FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with serum bilirubin levels > ULN and/or ALT and AST > 3.5 times the ULN concurrent with serum alkaline phosphatase levels > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Danish: Hos patienter med serumbilirubin > øvre normalværdi og/eller forhøjelse af ASAT/ALAT på > 3,5 gange øvre normalværdi og samtidig forhøjelse af basisk fosfatase på > 6 gange øvre normalværdi kan det ikke anbefales at reducere dosis.
English: 4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: 4.2.2 Injicer derefter den beregnede mængde præmix i en 250 ml infusionspose med enten 5 % glucoseinfusionsvæske eller natriumchloridinfusionsvæske 9 mg/ml (0,9 %).
English: 5-fluorouracil (F) 750 mg/m per day as a continuous infusion for 5 days.
Danish: 1 times infusion med cisplatin 75 mg/m på dag 1, efterfulgt af 5-fluoruracil som en kontinuerlig infusion på 750 mg/m pr. dag i fem dage.
English: Vomiting (G3/4: 4%);
Danish: Kvalme (G3/4: 4 %);
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis det skulle komme i berøring med slimhinderne, skal man straks skylle grundigt med vand.
English: (see sections 4.4 and 5.2).
Danish: 4.8 og 5.1).
English: Gastrointestinal disorders
Danish: Gastrointestinale smerter;
English: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion docetaxel
Danish: TAXOTERE 20 mg/0,5 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Danish: Hud og subkutane væv Alopeci; Neglesygdomme (alvorlig 0,7 %);
English: Constipation;
Danish: Konstipation;
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Danish: Stomatitis (G3/4: 18 %); Diarré (G3/4: 14 %); Kvalme (G3/4: 6 %); Opkastning (G3/4: 4 %); Konstipation (G3/4: 1 %); Mavesmerter (G3/4: 2 %); Dyspepsi
English: 95% CIAdjusted hazard ratio
Danish: 95 %CI P = Hazard ratio*
English: TAXOTERE 80 mg/4 ml sterile concentrate docetaxel
Danish: TAXOTERE 80 mg/4 ml sterilt koncentrat docetaxel intravenøs anvendelse
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft for TAXOTERE 100 mg/m² enkeltstof
English: Infection (G3/4: 6.3%); Neutropenic infection
Danish: 6,3 %); Neutropenisk infektion
English: 2.2 Solvent for TAXOTERE 20 mg/0.5 ml vial
Danish: 2.2 SOLVENS TIL TAXOTERE 20 mg/0,5 ml HÆTTEGLAS:
English: 2.2 Solvent for TAXOTERE 80 mg/2 ml vial
Danish: 2.2 SOLVENS TIL TAXOTERE 80 mg/2 ml HÆTTEGLAS:
English: You must not be given TAXOTERE:
Danish: Brug ikke TAXOTERE
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet fra hætteglasset med solvens til indholdet i hætteglasset med TAXOTERE 20 mg/0,5 ml, koncentrat il infusionsvæske, opløsning, sikrer en præmixkoncentration på 10 mg/ml docetaxel.
English: Tabulated list of adverse reactions in head and neck cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af hoved- og halskræft med TAXOTERE 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: Adjusted hazard ratio (95% CI) *p-value
Danish: Tilpasset hazard ratio (95 %CI) *p-værdi
English: Stomatitis/mucositis grade 4
Danish: Diarré grad 4
English: If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis TAXOTERE infusionskoncentrat, præmix-opløsning eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
English: If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis TAXOTERE infusionskoncentrat, præmix-opløsning eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
English: Somnolence (G3/4: 0%)
Danish: Lymfødem (G3/4: 0 %)
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med TAXOTERE 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: VIAL LABEL / TAXOTERE 80 mg/4 ml
Danish: HÆTTEGLAS ETIKET/TAXOTERE 80 mg/4ml
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet fra hætteglasset med solvens til indholdet i hætteglasset med TAXOTERE 80 mg/2 ml, koncentrat il infusionsvæske, opløsning, sikrer en præmixkoncentration på 10 mg/ml docetaxel.
English: Stomatitis/mucositis grade 3
Danish: Diarré grad 3
English: In TAXOTERE 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i TAXOTERE 20 mg/1 ml er 20 mg/ml.
English: Median survival (months) 95% CI
Danish: Median overlevelsestid (måneder) 95 %CI
English: This medicinal product contains 13 % (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine.
