FrancophonIA/ELRC3.0 huggingface dataset:
English: - Each Jentadueto 2.5 mg/850 mg film-coated tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Estonian: - Üks Jentadueto 2,5 mg/850 mg õhukese polümeerikattega tablett sisaldab 2,5 mg linagliptiini ja 850 mg metformiinvesinikkloriidi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED MULTIPAKI VÄLISSILT - KEERATUD LÄBIPAISTVASSE FOOLIUMISSE - KOOS BLUE BOX´IGA - 2,5 MG/850 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Estonian: TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 2,5 mg linagliptiini ja 1000 mg metformiinvesinikkloriidi.
English: Gastrointestinal disorders Decreased appetite uncommon
Estonian: Seedetrakti häired Söögiisu vähenemine aeg-ajalt
English: Jentadueto combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Estonian: Need ravimid on dipeptidüülpeptidaas 4 (DPP-4) inhibiitor linagliptiin ja biguaniidide klassi kuuluv metformiinvesinikkloriid.
English: Sulphonylureas:
Estonian: Sulfonüüluurea preparaadid:
English: Patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Estonian: Patsiendid, kellel metformiini maksimaalse talutava annuse ja insuliini kombineeritud raviga pole saavutatud piisavat kontrolli haiguse üle
English: Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Estonian: Jentadueto 2,5 mg/850 mg õhukese polümeerikattega tabletid Üks tablett sisaldab 2,5 mg linagliptiini ja 850 mg metformiinvesinikkloriidi.
English: 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)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/780/029 (120 (2 x 60 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/030 (180 (2 x 90 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/031 (200 (2 x 100 x 1) õhukese polümeerikattega tabletti)
English: - Each Jentadueto 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Estonian: - Üks Jentadueto 2,5 mg/1000 mg õhukese polümeerikattega tablett sisaldab 2,5 mg linagliptiini ja 1000 mg metformiinvesinikkloriidi.
English: 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.
Estonian: Jentadueto 2,5 mg/1000 mg õhukese polümeerikattega tabletid Üks tablett sisaldab 2,5 mg linagliptiini ja 1000 mg metformiinvesinikkloriidi.
English: 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
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/780/026 14 õhukese polümeerikattega tabletti EU/1/12/780/027 60 õhukese polümeerikattega tabletti EU/1/12/780/028 180 õhukese polümeerikattega tabletti
English: 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)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/780/032 (120 (2 x 60 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/033 (180 (2 x 90 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/034 (200 (2 x 100 x 1) õhukese polümeerikattega tabletti)
English: Jentadueto 2.5 mg / 850 mg film-coated tablets Jentadueto 2.5 mg / 1,000 mg film-coated tablets linagliptin/metformin hydrochloride
Estonian: Jentadueto 2,5 mg/850 mg õhukese polümeerikattega tabletid Jentadueto 2,5 mg/1000 mg õhukese polümeerikattega tabletid Linagliptiin/metformiinvesinikkloriid
English: Posology
Estonian: Südamefunktsioon
English: Difference from placebo (adjusted mean) (95% CI) Patients (n, %) achieving HbA1c
Estonian: Patsientide hulk (n, %), kes saavutasid HbA1c väärtuse < 7%
English: 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
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED MULTIPAKI VÄLISSILT - KEERATUD LÄBIPAISTVASSE FOOLIUMISSE - KOOS BLUE BOX´IGA - 2,5 MG/1000 MG ÕHUKESE POLÜMEERIKATTEGA TABLETTI
English: 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
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/780/012 14 õhukese polümeerikattega tabletti EU/1/12/780/013 60 õhukese polümeerikattega tabletti EU/1/12/780/014 180 õhukese polümeerikattega tabletti
English: Metformin HCl
Estonian: Metfor miinves inikklor iid
English: 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
Estonian: oksendamine kõhuvalu lihaskrambid üldine halb enesetunne koos tugeva väsimusega hingamisraskused kehatemperatuuri ja südamerütmi langus
English: Abdominal pain very common
Estonian: Kõhuvalu väga sage
English: It is not known whether linagliptin is excreted into human milk.
Estonian: Linagliptiini eritumine inimese rinnapiima ei ole teada.
English: Erythema very rare
Estonian: Erüteem väga harv
English: Linagliptin added to metformin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Estonian: Keskmiselt HbA1c algväärtuselt 8% parandas linagliptiin metformiinile lisatuna oluliselt HbA1c väärtust (muutus platseeboga võrreldes -0,64%).
