FrancophonIA/ELRC3.0 huggingface dataset:
English: Tritace has been authorised in the EU since 1989, first in France and then in the following countries: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Slovenian: Zdravilo Tritace je v EU odobreno od leta 1989, najprej je bilo odobreno v Franciji, nato pa še v naslednjih državah: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska in Združeno kraljestvo.
English: London, 18 March 2009 Doc.
Slovenian: London, 18. marca 2009 Sklic dok.
English: The areas harmonised include:
Slovenian: Področja, ki jih je treba uskladiti, so:
English: Tritace is authorised in the European Union (EU) via national procedures.
Slovenian: Zdravilo Tritace je odobreno v Evropski uniji (EU) z nacionalnimi postopki.
English: Co-rapporteur:
Slovenian: Soporočevalec:
English: The review was carried out under an ‘Article 30' referral1.
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom iz člena 301.
English: Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Tritace tablete in trde kapsule, ki vsebujejo 1,25 mg, 2,5 mg, 5 mg ali 10 mg ramiprila
English: The CHMP endorsed six contraindications:
Slovenian: CHMP je odobril šest kontraindikacij:
English: Ref. EMEA/CHMP/233264/2009
Slovenian: EMEA/202977/2009
English: The European Medicines Agency (EMEA) has completed a review of Tritace.
Slovenian: Evropska agencija za zdravila (EMEA) je zaključila pregled zdravila Tritace.
English: Why was Tritace reviewed?
Slovenian: Zakaj je bilo zdravilo Tritace ponovno pregledano?
English: The CHMP recommended a contra indication only for the second and third trimester of pregnancy.
Slovenian: CHMP je priporočil kontraindikacijo samo za drugo in tretje tromesečje nosečnosti.
English: The company that markets it is Sanofi-aventis
Slovenian: Družba, ki zdravilo trži, je Sanofi-aventis.
English: 4.1 Therapeutic Indications
Slovenian: 4.1 Terapevtske indikacije
English: Tritace can also be available in the EU and the EEA under other trade names: Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace.
Slovenian: Zdravilo Tritace je lahko v EU in EGP na voljo tudi pod naslednjimi imeni: Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra in Pramace.
English: • Hyperkalaemia
Slovenian: • Hiperkaliemija
English: • Cough
Slovenian: • Kašelj
English: • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
Slovenian: • 2. in 3. tromesečje nosečnosti (glejte poglavji 4.4 in 4.6);
English: This allows the heart to pump blood more easily, and the blood flow increases due to more blood being pumped into and through larger passageways.
Slovenian: Zaradi tega srce lažje črpa kri, pretok krvi pa se poveča, ker se poveča količina krvi, ki se prečrpa skozi večje žile.
English: The CHMP decided to include under this section the harmonised wording:
Slovenian: CHMP se je odločil v to poglavje vključiti sledeče usklajeno besedilo:
English: This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Slovenian: To je privedlo do razhajanj med državami članicami glede načina uporabe zdravila, kar je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanja in navodila za uporabo v državah, v katerih je zdravilo na trgu.
English: The CHMP discussed the areas where there was a divergence identified in the dose recommendations per indication: For each indication, the posology is presented as starting dose, titration schedule, maintenance dose and maximum dose.
Slovenian: CHMP je razpravljal o področjih, na katerih je prišlo do nesoglasij pri priporočilih glede odmerka za posamezno indikacijo: za vsako indikacijo je odmerjanje predstavljeno kot začetni odmerek, urnik titracije, vzdrževalni odmerek in največji odmerek.
English: • The CHMP agreed on the indication: Treatment of hypertension.
Slovenian: • CHMP se je strinjal z indikacijo: zdravljenje hipertenzije.
English: When the production of angiotensin II is lowered, the blood vessels relax and widen.
Slovenian: Ko se raven tvorjenja angiotenzina II zniža, se krvne žile sprostijo in razširijo.
English: This is in line with the recommendation of the CHMP's Pharmacovigilance Working Party on the use of ACE inhibitors in pregnancy.
