natgillin/translations-raw huggingface dataset:
Mirapexin 1,57 mg depottabletter
MIRAPEXIN 1.57 mg prolonged-release tablets
Mirapexin 1,05 mg depottabletter EU/1/97/051/019-021
MIRAPEXIN 1.05 mg prolonged-release tablets EU/1/97/051/019-021
Mirapexin 3,15 mg depottabletter EU/1/97/051/025-027
MIRAPEXIN 3.15 mg prolonged-release tablets EU/1/97/051/025-027
EU/1/97/051/022-024
EU/1/97/051/002 [100 tablets]
Mirapexin 0,7 mg tabletter Hver tablet indeholder 1,0 mg pramipexol dihydrochloridmonohydrat svarende til 0,7 mg pramipexol.
MIRAPEXIN 0.26 mg prolonged-release tablets Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,35 mg
INFORMATION IN BRAILLE MIRAPEXIN 0.35 mg
INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,52 mg depottabletter
INFORMATION IN BRAILLE MIRAPEXIN 0.52 mg prolonged-release tablets
Mirapexin 1,57 mg depottabletter EU/1/97/051/028-030
MIRAPEXIN 1.57 mg prolonged-release tablets EU/1/97/051/028-030
INFORMATION I BRAILLESKRIFT MIRAPEXIN 1,57 mg depottabletter
INFORMATION IN BRAILLE MIRAPEXIN 1.57 mg prolonged-release tablets
Hver tablet indeholder 0,125 mg pramipexol dihydrochloridmonohydrat svarende til 0,088 mg pramipexol.
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
1 MIRAPEXIN tablet á 0,088 mg
1 tablet MIRAPEXIN 0.088 mg
1 MIRAPEXIN tablet á 0,18 mg
1 tablet MIRAPEXIN 0.18 mg
3 MIRAPEXIN tabletter á 0,18 mg
3 tablets MIRAPEXIN 0.18 mg
INFORMATION I BRAILLESKRIFT MIRAPEXIN 2,1 mg depottabletter
INFORMATION IN BRAILLE MIRAPEXIN 2.1 mg prolonged-release tablets
1 MIRAPEXIN tablet á 0,18 mg 3 gange om dagen
1 tablet MIRAPEXIN 0.18 mg three times a day OR
2 MIRAPEXIN tabletter á 0,18 mg
2 tablets MIRAPEXIN 0.18 mg
LÆGEMIDLETS NAVN MIRAPEXIN 2,62 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.62 mg prolonged-release tablets Pramipexole
INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,18 mg
INFORMATION IN BRAILLE MIRAPEXIN 0.18 mg
Mirapexin 2,1 mg depottabletter
MIRAPEXIN 2.1 mg prolonged-release tablets
LÆGEMIDLETS NAVN MIRAPEXIN 0,088 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.088 mg tablets Pramipexole
6.1 Hjælpestoffer mannitol majsstivelse kolloid vandfri silica povidon K 25 magnesiumstearat
Colloidal anhydrous silica Magnesium stearate
Hver depottablet indeholder 1,5 mg pramipexol dihydrochloridmonohydrat svarende til 1,05 mg pramipexol.
Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
Hvis du har Parkinsons sygdom, bør du ikke stoppe behandlingen med MIRAPEXIN pludseligt, da det kan medføre en sygelig tilstand, der udgør en alvorlig helbredsrisiko (malignt neuroleptika syndrom).
If you suffer from Parkinson's disease you should not stop treatment with MIRAPEXIN abruptly.
INFORMATION I BRAILLESKRIFT MIRAPEXIN 0,7 mg
INFORMATION IN BRAILLE MIRAPEXIN 0.7 mg
• Vægttab samt nedsat appetit
- Vomiting (being sick) - Weight loss including decreased appetite
Mirapexin 0,52 mg depottabletter
MIRAPEXIN 0.52 mg prolonged-release tablets
Hver depottablet indeholder 3 mg pramipexol dihydrochloridmonohydrat svarende til 2,1 mg pramipexol.
Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
LÆGEMIDLETS NAVN MIRAPEXIN 0,35 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.35 mg tablets Pramipexole
Hver depottablet indeholder 3,75 mg pramipexol dihydrochloridmonohydrat svarende til 2,62 mg pramipexol.
Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,125 mg pramipexoldihydrochloridmonohydrat svarende til 0,088 mg pramipexol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
4 MIRAPEXIN tabletter á 0,088 mg
4 tablets MIRAPEXIN 0.088 mg
2 MIRAPEXIN tabletter á 0,088 mg
2 tablets MIRAPEXIN 0.088 mg
Dosis skal øges gradvist hver 5.-7. dag fra en startdosis på 0,264 mg base (0,375 mg salt)/døgn.
Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5-7 days.
• Ufrivillige bevægelser af arme og ben (dyskinesi) Hvis du har Parkinsons sygdom i fremskreden grad og samtidig behandles med levodopa, kan der være risiko for udvikling af ufrivillige bevægelser (dyskinesi), når MIRAPEXIN-dosis øges
If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of MIRAPEXIN.
Hver depottablet indeholder 4,5 mg pramipexol dihydrochloridmonohydrat svarende til 3,15 mg pramipexol.
Each prolonged-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 3.15 mg pramipexole.
LÆGEMIDLETS NAVN MIRAPEXIN 0,7 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.7 mg tablets Pramipexole
Hver depottablet indeholder 2,25 mg pramipexol dihydrochloridmonohydrat svarende til 1,57 mg pramipexol.
Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.
Hvis du tager beroligende medicin eller drikker alkohol, kan MIRAPEXIN påvirke din evne til at køre bil og håndtere maskiner.
4.7 Effects on ability to drive and use machines MIRAPEXIN can have a major influence on the ability to drive and use machines.
6 MIRAPEXIN tabletter á 0,088 mg
6 tablets MIRAPEXIN 0.088 mg
Hver tablet indeholder 0,5 mg pramipexol dihydrochloridmonohydrat svarende til 0,35 mg pramipexol.
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Dosis skal øges gradvist hver 5.-7. dag fra en startdosis på 0,26 mg base (0,375 mg salt)/dag.
Doses should be increased gradually from a starting dose of 0.26 mg of base (0.375 mg of salt) per day and then increased every 5-7 days.
LÆGEMIDLETS NAVN MIRAPEXIN 1,57 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.57 mg prolonged-release tablets Pramipexole
Mirapexin 0,26 mg depottabletter
MIRAPEXIN 0.26 mg prolonged-release tablets
LÆGEMIDLETS NAVN MIRAPEXIN 0,18 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.18 mg tablets Pramipexole
LÆGEMIDLETS NAVN MIRAPEXIN 1,05 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.05 mg prolonged-release tablets Pramipexole
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/016 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/017 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/018 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/016 [10 prolonged-release tablets] EU/1/97/051/017 [30 prolonged-release tablets] EU/1/97/051/018 [100 prolonged-release tablets]
LÆGEMIDLETS NAVN MIRAPEXIN 3,15 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 3.15 mg prolonged-release tablets Pramipexole
Hver tablet indeholder 0,25 mg pramipexol dihydrochloridmonohydrat svarende til 0,18 mg pramipexol.
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
I den første uge er dosis oftest 1 MIRAPEXIN tablet á 0,088 mg én gang daglig.
