FrancophonIA/ELRC3.0 huggingface dataset:
English: It is therefore recommended to adjust the maintenance daily dose of Levetiracetam Actavis, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Latvian: Tāpēc pacientiem ar vidēji smagiem un smagiem nieru darbības traucējumiem Levetiracetam Actavis dienas balstdevu ieteicams pielāgot kreatinīna klīrensam (skatīt 4.2. apakšpunktu).
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1,800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Latvian: Netika novērotas nevēlamas blakusparādības uz tēviņu vai mātīšu fertilitāti vai reproduktīvajām spējām žurkām, lietojot devas līdz pat 1800 mg/kg/dienā (x 6 maksimālā ieteicamā dienas deva, izsakot mg/m2) vecākiem un F1 pēcnācējiem.
English: Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Latvian: Reykjavikurvegur 76-78 220 Hafnarfjordur
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Latvian: Papildterapijai parciālu krampju ar vai bez sekundāras ģeneralizācijas ārstēšanai pieaugušajiem, pusaudžiem, bērniem un zīdaiņiem, kuri vecāki par 1 mēnesi, ar epilepsiju.
English: Monotherapy for adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks.
Latvian: Ieteicamā sākuma deva ir 250 mg divas reizes dienā, kas pēc divām nedēļām jāpalielina līdz sākotnējai terapeitiskai devai 500 mg divas reizes dienā.
English: in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Latvian: mioklonisku krampju ārstēšanai pieaugušajiem un pusaudžiem no 12 gadu vecuma ar Juvenīlo Mioklonisko Epilepsiju.
English: 500 mg tablet: Iron oxide yellow (E172), indigo carmine (E132).
Latvian: 500 mg tabletes: Dzeltenais dzelzs oksīds (E172), indigo karmīns (E132).
English: How to take Levetiracetam Actavis
Latvian: Kā lietot Levetiracetam Actavis
English: Name and address of the manufacturers responsible for batch release
Latvian: A. RAŽOTĀJS, KURŠ ATBILD PAR SĒRIJAS IZLAIDI Ražotāju, kas atbild par sērijas izlaidi, nosaukums un adrese
English: The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.
Latvian: Visbiežāk novērotās blakusparādības bija nazofaringīts, miegainība, galvassāpes, nogurums un reibonis.
English: CLcr (ml/min/1.73 m
Latvian: (ml/min/1,73 m2)
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
Latvian: Pusaudžiem, bērniem un zīdaiņiem KLkr ml/min/1,73 m2 var noteikt pēc seruma kreatinīna (mg/dl)
English: Contains colouring agent sunset yellow (E110).
Latvian: Satur arī krāsvielu - saulrieta dzelteno (E110).
English: Levetiracetam Actavis is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Latvian: Levetiracetam Actavis indicēts papildterapijai šādos gadījumos parciālu krampju ar sekundāru ģeneralizāciju vai bez tās ārstēšanai ar epilepsiju slimiem pieaugušajiem, pusaudžiem, bērniem un zīdaiņiem no 1 mēneša vecuma.
English: Titanium dioxide (E171) Indigo carmine (E132)
Latvian: Titāna dioksīds (E171) Indigo karmīns (E132)
English: The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2
Latvian: NOAEL (No Observed Adverse Effect Level (Lielākā noteiktā deva, pie kuras nav novērojamas blakusparādības)) grūsnām žurku mātītēm bija 360 mg/kg/dienā (x 12 maksimālā ieteicamā dienas deva izsakot mg/m2) un augļiem tā bija1200 mg/kg/dienā.
English: Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.
Latvian: Levetiracetam Actavis 500 mg tabletes ir ovālas, dzeltenas, 17.1 x 8.1 mm ar marķējumu “L” vienā pusē un marķējumu “500” otrā pusē.
