FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Slovenian: Imetnik dovoljenja za promet Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
English: Driving and using machines The effects on the ability to drive and to use machines have not been studied.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Študije vpliva na sposobnost upravljanja vozil in strojev niso bile opravljene.
English: Post-marketing experience of infusion-associated reactions revealed reporting of cyanosis, hypoxia, tachypnoea, pyrexia, vomiting, chills and erythema, in which some of these reactions were severe.
Slovenian: V obdobju trženja so pri infundiranju zaznali pojave cianoze, hipoksije, tahipneje, pireksije, bruhanja, mrzlice in eritema; nekatere od teh reakcij so bile resne.
English: ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 years of age and mainly of the severe phenotype, treated up to 12 months are listed below.
Slovenian: Neželeni učinki zdravila Aldurazyme, zabeleženi v drugi fazi študije pri 20 bolnikih, mlajših od 5 let in v glavnem s hujšo obliko fenotipa, zdravljenih do 12 mesecev, so navedeni v spodnji preglednici.
English: EU/1/03/253/003 25 Vials
Slovenian: EU/1/03/253/003 25 Vial
English: Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Če bolnik tehta 20 kg ali manj, za infundiranje uporabite 100 ml, in če tehta nad 20 kg, 250 ml raztopine natrijevega klorida 9 mg/ml (0,9%).
English: If not used immediately, in-use storage should not be longer than 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
Slovenian: Z mikrobiološkega varnostnega stališča je treba proizvod porabiti takoj, sicer pa lahko raztopino hranite največ 24 ur pri temperaturi med 2 C in 8 C, če ste jo pripravili v nadzorovanih in potrjeno aseptičnih pogojih.
English: Infusion 12 Mean ± SD
Slovenian: Infuzija 12 Srednja vrednost ± SD
English: 25 vials of concentrate for solution for infusion.
Slovenian: 25 vial s koncentratom za raztopino za infundiranje.
English: There are inadequate data on the use of Aldurazyme in pregnant women.
Slovenian: Ni natančnih podatkov o uporabi zdravila Aldurazyme pri nosečnicah.
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: Opozorilo morajo upoštevati bolniki, ki sledijo dieti z omejeno količino natrija.
English: Infusion 1 Mean ± SD
Slovenian: Infuzija 1 Srednja vrednost ± SD
English: The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles.
Slovenian: Bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina ne sme vsebovati vidnih delcev.
English: What you need to know before you are given Aldurazyme
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Aldurazyme
English: Aldurazyme should not be mixed with other medicinal products in the same infusion.
Slovenian: Raztopine za infundiranje z zdravilom Aldurazyme ne smete mešati z drugimi zdravili.
English: Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80,
Slovenian: Natrijev dihidrogenfosfat monohidrat, Natrijev hidrogenfosfat heptahidrat, Polisorbat 80,
English: Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8).
Slovenian: Aldurazyme uporabljajte previdno pri bolnikih, ki imajo protitelesa ali znake reakcij ob infuziji (glejte poglavje 4.3 in 4.8).
English: - The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.
Slovenian: - Pomožne snovi so natrijev klorid, monohidrat natrijevega dihidrogenfosfata, heptahidrat natrijevega hidrogenfosfata, polisorbat 80, voda za injekcije.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C).
English: Method of administration Aldurazyme is to be administered as an intravenous infusion.
Slovenian: Način uporabe Zdravilo Aldurazyme se daje v obliki intravenske infuzije.
English: The recommended dose group had the fewest number of patients who experienced ADRs and IARs.
Slovenian: V skupini, ki je prejemala priporočeni odmerek, je bilo najmanjše število bolnikov z neželenimi učinki zdravila ali reakcijami ob infuziji.
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol/ibuprofen and/or corticosteroids) and a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the previous reaction occurred.
Slovenian: V primeru ponavljajočih se zmernih reakcij ali ponovni nevarnosti po enkratni težki reakciji ob infuziji, bo morda potrebno predhodno zdravljenje (z antihistaminiki, paracetamolom ali ibuprofenom in/ali kortikosteroidi) in zmanjšanje hitrosti infundiranja na četrtino do polovico hitrosti, pri kateri se je pojavila prejšnja reakcija.
