FrancophonIA/ELRC3.0 huggingface dataset:
English: For this reason, a multivitamin supplement should be taken at bedtime.
Danish: Derfor bør patienten indtage et multivitamintilskud ved sengetid.
English: To see if your BMI is 28 or above, find your height on the chart.
Danish: Find din højde i skemaet for at se, om dit BMI er 28 eller derover.
English: Rectal bleeding
Danish: Rektal blødning
English: - if you are taking amiodarone for heart rhythm problems.
Danish: - tager amiodaron mod forstyrrelser i hjerterytmen.
English: If you are allergic to orlistat or any of the ingredients of this medicine (listed in section 6).
Danish: Tag ikke alli hvis du er allergisk over for orlistat eller et af de øvrige indholdsstoffer i alli (angivet i punkt 6).
English: • if you are taking amiodarone for heart rhythm problems.
Danish: • tager amiodaron mod forstyrrelser i hjerterytmen.
English: Taking the capsule with a meal containing too much fat may increase your chance of getting diet-related treatment effects (see section 4).
Danish: Hvis du tager kapslen under et måltid, der indeholder for meget fedt, øger du sandsynligheden for at opleve den effekt af behandlingen, som er beskrevet i punkt 4.
English: Importance of losing weight
Danish: Derfor er det vigtigt, at du taber dig
English: NAME OF THE MEDICINAL PRODUCT alli 60 mg hard capsules orlistat
Danish: LÆGEMIDLETS NAVN alli 60 mg hårde kapsler orlistat
English: High-density polyethylene (HDPE) bottle with child resistant closure containing 42, 60, 84, 90 or 120 tablets.
Danish: Beholder af HDPE (højdensitets polyethylen) med børnesikret låg, der indeholder 42, 60, 84, 90 eller 120 tabletter.
English: alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight (BMI 28 or above) adults, aged 18 or over.
Danish: alli er til voksne overvægtige (BMI 28 eller derover) på 18 år og derover.
English: High-density polyethylene (HDPE) bottle with childresistant closure containing 42, 60, 84, 90 or 120 hard capsules.
Danish: Beholder af HDPE (højdensitets polyethylen) med børnesikret låg, der indeholder 42, 60, 84, 90 eller 120 hårde kapsler.
English: • Cholestasis
Danish: • Kolestase
English: Make sure your three main meals are well balanced, reduced calorie, and lower-fat.
Danish: 3 hovedmåltider er varierede og har et lavt kalorie- og fedtindhold.
English: INFORMATION IN BRAILLE alli 27 mg chewable tablets
Danish: INFORMATION I BRAILLESKRIFT alli 27 mg tyggetabletter
English: - If you have cholestasis (condition where the flow of bile from the liver is blocked).
Danish: - har kolestase (tilstand, hvor udstrømningen af galde fra leveren er blokeret).
English: Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed active substance was the major route of elimination.
Danish: Undersøgelser hos normalvægtige og adipøse forsøgspersoner har vist, at den ikke-absorberede del af lægemidlet udskilles via fæces.
English: Can help you lose more weight than dieting alone.
Danish: Kan hjælpe dig til at tabe mere vægt, end diæt alene.
English: Do not take alli - If you are allergic to orlistat or any of the ingredients of this medicine (listed in section 6) - If you are pregnant or breast-feeding.
Danish: Tag ikke alli hvis du - er allergisk over for orlistat eller et af de øvrige indholdsstoffer i alli (angivet i punkt 6).
English: • do not take more than three capsules a day.
Danish: • Du må ikke tage mere end 3 kapsler om dagen.
English: Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation Flatulence
Danish: Olielignende pletter fra rektum Flatus med udflåd Imperiøs defækationstrang Fedt-/olieholdig afføring Olieagtige udtømninger Flatulens
English: Taking the tablet with a meal containing too much fat may increase your chance of getting diet-related treatment effects (see section 4).
Danish: Hvis du tager tabletten under et måltid, der indeholder for meget fedt, øger du sandsynligheden for at opleve den effekt af behandlingen, som er beskrevet i punkt 4.
English: What alli is and what it is used for alli is used for weight loss in adults aged 18 and over who are overweight, and have a body mass index (BMI) of 28 or above.
Danish: Virkning og anvendelse alli er et vægtreducerende lægemiddel til overvægtige voksne på 18 år og derover, som har et body mass index (BMI) på mindst 28. alli skal kombineres med en kalorie- og fedtfattig kost.
English: Based on reports from literature and post-marketing experience orlistat may potentially reduce the absorption of antiretroviral medicinal treatments for HIV and could negatively affect the efficacy of antiretroviral medicinal treatments for HIV (see section 4.4).
Danish: Ifølge rapporter fra litteraturen og postmarketing-erfaring kan orlistat muligvis reducere absorptionen af antiretrovirale lægemiddelbehandlinger mod HIVog dermed påvirke effekten af antiretrovirale lægemiddelbehandlinger negativt (se pkt.
English: Contents of the pack and other further information
Danish: Pakningsstørrelser og yderligere oplysninger alli indeholder:
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Danish: Tyggetabletterne indeholder også saccharose og bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactosemalabsorption og sucrase-isomaltasemangel.
English: 1 bottle containing 42 hard capsules 1 bottle containing 60 hard capsules 1 bottle containing 84 hard capsules 1 bottle containing 90 hard capsules 1 bottle containing 120 hard capsules
Danish: 1 beholder med 42 hårde kapsler 1 beholder med 60 hårde kapsler 1 beholder med 84 hårde kapsler 1 beholder med 90 hårde kapsler 1 beholder med 120 hårde kapsler
English: Below 65.7 kg
Danish: Under 65,7 kg
English: Antidiabetic medicinal products
Danish: Antidiabetika
English: Below 61.2 kg
Danish: Under 61,2 kg
English: 1200 calories
Danish: 1200 kalorier
English: Height
Danish: Højde
English: Do not take alli
Danish: Tag ikke alli, hvis du
English: Discard any capsules stored in the carry case for more than one month.
Danish: Anvend ikke kapslerne, hvis de har ligget i etuiet i mere end 1 måned.
English: Other medicines and alli alli with food and drink
Danish: Advarsler og forsigtighedsregler Brug af anden medicin sammen med alli Brug af alli sammen med mad og drikke Graviditet og amning
English: Based on reports from literature and post-marketing experience orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal product for HIV (see section 4.4).
Danish: Ifølge rapporter fra litteraturen og postmarketing-erfaring kan orlistat muligvis reducere absorptionen af antiretrovirale lægemidler mod HIVog dermed påvirke effekten af antiretrovirale lægemidler negativt (se pkt.
English: GlaxoSmithKline Consumer Healthcare GmbH & Co. KG,
Danish: GlaxoSmithKline Consumer Healthcare GmbH & Co.
English: Although you should focus on the calories and fat that you eat, it is important to eat a balanced diet. You should choose meals which contain a range of different nutrients and learn to eat healthily for the long term.
Danish: Du bør sammensætte måltider som indeholder en række forskellige næringskilder og lære at spise sundt i tiden der kommer.
English: 61.3 kg to 65.7 kg
Danish: 61,3 kg til 65,7 kg
English: Bullous eruption
Danish: Bulløst udslæt
English: MARKETING AUTHORISATION NUMBERS
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: If you take more alli than you should
Danish: Hvis du har taget for meget alli
English: Discard any tablets stored in the carry case for more than one month.
Danish: Anvend ikke tabletterne, hvis de har ligget i etuiet i mere end 1 måned.
English: 68.1 kg to 74.7 kg
Danish: 68,1 kg til 74,7 kg
English: Below 68.1 kg
Danish: Under 68,1 kg
English: alli contains lactose and sucrose
Danish: alli indeholder lactose og saccharose.
English: 42 chewable tablets 60 chewable tablets 84 chewable tablets 90 chewable tablets 120 chewable tablets
Danish: 42 tyggetabletter 60 tyggetabletter 84 tyggetabletter 90 tyggetabletter 120 tyggetabletter
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION alli 60 mg hard capsules orlistat
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) alli 60 mg hårde kapsler orlistat
English: alli can help you lose more weight than dieting alone.
Danish: alli kan hjælpe dig med at tabe mere vægt end diæt alene.
English: If you have taken too many tablets, contact a doctor as soon as possible.
Danish: Kontakt omgående en læge, hvis du har taget for mange tabletter.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption should not take this medicinal product.
Danish: Tyggetabletterne indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af heriditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: 65.8 kg to 70.2 kg
Danish: 65,8 kg til 70,2 kg
English: • if you have kidney disease.
Danish: • har en nyresygdom.
English: For further information about the alli weight loss programme visit <www.xxx.xxx>.
Danish: Yderligere oplysninger om alli vægttabsprogram, finder du på: www.alliplan.dk.