During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 1,0 mg pramipexoldihydrochloridmonohydrat svarende til 0,7 mg pramipexol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
1, delirium usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger (såsom overdrevent indkøbsmønster, ludomani, hyperseksualitet, uhæmmet fødeindtagelse)
Psychiatric disorders insomnia abnormal dreams restlessness confusion hallucinations libido disorder delusion hyperphagia paranoia mania delirium behavioural symptoms of impulse control disorders and compulsions (such as: compulsive shopping, pathological gambling, hypersexuality, binge eating)
LÆGEMIDLETS NAVN MIRAPEXIN 2,1 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.1 mg prolonged-release tablets Pramipexole
Kan forekomme hos mellem 1 og 10 ud af 100 patienter Ikke almindelig Kan forekomme hos mellem 1 og 10 ud af 1000 patienter Sjælden
Rare may affect up to 1 in 1,000 people
Tabletterne er hvide, flade, runde med delekærv på begge sider og er præget med en kode på begge sider (P9 hhv. Boehringer Ingelheim logo).
The tablets are white, flat, of round shape, scored on both sides, and have a code embossed (one side with the code P9, and one side with the Boehringer Ingelheim company symbol).
Tabletterne er hvide, flade, ovale med delekærv på begge sider og er præget med en kode på begge sider (P8 hhv. Boehringer Ingelheim logo)
The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,5 mg pramipexoldihydrochloridmonohydrat svarende til 0,35 mg pramipexol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 0,25 mg pramipexoldihydrochloridmonohydrat svarende til 0,18 mg pramipexol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/025 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/026 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/027 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/025 [10 prolonged-release tablets] EU/1/97/051/026 [30 prolonged-release tablets] EU/1/97/051/027 [100 prolonged-release tablets]
Tabletterne er hvide, flade, ovale med delekærv på begge sider og er præget med en kode på begge sider (P7 hhv. Boehringer Ingelheim logo).
The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P7, and one side with the Boehringer Ingelheim company symbol).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/031 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/032 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/033 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/031 [10 prolonged-release tablets] EU/1/97/051/032 [30 prolonged-release tablets] EU/1/97/051/033 [100 prolonged-release tablets]
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En depottablet indeholder 0,375 mg pramipexoldihydrochloridmonohydrat svarende til 0,26 mg pramipexol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/022 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/023 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/024 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/022 [10 prolonged-release tablets] EU/1/97/051/023 [30 prolonged-release tablets] EU/1/97/051/024 [100 prolonged-release tablets]
Hver depottablet indeholder 0,75 mg pramipexol dihydrochloridmonohydrat svarende til 0,52 mg pramipexol.
Each prolonged-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole.
• Unormale, ufrivillige bevægelser (dyskinesi)
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
MIRAPEXIN findes i blisterpakninger med 10 tabletter i hver blisterstrip.
All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/019 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/020 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/021 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/019 [10 prolonged-release tablets] EU/1/97/051/020 [30 prolonged-release tablets] EU/1/97/051/021 [100 prolonged-release tablets]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/028 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/029 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/030 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/028 [10 prolonged-release tablets] EU/1/97/051/029 [30 prolonged-release tablets] EU/1/97/051/030 [100 prolonged-release tablets]
Tabletterne er hvide til råhvide, runde med skrå kanter og er præget med en kode på begge sider (P1 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P1, and one side with the Boehringer Ingelheim company symbol).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/051/013 [MIRAPEXIN, 10 depottabletter] EU/1/97/051/014 [MIRAPEXIN, 30 depottabletter] EU/1/97/051/015 [MIRAPEXIN, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/013 [10 prolonged-release tablets] EU/1/97/051/014 [30 prolonged-release tablets] EU/1/97/051/015 [100 prolonged-release tablets]
MIRAPEXIN 0,088 mg er hvide, runde, flade tabletter og er uden delekærv.
What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.
LÆGEMIDLETS NAVN MIRAPEXIN 0,52 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.52 mg prolonged-release tablets Pramipexole
Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P5 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P5, and one side with the Boehringer Ingelheim company symbol).
Oversigt over indlægssedlen:
The following dose schedule is suggested:
Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P12 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol).
Tabletterne er hvide, flade, runde og præget med en kode på begge sider (P6 hhv. Boehringer Ingelheim logo).
The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol).
Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P13 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P13, and one side with the Boehringer Ingelheim company symbol).
Tabletterne er hvide til råhvide, runde med skrå kanter og er præget med en kode på begge sider (P2 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P2, and one side with the Boehringer Ingelheim company symbol).
- Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P4 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P4, and one side with the Boehringer Ingelheim company symbol).
LÆGEMIDLETS NAVN MIRAPEXIN 0,26 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.26 mg prolonged-release tablets Pramipexole
• Delirium (nedsat bevidsthed, forvirring, manglende realitetsopfattelse)*
(eating more food than normal and more than is needed to satisfy your hunger)* - Delirium (decreased awareness, confusion, loss of reality)
• Åndenød (dyspnø)
Dyspnoea hiccups
Tabletterne er hvide til råhvide, ovale, og er præget med en kode på begge sider (P3 hhv. Boehringer Ingelheim logo).
The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P3, and one side with the Boehringer Ingelheim company symbol).
Hos patienter med Parkinsons sygdom og nedsat nyrefunktion bør dosis reduceres, se pkt.
When prescribing MIRAPEXIN in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Dosering
Pramipexole
1 MIRAPEXIN tablet á 0,35 mg og 1
1 tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR
Nedsat nyrefunktion
Magnesium stearate
2 MIRAPEXIN 0,52 mg depottabletter, ELLER
two MIRAPEXIN 0.52 mg prolonged-release tablets, OR four MIRAPEXIN 0.26 mg prolonged-release tablets.
40 (1 patron x 40) tabletter
40 (1 cartridge x 40) tablets
Styrke Lægemiddelform Administration
Strength Pharmaceutical Form
Emballage Paknings-størrelse
Immediate Packaging Pack size
Styrke Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse EU/1/10/665/001 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 30 tabletter EU/1/10/665/002 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 60 tabletter EU/1/10/665/003 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 100 tabletter EU/1/10/665/004 Entacapone Teva 200 mg Filmovertrukket tablet Oral anvendelse Glas (HDPE) 175 tabletter
Strength Pharmaceutical Form Route of Administration
MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Alle indikationer er ikke godkendt i alle EU-medlemsstater.
All indications are not authorised in all EU MS.
Hypersensitivitetsreaktioner
Hypersensitivity reactions
Kun disse ændringer, der er vedtaget og omfattet af CMDh's standpunkt, er retligt bindende og skal gennemføres af medlemsstaterne.
Only these amendments, adopted and included in the CMDh position, are legally binding and must be implemented by the Member States.
2 - CMDh's reviderede standpunkt
2 - CMDh revised position
PRAC bemærkede, at den skønnede eksponering alene for de oprindelige produkter er over 50 mio. patientår på verdensbasis, og i EU cirka 6,8 mio. patientår gennem det seneste tiår.
The PRAC noted that the worldwide estimated exposure of the originator's products alone is over 50 million patient-years and, in the EU over the last decade, around 6.8 million patient-years.
Disse udgør størstedelen af den foreliggende evidens, navnlig ved de indikationer, der blev godkendt først (f.eks. indikationen som sekretolytisk middel).
These constitute the majority of the available evidence, in particular in the indications that were first authorised (e.g. secretolytic indication).
1 - Samlet resumé af PRAC's videnskabelige vurdering Spørgsmål vedrørende sikkerhed
1 - Overall summary of the scientific evaluation by the PRAC Safety issues
PDCO var desuden af den opfattelse, at disse produkter ikke længere er den foretrukne behandlingsmulighed ved IRDS.
The PDCO was also of the view that these products are no longer the preferred treatment option in IRDS.
CMDh's udtalelse blev overgivet til Europa-Kommissionen.
The CMDh position was forwarded to the European Commission.
Ud fra sin kliniske erfaring var PDCO af den opfattelse, at der ikke er behov for disse produkter til denne indikation til børn under 2 år.
Based on its clinical experience, the PDCO was of the view that there is no need for the use of these products in this indication in children below 2 years of age.
Det vedgås, at størstedelen af indikationerne bygger på gamle undersøgelser, der har begrænsninger og mangler.
It is acknowledged that most of the indications are supported by old studies presenting limitations and deficiencies.
Evidensens omfang gjorde det ikke muligt at foretage yderligere stratificering efter aldersgruppe.
The level of evidence did not allow for further stratification by age group.
Desuden er det ved sådanne sygdomme en udfordring at definere de relevante kliniske endepunkter og måle symptomerne (Rubin, 2007).
Further, the definition of the relevant clinical endpoints and the measurement of symptoms in these conditions are challenging (Rubin, 2007).
Mange lægemiddelreaktioner kan ikke skelnes fra naturligt forekommende eller infektionsbetingede eruptioner, hvorfor fejldiagnose er almindelig.
Many drug reactions cannot be distinguished from naturally occurring or infection-induced eruptions, and thus misdiagnosis is common.
Dette er ikke uventet i betragtning af de metodologiske udfordringer, der kendetegner dette behandlingsområde, og de normer og krav vedrørende evidens, der var gældende, da disse produkter først blev udviklet.
This is not unexpected considering the methodological challenges inherent to this therapeutic area and evidential standards and requirements at the time when these products were first developed.
Under et møde i Det Stående Udvalg for Humanmedicinske Lægemidler blev der af nogle medlemsstater under beslutningsprocessen rejst nye spørgsmål af teknisk art, som de ikke fandt tilstrækkeligt behandlet i PRAC's anbefaling og CMDh's udtalelse.
During the decision making process, at a meeting of the Standing Committee on Medicinal Products for Human Use, some Member States raised new questions of technical nature which they considered had not been sufficiently addressed in the PRAC recommendation and CMDh position.
Oftest får disse patienter flere forskellige lægemidler samtidig, og årsagssammenhængen er vanskelig at vurdere.
Most often these patients receive a number of drugs concomitantly and causality assessment is difficult.
På denne baggrund blev PRAC's anbefaling og CMDh's udtalelse henvist til agenturet til fornyet overvejelse.
In light of this, the PRAC recommendation and CMDh position was referred back to the Agency for further consideration.
Øjeblikkelig opdagelse af svære reaktioner og tidlig seponering af det udløsende lægemiddel er imidlertid den vigtigste faktor til minimering af morbiditet og mortalitet.
However, prompt recognition of severe reactions and early withdrawal of the causative agent is the most important factor to minimise morbidity and mortality.
Det vedgås, at den kliniske evidens fra undersøgelser hos børn er svag pga. deres uensartethed og det lavere antal indrullerede patienter.
It is acknowledged that clinical evidence from studies in children is weak due to their heterogeneity and to the lower number of children enrolled.
Desuden drøftede PRAC behovet for at udføre undersøgelser efter godkendelse og konkluderede, at sådanne undersøgelser sandsynligvis ikke ville føre til nye holdbare oplysninger eller mere endelige konklusioner.
In addition, the PRAC discussed the need to conduct post-authorisation studies, and concluded that such studies would likely not generate new robust information towards more definite conclusions.
Intervallet mellem PSUR'er bør derfor nedsættes til 3 år for at give mulighed for regelmæssig gennemgang af disse analyser.
Consequently the PSUR cycle should be shortened to a 3-yearly cycle in order to periodically review these analyses.
Lægemidler indeholdende ambroxol og bromhexin blev første gang registreret i en EU-medlemsstat i hhv. 1978 og 1963 og er nu godkendt i alle EU-medlemsstater (foruden Norge og Island) bortset fra Det Forenede Kongerige.
Ambroxol- and bromhexine-containing medicinal products have first been registered in a European Union (EU) Member State (MS) in 1978 and 1963, respectively, and are currently authorised in all EU MSs (as well as in Norway and Iceland) except the United Kingdom.
PRAC gennemgik også de foreliggende data hos den pædiatriske population.
The PRAC also considered the available data in the paediatric population.