FrancophonIA/ELRC3.0 huggingface dataset:
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Lyrica is taken together with medicines containing:
Danish: Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Lyrica tages sammen med lægemidler, der indeholder:
English: 473 ml oral solution
Danish: 473 ml oral opløsning
English: The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Danish: Lyricas sikkerhed og virkning hos børn under 12 år og unge (12-17 år) er ikke klarlagt.
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Danish: * Forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT).
English: This product contains lactose monohydrate: see the package leaflet for further information.
Danish: Dette produkt indeholder lactosemonohydrat: Se indlægssedlen for yderligere oplysninger.
English: If you have the impression that the effect of Lyrica is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du har indtryk af, at virkningen af Lyrica er for stærk eller alt for svag, skal du tale med din læge eller apoteket.
English: Date of first authorisation: 06 July 2004 Date of latest renewal: 06 July 2009
Danish: Dato for første markedsføringstilladelse: 6. juli 2004 Dato for seneste fornyelse: 6. juli 2009
English: Oxycodone - (used as a pain-killer) Lorazepam - (used for treating anxiety) Alcohol
Danish: Oxycodon - (smertestillende middel) Lorazepam - (anvendes til behandling af angst) Alkohol
English: Concomitant use with opioids
Danish: Samtidig brug af opioider
English: It is important to take your Lyrica capsules regularly at the same time each day.
Danish: Det er vigtigt, at du tager dine Lyrica kapsler regelmæssigt og på samme tid hver dag.
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: Du bør ikke køre bil, betjene indviklede maskiner eller udføre andre aktiviteter, der kan være farlige, før du ved, om denne medicin påvirker din evne til at udføre disse aktiviteter.
English: Repeat steps 2 to 4 as needed to achieve the required dose (Table 3).
Danish: Gentag trin 2 og 4 efter behov for at opnå den nødvendige dosis (tabel 3).
English: • A small number of people being treated with anti-epileptics such as Lyrica have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Lyrica har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).
Danish: Bemærk: Trin 4-7 skal muligvis gentages op til 2 gange for at opnå den totale dosis (se tabel 1).
English: The active substance is pregabalin.
Danish: Det aktive stof er pregabalin.
English: There are no adequate data from the use of pregabalin in pregnant women.
Danish: Der foreligger ikke tilstrækkelig data om brugen af pregabalin hos gravide.
English: These symptoms may occur more commonly or severely if you have been taking Lyrica for a longer period of time.
Danish: Disse symptomer kan forekomme oftere eller i en alvorligere grad, hvis du har taget Lyrica i længere tid.
English: In a case-control study of opioid users, those patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 - 2.36]).
Danish: I et case-kontrol-studie med opioidbrugere havde patienter, der tog pregabalin samtidig med et opioid, øget risiko for opioidrelateret død sammenlignet med brug af opioider alene (justeret odds ratio [aOR], 1,68 [95 % CI, 1,19 til 2,36]).
English: It is advised not to drink alcohol while taking Lyrica.
Danish: Det tilrådes ikke at drikke alkohol, når du tager Lyrica.
English: Supplementary dose following haemodialysis (mg) 25 (1.25 ml)
Danish: Supplerende dosis efter hæmodialyse (mg) 25 (1,25 ml)
English: Artificial strawberry flavour [contains small amounts of ethanol (alcohol)] Purified water
Danish: Kunstig jordbærsmag [indeholder små mængder ethanol (alkohol)] Renset vand
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 dit ansigt eller tunge hæver, eller hvis huden bliver rød og begynder at danne blærer eller skalle af, skal du straks kontakte læge eller skadestue.
English: Pfizer Manufacturing Deutschland GmbH Betriebsstātte Freiburg Mooswaldallee 1
Danish: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
English: Not required Not required Not required
Danish: Tredje optrækning (ml) Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig
English: Additional reactions reported from postmarketing experience are included in italics in the list below.
Danish: Yderligere bivirkninger, der er rapporteret efter markedsføring, er anført i kursiv i tabellen nedenfor.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption bør ikke anvende denne medicin.
English: It is important to take your Lyrica oral solution regularly at the same time each day.
Danish: Det er vigtigt, at du tager din Lyrica oral opløsning regelmæssigt og på samme tid hver dag.
English: Take your box or bottle of Lyrica oral solution with you.
Danish: Medbring pakningen eller flasken med Lyrica oral opløsning.
English: Lyrica may produce dizziness, sleepiness and decreased concentration.
Danish: Lyrica kan give svimmelhed, søvnighed og nedsat koncentrationsevne.
English: There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema.
Danish: Efter markedsføring har der været rapporter om overfølsomhedsreaktioner, herunder tilfælde af angioødem.
English: In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal products.
Danish: Efter markedsføring er der rapporteret om respirationssvigt, koma og dødsfald hos patienter, der tager pregabalin og opioider og/eller andre lægemidler, der supprimerer centralnervesystemet (CNS).
English: This increased risk was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 - 2.22]) and there was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 - 5.06]).
Danish: Denne øgede risiko blev set ved lave doser af pregabalin (≤ 300 mg, aOR 1,52 [95% CI, 1,04 til 2,22]) og der var en tendens til en større risiko ved høje doser pregabalin (> 300 mg, aOR 2,51 [95% CI 1,24 til 5,06]).
English: Peripheral and central neuropathic pain: Lyrica is used to treat long lasting pain caused by damage to the nerves.
Danish: Perifere og centrale neuropatiske smerter: Lyrica anvendes til behandling af langvarige smerter, som skyldes beskadigede nervebaner.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Lyrica, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Pfizer Europe MA EEIG (as MA Holder logo)
Danish: Pfizer Europe MA EEIG (som logo)
English: Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS depression (see section 4.5).
Danish: Der tilrådes forsigtighed, når pregabalin ordineres samtidig med opioider, grundet risikoen for CNSdepression (se pkt.
English: Pfizer Service Company, Hoge Wei 10, B1930 Zaventem, Belgium
Danish: Fremstiller: Pfizer Service Company, Hoge Wei 10, B 1930 Zaventem, Belgien.
English: Lyrica may have minor or moderate influence on the ability to drive and use machines.
Danish: Lyrica påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Some patients taking Lyrica have reported symptoms suggesting an allergic reaction.
Danish: • Hos nogle patienter, der tager Lyrica, er der rapporteret om symptomer, der tyder på en overfølsomhedsreaktion.
English: HDPE bottle containing 200 hard capsules.
Danish: HDPE-beholder, der indeholder 200 hårde kapsler.
English: Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:
Danish: Perifere og centrale neuropatiske smerter, epilepsi eller generaliseret angst:
English: Lyrica may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Danish: Lyrica kan forårsage svimmelhed og søvnighed, og derfor kan det påvirke evnen til at køre bil eller betjene maskiner.
English: Invert the bottle (with the syringe attached) and fill the syringe with the liquid by pulling the syringe plunger down to just beyond the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4).
Danish: Vend flasken med bunden i vejret (mens sprøjten sidder i) og fyld sprøjten med væske ved at trække stemplet tilbage til lige under den markering på sprøjten, der svarer til den mængde i milliliter (ml), som lægen har ordineret (figur 4).
English: • Lyrica has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Danish: • Lyrica er forbundet med svimmelhed og søvnighed, som kan øge risikoen for faldulykker hos ældre patienter.
English: Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Danish: Lyrica er indiceret som supplerende behandling til voksne med refraktære partielle anfald med eller uden sekundær generalisering.
English: BID = Two divided doses * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose Supplementary dose is a single additional dose
Danish: Engangsdosis * Total døgndosis (mg/døgn) skal fordeles som anført under dosisinterval for at give mg/dosis Supplerende dosis er en enkelt tillægsdosis.
English: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany.
Danish: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Tyskland.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika, ATC-kode: N03AX16
English: Method of Administration
Danish: Administrationsmetode
English: Sealed Pack Do not use if box has been opened.
Danish: Må ikke anvendes, hvis forseglingen er brudt.
English: Lyrica 20 mg/ml oral solution is a clear colourless solution in a white bottle containing 473 ml of oral solution, in a cardboard carton.
Danish: Lyrica 20 mg/ml er en klar, farveløs opløsning i en hvid flaske, der indeholder 473 ml oral opløsning.
English: Lyrica Dose (mg)
Danish: Lyrica dosis (mg)
English: • Lyrica may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Danish: • Lyrica kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående.
English: Pregabalin 14 mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo (p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo.
Danish: Pregabalin 14 mg/kg/dag reducerede væsentligt den log-transformerede hyppighed af partielle anfald versus placebo (p=0,0223); pregabalin 7 mg/kg/dag viste ingen forbedring i forhold til placebo.
English: • There have been reports of convulsions when taking Lyrica or shortly after stopping Lyrica.
Danish: • Der er set kramper i forbindelse med behandling med Lyrica og kort tid efter ophør af behandling med Lyrica.
English: Using the oral syringe, first withdraw 5 ml and empty contents of syringe directly into the mouth, then refill the oral syringe with 2.5 ml and empty the remaining contents into the mouth.]
Danish: Først fyldes sprøjten med 5 ml, og indholdet indtages direkte gennem munden, derefter fyldes sprøjten med 2,5 ml, og indholdet indtages gennem munden).
English: Lyrica should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Danish: Lyrica bør ikke tages under graviditet, eller mens du ammer medmindre din læge har givet dig en anden besked.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (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), not known (cannot be estimated from the available data).
Danish: De er anført efter organklasse og hyppighed (meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjældne (< 1/10.000)), hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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 studier og populations farmakokinetiske analyser Følgelig har in vivo studier ikke vist klinisk relevante farmakokinetiske interaktioner mellem pregabalin og phenytoin, carbamazepin, valproat, lamotrigin, gabapentin, lorazepam, oxycodon eller ethanol.
English: There are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Danish: Efter markedsføring er der rapporteret om bivirkninger relateret til nedsat funktion af mave-tarmkanalen (f.eks intestinal obstruktion, paralytisk ileus, obstipation), når pregabalin gives samtidig med lægemidler, der potentielt kan medføre obstipation, herunder opioide analgetika.
English: The capsule body is marked with a black band.
Danish: Kapslen er mærket med et sort bånd på underdelen af kapslen.
English: Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
Danish: Neuropatiske smerter Lyrica er indiceret til behandling af perifere og centrale neuropatiske smerter hos voksne.
English: 100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters.
Danish: 100 × 1 hårde kapsler i PVC/aluminium perforeret enkeltdosisblister.
English: Do not stop taking Lyrica unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Lyrica, medmindre din læge har bedt dig herom.
English: Warnings and Precautions Talk to your doctor or pharmacist before taking Lyrica.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Lyrica
English: In the postmarketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient.
Danish: Efter markedsføring er der set tilfælde af øjenbivirkninger, herunder synstab, sløring af synet eller andre forandringer i synsskarpheden, hvoraf mange var forbigående.
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Danish: Det aktive indholdsstof, pregabalin, er en gamma-aminosmørsyre analog [(S)-3-(aminomethyl)-5methylhexansyre].
English: What Lyrica contains
Danish: Lyrica indeholder
English: Excipients which may cause allergic reactions
Danish: Hjælpestoffer, der kan give overfølsomhedsreaktioner
English: If you stop taking Lyrica
Danish: Hvis du holder op med at tage Lyrica
English: Epilepsy: Lyrica is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation-epileptic fits starting on one specific part of the brain) in adults.
Danish: Epilepsi: Lyrica anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering - epileptiske anfald der starter i en bestemt del af hjernen) hos voksne.
English: Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double-blind relapse prevention phase of 6 months duration.
Danish: Pregabalin er undersøgt i 6 kontrollerede studier af 4-6 ugers varighed, et studie med ældre af 8 ugers varighed og et langtids relaps-forebyggelsesstudie med en dobbelt-blind relaps-forebyggelsesfase af 6 måneders varighed.
English: After stopping long and short-term Lyrica treatment, you need to know that you may experience certain side effects.
Danish: Når du stopper med at tage Lyrica efter langtidsbehandling eller korttidsbehandling, skal du vide, at du måske får visse bivirkninger.
English: If you forget to take Lyrica
Danish: Hvis du har glemt at tage Lyrica
English: • Take the solution as instructed by your doctor.
Danish: • Tag opløsningen, som lægen har ordineret.
English: Total Solution Volume (ml)
Danish: Total opløsning volume (ml)
English: Oral Syringe Withdrawals to Deliver Prescribed Dose of Lyrica
Danish: Optrækning med oral sprøjte af ordineret dosis af Lyrica
English: 473 ml oral solution with a 5 ml oral syringe and a Press-In Bottle Adapter (PIBA).
Danish: 473 ml oral opløsning med en 5 ml oral sprøjte og en tryk-i-flaskeadptor (PIBA).
English: Discharge the syringe contents into the mouth (Figure 7).
Danish: Tøm indholdet af sprøjten i munden (figur 7).
English: In addition, Lyrica is available in an HDPE bottle containing 200 capsules for the 25 mg, 75 mg, 150 mg and 300 mg strengths.
Danish: Derudover findes Lyrica i en HDPE-beholder, der indeholder 200 kapsler for 25 mg, 75 mg, 150 mg og 300 mg styrken.
English: CARTON
Danish: Karton
English: Other medicines and Lyrica
Danish: Brug af anden medicin sammen med Lyrica
English: Hard capsules
Danish: Hårde kapsler.
English: Lyrica is available in eight pack sizes made of PVC with an aluminium foil backing: a 14 capsules pack containing 1 blister strip, a 21 capsules pack containing 1 blister strip, a 56 capsules pack containing 4 blister strips, a 70 capsules pack containing 5 blister strips, a 84 capsules pack containing 4 blister strips, a 100 capsules pack containing 10 blister strips, a 112 capsules pack containing 8 blister strips and 100 x 1 capsules as perforated unit dose blisters.
Danish: En pakning med 14 kapsler i 1 blisterplade, 21 kapsler i 1 blisterplade, 56 kapsler i 4 blisterplader, 70 kapsler i 5 blisterplader, 84 kapsler i 4 blisterplader, 100 kapsler i 10 blisterplader, 112 kapsler i 8 blisterplader og 100 × 1 kapsel som perforeret enkeltdosisblister.
English: Remove air bubbles from the syringe by pushing the plunger up to the appropriate graduation mark.
Danish: Fjern luftboblerne fra sprøjten ved at skubbe stemplet tilbage i sprøjten til den relevante markering på sprøjten.
English: Lyrica may be taken with oral contraceptives.
Danish: Lyrica kan tages sammen med svangerskabsforebyggende medicin.
English: The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis.
Danish: Den mest almindelige bivirkning, der blev observeret i studiet af 12 ugers varighed med behandling med pregabalin, var døsighed, pyreksi, øvre luftvejsinfektioner, øget appetit, vægtøgning og nasopharyngitis.
English: There have been postmarketing reports of congestive heart failure in some patients receiving pregabalin.
Danish: Efter markedsføring er der rapporteret om hjerteinsufficiens hos nogle patienter i behandling med pregabalin.
English: Following an additional week the dose may be increased to 450 mg (22.5 ml) per day.
Danish: Efter yderligere 7 dage kan dosis øges til 450 mg (22,5 ml) dagligt.
English: Rinse the syringe and replace the cap on the bottle (PIBA remains in place) (Figures 8 and 9).
Danish: Rens sprøjten og sæt låget på flasken (PIBA bliver siddende) (figur 8 og 9).
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Lyrica than you should.
Danish: Du kan føle dig søvnig, forvirret, oprevet eller rastløs, hvis du har taget for mange Lyrica.
English: Lyrica may be taken with or without food.
Danish: Lyrica kan tages med eller uden mad.
English: What you need to know before you take Lyrica
Danish: Det skal du vide, før du begynder at tage Lyrica
English: The pregabalin safety profile observed in four paediatric studies in patients with partial seizures with or without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, n=295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n=175; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy.
Danish: Den sikkerhedsprofil for pregabalin, der blev observeret i 4 pædiatriske studier hos patienter med partielle anfald med eller uden sekundær generalisering (effekt- og sikkerhedsstudie af 12 ugers varighed hos patienter i alderen 4-16 år, n=295; effekt- og sikkerhedsstudie af 14 dages varighed hos patienter i alderen fra 1 måned til under 4 år, n=175; farmakokinetik- og tolerabilitetsstudier, n=65; og 1 års åben opfølgning af sikkerhedsstudiet, n=54), var den samme som den, der blev observeret i studier med voksne patienter med epilepsi.
English: Lyrica belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Danish: Lyrica tilhører den gruppe medicin, der anvendes til behandling af epilepsi, neuropatiske smerter og generaliseret angst hos voksne.
English: Do not use this medicine after the expiry date which is stated on the carton or bottle.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Epilepsy: Lyrica is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Danish: Epilepsi: Lyrica anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering) hos voksne.
English: The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).
Danish: • 75 mg, 100 mg, 200 mg, 225 mg og 300 mg kapsler indeholder også rød jernoxid (E172).
English: Push the syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove excess air.
Danish: Tryk sprøjtens stempel i bund (mod spidsen) for at fjerne overskydende luft.
English: Lyrica oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Danish: Lyrica oral opløsning indeholder methylparahydroxybenzoat og propylparahydroxybenzoat, som kan give overfølsomhedsreaktioner (muligvis forsinkede).
English: What Lyrica is and what it is used for What you need to know before you take Lyrica How to take Lyrica
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Lyrica Sådan skal du tage Lyrica Bivirkninger
English: Other ingredients include E216 (propyl parahydroxybenzoate) and E218 (methyl parahydroxybenzoate).
Danish: Øvrige hjælpestoffer inkluderer E216 (propylparahydroxybenzoat) og E218 (methylparahydroxybenzoat).