English: Tell your doctor who may need to adjust your anti-diabetic medicine.
Danish: Fortæl din læge, at du tager alli, da din dosis af sukkersygemedicin måske skal justeres.
English: - Soft stools.
Danish: - Tyndtflydende afføring.
English: - Diverticulitis (inflammation of the large intestine).
Danish: - Betændelse i tyktarmen (divertikulitis).
English: Hepatic and renal impairment
Danish: Nedsat lever og nyrefunktion
English: - Warfarin or other medicines used to thin the blood.
Danish: - Warfarin eller andre blodfortyndende lægemidler.
English: NAME OF THE MEDICINAL PRODUCT alli 27 mg chewable tablets
Danish: LÆGEMIDLETS NAVN alli 27 mg tyggetabletter
English: 1800 calories
Danish: 1800 kalorier
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION alli 27 mg chewable tablets orlistat
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) alli 27 mg tyggetabletter orlistat
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 60 mg orlistat.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 60 mg orlistat.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE alli 60 mg hard capsules: Medicinal product not subject to medical prescription.
Danish: alli 60 mg hårde kapsler: Lægemidlet er ikke receptpligtigt.
English: If you do, the action of the tablets will assist your efforts by helping you to lose more weight compared to dieting alone.
Danish: Hvis du spiser fedtfattigt, vil tabletten forstærke virkningen af din indsats, så du taber dig mere, end hvis du kun havde omlagt din kost.
English: Ireland.
Danish: Grækenland.
English: • Concurrent treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8) 4.4 Special warnings and precautions for use
Danish: 4.5 og 4.8) 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Gastrointestinale symptomer
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BEHOLDERENS ETIKET
English: NAME OF THE MEDICINAL PRODUCT alli 27 mg chewable tablets orlistat
Danish: LÆGEMIDLETS NAVN alli 27 mg tyggetabletter orlistat
English: 1400 calories
Danish: 1400 kalorier
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable tablet contains 27 mg orlistat.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tyggetablet indeholder 27 mg orlistat.
English: Discard any tablets stored in this case for more than one month.
Danish: Tabletter, der har ligget i etuiet i over 1 måned, må ikke anvendes.
English: - if you are taking medicines for HIV.
Danish: - tager medicin mod HIV.
English: Weight loss aid Can help you lose more weight than dieting alone.
Danish: Vægtreducerende Kan hjælpe dig til at tabe mere vægt, end diæt alene.
English: Do not take alli with these medicines - Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.
Danish: Ciclosporin anvendes efter organtransplantation, ved leddegigt og visse hudsygdomme.
English: - chew one tablet, three times a day with each main meal containing fat.
Danish: - Tyg 1 tablet 3 gange dagligt ved hvert fedtholdigt hovedmåltid.
English: • if you are taking warfarin or any other medicines used to thin the blood.
Danish: • tager warfarin eller anden blodfortyndende medicin.
English: Decide on your weight loss goal
Danish: Fastsæt et mål for dit vægttab
English: 1 bottle containing 42 chewable tablets 1 bottle containing 60 chewable tablets 1 bottle containing 84 chewable tablets 1 bottle containing 90 chewable tablets 1 bottle containing 120 chewable tablets
Danish: 1 beholder med 42 tyggetabletter 1 beholder med 60 typpetabletter 1 beholder med 84 tyggetabletter 1 beholder med 90 tyggetabletter 1 beholder med 120 tyggetabletter
English: - Keep the container tightly closed to protect from moisture.
Danish: - Hold beholderen tæt tillukket for at beskytte kapslerne mod fugt.
English: • if you are taking a medicine for diabetes.
Danish: • tager medicin mod sukkersyge.
English: If you do, the action of the capsules will assist your efforts by helping you to lose more weight compared to dieting alone.
Danish: Hvis du spiser fedtfattigt, vil kapslen forstærke virkningen af din indsats, så du taber dig mere, end hvis du kun havde omlagt din kost.
English: Elimination
Danish: Udskillelse
English: 1600 calories
Danish: 1600 kalorier
English: Pregnancy and breast-feeding Do not take alli if you are pregnant or breast-feeding Driving and using machines alli is unlikely to affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt at alli vil påvirke din evne til at føre motorkøretøjer eller betjene maskiner.
English: People who lose weight and maintain the loss make lifestyle changes, which include changes to what they eat and how active they are.