English: Propylene glycol
Estonian: Põiendpemfigoid harv
English: 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)
Estonian: Jentadueto 2,5 mg/1000 mg õhukese polümeerikattega tabletid EU/1/12/780/015 (10 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/016 (14 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/017 (28 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/018 (30 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/019 (56 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/020 (60 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/021 (84 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/022 (90 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/023 (98 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/024 (100 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/025 (120 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/026 (14 õhukese polümeerikattega tabletti, pudel) EU/1/12/780/027 (60 õhukese polümeerikattega tabletti, pudel) EU/1/12/780/028 (180 õhukese polümeerikattega tabletti, pudel) EU/1/12/780/032 (120 (2 x 60 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/033 (180 (2 x 90 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/034 (200 ( 2 x 100 x 1) õhukese polümeerikattega tabletti)
English: 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.
Estonian: I faasi ja II faasi andmete populatsioonipõhise farmakokineetilise analüüsi alusel ei omanud kehamassi indeks kliiniliselt olulist toimet linagliptiini farmakokineetikale.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Linagliptin/metformin hydrochloride
Estonian: RAVIMPREPARAADI NIMETUS Jentadueto 2,5 mg/850 mg tabletid Linagliptinum/metformini hydrochloridum
English: Baseline (mean) Change from baseline (adjusted mean)
Estonian: Muutus algväärtusega võrreldes (kohandatud keskmine)
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg film-coated tablets Linagliptin/metformin hydrochloride
Estonian: RAVIMPREPARAADI NIMETUS Jentadueto 2,5 mg/1000 mg tabletid Linagliptinum/metformini hydrochloridum
English: 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)
Estonian: Jentadueto 2,5 mg/850 mg õhukese polümeerikattega tableti EU/1/12/780/001 (10 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/002 (14 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/003 (28 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/004 (30 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/005 (56 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/006 (60 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/007 (84 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/008 (90 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/009 (98 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/010 (100 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/011 (120 x 1 õhukese polümeerikattega tabletti) EU/1/12/780/012 (14 õhukese polümeerikattega tabletti, pudel) EU/1/12/780/013 (60 õhukese polümeerikattega tabletti, pudel) EU/1/12/780/014 (180 õhukese polümeerikattega tabletti, pudel) EU/1/12/780/029 (120 (2 x 60 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/030 (180 (2 x 90 x 1) õhukese polümeerikattega tabletti) EU/1/12/780/031 (200 (2 x 100 x 1) õhukese polümeerikattega tabletti)
English: Patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea
Estonian: Patsiendid, kellel metformiini maksimaalse talutava annuse ja sulfonüüluurea kombineeritud raviga pole saavutatud piisavat kontrolli haiguse üle
English: Twice Daily
Estonian: Kihelus aeg-ajalt
English: 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
Estonian: EU/1/12/780/001 10 x 1 õhukese polümeerikattega tabletti EU/1/12/780/002 14 x 1 õhukese polümeerikattega tabletti EU/1/12/780/003 28 x 1 õhukese polümeerikattega tabletti EU/1/12/780/004 30 x 1 õhukese polümeerikattega tabletti EU/1/12/780/005 56 x 1 õhukese polümeerikattega tabletti EU/1/12/780/006 60 x 1 õhukese polümeerikattega tabletti EU/1/12/780/007 84 x 1 õhukese polümeerikattega tabletti EU/1/12/780/008 90 x 1 õhukese polümeerikattega tabletti EU/1/12/780/009 98 x 1 õhukese polümeerikattega tabletti EU/1/12/780/010 100 x 1 õhukese polümeerikattega tabletti EU/1/12/780/011 120 x 1 õhukese polümeerikattega tabletti
English: Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Estonian: I faasi ja II faasi andmete populatsioonipõhise farmakokineetilise analüüsi alusel ei omanud sugu kliiniliselt olulist toimet linagliptiini farmakokineetikale.
English: 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
Estonian: EU/1/12/780/015 10 x 1 õhukese polümeerikattega tabletti EU/1/12/780/016 14 x 1 õhukese polümeerikattega tabletti EU/1/12/780/017 28 x 1 õhukese polümeerikattega tabletti EU/1/12/780/018 30 x 1 õhukese polümeerikattega tabletti EU/1/12/780/019 56 x 1 õhukese polümeerikattega tabletti EU/1/12/780/020 60 x 1 õhukese polümeerikattega tabletti EU/1/12/780/021 84 x 1 õhukese polümeerikattega tabletti EU/1/12/780/022 90 x 1 õhukese polümeerikattega tabletti EU/1/12/780/023 98 x 1 õhukese polümeerikattega tabletti EU/1/12/780/024 100 x 1 õhukese polümeerikattega tabletti EU/1/12/780/025 120 x 1 õhukese polümeerikattega tabletti
English: 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.
