FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use in case of hypersensitivity of the target animals to macrolide antibiotics.
Danish: Bør ikke anvendes til måldyr med overfølsomhed over for antibiotika af macrolid gruppen.
English: 5 mg/ml Clear colourless to slightly yellow solution for injection.
Danish: 5 mg/ml Klar, farveløs til lysegul opløsning.
English: In case of accidental eye exposure, flush the eyes immediately with clean water.
Danish: I tilfælde af kontakt med øjnene ved hændeligt uheld skal øjnene straks skylles i rent vand.
English: The 500 ml vials must not be used for pigs and sheep.
Danish: Hætteglasset med 500 ml må ikke bruges til svin og får.
English: EXP Once broached use by
Danish: EXP Efter anbrud anvendes inden
English: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.
Danish: Behandling af tidlige faser af smitsom pododermatisis (klovsyge), som er forbundet med den virulente Dichelobacter nodosus, som kræver systemisk behandling.
English: MARKETING AUTHORISATION
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.
Danish: Det anbefales at benytte en gennemstikskanyle eller automatsprøjte ved gentagne udtag fra beholder for at undgå overdreven gennemhulning af proppen.
English: Bovine 300 µg/kg 200 µg/kg
Danish: Kvæg 300 μg/kg 200 μg/kg
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 etiketten efter EXP. Opbevaringstid efter første åbning af beholderen: 28 dage.
English: Do not use simultaneously with other macrolides or lincosamides (see section 4.8).
Danish: Bør ikke anvendes samtidigt med andre macrolider eller lincosamider (se pkt.
English: The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%.
Danish: Biotilgængeligheden af tulathromycin efter subkutan administration var hos kvæg ca. 90%.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke klarlagt.
English: The bioavailability of tulathromycin after intramuscular administration in sheep was 100%.
Danish: Biotilgængeligheden af tulathromycin efter intramuskulær administration var 100% hos får.
English: Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux.
Danish: Resistens mod macrolider kan udvikles ved mutation i gener der koder for ribosomal RNA (rRNA) eller nogle ribosomal proteiner; ved enzymatisk modifikation (metylering) af det specifikke 23S rRNA, hvilket ofte giver krydsresistens med lincosamider og gruppe B-streptogramin (MLSB resistens); ved enzymatisk inaktivering eller ved macrolid efflux.
English: Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.
Danish: Behandling af Infektiøs Bovin Keratokonjunktivitis (IBK) forårsaget af tulathromycinfølsomme Moraxella bovis.
English: Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma.
Danish: Maximal koncentration i plasma blev efterfulgt af en langsom udskillelse med en tilsyneladende halveringstid (t1/2) på 90 timer.
English: In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness.
Danish: Hos unge svin der vejede ca. 10 kg, blev der efter indgift af tre eller fem gange den terapeutiske dosis observeret forbigående tegn på ubehag på injektionsstedet samt skrigen og rastløshed.
English: Once broached use by
Danish: Efter anbrud anvendes inden
English: The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.
Danish: Biotilgængeligheden af tulathromycin efter intramuskulær administration var ca. 88% hos svin.
English: Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma.
Danish: Maximal koncentration i plasma blev efterfulgt af en langsom udskillelse med en tilsyneladende halveringstid (t1/2) på ca. 91 timer.
English: In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake.
Danish: Hos kvæg er der ved doser på tre, fem eller ti gange den anbefalede dosis observeret forbigående tegn på ubehag fra injektionsstedet samt rastløshed, hovedrystning, skraben i jorden og kortvarig nedsat foderindtagelse.
English: Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Danish: Må ikke anvendes til drægtige køer eller kvier, hvis mælk er bestemt til menneskeføde, inden for 2 måneder forud for den forventede fødselsdato.
English: In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated.
Danish: In vitro-aktivitet mod Dichelobactor nodosus (virulent), som er det bakterielle patogen, der oftest forbindes med smitsom klovsyge (pododermatitis), er påvist hos får.
English: Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Water for injections
Danish: Monothioglycerol Propylenglycol Citronsyre
English: Withdrawal periods: Meat and offal:
Danish: Tilbageholdelsestider: Slagtning:
English: Ovine, caprine
Danish: Får, geder
English: 4 000 µg/kg 8 000 µg/kg
Danish: 4000 μg/kg 8000 μg/kg
English: Vial sizes: 20 ml, 50 ml, 100 ml, 250 ml and 500 ml.