Danish: Det er ændringer i livsstilen, herunder kostomlægning og en øget motionsmængde, der fører til at vægten fastholdes.
English: - if you are taking a medicine for diabetes.
Danish: - tager medicin mod sukkersyge.
English: - Do not take more than 3 capsules a day.
Danish: - Du må ikke tage flere end 3 kapsler om dagen.
English: Do not take more than 3 tablets a day.
Danish: Du må ikke tage flere end 3 tabletter om dagen.
English: - The bottle contains two sealed canisters containing silica gel to keep the capsules dry.
Danish: - For at holde kapslerne tørre ligger der i beholderen 2 forseglede tørrekapsler med silicagel.
English: Do not take more than 3 capsules a day.
Danish: Du må ikke tage flere end 3 kapsler om dagen.
English: - Do not take more than 3 tablets a day.
Danish: - Du må ikke tage mere end 3 tabletter om dagen.
English: - The other ingredients are mannitol (E421), xylitol (E967), anhydrous lactose (see section 2 under ‘Alli contains lactose and sucrose'), sodium starch glycolate, microcrystalline cellulose (E460), povidone (E1201), glycerol dibehenate (E471), sucrose monopalmitate (E473) (see section 2 under ‘Alli contains lactose and sucrose'), sodium stearyl fumarate, macrogol stearate (E431).
Danish: - De øvrige indholdsstoffer er mannitol (E421), xylitol (E967), vandfri lactose (se punkt 2 under
English: Preparing to lose weight
Danish: Forbered dit vægttab
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON SLEEVE,
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDERKARTON
English: What alli looks like and contents of the pack
Danish: allis udseende og pakningsstørrelse
English: Adults, aged 18 or over, who are overweight.
Danish: alli er til voksne overvægtige på 18 år og derover.
English: Weight loss aid
Danish: LISTE OVER HJÆLPESTOFFER
English: 59.0 kg and over
Danish: Fra og med 59,0 kg
English: - The bottle contains two sealed canisters containing silica gel to keep the tablets dry.
Danish: - For at holde tabletterne tørre ligger der i beholderen 2 forseglede tørrekapsler med silicagel.
English: Τ.Θ.
Danish: KG,
English: Kidney disease
Danish: Galdestenssygdom
English: If you miss a meal, or your meal contains no fat, do not take a tablet.
Danish: Hvis du springer et måltid over, eller hvis maden ikke indeholder fedt, skal du ikke tage tabletten.
English: If you miss a meal, or your meal contains no fat, do not take a capsule.
Danish: Hvis du springer et måltid over, eller hvis maden ikke indeholder fedt, skal du ikke tage kapslen.
English: - If you miss a meal, or your meal contains no fat, do not take a tablet.
Danish: - Hvis du springer et måltid over, eller hvis maden ikke indeholder fedt, skal du ikke tage tabletten.
English: - If you miss a meal, or your meal contains no fat, do not take a capsule.
Danish: - Hvis du springer et måltid over, eller hvis maden ikke indeholder fedt, skal du ikke tage kapslen.
English: - If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.
Danish: - ifølge din læge har problemer med at optage næring fra føden (kronisk malabsorptionssyndrom).
English: The multivitamin should contain vitamins A, D, E and K. You should take the multivitamin at bedtime, when you will not be taking alli, to help ensure that the vitamins are absorbed.
Danish: Multivitaminpillen bør indeholde A-, D-, E- og K-vitamin.
English: As weight loss may be accompanied by improved metabolic control in diabetes, patients who are taking a medicinal product for diabetes should consult a doctor before starting treatment with alli, in case it is necessary to adjust the dose of the antidiabetic medicinal product.
Danish: Derfor skal diabetikere i medicinsk behandling konsultere en læge inden behandlingen med alli for at få undersøgt, om de skal have justeret doseringen af antidiabetika.
English: - if you are taking warfarin or any other medicines used to thin the blood.
Danish: - tager warfarin eller anden blodfortyndende medicin.
English: - If it is less than an hour since your last main meal, take the missed tablet.
Danish: - Tag den glemte tablet, hvis der er gået under en time siden sidste hovedmåltid.
English: The diet and exercise programme should continue to be followed when treatment with alli is stopped.
Danish: Efter endt behandling med alli bør patienten fortsat følge kost- og motionsprogrammet.
