natgillin/translations-raw huggingface dataset:
Indinavir og cimetidin kan administreres samtidigt uden dosisjustering.
Indinavir and cimetidine can be co-administered without dose adjustment.
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når erythromycin eller itraconazol administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole are concomitantly administered with indinavir/ritonavir.
Indinavir Cmin:  (I forhold til indinavir 800 mg TID alene)
Indinavir Cmin:  (Relative to Indinavir 800 mg TID alone)
Nedsat indinavirkoncentration og øget rifabutinkoncentration er forventelig.
Interaction with indinavir/ritonavir not studied Decreased indinavir concentrations and increased rifabutin concentrations are expected.
Dette betyder, at De i alt skal tage tolv 200 mg kapsler (2.400 mg) hver dag.
This means you will take a total of twelve 200 mg capsules (2400 mg) each day.
Ritonavir inducerer glucuronidering og som følge heraf forventes fald i atovaquons plasmakoncentration.
Interaction with indinavir/ritonavir not studied Ritonavir induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone.
CRIXIVAN, med eller uden ritonavir, bør ikke administreres samtidigt med amiodaron, terfenadin, cisaprid, astemizol, quetiapin, alprazolam, triazolam, midazolam administreret peroralt (mht. forsigtighed ved parenteralt administreret midazolam se pkt.
CRIXIVAN with or without ritonavir should not be administered concurrently with amiodarone, terfenadine, cisapride, astemizole, quetiapine, alprazolam, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), pimozide, ergot derivatives, simvastatin or lovastatin (see section 4.4).
CRIXIVAN 400 mg hårde kapsler
CRIXIVAN 400 mg hard capsules
Saquinavir 800 mg SD (blød gelkapselformulering) (Indinavir 800 mg TID)
Saquinavir 800 mg SD (soft gel capsule formulation) (Indinavir 800 mg TID)
Saquinavir 600 mg SD (hård gelkapselformulering) (Indinavir 800 mg TID)
Saquinavir 600 mg SD (hard gel capsule formulation) (Indinavir 800 mg TID)
Når CRIXIVAN gives sammen med lægemidlet ritonavir:
In addition, when CRIXIVAN is given at the same time as the medicine ritonavir: Do not take either CRIXIVAN or ritonavir:
Omhyggelig monitorering af serumkoncentrationen eller den terapeutiske virkning, når disse lægemidler administreres samtidigt med indinavir/ritonavir.
Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ritonavir.
Dette betyder, at De i alt skal tage to 400 mg kapsler (800 mg) hver dag.
This means you will take a total of two 400 mg capsules (800 mg) each day.
Lactose, vandfri.
Anhydrous lactose.
Indinavir og isoniazid kan administreres samtidigt uden dosisjustering.
Indinavir and isoniazid can be co-administered without dose adjustment.
Morphinkoncentrationen kan falde på grund af induktion af glucuronidering i forbindelse med samtidig administration af ritonavir.
Interaction with indinavir/ritonavir not studied Morphine levels may be decreased due to induction of glucuronidation by coadministered ritonavir.
Kontakt straks Deres læge, hvis der opstår blødninger eller hvis De føler Dem svag.
If you notice bleeding or if you feel weak, talk to your doctor straight away.
Dette betyder, at De i alt skal tage seks 400 mg kapsler (2.400 mg) hver dag.
This means you will take a total of six 400 mg capsules (2400 mg) each day.
Hvis der opstår tegn og symptomer på nefrolitiasis, inklusive lændesmerter med eller uden hæmaturi (inklusive mikroskopisk hæmaturi), bør midlertidig seponering af behandling (fx 1-3 dage) under den akutte episode med nefrolitiasis eller seponering af behandling overvejes.
(including microscopic haematuria) occur, temporary interruption of therapy (e.g. for 1-3 days) during the acute episode of nephrolithiasis or discontinuation of therapy may be considered.
Dette betyder, at De i alt skal tage fire 200 mg kapsler (800 mg) hver dag.
This means you will take a total of four 200 mg capsules (800 mg) each day.
Ved samtidig administration af itraconazol anbefales dosisreduktion af CRIXIVAN til 600 mg hver 8. time.
Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended with administering itraconazole concurrently.
Samtidig brug af indinavir og naturlægemidler med perikon (hypericum perforatum) er kontraindiceret (se pkt.
Concurrent use of indinavir with herbal preparations containing St John's wort (Hypericum perforatum) is contraindicated (see section 4.5).
