FrancophonIA/ELRC3.0 huggingface dataset:
English: After the menopause, oestrogen level drops which may cause bones to become thin and fragile.
Danish: Østrogenniveauerne falder efter menopausen (efter sidste menstruation i forbindelse med overgangsalderen), og det kan medføre, at knoglerne bliver tynde og skrøbelige.
English: • Inject the entire contents of the pre-filled syringe.
Danish: • Hele indholdet af den fyldte injektionssprøjte skal injiceres.
English: Where should you give the injection?
Danish: Her skal injektionen gives
English: Pinch (without squeezing) the skin between your thumb and forefinger.
Danish: Klem huden mellem tommelfinger og pegefinger sammen (uden at klemme for hårdt).
English: In a single phase III placebo-controlled clinical trial in patients with prostate cancer receiving ADT an imbalance in diverticulitis adverse events was observed (1.2% denosumab, 0% placebo).
Danish: I et enkelt placebokontrolleret, klinisk fase III-studie med patienter med prostatacancer, der fik ADT, blev der observeret forskel mellem denosumab og placebogrupperne i hyppigheden af bivirkninger med divertikulitis (1,2 % denosumab, 0 % placebo).
English: What to do before you give a subcutaneous injection of Prolia
Danish: Det skal du gøre, inden du giver en injektion med Prolia under huden
English: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands
Danish: Minervum 7061, 4817 ZK Breda, Holland
English: Most of the fractures occurred in the GC-C subpopulation.
Danish: De fleste frakturer forekom i underpopulationen, der fortsatte med glukokortikoid.
English: Each 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
Danish: Hver 1 ml fyldt injektionssprøjte indeholder 60 mg denosumab (60 mg/ml).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERED PRE-FILLED SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP FYLDT INJEKTIONSSPRØJTE I BLISTERPAKNING
English: In the glucocorticoid-initiating subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.1%, risedronate 0.8%; p < 0.001) and 2 years (Prolia 4.6%, risedronate 1.5%; p < 0.001)
Danish: I den underpopulation, der påbegyndte glukokortikoid, gav Prolia en højere stigning i BMD i columna lumbalis sammenlignet med risedronat efter 1 år (Prolia 3,1 %, risedronat 0,8 %; p < 0,001) og 2 år (Prolia 4,6 %, risedronat 1,5 %; p < 0,001)
English: The pre-filled syringe may be left outside the refrigerator to reach room temperature.
Danish: Du kan lade den fyldte injektionssprøjte ligge uden for køleskabet, indtil den har fået stuetemperatur.
English: Bone histology was evaluated in 62 postmenopausal women with osteoporosis or with low bone mass who were either naïve to osteoporosis therapies or had transitioned from previous alendronate therapy following 1-3 years treatment with Prolia.
Danish: Knoglehistologien efter 1-3 års behandling med Prolia blev undersøgt hos 62 postmenopausale kvinder med osteoporose eller med lav knoglemasse, der enten var naive over for osteoporosebehandling eller havde fået alendronat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED FYLDT INJEKTIONSSPRØJTE
English: While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
Danish: Du skal opretholde en god mundhygiejne og gå regelmæssigt til tandlæge, mens du er i behandling.
English: In the post-marketing setting, rare events of drug-related hypersensitivity, including rash, urticaria, facial swelling, erythema, and anaphylactic reactions have been reported in patients receiving Prolia.
Danish: Efter markedsføring af Prolia er der indberettet sjældne tilfælde af lægemiddelrelateret overfølsomhed, herunder udslæt, urticaria, hævelse i ansigtet, erytem samt anafylaktiske reaktioner.
English: Absolute risk reduction (%) (95% CI)
Danish: Absolut risikoreduktion (%) (95% CI)
English: Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
Danish: Forsøg ikke at tage den gennemsigtige kanylebeskyttelse af injektionssprøjten.
English: In order to reduce the risk of developing ONJ, there are some precautions you should take.
Danish: Der er nogle forsigtighedsregler, du skal følge for at mindske risikoen for, at du får ONJ.
English: DO NOT leave the syringe exposed to direct sunlight.
Danish: Injektionssprøjten må IKKE efterlades i direkte sollys.
English: Musculoskeletal pain, including severe cases, has been reported in patients receiving Prolia in the post-marketing setting.
Danish: Der er efter markedsføring indberettet smerter i bevægeapparatet, herunder alvorlige tilfælde, hos patienter, der fik Prolia.