English: 1.85 m 95.75 kg 6' 0''
Danish: 150 cm 63 kg 155 cm 67,25 kg 160 cm 71,75 kg 165 cm 76,25 kg 170 cm 81 kg 175 cm 85,75 kg 180 cm 90,75 kg 185 cm 95,75 kg 190 cm 101 kg
English: Do not take alli if you are pregnant or breast-feeding Driving and using machines alli is unlikely to affect your ability to drive and use machines.
Danish: Det er ikke sandsynligt at alli vil påvirke din evne til at føre motorkøretøjer eller betjene maskiner.
English: Anxiety†
Danish: Uro†
English: It is therefore important that you commit to a lower-fat diet to manage these effects.
Danish: For at begrænse disse gener er det vigtigt, at du holder dig til en fedtfattig kost.
English: Cholelithiasis
Danish: Gelatine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON SLEEVE,
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTONOMSLAG
English: - If it is more than an hour since your last main meal, do not take the missed capsule.
Danish: - Tag ikke den glemte kapsel, hvis der er gået over en time siden sidste hovedmåltid.
English: GlaxoSmithKline Consumer Healthcare s.a./n.v.
Danish: GlaxoSmithKline Consumer Healthcare S.p.A.
English: - If it is more than an hour since your last main meal, do not take the missed tablet.
Danish: - Tag ikke den glemte tablet, hvis der er gået over en time siden sidste hovedmåltid.
English: 1.90 m
Danish: 190 cm
English: Iron oxide black (E172) Propylene glycol
Danish: Sort jernoxid (E172)
English: How long should I take alli for?
Danish: Så længe skal du tage alli
English: 1.80 m
Danish: 180 cm
English: 1.75 m
Danish: 175 cm
English: 190 11 Avlona, Greece
Danish: 49 KM Athens-Lamia, 190 11 Avlona,
English: - If you have kidney disease.
Danish: - har en nyresygdom.
English: Do not swallow them.
Danish: Tørrekapslerne må ikke sluges.
English: 84.0 kg and over
Danish: Fra og med 84,0 kg
English: 1.60 m
Danish: 160 cm
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddeli, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: In the absence of pharmacokinetic interaction studies, alli is not recommended to be used by patients receiving acarbose.
Danish: Det frarådes at bruge orlistat sammen med acarbose på grund af manglende farmakokinetiske interaktionsundersøgelser.
English: Possible side effects
Danish: Tabel med bivirkninger
English: The chewable tablets are white to off-white, faceted and triangular in shape, debossed with ‘alli'.
Danish: Tyggetabletterne er hvide til off-white, facetterede og trekantede, præget ”alli” alli fås i pakninger med 42, 60, 84, 90 og 120 tabletter.
English: 1.70 m
Danish: 170 cm
English: 1.65 m
Danish: 165 cm
English: Soft stools
Danish: Løs afføring
English: It stops about a quarter of the fat in your meals from being absorbed.
Danish: alli forhindrer derved kroppen i at optage omkring en fjerdedel af fedtet i kosten.
English: These final reports should be provided by April 2018 and November 2019, for the ongoing 300 L and 2000 L stability studies, respectively.
Danish: De endelige rapporter bør fremlægges senest april 2018 og november 2019 for de igangværende stabilitetsstudier af hhv. 300 l og 2000 l.
English: 601 Cornhusker Highway 68521 Lincoln, Nebraska UNITED STATES
Danish: 601 Cornhusker Highway 68521 Lincoln, Nebraska USA
English: ATC vet code: QD11AH91
Danish: ATCvet-kode: QD11AH91
English: In such cases appropriate treatment should be administered immediately.
Danish: I sådanne tilfælde skal passende behandling straks gives.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/04/2017
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25/04/2017
English: The recommended minimum dose is 1 mg/kg bodyweight, once a month.
Danish: Den anbefalede minimums dosis er 1 mg/kg kropsvægt, en gang om måneden.
English: Water for injections
Danish: Vand til injektioner
English: Histidine hydrochloride monohydrate Trehalose dihydrate Disodium edetate
Danish: Histidinhydrochloridmonohydrat Trehalosedihydrat Disodiumedetat
English: The product should appear clear to opalescent without any visible particle.
Danish: Produktet skal fremstå klart til opalagtigt uden synlige partikler.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Active substance stability: The applicant should complete the ongoing lokivetmab stability evaluation up to 36 months at the different batch sizes.
Danish: Det virksomme stofs stabilitet: Ansøgeren bør gennemføre de igangværende 36 måneders stabilitetsevalueringer for lokivetmab i de forskellige batchstørrelser.