FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC : ↑ 21 % Cmin: ↑ 17 % Cmax: ↑ 15% (CYP3A4 inhibition)
Danish: AUC:  21 % Cmin:  17 % Cmax:  15 % (CYP3A4-hæmning)
English: Stocrin 200 mg film-coated tablets are supplied in bottles of 90.
Danish: Stocrin 200 mg filmovertrukne tabletter fås i beholdere med 90 tabletter.
English: The increased efavirenz concentrations observed following administration of STOCRIN with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Danish: De forhøjede koncentrationer af efavirenz, som er observeret efter administration af STOCRIN sammen med mad, kan føre til en øgning i bivirkningsfrekvensen (se pkt.
English: AUC: ↓ 26 % (↓ 15 to ↓ 36) Cmax: ↓ 20 % (↓ 11 to ↓ 28) Cmin: ↓ 32 % (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Danish: AUC: ↓ 26% (↓ 15 til ↓ 36) Cmax: ↓ 20% (↓ 11 til ↓ 28) Cmin: ↓ 32% (↓ 15 til ↓ 46) (CYP3A4- og CYP2B6-induktion)
English: AUC: ↓ 69 % (↓ 55 to ↓ 79) Cmax: ↓ 60 % (↓ 50 to ↓ 68) Cmin: ↓ 63 % (↓ 44 to ↓ 75) Desacetyl diltiazem:
Danish: AUC: ↓ 69% (↓ 55 til ↓ 79) Cmax: ↓ 60% (↓ 50 til ↓ 68) Cmin: ↓ 63% (↓ 44 til ↓ 75) Desacetyl diltiazem:
English: Dose adjustments of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin).
Danish: Dosisjustering af pravastatin kan være påkrævet (se SPC for pravastatin).
English: The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 24 ml orally, once daily.
Danish: Den anbefalede dosis af efavirenz i kombination med nukleosidanaloge reverse transkriptasehæmmere (NRTI'ere) med eller uden en PI'er (se pkt.
English: ---, not performed.
Danish: Ikke udført
English: ZDV + 3TC EFV + IDV 206
Danish: EFV + ZDV + 3TC 202 67%
English: AUC: ↓ 39 % (↓ 21 to ↓ 53) Cmax: ↓ 37 % (↓ 20 to ↓ 51) Cmin: ↓ 44 % (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction)
Danish: AUC: ↓ 39% (↓ 21 til ↓ 53) Cmax: ↓ 37% (↓ 20 til ↓ 51) Cmin: ↓ 44% (↓ 27 til ↓ 58) (fald i itraconazolkoncentrationen: CYP3A4-induktion)
English: Evening Cmax: ↔ Morning Cmin: ↑ 42 % (↑ 9 to b
Danish: Cmax aften: ↔ Cmin morgen: ↑ 42% (↑ 9 til ↑
English: STOCRIN 50 mg film-coated tablets Each film-coated tablet contains 50 mg of efavirenz.
Danish: STOCRIN 50 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 50 mg efavirenz.
English: Each film-coated tablet contains: efavirenz 600 mg
Danish: Hver filmovertrukken tablet indeholder: Efavirenz 600 mg
English: You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with Stocrin.
Danish: De fleste tilfælde af udslæt forsvinder dog uden ændring af din behandling med Stocrin.
English: Each film-coated tablet contains: efavirenz 200 mg
Danish: Hver filmovertrukken tablet indeholder: efavirenz 200 mg
English: Lopinavir/ritonavir tablets/ Efavirenz
Danish: Lopinavir/ritonavirtabletter/efavirenz
English: EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
Danish: EFV + NFV + NRTI'ere 65 70 (59, 82) EFV + NRTI'ere
English: ACID REDUCING AGENTS Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz (30 mL single dose/400 mg single dose)
Danish: Aluminiumhydroxidmagnesiumhydroxid-simeticon antacida/efavirenz (30 ml enkeltdosis/400 mg enkeltdosis) Famotidin/efavirenz (40 mg enkeltdosis/400 mg enkeltdosis)
English: STOCRIN 200 mg film-coated tablets Each film-coated tablet contains 200 mg of efavirenz.
