FrancophonIA/ELRC3.0 huggingface dataset:
English: Remove the needle cap by holding the barrel of the syringe with the needle pointing away from you and pulling the needle cap straight off (Figure H).
Slovenian: Odstranite pokrovček igle Odstranite pokrovček igle tako, da držite telo brizge z iglo obrnjeno stran od sebe in izvlečete pokrovček igle naravnost navzgor (slika H).
English: In APPROACH, the Phase 3 clinical study in patients with FCS, Waylivra reduced fasting triglycerides, total cholesterol, non-HDL cholesterol, apoC-III, apoB-48, and chylomicron triglyceride levels and increased LDL-C, HDL-C, and apoB (see Table 3).
Slovenian: V študiji APPROACH, klinični študiji 3. faze pri bolnikih s sindromom FCS, je zdravilo Waylivra na tešče zmanjšalo raven trigliceridov, celokupnega holesterola, ne-HDL holesterola, apoC-III, apoB-48
English: Dispose of the Used Syringe into a Sharps Container
Slovenian: Brizgo zavrzite v vsebnik za ostre odpadke
English: Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels <75 x 109/L and treatment with these medicinal products should be stopped at platelet levels < 50 x 109/L (see section 4.4).
Slovenian: Pri ravni trombocitov < 75 x 109/l je treba razmisliti o prekinitvi zdravljenja z antitrombotiki/NSAID/antikoagulansi, pri ravni trombocitov < 50 x 109/l pa je treba zdravljenje s temi zdravili ukiniti (glejte poglavje 4.4).
English: Pack sizes of one pre-filled syringe or multipacks containing 4 (4 packs of 1) pre-filled syringes.
Slovenian: Pakiranje z eno napolnjeno injekcijsko brizgo ali pakiranje po več enot, ki vsebuje štiri (štiri pakiranja po 1) napolnjene brizge.
English: Injection site reactions
Slovenian: Reakcija na mestu injiciranja
English: The percent change in fasting TG from Index Study Baseline to Open-label Month 6 and Month 12 for the APPROACH-volanesorsen patients was -54.8% and -35.1%, respectively.
Slovenian: Odstotna sprememba ravni trigliceridov na tešče od začetne vrednosti v indeksni študiji do šestega in dvanajstega meseca nezaslepljene študije je bila pri bolnikih, zdravljenih z volanesorsenom v študiji APPROACH, −54,8 % oziroma −35,1 %.
English: If it is not used within 6 weeks after first removing from the refrigerator, the medicine should be discarded.
Slovenian: Če zdravilo ni uporabljeno v šestih tednih po tem, ko je prvič vzeto iz hladilnika, ga je treba nemudoma zavreči.
English: You should see your doctor immediately if you have any signs of low platelet levels, such as unusual or prolonged bleeding, patches of red appearing on the skin (called petechiae), unexplained bruising, bleeding which will not stop, or nosebleeds, or if you get neck stiffness or a severe headache.
Slovenian: Če imate kakršne koli znake nizkega števila trombocitov v krvi, kakršni so neobičajna ali dolgotrajna krvavitev, rdeče lise na koži (imenovane petehije), nepojasnjene podplutbe, krvavitve, ki se ne ustavijo, ali krvavitve iz nosu ali če se pri vas pojavi tog vrat ali hud glavobol, morate takoj obiskati zdravnika.
English: mg/dL -19 (-24, -15) mmol/L
Slovenian: −19 (−24, −15) mmol/l
English: No evidence of altered safety profile or clinical response was associated with presence of anti-drug antibodies.
Slovenian: Imunogenost in vnetje Prisotnosti protiteles proti zdravilu niso povezali z nobenim znakom spremenjenega varnostnega profila ali kliničnega odziva.
English: Do not hold the plunger rod or the plunger head while removing the needle cap.
Slovenian: Pri odstranjevanju pokrovčka igle ne držite bata ali glave bata.
English: Antithrombotic agents and medicinal products that may lower platelet count It is not known whether the risk of bleeding is increased by concomitant use of volanesorsen and antithrombotic agents or medicinal products that may lower platelet count or affect platelet function.
Slovenian: Ni znano, ali se tveganje za krvavitev povečuje s sočasno uporabo volanesorsena in antitrombotikov ali zdravil, ki lahko zmanjšajo število trombocitov ali vplivajo na delovanje trombocitov.
English: If a dose is missed and noticed within 48 hours, the patient should be directed to give the missed dose as soon as possible.
Slovenian: Če bolnik odmerek izpusti in to opazi v 48 urah, mu je treba naročiti, da si izpuščeni odmerek da čim prej.
English: Alternate the injection area for each injection.
Slovenian: Pri vsakem injiciranju izberite drug predel za injiciranje.
English: *p-value < 0.0001 (primary efficacy endpoint) Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model)
Slovenian: Razlika = sprememba povprečja najmanjših kvadratov [za volanesorsen v odstotkih - za placebo v odstotkih] (model ANCOVA)
English: Headache (8, 9%) Hypoaesthesia (1, 1%) Presyncope (1, 1%) Retinal migraine (1, 1%) Syncope (2, 2%) Dizziness (1, 1%) Tremor (1, 1%)
Slovenian: Glavobol (8; 9 %) Hipestezija (1; 1 %) Predsinkopa (1; 1 %) Retinalna migrena (1; 1 %) Sinkopa (2; 2 %) Omotica (1; 1 %) Tremor (1; 1 %)
English: mg/dL (26.5 μmol/L) that is >ULN is recorded, or creatinine clearance estimated by the CKD-EPI equation is ≤ 30 mL/min/1.73m2.
Slovenian: (26,5 μmol/l), ki je > ZMN (zgornja meja normale), ali če je očistek kreatinina, ocenjen po enačbi
English: It is important to rotate sites for injection.
Slovenian: Pomembno je, da mesta za injiciranje menjate.
English: mg/dL -20 (-26, -15) mmol/L
Slovenian: −20 (−26, −15) mmol/l
English: Dose and time-dependent reductions in platelet counts were observed in Cynomolgus monkey repeated dose studies.
Slovenian: Pri študijah ponavljajočih se odmerkov na opicah Cynomolgus so opazili od odmerka in časa odvisno zmanjšanje števila trombocitov.
English: Do not use Waylivra if the expiry date has passed or if it was stored for longer than 6 weeks at room temperature.
Slovenian: Če je potekel datum izteka roka uporabnosti ali če je bilo zdravilo Waylivra pri sobni temperaturi shranjeno dlje kot šest tednov, zdravila ne smete uporabiti.
English: Do not recap the syringe.
Slovenian: Pokrovčka ne nameščajte nazaj na iglo.
English: This medicinal product has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter tega zdravila niso proučevali.
English: Treatment should also be discontinued for any clinical symptoms or signs of renal impairment pending the previous confirmatory assessments.
Slovenian: Zdravljenje je treba do omenjenih potrditvenih preiskav prekiniti tudi ob vsakem kliničnem simptomu ali znaku okvare ledvic.
English: Before initiation of treatment, platelet count should be measured.
Slovenian: Pred začetkom zdravljenja je treba določiti število trombocitov.
English: o Reporting of any adverse drug reaction to a health professional
Slovenian: o Poročanje zdravstvenemu delavcu o vsakršnem neželenem učinku zdravila.
English: Prepare injection site
Slovenian: Pripravite si mesto za injiciranje
English: Injection site haematoma (7, 8%) Injection site reaction (6, 7%) Injection site urticaria (5, 6%) Injection site warmth (5, 6%) Chills (5, 6%)
Slovenian: Astenija (8; 9 %) Utrujenost (8; 9 %) Hematom na mestu injiciranja (7; Reakcija na mestu injiciranja (6; Urtikarija na mestu injiciranja (5; Toplota na mestu injiciranja (5; Mrzlica (5; 6 %)
English: Parameter at Month 3a
Slovenian: Parameter po treh meseciha
English: Renal toxicity has been observed after administration of volanesorsen and other subcutaneously and intravenously administered antisense oligonucleotides.
Slovenian: Ledvična toksičnost je bila ugotovljena po dajanju volanesorsena in drugih protismiselnih oligonukleotidov, ki se dajejo subkutano ali intravensko.
English: LDL-C
Slovenian: Raven LDL-C
English: APPROACH-volanesorsen (Index Study Baselinea, N=14)
Slovenian: Skupina, zdravljena z volanesorsenom v študiji APPROACH (izhodišče v indeksni študijia, n = 14)
English: Ask your pharmacist or see your local public health government website (where available) for more details on how you should dispose of sharps in your location.
Slovenian: Za več informacij o tem, kako je treba zavreči ostre predmete na vaši lokaciji, se posvetujte s farmacevtom ali obiščite spletno mesto svojega lokalnega javnozdravstvenega organa (če je na voljo).
English: Do not inject into tattoos, moles, scars, birthmarks, bruises, rashes, or areas where the skin is tender, red, hard, damaged, burned, or inflamed.
Slovenian: brazgotine, materina znamenja, podplutbe, izpuščaje ali predele, kjer je koža občutljiva, rdeča, trda, poškodovana, opečena ali vneta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK WITH BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - PAKET Z MODRIM OKENCEM
English: The percent change in fasting TG from Index Study Baseline to Open-label Month 3 for the APPROACH- and CS16-volanesorsen patients was -49.2% and -64.9%, respectively.
Slovenian: Odstotna sprememba ravni trigliceridov na tešče od začetne vrednosti v indeksni študiji do tretjega meseca nezaslepljene študije je bila za bolnike, zdravljene z volanesorsenom v študijah APPROACH in CS16, −49,2 % oziroma
English: As a precautionary measure, it is preferable to avoid the use of this medicinal product during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi volanesorsena bolje izogibati.
English: You should continue the very low-fat diet that your doctor has prescribed during treatment with Waylivra.
Slovenian: Med zdravljenjem z zdravilom Waylivra morate še naprej uživati prehrano z zelo nizko vsebnostjo maščob, ki vam jo je predpisal zdravnik.
English: Pre-filled syringe components
Slovenian: Sestavine napolnjene injekcijske brizge
English: LS Mean Absolute Change (95% CI) mg/dL or mmol/L
Slovenian: Sprememba povprečja najmanjših kvadratov v odstotkih (95% IZ) Absolutna sprememba povprečja najmanjših kvadratov (95% IZ) mg/dl ali mmol/l
English: You should see your doctor immediately if you have any signs of liver damage, such as yellowing of your skin and eyeballs, pain or swelling in your abdomen, feeling or being sick, confusion or a general feeling of being unwell.
Slovenian: Če imate kakršne koli znake okvare jeter, kot so porumenela koža in zrkla, bolečina ali otekanje trebuha, slabost ali občutek slabosti, zmedenost ali splošen občutek slabega počutja, nemudoma obiščite zdravnika.
English: Diabetes mellitus (1, 1%)
Slovenian: Sladkorna bolezen (1; 1 %)
English: Waylivra 285 mg injection volanesorsen
Slovenian: Waylivra 285 mg injekcija volanesorsen sc.
English: There may be special local laws regarding how you should throw away used needles and syringes.
Slovenian: Način, kako je treba zavreči uporabljene igle in brizge, je lahko predpisan s posebnimi lokalnimi zakoni.
English: It is important to tell your doctor if you are already being treated with any of the following: - Medicines to prevent blood clots, e.g., acetylsalicylic acid, dipyridamol or warfarin.
Slovenian: - zdravila za preprečevanje krvnih strdkov, npr. acetilsalicilna kislina, dipiridamol ali varfarin;
English: CS16-volanesorsen (Index Study Baselinea, N=3)
Slovenian: Skupina, zdravljena z volanesorsenom v študiji CS16 (izhodišče v indeksni študijia, n = 3)
English: Haemoglobin decreased (1, 1%) Hepatic enzyme increased (1, 1%) International normalised ratio increased (1, 1%)
Slovenian: Zmanjšan ledvični očistek kreatinina (1; 1 %) Zvišana raven transaminaz (1; Zmanjšano število levkocitov (1; Zmanjšana raven hemoglobina Zvišana raven jetrnih encimov Zvišano mednarodno normalizirano razmerje (1; 1 %)
English: In this 6-week period, it can be kept as needed between refrigerated and room temperature (up to 30 °C).
Slovenian: V tem šesttedenskem obdobju se lahko hrani ohlajeno ali pri sobni temperaturi (do
English: Treat the Injection Site
Slovenian: Izberite mesto za injiciranje
English: Patients should be re-downtitrated to 285 mg every 2 weeks if the higher 285 mg once weekly dose does not provide significant additional triglyceride reduction after 9 months.
