FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood urea increased (1, 1%) Creatinine renal clearance decreased (1, 1%) Transaminases increased (1, 1%) White blood cell count decreased
Danish: Øgede transaminaser (1, 1 %) Nedsat antal hvide blodlegemer (1,
English: Waylivra 285 mg solution for injection in pre-filled syringe
Danish: Waylivra 285 mg injektionsvæske, opløsning i fyldt injektionssprøjte.
English: ApoB
Danish: Stempelstav
English: If any of the above apply to you, or you are not sure, talk to your doctor, nurse or pharmacist before using Waylivra.
Danish: Kontakt lægen, sundhedspersonalet eller apotekspersonalet, inden du begynder at bruge Waylivra, hvis noget af ovenstående gør sig gældende for dig, eller du er i tvivl.
English: Injection site mass (2, 2%) Pain (2, 2%)
Danish: Ekstremitetssmerter (5, 6 %) Artritis (2, 2 %)
English: If you have any questions about how to use Waylivra, please contact your doctor or pharmacist.
Danish: Kontakt lægen eller apoteksspørgsmålet, hvis du har spørgsmål vedrørende brugen af Waylivra.
English: Posology
Danish: Nålehætte
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Danish: o Produktresume o Vejledning til sundhedspersonale
English: Epistaxis (3, 3%) Cough (1, 1%) Dyspnoea (2, 2%) Nasal congestion (1, 1%) Pharyngeal oedema (1, 1%) Wheezing (1, 1%)
Danish: Dyspnø (2, 2 %) Tilstoppet næse (1, 1 %) Faryngealt ødem (1, 1 %) Pibende vejrtrækning (1, 1 %)
English: Elderly population
Danish: Geriatrisk population
English: Remove needle cap
Danish: Tag kanylehætten af
English: If you use more Waylivra than you should
Danish: Hvis du har brugt for meget Waylivra
English: Non-cardiac chest pain (1, 1%) Vessel puncture site haemorrhage
Danish: Ikke-kardielle brystsmerter (1, 1 %) Blødning på karpunkturstedet (1,
English: Pyrexia (4, 5%)
Danish: Artralgi (6, 7 %)
English: Solution for injection in pre-filled syringe 1 pre-filled syringe.
Danish: Injektionsvæske, opløsning i fyldt injektionssprøjte.
English: • Leak-resistant,
Danish: • Er tæt,
English: Sodium
Danish: Dosis
English: Do not take more medicine than prescribed.
Danish: De må ikke tage mere medicin end foreskrevet.
English: The patient should be informed about this at the start of the treatment.
Danish: Patienten bør informeres om dette ved initiering af behandlingen.
English: In that case, just carry on with the next dose as normal.
Danish: I så fald skal De fortsætte med at tage Deres næste dosis som normalt.
English: After first opening of the container: 6 months.
Danish: Efter første anbrud af beholderen: 6 måneder.
English: Your doctor will determine what dose is appropriate for you.
Danish: Deres læge vil fastsætte den dosis, der passer til Dem.
English: Creatinine clearance (CLcr) (ml/min)
Danish: Kreatininclearance (CLcr) (ml/min)
English: If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Danish: Hvis De glemmer at tage en dosis, skal De tage den straks, De kommer i tanke herom, medmindre det er ved at være tid for Deres næste dosis.
English: Do not use this medicine after the expiry date which is stated on the blister, container or carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren, beholderen eller kartonen.
English: These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Danish: Disse estimerede doser er ca. 7 % af moderens samlede daglige dosis baseret på mg/kg.
English: EXP Use within 6 months after first opening.
Danish: EXP Anvendes senest 6 måneder efter første åbning.
English: Following repeated administration, steady state is achieved within 24 to 48 hours.
Danish: Efter gentagne doser nås steady-state indenfor 24-48 timer.
English: Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom endpoint.
Danish: Pregabalin opnåede ikke non-inferioritet over for lamotrigin baseret på 6-måneders anfaldsfrihed som endepunkt.
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Danish: Variabiliteten i farmakokinetikken for pregabalin hos forskellige forsøgspersoner er lav (< 20 %).
English: If you have the impression that the effect of Pregabalin Sandoz is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis De har indtryk af, at virkningen af Pregabalin Sandoz er for stærk eller alt for svag, skal De tale med Deres læge eller apotekspersonalet.
English: HDPE bottles: Use within 6 months after first opening.
Danish: HDPE-flasker: Anvendes senest 6 måneder efter første åbning.
