FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnoea requiring medical treatment have been reported in clinical trials with bupropion.
Slovenian: V kliničnih študijah z bupropionom so poročali o anafilaktoidnih/anafilaktičnih reakcijah, za katere so značilni simptomi, kot so pruritus, urtikarija, angioedem, in dispneji, ki so zahtevale zdravljenje.
English: Taste disorders (B)
Slovenian: zlatenica (B)
English: If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo Mysimba vsebuje laktozo (vrsto sladkorja) Če so vam povedali, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: Diarrhoea, Flatulence, Haemorrhoids , Ulcer
Slovenian: neznana driska, napenjanje, hemoroidi, razjeda
English: • Week 4 and onwards: Two tablets in the morning and two tablets in the evening The maximum recommended daily dose of Mysimba is two tablets taken twice daily for a total dose of 32 mg naltrexone hydrochloride and 360 mg bupropion hydrochloride.
Slovenian: Največji priporočeni dnevni odmerek zdravila Mysimba je dve tableti dvakrat dnevno v skupnem odmerku 32 mg naltreksonijevega klorida in 360 mg bupropionijevega klorida.
English: Irregular menstruation, Vaginal haemorrhage, Vulvovaginal dryness
Slovenian: Motnje reprodukcije in dojk občasni erektilna disfunkcija redki neredna menstruacija, vaginalna krvavitev, suhost vulve/nožnice
English: LS
Slovenian: O
English: How to store Mysimba
Slovenian: Shranjevanje zdravila Mysimba
English: CI, Confidence Interval; LS, Least Squares.
Slovenian: IZ, interval zaupanja.
English: Musculoskeletal and Connective Tissue Disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni trzanje (B)
English: In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced, as these patients may have higher drug concentrations which could result in an increase in adverse drug reactions.
Slovenian: Pri bolnikih z blago jetrno okvaro je treba največji priporočeni dnevni odmerek kombinacije naltrekson/bupropion zmanjšati, saj imajo lahko ti bolniki večje koncentracije zdravila, kar lahko povzroči povečanje neželenih učinkov zdravila (glejte poglavji 4.2 in 5.2).
English: Talk to your doctor or pharmacist before taking Mysimba.
Slovenian: Pred začetkom jemanja zdravila Mysimba se posvetujte z zdravnikom ali farmacevtom.
English: (angioedema) - Excessive loss of body water (dehydration) - Hallucinations - Fainting, almost fainting (presyncope), loss of consciousness - Fits - Passage of fresh blood through the anus usually in or with stool (haematochezia) - Projection of an organ or the tissue encompassing an organ through the wall of the cavity that normally contains it (hernia) - Toothache - Dental caries, cavities - Pain in the lower part of the abdomen - Injury to the liver due to drug toxicity - Jaw pain - A disorder characterised by a sudden compelling urge to urinate (micturition urgency) - Irregular menstrual cycle, vaginal bleeding, dryness of the female vulva and vagina
Slovenian: - epileptični napadi; - izločanje sveže krvi skozi zadnjik, običajno v blatu ali z njim (hematohezija); - izboklina organa ali tkiva, ki obkroža organ, skozi steno votline, kjer se običajno nahaja
English: Hallucination
Slovenian: redki halucinacije
English: Since bupropion is extensively metabolised, caution is advised when naltrexone / bupropion is co-administered with medicinal products known to induce CYP2B6 (e.g., carbamazepine, phenytoin, ritonavir, efavirenz) as these may affect the clinical efficacy of naltrexone / bupropion.
Slovenian: Bupropion se obsežno presnavlja, zato se priporoča previdnost pri sočasni uporabi kombinacije naltrekson/bupropion in zdravil, za katere je znano, da inducirajo encim CYP2B6 (npr. karbamazepin,
English: The two co-primary endpoints were percent change from baseline body weight and the proportion of subjects achieving ≥5% total decreased body weight.
Slovenian: Izhodiščna povprečna vrednost ITM je bila 36 kg/m2, povprečni obseg pasu pa je bil 110 cm. Sočasna primarna cilja sta bila odstotna sprememba glede na izhodiščno telesno maso in delež preiskovancev, ki so skupno zmanjšali telesno maso za ≥5 %.
English: HOMA-IR, % change + Based on LOCF with the last on-drug observation carried forward.