English: Levetiracetam Actavis is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Latvian: Terapeitiskās indikācijas Levetiracetam Actavis indicēts monoterapijā parciālu krampju ar sekundāru ģeneralizāciju vai bez tās ārstēšanai pieaugušajiem un pusaudžiem no 16 gadu vecuma ar pirmreizēji diagnosticētu epilepsiju.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets
Latvian: 20 apvalkotās tabletes 30 apvalkotās tabletes 50 apvalkotās tabletes 60 apvalkotās tabletes 100 apvalkotās tabletes 120 apvalkotās tabletes 200 apvalkotās tabletes
English: Levetiracetam Actavis 1,000 mg tablets are oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.
Latvian: Levetiracetam Actavis 1000 mg tabletes ir ovālas, baltas, 19.0 x 10.0 mm ar marķējumu “L” vienā pusē un marķējumu “1000” otrā pusē.
English: Completed suicide, personality disorder, thinking abnormal, delirium
Latvian: Pašnāvība, personības traucējumi, patoloģiskas domas,
English: Talk to your doctor before taking Levetiracetam Actavis
Latvian: Pirms Levetiracetam Actavis lietošanas konsultējieties ar savu ārstu
English: Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Latvian: Levetiracetam Actavis 750 mg tabletes ir ovālas, oranžas, 19.0 x 9.3 mm ar marķējumu “L” vienā pusē un marķējumu “750” otrā pusē.
English: basis) and 1,200 mg/kg/day for fetuses.
Latvian: 1800 mg/kg/dienā lielas devas.
English: confusion, panic attack, emotional instability/mood swings, agitation;
Latvian: halucinācijas, dusmas, apjukums, panikas lēkmes, emocionāla nestabilitāte/garastāvokļa svārstības, satraukums;
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Latvian: Dzeltenais dzelzs oksīds (E172) Indigo karmīns (E132)
English: Levetiracetam Actavis 250 mg film-coated tablets are oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Latvian: Levetiracetam Actavis 250 mg apvalkotās tabletes ir ovālas, gaiši zilas, 13,6 x 6,4 mm ar marķējumu “L” vienā pusē un marķējumu “250” otrā pusē.
English: Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Latvian: Levetiracetāma monoterapijas efektivitāte 576 pacientiem (16 gadus veciem vai vecākiem) ar pirmreizēji vai nesen diagnosticētu epilepsiju tika pierādīta dubultmaskētā paralēlu grupu ne sliktākas efektivitātes salīdzinājumā ar karbamazepīna ilgstošas darbības zāļu formu (ID).
English: With continued long-term treatment, 47.4 % of the patients were free of tonic-clonic seizures for at least 6 months and 31.5 % were free of tonic-clonic seizures for at least 1 year.
Latvian: pacientu neradās toniski-kloniski krampji vismaz 6 mēnešus un 31,5 % toniski kloniski-krampji neradās vismaz 1 gadu.
English: Levetiracetam Actavis 1,000 mg tablets Levetiracetam
Latvian: Levetiracetam Actavis 1000 mg apvalkotās tabletes Levetiracetamum
English: What Levetiracetam Actavis looks like and contents of the pack
Latvian: Levetiracetam Actavis ārējais izskats un iepakojums
English: Levetiracetam Actavis 1,000 mg film-coated tablets Each film-coated tablet contains 1,000 mg levetiracetam.
Latvian: Levetiracetam Actavis 1000 mg apvalkotās tabletes Katra apvalkotā tablete satur 1000 mg levetiracetāma (Levetiracetamum).
English: With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0 % were free of myoclonic seizures for at least 1 year.
Latvian: pacientu neradās miokloniski krampji vismaz 6 mēnešus un 21,0 % neradās miokloniski krampji vismaz 1 gadu.
English: One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam.
Latvian: Katra Levetiracetam Actavis 500 mg tablete satur 500 mg levetiracetāma.
English: Actavis treatment for as long as your doctor has told you.
Latvian: cik to norādījis Jūsu ārsts.
English: Levetiracetam Actavis 750 mg tablets Levetiracetam
Latvian: Levetiracetam Actavis 750 mg tabletes Levetiracetamum
English: Each tablet contains 1,000 mg levetiracetam.