Slovenian: Če večji odmerek 285 mg enkrat na teden po 9 mesecih ne privede do pomembnega dodatnega znižanja ravni trigliceridov, je treba odmerek pri bolnikih zmanjšati na 285 mg vsaka 2 tedna.
English: Insomnia (1, 1%)
Slovenian: Nespečnost (1; 1 %)
English: Haematoma (3, 3%) Hypertension (1, 1%) Haemorrhage (1, 1%) Hot flush (1, 1%)
Slovenian: Hematom (3; 3 %) Hipertenzija (1; 1 %) Krvavitev (1; 1 %)
English: Accumulation in Ctrough was observed (7- to 14-fold) and little or no increase in Cmax or AUC was observed following weekly SC administration over a dose of 200 to 400 mg.
Slovenian: Po tedenskem subkutanem dajanju odmerka od 200 do 400 mg volanesorsena je bilo ugotovljeno kopičenje Cmin (od 7- do 14-kratno) in le malo ali nič povečanja Cmaks ali AUC.
English: Waylivra is provided in a carton as a single-dose syringe with needle and needle cap, pre-filled with a clear, colourless to pale yellow solution.
Slovenian: Zdravilo Waylivra je na voljo v škatli v obliki injekcijske brizge za enkratno uporabo z iglo in pokrovčkom za iglo, napolnjene z bistro, brezbarvno do bledorumeno raztopino.
English: Haematuria (1, 1%) Proteinuria (1, 1%)
Slovenian: Hematurija (1; 1 %) Proteinurija (1; 1 %)
English: You should see your doctor immediately if you have any signs of kidney damage, such as swelling in your ankles, legs and feet, passing smaller amounts of urine than usual, shortness of breath, feeling sick, confusion or feeling very tired or drowsy.
Slovenian: Če imate kakršne koli znake okvare ledvic, kot so otekanje gležnjev, nog in stopal, odvajanje manjše količine urina, kot je običajno, kratka sapa, občutek slabega počutja, zmedenost in občutek velike utrujenosti ali zaspanost, morate nemudoma obiskati zdravnika.
English: Choose an injection site If self-injecting:
Slovenian: Če si zdravilo injicirate sami:
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
English: Diet
Slovenian: Prehrana
English: Gastrointestinal disorders
Slovenian: Hilomikronski trigliceridi
English: • The patient information pack should contain: o Patient information leaflet o A patient/carer guide
Slovenian: • Paket informacij za bolnika mora vsebovati:
English: Percent of patientsc with ≥ 40% reduction in fasting triglycerides** a The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Slovenian: Odstotek bolnikovb s plazemsko ravnijo trigliceridov na tešče < 750 mg/dl (8,5 mmol/l)* Odstotek bolnikovc z ≥ 40odstotnim zmanjšanjem ravni trigliceridov na tešče** a Izid po treh mesecih je bila opredeljen kot povprečje ocene na tešče v 12.
English: Do not use the pre-filled syringe if the needle appears damaged.
Slovenian: Če je igla videti poškodovana, brizge ne smete uporabiti.
English: Mean body mass index was 25 kg/m2.
Slovenian: 25 kg/m2.
English: Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels < 75 x 109/L.
Slovenian: Pri ravni trombocitov < 75 x 109/l je treba razmisliti o prekinitvi zdravljenja z antitrombotičnimi zdravili/NSAID/antikoagulansi.
English: Waylivra 285 mg solution for injection in pre-filled syringe volanesorsen
Slovenian: Waylivra 285 mg raztopina za injiciranje v napolnjeni injekcijski brizgi volanesorsen
English: Waylivra 285 mg solution for injection in pre-filled syringe
Slovenian: Waylivra 285 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Asthenia (8, 9%) Fatigue (8, 9%)
Slovenian: Navzea (8; 9 %)
English: LS mean percent change from baseline in fasting triglycerides based on the observed data are displayed.
Slovenian: Prikazana je odstotna sprememba povprečja najmanjših kvadratov od začetne vrednosti za trigliceride na tešče.
English: - Injection site reactions (pain, redness, heat, dryness, swelling, itching, tingling, hardening, pimpling, bruising, bleeding, numbness, change in colour or a burning feeling at the injection site).
Slovenian: Drugi neželeni učinki Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - Reakcije na mestu injiciranja (bolečina, rdečina, vročina, suha koža, oteklina, srbenje, mravljinčenje, otrdelost, mozoljavost, podplutba, krvavitev, otrplost, sprememba barve ali pekoč občutek na mestu injiciranja).
English: Talk to your healthcare provider if you are unsure of where to inject.
Slovenian: Če niste prepričani, kam injicirati, se posvetujte z zdravstvenim delavcem.
English: Injection site dryness (4, 5%) Injection site haemorrhage (4,
Slovenian: Pireksija (4; 5 %) Suhost na mestu injiciranja (4; Krvavitev na mestu injiciranja Hipestezija na mestu injiciranja Vezikli na mestu injiciranja (3;
English: Injection site paraesthesia (1, 1%) Injection site scab (1, 1%) Injection site papule (1, 1%) Oedema (1, 1%)
Slovenian: Parestezija na mestu injiciranja Krasta na mestu injiciranja (1; Papula na mestu injiciranja (1; Edem (1; 1 %)
English: Figure 1: LS Mean Percent Change in Fasting Triglycerides in Phase 3 Study in Patients with FCS (APPROACH)
Slovenian: Odstotna sprememba povprečja najmanjših kvadratov za raven trigliceridov na tešče v študiji 3. faze pri bolnikih s sindromom FCS (APPROACH)
English: Observed Value change from Baseline in CS7 n
Slovenian: Odstotek spremem be od izhodišča v študiji C S7 n
English: Check the expiry date
Slovenian: Preverite rok uporabe
English: If you get any of the following side effects, contact your doctor immediately: - Symptoms that could indicate low counts of platelets in your blood (platelets are cells important for blood clotting).
Slovenian: - Simptomi, ki lahko pomenijo nizko število trombocitov v krvi (trombociti so celice,
English: Epistaxis (3, 3%) Cough (1, 1%) Dyspnoea (2, 2%) Nasal congestion (1, 1%) Pharyngeal oedema (1, 1%) Wheezing (1, 1%)
Slovenian: Epistaksa (3; 3 %) Kašelj (1; 1 %) Dispneja (2; 2 %) Zamašen nos (1; 1 %) Edem žrela (1; 1 %) Piskanje (1; 1 %)
English: Solution for injection 1 pre-filled syringe
Slovenian: Raztopina za injiciranje Napolnjena injekcijska brizga
English: Leukopenia (2, 2%) Eosinophilia (1, 1%) Immune thrombocytopenic purpura (1, 1%)
Slovenian: Levkopenija (2; 2 %) Eozinofilija (1; 1 %)
English: Breastfeeding
Slovenian: Trigliceridi
English: Figure K
Slovenian: −Slika K
English: Injection site induration (17, 20%) Injection site bruising (10, 12%) Injection site oedema (10, 12%)
Slovenian: Obarvanje na mestu injiciranja Zatrdlina na mestu injiciranja (17; Podplutba na mestu injiciranja Edem na mestu injiciranja (10;
English: Injection site mass (2, 2%) Pain (2, 2%)
Slovenian: Bolečina (2; 2 %)
English: LS Mean % Change from Baseline
Slovenian: Odstotna sprememba povprečja najmanjših kvadratov od izhodišča
English: Treatment-naïve Group (Open-label Study Baselinea, N=51)
Slovenian: (izhodišče v nezaslepljeni študijia, n = 51)
English: o Platelet monitoring recommendations including dosage adjustment recommendations, both before and during treatment.
Slovenian: o Priporočila za spremljanje trombocitov, vključno s priporočili o prilagajanju odmerka,
English: were identified in human urine.
