FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 measuring syringe.
Danish: 1 doseringssprøjte.
English: Due to the mode of action of the veterinary medicinal product, transient hypotension may occur.
Danish: På grund af produktets virkningsmekanisme kan der forekomme forbigående hypotension.
English: Carton for 35 ml
Danish: Karton til 35 ml
English: Very limited data are available regarding interactions in cats with hypertension between telmisartan and other medicinal products that lower blood pressure (such as amlodipine) or interfere with RAAS (such as ARBs or ACEis).
Danish: Der er meget begrænsede data tilgængelige vedrørende interaktioner mellem telmisartan og andre lægemidler, der nedsætter blodtrykket (såsom amlodipin) eller som påvirker RAAS (såsom ARB eller ACEi) hos katte med hypertension.
English: As known from substances acting on the Renin-Angiotensin-Aldosterone System (RAAS), a slight decrease in red blood cell count may occur.
Danish: Det er kendt at lægemidler, der indvirker på renin-angiotensin-aldosteron-systemet (RAAS), kan medføre et lille fald i antallet af røde blodlegemer.
English: Effects attributable to the pharmacological activity of the product observed at the recommended treatment dose included reductions in blood pressure and decreases in red blood cell counts.
Danish: Virkningerne, som kan tilskrives farmakologisk aktivitiet af produktet ved den anbefalede behandlingsdosis, omfatter blodtryksreduktion og fald i antal af røde blodlegemer.
English: During concomitant therapy with amlodipine at the recommended dose, no clinical evidence of hypotension was observed.
Danish: Ved samtidig behandling med amlodipin ved anbefalet dosering er der ikke observeret kliniske tegn på hypotension.
English: Effects observed at the recommended treatment dose included mild decreases in red blood cell counts.
Danish: Virkningerne observeret ved den anbefalede behandlingsdosis, omfatter let fald i antal røde blodlegemer.
English: During concomitant therapy with amlodipine at the recommended dose for the reduction of proteinuria associated with chronic kidney disease (CKD) in cats no clinical evidence of hypotension was observed.
Danish: Ved samtidig behandling med amlodipin ved anbefalet dosering til reduktion af proteinuria associeret med kronisk nyresygdom (CKD) hos katte er der ikke observeret kliniske tegn på hypotension.
English: In the event that hypotension (low blood pressure) does occur, symptomatic treatment, e.g. fluid therapy, should be provided.
Danish: I tilfælde af hypotension (for lavt blodtryk) bør der gives symptomatisk behandling, f.eks. væsketerapi.
English: Interaction with other medicinal products and other forms of interaction During concomitant therapy with amlodipine at the recommended dose no clinical evidence of hypotension was observed.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Ved samtidig behandling med amlodipin ved anbefalet dosering er der ikke observeret kliniske tegn på hypotension.
English: Excipients: Benzalkonium chloride 0.1 mg
Danish: Hjælpestoffer: Benzalkoniumklorid 0,1 mg
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr I tilfælde af indgift ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Pack size of one plastic bottle filled with 35 ml and one measuring syringe.
Danish: Pakningsstørrelse med en plastikflaske fyldt med 35 ml og en doseringsprøjte.
English: Pack size of one bottle and one measuring syringe.
Danish: Pakningsstørrelse med en flaske og en doseringsprøjte.
English: 1 measuring syringe
Danish: 1 doseringssprøjte
English: If SBP is below the target or if there are concurrent signs of hypotension, please refer to section 4.5.
Danish: Hvis SBT ligger under det ønskede interval, eller hvis der er aktuelle tegn på hypotension, henvises til pkt.
English: In the event that hypotension does occur, symptomatic treatment, e.g. fluid therapy, should be provided.
Danish: I tilfælde af hypotension bør der gives symptomatisk behandling, f.eks. væsketerapi.
English: Date of first authorisation: Date of last renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse af markedsføringstilladelse: 16.01.2018
English: Bottle for 100 ml
Danish: Plasticflaske, 100 ml
English: Bottle for 30 ml
Danish: Plasticflaske, 30 ml
English: Turn the bottle/syringe upside down.
Danish: Vend bunden i vejret på flasken/sprøjten.
English: Bottle for 35 ml
Danish: Plasticflaske, 35 ml
English: The dosing regimen for hypertensive cats with concomitant chronic kidney disease is as described above except that for these cats the recommended minimum effective dose is 1 mg/kg.
Danish: Dog gælder for disse katte, at den anbefalede lavest effektive dosis er 1 mg/kg.
English: One ml contains: Telmisartan
Danish: En ml indeholder Telmisartan
English: After administration of up to 2.5 times the initial recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section 4.6.
Danish: Efter administration af op til 2,5 gange den initialt anbefalede dosis i 6 måneder til unge voksne, raske katte observeredes bivirkninger i overensttemmelse med de, der er nævnt i punkt 4.6.
English: After administration of up to 5 times the recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section 4.6.
Danish: Efter administration af op til 5 gange den anbefalede dosis i 6 måneder til unge voksne, raske katte observeredes bivirkninger i overensttemmelse med de, der er nævnt i punkt 4.6 .
English: PACKAGE LEAFLET: Semintra 10 mg/ml oral solution for cats
Danish: INDLÆGSSEDDEL: Semintra 10 mg/ml oral opløsning til katte
English: PACKAGE LEAFLET: Semintra 4 mg/ml oral solution for cats
Danish: INDLÆGSSEDDEL: Semintra 4 mg/ml oral opløsning til katte
English: Semintra 10 mg/ml oral solution for cats
Danish: Semintra 10 mg/ml oral opløsning til katte
English: Semintra 4 mg/ml oral solution for cats
Danish: Semintra 4 mg/ml oral opløsning til katte
English: Administration of the product at overdose (up to 2.5 times the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN).
Danish: Administration af produktet med overdosering (op til 2,5 gange den anbefalede dosis i 6 måneder) resulterede i markant fald i blodtryk, fald i antallet af røde blodlegemer (virkning der kan henføres til den farmakologiske aktivitet af produktet) og en stigning i Blod-Urea-Nitrogen (BUN).
English: Administration of the product at overdose (3 to 5 times of the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN).
Danish: Administration af produktet ved overdosering (3 til 5 gange den anbefalede dosis i 6 måneder) resulterede i markante fald i blodtryk, fald i antallet af røde blodlegemer (effekter der kan henføres til den farmakologiske aktivitet af produktet) og en stigning i Blod-Urea-Nitrogen (BUN).
English: Symptomatic treatment, e.g. fluid therapy, should be provided in case of any clinical signs of hypotension.
Danish: I ethvert tilfælde af kliniske tegn på hypotension bør der gives symptomatisk behandling, f.eks. væsketerapi.
English: Semintra 10 mg/ml oral solution for cats Telmisartan
Danish: Semintra 10 mg/ml oral opløsning til katte Telmisartan
English: Overdose (symptoms, emergency procedures, antidotes) After administration of up to 2.5 times the initial recommended dose for 6 months to young adult healthy cats, adverse reactions were consistent with those mentioned in section “Adverse reactions”.
Danish: Efter administration af op til 2,5 gange den initialt anbefalede dosis i 6 måneder til unge voksne, raske katte var bivirkningerne i overensstemmelse med de, der er nævnt i afsnittet ”Bivirkninger”.
English: Semintra 4 mg/ml oral solution for cats Telmisartan
Danish: Semintra 4 mg/ml oral opløsning til katte telmisartan
English: Semintra 4 mg/ml oral solution for cats telmisartan
Danish: Semintra 4 mg/ml oral opløsning til katte Telmisartan
English: Incompatibilities
Danish: INDIKATIONER
English: Use entire content.
Danish: Brug hele indholdet.
English: The condition may manifest itself as an insufficient clinical response.
Danish: Tilstanden kan manifestere sig som utilstrækkeligt klinisk respons.
English: Make sure that no blood enters the syringe.
Danish: Sørg for, at der ikke kommer blod ind i sprøjten.
English: Distribution and elimination
Danish: Distribution og elimination
English: Overall, 9 out of 60 (15%) developed inhibitors.
Danish: I alt 9 ud af 60 (15%) udviklede inhibitorer.
English: Fertility There are no fertility data available.
Danish: Fertilitet Fertilitetsdata er ikke tilgængelige.
English: Follow the directions given by your doctor closely and use the instructions below as a guide:
Danish: Følg din læges anvisninger nøje og brug vejledningen nedenfor som en rettesnor:
English: Rarely, inhibitors may develop after the first 100 exposure days.
Danish: I sjældne tilfælde kan inhibitorer udvikles efter de første 100 eksponeringsdage.
English: Not known: frequency cannot be estimated from the available data
Danish: Hyppigheden kan ikke vurderes ud fra tilgængelige data
English: • This medicine must not be mixed with other infusion solutions.
Danish: • Dette lægemiddel må ikke blandes med andre infusionsvæsker.
English: The risk of developing inhibitors is correlated to the exposure to factor VIII and to genetic factors among others, this risk being highest within the first 20 exposure days.
Danish: Risikoen for at udvikle inhibitorer er bl.a. forbundet med eksponeringen for faktor VIII og genetiske faktorer og er størst inden for de første 20 eksponeringsdage.
English: • Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Danish: • Brug altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens eller apotekspersonalets anvisning.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabel over bivirkninger Tabellen nedenfor er i henhold til MedDRA-systemorganklassifikationen (SOC og foretrukket term).
English: Finally, apply a small pressure dressing to the wound.
Danish: Til slut lægges en lille kompressionsforbinding på såret.
English: Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Danish: Varm begge uåbnede hætteglas i hænderne til en behagelig temperatur (højst 37 °C).
English: Overall list of possible side effects:
Danish: Samlet liste over bivirkninger:
English: One patient was lost to follow up and one patient developed a low-titre inhibitor during post study follow-up.
Danish: En patient var tabt for opfølgning, og en patient udviklede en inhibitor med lav titer under opfølgningen efter studiet.
English: 100 % (1 IU/ml) 60 % (0.6 IU/ml) 40 % (0.4 IU/ml)
Danish: 100% (1 IE/ml) 60% (0,6 IE/ml) 40% (0,4 IE/ml)
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 ml syringe - 2 alcohol swabs for single use
Danish: • En yderligere pakke med: - 1 filtersystem til overførsel af lægemidlet 20/20 [Mix2Vial] - 1 venepunktursæt - 1 engangssprøjte (5 ml) - 2 spritservietter til engangsbrug
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Danish: Derfor anbefales det at overvåge alle patienter omhyggeligt for forekomst af inhibitorer efter skift af lægemiddel.
English: Helixate NexGen should be reconstituted and administered with the components provided with each package.
Danish: Helixate NexGen skal rekonstitueres og administreres ved hjælp af de komponenter, der leveres i hver pakning.
English: Example for calculation of infusion rate for continuous infusion after initial bolus injection
Danish: Eksempel til udregning af infusionshastighed ved kontinuerlig infusion efter initial bolusinjektion Ønsket
English: In patients where immune tolerance was achieved the bleedings could be prevented or controlled with Helixate NexGen again, and the patients could continue with prophylactic treatment as maintenance therapy.
Danish: Hos patienter, hvor immuntolerans blev opnået, kunne blødningerne igen forhindres eller kontrolleres med Helixate NexGen, og patienten kunne fortsætte med profylaktisk behandling som vedligeholdelsesbehandling.
English: However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion".
Danish: Men i in vitro-studier er kemisk og fysisk stabilitet under brug blevet påvist i 24 timer ved 30 °C i PVC-poser til kontinuerlig infusion.
English: Data show that Helixate NexGen has been used to induce immune tolerance.
Danish: Data viser, at Helixate NexGen er blevet anvendt til at inducere immuntolerans.
English: Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog).
Danish: Selv doser, der er adskillige gange større end den anbefalede kliniske dosis (relateret til legemsvægt) viste ingen akutte eller subakutte toksiske virkninger for Helixate NexGen hos dyr (mus, rotter, kaniner og hunde).
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Danish: • Hvis du har fået at vide, at du har en hjertesygdom, eller du har risiko for at få en hjertesygdom, skal du fortælle det til lægen eller apotekspersonalet.
English: No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Danish: Der er ikke foretaget studier af Helixate NexGen's mutagene potentiale, eftersom der ikke kunne detekteres noget mutagent potentiale in vitro eller in vivo for forgængeren til Helixate NexGen.
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Danish: Hold sprøjten opad, og tryk på stemplet, indtil der ikke er mere luft i sprøjten.
English: Duration of treatment Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Danish: Din læge vil fortælle dig, hvor ofte og med hvilke intervaller behandling med dette lægemiddelskal foretages.
English: Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Danish: Din læge vil beregne den dosis af lægemidlet, du skal have, og hvor hyppigt du skal bruge det, for at få den nødvendige faktor VIII-aktivitet i blodet.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Danish: Generelt skal alle patienter, der behandles med rekombinant koagulationsfaktor VIII-præparater, nøje overvåges for udvikling af inhibitorer ved passende kliniske observationer og laboratorieundersøgelser.
English: PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below
Danish: TUP'er = tidligere ubehandlede patienter TBP'er = tidligere behandlede patienter MBP'er = minimalt behandlede patienter * Se afsnittet nedenfor.
English: The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII.
Danish: Graden og varigheden af normaliseringen af aPTT, der er observeret efter indgift af Helixate NexGen, svarer til det, der kan opnås med plasmaderiveret faktor VIII.
English: For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 ml/h/kg) and then adjust accordingly.
Danish: Til beregning af den initiale indgiftshastighed kan clearance opnås ved at foretage en præoperativ henfaldskurve eller ved at begynde med en gennemsnitlig populationsværdi (3,0-3,5 ml/time/kg), og derefter justere i overensstemmelse hermed.
English: Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Danish: Eksempel: Ved en patient, der vejer 75 kg og har en clearance på 3 ml/time/kg, vil den initiale infusionstighed være 3 IE/time/kg for at opnå et FVIII-niveau på 100%.
English: • Your doctor may carry out tests to ensure that your current dose of this medicine provides adequate factor VIII levels.
Danish: • Din læge ønsker måske at foretage undersøgelser for at sikre, at din nuværende dosis af dette lægemiddel er tilstrækkelig til, at der kan opnås et tilstrækkeligt niveau af faktor VIII (koagulationsfaktor).
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Danish: Hos patienter med et højt inhibitor-niveau kan det forekomme, at behandling med faktor VIII ikke er effektiv, og andre behandlingsmuligheder skal overvejes.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Danish: Gentag infusionen hver 12.-24. time i 3-4 dage eller mere, indtil smerte og funktionsnedsættelse er forsvundet.
English: Only the provided administration sets can be used because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Danish: Anvend kun det medfølgende administrationsudstyr, da behandlingssvigt kan forekomme som følge af adsorption af human rekombinant koagulationsfaktor VIII til den indre overflade af visse infusionssæt.
English: The safety and efficacy of Helixate NexGen in children of all ages have been established.
Danish: Helixate NexGens sikkerhed og virkning hos børn i alle aldre er klarlagt.
English: Each package of Helixate NexGen contains:
Danish: Hver pakke med Helixate NexGen indeholder:
English: a) By bolus infusions Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Danish: a) Ved bolusindgifter Gentag indgiften hver 8.-24. time, indtil der er opnået en passende sårheling, Fortsæt derefter behandlingen i yderligere mindst syv dage for at opretholde en faktor VIII-aktivitet på 30-60% (IE/dl).
English: The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for Helixate NexGen.
Danish: Analysen af alle registrerede in vivo-bedringer hos tidligere behandlede patienter viste en middel stigning på 2% pr. IE/kg legemsvægt for Helixate NexGen.
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Danish: Sørg for kun at fjerne blisterpakningen og ikke Mix2Vial-sættet.
English: The vial contains a dry white to slightly yellow powder or cake, as well as water for injections to be used to reconstitute the contents of the vial.
Danish: Hætteglasset indeholder et tørt, hvidt til svagt gult pulver eller en pulverkage, samt vand til injektionsvæsker, der skal anvendes til at rekonstituere indholdet i hætteglasset.
English: The specific activity of Helixate NexGen is approximately 4000 IU/mg protein.
Danish: Helixate NexGen specifikke aktivitet er omtrent 4000 IE/mg protein.
English: Helixate NexGen can be infused by continuous infusion.
Danish: Helixate NexGen kan infunderes ved kontinuerlig infusion.
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 exposure days.
Danish: 5 ud af 37 (14%) TUP-patienter og 4 ud af 23 (17%) MBP-patienter, som blev behandlet med Helixate NexGen, udviklede inhibitorer inden for 20 eksponeringsdage.
English: No interactions of Helixate NexGen with other medicinal products have been reported.
Danish: Der er ikke rapporteret interaktioner mellem Helixate NexGen og andre lægemidler.
English: Animal reproduction studies have not been conducted with Helixate NexGen.
Danish: Der er ikke gennemført reproduktionsstudier på dyr med Helixate NexGen.
English: Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Danish: Fastsættelse af den aktiverede partielle tromboplastintid (aPTT) er en konventionel in vitro analysemetode for faktor VIII's biologiske aktivitet.
English: Do not use solutions containing visible particles or that are cloudy.
Danish: Anvend ikke opløsninger, der indeholder synlige partikler eller er uklare.
English: Helixate NexGen should be injected intravenously over several minutes.
Danish: Helixate NexGen bør injiceres intravenøst over adskillige minutter.
English: • If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine.
Danish: • Hvis du får trykken for brystet, bliver svimmel, føler dig syg eller svag, eller bliver svimmel, når du står op, drejer det sig måske om en sjælden, alvorlig, pludseligt opstået allergisk reaktion (en såkaldt anafylaktisk reaktion) over for dette lægemiddel.
English: After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Danish: Efter administration af Helixate NexGen, fulgte peak faktor-VIII-aktiviteten en bi-fasisk eksponentiel eliminationskurve med en middel terminal halveringstid på omkring 15 timer.
English: If you are using Helixate NexGen to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Danish: Hvis du får Helixate NexGen for at forebygge blødninger (profylaktisk), vil din læge udregne din dosis.
English: Allergic type hypersensitivity reactions are possible with Helixate NexGen.
Danish: Der kan forekomme allergilignende overfølsomhedsreaktioner med Helixate NexGen.
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of Helixate NexGen per kg body weight at intervals of 2 to 3 days.
Danish: Ved landtidsforebyggelse af blødninger hos patienter med svær hæmofili A er den sædvanlige dosis på 20-40 IE Helixate NexGen pr. kg legemsvægt med 2-3 dages mellemrum.
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5
Danish: Nødvendig IE = legemsvægt (kg) × den ønskede faktor VIII-stigning (% af normal) × 0,5
English: Desired plasma FVIII level
Danish: FVIII-niveau i plasma
English: Helixate NexGen contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Danish: Helixate NexGen har et lavt indhold af hjælpestoffet polysorbat-80, som er kendt for at øge ekstraktionshastigheden for di-(2-ethylhexyl)phthalat (DEHP) fra polyvinylkloridmaterialer (PVC).
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Danish: På grund af den sjældne forekomst af hæmofili A hos kvinder er der ingen erfaring med anvendelse af Helixate NexGen under graviditet og amning.