Danish: Dette lægemiddel indeholder 13% (w/w) ethanol 95% v/v (alkohol), dvs. op til 252 mg ethanol 95% v/v per solvens-hætteglas, svarende til 6 ml øl eller 2,6 ml vin.
English: Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Danish: Diarré (G3/4: 2,9 %); Opkastning (G3/4:
English: Vomiting (G3/4: 3%)
Danish: Opkastning (G3/4: 3 %)
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion vial
Danish: TAXOTERE 20 mg/0,5 ml koncentrat til infusionsvæske, opløsning hætteglas
English: This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 932 mg ethanol 95% v/v per solvent vial, equivalent to 23 ml of beer or 9.5 ml wine.
Danish: Dette lægemiddel indeholder 13% (w/w) ethanol 95% v/v (alkohol), dvs. op til 932 mg ethanol 95% v/v per solvens-hætteglas, svarende til 23 ml øl eller 9,5 ml vin.
English: 15 ml clear glass Type I vial with a transparent colourless flip-off cap.
Danish: 15 ml klart Type I hætteglas med en klar afrivningshætte.
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4:
Danish: Dysgeusi/parosmi Perifer sensorisk neuropati (G3/4: 0,6 %)
English: Neutropenia (G3/4:
Danish: Konstipation (G3/4:
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Danish: Væskeretention (alvorlig: 6,5 %) Asteni (alvorlig: 11,2 %); smerter
English: • flushing, skin reactions, itching
Danish: • Rødme i ansigtet, hudreaktioner, kløe
English: Second primary malignancies
Danish: Hoved- og halskræft
English: Conjunctivitis (G3/4:
Danish: Opkastning (G3/4:
English: In these metastatic prostate cancer patients, the median overall survival was significantly longer in docetaxel treatment groups than in the standard of care alone group, with a median overall survival 19 months longer with the addition of docetaxel to standard of care (HR = 0.76, 95% CI = 0.62-0.92, p=0.005).
Danish: Den samlede median overlevelse var 19 måneder længere med tilføjelse af docetaxel til standardplejen (HR = 0,76, 95 % CI = 0,62 -0,92 p=0,005).
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: • Injicer via en enkelt injektion (et stik) den nødvendige mængde TAXOTERE koncentrat til infusionsvæske, opløsning i en 250 ml infusionspose eller -flaske indeholdende enten en 5 % glucoseinfusionsvæske eller en 0,9 % natriumchloridinfusionsvæske.
English: VIAL/SOLVENT FOR TAXOTERE 20 mg/0.5 ml
Danish: HÆTTEGLAS/ SOLVENS TIL TAXOTERE 20 MG/0,5 ml
English: In TAXOTERE 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i TAXOTERE 80 mg/4 ml er 20 mg/ml.
English: Stomatitis (G3/4:
Danish: Neglesygdomme (G3/4:
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4:
Danish: Mave-tarmkanalen Kvalme (G3/4: 5,0 %) Stomatitis (G3/4:
English: More than one vial of TAXOTERE concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Danish: For at kunne udtage den korrekte dosis til patienten, kan det være nødvendigt at anvende mere end et hætteglas TAXOTERE koncentrat til infusionsvæske, opløsning.
English: Alopecia; Skin reaction (G3/4:
Danish: Hud og subkutane væv Alopeci; Hudlidelser (G3/4:
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion
Danish: TAXOTERE 80 mg/2 ml koncentrat og solvens til infusionsvæske, opløsning.
English: Lymphoedema
Danish: Leukæmi
English: Nail disorders (severe: 0.8%)
Danish: Neglesygdomme (alvorlig 0,4 %);
English: TAXOTERE 20 mg/1 ml concentrate for solution for infusion
Danish: TAXOTERE 20 mg/1 ml koncentrat til infusionsvæske, opløsning.
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion
Danish: TAXOTERE 80 mg/4 ml koncentrat til infusionsvæske, opløsning.
English: 7 ml clear glass Type I vial with a transparent colourless flip-off cap.
Danish: 7 ml klart Type I hætteglas med en klar afrivningshætte.
English: Diarrhoea (G3/4: 4%); Nausea (G3/4: 4%);
Danish: Diarré (G3/4: 3,4 %); Obstipation (G3/4:
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af brystkræft med TAXOTERE 100 mg/m² enkeltstof:
English: 4.2.3 Mix the infusion bag or bottle manually using a rocking motion.
Danish: 4.2.3 Bland infusionsvæsken ved manuel rotation af infusionsposen.