Estonian: I faasi ja II faasi andmete populatsioonipõhise farmakokineetilise analüüsi alusel ei omanud vanus kliiniliselt olulist toimet linagliptiini farmakokineetikale.
English: Co-administration of metformin with
Estonian: Metformiini koosmanustamine:
English: Lactic acidosis very rare
Estonian: Laktatsidoos väga harv
English: Investigations Amylase increased uncommon
Estonian: Uuringud Amülaasi aktiivsuse suurenemine aeg-ajalt
English: If you have symptoms of acute pancreatitis, like persistent, severe abdominal pain, you should consult your doctor.
Estonian: Pidage nõu oma arstiga kui teil on ägeda kõhunäärmepõletiku sümptomid, nagu püsiv, tugev kõhuvalu.
English: Jentadueto 2.5 mg/1,000 mg are oval, biconvex light pink film-coated tablets (tablets).
Estonian: Jentadueto 2,5 mg/1000 mg on ovaalsed kaksikkumerad heleroosad õhukese polümeerikattega tabletid.
English: Jentadueto 2.5 mg/850 mg film-coated tablets
Estonian: Jentadueto 2,5 mg/850 mg õhukese polümeerikattega tabletid Õhuke polümeerikate
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Estonian: 1000 patsiendiaasta kohta), p=0,0023, ja võrreldes sulfonüüluurea preparaadi ja insuliini monoteraapia rühmadega (40,1 sündmust 1000 patsiendiaasta kohta), p=0,0034;
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets
Estonian: Jentadueto 2,5 mg/1000 mg õhukese polümeerikattega tabletid Õhuke polümeerikate
English: - Very rare (may affect up to 1 in 10,000 people): decreased vitamin B12 levels, hepatitis (a problem with your liver), skin reaction as redness of the skin (erythema).
Estonian: Ainult metformiini kasutamisel võivad esineda alljärgnevaid kõrvaltoimeid, mida ei kirjeldatud Jentadueto kõrvatoimetena: - väga sage: kõhuvalu; - sage (võib esineda kuni 1 kasutajal 10-st): metallimaitse suus (maitsemeele häired); - väga harv (võib esineda kuni 1 kasutajal 10 000-st): vitamiin B12 sisalduse vähenemine, hepatiit
English: Bullous pemphigoid
Estonian: Pankreatiit harv
English: Urticaria rare
Estonian: Põiendpemfigoid
English: Lactic acidosis
Estonian: Kõhulahtisus sage
English: Twice Daily Metformin HCl 500 mg
Estonian: Linagliptiin 2,5 mg kaks korda ööpäevas metformiinv esinikkloriid 500 mg kaks korda ööpäevas
English: INFORMATION IN BRAILLE Jentadueto
Estonian: Iiveldus sage
English: Jentadueto 2.5 mg/850 mg are oval, biconvex, light orange, film-coated tablets (tablets).
Estonian: Jentadueto 2,5 mg/850 mg on ovaalsed kaksikkumerad heleoranžid õhukese polümeerikattega tabletid.
English: Silica, colloidal anhydrous
Estonian: Kolloidne veevaba ränidioksiid
English: Package size
Estonian: Pakendi suurus
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Estonian: Tugevus Ravimvorm
English: 14 October 2016 EMA/610687/2016 EMEA/H/C/004080
Estonian: 14. oktoober 2016 EMA/610687/2016 EMEA/H/C/004080
English: The company had not yet responded to the questions at the time of the withdrawal.
Estonian: Ettevõte ei olnud taotluse tagasivõtmise ajaks neile küsimustele veel vastanud.
English: This upsets the essential functions that keep the cells alive, and kills the bacteria.
Estonian: See häirib rakke elus hoidvaid hädavajalikke funktsioone ja hävitab bakterid.
English: • gynaecological infections;
Estonian: • günekoloogilised infektsioonid;
English: 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.
Estonian: Kirjas, milles ettevõte teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et otsus taotlus tagasi võtta põhineb praeguse turuolukorra hindamisest lähtuvatel ärilistel põhjusel.
English: • foot infections in diabetes patients.
Estonian: • jalainfektsioonid diabeediga patsientidel.