English: Common Common Uncommon Uncommon Uncommon
Danish: Almindelig Almindelig Ikke almindelig Ikke almindelig Ikke almindelig
English: Effect on vertebral fractures
Danish: Effekt på vertebrale frakturer
English: In the glucocorticoid-continuing subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.6%, risedronate 2.0%; p < 0.001) and 2 years (Prolia 4.5%, risedronate 2.2%; p < 0.001).
Danish: I den underpopulation, der fortsatte med glukokortikoid, gav Prolia en højere stigning i BMD i columna lumbalis sammenlignet med risedronat efter 1 år (Prolia 3,6 %, risedronat 2,0 %; p < 0,001) og 2 år (Prolia 4,5 %, risedronat 2,2 %; p < 0,001).
English: Instructions for injecting with the Prolia pre-filled syringe
Danish: Instruktioner til injektion med den fyldte Prolia-injektionssprøjte
English: Relative risk reduction (%) (95% CI)
Danish: Relativ risikoreduktion (%) (95% CI)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Ear infection
Danish: Øreinfektion
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL pre-filled syringe containing 60 mg of denosumab (60 mg/mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml fyldt injektionssprøjte indeholdende 60 mg denosumab (60 mg/ml).
English: Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia.
Danish: Der kan i sjældne tilfælde opstå usædvanlige brud på lårbenet hos patienter, der får Prolia.
English: Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Danish: Tag ikke den grå kanylehætte af den fyldte injektionssprøjte, før du er klar til at tage injektionen.
English: Pain in extremity Musculoskeletal pain1
Danish: Ekstremitetssmerter Muskuloskeletale smerter1 Osteonekrose i kæben1
English: Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design The cumulative incidence of new vertebral and non-vertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1,278).
Danish: Den kumulative incidens af nye vertebrale og non-vertebrale frakturer var henholdsvis cirka 6,8 % og 13,1 % hos patienter, der fortsatte i behandling med denosumab i 10 år (n = 1.278).
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Prolia.
Danish: Fortæl det til din tandlæge, at du er i behandling med Prolia, hvis du i øjeblikket får tandbehandling eller skal have en tandoperation (for eksempel udtrækning af tænder), og informér din læge om det.
English: In the post-marketing setting, rare cases of severe symptomatic hypocalcaemia have been reported predominantly in patients at increased risk of hypocalcaemia receiving Prolia, with most cases occurring in the first weeks of initiating therapy.
Danish: Efter markedsføring af Prolia er der indberettet sjældne tilfælde af alvorlig, symptomgivende hypokalcæmi fortrinsvist hos patienter med øget risiko for hypokalcæmi.
English: Next injection Prolia 60 mg injection denosumab SC
Danish: Næste injektion Prolia 60 mg injektion denosumab s.c.
English: One pre-filled syringe with automatic needle guard.
Danish: Én fyldt injektionssprøjte med automatisk kanylehætte.
English: There are no clinical data on the co-administration of denosumab and hormone replacement therapy (oestrogen), however the potential for a pharmacodynamic interaction is considered to be low.
Danish: Der er ingen kliniske data vedrørende samtidig indgivelse af denosumab og hormonsubstitutionsterapi (østrogen).
English: Osteonecrosis of the external auditory canal has been reported with denosumab.
Danish: Der er rapporteret osteonekrose i ydre øregang efter behandling med denosumab.
English: In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Danish: Prolia nedsætter signifikant risikoen for vertebrale og nonvertebrale frakturer samt hoftefrakturer hos postmenopausale kvinder.
English: During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.
Danish: Patienterne skal informeres om at indberette nye eller usædvanlige smerter i lår, hofte eller lyske under behandling med denosumab.
English: Each pack contains one pre-filled syringe.
Danish: Hver pakning indeholder en fyldt injektionssprøjte.
English: How to use Prolia
Danish: Sådan skal du bruge Prolia
English: C.A.
Danish: s.c.
English: Osteonecrosis of the Jaw (ONJ) ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).
Danish: ONJ er blevet rapporteret med frekvensen sjælden hos patienter, der fik Prolia til behandling af osteoporose (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Prolia 60 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: Common Common Common Uncommon
Danish: Almindelig Almindelig Almindelig Ikke almindelig
English: • Keep the pre-filled syringe out of the sight and reach of children.
Danish: • Opbevar den fyldte injektionssprøjte utilgængeligt for børn.
English: • rash,
Danish: • udslæt,
English: Remember: if you have any problems, please ask your doctor or healthcare provider for help and advice.