English: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
Danish: TAXOTERE 20 mg/0,5 ml koncentrat og solvens til infusionsvæske, opløsning.
English: Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Danish: Arytmi (G3/4: 0,2 %); Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4:
English: Vomiting (G3/4: 1.2%)
Danish: Ødemer (G3/4: 1,2%)
English: Hazard ratio (95% CI) **p-value
Danish: Hazard ratio (95 %CI) **p-værdi
English: Asthenia (G3/4:
Danish: Infektion (G3/4:
English: Dizziness (G3/4:
Danish: Svimmelhed (G3/4:
English: Myocardial ischemia (G3/4:1.7%)
Danish: Iskæmisk hjertesygdom (G3/4: 1,7 %)
English: In TAXOTERE 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen af docetaxel i TAXOTERE 80 mg/4 ml er 20 mg/ml
English: Skin disorder (G3/4:
Danish: Hudsygdomme (G3/4:
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736
Danish: I studiet TAX316 forekom amenorré i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 202 af 744 TAC patienter (27,2 %) og hos 125 af 736 FAC patienter (17,0 %).
English: Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%.
Danish: Første episode: Reducer 5-FU-dosis med 20 % Anden episode: Reducer så docetaxel-dosis med 20 %
English: Failure-Free survivalb
Danish: Fejlfri overlevelse b
English: including more severe hypersensitivity reaction.
Danish: som resulterede i usædvanlig kraftigt tåreflod.
English: VIAL/TAXOTERE 20 mg/0.5 ml
Danish: HÆTTEGLAS/TAXOTERE 20 MG/0,5 ml
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Danish: Neutropenisk infektion (G3/4: 2,6%)
English: (G3/4: 0.2%)
Danish: Vægttab (G3/4: 0,2 %)
English: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Danish: I kombination med cisplatin og 5-fluoruracil Docetaxel-dosis bør reduceres fra 75 til 60 mg/m2, hvis der trods anvendelse af G-CSF opstår: 1) febril neutropeni, 2) prolongeret neutropeni, 3) eller neutropenisk infektion.
English: Elderly
Danish: Letargi
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER)I MEDLEMSSTATERNE
English: Pharmaceutical Form
Danish: Lægemiddelform Indgivelesvej
English: Member State Marketing Authorisation Holder Invented Name
Danish: Indehaver af markedsføringstilladelse
English: 2 bottles of 240
Danish: 2 beholdere a 240
English: l t o r d
Danish: r l
English: 240 ml (15 mg/ml) 1 bottle + 20 ml measuring cup
Danish: 240 ml (15 mg/ml) 1 flaske og et 20 ml målebæger
English: EU Number
Danish: EU-nummer Særnavn
English: 15 mg/ml Oral solution
Danish: EU/1/00/148/004 AGENERASE 15 mg/ml
English: Novem alone will not provide adequate pain relief during the dehorning procedure.
Danish: Novem alene vil ikke give tilstrækkelig smertelindring under afhorning.
English: This local reaction resolved within 8 hours following subcutaneous administration.
Danish: Denne lokale reaktion forsvandt inden for 8 timer efter subkutan administration.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the relase of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: To obtain the best possible pain relieving effect post-surgery Novem should be administered 30 minutes before surgical intervention.
Danish: For at opnå den bedst mulige postoperative smertelindrende effekt, bør Novem administreres 30 minutter før et kirurgisk indgreb.
English: Do not use in pigs less than 2 days old.
Danish: Må ikke anvendes til grise, som er under 2 dage gamle.
English: In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
Danish: På grund af risikoen for selvinjektion ved hændeligt uheld og de kende klasse-bivirkninger af NSAID'er og andre prostaglandinhæmmere på gravide og/eller embryoføtal udvikling, bør veterinærlægemidlet ikke administreres af gravide kvinder eller kvinder, der forsøger at blive gravide.
English: Treatment of calves with Novem 20 minutes before dehorning reduces post-operative pain.
Danish: Behandling af kalve med Novem 20 minutter før afhorning reducerer postoperativ smerte.
English: Treatment of piglets with Novem before castration reduces post-operative pain.
Danish: Behandling af smågrise med Novem inden kastration reducerer postoperative smerter.
English: The active substance in Novem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Novem er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) nr. 37/2010:
English: Cattle (calves and young cattle) and pigs
Danish: Kvæg (kalve og ungkvæg) og grise
English: For the relief of post-operative pain associated with minor soft tissue surgery such as castration.
