natgillin/translations-raw huggingface dataset:
Det kan betyde, at du ikke får nok ilt ud i vævene, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler') - hvis du har en leversygdom - hvis du drikker meget alkohol, enten hver dag eller kun nogle gange (se 'Jentadueto sammen med alkohol').
- if you drink alcohol to excess, either every day or only from time to time (see section 'Jentadueto with alcohol').
Jentadueto 2,5 mg/850 mg er ovale, bikonvekse lysorange filmovertrukne tabletter.
Jentadueto 2.5 mg/850 mg are oval, biconvex, light orange, film-coated tablets (tablets).
En hovedmetabolit med en relativ eksponering på 13,3 % af linagliptin-dosis ved steady state blev påvist.
One main metabolite with a relative exposure of 13.3% of linagliptin at steady-state was detected which was found to be pharmacologically inactive, and thus does not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Der er blevet observeret bulløs pemfigoid hos patienter, der tog linagliptin.
Bullous pemphigoid has been observed in patients taking linagliptin.
Det skal du vide, før du begynder at tage Jentadueto Sådan skal du tage Jentadueto Bivirkninger
What Jentadueto is and what it is used for What you need to know before you take Jentadueto How to take Jentadueto
Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter Filmovertræk
Jentadueto 2.5 mg/1,000 mg film-coated tablets Film coating
Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter linagliptin/metforminhydrochlorid
Jentadueto 2.5 mg / 850 mg film-coated tablets Jentadueto 2.5 mg / 1,000 mg film-coated tablets linagliptin/metformin hydrochloride
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - INDERPAKNING UDEN BLUE BOX - 2,5 mg/1.000 mg FILMOVERTRUKNE TABLETTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/032 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/033 (180 (2 x 90 x 1) filmovertrukne tabletter ) EU/1/12/780/034 (200 (2 x 100 x 1) filmovertrukne tabletter )
MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
LÆGEMIDLETS NAVN Jentadueto 2,5 mg/1.000 mg tabletter linagliptin/metformin HCl
NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg tablets Linagliptin/metformin HCl
LÆGEMIDLETS NAVN Jentadueto 2,5 mg/850 mg tabletter linagliptin/metformin HCl
NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg tablets Linagliptin/metformin HCl
Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikke-dødeligt MI, ikke-dødelig apopleksi) Sekundært sammensat renalt (nyredød, ESRD, 40 % vedvarende reduktion i eGFR) Mortalitet uanset årsag
Secondary renal composite (renal death, ESRD, 40% sustained decrease in eGFR)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/029 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/030 (180 (2 x 90 x 1) filmovertrukne tabletter ) EU/1/12/780/031 (200 (2 x 100 x 1) filmovertrukne tabletter )
MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Hver tablet indeholder 2,5 mg linagliptin og 850 mg metforminhydrochlorid.
Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter Hver tablet indeholder 2,5 mg linagliptin og 1.000 mg metforminhydrochlorid.
Jentadueto 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg linagliptin og 850 mg metforminhydrochlorid
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride
Et 12-ugers dobbeltblindet placebokontrolleret studie undersøgte effekt og sikkerhed af linagliptin 2,5 mg 2 gange dagligt vs 5 mg én gang dagligt i kombination med metformin hos patienter i metformin-monoterapi med utilstrækkelig glykæmisk kontrol.
The efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 12 weeks duration.
Etnisk oprindelse
Gender
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg linagliptin og 1.000 mg metforminhydrochlorid
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride
Iodholdige kontrastmidler
Iodinated contrast agents
så fald vil lægen måske nedsætte dosis af insulin eller sulfonylurinstof for at undgå lavt blodsukker (hypoglykæmi).
Jentadueto in order to avoid low blood sugar (hypoglycaemia).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE AF MULTIPAKNING PAKKET I TRANSPARENT FOLIE - MED BLUE BOX - 2,5 mg/1.000 mg FILMOVERTRUKNE TABLETTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
Linagliptin 2,5 mg to gange dagligt + metformin HCl 500 mg to gange dagligt
Twice Daily Metformin HCl 500 mg
Du må ikke holde op med at tage Jentadueto uden at tale med lægen først.