Danish: Hætteglasstørrelser: 20 ml, 50 ml, 100 ml, 250 ml og 500 ml.
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)
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: Porcine 800 µg/kg 300 µg/kg
Danish: Svin 800 μg/kg 300 μg/kg
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Danish: Må ikke anvendes til drægtige dyr, hvis mælk er bestemt til menneskeføde, inden for 2 måneder forud for den forventede fødselsdato.
English: In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating.
Danish: Hos lam (ca. 6 uger gamle) er der ved doser på tre eller fem gange den anbefalede dosis observeret forbigående tegn, der blev tilskrevet ubehag på injektionsstedet, herunder at gå baglæns, hovedrystning, gnubben på injektionsstedet, lægge sig ned og rejse sig op, brægen.
English: Pack size: Cardboard box containing one vial.
Danish: Pakningsstørrelse: Papæske med 1 hætteglas.
English: Withdrawal period: Meat and offal: 13 days.
Danish: Tilbageholdelsestid: Slagtning: 13 dage.
English: 4500 µg/kg 3000 µg/kg
Danish: 4500 μg/kg 3000 μg/kg
English: In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection.
Danish: Hos får er forbigående tegn på ubehag (hovedrystning, gnubben på injektionsstedet, gå baglæns) meget almindelige efter intramuskulære injektioner.
English: Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose.
Danish: Hos kvæg doseret med 5-6 gange anbefalet dosis er observeret mild myokardiedegeneration.
English: For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.
Danish: Til behandling af kvæg over 300 kg legemsvægt deles dosen således at ikke mere end 7,5 ml injiceres på samme sted.
English: For treatment of pigs over 40 kg bodyweight, divide the dose so that no more than 4 ml are injected at one site.
Danish: Til behandling af svin over 40 kg legemsvægt deles dosen således at ikke mere end 4 ml bliver injiceret på samme sted.
English: For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.
Danish: Til behandling af svin over 80 kg legemsvægt deles dosen således at ikke mere end 2 ml bliver injiceret på samme sted.
English: In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours.
Danish: Hos får blev den farmakokinetiske profil af tulathromycin efter en enkelt intramuskulær applikation af 2,5 mg/kg legemsvægt opnået ved en maksimal plasmakoncentration (Cmax) på 1,19 µg/ml.
English: Cattle (treatment and metaphylaxis) 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Danish: Kvæg (behandling og metafylakse) 2,5 mg tulathromycin/kg legemsvægt (svarende til 1ml/40 kg legemsvægt).
English: In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Danish: Hos kvæg, var den farmakokinetiske profil af tulathromycin efter en enkel subkutan applikation af 2,5 mg pr. kg legemsvægt karakteriseret af hurtig og fuldstændigt absorption efterfulgt af en høj fordeling og langsom udskillelse.
English: Withdrawal period: Meat and offal: 22 days.
Danish: Tilbageholdelsestid: Slagtning: 22 dage.
English: Pigs.
Danish: Svin:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (20 ml / 50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas (20 ml / 50 ml)
English: In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Danish: Hos svin, var den farmakokinetiske profil af tulathromycin efter en enkel intramuskulær applikation af 2,5 mg pr. kg legemsvægt, karakteriseret af hurtig og fuldstændigt absorption efterfulgt af en høj fordeling og langsom udskillelse.
English: Cattle: SC. Pigs and sheep: IM.
Danish: Svin og får: i.m.
English: 4.11 Withdrawal period(s)
Danish: 4.11 Tilbageholdelsestider
English: Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are present for approximately 30 days after injection.
Danish: Patomorfologiske forandringer på injektionsstedet (herunder reversible ændringer af kongestion, ødemer, fibrose og blødninger) findes i omkring 30 dage efter injektion.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml / 50 ml / 100 ml / 250 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske (20 ml / 50 ml / 100 ml / 250 ml)
English: MRLs
Danish: i.m.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Danish: MÆNGDEN AF AKTIVT STOF
English: Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.
Danish: Patomorfologiske reaktioner på injektionsstedet (herunder reversible ændringer af kongestion, ødemer, fibrose og blødninger) er meget almindelige hos kvæg og svin i omkring 30 dage efter injektion.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas (50 ml )
English: EXP Shelf life after first opening the container: 28 days.