• smerte ved vandladning
• pain on urination
Ved steady state efter et dosisregime på 800 mg/100 mg indinavir/ritonavirterapi hver 12. time i kombination med et fedtfattigt måltid, opnåedes i en undersøgelse følgende geometriske middelværdier: AUC0-12 timer på 116067 nM·t (90% konfidensinterval = 101680, 132490), maksimale plasmakoncentrationer på 19001 nM (90% konfidensinterval = 17538,
At steady state following a dose regimen of 800 mg every 8 hours, HIV-seropositive adult patients in one study achieved geometric means of: AUC0-8h of 27,813 nM*h (90 % confidence interval = 22,185, 34,869), peak plasma concentrations 11,144 nM (90 % confidence interval = 9,192, 13,512) and plasma concentrations at 8 hours post dose 211 nM (90 % confidence interval = 163,
Antimykotika Fluconazol 400 mg QD (Indinavir 1000 mg TID)
Fluconazole 400 mg QD (Indinavir 1,000 mg TID)
Pruritus
Lactose
Yderligere bivirkninger
Possible side effects
CRIXIVAN 200 mg hårde kapsler Indinavir
CRIXIVAN 200 mg hard capsules indinavir
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når morphin administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when morphine is concomitantly administered with indinavir/ritonavir.
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge erythromycins og itraconazols plasmakoncentrationer.
Erythromycin, Itraconazole Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of erythromycin and itraconazole.
Indinavir og theophyllin kan administreres samtidigt uden dosisjustering.
Indinavir and theophylline can be co-administered without dose adjustment.
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når ketoconazol administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ritonavir.
Omhyggelig monitorering af terapeutisk virkning og bivirkninger anbefales, når dexamethason administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir.
Omhyggelig monitorering af terapeutisk virkning og bivirkninger anbefales, når tacrolimus administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ritonavir.
Insomnia, hypæstesi, paræstesi
headache, dizziness insomnia, hypoaesthesia; paraesthesia oral paraesthesia.
ANTIHISTAMINER Fexofenadin
ANTIHISTAMINES Fexofenadine
Osteonekrose
Osteonecrosis:
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når atovaquon administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir.
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når fentanyl administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ritonavir.
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når carbamazepin administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ritonavir.
Brug af anden medicin sammen med CRIXIVAN Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis De tager anden medicin, eller De har gjort det for nylig.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
• luft i maven
• acid reflux
samtidig administration
Recommendations concerning co-administration
CRIXIVAN 400 mg hårde kapsler indinavir
CRIXIVAN 400 mg hard capsules indinavir
CRIXIVAN 400 mg hårde kapsler Indinavir
CRIXIVAN 400 mg hard capsules Indinavir
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når fexofenadin administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when fexofenadine is concomitantly administered with indinavir/ritonavir.
Bivirkninger CRIXIVAN
Other medicines and CRIXIVAN
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge carbamazepins plasmakoncentration.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine.
Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når loratidin administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ritonavir.
Er De i tvivl så spørg lægen, apotekspersonalet eller sundhedspersonalet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge ketoconazols plasmakoncentration.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole.
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge fentanyls plasmakoncentration.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge tacrolimus' plasmakoncentration.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus.
Omhyggelig monitorering af terapeutisk virkning og bivirkninger anbefales, når buspiron administreres samtidigt med indinavir/ritonavir.
Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ritonavir.
800 mg/160 mg BID (Indinavir 400 mg QID)
Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (Indinavir 400 mg QID)
Asteni/træthed, smagsforstyrrelser, mavesmerter
Very common asthenia/fatigue, taste perversion, abdominal pain.
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge loratidins plasmakoncentration.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Oral paræstesi
Antifungals
Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge buspirons plasmakoncentration.
Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
CRIXIVAN 200 hårde kapsler indinavir
CRIXIVAN 200 mg hard capsules Indinavir
Merck Sharp & Dohme B.V., Waarderweg 39, P.O. Box 581, 2003 PC Haarlem, Holland
Box 581, 2003 PC Haarlem, The Netherlands
Internationalt fællesnavn (INN): anecortave
International Non-proprietary Name (INN): anecortave
De to kliniske hovedundersøgelser er udført hos patienter i alderen 51 til 96 år og har strakt sig over indtil to år.
The two main clinical studies were carried out in patients aged between 51 and 96 years of age, and lasted up to two years.
Denne ansøgning var på dag 180, da firmaet trak den tilbage.
The application was at Day 180 when the Company withdrew.
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for RETAANE
QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for RETAANE
Sammenlignet med fotodynamisk behandling var Retaane ikke lige så effektivt.
Compared to photodynamic therapy, Retaane was not as effective.
Hvad er Retaane?
What is Retaane?
Virkningerne af Retaane er først blevet testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
The effects of Retaane were first tested in experimental models before being studied in humans.
Firmaet har oplyst til CHMP, at der er kliniske undersøgelser i gang i Europa.
The Company has informed the CHMP that there are clinical trials currently running in Europe.
Det indeholder 30 mg/ml af det aktive stof anecortavacetat.
It contains 30 mg/ml of the active substance anecortave acetate.
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ikke var tilfredsstillende godtgjort og ikke opvejede de påviste risici.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig denne behandling.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Det er i stand til at standse eller bremse dannelsen af nye blodkar ved at gribe ind i produktionen af de proteiner, der er nødvendige for opbygningen af karrene, og af de vækstfaktorer, der er nødvendige for, at karrene kan brede sig.
It is able to stop or slow down the development of new blood vessels by interfering with the production of the proteins needed to build the vessels, and of the growth factors needed for the blood vessels to spread.
I undersøgelserne måltes synsstyrken (resultaterne af en synsprøve) for at finde ud af, hvordan patienterne havde reageret på behandlingen.
The studies measured visual acuity (the results of an eye test) to see how the patients had responded to treatment.
Firmaets brev til EMEA med meddelelsen om tilbagetrækningen for Retaane kan ses her.
The letter from the Company notifying the EMEA of the withdrawal of Retaane is available here.
Retaane skulle indsprøjtes hver 6. måned direkte i området bag øjet som en "depotindsprøjtning" (en form for indsprøjtning, hvor lægemidlet er præpareret på en sådan måde, at det optages meget langsomt i kroppen).
Retaane was to be injected every 6 months directly into the space behind the eye, as a ‘depot' injection (a type of injection where the medicine is prepared in such a way that it is absorbed by the body very slowly).
Retaane er en suspension til injektion i den ydre del af øjeæblet.
Retaane is a suspension for injection onto the outer part of the eye ball.
I den ene sammenlignedes Retaane i forskellige styrker (3 mg, 15 mg og 30 mg) med virkningsløs behandling (placebo) hos 128 patienter.
One compared Retaane at various strengths (3 mg, 15 mg or 30 mg) with a dummy treatment (placebo) in 128 patients.
Retaane forventedes at standse eller bremse denne dannelse af nye blodkar (neovaskularisering) i øjet.
Retaane was expected to be used to stop or slow down the development of these new blood vessels (neovascularisation) in the eye.
Hvad forventedes Retaane anvendt til?
What was Retaane expected to be used for?
Et program til anvendelse med særlig udleveringstilladelse er et program, hvor en læge kan anmode om udlevering af et lægemiddel til en bestemt sygdom, før lægemidlet er endeligt godkendt.
A compassionate use programme is a programme through which doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised.
CHMP fandt grund til betænkelighed ved, at virkningen af Retaane var ringere end udvalget forventede: Retaane havde nogen virkning i forhold til placebo, men mange patienter "faldt ud" (udgik af undersøgelsen), før den var afsluttet, og dette anfægter resultaternes pålidelighed.
The CHMP had concerns that the effectiveness of Retaane was less than what they expected to see: Compared to placebo, Retaane has some effectiveness, but many patients were ‘lost' (exited the study) before the end of the study; and this affects the reliability of the results.
Anecortav, det aktive stof i Retaane, minder i sin struktur om cortisol, der er et naturligt hormon i organismen.
Anecortave, the active substance in Retaane, is similar in structure to cortisol, a natural hormone in the body.
Efter at CHMP havde vurderet firmaets besvarelse af en række spørgsmål, tilbagestod der fortsat uafklarede punkter.
After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues.
På grundlag af gennemgangen af den indledende dokumentation opstiller CHMP en række spørgsmål (på dag 120), der forelægges
Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
I den anden sammenlignedes virkningen af Retaane 15 mg med fotodynamisk behandling (standardbehandlingen af den våde form af AMD, hvor man ved hjælp af laser ødelægger de nydannede blodkar) hos 530 patienter.
The second compared the effect of Retaane 15 mg to photodynamic therapy (the standard treatment for the wet form of AMD, where laser treatment is used to destroy the newly formed blood vessels) in 530 patients.
Hvordan forventes Retaane at virke?
How is Retaane expected to work?
Firmaet vil fortsætte de to kliniske undersøgelser hos patienter med våd AMD samt den kliniske undersøgelse af patienter, der har tør AMD og risiko for at vikle våd AMD.
The Company plans to continue the two clinical trials in wet AMD patients, as well as the clinical trial in dry AMD patients at risk of developing wet AMD.
Firmaet har desuden til hensigt at forsætte programmet for anvendelse med særlig udleveringstilladelse, baseret på engangsanvendelse.
The Company also plans to continue their compassionate use programme on a case-by-case basis.
Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål var der i CHMP betænkelighed, og udvalgets foreløbige standpunkt var, at Retaane ikke kunne godkendes til behandling af subfoveal koroidal neovaskularisering med klassisk komponent som følge af aldersbetinget makuladegeneration.
Based on the review of the data submitted and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Retaane could not be approved for the treatment of subfoveal choroidal neovascularisation with classic component due to age-related macular degeneration.
Retaane forventedes anvendt til behandling af den våde form af aldersbetinget makuladegeneration.
Retaane was expected to be used to treat patients with the wet form of age-related macular degeneration.
Sygdommen angriber den centrale del af nethinden (som kaldes den gule plet eller makula) bagest i øjet og medfører synstab.
This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision.
Den 28. februar 2006 underrettede Alcon Laboratories (U.K.) Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP) om, at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for Retaane til behandling af subfoveal koroidal neovaskularisering (CNV) med klassisk komponent som følge af aldersbetinget makuladegeneration (AMD).
have officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Retaane, for the treatment of subfoveal choroidal neovascularisation (CNV) with classic component due to age-related macular degeneration (AMD).
Den våde form af sygdommen skyldes dannelse af abnorme blodkar under nethinden og den gule plet.
The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid.
Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (på dag 180).
may, before giving an opinion, ask any remaining question(s) (at day 180).
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Retaane eller i programmer for anvendelse med særlig udleveringstilladelse?
What are the consequences of the withdrawal for patients undergoing clinical trials /
Syv undersøgelsescentre i tre lande er blevet undersøgt.
Seven sites in three countries have been investigated.
Undersøgelsen var veludført og i overensstemmelse med gældende videnskabelige standarder.
The study was well conducted and according to current scientific standards.
Den 27. September 2012 afholdtes plenarmøde i Det Stående Udvalg for Veterinærlægemidler.
On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place.
Ansøgningen blev indgivet med Tyskland som referencemedlemsstat og med Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien og Det Forenede Kongerige som berørte medlemsstater.
The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Relevansen af det valgte positive kontrolprodukt
Relevance of the choice of positive control product
Den højere dosering og behandlingsvarighed er godkendt i en række EU medlemsstater, f.eks. Danmark, Nederlandene og Det Forenede Kongerige.
These higher doses and duration of treatment are authorised in a number of EU Member States, e.g. Denmark, the Netherlands and the United Kingdom.
Efter gennemgang af de forelagte oplysninger konkluderede udvalget følgende vedrørende de rejste spørgsmål i anmeldelsen fra Tyskland.
Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Liste over navne, lægemiddelform, styrke på det veterinærmedicinske produkt, dyrearter, administrationsmåde, ansøger i medlemslandene
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
I henhold til bestemmelserne i bilag I til direktiv 2001/82/EF skal et positivt kontrolprodukt være godkendt efter gældende europæisk lovgivning.
According to the legal provisions set out in Annex I of Directive 2001/82/EC a positive control product should be an authorised product according to current European legislation.
Undersøgelsens design skal følge designet af feltundersøgelse V-0049-0059 hvad angår inklusions- og eksklusionskriterier og kliniske endepunkter.
The design of the field study should follow the design of the field study V-0049-0059 in terms of the inclusion/exclusion criteria and clinical endpoints.
Der foreligger ikke sikre oplysninger om fordelingen af florfenicol på infektionsstedet.
No robust information is available about the distribution of florfenicol to the site of infection.
Da aktiviteten af florfenicol er tidsafhængig, skal den aktive koncentration være over MIC-værdien i et vist tidsrum.
As the activity of florfenicol is time dependent, the active concentration has to be above MIC for a certain time.