Keep taking Jentadueto until your doctor tells you to stop.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/026 14 filmovertrukne tabletter EU/1/12/780/027 60 filmovertrukne tabletter EU/1/12/780/028 180 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/026 14 film-coated tablets EU/1/12/780/027 60 film-coated tablets EU/1/12/780/028 180 film-coated tablets
Hvis du har taget for meget Jentadueto
If you take more Jentadueto than you should
Jentadueto kan dog sammen med sulfonylurinstof eller insulin medføre for lavt blodsukker (hypoglykæmi).
However, taking Jentadueto in combination with medicines called sulphonylureas or with insulin can cause too low blood sugar level (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold.
Beholder Hold beholderen tæt tillukket for at beskytte mod fugt.
Bottle Keep the bottle tightly closed in order to protect from moisture.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/012 14 filmovertrukne tabletter EU/1/12/780/013 60 filmovertrukne tabletter EU/1/12/780/014 180 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/012 14 film-coated tablets EU/1/12/780/013 60 film-coated tablets EU/1/12/780/014 180 film-coated tablets
Samtidig administration af metformin og
Co-administration of metformin with
Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde køn ikke nogen klinisk relevant indvirkning på linagliptins farmakokinetik.
Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Beholder: Beholderen holdes lukket for at beskytte mod fugt.
Bottle: Keep the bottle tightly closed in order to protect from moisture.
LÆGEMIDLETS NAVN Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter linagliptin/metforminhydrochlorid
NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg film-coated tablets Linagliptin/metformin hydrochloride
Hver Jentadueto 2,5 mg/850 mg filmovertrukket tablet indeholder 2,5 mg linagliptin og 850 mg metforminhydrochlorid.
- Each Jentadueto 2.5 mg/850 mg film-coated tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
LÆGEMIDLETS NAVN Jentadueto 2,5 mg/850 mg filmovertrukne tabletter linagliptin/metforminhydrochlorid
NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Linagliptin/metformin hydrochloride
Den maksimale daglige dosis er 3.000 mg Dosisreduktion kan overvejes i forbindelse med tiltagende nedsættelse af nyrefunktionen.
Dose reduction may be considered in relation to declining renal function.
Lactatacidose meget sjælden
Lactic acidosis very rare
Hver Jentadueto 2,5 mg/1.000 mg filmovertrukket tablet indeholder 2,5 mg linagliptin og 1.000 mg metforminhydrochlorid.
- Each Jentadueto 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
De er præget med henholdsvis Boehringer Ingelheims logo og D2/1000.
They have "D2/1000" debossed on one side and the Boehringer Ingelheim logo debossed on the other.
Kontakt lægen for at få yderligere vejledning, hvis noget af ovennævnte gælder for dig.
If any of the above apply to you, talk to your doctor for further instructions.
Hvis du er overvægtig, skal du fortsætte med din energibegrænsede diæt, som du er blevet instrueret i. Det er ikke sandsynligt, at Jentadueto medfører unormalt lavt blodsukker (hypoglykæmi).
If you are overweight, continue your energy-restricted diet as instructed.
opkastning mavesmerter muskelkramper almen utilpashed med udpræget træthed vejrtrækningsbesvær nedsat kropstemperatur og langsommere puls
Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Bulløs pemfigoid sjælden
Bullous pemphigoid rare #
Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde alder ikke nogen klinisk relevant indflydelse på linagliptins farmakokinetik.
Age did not have a clinically relevant impact on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
- hvis du tager insulin eller et sulfonylurinstof (anden diabetesmedicin) sammen med Jentadueto.
- if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or sulphonylurea when you take either of them together with
De er præget med henholdsvis Boehringer Ingelheims logo og D2/850.
They have "D2/850" debossed on one side and the Boehringer Ingelheim logo debossed on the other.
Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter EU/1/12/780/015 (10 x 1 filmovertrukne tabletter) EU/1/12/780/016 (14 x 1 filmovertrukne tabletter) EU/1/12/780/017 (28 x 1 filmovertrukne tabletter) EU/1/12/780/018 (30 x 1 filmovertrukne tabletter) EU/1/12/780/019 (56 x 1 filmovertrukne tabletter) EU/1/12/780/020 (60 x 1 filmovertrukne tabletter) EU/1/12/780/021 (84 x 1 filmovertrukne tabletter) EU/1/12/780/022 (90 x 1 filmovertrukne tabletter) EU/1/12/780/023 (98 x 1 filmovertrukne tabletter) EU/1/12/780/024 (100 x 1 filmovertrukne tabletter) EU/1/12/780/025 (120 x 1 filmovertrukne tabletter) EU/1/12/780/026 (14 filmovertrukne tabletter, beholder) EU/1/12/780/027 (60 filmovertrukne tabletter, beholder) EU/1/12/780/028 (180 filmovertrukne tabletter, beholder) EU/1/12/780/032 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/033 (180 (2 x 90 x 1) filmovertrukne tabletter) EU/1/12/780/034 (200 ( 2 x 100 x 1) filmovertrukne tabletter)
Jentadueto 2.5 mg/1,000 mg film-coated tablets EU/1/12/780/015 (10 x 1 film-coated tablets) EU/1/12/780/016 (14 x 1 film-coated tablets) EU/1/12/780/017 (28 x 1 film-coated tablets) EU/1/12/780/018 (30 x 1 film-coated tablets) EU/1/12/780/019 (56 x 1 film-coated tablets) EU/1/12/780/020 (60 x 1 film-coated tablets) EU/1/12/780/021 (84 x 1 film-coated tablets) EU/1/12/780/022 (90 x 1 film-coated tablets) EU/1/12/780/023 (98 x 1 film-coated tablets) EU/1/12/780/024 (100 x 1 film-coated tablets) EU/1/12/780/025 (120 x 1 film-coated tablets) EU/1/12/780/026 (14 film-coated tablets, bottle) EU/1/12/780/027 (60 film-coated tablets, bottle) EU/1/12/780/028 (180 film-coated tablets, bottle) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
EU/1/12/780/001 10 x 1 filmovertrukne tabletter EU/1/12/780/002 14 x 1 filmovertrukne tabletter EU/1/12/780/003 28 x 1 filmovertrukne tabletter EU/1/12/780/004 30 x 1 filmovertrukne tabletter EU/1/12/780/005 56 x 1 filmovertrukne tabletter EU/1/12/780/006 60 x 1 filmovertrukne tabletter EU/1/12/780/007 84 x 1 filmovertrukne tabletter EU/1/12/780/008 90 x 1 filmovertrukne tabletter EU/1/12/780/009 98 x 1 filmovertrukne tabletter EU/1/12/780/010 100 x 1 filmovertrukne tabletter EU/1/12/780/011 120 x 1 filmovertrukne tabletter
EU/1/12/780/001 10 x 1 film-coated tablets EU/1/12/780/002 14 x 1 film-coated tablets EU/1/12/780/003 28 x 1 film-coated tablets EU/1/12/780/004 30 x 1 film-coated tablets EU/1/12/780/005 56 x 1 film-coated tablets EU/1/12/780/006 60 x 1 film-coated tablets EU/1/12/780/007 84 x 1 film-coated tablets EU/1/12/780/008 90 x 1 film-coated tablets EU/1/12/780/009 98 x 1 film-coated tablets EU/1/12/780/010 100 x 1 film-coated tablets EU/1/12/780/011 120 x 1 film-coated tablets
På grund af det aktive stof metformin anbefales Jentadueto ikke til patienter med nedsat leverfunktion (se pkt.