English: Because Ertapenem Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Estonian: Kuna Ertapenem Hospira on loodud kui geneeriline ravim, esitas ettevõte uuringute tulemused, mis näitavad ravimi kvaliteeti.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Estonian: Taotlus võeti tagasi pärast seda, kui inimravimite komitee oli hinnanud ettevõtte esialgselt esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
English: 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:
Estonian: Ertapenem Hospirat kavatseti kasutada täiskasvanutel ja üle 3kuustel lastel järgmiste infektsioonide raviks, kui neid põhjustavad ertapeneemi suhtes tõenäoliselt tundlikud bakterid:
English: What is Ertapenem Hospira?
Estonian: Mis on Ertapenem Hospira?
English: Ertapenem Hospira was also expected to be used to prevent infection at the site of colorectal surgery (surgery in the lower part of the bowel, including the rectum and anus).
Estonian: Ertapenem Hospirat kavatseti kasutada ka infektsiooni ennetamiseks kolorektaaloperatsiooni kohas (operatsioon soolestiku alumises osas, sealhulgas pärasoolel ja pärakul).
English: 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.
Estonian: Inimravimite komitee ettevaatlikkuse põhjused olid toimeaine valmistamisel kasutatavate algmaterjalide valik, ravimi tootmiseks kasutatav protsess, ravimi puhtuse kontrollimise meetod ja ravimi kõlblikkusaeg.
English: • community-acquired pneumonia (infection of the lungs caught away from hospital);
Estonian: • olmetekkene kopsupõletik (kopsupõletik, mis on tekkinud väljaspool haiglasituatsiooni);
English: 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.
Estonian: Hospira UK Limited teatas 13. septembril 2016 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Ertapenem Hospira müügiloa taotlus.
English: 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.
Estonian: Lisauuringuid ei olnud vaja, sest Ertapenem Hospira on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Invanz.
English: Ertapenem attaches to certain proteins on the surface of the bacteria cells.
Estonian: Ertapeneem kinnitub bakterirakkude pinnal teatud valkude külge.
English: Ertapenem Hospira is an antibiotic medicine that contains the active substance ertapenem.
Estonian: Ertapenem Hospira on antibiootikum, mis sisaldab toimeainena ertapeneemi.
English: 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.
Estonian: Tuginedes esitatud andmete analüüsile, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Ertapenem Hospira kasutamist infektsioonide raviks ja infektsioonide ennetamiseks kolorektaaloperatsioonide ajal ei ole võimalik heaks kiita.
English: This means that Ertapenem Hospira was intended to be similar to a ‘reference medicine' already authorised in the European Union called Invanz.
Estonian: See tähendab, et Ertapenem Hospira pidi olema sarnane võrdlusravimiga Invanz, millel juba on Euroopa Liidus müügiluba.
English: It was to be available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein.
Estonian: Ravimit kavatseti turustada viaali pakendatud pulbrina, mis tuleb (veeni tilgutatava) infusioonilahusena enne kasutamist lahustada.
English: Ertapenem can work on a range of different bacteria.
Estonian: Ertapeneem toimib mitmesuguste eri bakterite suhtes.
English: How does Ertapenem Hospira work?
Estonian: Kuidas Ertapenem Hospira toimib?
English: 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.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ettevõte ei olnud komitee ettevaatlikkuse põhjuseid piisavalt käsitlenud ja ravimi Ertapenem Hospira kvaliteet ei olnud tõendatud.
English: The active substance in Ertapenem Hospira and Invanz, ertapenem, belongs to a group of antibiotics known as ‘carbapenems'.
Estonian: Ertapenem Hospira toimeaine ertapeneem kuulub karbapeneem-antibiootikumide rühma.
English: Ertapenem Hospira was developed as a ‘generic medicine'.
Estonian: Ertapenem Hospira töötati välja geneerilise ravimina.
English: What was Ertapenem Hospira expected to be used for?
Estonian: Milleks kavatseti Ertapenem Hospirat kasutada?
English: • infections in the abdomen;
Estonian: • kõhuõõne infektsioonid;
English: Ertapenem Hospira is expected to work in the same way as the reference medicine, Invanz.
Estonian: Ertapenem Hospira eeldatav toime on samalaadne võrdlusravimi Invanzi toimega.
English: Frequency not known (cannot be estimated from the available data)
Estonian: Esinemissagedus teadmata (ei saa hinnata olemasolevate andmete alusel)
English: - if you have active cancer.
Estonian: - kui teil on aktiivne vähk;
English: • Information on pregnancy prevention.
Estonian: • raseduse ärahoidmist puudutav teave.