FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Waylivru Lijek čuvajte izvan pogleda i dohvata djece.
English: For discontinued patients, a haematologist should be consulted prior to resuming treatment.
Croatian: x109/L . Za bolesnike koji su prekinuli liječenje, potrebno je konzultirati hematologa prije nastavka liječenja.
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.
Croatian: Postotak promjene početne razine triglicerida natašte u indeksirajućem ispitivanju u odnosu na otvoreno ispitivanje u 6. mjesecu za bolesnike koji su primali volanesorsen u ispitivanju APPROACH bio je -54,8% odnosno -35,1% u 12. mjesecu.
English: b The denominator for percentage calculation was the total number of patients in FAS with baseline fasting triglyceride ≥ 750 mg/dL (or 8.5 mmol/L) in each treatment group.
Croatian: Nazivnik za izračun postotka bio je ukupni broj bolesnika u potpunom skupu podataka za analizu koji su imali početnu razinu triglicerida natašte ≥ 750 mg/dL (ili 8,5 mmol/l) u svakoj skupini za liječenje.
English: Feeling hot (2, 2%) Influenza-like illness (2, 2%) Injection site discomfort (2, 2%) Injection site inflammation (2,
Croatian: Bolest nalik influenci (2, 2%) Nelagoda na mjestu injekcije (2,
English: - Any liver or kidney problems.
Croatian: - Bilo kakve probleme s jetrom.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane od češćih prema rjeđim.
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.
Croatian: Nije poznato povećava li se rizik od krvarenja pri istodobnoj uporabi volanesorsena i antitrombotika ili lijekova koji mogu sniziti broj trombocita ili utjecati na funkciju trombocita.
English: Each single-use, prefilled syringe of this medicine gives you a dose of 285 mg in 1.5 ml.
Croatian: Svaka napunjena štrcaljka ovog lijeka namjenjena je za jednokratnu uporabu i omogućuje primjenu doze od 285 mg u 1,5 ml.
English: The expiry date on the package refers to the life of the product when refrigerated.
Croatian: Rok valjanosti na pakiranju odnosi se na rok valjanosti lijeka koji se čuva u hladnjaku.
English: Each single-dose pre-filled syringe contains 285 mg of volanesorsen in 1.5 ml solution.
Croatian: Jedna napunjena štrcaljka s jednom dozom sadrži 285 mg volanesorsena u 1,5 ml otopine.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, ili ljekarniku ili medicinskoj sestri.
English: Headache (8, 9%) Hypoaesthesia (1, 1%) Presyncope (1, 1%) Retinal migraine (1, 1%) Syncope (2, 2%) Dizziness (1, 1%) Tremor (1, 1%)
Croatian: Glavobolja (8, 9%) Hipoestezija (1, 1%) Presinkopa (1, 1%) Retinalna migrena (1, 1%) Sinkopa (2, 2%) Omaglica (1, 1%) Tremor (1, 1%)
English: Injection site induration (17, 20%) Injection site bruising (10, 12%) Injection site oedema (10, 12%)
Croatian: Induracija na mjestu injekcije (17, Nastanak modrice na mjestu injekcije (10, 12%) Edem na mjestu injekcije (10,
English: Platelet monitoring and dose adjustments
Croatian: Praćenje trombocita i prilagodba doziranja
English: Waylivra 285 mg injection volanesorsen
Croatian: Waylivra 285 mg injekcija volanesorsen s.c.
English: Figure H
Croatian: slika H
English: Renal toxicity has been observed after administration of volanesorsen and other subcutaneously and intravenously administered antisense oligonucleotides.
Croatian: Bubrežna toksičnost uočena je nakon primjene volanesorsena i drugih supkutano i intravenski primijenjenih antisense oligonukleotida.
English: Solution for injection in pre-filled syringe Multipack: 4 (4 packs of 1) pre-filled syringes
Croatian: Višestruko pakiranje: 4 (4 pakiranja od 1) napunjene štrcaljke
English: Do not use the pre-filled syringe if it is dropped with the needle cap removed.
Croatian: Nemojte koristiti napunjenu štrcaljku ako ste je ispustili bez kapice.
English: Haemoglobin decreased (1, 1%) Hepatic enzyme increased (1, 1%) International normalised ratio increased (1, 1%)
Croatian: Povišeni jetreni enzimi (1, 1%) Povišen internacionalni normalizirajući omjer (1, 1%)
English: Daily a See section 4.4 for recommendations regarding use of antiplatelet agents/NSAIDs/anticoagulants b Consultation of a haematologist is needed to reconsider the benefit/risk for possible further treatment with volanesorsen.
