FrancophonIA/ELRC3.0 huggingface dataset:
English: Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs
Danish: Activyl Tick Plus 75 mg + 240 mg spot-on, opløsning, til miniaturehunde Activyl Tick Plus 150 mg + 480 mg spot-on, opløsning, til små hunde Activyl Tick Plus 300 mg + 960 mg spot-on, opløsning, til mellemstore hunde Activyl Tick Plus 600 mg + 1920 mg spot-on, opløsning, til store hunde Activyl Tick Plus 900 mg + 2880 mg spot-on, opløsning, til ekstra store hunde
English: Activyl Tick Plus for very small dogs Activyl Tick Plus for small dogs Activyl Tick Plus for medium dogs Activyl Tick Plus for large dogs Activyl Tick Plus for extra large dogs The appropriate combination of pipettes should be used
Danish: 1,2 - 5 Activyl Tick Plus til miniaturehunde 5,1 - 10 Activyl Tick Plus til små hunde 10,1 - 20 Activyl Tick Plus til mellemstore hunde 20,1 - 40 Activyl Tick Plus til store hunde 40,1 - 60 Activyl Tick Plus til ekstra store hunde > 60 Den passende kombination af ovenstående pipetter bør anvendes
English: Do not apply an excessive amount of solution at any one spot in order to prevent run-off. Should run-off occur, re-application is not necessary.
Danish: Undgå at påføre for meget af produktet på et enkelt sted for at sikre, at det ikke løber.
English: One unit-dose pipette holds 0.5 ml, 1 ml, 2 ml, 4 ml, or 6 ml spot-on solution.
Danish: Hver enkeltdosispipette indeholder 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml spot-on, opløsning.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Opbevar pipetterne i den originale emballage indtil brug.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For spot-on use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Snap the tip open by bending it and folding it back on itself.
Danish: Pipetten åbnes ved at bøje toppen af spidsen bagover og ned.
English: TARGET SPECIES
Danish: DYREARTER
English: Cardboard box of 4 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Danish: Æske med 4 pipetter indeholdende 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml.
English: Cardboard box of 6 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Danish: Æske med 6 pipetter indeholdende 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml.
English: Cardboard box of 1 pipette of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Danish: Æske med 1 pipette indeholdende 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml.
English: Ticks
Danish: Flåter
English: DANGER - Do not use in cats
Danish: Advarsel: Må ikke anvendes til katte.
English: Special warnings for each target species:
Danish: Særlige forholdsregler til brug hos dyr:
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: Before having an operation
Danish: Før en operation
English: Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
Danish: Dato for første markedsføringstilladelse: 22. januar 2001 Dato for seneste fornyelse: 29. november 2010
English: This can be due to the high dosages usually used in this population.
Danish: Dette kan skyldes de høje doser, der normalt er anvendt hos denne population.
English: Injections should be repeated as required to maintain good function and minimise pain.
Danish: Injektioner bør gentages efter behov for at bibeholde god funktion og minimere smerter.
English: The risk of spreading of effect is greater than in adults, and more frequently severe.
Danish: Risikoen for spredning af virkning er større end hos voksne og hyppigere alvorlig.
English: On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Danish: På disse skalaer angiver en score på 50 ingen ændring, 0 meget værre og 100 meget bedre.
English: The risks, which can include death, may outweigh the potential benefits.
Danish: Risici, som kan omfatte dødsfald, kan opveje de mulige fordele.
English: The frequency of these side effects is not known.
Danish: Hyppigheden af disse bivirkninger er ikke kendt.
English: Results of comparisons of the primary and secondary efficacy variables are summarised in Table 1.
Danish: Resultater af sammenligninger mellem de primære og sekundære effektvariabler er opsummeret i tabel 1.
English: 5 years, as packaged for sale.
Danish: 5 år i salgspakningen.
English: STUDY 2 (A-Responsive Patients)
Danish: UNDERSØGELSE 2 (A-Responsive patienter)
English: General precaution:
Danish: Generel forsigtighedsregel:
English: The available reports indicate that the product has been used in the paediatric population.