Danish: EXP Opbevaringstid efter anbrud: 28 dage.
English: Clear colourless to slightly yellow solution.
Danish: Klar, farveløs til lysegul opløsning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske (50 ml / 100 ml / 250 ml)
English: For animal treatment only.
Danish: TEKSTEN KUN TIL DYR
English: The maximum concentration (Cmax) in plasma was approximately 0.6 µg/ml; this was achieved approximately 30 minutes post-dosing (Tmax).
Danish: Den maksimale plasmakoncentration (Cmax) var ca.0,6 µg/ml.
English: The maximum concentration (Cmax) in plasma was approximately 0.5 µg/ml; this was achieved approximately 30 minutes post-dosing (Tmax).
Danish: Den maksimale plasmakoncentration (Cmax) var ca. 0,5 µg/ml.
English: Sheep (meat and offal): 16 days.
Danish: Får: Slagtning: 16 dage.
English: The volume of distribution at steady-state (VSS) determined after intravenous administration was 11 l/kg.
Danish: Fordelingsvolumen ved steady-state (Vss) bestemt efter intravenøs indgift var 11 l/kg.
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin.
Danish: Behandling og metafylakse af luftvejsinfektioner hos svin (SRD) forårsaget af Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis og Bordetella bronchiseptica følsomme for tulathromycin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (500 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske (500 ml)
English: Draxxin 100 mg/ml solution for injection for cattle tulathromycin
Danish: Draxxin 100 mg/ml, injektionsvæske, opløsning til kvæg tulathromycin
English: Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumonia, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Danish: Tulathromycin er aktivt in vitro mod Mannheimia haemolytica, Pasteurella multocida, Histophilus somni og Mycoplasma bovis, samt mod Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis og Bordetella bronchiseptica de patogen bakterier, som oftest forårsager luftvejsinfektioner hos henholdsvis kvæg og svin.
English: Cattle (meat and offal): 22 days.
Danish: Kvæg: Slagtning: 22 dage.
English: Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg.
Danish: Fordelingsvolumen ved steady-state (Vss) bestemt efter intravenøs indgift var 31,7 l/kg.
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/kg.
Danish: Fordelingsvolumen ved steady-state (Vss) bestemt efter intravenøs indgift var 13,2 l/kg.
English: Vial sizes: 50, 100 and 250 ml.
Danish: Hætteglasstørrelser: 50 ml, 100 ml og 250 ml.
English: Not for use in animals from which milk is produced for human consumption.
Danish: Må ikke anvendes til dyr, hvis mælk er bestemt til menneskeføde.
English: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin.
Danish: Behandling og metafylakse af luftvejsinfektioner hos kvæg (BRD) forårsaget af tulathromycinfølsomme Mannheimia haemolytica, Pasteurella multocida, Histophilus somni og Mycoplasma bovis.
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Danish: Draxxin 100 mg/ml, injektionsvæske, opløsning til kvæg, svin og får
English: Not authorised for use in lactating cattle producing milk for human consumption.
Danish: Må ikke anvendes til lakterende kvæg, hvis mælk er bestemt til menneskeføde.
English: 5 mg/ml For the full list of excipients, see section 6.1.
Danish: 5 mg/ml Alle hjælpestoffer er anført under pkt.
English: PACKAGE LEAFLET: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Danish: INDLÆGSSEDDEL Draxxin 100 mg/ml, injektionsvæske, opløsning til kvæg, svin og får
English: Draxxin 25 mg/ml solution for injection for pigs tulathromycin
Danish: Draxxin 25 mg/ml, injektionsvæske, opløsning til svin tulathromycin
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial (100 ml / 250 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas (100 ml / 250 ml)
English: A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Danish: En enkelt subkutan injektion med 2,5 mg tulathromycin/kg legemsvægt (svarende til 1 ml/40 kg legemsvægt).
English: Draxxin 25 mg/ml solution for injection for pigs
Danish: Draxxin 25 mg/ml, injektionsvæske, opløsning til svin
English: Meat and offal: 13 days.
Danish: Slagtning: 13 dage.
English: PACKAGE LEAFLET: Draxxin 25 mg/ml solution for injection for pigs
Danish: INDLÆGSSEDDEL Draxxin 25 mg/ml, injektionsvæske, opløsning til svin
English: Pigs (meat and offal): 13 days.
Danish: Svin: Slagtning: 13 dage.