Jentadueto is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Jentadueto 2,5 mg/850 mg filmovertrukne tabletter EU/1/12/780/001 (10 x 1 filmovertrukne tabletter) EU/1/12/780/002 (14 x 1 filmovertrukne tabletter) EU/1/12/780/003 (28 x 1 filmovertrukne tabletter) EU/1/12/780/004 (30 x 1 filmovertrukne tabletter) EU/1/12/780/005 (56 x 1 filmovertrukne tabletter) EU/1/12/780/006 (60 x 1 filmovertrukne tabletter) EU/1/12/780/007 (84 x 1 filmovertrukne tabletter) EU/1/12/780/008 (90 x 1 filmovertrukne tabletter) EU/1/12/780/009 (98 x 1 filmovertrukne tabletter) EU/1/12/780/010 (100 x 1 filmovertrukne tabletter) EU/1/12/780/011 (120 x 1 filmovertrukne tabletter) EU/1/12/780/012 (14 filmovertrukne tabletter, beholder) EU/1/12/780/013 (60 filmovertrukne tabletter, beholder) EU/1/12/780/014 (180 filmovertrukne tabletter, beholder) EU/1/12/780/029 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/030 (180 (2 x 90 x 1) filmovertrukne tabletter) EU/1/12/780/031 (200 (2 x 100 x 1) filmovertrukne tabletter)
Jentadueto 2.5 mg/850 mg film-coated tablets EU/1/12/780/001 (10 x 1 film-coated tablets) EU/1/12/780/002 (14 x 1 film-coated tablets) EU/1/12/780/003 (28 x 1 film-coated tablets) EU/1/12/780/004 (30 x 1 film-coated tablets) EU/1/12/780/005 (56 x 1 film-coated tablets) EU/1/12/780/006 (60 x 1 film-coated tablets) EU/1/12/780/007 (84 x 1 film-coated tablets) EU/1/12/780/008 (90 x 1 film-coated tablets) EU/1/12/780/009 (98 x 1 film-coated tablets) EU/1/12/780/010 (100 x 1 film-coated tablets) EU/1/12/780/011 (120 x 1 film-coated tablets) EU/1/12/780/012 (14 film-coated tablets, bottle) EU/1/12/780/013 (60 film-coated tablets, bottle) EU/1/12/780/014 (180 film-coated tablets, bottle) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
EU/1/12/780/015 10 x 1 filmovertrukne tabletter EU/1/12/780/016 14 x 1 filmovertrukne tabletter EU/1/12/780/017 28 x 1 filmovertrukne tabletter EU/1/12/780/018 30 x 1 filmovertrukne tabletter EU/1/12/780/019 56 x 1 filmovertrukne tabletter EU/1/12/780/020 60 x 1 filmovertrukne tabletter EU/1/12/780/021 84 x 1 filmovertrukne tabletter EU/1/12/780/022 90 x 1 filmovertrukne tabletter EU/1/12/780/023 98 x 1 filmovertrukne tabletter EU/1/12/780/024 100 x 1 filmovertrukne tabletter EU/1/12/780/025 120 x 1 filmovertrukne tabletter
EU/1/12/780/015 10 x 1 film-coated tablets EU/1/12/780/016 14 x 1 film-coated tablets EU/1/12/780/017 28 x 1 film-coated tablets EU/1/12/780/018 30 x 1 film-coated tablets EU/1/12/780/019 56 x 1 film-coated tablets EU/1/12/780/020 60 x 1 film-coated tablets EU/1/12/780/021 84 x 1 film-coated tablets EU/1/12/780/022 90 x 1 film-coated tablets EU/1/12/780/023 98 x 1 film-coated tablets EU/1/12/780/024 100 x 1 film-coated tablets EU/1/12/780/025 120 x 1 film-coated tablets
(se pkt.
(pancreatitis).
Forstoppelse ikke almindelig
Constipation uncommon
Tag ikke Jentadueto: - hvis du er allergisk over for linagliptin eller metformin eller et af de øvrige indholdsstoffer i Jentadueto (angivet i afsnit 6) - hvis du har alvorligt nedsat nyrefunktion - hvis du har sukkersyge (diabetes), der ikke er under kontrol, f.eks. med for højt blodsukker (alvorlig hyperglykæmi), kvalme, opkastning, diarré, hurtigt vægttab, laktatacidose (se ”Risiko for laktatacidose” nedenfor) eller ketoacidose.
if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
BILAG II A. FREMSTILLER(E) ANSVARLIGE 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.
Laktatacidose
Posology
tillægs-placebo -0,47 % (95 %-CI: -0,66; -0,28)).
with a mean treatment difference of 0.20% (97.5% CI: 0.09, 0.299).
Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde BMI ikke nogen klinisk relevant indvirkning på linagliptins farmakokinetik.