Slovenian: + Po metodi prenosa zadnjega opazovanja v zvezi z zdravilom naprej (LOCF).
English: What you need to know before you take Mysimba
Slovenian: Kaj je zdravilo Mysimba in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Mysimba Kako jemati zdravilo Mysimba
English: Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Bolniki z jetrno okvaro Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.3).
English: A patient should stop taking naltrexone / bupropion and consult a doctor if experiencing allergic or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, oedema, and shortness of breath) during treatment.
Slovenian: Če se med zdravljenjem pri bolniku pojavijo alergijske ali anafilaktoidne/anafilaktične reakcije (npr. kožni izpuščaji, pruritus, urtikarija, bolečine v prsnem košu, edem in kratka sapa), mora prenehati jemati naltrekson/bupropion in se posvetovati z zdravnikom.
English: A patient with suspected DILI should stop taking naltrexone / bupropion.
Slovenian: Bolnik, pri katerem sumimo na poškodbe jeter, povzročene z zdravili, mora prenehati jemati naltrekson/bupropion.
English: Ejaculation delayed (N)
Slovenian: Pogosti zmanjšan apetit (N)
English: Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme including certain antidepressants (SSRIs and many tricyclic antidepressants, e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product.
Slovenian: antipsihotiki (npr. haloperidol, risperidon in tioridazin), antagonisti adrenergičnih receptorjev beta (npr. metoprolol) in antiaritmiki skupine 1C (npr. propafenon in flekainid), mora potekati previdno,
English: Cough, Dysphonia, Dyspnoea, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sinus disorder, Sneezing, Yawning
Slovenian: neprijeten občutek v nosu, bolečina v ustih/žrelu, rinoreja, težave s sinusi, kihanje, zehanje
English: Immune System Disorders
Slovenian: Bolezni imunskega sistema zelo redki
English: Frequency Adverse Reaction
Slovenian: Pogostnost Neželeni učinek
English: Blood and Lymphatic System Disorders Rare
Slovenian: Presnovne in prehranske motnje redki dehidracija
English: Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Slovenian: tedensko (študije NB-301, NB-302 in NB-304) ali 28-tedensko (NB-303) zdravljenje.
English: The most frequent adverse reactions for naltrexone / bupropion are nausea, constipation, vomiting, dizziness, and dry mouth.
Slovenian: Najpogostejši neželeni učinki pri kombinaciji naltrekson/bupropion so navzea, zaprtje, bruhanje,
English: Fatigue, Feeling jittery, Irritability Uncommon Asthenia, Feeling abnormal, Feeling hot, Increased appetite, Thirst
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti utrujenost, občutek živčnosti, razdražljivost občasni astenija, neobičajno počutje, občutek vročine, povečan apetit, žeja redki bolečina v prsnem košu, hladne okončine,
English: Rare side effects (may affect up to 1 in 1,000 people): - Low amount of certain white blood cells (Lymphocyte count decreased) - Decreased haematocrit (indicating loss of red blood cell volume) - Swelling of eyelids, face, lips, tongue or throat, which can cause great difficulty in breathing
Slovenian: - znižana raven nekaterih belih krvnih celic (zmanjšano število limfocitov); - zmanjšanje hematokrita (kaže na zmanjšanje volumna rdečih krvnih celic);
English: España Laboratorios Farmacéuticos ROVI, S.A.
Slovenian: Bruno Farmaceutici S.p.A.
English: Bruno Farmaceutici S.p.A. Tel. 800-781-623
Slovenian: Tel. 800-781-623
English: • Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening
Slovenian: • 3. teden: tri tablete vsak dan, dve zjutraj in ena zvečer; • 4. teden in naprej: dve tableti dvakrat dnevno, dve zjutraj in dve zvečer.
English: • history of head trauma
Slovenian: • poškodba glave v anamnezi;
English: Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity have been reported in association with bupropion.
Slovenian: V povezavi z bupropionom so poročali o artralgiji, mialgiji in povišani telesni temperaturi z izpuščaji ter drugih simptomih, ki kažejo na zapoznelo preobčutljivost.
English: 19.3% of placebo-treated subjects (Week 16 Responders).
Slovenian: (odzivni preiskovanci 16. tedna).
English: Orexigen Therapeutics Ireland Limited Tel. +49 89121409178
Slovenian: Tel. +49 89121409178
English: • you have high blood pressure before taking Mysimba, because it can become worse.