Danish: STOCRIN 200 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 200 mg efavirenz.
English: Each film-coated tablet contains: efavirenz 50 mg
Danish: Hver filmovertrukken tablet indeholder: Efavirenz 50 mg
English: Other medicines used forHIV infection: protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
Danish: proteasehæmmere: darunavir, indinavir, lopinavir/ritonavir, ritonavir, atazanavir forstærket af ritonavir, saquinavir eller fosamprenavir/saquinavir.
English: STOCRIN 50 mg film-coated tablets
Danish: STOCRIN 50 mg filmovertrukne tabletter
English: AUC: ↓ 64 % (↓ 62 to ↓ 67) Cmax: ↓ 46 % (↓ 39 to ↓ 52) Cmin: ↓ 82 % (↓ 79 to ↓ 85) Levonorgestrel
Danish: AUC: ↓ 64% (↓ 62 til ↓ 67) Cmax: ↓ 46% (↓ 39 til ↓ 52) Cmin: ↓ 82% (↓ 79 til ↓ 85) Levonorgestrel (aktiv metabolit):
English: AUC: ↓ 39 % (↓ 27 to ↓ 50) Cmax: ↓ 29 % (↓ 15 to ↓ 40) Cmin: ↓ 46 % (↓ 31 to ↓ 58) Efavirenz:
Danish: AUC: ↓ 39% (↓ 27 til ↓ 50) Cmax: ↓ 29% (↓ 15 til ↓ 40) Cmin: ↓ 46% (↓ 31 til ↓ 58) Efavirenz:
English: AUC: ↓ 39 % (↓ 30 to ↓ 46) Cmax: ↓ 26 % (↓ 15 to ↓ 35) Clarithromycin
Danish: AUC: ↓ 39 % (↓ 30 til ↓ 46) Cmax: ↓ 26 % (↓ 15 til ↓ 35) Clarithromycins 14hydroxymetabolit:
English: STOCRIN 600 mg film-coated tablets Each film-coated tablet contains 600 mg of efavirenz.
Danish: STOCRIN 600 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 600 mg efavirenz.
English: AUC: ↓ 27 % (↓ 20 to ↓ 33) Cmax: ↓ 20 % (↓ 15 to ↓ 24) Cmin: ↓ 35 % (↓ 24 to ↓ 44) Efavirenz:
Danish: AUC: ↓ 27% (↓ 20 til ↓ 33) Cmax: ↓ 20% (↓ 15 til ↓ 24) Cmin: ↓ 35% (↓ 24 til ↓ 44) Efavirenz:
English: Vascular disorders uncommon flushing
Danish: Mave-tarmkanalen Almindelig
English: ANTI-INFECTIVES HIV antivirals
Danish: • Anden medicin mod hiv-infektion:
English: Nervous system symptoms of moderate-to-severe intensity were experienced by 19 % (severe 2.0 %) of patients compared to 9 % (severe 1 %) of patients receiving control regimens.
Danish: I kliniske, kontrollerede undersøgelser var de hyppigt indberettede bivirkninger bl.a. følgende: Svimmelhed, søvnløshed, døsighed, nedsat koncentrationsevne og unormal drømmeaktivitet.19% af patienterne oplevede symptomer fra nervesystemet af moderat til svær intensitet (heraf 2% af svær intensitet) sammenlignet med 9% af de patienter (heraf 1% af svær intensitet), der fik kontrolregimerne.
English: • Each Stocrin film-coated tablet contains 600 mg of the active substance efavirenz.
Danish: • Hver Stocrin filmovertrukken tablet indeholder 600 mg af det aktive stof efavirenz.
English: • Each Stocrin film-coated tablet contains 50 mg of the active substance efavirenz.
Danish: • Hver Stocrin filmovertrukken tablet indeholder 50 mg af det aktive stof efavirenz.
English: AUC: ↓ 38 % (↓ 28 to ↓ 47) Cmax: ↓ 32 % (↓ 15 to ↓ 46) Cmin: ↓ 45 % (↓ 31 to ↓ 56) Efavirenz:
Danish: AUC: ↓ 38 % (↓ 28 til ↓ 47) Cmax: ↓ 32 % (↓ 15 til ↓ 46) Cmin: ↓ 45 % (↓ 31 til ↓ 56) Efavirenz:
English: • Each Stocrin film-coated tablet contains 200 mg of the active substance efavirenz.
Danish: • Hver Stocrin filmovertrukken tablet indeholder 200 mg af det aktive stof efavirenz.
English: AUC: ↓ 36 % (↓ 32 to ↓ 40) Cmax: ↓ 21 % (↓ 15 to ↓ 26) Cmin: ↓ 47 % (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction) The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Danish: AUC: ↓ 36% (↓ 32 til ↓ 40) Cmax: ↓ 21% (↓ 15 til ↓ 26) Cmin: ↓ 47% (↓ 41 til ↓ 53) (fald i carbamazepin-koncentrationen: CYP3A4-induktion; fald i efavirenzkoncentrationen: CYP3A4- og CYP2B6induktion).
English: AUC: ↓ 25 % (↓ 16 to ↓ 32) Cmax: ↓ 17 % (↓ 6 to ↓ 26) Cmin: ↓ 50 % (↓ 40 to ↓ 59) Efavirenz:
Danish: AUC: ↓ 25% (↓ 16 til ↓ 32) Cmax: ↓ 17% (↓ 6 til ↓ 26) Cmin: ↓ 50% (↓ 40 til ↓ 59) Efavirenz:
English: If you take more Stocrin than you should
Danish: Hvis du har taget for meget Stocrin
English: ANTIANXIETY AGENTS Lorazepam/Efavirenz (2 mg single dose/600 mg once daily)
Danish: Lorazepam/efavirenz (2 mg enkeltdoser/600 mg én gang dagligt)
English: AUC: ↓ 37 % (↓ 14 to ↓ 55) Cmax: ↓ 35 % (↓ 12 to ↓ 52) Cmin: ↓ 43 % (↓ 18 to ↓ 60) Efavirenz:
Danish: AUC: ↓ 37% (↓ 14 til ↓ 55) Cmax: ↓ 35% (↓ 12 til ↓ 52) Cmin: ↓ 43% (↓ 18 til ↓ 60) Efavirenz:
English: Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Danish: Samtidig administration med terfenadin, astemizol, cisaprid, midazolam, triazolam, primozid, bepridil eller sekalealkaloider (fx ergotamin, dihydroergotamin, ergonovin og methylergonovin), da konkurrence om CYP3A4 fra efavirenz kan resultere i hæmning af metaboliseringen.
English: Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Danish: Der er set krampeanfald hos patienter i efavirenzbehandling, disse patienter havde sædvanligvis krampeanfald i anamnesen.
English: EFV + IDV + NRTIs IDV + NRTIs
Danish: NFV + NRTI'ere
English: Taking Stocrin on an empty stomach may reduce the undesirable effects.
Danish: Det kan nedsætte bivirkningerne, hvis Stocrin tages på tom mave.
English: • Stocrin is for oral use.
Danish: • Stocrin skal tages gennem munden.
English: Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when efavirenz and artemether/lumefantrine tablets are coadministered.
Danish: Forsigtighed tilrådes når efavirenz og artemether/lumefantrintabletter tages samtidigt, da fald i koncentrationen af artemether, dihydroartemisinin eller lumefantrin kan resultere i nedsat effekt mod malaria.