Slovenian: - Kri ali beljakovine v urinu
English: Triglycerides Total Cholesterol
Slovenian: Celokupni holesterol LDL-C
English: Erythema (4, 5%) Pruritus (4,5 %) Urticaria (3, 3%) Hyperhidrosis (2, 2%) Rash (3, 3%) Petechiae (1, 1%) Ecchymosis (1, 1%) Night sweats (1, 1%) Papule (1, 1%) Skin hypertrophy (1, 1%) Swelling face (1, 1%)
Slovenian: Eritem (4; 5 %) Pruritus (4; 5 %) Koprivnica (3; 3 %) Hiperhidroza (2; 2 %)
English: Spontaneous haematoma (1, 1%)
Slovenian: Imunska trombocitopenična purpura (1; 1 %) Spontani hematom (1; 1 %)
English: Solution for injection in pre-filled syringe 1 pre-filled syringe.
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Elevations of liver enzymes have been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Slovenian: Po dajanju drugih protismiselnih oligonukleotidov, ki se dajejo subkutano ali intravensko, je bilo opaženo zvišanje jetrnih encimov.
English: Conjunctival haemorrhage (1, Vision blurred (1, 1%)
Slovenian: Hipertrofija kože (1; 1 %) Otekanje obraza (1; 1 %)
English: Injection site hypoaesthesia (4,
Slovenian: Bolečina na mestu injiciranja (38;
English: Platelet count decreased (34, 40%) Blood creatinine increased (1,
Slovenian: Zvišana raven kreatinina v krvi Zvišana raven sečnine v krvi (1;
English: Do not use the pre-filled syringe if it is dropped with the needle cap removed.
Slovenian: Če vam brizga z odstranjenim pokrovčkom igle pade iz rok, je ne smete uporabiti.
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Slovenian: • Izobraževalno gradivo za zdravnika mora vsebovati:
English: If you use more Waylivra than you should
Slovenian: Če je število trombocitov manjše od
English: Do not use the pre-filled syringe if the liquid is cloudy or has floating particles.
Slovenian: Če je tekočina motna ali v njej opazite lebdeče delce,
English: Non-cardiac chest pain (1, 1%) Vessel puncture site haemorrhage
Slovenian: Nekardialna bolečina v prsnem košu (1; 1 %) Krvavitev na mestu preboda žile
English: Nausea (8, 9%) Diarrhoea (4, 5%) Dry mouth (1,1 %)
Slovenian: Suha usta (1; 1 %) Krvavitev iz dlesni (1; 1 %) Krvavitev v ustni votlini (1; 1 %)
English: Elimination
Slovenian: Skladiščenje
English: Immunisation reaction (3, 3%) Hypersensitivity (1, 1%) Serum sickness-like reaction (1,
Slovenian: Serumski bolezni podobna reakcija (1; 1 %)
English: • Inappropriate behaviour.
Slovenian: • Neprimerno vedenje.
English: Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucure ti
Slovenian: Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucureti
English: • Slow or reduced movement of the body.
Slovenian: • Počasno ali okrnjeno gibanje telesa.
English: Date of first authorisation: 19 June 2015
Slovenian: Datum prve odobritve: 19. 6. 2015
English: EXP Use within 6 months after first opening.
Slovenian: EXP Uporabite v 6 mesecih od prvega odprtja.
English: After first opening of the container: 6 months.
Slovenian: 3 leta Po prvem odprtju vsebnika: 6 mesecev.
English: • Difficulties with erection.
Slovenian: • Težave z erekcijo.
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz normally except if you have problems with your kidneys.
Slovenian: Če ste starejši bolnik (nad 65 let), lahko jemljete zdravilo Pregabalin Sandoz normalno, razen če imate težave z ledvicami.
English: Do not use this medicine after the expiry date which is stated on the blister, container or carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, vsebniku ali škatli.
English: Pregabalin Sandoz should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Slovenian: Zdravila Pregabalin Sandoz se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del multipakiranja, ni za posamično prodajo.
English: • Coldness of hands and feet.
Slovenian: • Hladne dlani in stopala.
English: Tell your doctor if you experience constipation, especially if you are prone to this problem.
Slovenian: Povejte svojemu zdravniku, če se pojavi zaprtost, še posebno, če ste nagnjeni k temu problemu.
English: A-6250 Kundl
Slovenian: 6250 Kundl
English: • Difficulty with writing properly.
Slovenian: • Težave s pisanjem.
English: Do not take Pregabalin Sandoz: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Pregabalin Sandoz: • Če ste alergični na pregabalin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Slovenian: *zvišanje alanin aminotransferaze (ALT) in aspartat aminotransferaze (AST)