Slovenian: • če imate visok krvni tlak pred jemanjem zdravila Mysimba, kajti stanje se lahko poslabša; pred začetkom jemanja zdravila Mysimba in med jemanjem naj vam izmerijo krvni tlak in srčni utrip; če se vam krvni tlak ali srčni utrip izrazito poveča, boste morali prenehati jemati zdravilo
English: Uncommon Cholecystitis, ALT increased, AST increased, Hepatic enzyme increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni holecistitis, zvišane vrednosti ALT, zvišane vrednosti AST, povečanje vrednosti jetrnih encimov redki poškodbe jeter zaradi zdravila neznana hepatitis
English: There is no clinical experience with overdose with combined use of bupropion and naltrexone.
Slovenian: Pri kombinirani uporabi bupropiona in naltreksona ni kliničnih izkušenj s prevelikim odmerjanjem.
English: - Feeling shaky (tremor) - Difficulty in sleeping (make sure you do not take Mysimba near to bedtime) - Changes in the taste of food (dysgeusia), dry mouth - Difficulty concentrating - Feeling of tiredness (fatigue) and sleepiness, drowsiness or lack of energy (lethargy) - Ringing in the ears (tinnitus) - Fast or irregular heartbeat - Hot flush - Increased blood pressure (sometimes severe) - Pain in the upper part of the abdomen - Pain in the abdomen - Excessive sweating (hyperhidrosis) - Rash, itching (pruritus) - Hair loss (alopecia) - Irritability - Feeling jittery
Slovenian: - hiter ali nepravilen srčni utrip; - vročinski oblivi; - zvišan krvni tlak (včasih resno); - bolečina v zgornjem delu trebuha; - bolečina v trebuhu; - čezmerno potenje (hiperhidroza); - izpuščaji, srbenje (pruritus);
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core:
Slovenian: 6.1 Seznam pomožnih snovi
English: Dry mouth, Abdominal pain upper, Abdominal pain Uncommon Abdominal discomfort, Dyspepsia, Eructation, Rare
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora neznana kašelj, disfonija, dispneja, zamašen nos,
English: (photophobia) - Ear pain, ear discomfort - Fluctuating blood pressure - Difficulty in breathing - Nasal discomfort, congestion, runny nose, sneezing, sinus disorder - Sore throat, disorder of the voice, cough, yawning - Haemorrhoids, ulcer - Diarrhoea - Passing wind (flatulence) - Hepatitis - Acne - Groin pain - Muscle pain - Joint pain - Abnormally frequent urination, painful urination - Chills - Increased energy
Slovenian: - vneto žrelo, motnje glasu, kašelj, zehanje; - hemoroidi, razjeda; - driska; - vetrovi (flatulenca); - hepatitis; - akne;
English: Suicide and suicidal behaviour
Slovenian: (vključno s samomorilnimi mislimi).
English: Not known side effects (frequency cannot be estimated from the available data): - Swollen glands in the neck, armpit or groin (lymphadenopathy) - Mood disorders - Irrational ideas (delusions) - Psychosis - Loss of sexual desire - Feeling hostile - Severe suspiciousness (paranoia) - Aggression - Attention disturbance - Nightmares - Confusion, disorientation - Memory impairment - Restlessness - Muscle stiffness, uncontrolled movements, problems with walking or coordination - Blurred vision, eye pain, eye irritation, eye swelling, watery eyes, increased sensitivity to light
Slovenian: - otekle bezgavke na vratu, pod pazduho ali v dimljah (limfadenopatija); - motnje razpoloženja; - iracionalne ideje (blodnje); - psihoza; - izguba spolne sle; - občutek sovražnosti;
English: Close supervision of patients, particularly those at high risk, should accompany therapy with naltrexone / bupropion especially in early treatment and following dose changes.
Slovenian: Med zdravljenjem z naltreksonom/bupropionom, zlasti po uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati, še posebno bolnike z velikim tveganjem.
English: Common side effects (may affect up to 1 in 10 people): - Anxiety - Dizziness, feeling of dizziness or “spinning” (vertigo)
Slovenian: - omotica, občutek omotice ali “vrtenja” (vertigo); - občutek tresenja (tremor);
English: Baseline (kg)
Slovenian: (DMC).
English: Uncommon side effects (may affect up to 1 in 100 people): - Hives (uticaria) - Hypersensitivity - Abnormal dreams, - Feeling nervous, feeling spacey, tension, agitation, mood swings, Tremor of the head or a limb which increases when trying to perform a particular function (intention tremor) - Balance disorder - Loss of memory (amnesia), Tingling or numbness of the hands or feet - Motion sickness - Burping - Abdominal discomfort - Indigestion - Inflammation of the gallbladder (cholecystitis) - Increased creatinine levels in the blood (indicating loss of kidney function) - Increased liver enzymes and bilirubin levels, liver disorders - Difficulty in getting or keeping an erection - Feeling abnormal, weakness (asthenia) - Thirst, feeling hot - Chest pain - Increased appetite, weight gain
Slovenian: - občutek živčnosti, občutek odsotnosti, napetost, agitacija, nihanje razpoloženja; - tremor glave ali okončine, ki se okrepi, kadar poskušate narediti kako dejanje (intencijski tremor); - motnje ravnotežja; - izguba spomina (amnezija);
English: Committee for Human Medicinal Products.
Slovenian: 1 Odbor za zdravila za uporabo v humani medicini.
English: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party.
Slovenian: Vprašanja in odgovori: stališča v zvezi z določenimi vprašanji, postavljenimi delovni skupini za farmakokinetiko.
English: The company wanted the authorisation to be recognised in Germany (the ‘concerned Member State').
Slovenian: Družba je želela, da se dovoljenje za promet z zdravilom prizna v Nemčiji (zadevni državi članici).
English: The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance1 for products of this type.
Slovenian: Odbor je prav tako izpostavil, da je predlagatelj te študije opravil pred objavo zadnje posodobljene smernice1 za to vrsto zdravil.
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Hexal.
Slovenian: Evropska agencija za zdravila je 25. julija 2013 zaključila arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve dovoljenja za promet z zdravilom Methylphenidate Hexal.
English: Why was Methylphenidate Hexal reviewed?
Slovenian: Zakaj je bilo zdravilo Methylphenidate Hexal pregledano?
English: Methylphenidate Hexal is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Slovenian: Methylphenidate Hexal je generično zdravilo na osnovi „referenčnega zdravila“ Concerta, ki je odobreno v vseh državah članicah EU.
English: Questions and answers on Methylphenidate Hexal (methylphenidate hydrochloride, prolonged-release tablet 18, 36 and 54 mg)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Methylphenidate Hexal (metilfenidatijev klorid, tableta s podaljšanim sproščanjem, 18, 36 in 54 mg)
English: What is Methylphenidate Hexal?
Slovenian: Kaj je zdravilo Methylphenidate Hexal?
English: As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation.
Slovenian: Ker je v informacijah o zdravilu navedeno, da se lahko tableta vzame s hrano ali brez nje, je bila za odobritev dovoljenja za promet z zdravilom potrebna študija o biološki enakovrednosti pri jemanju na poln želodec.
English: Hexal A/S submitted Methylphenidate Hexal for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Ireland.
Slovenian: Družba Hexal A/S je predložila vlogo za pridobitev dovoljenja za promet z zdravilom Methylphenidate Hexal po postopku z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet z zdravilom, izdanega 29. marca 2012 na Danskem in prav tako veljavnega na Irskem v skladu z decentraliziranim postopkom.
English: It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Slovenian: Na voljo je od petdesetih let 20. stoletja v obliki tablet s takojšnjim sproščanjem in kapsul, ki takoj sprostijo metilfenidat, ter tablet s prirejenim sproščanjem, ki sprostijo del ali celotno zdravilno učinkovino počasneje, v več urah.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Hexal and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Slovenian: Na podlagi razpoložljivih podatkov in znanstvene razprave znotraj odbora je ta ugotovil, da biološke enakovrednosti med zdravilom Methylphenidate Hexal in referenčnim zdravilom v fazi s takojšnjim sproščanjem ni bilo mogoče dokazati zaradi razlik med bolniki glede učinkov obroka z veliko vsebnostjo maščob na to, kako telo obdela zdravila, in ne zaradi razlik v formulacijah teh dveh zdravil, zato je sklenil, da je bila biološka enakovrednost referenčnemu zdravilu dokazana.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Hexal outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Methylphenidate Hexal večje od z njim povezanih tveganj ter da se lahko dovoljenje za promet, izdano na Danskem, odobri v drugih državah članicah EU.
English: The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Hexal was bioequivalent for the immediate-release phase to its reference product.
Slovenian: Podlaga za napotitev so bili pomisleki Nemčije in Nizozemske, ki sta menili, da študija biološke enakovrednosti pri jemanju na poln želodec ni pokazala, da je faza takojšnjega sproščanja pri zdravilu Methylphenidate Hexal biološko enakovredna referenčnemu zdravilu.
English: The CHMP therefore concluded that the benefits of Methylphenidate Hexal outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Slovenian: Zato je sklenil, da koristi zdravila Methylphenidate Hexal odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet z zdravilom odobri v zadevnih državah članicah.
English: A: We recommend no longer than one hour.
Slovenian: O: Priporočamo, da ne dlje kot eno uro.
English: Repeat steps 8 and 9 until it appears.
Slovenian: Ponavljajte koraka 8 in 9, dokler se ne pojavi.
English: Be patient.
Slovenian: Bodite potrpežljivi.
English: Do not use alcohol.
Slovenian: Ne uporabljajte alkohola.
English: The results of both studies were similar.
Slovenian: Rezultati obeh študij so bili podobni.
English: Part IV: Commonly Asked Questions
Slovenian: IV. del: Pogosto zastavljena vprašanja
English: Date of first authorisation: 16 February 2001 Date of latest renewal: 16 February 2006
Slovenian: Datum prve odobritve: 16. februar 2001 Datum zadnjega podaljšanja: 16. februar 2006
English: Personality changes or abnormal behaviour.
Slovenian: Osebnostne spremembe ali nenormalno vedenje.
English: Always use the needles recommended.
Slovenian: Vedno uporabljajte priporočene igle.
English: Thus, the risk for humans is unknown.
Slovenian: Tveganje za ljudi tako ni znano.
English: The greatest risk is at the beginning of treatment.
Slovenian: Tveganje je največje na začetku zdravljenja.
English: This happens generally in patients who grow rapidly.
Slovenian: To se običajno zgodi pri bolnikih, ki hitro rastejo.
English: No animal data are available.
Slovenian: Podatki pri živalih niso na voljo.
English: • Do not use the same needle for more than one person.
Slovenian: • Posamezne igle ne uporabljajte za več kot eno osebo.
English: See also section “warning and precautions”.
Slovenian: Glejte tudi poglavje “Opozorila in previdnostni ukrepi”.
English: • if you have an active tumour (cancer).
Slovenian: • če imate aktivni tumor (raka).
English: (Be careful not to touch the rubber seal.)
Slovenian: (Pazite, da se ne dotaknete gumijaste zapore.)
English: If you travel outside the European Union, make sure you take enough needles for the duration of your stay.
Slovenian: Če potujete zunaj Evropske unije, poskrbite, da boste imeli s seboj dovolj igel za ves čas bivanja zunaj EU.
English: No data for other races are available.
Slovenian: Podatki za druge rase niso na voljo.
English: A drop of blood may appear.
Slovenian: Pokaže se lahko kapljica krvi.
English: Part I: Preparing and Injecting
Slovenian: I. del: Priprava in injiciranje
English: Protect from intense light.
Slovenian: Zaščitite pred močno svetlobo.
English: This can start during adult life or continue from when you were a child.
Slovenian: Stanje se lahko začne v odrasli dobi ali pa nadaljuje iz otroštva.
English: The maximum recommended daily dose should not be exceeded (see section 4.2).
Slovenian: Največjega priporočenega dnevnega odmerka se ne sme preseči (glejte poglavje 4.2).
English: Tell your doctor if you have or have had an active tumour.
Slovenian: Obvestite zdravnika, če imate ali ste imeli aktivni tumor.
English: • Use needles only once.
Slovenian: • Iglo uporabite samo enkrat.
English: • in particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Slovenian: • Še posebej pa zdravnika obvestite, če jemljete ali ste pred kratkim jemali katero koli od naslednjih zdravil.
English: Q: What does a blinking “bt‟ mean in the LCD?
Slovenian: V: Kaj pomeni utripajoč ‘bt' na prikazovalniku LCD?
English: • if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na somatropin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The improvements in growth were not accompanied by undue advancement of bone age, which would jeopardise future growth potential.
Slovenian: Izboljšanje rasti ni spremljalo čezmerno napredovanje kostne starosti, ki bi ogrozilo prihodnjo rast.