Body mass index had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
opkastning, stigning i blodenzymer (forhøjet amylase), kløe (pruritus).
feeling sick (nausea) - Uncommon: inflamed nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), being sick (vomiting), blood enzyme increase (amylase increase), itching (pruritus) - Rare: blistering of skin (bullous pemphigoid)
Et 24-ugers dobbeltblindet placebokontrolleret studie undersøgte effekt og sikkerhed af linagliptin i kombination med metformin hos patienter i metformin-monoterapi med utilstrækkelig glykæmisk kontrol.
The efficacy and safety of linagliptin in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Køn
Race
da det kan være et tegn på betændelse i bugspytkirtlen (pankreatitis).
These may be used to control fits (seizures) or chronic pain.
24 måneders data for linagliptin som supplement til metformin, sammenlignet med glimepirid Et studie med patienter i metformin-monoterapi uden tilstrækkelig glykæmisk kontrol undersøgte effekt og sikkerhed ved supplement af enten linagliptin 5 mg eller glimepirid (gennemsnitlig dosis 3 mg).
Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
Paknings-størrelse
Package size
Lægemiddelform Indgivelsesvej
Invented name Strength Pharmaceutical Form Route of Administration Packaging
14. oktober 2016 EMA/610687/2016 EMEA/H/C/004080
14 October 2016 EMA/610687/2016 EMEA/H/C/004080
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen af ansøgningen skyldtes forretningsmæssige grunde, der var baseret på en vurdering af den aktuelle markedssituation.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal of the application is based on commercial reasons following an evaluation of the current market situation.
Virksomheden havde endnu ikke besvaret spørgsmålene, da ansøgningen blev trukket tilbage.
The company had not yet responded to the questions at the time of the withdrawal.
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Ertapenem Hospira forventedes anvendt hos voksne og børn over 3 måneder til behandling af følgende infektioner, hvis de var forårsaget af bakterier, som ertapenem forventedes at dræbe:
Ertapenem Hospira was expected to be used in adults and children aged over 3 months to treat the following infections, if caused by bacteria likely to be killed by ertapenem:
Den 13. september 2016 meddelte Hospira UK Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Ertapenem Hospira til behandling af visse infektioner og til forebyggelse af infektion ved kolorektale operationer.
On 13 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ertapenem Hospira, for the treatment of certain infections and for the prevention of infection in colorectal surgery.
Ertapenem bindes til visse proteiner på overfladen af bakteriecellerne.
Ertapenem attaches to certain proteins on the surface of the bacteria cells.
CHMP havde betænkeligheder ved valget af udgangsmaterialer til fremstilling af det aktive stof, den anvendte fremstillingsproces for lægemidlet, metoden til test af renheden af lægemidlet og lægemidlets holdbarhed.
The CHMP had concerns about the choice of the starting materials for making the active substance, the process used to manufacture the medicine, the method for testing the purity of the medicine and the medicine's shelf life.
Da Ertapenem Hospira er udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser til dokumentation af lægemidlets kvalitet.
Because Ertapenem Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Hvad forventedes Ertapenem Hospira anvendt til?
What was Ertapenem Hospira expected to be used for?
Dette forstyrrer bakteriernes livsvigtige funktioner, så de dør.
This upsets the essential functions that keep the cells alive, and kills the bacteria.
På baggrund af gennemgangen af dataene havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Ertapenem Hospira ikke kunne være blevet godkendt til behandling af infektioner og til forebyggelse af infektioner ved kolorektale operationer.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ertapenem Hospira could not have been approved for the treatment of infections and for the prevention of infection in colorectal surgery.
Det vil sige, at Ertapenem Hospira skulle have været identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Invanz.
This means that Ertapenem Hospira was intended to be similar to a ‘reference medicine' already authorised in the European Union called Invanz.
Der er ikke udført yderligere undersøgelser, da Ertapenem Hospira er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Invanz.
No further studies were carried out because Ertapenem Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Invanz.
Hvad er Ertapenem Hospira?
What is Ertapenem Hospira?
CHMP var på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde afhjulpet udvalgets betænkeligheder, og at kvaliteten af Ertapenem Hospira ikke var blevet påvist.
At the time of the withdrawal, the CHMP was of the opinion that the company had not addressed its concerns and the quality of Ertapenem Hospira had not been demonstrated.