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep Tulathromycin
Danish: Draxxin 100 mg/ml, injektionsvæske, opløsning til kvæg, svin og får tulathromycin
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep tulathromycin
Danish: Draxxin 100 mg/ml, injektionsvæske, opløsning til kvæg, svin og får Tulathromycin
English: A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) in the neck.
Danish: En enkelt intramuskulær injektion med 2,5 mg tulathromycin/kg legemsvægt (svarende til 1 ml/40 kg legemsvægt) i nakkemusklen.
English: A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/10 kg bodyweight) in the neck.
Danish: En enkelt injektion med 2,5 mg tulathromycin/kg legemsvægt (svarende til 1 ml/10 kg legemsvægt) i nakkemusklen.
English: Liver Kidney
Danish: Dyrearter MRL
English: generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux.
Danish: Resistens mod makrolider kan udvikles ved mutation i gener der koder for ribosomal RNA (rRNA) eller nogle ribosomal proteiner; ved enzymatisk modifikation (metylering) af det specifikke 23S rRNA, hvilket ofte giver krydsresistens med lincosamider og gruppe B-streptogramin (MLSB resistens); ved enzymatisk inaktivering eller ved macrolid efflux.
English: 90 (3 x 30) tablets
Danish: Filmovertrukket tablet Oral anvendelse flaske (HDPE) 90 (3 x 30) tabletter
English: 30 tablets
Danish: Filmovertrukket tablet Oral anvendelse flaske (HDPE) 30 tabletter
English: (Invented) name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Pack size
Danish: Pakningsst ørrelse
English: Annex III Amendments to relevant sections of the Product Information
Danish: Bilag III Ændringer til relevante sektioner i produktinformationen
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformation kan efterfølgende blive opdateret efter behov af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4 i direktiv 2001/83/EC.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Danish: Den eksisterende produktinformation skal ændres (enten ved indsætning, udskiftning eller sletning af tekst) for at afspejle nedenstående vedtagede ordlyd.
English: Administration of <invented name and strength(s)> should be stopped, and the patient's condition should be treated accordingly.
Danish: Administration af < Lægemidlets (sær)navn styrke(r)> bør stoppes, og patientens tilstand bør behandles efter omstændighederne.
English: In case of combined package leaflet with strength(s) not included in Annex I, the strength(s) of products in Annex I should be specified in the subheading above]
Danish: I tilfælde af sammenlagt indlægsseddel med styrke(r), der ikke er inkluderet i Bilag I, skal styrken af produkterne i bilag I specificeres i den ovenstående overskrift]
English: 4.3 Contraindications [The following contraindication should be included]
Danish: 4.3 Kontraindikationer [Den følgende kontraindikation skal inkluderes]
English: Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions.
Danish: Kontakt lægen eller apotekspersonalet eller sundhedspersonalet, før <De> <du> <tager> {X}, hvis du har nogen af følgende tilstande.
English: Serious allergic reactions have occurred in patients allergic to cow's milk.
Danish: Alvorlige allergiske reaktioner er forekommet hos patienter med mælkeallergi.
English: Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions.
Danish: Der er blevet rapporteret alvorlige allergiske reaktioner, inklusive bronkospasmer og anafylaksi, hos patienter med allergi over for mælkeproteiner, og som blev behandlet for akutte allergiske reaktioner.
English: If you are allergic or suspected to be allergic to cow's milk.
Danish: Hvis du har allergi eller har formodet allergi over for mælk.
English: <Invented name and strength(s)> contains lactose <monohydrate> produced from bovine origin as an excipient and may therefore contain trace amounts of cow's milk proteins (the allergens of cow's milk).
Danish: < Lægemidlets (sær)navn styrke(r)> indeholder hjælpestoffet laktose<monohydrat> fremstillet fra kvæg og kan derfor indeholde spor af mælkeproteiner (allergener fra komælk).
English: Allergic reactions to cow's milk proteins should be considered in patients receiving <invented name and strength(s)> for the treatment of acute allergic conditions in whom symptoms worsen or who are presenting new allergic symptoms (see section 4.3).
Danish: Allergiske reaktioner over for mælkeproteiner bør overvejes hos patienter, der får < Lægemidlets (sær)navn styrke(r)> til behandling af akutte allergiske reaktioner, hvor deres symptomer forværres, eller hvis de udviser nye allergiske symptomer (se punkt 4.3).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS