FrancophonIA/ELRC3.0 huggingface dataset:
English: Rhiniseng is a vaccine containing a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells (inactivated means that the bacteria are killed so that they cannot cause the disease anymore).
Danish: RHINISENG er en vaccine, der indeholder et ikketoksisk rekombinant derivat af Pasteurella multocidatoksinet og inaktiverede Bordetella bronchiseptica-celler (inaktiveret betyder, at bakterierne er blevet dræbt, således at de ikke længere kan fremkalde sygdommen).
English: As a consequence of reduced atrophic rhinitis disease, the incidence of respiratory symptoms and subsequent treatment with antibiotics of the pigs is also reduced.
Danish: Som følge af den reducerede forekomst af atrofisk rhinitis sker der ligeledes en reduktion af forekomsten af luftvejssymptomer og efterfølgende behandling af svin med antibiotika.
English: The efficacy of RHINISENG was demonstrated for the category of the target species for which the vaccine is recommended (gilts and sows) by the recommended route of administration (intramuscular) using the proposed schedule of administration (first vaccination at 6-8 weeks before farrowing and revaccination 3-4 weeks later).
Danish: Virkningen af RHINISENG blev påvist for den kategori af måldyr, som vaccinen anbefales til (gylter og søer), via den anbefalede indgivelsesvej (intramuskulært) og ved anvendelse af den anbefalede behandlingsplan (den første injektion skal indgives 6-8 uger inden den forventede faringsdato, og revaccination gives 3-4 uger senere).
English: Inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs
Danish: Inaktiveret vaccine til forebyggelse af progressiv og nonprogressiv atrofisk rhinitis hos svin
English: What is the risk associated with RHINISENG?
Danish: Hvilken risiko er der forbundet med RHINISENG?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RHINISENG exceed the risks for the treatment of piglets via colostrum from sows and gilts actively immunised with the vaccine to prevent the clinical signs and lesions of progressive and nonprogressive atrophic rhinitis and recommended that RHINISENG be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved RHINISENG er større end risiciene, når det anvendes til behandling af smågrise via kolostrum fra søer og gylter, der er aktivt immuniseret med vaccinen for at forebygge de kliniske symptomer og læsioner forårsaget af progressiv og nonprogressiv atrofisk rhinitis, og anbefalede udstedelse af markedsføringstilladelse for RHINISENG.
English: Why has RHINISENG been approved?
Danish: Hvorfor blev RHINISENG godkendt?
English: Rhiniseng is presented in fluid form as a suspension for injection which is stored in a glass or plastic bottle.
Danish: RHINISENG fås i flydende form som injektionsvæske, suspension, i glas- eller plastikflaske.
English: RHINISENG is used for the protection of piglets via the sow's colostrum (first milk) after injection of sows and gilts.
Danish: RHINISENG anvendes til beskyttelse af smågrise via soens kolostrum (råmælk) efter injektion hos søer og gylter.
English: It is used to reduce the clinical signs and lesions of a disease called progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Danish: Det anvendes til at reducere de kliniske tegn og læsioner forårsaget af en sygdom kaldet progressiv og nonprogressiv atrofisk rhinitis (nysesyge), samt til at reducere det vægttab, der ledsager infektioner med Bordetella bronchiseptica og Pasteurella multocida, i opvækstperioden.
English: The pigs, which have received antibodies against progressive atrophic rhinitis via colostrum, need a shorter time to reach the slaughter weight.
Danish: Svin, som via kolostrum har modtaget antistoffer mod progressiv atrofisk rhinitis, når hurtigere den rette slagtevægt.
English: What is RHINISENG?
Danish: Hvad er RHINISENG?
English: What is RHINISENG used for?
Danish: Hvad anvendes RHINISENG til?
English: RHINISENG reduces the incidence and severity of the disease called progressive and non-progressive atrophic rhinitis in pigs.
Danish: RHINISENG reducerer forekomsten og sværhedsgraden af progressiv og nonprogressiv atrofisk rhinitis hos svin.
English: How has RHINISENG been studied?
Danish: Hvordan blev RHINISENG undersøgt?
English: What benefit has RHINISENG shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved RHINISENG?
English: How does RHINISENG work?
Danish: Hvordan virker RHINISENG?
English: (If required)
Danish: (Hvis nødvendigt)
English: What you need
Danish: Du har brug for
English: Take this medicine one or two times a day every day with food.
Danish: Tag denne medicin en eller to gange dagligt sammen med mad.
English: − if you are currently taking any of the following medicines:
Danish: − hvis du for øjeblikket tager ét eller flere af følgende lægemidler:
English: Use within 2 hours.
Danish: Anvendes indenfor 2 timer.
English: This is especially important for infants and young children.
Danish: Dette er særligt vigtigt for spædbørn og mindre børn.
English: • laboratory test results:
Danish: • resultater af laboratorietest:
English: changes in blood test results
Danish: ændringer i resultaterne af blodprøver
English: Any mixing outside the recommendations is the responsibility of the health care professional or the user.
Danish: Enhver blanding udenfor anbefalingerne er på sundhedspersonens eller brugerens eget ansvar.
English: (µg•h/ml) t½ (h)
Danish: (µg•t/ml) t½ (t)
English: Date of first authorisation: 26 August 1996 Date of latest renewal: 26 August 2006
Danish: Dato for første tilladelse: 26. august 1996 Dato for seneste fornyelse: 26. august 2006
English: You will need to use a new syringe if:
Danish: Du skal bruge en ny sprøjte, hvis:
English: b. Each 0.2 ml is shown as a smaller line between the numbers.
Danish: b. Hver 0,2 ml vises som en mindre linie mellem numrene.
English: If there are still lumps, keep shaking until they have all gone.
Danish: Hvis der stadig er klumper, skal du blive ved med at ryste til de alle er væk.
English: Norvir can be used during pregnancy if clinically needed.
Danish: Norvir kan anvendes under graviditet, hvis det er klinisk nødvendigt.
English: 30 sachets per carton.
Danish: 30 breve pr. karton.
English: Norvir should be taken every day to help control your HIV, no matter how much better you feel.
Danish: Norvir skal tages hver dag for at medvirke til at kontrollere din hiv-infektion, uanset hvor meget bedre tilpas du føler dig.
English: You may need more than 1 sachet for each dose.
Danish: Du kan få brug for mere end 1 brev til hver dosis.
English: There may be additional information in those leaflets about situations when Norvir should be avoided.
Danish: Der kan være yderligere oplysninger i disse indlægssedler om situationer, hvor Norvir bør undgås.
English: Children (2 - 12 years of age) will start with a dose smaller than this and continue up to the maximum allowed for their size.
Danish: Børn (2-12 år) starter med en lavere dosis end denne og fortsætter op til den maksimalt tilladte dosis for deres størrelse.
English: Some patients taking
Danish: Nogle patienter, som tager
English: Some people had other illnesses or were taking other medicines.
Danish: Nogle patienter havde andre sygdomme eller tog anden medicin.
English: If you need to use more than one sachet, repeat the process from the beginning.
Danish: Hvis du har brug for mere end et brev, gentages processen fra begyndelsen.
English: • you cannot read the scale
Danish: • du ikke kan aflæse skalaen
English: Currently, there are no data specific to this patient population and therefore specific dosage recommendations cannot be made.
Danish: Der er i øjeblikket ingen specifikke data for denne patientgruppe, og der kan derfor ikke gives konkrete anbefalinger vedrørende dosering.
English: c. Check if the sachet is empty.
Danish: c. Kontrollér at brevet er tomt.
English: Prepare only one dose at a time using the correct number of sachets.
Danish: Tilbered kun en dosis af gangen ved at anvende det korrekte antal breve.
English: In more than a half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de rapporterede tilfælde blev behandlingen med proteasehæmmere fortsat eller genoptaget, hvis behandlingen var blevet afbrudt.
English: Hypromellose Titanium dioxide (E171) Macrogols
Danish: Hypromellose Titandioxid (E171) Macrogoler
English: Do not use Norvir after the expiry date on the label.
Danish: Brug ikke Norvir efter den udløbsdato, der står på etiketten.
English: All of the mixed soft food must be administered within 2 hours.
Danish: Al den blandede bløde mad skal administreres indenfor 2 timer.
English: Tell your doctor if you experience:
Danish: Fortæl det til lægen, hvis du oplever:
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Dosisjustering af midazolam bør overvejes, specielt hvis der administreres mere end en enkelt dosis midazolam.
English: Do not wash these in the dishwasher.
Danish: Disse ting må ikke vaskes i opvaskemaskinen.
English: Therefore, an alternative, effective and safe method of contraception should be used during treatment.
Danish: Derfor bør der anvendes en alternative, effektiv og sikker kontraceptionsmetode under behandling.
English: To avoid transmitting the infection, mothers with HIV must not breast feed their babies.
Danish: For at undgå at overføre smitte må mødre med hiv ikke amme deres børn.
English: • Once the powder is mixed, the prepared suspension should be used within 2 hours.
Danish: • Når pulveret er blandet, skal den tilberedte suspension bruges indenfor 2 timer.
English: − if you have severe liver disease.
Danish: − hvis du har alvorlige leversygdomme.
English: There are some medicines you cannot take at all with Norvir.
Danish: Der er nogle lægemidler, som du slet ikke må tage sammen med Norvir.
English: c. If you push out too much liquid, start again from Step 7.
Danish: c. Hvis du presser for meget væske ud, startes forfra igen fra trin 7.
English: (such as blood chemistry and blood count)
Danish: (såsom blodkemi og blodtal)
English: When you travel or need to stay in the hospital, make sure you have enough Norvir to last until you can get a new supply.
Danish: Når du er på rejse eller skal indlægges på hospitalet, skal du sørge for at have tilstrækkeligt med Norvir, indtil du kan få en ny forsyning.
English: †In some instances, the volumes and/or doses have been adjusted to ensure the recommended final dose and dosing volume.
Danish: †I nogle tilfælde, er volumen og/eller dosis tilpasset for at sikre den endeligt anbefalede dosis eller doseringvolumen.
English: The mechanism of this interaction is not clear, but may be the result of transporter inhibition.
Danish: Mekanismen bag denne interaktion er ikke klarlagt, men kan være resultatet af transporter hæmning.
English: The Marketing Authorisation Holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Follow the instructions below:
Danish: Følg vejledningen nedenfor:
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV-infected patients.
Danish: Den officielle vejledning vedrørende den hensigtsmæssige behandling af tuberkulose hos hiv-inficerede patienter bør tages i betragtning.
English: c. The liquid may look cloudy - this is okay.
Danish: c. Væsken kan se uklar ud - dette er i orden.
English: Taking Norvir with food and drink
Danish: Brug af Norvir sammen med mad og drikke
English: e. You may see some small bubbles on top of the liquid - this is also okay (see Figure 7).
Danish: e. Det kan være, at du kan se nogle små bobler i overfladen af væsken - dette er også i orden (se figur 7).
English: This will move any bubbles to the tip.
Danish: Dette vil bevæge eventuelle bobler mod spidsen.
English: Be sure to remove the bubbles prior to dose administration.
Danish: Sørg for at fjerne boblerne inden administration af dosis.
English: These are listed earlier in section 2, under ‘Do not take Norvir'.
Danish: Disse lægemidler er anført tidligere under punkt 2 i afsnittet ‘Tag ikke Norvir'.
English: The time to maximum concentration (Tmax) remained constant at approximately 4 hours with increasing dose.
Danish: Tiden til maksimumkoncentration (Tmax) forblev konstant på hen ved 4 timer ved øget dosering.
English: Food slightly decreases the bioavailability of the Norvir tablet.
Danish: Føde nedsætter biotilgængeligheden af Norvir-tabletten lidt.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {DD/ÅÅÅÅ}
English: Always keep enough Norvir on hand so you don't run out.
Danish: Sørg altid for at have tilstrækkeligt med Norvir på lager, så du ikke løber tør.
English: The safety profile of Norvir in children 2 years of age and older is similar to that seen in adults.
Danish: Sikkerhedsprofilen for Norvir hos børn på 2 år og ældre, svarer til den, der ses hos voksne.
English: Discuss with your physician the precautions needed to avoid infecting other people.
Danish: Tal med din læge om, hvilke forholdsregler der er nødvendige for at undgå at smitte andre personer.
English: * Your doctor may decide that you can take rifabutin and/or voriconazole with a booster (lower dose) of Norvir but a full dose of Norvir must not be taken together with these two medicines.
Danish: * Din læge kan beslutte, at du kan tage rifabutin og/eller voriconazol sammen med en boosterdosis (lavere dosis) af Norvir, men du må ikke tage en fuld dosis Norvir sammen med disse to lægemidler.
English: Using the syringe Reading the scale a. Each millilitre (ml) is shown as a number with a big line.
Danish: Anvendelse af sprøjten Aflæsning af skalaen a. Hver milliliter (ml) vises som et nummer med en stor linie.
English: Norvir did not appear to increase the chance of developing birth defects compared to the general population.
Danish: Norvir synes ikke at øge risikoen for medfødte misdannelser sammenlignet med den generelle population.
English: Because of the potential for (1) HIV transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-postive infants) and (3) serious adverse reactions in a breastfed infant, HIV infected women should not breast feed their infants under any circumstances if they are receiving Norvir.
Danish: På grund af muligheden for (1) hiv-transmission (hos hiv-negative spædbørn), (2) udvikling af viral resistens (hos hiv-positive spædbørn) og (3) alvorlige bivirkninger hos et ammende barn bør hiv-inficerede kvinder under ingen omstændigheder amme deres børn, hvis de får Norvir.
English: If the dates for submission of a PSUR and the update of a RMP conincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for datering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Body surface area can be calculated with the following equation: BSA (m2) = √(Height (cm) X Weight (kg) /
Danish: *Kroppens overflade kan beregnes efter følgende ligning: BSA (m2) = √ (højde (cm) x vægt (kg) /
English: Administering with food
Danish: Administration med mad
English: Effects on the Electrocardiogram
Danish: Effekt på elektrokardiogram
English: • If the syringe breaks or becomes hard to use, the syringe should be thrown away and the new one used.
Danish: • Hvis doseringssprøjten bliver beskadiget eller bliver svær at bruge, skal sprøjten smides ud og en ny tages i brug.
English: Dizziness is a known undesirable effect that should be taken into account when driving or using machinery.
Danish: Svimmelhed er en kendt bivirkning, som der skal tages hensyn til, når man kører bil eller anvender maskiner.
English: − Digoxin (heart medicine).
Danish: − Digoxin (hjertemedicin).
English: Maximum PR interval was 252 msec and no second or third degree heart block was observed (see section 4.4).
Danish: Det maksimale PR-interval var 252 msek, og der blev ikke observeret nogen anden eller tredie grads hjerte-blokade (se punkt 4.4).
English: c. Give the patient the full dose within 2 hours of opening the sachet.
Danish: c. Giv patienten hele dosis indenfor 2 timer efter åbning af brevet.
English: − colchicine, a treatment for gout.
Danish: − colchicin, til behandling af gigt.
English: ND: Not determined
Danish: ND: Ikke fastsat
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Danish: En kausal relation er blevet udarbejdet, mens virkningsmekanismen ikke er blevet klarlagt.
English: Your doctor will discuss with you the best combination of medicines for you.
Danish: Din læge vil drøfte med dig, hvilken kombination af lægemidler der er bedst for dig.
English: The following warnings apply when Norvir is taken as a full dose.
Danish: Følgende advarsler gælder, når Norvir tages i fuld dosis.
English: It is recommended that a condom or other non-hormonal method of contraception is used instead.
Danish: Det anbefales derfor i stedet at anvende kondom eller en anden ikkehormonel præventionsform.
English: However, the AUC of the M-2 metabolite was approximately 3% of the AUC of parent compound.
Danish: Men AUC for M-2 metabolitten var ca. 3 % af moderstoffets AUC.
English: (See section 4 Possible side effects)
Danish: (Se punkt 4 Bivirkninger)
English: Check the syringe before each use
Danish: Kontrollér sprøjten inden brug hver gang
English: If you have any further questions about Norvir (ritonavir) or the other medicines prescribed, please ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål om Norvir (ritonavir) eller den anden ordinerede medicin, skal du spørge din læge eller på apoteket.
English: There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.
Danish: Der er ingen oplysninger om virkningerne af ritonavir på det ammende barn eller virkningen af lægemidlet på mælkeproduktion.
English: Your doctor may need to adjust the dose of digoxin and monitor you while you are taking digoxin and Norvir in order to avoid heart problems.
Danish: Din læge kan være nødt til at justere dosen af digoxin og følge dig nøje, mens du tager digoxin og Norvir, for at undgå hjerteproblemer.
English: • Close the lid and shake hard for at least 90 seconds until all the lumps have dissolved.
Danish: • Luk låget og ryst kraftigt i mindst 90 sekunder indtil alle klumper er opløst.
English: f. If there are any large air bubbles, empty the liquid from the syringe into the mixing cup and start again from Step 7.
Danish: f. Hvis der er nogen store luftbobler, tømmes væsken ud af sprøjten i blande-koppen og der startes igen fra trin 7.
English: White, oval, debossed with [Abbott logo] and “NK”.
Danish: Hvid, oval, præget med med [Abbott logo] og “NK”.
English: A large amount (6100 live births) of pregnant women were exposed to ritonavir during pregnancy; of these, 2800 live births were exposed during the first trimester.
Danish: Et stort antal (6100 levende fødsler) af gravide kvinder har været eksponeret for ritonavir under graviditet; af disse har 2800 levende fødsler været eksponeret i første trimester.
English: Child resistant closure
Danish: Børnesikret lukning
English: − ergonovine, methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion);
Danish: − ergonovin, methylergonovin (bruges til at standse voldsom blødning, som kan forekomme efter en fødsel eller abort);
English: When mixing the powder with food or liquid, be sure to take the whole dose within 2 hours.
Danish: Når pulveret blandes med mad eller væske, skal du sørge for at hele dosis tages indenfor 2 timer.
English: 52.6 ml (526 mg) *When mixed with 9.4 ml of liquid the concentration of the suspension is 10 mg/ml.
Danish: 52,6 ml (526 mg) *Ved blanding med 9,4 ml væske er suspensions koncentration 10 mg/ml.
English: Treatment of overdose with ritonavir should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering med ritonavir bør bestå i generelle forholdsregler såsom overvågning af vitale tegn og observation af patientens kliniske tilstand.
English: This will help to break up the bubbles and make sure they are all at the tip (see Figure 3).
Danish: Dette vil hjælpe med til at opløse boblerne og sikre, at de alle er i spidsen (se figur 3).
English: If you are currently taking any of these medicines, ask your doctor about switching to a different medicine while you are taking Norvir.
Danish: Hvis du i øjeblikket tager ét eller flere af disse lægemidler, skal du rådføre dig med din læge om at skifte til et andet lægemiddel, medens du tager Norvir.
English: The extent of increase in AUC and Cmax depends on the timing of ritonavir administration.
Danish: Størrelsen af stigningen i AUC og Cmax afhænger af tidspunktet for administartion af ritonavir.
English: AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Holland På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af det pågældende batch.
English: No subject experienced an increase in QTcF of ≥ 60 msec from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 msec.
Danish: Ingen individer oplevede en øgning i QTcF på ≥ 60 msek fra baseline eller et QTcF-interval, som oversteg den potentielt kliniske relevante grænse på 500 msek.
English: The patient/caregiver is to be instructed to follow the directions below:
Danish: Patienten eller sundhedspersonalet instrueres i at følge instruktionen nedenfor:
English: b. Tap the syringe with your other hand.
Danish: b. Bank på sprøjten med din anden hånd.
English: Immediately wash the spoon and cup in warm water and dish soap (see Figure 7).
Danish: Vask straks skeen og koppen i varmt vand og opvaskemiddel (se figur 7).
English: Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
Danish: Fortæl din læge, hvis du tager tadalafil mod pulmonal hypertension.
English: Rinse with water and allow to air dry.
Danish: Skyl med vand og lad det lufttørre.
English: The AUC of the metabolite prednisolone increased by 37 and 28% after 4 and 14 days ritonavir, respectively.
Danish: AUC for metaboliten prednisolon steg med 37 og 28 % efter henholdsvis 4 og 14 dage med ritonavir.
English: Even if you feel better, do not stop taking Norvir without talking to your doctor.
Danish: Selv om du føler dig bedre tilpas, må du ikke holde op med at tage Norvir uden først at have talt med din læge.
English: Dose of NORVIR (mg)
Danish: Dosis af Norvir (mg)
English: − if you are allergic to ritonavir or any of the other ingredients of Norvir (see section 6).
Danish: − hvis du er allergisk over for ritonavir eller et af de øvrige indholdsstoffer i Norvir (se punkt 6).
English: On rare occasions these muscle disorders have been serious (rhabdomyolysis).
Danish: Muskellidelser har i sjældne tilfælde været alvorlige (rhabdomyolyse).
English: Some patients taking Norvir can develop serious problems with their pancreas.
Danish: Nogle patienter, som tager Norvir, kan udvikle alvorlige problemer med bugspytkirtlen.