Danish: Til lindring af postoperative smerter i forbindelse med mindre bløddelskirurgi såsom kastration.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under afsnit 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Cattle and pigs
Danish: Kvæg og grise.
English: Date of first authorisation: Date of last renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse af markedsføringstilladelse:
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Danish: Til supplerende behandling af puerperal sepsis og toksikæmi (mastitis-metritis-agalaktisk syndrom) med passende antibiotika-behandling.
English: People with known hypersensitivity to non-steroidal antiinflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for nonsteroide antiinflammatoriske lægemidler (NSAID-præparater) bør undgå kontakt med veterinærlægemidlet.
English: Cattle: Single SC injection.
Danish: Kvæg: Enkelt s.c. injektion.
English: Shelf-life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials): 3 years
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning (20 ml, 50 ml, 100 ml eller 250 ml hætteglas): 3 år
English: Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Danish: Hvert hætteglas er lukket med en gummiprop og forseglet med en aluminiumshætte.
English: IM injection.
Danish: injektion.
English: Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Danish: Meloxicam elimineres med en halveringstid på 26 timer efter subkutan injektion hos ungkvæg.
English: Cattle: SC injection.
Danish: Kvæg: s.c. injektion.
English: In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner som kan være alvorlige (herunder dødelige) forekomme.
English: Take care of accurate dosing, use of appropriate dosing device and estimation of body weight.
Danish: Sørg for at dosere nøjagtigt, at bruge passende injektionssprøjte samt at vurdere legemsvægten.
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Danish: Må ikke anvendes til dyr, som lider af nedsat lever-, hjerte- eller nyrefunktion og hæmoragiske lidelser, eller i tilfælde hvor der er tegn på ulcerogene gastrointestinale læsioner.
English: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Danish: Grise: Til anvendelse ved ikke-smitsomme lokomotoriske forstyrrelser med henblik på at reducere halthed og inflammation.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions)) - 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: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Danish: Meloxicam Meloxicam Kvæg, geder, grise, kaniner, dyr af hestefamilien
English: For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Danish: Ved behandling af diarré hos kvæg bør præparatet ikke anvendes til dyr, som er mindre end en uge gamle.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på ydre emballage og flaske efter EXP.
English: Single IM injection before surgery.
Danish: injektion inden operation.
English: Meloxicam in Novem 20 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Meloxicam i Novem 20 mg/ml injektionvæske, opløsning til kvæg og grise er et godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Meloxicam in Novem 5 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Meloxicam i Novem 5 mg/ml injektionvæske, opløsning til kvæg og grise er et godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider (oxicam).
English: Disposal: read the package leaflet.
Danish: Affaldshåndtering: Læs indlægssedlen.
English: EXP {month/year} Once broached, use by…
Danish: EXP {måned/år} Efter anbrud anvendes inden …
English: EXP {month/year} Shelf-life of broached vial: 28 days.
Danish: EXP.{måneder/år} Holdbarhed af anbrudt hætteglas: 28 dage.
English: Withdrawal periods:
Danish: Tilbageholdelsestid:
English: Interaction with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Danish: Interaktion med andre lægemidler og andre former for interaktion Må ikke gives samtidig med glucokortikosteroider, andre non-steroid antiinflammatoriske lægemidler eller sammen med antikoagulantia.
English: Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Danish: Karton med 1 eller 12 farveløse hætteglas à 20 ml, 50 ml eller 100 ml, lukket med gummiprop og forseglet med aluminiumshætte.
English: Subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Danish: Subkutan og intramuskulær administration tolereres godt; kun hos mindre end 10 % af behandlet kvæg i kliniske studier sås let og forbigående hævelse på injektionsstedet efter subkutan injektion.
English: EXP {month/year} Once broached use within 28 days.
Danish: EXP {måned/år} Anvendes inden 28 dage efter anbrud.
English: Pregnancy and lactation Can be used during pregnancy and lactation.
Danish: Drægtighed og laktation Kan anvendes under drægtighed og laktation.
English: Subcutaneous and intramuscular injection is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Danish: Subkutan og intramuskulær injektion tolereres godt; kun hos mindre end 10 % af behandlet kvæg i kliniske studier sås let og forbigående hævelse på injektionsstedet efter subkutan injektion.
English: Sodium hydroxide Glycofurol Meglumine Water for injection
Danish: Natriumhydroxid Glycofurol
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, eller over for et eller flere af hjælpestofferne.