English: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Danish: Sikkerheden og virkningen hos børn og unge (under 18 år) er ikke klarlagt, og derfor bør pregabalin ikke anvendes til denne aldersgruppe.
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.
Danish: Hvis De er ældre (over 65 år), skal De tage Pregabalin Sandoz som normalt, medmindre De har nyreproblemer.
English: These symptoms may occur more commonly or severely if you have been taking Pregabalin Sandoz for a longer period of time.
Danish: Disse symptomer kan forekomme oftere eller i en alvorligere grad, hvis De har taget Pregabalin Sandoz i længere tid.
English: Pregabalin Sandoz is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Danish: Pregabalin Sandoz er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
English: • The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Danish: • Den dosis, som er blevet tilpasset til Dem og Deres tilstand, vil normalt være 150-600 mg dagligt.
English: Pregabalin Sandoz and certain other medicines may influence each other (interaction).
Danish: Pregabalin Sandoz og anden medicin kan påvirke hinanden (interaktion).
English: [For outer carton only] 18.
Danish: [Gælder kun for ydre karton] 18.
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).
Danish: Pregabalin Sandoz bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/det nyfødte barn).
English: It is advised not to drink alcohol while taking Pregabalin Sandoz.
Danish: Det tilrådes ikke at drikke alkohol, når De tager Pregabalin Sandoz.
English: It is important to take your Pregabalin Sandoz capsules regularly at the same time each day.
Danish: Det er vigtigt, at De tager Deres Pregabalin Sandoz kapsler regelmæssigt og på samme tid hver dag.
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).
Danish: Tag ikke Pregabalin Sandoz: Hvis De er allergisk over for pregabalin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Danish: Efter en dosis radiomærket pregabalin genfindes ca. 98 % af radioaktiviteten i urinen som uomdannet pregabalin.
English: [For outer carton only] PC:
Danish: [Gælder kun for ydre karton] PC:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA [For outer carton only]
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA [Gælder kun for ydre karton]
English: • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
Danish: • Inden De tager denne medicin, skal De fortælle lægen, hvis De nogensinde har misbrugt eller været afhængig af alkohol, medicin eller stoffer.
English: Starting dose (mg/day) Maximum dose (mg/day)
Danish: Startdosis (mg/døgn) Maksimal dosis (mg/døgn)
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in tmax to approximately 2.5 hours.
Danish: Absorptionshastigheden af pregabalin nedsættes ved samtidig indtagelse af føde, hvilket nedsætter Cmax med ca. 25-30 % og en forsinkelse i tmax på ca. 2½ time.
English: The adverse reactions listed may also be associated with the underlying disease and / or concomitant medicinal products.
Danish: De anførte bivirkninger kan også have forbindelse til den tilgrundliggende sygdom og / eller anden samtidig behandling.
English: Your doctor will tell you to take Pregabalin Sandoz either twice or three times a day.
Danish: Deres læge vil fortælle, at De enten skal tage Pregabalin Sandoz 2 gange eller 3 gange dagligt.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Sandoz have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Pregabalin Sandoz, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system,
Danish: Pregabalin bindes til en hjælpeundergruppe (α2-δ protein) i de spændingsafhængige calciumkanaler i centralnervesystemet.
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.
Danish: En metaanalyse af randomiserede, placebokontrollerede forsøg med antiepileptika har også vist en let forøget risiko for selvmordstanker og -adfærd.
English: Warnings and Precautions Talk to your doctor or pharmacist before taking Pregabalin Sandoz.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før De tager Pregabalin Sandoz.
English: Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Danish: Pregabalin blev udskilt i mælken med gennemsnitlige koncentrationer ved steady state på ca. 76 % af de koncentrationer, der sås i moderens plasma.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz is taken together with medicines containing:
Danish: Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Sandoz tages sammen med lægemidler, der indeholder:
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Danish: De bør ikke køre bil, betjene indviklede maskiner eller udsætte Dem for andre aktiviteter, der kan være farlige, før De ved, om denne medicin påvirker Deres evne til at udføre disse aktiviteter.
English: If at any time you have these thoughts, immediately contact your doctor.
Danish: Hvis De på noget tidspunkt får sådanne tanker, bør De straks kontakte Deres læge.
English: Your doctor will prescribe Pregabalin Sandoz for you to help treat your epilepsy when your current treatment is not controlling your condition.
Danish: Deres læge vil udskrive Pregabalin Sandoz til behandling af Deres epilepsi, hvis Deres nuværende behandling ikke kan kontrollere Deres tilstand.
English: If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.
Danish: Hvis Deres ansigt eller tunge hæver eller, hvis huden bliver rød og begynder at danne blærer eller skalle af, skal De straks kontakte læge eller skadestue.
English: Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.
Danish: Pregabalin har vist sig at krydse placenta hos rotter og genfindes i mælk hos ammende rotter.
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Danish: Biotilgængeligheden af oral pregabalin anslås at være ≥ 90 %, og er ikke dosisafhængig.
English: Pregabalin Sandoz is available in the following presentations: PVC/PVDC//Alu blisters packed in carton.
Danish: Pregabalin Sandoz findes i de følgende præsentationer: PVC/PVDC//Alu-blistere pakket i æske.
English: Ophthamologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Danish: Oftalmologisk undersøgelse (herunder synsskarphedstest, formel synsfelttest og udvidet fundoskopi) blev udført på over 3.600 patienter i de kontrollerede kliniske undersøgelser.
English: Continue taking Pregabalin Sandoz until your doctor tells you to stop.
Danish: Fortsæt med at tage Pregabalin Sandoz, indtil Deres læge beder Dem om at stoppe.
English: Pregabalin Sandoz may be taken with or without food.
Danish: Pregabalin Sandoz kan tages med eller uden mad.
English: The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Danish: Det N-methylerede derivat af pregabalin, der er pregabalins hovedmetabolit, genfindes i urin og svarer til 0,9 % af dosis.
English: In addition to the daily dose, a supplementary dose should be given immediately following every 4hour haemodialysis treatment (see Table 1).
Danish: Udover den daglige dosis, skal supplerende dosis gives umiddelbart efter hver 4. times hæmodialysebehandling (se tabel 1).
English: Women of childbearing potential / Contraception in males and females As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
Danish: Kvinder i den fertile alder / antikonception hos mænd og kvinder Da den potentielle risiko for mennesker er ukendt, skal kvinder i den fertile alder anvende sikker antikonception.
English: No specific pharmacokinetic studies were carried out in patients with impaired liver function.
Danish: Der er ikke gennemført specifikke farmakokinetiske forsøg på patienter med nedsat leverfunktion.
English: For three times a day take Pregabalin Sandoz once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Danish: For 3 gange dagligt skal Pregabalin Sandoz tages én gang om morgenen, én gang om eftermiddagen og én gang om aftenen og på omtrent samme tid hver dag.
English: You should take Pregabalin Sandoz in addition to your current treatment.
Danish: De skal tage Pregabalin Sandoz sammen med Deres nuværende behandling.
English: In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day.
Danish: I et klinisk forsøg, udført for at vurdere spermens motilitet, fik raske mandlige forsøgspersoner pregabalindoser på 600 mg/dag.
English: In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
Danish: Derudover kan pregabalin effektivt fjernes fra plasma via hæmodialyse (efter 4 timers hæmodialysebehandling er plasmakoncentrationerne af pregabalin reduceret med ca. 50 %).
English: Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).
Danish: Pregabalin fjernes effektivt fra plasma via hæmodialyse (50 % af lægemiddelstoffet på 4 timer).
English: Adverse reactions were usually mild to moderate in intensity.
Danish: Bivirkningerne er som regel milde til moderate.
English: Pregabalin Sandoz with food, drink and alcohol Pregabalin Sandoz capsules may be taken with or without food.
Danish: Brug af Pregabalin Sandoz sammen med mad, drikke og alkohol Pregabalin Sandoz kapsler kan tages både sammen med og uden mad.
English: Pregabalin Sandoz is for oral use only.
Danish: Pregabalin Sandoz er kun til oral anvendelse.
English: - The other ingredients are pregelatinised maize starch, maize starch, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172) (all strengths except 150 mg), red iron oxide (E172) (all strengths except 50 mg and 150 mg), black iron oxide (E172) (only 25 mg and 300 mg).
Danish: • Øvrige indholdsstoffer: pregelatineret majsstivelse, majsstivelse, talcum, gelatine, titandioxid (E171), gul jernoxid (E172) (alle styrker undtagen 150 mg), rød jernoxid (E172) (alle styrker undtagen 50 mg og 150 mg), sort jernoxid (E172) (kun 25 mg og 300 mg).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sandoz
English: Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study.
Danish: Pregabalins farmakokinetik blev evalueret hos pædiatriske patienter med epilepsi (aldersgrupper: 1-23 måneder, 2-6 år, 7-11 år og 12-16 år) ved dosisniveauer på 2,5, 5, 10 og 15 mg/kg dagligt i et farmakokinetik- og tolerabilitetsstudie.
English: In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys.
Danish: I prækliniske studier har det vist sig, at pregabalin krydser blod-hjernebarrieren hos mus, rotter og aber.
English: In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Danish: In-vivo forsøg og populationsfarmakokinetiske analyser Følgelig har in-vivo forsøg ikke vist klinisk relevante farmakokinetiske interaktioner mellem pregabalin og phenytoin, carbamazepin, valproat, lamotrigin, gabapentin, lorazepam, oxycodon eller ethanol.
English: Appetite increased
Danish: Øget appetite.
English: BATCH NUMBER
Danish: BATCNUMMER
English: A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med pregabalin skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart beat, heart failure.
Danish: • Hjerterytmeforstyrrelser, hurtigere hjerterytme (puls), lavt blodtryk, højt blodtryk, ændringer i hjerteslag, hjertesvigt.
English: For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Danish: Hos patienter, der oplevede søvnighed er responderraterne 48 % på pregabalin og 16 % på placebo.
English: Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of pregabalin.
Danish: Kliniske forsøg tyder på, at køn ikke har nogen klinisk betydende indflydelse på plasmakoncentrationen af pregabalin.
English: • Pregabalin Sandoz may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Danish: • Pregabalin Sandoz kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående.
English: Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Danish: Orale kontraceptiva, norethisteron og/eller ethinylestradiol Samtidig indgift af pregabalin og orale kontraceptiva norethisteron og/eller ethinyløstradiol påvirker ikke steady-state farmakokinetikken af nogen af stofferne.
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Sandoz than you should.
Danish: De kan føle Dem søvnig, forvirret, oprevet eller rastløs, hvis De har taget for meget Pregabalin Sandoz.
English: Pregabalin clearance is directly proportional to creatinine clearance.
Danish: Pregabalin-clearance er direkte proportionalt med kreatininclearance.
English: Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
Danish: Fortæl lægen, hvis De har eller tidligere har haft en alvorlig sygdom, herunder lever- eller nyresygdom.
English: Withdrawal of concomitant antiepileptic medicinal products
Danish: Seponering af andre antiepileptika
English: Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Danish: Seponering af behandling med pregabalin kan føre til en normalisering eller forbedring af af disse synssymptomer.
English: 1407 София
Danish: 1407 СофияTeл.
English: Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules Pregabalin
Danish: Pregabalin Sandoz 25 mg hårde kapsler Pregabalin Sandoz 50 mg hårde kapsler Pregabalin Sandoz 75 mg hårde kapsler Pregabalin Sandoz 100 mg hårde kapsler Pregabalin Sandoz 150 mg hårde kapsler Pregabalin Sandoz 200 mg hårde kapsler Pregabalin Sandoz 225 mg hårde kapsler Pregabalin Sandoz 300 mg hårde kapsler Pregabalin
English: Tell your doctor if you experience constipation, especially if you are prone to this problem.
Danish: Fortæl lægen, hvis De får forstoppelse, især hvis De er tilbøjelig til at få forstoppelse.
English: • Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Danish: • Pregabalin er forbundet med svimmelhed og søvnighed, som kan øge risikoen for faldulykker hos ældre patienter.
English: Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have been reported).
Danish: Der bør udvises forsigtighed ved behandling af patienter, der tidligere har haft et misbrug, og patienten bør overvåges for symptomer på forkert brug, misbrug eller afhængighed af pregabalin (der er rapporteret om udvikling af tolerans, dosisstigning og stofsøgende adfærd).
English: OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER
Danish: YDRE KARTON TIL BEHOLDER OG ETIKET TIL BEHOLDER
English: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain.
Danish: Pregabalins steady-state farmakokinetik er ens hos raske forsøgspersoner, hos patienter med epilepsi i anti-epileptisk behandling og hos patienter med kroniske smerter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDREETIKET TIL MULTIPAKNING, DER ER PAKKET IND I FOLIE (INKLUSIVE DEN BLÅ BOKS)
English: In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Danish: I de kontrollerede kliniske studier (af 4-8 ugers varighed) opnåede 52 % af patienterne behandlet med pregabalin og 38 % af patienterne på placebo mindst en 50 % forbedring i HAM-A totalscore fra baseline til endpoint.
English: • Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
Danish: • Nogle diabetespatienter kan få vægtøgning, når de tager pregabalin, og kan derfor have behov for at ændre deres diabetesmedicin.
English: The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Danish: Pregabalins sikkerhed og virkning hos børn under 12 år og unge (12-17 år) er ikke klarlagt.