Croatian: b Potrebne su konzultacije s hematologom kako bi se razmotrila korist/rizik za moguće daljnje liječenje volanesorsenom.
English: Immunogenicity and inflammation
Croatian: Imunogenost i upala
English: Figure N
Croatian: slika N
English: Table 4: Mean Change from Baseline in Fasting Triglycerides in the Phase 3 PlaceboControlled Study in Patients with FCS at Month 3 (APPROACH)
Croatian: Tablica 4: Srednja vrijednost promjene razine triglicerida natašte u 3. mjesecu u odnosu na početnu vrijednost u placebom kontroliranom ispitivanju faze 3 u bolesnika s FSCom (APPROACH) Placebo (N=33)
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.
Croatian: Postotak promjene razine triglicerida natašte izmjerenih na početku indeksirajućeg ispitivanja u odnosu na razine izmjerene u 3.mjesecu otvorenog ispitivanja CS7 za bolesnike u skupini prethodno liječenoj volansersonom u sklopu ispitivanja APPROACH iznosili su -49,2% odnosno -64,9% u ispitivanju CS16.
English: Do not recap the syringe.
Croatian: Nemojte ponovno vraćati kapicu igle na štrcaljku.
English: Most patients receiving volanesorsen experienced a clinically significant reduction in triglycerides.
Croatian: Dodatni rezultati djelotvornosti za promjene triglicerida prikazani su u Tablici 5. Većina bolesnika koja je primala volanesorsen postigla je klinički značajno smanjenje triglicerida.
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.
Croatian: Morate se odmah javiti liječniku ako imate ikakve bilo kakve znakove oštećenja jetre poput žutila kože i bjeloočnica, boli ili oticanja u trbuhu, mučninu ili povraćanje, zbunjenosti ili općeg lošeg osjećanja.
English: The estimated steady-state volume of distribution (Vss) in patients with FCS is 330 L. Volanesorsen is highly bound to human plasma proteins (>98%) and the binding is concentration independent.
Croatian: Volanesorsen se u visokom postotku veže za proteine plazme (> 98%), a vezivanje ne ovisi o koncentraciji.
English: Pre-filled syringe components
Croatian: Dijelovi napunjene štrcaljke
English: Study Day 1) showed a significant reduction in pancreatitis attacks in volanesorsen-treated patients compared to placebo treated patients (p=0.0242).
Croatian: Analiza bolesnika s anamnezom događaja recidivirajućeg pankreatitisa (≥ 2 događaja u 5 godina prije dana 1 ispitivanja) pokazala je značajno smanjenje u napadajima pankreatitisa u skupini bolesnika koji su liječeni volanesorsenom u usporedbi s bolesnicima koji su liječeni placebom (p=0,0242).
English: Figure C
Croatian: slika C
English: Dose and time-dependent reductions in platelet counts were observed in Cynomolgus monkey repeated dose studies.
Croatian: Snižavanja broja trombocita ovisna o dozi i vremenu uočena su u ispitivanjima ponovljene doze na makaki majmunima.
English: A total of 67 patients have been treated and 50 (74%) patients remain on treatment, made up of 38 (76%) patients in the treatment-naïve group, 9 (18%) in the APPROACH-volanesorsen group and 3 (6%) in the CS16-volanesorsen group.
Croatian: Liječeno je ukupno 67 bolesnika, a njih 50 (74%) nastavilo je primati terapiju što čini 38 (76%) bolesnika u skupini koja nije prethodno liječena, 9
English: Insomnia (1, 1%)
Croatian: Nesanica (1, 1%)
English: Haematuria (1, 1%) Proteinuria (1, 1%)
Croatian: Hematurija (1, 1%) Proteinurija (1, 1%)
English: • Leak-resistant,
Croatian: • otporan na propuštanje,
English: Injection site mass (2, 2%) Pain (2, 2%)
Croatian: Upala na mjestu injekcije (2, 2%) Masa na mjestu injekcije (2, 2%) Bol (2, 2%)
English: In vitro studies show that volanesorsen is not a substrate or inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptides (OATP1B1, OATP1B3), bile salt export pump (BSEP), organic cation transporters (OCT1, OCT2), or organic anion transporters (OAT1, OAT3).