English: Skin and subcutaneous tissue disorders very common rash (11.6 %)*
Danish: Udslæt (11,6%)*
English: What Stocrin is and what it is used for What you need to know before you take Stocrin How to take Stocrin
Danish: Det skal du vide, før du begynder at tage Stocrin Sådan skal du tage Stocrin Bivirkninger
English: rare delusion
Danish: Sløret syn
English: Concomitant administration of STOCRIN with elbasvir/grazoprevir is contraindicated (see section 4.3) because it may lead to loss of virologic response to elbasvir/grazoprevir.
Danish: Samtidig administration af STOCRIN og elbasvir/grazoprevir er kontraindiceret (se pkt.
English: AUC: ↑ 21 % (↑ 10 to ↑ 34) Cmax: ↑ 14 % (↑ 4 to ↑ 26) Cmin: ↑ 25 % (↑ 7 to ↑ 46) (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Danish: AUC: ↑ 21% (↑ 10 til ↑ 34) Cmax: ↑ 14% (↑ 4 til ↑ 26) Cmin: ↑ 25% (↑ 7 til ↑ 46) (hæmning af CYP-medieret oxidativ metabolisme).
English: Evening Cmin: ↑ 24 % (↑ 3 to
Danish: Cmin aften: ↑ 24% (↑ 3 til ↑ 50) Efavirenz:
English: STOCRIN 50 mg film-coated tablets efavirenz
Danish: STOCRIN 50 mg filmovertrukne tabletter efavirenz
English: Cmax: ↑ 50% (↑ 20 to ↑ 80)
Danish: Cmax: ↑ 50% (↑ 20 til ↑ 80) (CYP2B6-induktion)
English: STOCRIN 200 mg film-coated tablets efavirenz
Danish: Stocrin 200 mg filmovertrukne tabletter efavirenz
English: Stocrin 200 mg film-coated tablets efavirenz
Danish: STOCRIN 200 mg filmovertrukne tabletter efavirenz
English: Itraconazole/Efavirenz (200 mg q12h/600 mg once daily)
Danish: Itraconazol/efavirenz (200 mg hver12.
English: Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65)
Danish: AUC: ↓ 43 % (↓ 7 til ↓ 65) Cmax: ↔
English: Stocrin 600 mg film-coated tablets efavirenz
Danish: STOCRIN 600 mg filmovertrukne tabletter efavirenz
English: STOCRIN 600 mg film-coated tablets efavirenz
Danish: Stocrin 600 mg filmovertrukne tabletter efavirenz
English: Rash
Danish: Flushing
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Danish: AUC: ↓ 75 % (↓ 62 til ↓ 84) Cmax: ↓ 44 % (↓ 20 til ↓ 61)
English: Hydroxyitraconazole: AUC: ↓ 37 % (↓ 14 to ↓ 55) Cmax: ↓ 35 % (↓ 12 to ↓ 52) Cmin: ↓ 43 % (↓ 18 to ↓ 60) Efavirenz:
Danish: AUC: ↓ 37 % (↓ 14 til ↓ 55) Cmax: ↓ 35 % (↓ 12 til ↓ 52) Cmin: ↓ 43 % (↓ 18 til ↓ 60) Efavirenz:
English: Posology
Danish: Vrangforestillinger
English: If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
Danish: Spørg din læge eller apotekspersonalet, hvis du har brug for hjælp til at planlægge, hvornår det er bedst at tage din medicin.
English: uncommon hepatitis acute rare hepatic failure
Danish: Vaskulære sygdomme Ikke almindelig
English: Macrogol 6,000
Danish: Makrogol 6000
English: General advice:
Danish: Generelle råd:
English: - If your kidneys are not functioning normally.
Danish: - hvis dine nyrer ikke fungerer normalt.
English: - Choose one day of the month that will be easy to remember.
Danish: - Vælg en månedsdato, så det er let at huske.
English: Especially:
Danish: Specielt:
English: You can drink water but no other drinks (see 3.
Danish: Du må drikke vand, men ingen andre drikkevarer (se 3.
English: - If you can't stand or sit upright for at least one hour (60 minutes) at a time.