Danish: Husk: spørg din læge eller sygeplejerske om hjælp og vejledning, hvis du har problemer.
English: In genetically engineered mice in which RANKL has been turned off by gene removal (a “knockout mouse”), studies suggest absence of RANKL (the target of denosumab see section 5.1) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3).
Danish: Studier med genetisk manipulerede mus, hvor RANKL er deaktiveret ved at fjerne gener (”knockout”-mus), tyder på, at mangel på RANKL (målet for denusomab se pkt.
English: To avoid bending the needle, gently pull the cover from the needle straight off without twisting, as shown in pictures 1 and 2.
Danish: For at undgå at bøje kanylen skal hætten forsigtigt trækkes af kanylen i en lige bevægelse uden at dreje hætten.
English: DO NOT remove the needle cover from the pre-filled syringe until you are ready to inject.
Danish: Hættehylsteret må IKKE tages af injektionssprøjten, før du er klar til injektionen.
English: Prolia increased BMD by 9.2% at the lumbar spine, 6.0% at the total hip, 4.8% at the femoral neck, 7.9% at the hip trochanter, 3.5% at the distal 1/3 radius and 4.1% at the total body over 3 years (all p < 0.0001).
Danish: Prolia øgede BMD med 9,2 % i columna lumbalis, med 6,0 % i total hofte, med 4,8 % i lårbenshalsen, med 7,9 % i trochanter, med 3,5 % ved den distale 1/3 radius og med 4,1 % over hele kroppen i løbet af 3 år (alle p < 0,0001).
English: Each pack contains one pre-filled syringe with a needle guard.
Danish: Hver pakning indeholder en fyldt injektionssprøjte med kanylehætte.
English: Major non-vertebral fracture3
Danish: Større non-vertebral fraktur3 Større osteoporotisk fraktur4
English: Uncommon cases of cellulitis, rare cases of hypocalcaemia, hypersensitivity, osteonecrosis of the jaw and atypical femoral fractures (see section 4.4 and section 4.8 - description of selected adverse reactions) have been observed in patients taking Prolia.
Danish: Cellulitis er observeret med frekvensen ”ikke almindelig” og hypokalcæmi, overfølsomhed, osteonekrose i kæben og atypisk femurfraktur er observeret med frekvensen ”sjælden” (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WITH OR WITHOUT NEEDLE GUARD (BLISTERED)
Danish: ETIKET TIL FYLDT INJEKTIONSSPRØJTE MED ELLER UDEN KANYLEHÆTTE (I BLISTERPAKNING)
English: What Prolia is and what it is used for What you need to know before you use Prolia How to use Prolia
Danish: Det skal du vide, før du begynder at bruge Prolia Sådan skal du bruge Prolia Bivirkninger
English: Osteonecrosis of the external auditory canal2
Danish: Osteonekrose i ydre øregang2
English: Prolia significantly increased BMD at all clinical sites measured, relative to placebo at 12 months: 4.8% at lumbar spine, 2.0% at total hip, 2.2% at femoral neck, 2.3% at hip trochanter, and 0.9% at distal 1/3 radius (all p < 0.05).
Danish: Efter 12 måneder havde Prolia øget BMD signifikant i alle de klinisk målte områder i forhold til placebo: 4,8 % i columna lumbalis, 2,0 % i total hofte, 2,2 % i lårbenshalsen, 2,3 % i hoftetrochanter og 0,9 % i distale 1/3 radius (alle p < 0,05).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL (UNBLISTERED)
Danish: ETIKET TIL FYLDT INJEKTIONSSPRØJTE (PAKNING UDEN BLISTER)
English: In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but it can occur later.
Danish: Efter markedsføring er der indberettet alvorlig, symptomatisk hypokalcæmi (herunder tilfælde med dødeligt udfald) (se pkt.
English: Important Before you use a Prolia pre-filled syringe with automatic needle guard, read this important information:
Danish: Læs disse vigtige informationer, inden du tager den fyldte Prolia-injektionssprøjte med automatisk kanylebeskyttelse i brug:
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Hvis noget af ovenstående er tilfældet, skal du kontakte din læge eller sundhedspersonalet.
English: Lichenoid drug eruptions
Danish: Lichenoid lægemiddeludslæt
English: Osteonecrosis of the jaw
Danish: Osteonekrose i ydre øregang
English: No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium).
Danish: 4.4 vedrørende anbefalinger til monitorering af calcium).
English: Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 3 years: 7.9% at the lumbar spine, 5.7% at the total hip, 4.9% at the femoral neck, 6.9% at the hip trochanter, 6.9% at the distal 1/3 radius and 4.7% at the total body (all p < 0.0001).