Croatian: In vitro ispitivanja pokazuju da volanesorsen nije supstrat ili inhibitor P-glikoproteina (P-gp), proteina otpornosti raka dojke na lijekove (BCRP), transportnih polipeptida za organske anione
English: Figure O
Croatian: slika O
English: What you need to know before you use Waylivra Do not use Waylivra if:
Croatian: Nemojte primjenjivati Waylivru ako:
English: Figure D
Croatian: slika D
English: Figure L
Croatian: slika L
English: Wash hands and gather supplies
Croatian: Operite ruke i pripremite sve što Vam je potrebno za injekciju
English: Diabetes mellitus (1, 1%)
Croatian: Dijabetes melitus (1, 1%)
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%)
Croatian: Eritem (4, 5%) Pruritus (4, 5%) Urtikarija (3, 3%) Hiperhidroza (2, 2%) Osip (3, 3%) Petehije (1, 1%) Ekhimoza (1, 1%)
English: Do not rub the site after you've injected.
Croatian: Nemojte trljati mjesto davanja injekcije nakon injekcije.
English: This medicinal product has not been studied in patients with hepatic impairment.
Croatian: Ovaj lijek nije ispitivan u bolesnika s oštećenjem funkcije jetre.
English: Figure M
Croatian: slika M
English: o Information about the FCS disease registry and the PASS study and the importance of contributing to those studies.
Croatian: Bolesnike se mora podsjećati da pročitaju uputu o lijeku te vodič za bolesnika/njegovatelja o Informacije o registru za FCS te PASS ispitivanje kao i važnost doprinosa tim ispitivanjima
English: Weekly
Croatian: Tjedno
English: Eye disorders
Croatian: Poremećaj oka
English: Figure P
Croatian: slika P
English: Remove needle cap
Croatian: Skinite kapicu igle
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.
Croatian: Morate se odmah javiti liječniku ako imate bilo kakve znakove oštećenja bubrega poput oticanja u gležnjevima, nogama ili stopalima, smanjeno izmokravanje u odnosu na inače, nedostatak zraka, mučninu, zbunjenost ili osjećaj velikog umora ili omamljenost.
English: Waylivra should be injected under your skin in the way the doctor, nurse or pharmacist has shown you, and you should make sure you inject all of the liquid in the syringe.
Croatian: Waylivra se mora injicirati pod kožu (supkutano) na način koji Vam je pokazao liječnik,
English: Waylivra 285 mg solution for injection in pre-filled syringe
Croatian: Waylivra 285 mg otopina za injekciju u napunjenoj štrcaljki
English: Waylivra 285 mg solution for injection in pre-filled syringe volanesorsen
Croatian: Waylivra 285 mg otopina za injekciju u napunjenoj štrcaljki volanesorsen
English: P-values from logistic regression model with treatment, presence of pancreatitis and presence of concurrent omega-3 fatty acids and/or fibrates as factors, and logarithm-transformed baseline fasting triglycerides as a covariate.
Croatian: P-vrijednosti iz modela logističke regresije s liječenjem, prisutnošću pankreatitisa i istodobne terapije omega-3
English: They may change how often you use it, or may stop it for a period or permanently, depending on the results of your blood and urine tests or occurrence of side effects.
Croatian: Liječnik Vam može promijeniti učestalost primjene ovog lijeka ili može privremeno ili trajno prekinuti liječenje njime, ovisno o
English: Epistaxis (3, 3%) Cough (1, 1%) Dyspnoea (2, 2%) Nasal congestion (1, 1%) Pharyngeal oedema (1, 1%) Wheezing (1, 1%)
Croatian: Epistaksa (3, 3%) Kašalj (1, 1%) Dispneja (2, 2%) Nazalna kongestija (1, 1%) Faringealni edem (1, 1%) Piskanje (1, 1%)
English: Treat the Injection Site
Croatian: Pobrinite se za mjesto davanja injekcije
English: LDL-C
Croatian: Razine LDL-C
English: Table 1.
Croatian: Slika 1:
English: APPROACH-volanesorsen (Index Study Baselinea, N=14)
Croatian: (početak indeksirajućeg ispitivanjaa, N=14)
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku ili medicinskoj sestri.
English: Choose an injection site If self-injecting:
Croatian: Ako si sami dajete injekciju:
English: Haematoma (3, 3%) Hypertension (1, 1%) Haemorrhage (1, 1%) Hot flush (1, 1%)
Croatian: Hematom (3, 3%) Hipertenzija (1, 1%) Krvarenje (1, 1%) Navala crvenila (1, 1%)
English: Figure J
Croatian: slika J
English: Figure G
Croatian: slika G
English: Treatment-naïve Group (Open-label Study Baselinea, N=51)
Croatian: (početak otvorenog ispitivanjaa, N=51)
English: Pyrexia (4, 5%)
Croatian: Zimica (5, 6%) Pireksija (4, 5%)
English: Dispose of the Used Syringe into a Sharps Container
Croatian: Nakon davanja injekcije 12. Bacite iskorištenu štrcaljku u spremnik za oštre predmete
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).