Danish: De tilgængelige rapporter indikerer, at præparatet er blevet anvendt hos den pædiatriske population.
English: Patient evaluations continued for 16 weeks post injection.
Danish: Patientevalueringer fortsatte i 16 uger post injektion.
English: Cases of overdose (some with signs of systemic toxicity) have been reported.
Danish: Tilfælde af overdosering (nogle med tegn på systemisk toksicitet) er indberettet.
English: In the event of an overdose, general medical supportive measures should be instituted.
Danish: I tilfælde af en overdosis skal der iværksættes generelle lægelige foranstaltninger.
English: However, the pharmacological characteristics do not indicate any need to adjust the dose.
Danish: De farmakologiske egenskaber angiver dog ikke noget behov for at justere dosen.
English: There were 77 subjects enrolled into the first study and 109 subjects into the second.
Danish: Der var tilmeldt 77 forsøgspersoner i den første undersøgelse og 109 forsøgspersoner i den anden.
English: You may feel pain at the place where you had the injection, but this should wear off after a few minutes.
Danish: De kan have smerter på det sted, hvor De har fået indsprøjtningen, men disse bør fortage sig efter et par minutters forløb.
English: Very Common
Danish: Meget almindelig
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette forekommer, må De ikke køre bil eller arbejde med værktøj eller maskiner.
English: You may need urgent medical treatment.
Danish: De kan have behov for akut medicinsk behandling.
English: P-Value* * Analysis of covariance, two-tailed tests, a = 0.05
Danish: P-Værdi* * Analyse af kovarians, to-grenede prøver, a = 0,05
English: Elderly No dose adjustment is required in older people ≥ 65 years of age.
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre personer ≥ 65 år.
English: Wear waterproof gloves and soak up the liquid with an appropriate absorbent.
Danish: Brug vandtætte handsker og absorbér væsken med et hensigtsmæssigt absorberingsmiddel.
English: They may happen days to weeks after you have had the injection.
Danish: De kan forekomme dage til uger, efter at De har fået indsprøjtningen.
English: You must not be given NeuroBloc if any of the above applies to you.
Danish: De må ikke få NeuroBloc hvis noget af det ovenstående gælder for Dem.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> Other sources of information
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}> Andre informationskilder
English: Table 1 Efficacy Results from Phase III NeuroBloc Studies STUDY 1 (A-Resistant Patients)
Danish: Tabel 1 Effektresultater fra fase III NeuroBloc undersøgelser UNDERSØGELSE 1 (A-Resistente patienter)
English: Recovery usually takes place over a period of time.
Danish: Der ses normalt bedring efter et stykke tid.
English: Luxembourg
Danish: Luxemburg
English: If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
Danish: Hvis De mener, at virkningen af NeuroBloc er for kraftig eller for svag, bør De tale med Deres læge herom.
English: Specifically, these studies showed approximately 19-25% seroconverted within 18 months of initiation of treatment, increasing to approximately 33-44% with up to 45 months of treatment.
Danish: Specielt viste disse undersøgelser ca. 19-25 % serokonversion inden for 18 måneder fra behandlingens påbegyndelse; dette forøgedes til ca. 33-44 % med op til 45 måneders behandling.
English: Restricted to hospital use only.
Danish: Begrænset kun til hospitalsanvendelse.
English: In these studies, the average dosing frequency was approximately every 12 weeks.
Danish: I disse undersøgelser var den gennemsnitlige doseringshyppighed ca. hver 12. uge.
English: The total dose was divided between the selected muscles and 1 to 5 injections per muscle were administered.
Danish: Den totale dosis blev opdelt mellem de valgte muskler, og 1-5 injektioner pr. muskel blev administreret.
English: Justification for not including Braille accepted.
Danish: Begrundelse for ikke at inkludere brailleskrift accepteret.
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development.
Danish: Data fra reproduktionsforsøg med dyr er utilstrækkelige hvad angår virkningerne på graviditet og den embryonale/føtale udvikling.