Danish: - hvis du ikke kan stå eller sidde oprejst i mindst én time (60 minutter) ad gangen.
English: Choose the date that best fits your routine.
Danish: Vælg en dato som bedst passer til dine rutiner.
English: Bondenza with food and drink:
Danish: Brug af Bondenza sammen med mad og drikke
English: You may be having an allergic reaction to the medicine
Danish: Du kan have fået en allergisk reaktion over for medicinen.
English: Never take two Bondenza tablets within the same week.
Danish: Tag aldrig to Bondenza tabletter i den samme uge.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Danish: EFFEKTIV ANVENDELSE AF LÆGEMIDLET Ikke relevant.
English: Bondenza is less effective if it's taken with food.
Danish: Bondenza er mindre effektivt, når det indtages sammen med mad.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGLESER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG
English: It's important to keep taking Bondenza every month.
Danish: Det er vigtigt at tage Bondenza hver måned.
English: If you've taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Danish: Hvis du ved en fejl har indtaget mere end én tablet, skal du drikke et helt glas mælk og straks kontakte lægen.
English: Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) ,very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret på følgende måde: meget almindelig (> 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Danish: I en multivariant analyse kunne alder ikke påvises som en uafhængig faktor for nogen af de undersøgte farmakokinetiske parametre.
English: - If you have heart problems and the doctor recommended to limit your daily fluid intake
Danish: - Hvis du har problemer med hjerte, og din læge anbefaler, at du begrænser din daglige væskeindtagelse.
English: If you develop these symptoms, stop taking Bondenza and tell your doctor straight away (see section 3).
Danish: Hvis du udvikler disse symptomer, skal du stoppe med at tage Bondenza og straks kontakte din læge (se punkt 3).
English: Taking your monthly tablet
Danish: Ved indtagelsen af din månedlige tablet
English: Do not take Bondenza with food.
Danish: Indtag ikke Bondenza sammen med mad.
English: Choose one day of the month that will be easy to remember: - either the same date (such as the 1st of each month) - or the same day (such as the first Sunday of each month).
Danish: Vælg en månedsdato, der er let at huske: - enten den samme dato (som f.eks. den 1. i hver måned) - eller den samme dag (som f.eks. den første søndag i hver måned).
English: - After you've waited for an hour, you can have your first food and drink of the day.
Danish: - Efter du har ventet én time, kan du indtage dagens første måltid eller drikkevarer.
English: If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Danish: Hvis du glemmer at tage din tablet om morgenen på den valgte dag, må du ikke tage tabletten senere på dagen.
English: *See further information below †Identified in post-marketing experience.
Danish: * Se yderligere information nedenfor † Identificeret ved erfaring efter markedsføring
English: • Dispose of the full container according to local requirements or as instructed by your healthcare provider.
Danish: • Destruer den fyldte kanyleboks i henhold til lokale retningslinjer eller i følge vejledning fra din sundhedsperson.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Bondenza on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af Bondenza for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: • serious, potentially life-threatening allergic reaction (see section 2).
Danish: • alvorlig, eventuelt livstruende, allergisk reaktion (se punkt 2)
English: You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Bondenza tablet.
Danish: Du kan vælge enten den samme dato (som f.eks. den 1. i hver måned) eller den samme dag (som f.eks. den første søndag i hver måned) til indtagelsen af din Bondenzatablet.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONALS
Danish: INFORMATION TIL SUNDHEDSPERSONALET
English: - Swallow your tablet whole - do not chew it, crush it or let it dissolve in your mouth.
Danish: - Synk tabletten hel - lad være med at tygge den, knuse den eller opløse den i munden.
English: Use the peel-off stickers below to mark the dates on your calendar.
Danish: Anvend de aftagelige klistermærker, som er vist nedenfor, til at markere datoen i din kalender.
English: Bisphosphonates (like Bondenza) may also do so.
Danish: Bisphosphonater (som Bondenza) kan virke på samme måde.
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6 %.
Danish: Maksimal plasmakoncentration opnås i løbet af 0,5 til 2 timer (median 1 time) i fastetilstand, og den absolutte biotilgængelighed er ca. 0,6 %.
English: • serious, potentially life-threatening allergic reaction
Danish: • alvorlig, eventuelt livstruende, allergisk reaktion.
English: If you are unable to do so, you should inform your doctor
Danish: Hvis du ikke kan det, skal du kontakte din læge.
English: If there is a concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Danish: Hvis der er usikkerhed omkring potentielt høje calciumkoncentrationer i postevandet (hårdt vand), anbefales det at bruge vand på flaske med et lavt mineralindhold.
English: The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Danish: Hovedparten af rapporterne omhandler kræftpatienter, men lignende tilfælde er også rapporteret hos patienter, der behandes for osteoporose.
English: They are designed to help your Bondenza tablet reach your stomach quickly, so it's less likely to cause irritation.
Danish: De er lavet med henblik på, at Bondenza tabletten hurtigt når frem til maven, så der er mindst mulig sandsynlighed for at forårsage irritation
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Danish: Under behandling, bør patienterne undgå invasive tandbehandlinger.
English: You should not be given Bondenza if you are pregnant, or if there is a possibility you may become pregnant.
Danish: Du må ikke tage Bondenza hvis du er gravid eller der er mulighed for at du bliver gravid.
English: Since Nonsteroidal Anti-Inflammatory medicinal products and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Danish: Idet både nonsteroide antiinflammatoriske lægemidler og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed ved samtidig administration.
English: The marketing authorisation holder shall submit PSURs 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: In some cases, these events did not resolve until the ibandronic acid was discontinued.
Danish: I nogle tilfælde ophørte disse hændelser ikke før ibandronsyre blev seponeret.
English: Do not make yourself vomit, and do not lie down - this could cause Bondenza to irritate your oesophagus.
Danish: Fremkald ikke opkastning, og læg dig ikke ned - dette kan medføre, at Bondenza irriterer spiserøret.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Film-coated tablet:
Danish: A FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Filmovertrukne tabletter:
English: - Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
Danish: - Patienten må ikke tygge eller sutte på tabletterne på grund af risiko for orofaryngeal ulceration.
English: Children and adolescents Do not give Bondenza to children or adolescents below 18 years.
Danish: Børn og teenagere Giv ikke Bondenza til børn og teenagere under 18 år.
English: Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or increased mechanical strength even at doses in the toxic range.
Danish: Både daglig og intermitterende langtidsadministration (med forlængede dosisfri intervaller) til rotter, hunde og aber resulterede i dannelse af ny knogle med normal kvalitet og bevaret eller øget mekanisk styrke, selv ved toksiske doser.
English: Bondenza may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference.
Danish: Bondenza kan ophæve knogletab ved at forhindre yderligere tab af knoglevæv og ved at øge knoglemassen hos kvinder, som tager det, selvom de ikke vil kunne se eller føle en forskel.
English: If too much Bondenza is given
Danish: Hvis der gives for meget Bondenza
English: - For the next hour (60 minutes) after you've taken your tablet do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus do not eat anything do not drink anything (except water if you need it) do not take any other medicines
Danish: - I løbet af den følgende time (60 minutter) efter at du har indtaget tabletten lig ikke ned: Hvis du ikke er oprejst (stående eller siddende), kan noget af medicinen spis ikke noget drik ikke noget (undtagen postevand, hvis du har brug for det) indtag ikke anden medicin
English: Talk to a nurse or a doctor straight away if you notice any of the following serious side effectsyou may need urgent medical treatment:
Danish: Tal straks med sundhedspersonalet eller lægen, hvis du oplever nogle af følgende alvorlige bivirkninger - du kan have brug for akut lægehjælp:
English: Bondenza contains lactose.
Danish: Bondenza indeholder lactose.
English: If a dose of Bondenza is missed
Danish: Hvis en dosis af Bondenza glemmes