Danish: I forhold til placebo øgede Prolia signifikant BMD i alle de klinisk undersøgte områder efter 3 år: 7,9 % ved columna lumbalis, 5,7 % i total hofte, 4,9 % i lårbenshals, 6,9 % i trochanter, 6,9 % i distale 1/3 radius og 4,7 % i hele kroppen (alle p < 0,0001).
English: Lichenoid drug eruptions1
Danish: Lichenoid lægemiddeludslæt1
English: Similar fractures reported in association with bisphosphonates are often bilateral; therefore the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture.
Danish: Derfor bør den kontralaterale femur undersøges hos denosumab-behandlede patienter med femurskaft-fraktur.
English: DO NOT pick up the pre-filled syringe by the plunger or needle cover.
Danish: TAG IKKE fat i injektionssprøjten på stemplet eller hættehylsteret.
English: • abdominal discomfort,
Danish: • ubehag i maven,
English: If you become pregnant during treatment with Prolia or less than 5 months after stopping treatment with Prolia, please inform your doctor.
Danish: Fortæl det til lægen, hvis du bliver gravid, mens du er i behandling med Prolia, eller inden for 5 måneder efter at behandlingen med Prolia er stoppet.
English: All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Danish: Alle mænd fik tilskud af calcium (mindst 1.000 mg) og vitamin D (mindst 800 IE) dagligt.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Tilskud af calcium og D-vitamin
English: Skin infections
Danish: Hudinfektioner
English: Patients received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Danish: Patienterne fik dagligt tilskud af calcium (mindst 1.000 mg) og D-vitamin (mindst 800 IE).
English: Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 2 years: 7.6% at lumbar spine, 4.7% at total hip, 3.6% at femoral neck, 5.9% at hip trochanter, 6.1% at distal 1/3 radius and 4.2% at total body (all p < 0.0001).
Danish: I forhold til placebo øgede Prolia signifikant BMD i alle de klinisk undersøgte områder efter 2 år: 7,6 % i columna lumbalis, 4,7 % i total hofte, 3,6 % i lårbenshals, 5,9 % i trochanter, 6,1 % i distale 1/3 radius og 4,2 % for hele kroppen (alle p < 0,0001).
English: One pre-filled syringe.
Danish: Én fyldt injektionssprøjte.
English: Alcohol wipes or similar.
Danish: en ny fyldt injektionssprøjte med Prolia en alkoholserviet eller lignende.
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg injection denosumab
Danish: Prolia 60 mg injektionsvæske denosumab
English: Keep the syringe and sharps disposal container out of sight and reach of children.
Danish: Opbevar injektionssprøjterne og kanylebøtten utilgængeligt for børn.
English: How do you use the Prolia pre-filled syringe?
Danish: Sådan bruges den fyldte injektionssprøjte med Prolia
English: Sciatica
Danish: Dosering
English: DO NOT shake the pre-filled syringe.
Danish: Ryst ikke den fyldte injektionssprøjte.
English: In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Danish: Prolia nedsætter signifikant risikoen for vertebrale frakturer hos mænd med prostatacancer, der er i antihormonbehandling.
English: Prolia 60 mg solution for injection in pre-filled syringe denosumab
Danish: Prolia 60 mg injektionsvæske, opløsning, i fyldt injektionssprøjte denosumab
English: For instructions on how to inject Prolia, please read the section at the end of this leaflet.
Danish: Afsnittet sidst i denne indlægsseddel indeholder instruktioner om injektion af Prolia.
English: Warnings for excipients
Danish: Advarsler om hjælpestoffer
English: Women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Danish: Kvinderne fik dagligt tilskud af calcium (mindst 1.000 mg) og D-vitamin (mindst 400 IE).
English: All women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Danish: Alle kvinder fik dagligt tilskud af calcium (mindst 1.000 mg) og D-vitamin (mindst 400 IE).
English: • Keep used syringes out of the reach and sight of children.
Danish: • Brugte injektionssprøjter skal opbevares utilgængeligt for børn.
English: All men received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Danish: Alle mænd fik dagligt tilskud af calcium (mindst 1.000 mg) og D-vitamin (mindst 400 IE).
English: Step 2: Get ready A Wash your hands thoroughly.
Danish: A Vask dine hænder grundigt.
English: Hepatic impairment
Danish: Osteonekrose i kæben
English: Absorption: Several studies have been conducted.