English: Mean at Week 4 P-Value*
Danish: Middel ved uge 4 P-Værdi*
English: The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: INSTRUKTIONER VEDRØRENDE ANVENDELSE, HÅNDTERING OG BORTSKAFFELSE
English: This means it is essentially “sodium free”.
Danish: Det betyder, at det er i det væsentlige natrium-frit.
English: The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.
Danish: Doseringshyppigheden bør derfor tilpasses, baseret på klinisk bedømmelse/respons af den enkelte patient.
English: The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/kg.
Danish: Det blev påvist, at det systemiske ikke-observerede effektniveau (NOEL) var ca. 960 E/kg.
English: The safety of NeuroBloc outside the approved indication has not been established.
Danish: Neuroblocs sikkerhed uden for den godkendte indikation er ikke klarlagt.
English: Mean at Week 4
Danish: Middel ved uge 4
English: The immunogenicity of NeuroBloc has been evaluated in two clinical studies and an open-label extension study.
Danish: NeuroBlocs immunogenicitet er blevet vurderet i to kliniske undersøgelser samt en forlængelsesundersøgelse med åben etiket.
English: The medicinal product is ready to use and no reconstitution is required.
Danish: Lægemidlet er klar til brug og ingen fortynding er nødvendig.
English: It is possible that cervical dystonia could become worse after you have had your injection.
Danish: Det er muligt, at cervikal dystoni kan blive værre, efter at De har fået indsprøjtningen.
English: Seroconversion
Danish: Serokonversion
English: Read package leaflet for special precautions for handling, in-use storage and disposal.
Danish: Læs indlægssedlen for særlige forholdsregler for håndtering, opbevaring under brug og bortskaffelse.
English: However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Danish: Der er dog ikke udført farmakokinetiske undersøgelser eller absorptions-, distributions-, stofskifte- og eliminations- (ADME-) undersøgelser.
English: Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Danish: Doser på indtil 15.000 enheder har i sjældne tilfælde medført klinisk signifikant systemisk toksicitet hos voksne.
English: For patients with reduced muscle mass the dose should be adjusted according to individual patient need.
Danish: Til patienter med reduceret muskelmasse bør dosen justeres i henhold til den enkelte patients behov.
English: Case reports are more likely to be serious in children (40%) compared to those in adults and older people (12%), possibly as a result of using an inappropriately high dosage for the child (see section 4.9).
Danish: Det er mere sandsynligt, at bivirkningsrapporter fra børn er alvorlige (40 %), sammenlignet med rapporter fra voksne og ældre personer (12 %), muligvis som et resultat af anvendelse af en upassende høj dosis til barnet (se pkt.
English: Placebo 10,000 U Placebo 5000 U 10,000 U
Danish: Placebo 10.000 E Placebo 5.000 E 10.000 E
English: These include dysphagia and breathing difficulties.
Danish: Disse omfatter dysfagi og vejrtrækningsbesvær.
English: Spread of toxin effect
Danish: Virkning fra spredning af toksin
English: Once diluted, the medicinal product must be used immediately as the formulation does not contain a preservative.
Danish: Efter fortynding skal lægemidlet bruges omgående, da præparatet ikke indeholder et konserveringsmiddel.
English: No fertility studies have been performed and it is not known whether NeuroBloc can affect reproduction capacity.
Danish: Der er ikke blevet udført fertilitetsundersøgelser, og det er ukendt, om NeuroBloc kan påvirke reproduktionsevnen.
English: Adverse reactions seen in all clinical studies are listed below according to MedDRA system organ class and in decreasing frequency which is defined as follows: Very Common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1000 to <1/100).
Danish: Bivirkninger, der forekom i alle kliniske undersøgelser, er angivet nedenfor i systemorganklasser i henhold til MedDRA-konventionen og i aftagende hyppighed, som er defineret på følgende måde: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1000 til <1/100).
English: Vials should be visually inspected prior to use.
Danish: Hætteglassene bør undersøges visuelt inden brug.
English: The presence of antibodies in these studies was assessed using the mouse protection assay (also known as the Mouse Neutralization Assay, MNA).
Danish: Tilstedeværelsen af antistoffer i disse undersøgelser blev vurderet vha. beskyttelsesassays for mus (også kaldet Mouse Neutralization Assay, MNA).
English: Further clinical studies and open label follow-up have shown that subjects can continue to respond to NeuroBloc for prolonged periods of time, with some subjects receiving more than 14 treatment sessions over a period of more than 3.5 years.
Danish: Yderligere kliniske undersøgelser og opfølgning med åben etiket har vist, at forsøgspersoner kan fortsætte med at respondere på NeuroBloc i længere tidsperioder, hvor nogle forsøgspersoner fik mere end 14 behandlingssessioner over en periode på mere end 3,5 år.
English: The primary efficacy outcome variable for both studies was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score (range of possible scores is 0-87) at Week 4.
Danish: Den primære effektresultatsvariabel for begge undersøgelser var det totale score på Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (muligt scoreområde er 0-87) i uge 4.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: In the event of an overdose or injection into a muscle that normally compensates for the cervical dystonia, it is conceivable that the dystonia may worsen.
Danish: I tilfælde af en overdosis eller injektion i en muskel, der normalt kompenserer for cervikal dystoni, er det muligt, at dystonien vil blive forværret.
English: The mechanism by which muscle paralysis is reversed over time remains unknown, but may be associated with the intraneuronal turnover of the affected protein and/or sprouting of the nerve ending.
Danish: Mekanismen, hvorved muskelparalysen i tidens løb reverseres, er stadig ukendt, men kan være forbundet med den intraneuronale omdannelse af det påvirkede protein og/eller fremskydning af nerveenden.
English: Development studies in rats and rabbits have shown no evidence of foetal malformations or changes to fertility.
Danish: Udviklingsforsøg med rotter og kaniner har ikke vist tegn på misdannelse af fosteret eller ændringer i fertiliteten.
English: The dose resulting in death was 2400 U/kg.
Danish: Det blev påvist, at dosen, som medførte dødelighed, var ca. 2400 E/kg.
English: This warning includes use in children and in any other indication besides cervical dystonia.
Danish: Denne advarsel omfatter anvendelse til børn og til andre indikationer end cervikal dystoni.
English: Pre-Existing neuromuscular disorders
Danish: Eksisterende neuromuskulære sygdomme
English: Very common (may affect more than 1 in 10 people) dry mouth difficulty swallowing headache
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) mundtørhed synkebesvær hovedpine
English: Paediatric use (non approved): in children, clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Danish: Pædiatrisk anvendelse (ikke-godkendt): hos børn er klinisk signifikant systemisk toksicitet indtruffet ved doser, der er godkendt til behandling af voksne patienter.
English: Intramuscular use.
Danish: Intramuskulær anvendelse.
English: NeuroBloc is not to be used in children aged less than18 years.
Danish: NeuroBloc må ikke anvendes til børn under 18 år.
English: The secondary endpoints included Visual Analogue Scales (VAS) to quantify the Patient Global Assessment of change and the Physician Global Assessment of change, both from baseline to Week 4.
Danish: De sekundære endpoints inkluderede visuelle analoge skalaer (VAS) til at kvantificere patientens globale vurdering af ændringen og lægens globale vurdering af ændringen, begge fra basislinie til uge 4.
English: Because of the nature of the product, no animal studies have been carried out to establish the carcinogenic effects of NeuroBloc.
Danish: På grund af præparatets beskaffenhed, er der ikke blevet udført dyreforsøg for at fastslå NeuroBlocs carcinogene virkninger.
English: Following NeuroBloc treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.
Danish: Efter NeuroBloc-behandling bør alle patienter samt plejepersonale rådes til at søge lægehjælp, hvis der optræder åndedrætsbesvær, kvælning eller ny eller forværret dysfagi.
English: Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.
Danish: Data fra kliniske undersøgelser tyder på, at effekten er dosisafhængig, men da disse undersøgelser ikke havde styrke til en sammenligning, viser de ikke en signifikant forskel mellem 5000 E og 10.000 E. En initialdosis på 5000 E kan derfor også overvejes, men en dosis på 10.000 E kan øge sandsynligheden for klinisk udbytte.
English: This is because swallowing problems could make you breathe food or liquids into your lungs, which could then cause very serious pneumonia
Danish: Dette skyldes, at synkeproblemer kan få Dem til at få mad eller væske ned i lungerne, når De trækker vejret, hvilket kan medføre meget alvorlig lungebetændelse.
English: The safety of NeuroBloc when used to treat other conditions is not known: some side effects may be fatal.
Danish: Neuroblocs sikkerhed ved behandling af andre tilstande er ukendt, nogle bivirkninger kan være dødelige.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are given NeuroBloc.
Danish: Hvis De er i tvivl om, at noget af det ovenstående gælder for Dem, skal De tale med lægen eller på apoteket, før De får NeuroBloc.
English: Pack size of 1.
Danish: Pakningsstørrelse på 1 stk.
English: NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc.
Danish: NeuroBloc indeholder mindre end 1 mmol (23 mg) natrium pr. 10.000 enheder NeuroBloc.
English: NeuroBloc should not be used during pregnancy unless the clinical condition of the woman requires treatment with Botulinum Toxin Type B (see section 5.3).
Danish: NeuroBloc bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med botulismetoksin type B (se pkt.
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of the date at which the medicine was taken out from the refrigerator will be put on the outer carton if the medicine is diluted, the doctor will use it immediately before using the medicine the doctor will check that the solution is clear and colourless/light yellow.
Danish: Ved slutningen på denne periode må produktet ikke sættes på køl igen og skal bortskaffes den dato, hvor medicinen tages ud af køleskabet, vil anføres på den ydre karton hvis medicinen er fortyndet, vil lægen omgående anvende den før opløsningen anvendes vil lægen kontrollere, at opløsningen er klar og farveløs/lysegul.
English: The medicinal product was injected on a single occasion into 2 to 4 of the following muscles: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus and scalene.
Danish: Lægemidlet blev injiceret ved en enkelt lejlighed i 2- 4 af følgende muskler: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus og scalene.
English: If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored.
Danish: Hvis Deres læge har mistanke om, at botulisme kan have opstået, vil De blive indlagt på hospitalet, og Deres vejrtrækning (respiratorisk funktion) vil blive overvåget.
English: As with other botulinum toxins spontaneous recovery will occur over a period of time.
Danish: Som for andre botulismetoksiner vil spontan helbredelse indtræde i løbet af en periode.
English: Two Phase III randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
Danish: To fase III randomiserede, multicenter, dobbeltblinde, placebo-kontrollerede undersøgelser er blevet udført hos patienter med cervikal dystoni.
English: Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Danish: Patienter behandlet med terapeutiske doser kan opleve forøget muskelsvaghed.
English: Pharmacotherapeutic group: muscle relaxant, peripherally acting agents, ATC code: M03AX 01.
Danish: Farmakoterapeutisk klassifikation: perifert virkende muskelrelaksantia, ATC-kode: M03AX 01.
English: If you are going to have an operation, please tell your doctor that you have been given NeuroBloc.
Danish: Hvis De skal opereres, bør De fortælle lægen, at De har fået NeuroBloc.
English: The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established.
Danish: NeuroBlocs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: A serious condition called “botulism” which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body.
Danish: En alvorlig tilstand, som kaldes “botulisme”, og som forårsager muskellammelse og åndedrætsstop, kan forekomme, hvis for meget af det aktive stof (botulismetoksin) indsprøjtes i kroppen.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: aminoglycoside antibiotics for an infection medicines to stop blood clotting, such as warfarin
Danish: Fortæl det især til lægen eller på apoteket, hvis De tager noget af den følgende medicin: aminoglycosid antibiotika for en infektion medicin til at stoppe størkning af blod, såsom warfarin