English: Pack sizes: 1, 10 and 25 vials.
Slovenian: Škatlica vsebuje 1, 10 ali 25 vial.
English: Shoulder flexion Range Of Motion (degrees)
Slovenian: Indeks apneja/hipopneja (IAH) obseg gibanja ramena (stopinje)
English: The number of these reactions decreased the longer that patients were on Aldurazyme.
Slovenian: Dlje kot so bili bolniki na terapiji z zdravilom Aldurazyme, manjše je bilo število teh reakcij.
English: 10 vials of concentrate for solution for infusion.
Slovenian: 10 vial s koncentratom za raztopino za infundiranje.
English: The patients were scheduled to receive Aldurazyme 100 U/kg weekly infusions for a total duration of 52 weeks.
Slovenian: Bolniki so 52 tednov tedensko prejemali infuzije zdravila Aldurazyme po 100 e/kg.
English: Patients received either 100 U/kg of Aldurazyme or placebo every week for a total of 26 weeks.
Slovenian: Študija je trajala 26 tednov in bolniki so vsak teden prejeli 100 e/kg zdravila Aldurazyme ali placeba.
English: In this 26-week open label study, 33 MPS I patients received 1 of 4 dose regimens of Aldurazyme: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks; or 300 U/kg IV every 2 weeks.
Slovenian: V tej 26-tedenski odprti študiji je 33 bolnikov z MPS I prejemalo 1 izmed 4 režimov odmerjanja: 100 e/kg i.v.
English: An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”).
Slovenian: To so kakršnikoli neželeni učinki, ki se pojavijo med infundiranjem ali do konca dneva, ko ste prejeli infuzijo (glejte poglavje 4.
English: If you experience any reaction like this, you should contact your doctor immediately.
Slovenian: Če ste opazili kakršne koli reakcije, podobne spodaj navedenim, nemudoma obvestite svojega zdravnika.
English: Before dilution, visually inspect each vial for particulate matter and discoloration.
Slovenian: Pred pripravo raztopine si pozorno oglejte vsako vialo, ali vsebuje drobne delce in ali je vsebina razbarvana.
English: How to store Aldurazyme
Slovenian: Kako boste prejeli zdravilo Aldurazyme
English: The infusion can be restarted with a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the reaction occurred.
Slovenian: V nadaljevanju lahko dajete bolniku infuzijo s hitrostjo, ki je za četrtino do polovico manjša od hitrosti, ob kateri je prišlo do reakcije.
English: If you are treated with Aldurazyme, you may develop infusion-associated reactions.
Slovenian: Med zdravljenjem z zdravilom Aldurazyme se lahko pojavijo z infuzijo povezane reakcije.
English: One ml of the solution in the vial contains 100 U of laronidase.
Slovenian: En ml raztopine v viali vsebuje 100 enot (e) laronidaze.
English: • swelling of the neck
Slovenian: • otekanje vratu
English: Talk to your doctor before using Aldurazyme.
Slovenian: Pred začetkom uporabe zdravila Aldurazyme se posvetujte s svojim zdravnikom.
English: The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion.
Slovenian: Pri zdravilu Aldurazyme priporočamo uporabo enkrat tedensko z odmerki 100 e/kg telesne mase v obliki intravenske infuzije.
English: Infusion-associated reactions
Slovenian: Reakcije ob infuziji
English: Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes.
Slovenian: Iz vial z zdravilom Aldurazyme odmerite potrebne količine zdravila in jih zmešajte.
English: This can replace the natural enzyme which is lacking in MPS I disease.
Slovenian: Aldurazyme je umetni encim laronidaza, ki lahko nadomesti naravni encim, ki ni prisoten pri bolezni MPS I.
English: A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face.
Slovenian: Nekaj bolnikov s predhodnimi pojavi hude MPS I, povezane z zgornjimi dihali in pljuči, je imelo resne reakcije, vključno s bronhospazmom (zoženjem dihalnih poti), zastojem dihanja in oteklino obraza.Pogostnosti bronhospazma in zastoja dihanja nista znani.
English: Aldurazyme contains sodium
Slovenian: Zdravilo Aldurazyme vsebuje natrij
English: In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every 2 weeks.
Slovenian: V 4. fazi študije je 33 bolnikov z MPS I prejemalo 1 izmed 4 režimov odmerjanja: 100 e/kg i.v.
English: Urinary GAG levels decreased by 77% and 66% in the Placebo/Aldurazyme and Aldurazyme/Aldurazyme groups, respectively; at the end of the study one-third of the patients (15 of 45) had reached normal urinary GAG levels.
Slovenian: Vrednosti GAG v urinu so se znižale za 77 % pri placebo/Aldurazyme skupini oziroma 66 % pri Aldurazyme/Aldurazyme skupini.
English: MedDRA Preferred term
Slovenian: prednostni izraz (po MedDRA)
English: The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week.
Slovenian: Priporočeni režim odmerjanja je pri zdravilu Aldurazyme enkrat tedensko z odmerkom 100 e/kg telesne mase.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 U of laronidase.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml vsebuje 100 e laronidaze.
English: Preclinical data did not reveal any significant adverse finding (see section 5.3).
Slovenian: Kliničnih podatkov o vplivu laronidaze na plodnost ni. Neklinični podatki ne kažejo pomembnih neželenih učinkov (glejte poglavje 5.3).
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Slovenian: Raztopino za infundiranje pripravite tako, da koncentrat razredčite s fiziološko raztopino (0,9 % natrijev klorid) z uporabo aseptične tehnike.
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol/ibuprofen should be considered and/or a reduction in the infusion rate to half the infusion rate at which the reaction occurred.
Slovenian: Ob pojavu blage ali zmerne reakcije ob infuziji poskusite zdraviti bolnika z antihistaminiki in paracetamolom ali ibuprofenom in/ali za polovico zmanjšati hitrost infundiranja, ob kateri je prišlo do reakcije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Slovenian: IME ZDRAVILA IN POT (I) UPORABE Aldurazyme, 100 e/ml koncentrat za raztopino za infundiranje laronidaza
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo natančno preberite priloženo navodilo!
English: It is recommended to stop breast-feeding during treatment with Aldurazyme.
Slovenian: Med zdravljenjem z zdravilom Aldurazyme priporočamo, da dojenje prekinete.
English: Patients treated with Aldurazyme may develop infusion-associated reactions (IARs), defined as any related adverse event occurring during the infusion or until the end of the infusion day (see section 4.8).
Slovenian: To so kakršnikoli z infuzijo povezani neželeni dogodki, ki se pojavijo med infundiranjem ali do konca dneva, ko je bolnik prejel infuzijo (glejte poglavje 4.8).
English: OTHER
Slovenian: - NL
English: The most frequent adverse drug reactions (ADRs) were: headache, nausea, abdominal pain, rash, arthralgia, backpain, pain at extremity, flushing, pyrexia, infusion site reactions, blood pressure increased, oxygen saturation decreased,
Slovenian: izpuščaji, artlargija, bolečine v hrbtu, bolečine v udih, navali vročine, pireksija, reakcije na mestih infuzije, zvišani krvni tlak, zmanjšana nasičenost s kisikom, tahikardija in mrzlica.
English: Do not use vials exhibiting particles or discoloration.
Slovenian: Ne uporabljajte vial, če je koncentrat razbarvan ali če v njem opazite majhne delce.
English: • dizziness
Slovenian: • ščemenje
English: Tachycardia
Slovenian: laronidaza
English: Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Slovenian: Iz vrečke za infuzijo odstranite in zavrzite količino 0,9% raztopine natrijevega klorida (9 mg/ml), ki je enaka količini zdravila Aldurazyme, ki ga boste dodali.
English: Some of the IARs were severe.
Slovenian: Nekatere od IARs (reakcij, povezane z infuzijami) so bile resne.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Okvarjeno delovanje ledvic in jeter
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom,farmacevtom ali medicinsko sestro.
English: NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Aldurazyme, 100 e/ml koncentrat za raztopino za infundiranje.
English: Dosage
Slovenian: mediana
English: - If you have any further questions, ask your doctor or your pharmacist.
Slovenian: Morda ga boste želeli ponovno prebrati - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Mix the solution for infusion gently.
Slovenian: • Raztopino previdno premešajte.
English: • diarrhoea
Slovenian: • nemirnost
English: Musculoskeletal pain
Slovenian: • bolečine v mišicah
English: Prior to use visually inspect the solution for particulate matter.
Slovenian: Pred uporabo si pozorno oglejte, ali raztopina vsebuje drobne delce.
English: People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body.
Slovenian: Ljudje z boleznijo MPS I imajo ali zmanjšano stopnjo aktivnosti encima -L-iduronidaza ali pa le-ta sploh ni prisoten.
English: Tél: 0 800 222 555
Slovenian: France sanofi-aventis France Tél: 0 800 222 555
English: They accumulate in many tissues in the body, which causes the symptoms of MPS I.
Slovenian: Posledica odsotnosti oz. zmanjšane aktivnosti encima je, da se glikozaminoglikani ne razgradijo in ne predelajo v telesu, ampak se nabirajo v mnogih tkivih v telesu, kar povzroča simptome MPS I.
English: NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Slovenian: Aldurazyme, 100 e/ml koncentrat za raztopino za infundiranje laronidaza
English: Careful consideration should be given to the patient's clinical status prior to administration of Aldurazyme.
Slovenian: Bolniki s predhodnimi akutnimi obolenji so še bolj izpostavljeni reakcijam ob infuziji zdravila Aldurazyme, zato je pri takih bolnikih potrebno nameniti dodatno pozornost na klinično stanje bolnika pred infundiranjem zdravila Aldurazyme.
English: Mean change from pre-treatment baseline Percent predicted FVC (%)1
Slovenian: Aldurazyme/Aldurazyme Placebo/Aldurazyme po 208 tednih po 182 tednih povprečna sprememba glede na izhodišče pred zdravljenjem predvideni odstotek FVC (%)1
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PRILOGA II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: ADRs were all mild to moderate in severity.
Slovenian: Vsi neželeni učinki so bili blagi ali zmerni.
English: Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: To količino zdravila Aldurazyme nato dodajte raztopini 0,9% natrijevega klorida za infundiranje.
English: • paleness
Slovenian: • omotica
English: Patients with an acute underlying illness at the time of Aldurazyme infusion appear to be at greater risk for IARs.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Aldurazyme, se lahko razvijejo reakcije ob infuziji.
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80
Slovenian: Natrijev dihidrogenfosfat monohidrat
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: Thereafter, they progressively decreased during the following weeks.
Slovenian: Nato sta se v nadaljnjih tednih postopoma zmanjševala.
English: The most important points are:
Slovenian: Najpomembnejše točke so:
English: This is done once and is called the ‘activation' process.
Slovenian: To je treba narediti le enkrat in ta postopek imenujemo "aktivacija".
English: Steps 1 to 5 below show you how to do this.
Slovenian: Koraki, oštevilčeni od 1 do 5 spodaj, kažejo, kako to naredite.
English: This is used in exactly the same way.
Slovenian: Ta se uporablja povsem enako.
English: If it is orange, go to Section 2.
Slovenian: Če je oranžno, pojdite na 2. poglavje.
English: Specific recommendations regarding intake of such medicinal products are given in section 4.5.
Slovenian: Specifična priporočila glede jemanja takšnih zdravil so navedena v poglavju 4.5.
English: Printed on the inside:
Slovenian: Natisnjeno na notranji strani:
English: After first use: 14 days
Slovenian: Po prvi uporabi: 14 dni
English: Section 1 - IMPORTANT INFORMATION
Slovenian: 1. poglavje - POMEMBNE INFORMACIJE
English: Take care not to injure yourself when the needle is exposed.
Slovenian: Pazite, da se ne poškodujete, ko je igla izpostavljena.
English: You must first use all 14 doses from this pen.
Slovenian: Najprej morate porabiti vseh 14 odmerkov iz tega peresnika.
English: Your dose will be correct and you can keep following the instructions.
Slovenian: Odmerek, ki ga boste dobili, bo pravilen in še naprej lahko sledite navodilom.
English: Insulin glargine was continuously titrated during this period.
Slovenian: Insulin glargin so med tem obdobjem stalno titrirali.
English: Using the wrong medicine could be harmful to your health.
Slovenian: Uporaba nepravega zdravila lahko škoduje zdravju.
English: Section 2 - GETTING STARTED
Slovenian: 2. poglavje - KAKO ZAČETI
English: Both pens are used in the same way.
Slovenian: Oba peresnika se uporabljata na enak način.
English: What if there are air bubbles in the container?
Slovenian: Kaj, če so v vsebniku zračni mehurčki?
English: Do not take two doses at the same time to make up for a forgotten injection.
Slovenian: Ne uporabite dveh odmerkov hkrati, da bi nadomestili pozabljeno injekcijo.
English: Your dose has now been given.
Slovenian: Zdaj ste dobili odmerek.
English: A treatment initiation pack is also available for use during the first 28 days of treatment.
Slovenian: Za uporabo v prvih 28 dneh zdravljenja je na voljo tudi pakiranje za uvedbo zdravljenja.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Ker študij kompatibilnosti ni, tega zdravila ne smemo mešati z drugimi zdravili.
English: Check the liquid.
Slovenian: Preverite tekočino.
English: The arrow will now be pointing towards the needle.
Slovenian: Puščica bo zdaj kazala k igli.
English: What if no liquid comes out during activation?
Slovenian: Kaj, če med aktiviranjem ne pride ven nič tekočine?
English: For your first injection go directly to Section 3 - Step C.
Slovenian: Za prvo injiciranje pojdite naravnost na 3. poglavje - korak C.
English: Warfarin and other coumarin derivatives
Slovenian: Varfarin in ostali kumarinski derivati
English: Glycerol 85%
Slovenian: 85 % glicerol
English: Small air bubbles in the container are normal - they will not harm you.
Slovenian: Prisotnost majhnih zračnih mehurčkov je normalna in vam ne bodo škodovali.
English: These medicinal products should be taken in a standardised way in relation to lixisenatide.
Slovenian: Takšna zdravila je treba jemati na standardiziran način glede na liksenatid.
English: Frequencies of adverse reactions are defined as: 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; very rare: <1/10,000).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 do < 1/10, občasni: ≥ 1/1.000 do < 1/100, redki: ≥ 1/10.000 do < 1/1.000, zelo redki: < 1/10.000).
English: • Always read the "Instructions for Use" provided in the box.
Slovenian: • Vedno preberite "Navodila za uporabo", ki so priložena v škatli.
English: Coronary revascularization 368 (12.1%) 356 (11.7%) procedure
Slovenian: Koronarni revaskularizacijski 368 (12,1 %) 356 (11,7 %) postopek
English: This may make it difficult to concentrate and you may feel dizzy or sleepy.
Slovenian: Posledica je lahko, da se težko zberete, in lahko ste omotični ali zaspani.
English: Lixisenatide has a moderate level of binding (55%) to human proteins.
Slovenian: Liksisenatid se zmerno (55 %) veže na človeške beljakovine.
English: The majority of reactions were mild in intensity and usually did not result in discontinuation of the treatment.
Slovenian: Večina reakcij je bila blagih in po navadi niso povzročile prekinitve zdravljenja.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti zdravila.
English: (-2.593 to -1.396)*
Slovenian: (-2,593 do -1,396)*
English: These reactions were mostly mild and transient.
Slovenian: Ti učinki so bili večinoma blagi in prehodni.
English: Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 only.
Slovenian: Odstranite iglo s peresnika, namestite novo in ponovite samo 4. in 5. korak.
English: In the example above, the dose number shows there are 13 injections left.
Slovenian: V zgornjem primeru število odmerkov kaže, da je preostalo še 13 injiciranj.
English: Do this even if there is some medicine left in the pen.
Slovenian: To storite tudi v primeru, da je v njem še ostalo nekaj zdravila.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 February 2013
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 01 Februar 2013 Datum zadnjega podaljšanja:
English: It is used in adults with type 2 diabetes.
Slovenian: Uporablja se pri odraslih s sladkorno boleznijo tipa 2.
English: The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weak, dizzy, confused or irritable, feeling hungry, fast heart beat and feeling jittery.
Slovenian: Med opozorilnimi znaki nizkega krvnega sladkorja so lahko hladno znojenje, hladna bleda koža, glavobol, zaspanost, šibkost, omotičnost, zmedenost ali razdražljivost, občutek lakote, hitro bitje srca in občutek tresenja.