Danish: Absorption: Flere forsøg er blevet udført.
English: If no improvement is noted within 48 hours, the diagnosis should be confirmed.
Danish: Hvis der ikke ses bedring inden for 48 timer, skal diagnosen bekræftes.
English: 8 hours 8 hours
Danish: 8 timer 8 timer
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Danish: Der skal tages højde for officielle nationale og regionale antimikrobielle politikker ved anvendelse af produktet.
English: 1 hour 1 hour
Danish: 1 time 1 time
English: • Avoid contact with skin and eyes.
Danish: • Undgå kontakt med hud og øjne.
English: The treatment appears to be intended to be preventive, which is not in line with the principles of prudent use of antibiotics.
Danish: Behandlingen synes at være tiltænkt som forebyggelse, hvilket ikke er i overensstemmelse med principperne for forsigtig brug af antibiotika.
English: No data to support the term “control” were provided.
Danish: Der blev ikke forelagt data til dokumentation af udtrykket “kontrol”.
English: It is believed to affect protein synthesis.
Danish: Det menes at påvirke proteinsyntese.
English: • Ensure that animals are properly restrained, including those in the vicinity.
Danish: • Sørg for, at dyr fastholdes tilstrækkeligt, herunder dyr i nærheden.
English: 35396 Gießen GERMANY
Danish: 35396 Gießen TYSKLAND
English: 1000 Brussel
Danish: 1000 Brussel BELGIEN
English: Discard date..............................
Danish: Kasseringsdato..............................
English: Via A. Gramsci, 731/733 Sesto Fiorentino ITALY
Danish: Via A. Gramsci, 731/733 Sesto Fiorentino ITALIEN
English: An overdosage is likely to happen for such a small amount of product.
Danish: Der må forventes at kunne ske overdosering ved administration af så lille en mængde af et produkt.
English: 3991 RA Houten THE NETHERLANDS
Danish: 3991 RA Houten HOLLAND
English: These results suggest that intravenous epinephrine may be contraindicated.
Danish: Disse resultater antyder, at intravenøs epinefrin kan være kontraindiceret.
English: Each vial is packed into a carton.
Danish: Hvert hætteglas er pakket i et karton.
English: It has bacteriostatic action but at high concentrations it may be bactericidal.
Danish: Det har bakteriostatisk virkning, men kan ved højere koncentrationer være bakteriedræbende.
English: Overall it can be concluded that data to substantiate the proposed indications in rabbits is minimally reported or lacking.
Danish: Overordnet kan det konkluderes, at data til underbygning af de ansøgte indikationer hos kaniner er summarisk beskrevet eller savnes.
English: The half-life following subcutaneous injection in cattle is 2-3 days.
Danish: Halveringstiden efter subkutan injektion hos kvæg er 2-3 dage.
English: However the bulk of the tilmicosin is excreted unchanged.
Danish: Størstedelen af tilmicosin udskilles dog uændret.
English: Furthermore, the safety of margin of the product is not in line with a safe use of the product in the rabbit species given the very small volume to administer.
Danish: Produktets sikkerhedsmargin er desuden ikke forenelig med risikofri anvendelse af produktet til dyrearten kaniner på grund af det meget lille volumen, der skal administreres.
English: Do not administer to horses, donkeys, pigs, goats or primates.
Danish: Må ikke indgives til heste, æsler, svin, geder eller primater.
English: The main areas of disharmony in the existing SPCs relate to:
Danish: De vigtigste uoverensstemmelser mellem de eksisterende produktresuméer vedrører:
English: Interactions between macrolides and ionophores could be observed in some species.
Danish: Interaktioner mellem makrolider og ionoforer kunne observeres hos visse dyrearter.
English: 4600 Wels AUSTRIA
Danish: 4600 Wels ØSTRIG
English: Phosphoric acid (for pH adjustment)
Danish: Fosforsyre (til justering af pH)
English: LILLY FRANCE 13 Rue Pages 92158 Suresnes Cedex FRANCE
Danish: LILLY FRANCE 13 Rue Pages 92158 Suresnes Cedex FRANKRIG
English: Occasionally, a soft diffuse swelling may occur at the injection site but this disappears within five to eight days.
Danish: Blød, diffus hævelse kan undertiden forekomme på injektionsstedet, men hævelsen forsvinder efter fem til otte dage.
English: At day 10 tilmicosin still appeared to have lower udderscores although no longer significant.
Danish: På dag 10 syntes tilmicosin stadig at give lavere yverscore, skønt der ikke længere var signifikans.