Croatian: - simptomi koji mogu ukazivati na nizak broj trombocita u Vašoj krvi (trombociti su stanice bitne za zgrušavanje krvi).
English: a Baseline values for treatment-naïve group were taken from the open-label study CS7 and baseline for
Croatian: Početne vrijednosti za skupinu koja nije prethodno liječena uzete su iz otvorenog ispitivanja CS7, a za skupine liječene volanesorsenom u sklopu ispitivanja APPROACH i CS16 uzete su iz odgovarajućeg indeksirajućeg ispitivanja.
English: Injection site hypoaesthesia (4,
Croatian: Krvarenje na mjestu injekcije (4, Hipoestezija na mjestu injekcije
English: Blood urea increased (1, 1%) Creatinine renal clearance decreased (1, 1%) Transaminases increased (1, 1%) White blood cell count decreased
Croatian: Povišen kreatinin u krvi (1, 1%) Povišena urea u krvi (1, 1%) Smanjen bubrežni klirens kreatinina (1, 1%) Povišene transaminaze (1, 1%) Smanjen broj leukocita (1, 1%) Smanjen hemoglobin (1, 1%)
English: Percent Change from Baseline in Fasting Triglycerides: Subset of Patients with Non-Missing Endpoints, Full Analysis Set
Croatian: Podskupina bolesnika bez nedostajućih mjera ishoda, potpuni skup podataka za analizu
English: o That patients should be made aware of the possibility of thrombocytopaenia and to seek medical attention immediately in case of signs of bleeding.
Croatian: o Preporuke za praćenje razine trombocita koje uključuju preporuke za prilagodbu doziranja, i prije i tijekom liječenja o Potrebno je osigurati da su bolesnicima svjesni mogućnosti trombocitopenije te da je potrebno odmah potražiti liječničku pomoć u slučaju znakova krvarenja.
English: % change from Baseline in CS16
Croatian: Liječeni volanesorsenom u ispitivanju CS16
English: Figure K
Croatian: slika K
English: Figure 1: LS Mean Percent Change in Fasting Triglycerides in Phase 3 Study in Patients with FCS (APPROACH)
Croatian: LS srednja vrijednost postotka promjene razine triglicerida natašte u bolesnika s FCS-om (APPROACH) u ispitivanju faze 3
English: Almac Pharma Services Ireland Ltd. Finnabair Industrial Estate Dundalk
Croatian: Almac Pharma Services Ireland Ltd.
English: Solution for injection in pre-filled syringe 1 pre-filled syringe.
Croatian: Otopina za injekciju u napunjenoj štrcaljki.
English: Prepare injection site
Croatian: Injiciranje 6. Pripremite mjesto injiciranja
English: Gastrointestinal disorders
Croatian: Hilomikronski trigliceridi
English: Nausea (8, 9%) Diarrhoea (4, 5%) Dry mouth (1,1 %)
Croatian: Proljev (4, 5%) Suha usta (1, 1%) Krvarenje desni (1, 1%)
English: LS Mean % Change from Baseline
Croatian: LS srednja vrijednost % promjene u odnosu na početnu vrijednost
English: Leukopenia (2, 2%) Eosinophilia (1, 1%) Immune thrombocytopenic purpura (1, 1%)
Croatian: Leukopenija (2, 2%) Eozinofilija (1, 1%)
English: Injection site haematoma (7, 8%) Injection site reaction (6, 7%) Injection site urticaria (5, 6%) Injection site warmth (5, 6%) Chills (5, 6%)
Croatian: Hematom na mjestu injekcije (7, Reakcija na mjestu injekcije (6, Urtikarija na mjestu injekcije (5,
English: 0 NC
Croatian: 0 NI
English: Clinically relevant pharmacokinetic interactions are not expected between volanesorsen and substrates, inducers or inhibitors of cytochrome P450 (CYP) enzymes, and drug transporters.
Croatian: induktora ili inhibitora citokroma P450 (CYP) te transportera lijeka.
English: Diet
Croatian: Prehrana
English: Posology
Croatian: slika
English: Breastfeeding
Croatian: Trigliceridi
English: Patients with lower body weight (less than 70 kg) may be more prone to thrombocytopenia during treatment with this medicinal product.
Croatian: mogu biti skloniji trombocitopeniji tijekom liječenja ovim lijekom.
English: LDL-C Levels
Croatian: Ukupni kolesterol LDL-C
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.
Croatian: Bolesnicima treba ponovno smanjiti doziranje lijeka na 285 mg svaka 2 tjedna ako doziranje od 285
English: In the placebo group, of the 4 patients who had 17 adjudicated pancreatitis attacks in the prior 5 years, 3 patients experienced 4 pancreatitis attacks during the 52-week treatment period.
Croatian: događaja procijenjenih kao napadaj pankreatitisa u prethodnih 5 godina, 3 bolesnika iskusila su 4
English: The medicine should be clear to slightly yellow in color.
Croatian: Tekućina mora biti bistra te bezbojna do žućkasta.
English: Do not attempt to remove the air bubble.
Croatian: Nemojte ga pokušavati istisnuti.
English: How to store Waylivra 6.
Croatian: Moguće nuspojave 5. Kako čuvati Waylivru
English: • The patient information pack should contain: o Patient information leaflet o A patient/carer guide
Croatian: • Paket s informacijama za bolesnika treba sadržavati:
English: Do not inject into tattoos, moles, scars, birthmarks, bruises, rashes, or areas where the skin is tender, red, hard, damaged, burned, or inflamed.
Croatian: Nemojte injicirati lijek u tetovaže, madeže, urođene promjene na koži, modrice, osipe ili područja gdje je slika F
English: Figure A
Croatian: slika E
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Trombocitopenija
English: Table 3: Mean Baseline and Percent Change in Lipid Parameters from Baseline to Month 3
Croatian: Tablica 3: Srednje vrijednosti lipidnih parametara na početku liječenja i postotak promjene u 3. mjesecu u odnosu na početne vrijednosti
English: CS16-volanesorsen (Index Study Baselinea, N=3)
Croatian: (početak indeksirajućeg ispitivanjaa, N=3)
English: Spontaneous haematoma (1, 1%)
Croatian: Imuna trombocitopenična purpura (1, 1%) Spontani hematom (1, 1%)
English: Monitoring Frequency
Croatian: Mehanizam djelovanja
English: Injecting 6.
Croatian: Suhoća na mjestu injekcije (4,
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ili ljekarnika ili medicinsku sestru.
English: Insert needle
Croatian: Prijavljivanje nuspojava
English: Injection site paraesthesia (1, 1%) Injection site scab (1, 1%) Injection site papule (1, 1%) Oedema (1, 1%)
Croatian: Papule (1, 1%) Hipertrofija kože (1, 1%) Oticanje lica (1, 1%)
English: After first opening of the container: 6 months.
Croatian: Nakon prvog otvaranja spremnika: 6 mjeseci.
English: [For outer carton only] PC:
Croatian: (Samo za vanjsko pakiranje) PC:
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.
Croatian: Ako ste bolesnik u starijoj dobi (iznad 65 godina), lijek Pregabalin Sandoz trebate uzimati normalno, osim ako imate problema s bubrezima.
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 webportal.
Croatian: Zahtjevi za podnošenjem ažuriranih periodičkih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i naknadne izmjene objavljene na europskom internetskom portalu za lijekove.
English: Warnings and Precautions Talk to your doctor or pharmacist before taking Pregabalin Sandoz.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Sandoz.
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Croatian: *povećanje alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST).
English: HDPE bottles: Use within 6 months after first opening.
Croatian: HDPE boce: Uporabiti unutar 6 mjeseci od prvog otvaranja.
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).
Croatian: Nemojte uzimati Pregabalin Sandoz: Ako ste alergični na pregabalin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Croatian: Nakon primjene doze radioaktivno označenog pregabalina oko 98 % radioaktivnosti ustanovljene u mokraći bio je nepromijenjen pregabalin.
English: Pregabalin Sandoz and certain other medicines may influence each other (interaction).
Croatian: Pregabalin Sandoz i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
English: Seizures were also reported.
Croatian: Napadaji su također prijavljeni.
English: A meta- analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Croatian: Meta-analiza randomiziranih placebom kontroliranih ispitivanja antiepileptika ukazala je i na malo povećan rizik od suicidalnih ideja i ponašanja.
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).
Croatian: Pregabalin Sandoz se ne smije primjenjivati tijekom trudnoće osim ako to nije neophodno (ako korist liječenja za majku jasno nadilazi mogući rizik za plod).
English: The adverse reactions listed may also be associated with the underlying disease and / or concomitant medicinal products.
Croatian: Navedene nuspojave mogu biti povezane i s osnovnom bolešću i/ili istodobno primijenjenim lijekovima.
English: Withdrawal of concomitant antiepileptic medicinal products
Croatian: Ukidanje istodobno primjenjivanih antiepileptika
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Croatian: Razlike u farmakokinetici pregabalina od osobe do osobe su male (< 20 %).
English: If you take more Pregabalin Sandoz than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Croatian: Ako uzmete više lijeka Pregabalin Sandoz nego što ste trebali Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice.