Študije na živalih za to zdravilo ne zadoščajo za celovito ocenitev možnega vpliva na sposobnost razmnoževanja.
English: This medicinal product is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of GHD.
Slovenian: To zdravilo ni indicirano za zdravljenje bolnikov, ki ne rastejo zaradi Prader-Willijevega sindroma, razen če so bili diagnosticirani tudi z GHD.
English: Clinical trials included approximately 530 patients treated with Somatropin Biopartners.
Slovenian: V kliničnih preskušanjih je bilo vključenih približno 530 bolnikov, zdravljenih z zdravilom Somatropin Biopartners.
English: Insert the full length of the needle into the skin fold at a right angle (90 degrees) as shown in figure 12.
Slovenian: V kožno gubo vstavite polno dolžino igle pod pravim kotom (90 stopinj), kot prikazuje slika 12.
English: The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be increased resulting in lower plasma levels of these compounds.
Slovenian: Očistek spojin, ki jih presnavlja citokrom P450 3A4 (npr. spolni steroidi, kortikosteroidi, antikonvulzivi in ciklosporin), se lahko poveča, kar povzroči manjše koncentracije teh spojin v plazmi.
English: Some patients may develop antibodies to this medicinal product.
Slovenian: Pri nekaterih bolnikih se lahko razvijejo protitelesa na to zdravilo.
English: The somatropin in this medicinal product is synthesised in yeast (Saccharomyces cerevisiae).
Slovenian: Somatropin v tem zdravilu se sintetizira v celicah kvasovk (Saccharomyces cerevisiae).
English: The binding activity of these antibodies has been low and no clinical consequences have been associated with their formation.
Slovenian: Vezavna dejavnost teh protiteles je bila nizka, njihov nastanek pa ni imel nobenih kliničnih posledic.
English: After the powder is evenly mixed with the solvent provided, this medicine is injected under the skin.
Slovenian: Ko je prašek enakomerno premešan s priloženim vehiklom, se zdravilo injicira pod kožo.
English: Safety and efficacy in adults with GHD was assessed in a phase III, double-blind, randomized, placebo-controlled, parallel-group, multicentre study.
Slovenian: Varnost in učinkovitost pri odraslih s pomanjkanjem rastnega hormona so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani, vzporedni, multicentrični študiji faze III.
English: - You must have regular thyroid function tests as this medicine can affect the amount of thyroid
Slovenian: - Redno morate opravljati teste delovanja ščitnice, saj lahko to zdravilo vpliva na količino
English: For dosage instruction, see table below.
Slovenian: Za navodila glede odmerjanja glejte spodnjo preglednico.
English: Additionally, it promotes cellular protein synthesis and nitrogen retention.
Slovenian: Poleg tega spodbuja celično sintezo beljakovin in zadrževanje dušika.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Somatropin has not been shown to increase the incidence or severity of scoliosis.
Slovenian: Somatropin ni povečal incidence ali resnosti skolioze.
English: The safety profile of Somatropin Biopartners is generally consistent with the well known safety profile of daily growth hormone treatments.
Slovenian: Varnostni profil zdravila Somatropin Biopartners je v glavnem v skladu z dobro znanim varnostnim profilom vsakodnevnega zdravljenja z rastnim hormonom.
English: In the pivotal paediatric study, antibody responses to somatropin at two or more consecutive visits were observed in 33% of the patients.
Slovenian: V osrednji pediatrični študiji, so opazili odzive protiteles na somatropin pri dveh ali več zaporednih obiskih pri 33 % bolnikov.
English: Patient bodyweight (kg)
Slovenian: Telesna masa bolnika (kg)
English: If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
Slovenian: Če je edem papile potrjen, je treba razmisliti o diagnozi benigne intrakranialne hipertenzije in, če je potrebno, prekiniti zdravljenje z rastnim hormonom.
English: Long term over-dosing could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of hGH excess.
Slovenian: Dolgotrajno preveliko odmerjanje lahko povzroči pojav znakov in simptomov gigantizma in/ali akrogemalije, ki so podobni tistim pri čezmernem izločanju hGH.
English: Malignancies/tumours
Slovenian: Malignosti/tumorji
English: Somatropin Biopartners contains human growth hormone, also called somatropin.
Slovenian: Zdravilo Somatropin Biopartners vsebuje humani rastni hormon, imenovan tudi somatropin.
English: No information in patients with renal or hepatic impairment is available and particular dose recommendations cannot be given.
Slovenian: Podatkov o bolnikih z okvarjenim delovanjem ledvic ali jeter ni, zato posebnih priporočil o odmerjanju ni mogoče dati.
English: If the flow stops or bubbles appear, gently tap the syringe with your fingers.
Slovenian: Če se tok ustavi ali se pojavijo mehurčki, s prsti nežno potrkajte po injekcijski brizgi.
English: The injection site should be cleaned with an alcohol swab and the suspension injected over a period of 5 seconds.
Slovenian: Mesto injiciranja očistite z alkoholno blazinico in injicirajte suspenzijo v obdobju 5 sekund.
English: *produced in Saccharomyces cerevisiae by recombinant DNA technology For the full list of excipients, see section 6.1.
Slovenian: *Izdelanega v celicah Saccharomyces cerevisiae z metodo rekombinantne DNA Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: BioPartners GmbH Kaiserpassage 11 D-72764 Reutlingen Germany
Slovenian: BioPartners GmbH Kaiserpassage 11 D-72764 Reutlingen Nemčija
English: A similar improvement was observed for the secondary efficacy endpoints namely increase in lean body mass, serum IGF-I and IGF-I SDS.
Slovenian: Podobno izboljšanje so opazili za sekundarne opazovane parametre učinkovitosti, namreč povečanje puste telesne mase, serumskega IGF-I in SDS IGF-I.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: EXP After reconstitution, use immediately.
Slovenian: EXP Uporabite takoj po rekonstituciji.
English: Somatropin Biopartners is administered subcutaneously once a week.
Slovenian: Zdravilo Somatropin Biopartners se daje subkutano enkrat na teden.
English: • Somatropin must not be used when there is any evidence of tumour activity.
Slovenian: • Somatropina se ne sme uporabljati, če obstajajo znaki dejavnega tumorja.
English: Treatment with growth hormone may facilitate the development of adrenal insufficiency and potentially fatal adrenal crises in patients with organic GHD or idiopathic panhypopituitarism.
Slovenian: Zdravljenje z rastnim hormonom lahko pospeši razvoj insuficience nadledvične žleze in morebitnih smrtnih adrenalnih kriz pri bolnikih z organskim GHD ali idiopatičnim panhipopituitarizmom.
English: Where childhood-onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass).
Slovenian: Kjer se GHD, ki se je začelo v otroštvu, nadaljuje tudi v adolescenci, je treba z zdravljenjem nadaljevati, da dosežemo popoln somatski razvoj (npr. telesna sestava, kostna masa).
English: Animal studies with other somatropin formulations have shown adverse effects but the available nonclinical data are considered insufficient to draw firm conclusions on the use in humans (see section
Slovenian: Študije na živalih z drugimi oblikami somatropina so pokazale neželene učinke, vendar razpoložljivi predklinični podatki ne zadoščajo za sklepanje o uporabi pri ljudeh (glejte poglavje 5.3).
English: It is unknown whether somatropin or its metabolites are excreted in human breast milk; however, absorption of intact protein from the gastrointestinal tract of the infant is unlikely.
Slovenian: Ni znano, ali se somatropin ali njegovi presnovki izločajo v materino mleko, vendar pa ni verjetno, da bi se nepoškodovane beljakovine absorbirale iz prebavil dojenčkov.
English: During normal pregnancy, levels of pituitary growth hormone fall markedly after 20 weeks of gestation, being replaced almost entirely by placental growth hormone by 30 weeks.
Slovenian: Med normalno nosečnostjo ravni hipofiznega rastnega hormona po 20 tednih nosečnosti močno padejo, do 30 tedna pa jih skoraj v celoti nadomesti rastni hormon posteljice.
English: Not all pack sizes may be available in your country.
Slovenian: Na trgu v vaši državi morda ni vseh navedenih pakiranj.
English: Accidental injection of this medicine into the muscle instead of under the skin may result in blood sugar levels becoming too low.
Slovenian: Če si po pomoti injicirate zdravilo v mišico namesto v kožo, lahko to povzroči prenizke ravni krvnega sladkorja.