Slovenian: To je skladno s priporočilom delovne skupine za farmakovigilanco odbora CHMP v povezavi z uporabo zaviralcev angiotenzinske konvertaze med nosečnostjo.
English: What is Tritace?
Slovenian: Kaj je zdravilo Tritace?
English: • Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
Slovenian: • zunajtelesna zdravljenja, pri katerih pride do stika krvi z negativno naelektrenimi površinami (glejte poglavje 4.5);
English: Tritace is also used to prevent cardiovascular disease in patients who are at cardiovascular risk (such as patients who already have coronary artery disease), and to prevent any further heart attack (acute myocardial infarction [MI]) in patients who have already had one.
Slovenian: Zdravilo Tritace se uporablja tudi za preprečevanje kardiovaskularnih bolezni pri bolnikih s tveganjem zanje (kot so bolniki, ki že imajo bolezen koronarnih arterij) in preprečiti nadaljnje srčne napade (akutni miokardni infarkt [MI]) pri bolnikih, ki so že doživeli srčni napad.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritace in the European Union (EU) and the European Economic Area (EEA).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri tej agenciji je zaključil, da je treba v Evropski uniji (EU) in Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Tritace.
English: • Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Slovenian: • ramipril se ne sme uporabljati pri bolnikih s hipotenzijsko ali hemodinamično nestabilnimi stanji.
English: The CHMP agreed adding a seventh contraindication: Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states
Slovenian: Odbor CHMP se je strinjal z vključitvijo sedme kontraindikacije: ramipril se ne sme uporabljati pri bolnikih s hipotenzijsko ali hemodinamično nestabilnimi stanji.
English: Tritace is used to treat hypertension and symptomatic heart failure.
Slovenian: Zdravilo Tritace se uporablja za zdravljenje hipertenzije in simptomatskega srčnega popuščanja.
English: The CHMP also noted that Tritace had an indication for nephroprotection in some countries.
Slovenian: CHMP je prav tako ugotovil, da je bilo zdravilo Tritace v nekaterih državah indicirano za zaščito ledvic.
English: After discussion the CHMP agreed on including the harmonised indication: Treatment of renal disease
Slovenian: Po razpravi se je CHMP strinjal o vključitvi v usklajene indikacije: zdravljenje bolezni ledvic.
English: • Hypotension and renal dysfunction after acute myocardial infarction occurred more frequently with ramipril than placebo in the target population in the AIRE study.
Slovenian: • Hipotenzija in ledvična disfunkcija po akutnem miokardnem infarktu se pojavi pogosteje pri uporabi ramiprila kot placeba pri ciljni populaciji v študiji AIRE.
English: When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Slovenian: Če pride do diagnoze nosečnosti, je treba takoj prekiniti zdravljenje z zaviralci angiotenzinske konvertaze ali antagonisti receptorjev za angiotenzin II in, če je primerno, začeti z alternativnim zdravljenjem (glejte poglavji 4.3 in 4.6).
English: • Manifest glomerular non-diabetic nephropathy as defined by macroproteinuria ≥ 3g/day
Slovenian: • izražena glomerularna nediabetična nefropatija, kot jo opredeljuje makroproteinurija ≥ 3 g/dan.
English: • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
Slovenian: • znatna obojestranska stenoza renalne arterije ali stenoza renalne arterije pri eni sami delujoči ledvici;
English: 24 January 2008
Slovenian: 28. april 2008, 24. oktober 2008
English: • When considering the indication in heart failure, the CHMP took into consideration previous harmonisations referrals for other ACE-inhibitors (enalapril, perindopril and lisinopril), and agreed on the indication: Treatment of symptomatic heart failure.
Slovenian: • Pri upoštevanju indikacije za srčno popuščanje je CHMP upošteval prejšnje napotitvene postopke za usklajevanja za druge zaviralce angiotenzinske konvertaze (enalapril, perindopril and lizinopril) ter se strinjal z indikacijo: zdravljenje simptomatskega srčnega popuščanja.
English: • Surgery: It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Slovenian: • Kirurgija: priporoča se, da se zdravljenje z zaviralci angiotenzinske konvertaze, kot je ramipril, prekine en dan pred kirurškim posegom, če je mogoče.
English: • For the secondary prevention after MI in patients with heart failure, the CHMP endorsed the harmonised indication: Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started >48 hours following acute myocardial infarction.
Slovenian: • Za sekundarno preprečevanje po miokardnem infarktu pri bolnikih s srčnim popuščanjem je CHMP odobril usklajeno indikacijo: sekundarno preprečevanje po akutnemu miokardnem infarktu: zmanjšanje umrljivosti zaradi akutne faze miokardnega infarkta pri bolnikih s kliničnimi znaki srčnega popuščanja, če se začne >48 ur po akutnemu miokardnem infarktu.
English: • Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor
Slovenian: • izražena glomerularna diabetična nefropatija, kot jo opredeljuje makroproteinurija pri bolnikih, ki imajo vsaj en dejavnik za tveganje srčno-žilnih bolezni;
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Ob upoštevanju predloženih podatkov in znanstvene razprave je CHMP menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo uskladiti v vsej EU.
English: • Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Slovenian: • Nosečnost: zaviralcev angiotenzinske konvertaze, kot so ramipril ali antagonisti receptorjev za angiotenzin II, se ne sme vbrizgati med nosečnostjo.
English: • The CHMP also discussed the indications in the treatment of cardiovascular secondary prevention, and primary prevention in high-risk patients, and endorsed the harmonised indication: Cardiovascular prevention: reduction cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor.
Slovenian: • CHMP je razpravljal tudi o indikacijah za zdravljenje kardiovaskularnih bolezni pri sekundarnem in primarnem preprečevanju pri bolnikih z visokim tveganjem ter odobril usklajeno indikacijo: preprečevanje kardiovaskularnih bolezni: zmanjšanje obolevnosti in umrljivosti zaradi kardiovaskularnih bolezni pri bolnikih: i)z izraženo srčno-žilno boleznijo zaradi arterijske tromboze (anamneza koronarne srčne bolezni, infarkta ali periferne vaskularne bolezni) ali, ii) s sladkorno boleznijo ob prisotnosti vsaj enega dejavnika tveganja za srčno-žilne bolezni.
English: The CHMP noted that there were contraindications present in one or several local SPCs.
Slovenian: CHMP je ugotovil, da so v enem ali več lokalnih povzetkih glavnih značilnosti zdravila prisotne kontraindikacije.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Slovenian: Zaviralci angiotenzinske konvertaze znižajo raven tvorjenja angiotenzina II, močnega vazokonstriktorja (snovi, ki oži krvne žile).
English: The active substance in Tritace, ramipril, is an angiotensinconverting enzyme (ACE) inhibitor.
Slovenian: Zdravilna učinkovina zdravila Tritace, ramipril, je zaviralec angiotenzinske konvertaze (ACE).
English: Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Če nadaljevanje zdravljenja z zaviralcem angiotenzinske konvertaze ali antagonisti receptorjev za angiotenzin II ni življenjskega pomena, morajo bolnice, ki načrtujejo zanositev, začeti jemati alternativna zdravila proti hipertenziji, ki imajo ugotovljen varnostni profil za uporabo med nosečnostjo.
English: • Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria
Slovenian: • začetna glomerularna diabetična nefropatija, kot jo opredeljuje prisotnost mikroalbuminurije;
English: • Neutropenia/agranulocytosis
Slovenian: • Nevtropenija/agranulocitoza
English: Therefore the CHMP agreed on including the wording: Transient or persistent heart failure post MI
Slovenian: Zaradi tega se je odbor CHMP strinjal z naslednjim besedilom: prehodno ali vztrajno srčno popuščanje po miokardnem infarktu
English: On 3 January 2008 the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Tritace in the EU and the EEA.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Tritace v EU in EGP, je dne 3. januarja 2008 zadevo napotila na Odbor za zdravila za uporabo v humani medicini (CHMP).
English: Company responses provided on: 28 April 2008, 24 October 2008 Opinion date:
Slovenian: Datum začetka napotitvenega postopka: 24. januar 2008 Odgovori družbe, poslani dne:
English: Tritace has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Tritace potrebno usklajevanje.
English: • History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE
Slovenian: • anamneza angioedema (dednega, idiopatičnega ali zaradi predhodnega angioedema z zaviralci ACE ali agonisti AIIRA (antagonisti receptorjev za angiotenzin II);
English: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin
Slovenian: • preobčutljivost na zdravilno učinkovino, na katero koli od pomožnih snovi ali druge zaviralce angiotenzinske konvertaze (ACE) (glejte poglavje 6.1);
English: Content Package Size
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: EU Number Invented Name
Slovenian: EU številka
English: Target Species Route of Administration
Slovenian: Ciljna živalska vrsta
English: Tell your doctor immediately if you:
Slovenian: Takoj obvestite zdravnika, če:
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
English: The mechanism for this increased risk is not known.
Slovenian: Mehanizem nastanka tega povečanega tveganja ni znan.
English: General supportive measures should be employed.
Slovenian: Uvesti je treba splošne podporne ukrepe.
English: Your doctor will tell you when you need your next injection.
Slovenian: Zdravnik vam bo povedal, kdaj morate prejeti naslednjo injekcijo.
English: Note: Negative change in score indicates improvement.
Slovenian: Opomba: negativna sprememba rezultata pomeni izboljšanje.
English: Close supervision and monitoring should continue until the patient recovers.
Slovenian: S pozornim nadziranjem in spremljanjem je treba nadaljevati, dokler bolnik ne okreva.
English: • increased appetite
Slovenian: • povečan apetit
English: Dosing adjustments were only allowed in the first 12 weeks of the maintenance period.
Slovenian: Prilagajanje odmerjanja je bilo dovoljeno samo v prvih 12 tednih vzdrževalnega obdobja.
English: The suspension is pH neutral (approximately 7.0).
Slovenian: Vrednost pH suspenzije je nevtralna (približno 7,0).
English: Date of first authorisation: 04 March 2011 Date of latest renewal:16 December 2015
Slovenian: Datum prve odobritve: 04. marec 2011 Datum zadnjega podaljšanja: 16. december 2015
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Slovenian: To je treba upoštevati v primerih, kadar je potrebna popolna budnost in pozornost, npr. med vožnjo avtomobila ali pri upravljanju strojev.
English: Schizophrenia is a disease with “positive” and “negative” symptoms.
Slovenian: Shizofrenija je bolezen s »pozitivnimi« in »negativnimi« simptomi.
English: Consequently, newborns should be monitored carefully.
Slovenian: Posledično je treba takšne novorojenčke skrbno nadzirati.
English: No clinically significant differences were observed between men and women.
Slovenian: Med moškimi in ženskami niso opazili nobenih klinično pomembnih razlik.
English: It is important not to miss your scheduled dose.
Slovenian: Pomembno je, da ne izpustite načrtovanega odmerka.
English: • excessive passing of gas or wind
Slovenian: • prekomerno izločanje plina ali vetrov
English: The majority of these reactions were reported to be of mild to moderate severity.
Slovenian: Večina teh reakcij je bila blaga do zmerna.
English: Some patients may benefit from gradual withdrawal.
Slovenian: Nekaterim bolnikom lahko koristi postopna prekinitev.
English: It is also recommended to alternate between left and right sides (see below).
Slovenian: Prav tako je priporočljivo izmenično injiciranje v levo in desno stran (glejte spodaj).
English: The system is fully activated when a ‘click' is heard.
Slovenian: Sistem je popolnoma aktiviran, ko zaslišite klik.
English: • loss of menstrual periods
Slovenian: • izguba menstruacije
English: The difference is unlikely to be of clinical relevance.
Slovenian: Razlika verjetno ni klinično pomembna.
English: Overall mortality
Slovenian: Celokupna smrtnost
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Slovenian: Vzpostavite in vzdržujte prehodno dihalno pot ter zagotovite zadostno oksigenacijo in ventilacijo.
English: It must not be administered by any other route.
Slovenian: Ne sme se ga injicirati po kateri koli drugi poti.
English: Children and adolescents This medicine is not for people who are under 18 years old.
Slovenian: Otroci in mladostniki Tega zdravila se ne sme uporabljati pri osebah, mlajših od 18 let.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to Xeplion is known.
Slovenian: Zato je treba bolnikom svetovati, naj ne vozijo ali upravljajo s stroji, dokler ne bodo poznali svoje individualne občutljivosti za zdravilo Xeplion.
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Slovenian: Če je ta kombinacija, predvsem v zadnjem stadiju Parkinsonove bolezni, vseeno potrebna, je treba predpisati najmanjši učinkoviti odmerek vsakega od teh zdravil.
English: People with this disease may also feel depressed, anxious, guilty, or tense.
Slovenian: Ljudje s to boleznijo so lahko tudi depresivni, tesnobni, imajo občutek krivde ali so napeti.
English: Xeplion with alcohol Alcohol should be avoided.
Slovenian: Zdravilo Xeplion skupaj z alkoholom Uživanju alkohola se je treba izogibati.
English: Immediate medical treatment may be needed.
Slovenian: Morda bo potrebna takojšnja zdravstvena oskrba.
English: Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.
Slovenian: Brizgo močno pretresajte vsaj 10 sekund, da postane suspenzija homogena.
English: Parkinson's disease and dementia with Lewy bodies
Slovenian: Parkinsonova bolezen in demenca z Lewyjevimi telesci
English: Select the appropriate needle.
Slovenian: Izberite ustrezno iglo.
English: It should be noted that a broader spectrum of symptoms are included that do not necessarily have an extrapyramidal origin.
Slovenian: Potrebno je opozoriti, da je vključen širši spekter simptomov, ki niso nujno ekstrapiramidnega izvora.
English: B-2340 Beerse Belgium
Slovenian: B-2340 Beerse Belgija
English: Adjustment of the maintenance dose may be made monthly.
Slovenian: Vzdrževalni odmerek lahko prilagajamo mesečno.
English: Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Slovenian: Približno 80% uporabljene radioaktivnosti so odkrili v urinu, 11% pa v blatu.
English: The following side effects may happen:
Slovenian: Pojavijo se lahko naslednji neželeni učinki:
English: • allergic reaction
Slovenian: • alergijske reakcije
English: Elderly Efficacy and safety in elderly > 65 years have not been established.
Slovenian: Starejši Učinkovitosti in varnosti pri bolnikih, starejših od 65 let niso dokazali.
English: IFIS may increase the risk of eye complications during and after the operation.
Slovenian: IFIS lahko poveča tveganje za nastanek zapletov na očeh med operacijo in po operaciji.
English: • eye infection
Slovenian: • okužba očesa
English: What Xeplion is and what it is used for
Slovenian: Kaj je zdravilo Xeplion in za kaj ga uporabljamo
English: • priapism (a prolonged penile erection that may require surgical treatment)
Slovenian: • priapizem (dolgotrajna erekcija, ki lahko zahteva kirurško zdravljenje)
English: Positive means an excess of symptoms that are not normally present.
Slovenian: Pozitivni odražajo pretirano prisotnost simptomov, ki normalno niso prisotni.
English: • tremor (shaking)
Slovenian: • tremor (tresenje)
English: The dose should not be given in divided injections.
Slovenian: Odmerka ne smete dajati v ločenih injiciranjih.
English: • sleep-related eating disorder
Slovenian: • s spanjem povezane motnje hranjenja
English: This medicine may cause you to gain weight.
Slovenian: To zdravilo lahko povzroči, da se zredite.