Latvian: Katra apvalkotā tablete satur 1000 mg levetiracetāma.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 1,000 mg film-coated tablets
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ BLISTERA VAI PLĀKSNĪTES Blisters 1000 mg apvalkotajām tabletēm
English: EU/1/11/713/001 EU/1/11/713/002 EU/1/11/713/003 EU/1/11/713/004 EU/1/11/713/005 EU/1/11/713/006 EU/1/11/713/007 EU/1/11/713/008 EU/1/11/713/009 EU/1/11/713/010 EU/1/11/713/041
Latvian: EU/1/11/713/003 EU/1/11/713/004 EU/1/11/713/005 EU/1/11/713/006 EU/1/11/713/007 EU/1/11/713/008 EU/1/11/713/009 EU/1/11/713/010 EU/1/11/713/041
English: EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets
Latvian: EU/1/11/713/018 30 tabletes EU/1/11/713/019 100 tabletes EU/1/11/713/020 200 tabletes
English: Levetiracetam Actavis 250 mg tablets Levetiracetam
Latvian: Levetiracetam Actavis 250 mg tabletes Levetiracetamum
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ TIEŠĀ IEPAKOJUMA Etiķete 1000 mg apvalkotajām tabletēm pudelītē
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 250 mg film-coated tablets
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ BLISTERA VAI PLĀKSNĪTES Blisters 250 mg apvalkotajām tabletēm
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 750 mg film-coated tablets
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ BLISTERA VAI PLĀKSNĪTES Blisters 750 mg apvalkotajām tabletēm
English: One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam.
Latvian: Katra Levetiracetam Actavis 250 mg tablete satur 250 mg levetiracetāma.
English: Levetiracetam Actavis 500 mg tablets Levetiracetam
Latvian: Levetiracetam Actavis 500 mg tabletes Levetiracetamum
English: Contact your doctor if you took more tablets than you should.
Latvian: Ja Jūs esat lietojis vairāk tablešu nekā noteikts, sazinieties ar savu ārstu.
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily
Latvian: 500 līdz 1500 mg divas reizes dienā
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ TIEŠĀ IEPAKOJUMA Etiķete 750 mg apvalkotajām tabletēm pudelītē
English: Each tablet contains 250 mg levetiracetam.
Latvian: Katra tablete satur 250 mg levetiracetāma.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA Kartona kastīte 1000 mg apvalkotajām tabletēm pudelītē
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ TIEŠĀ IEPAKOJUMA Etiķete 250 mg apvalkotajām tabletēm pudelītē
English: 72.2 % of the levetiracetam treated patients and 45.2 % of the patients on placebo had a 50 % or greater decrease in the frequency of PGTC seizures per week.
Latvian: 72,2 % pacientu, kuri lietoja levetiracetāmu, un 45,2 % pacientu, kuri lietoja placebo, bija par 50 %
English: One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam.
Latvian: Katra Levetiracetam Actavis 750 mg tablete satur 750 mg levetiracetāma.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA Kartona kastīte 750 mg apvalkotajām tabletēm pudelītē
English: One tablet of Levetiracetam Actavis 1,000 mg contains 1,000 mg of levetiracetam.
Latvian: Katra Levetiracetam Actavis 1000 mg tablete satur 1000 mg levetiracetāma.
English: Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000
Latvian: Koloidālais bezūdens silīcija dioksīds Magnija stearāts
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ TIEŠĀ IEPAKOJUMA Etiķete 500 mg apvalkotajām tabletēm pudelītē
English: EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets
Latvian: EU/1/11/713/028 30 tabletes EU/1/11/713/029 100 tabletes EU/1/11/713/030 200 tabletes
English: EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets
Latvian: EU/1/11/713/008 30 tabletes EU/1/11/713/009 100 tabletes EU/1/11/713/010 200 tabletes
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 500 mg film-coated tablets
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ BLISTERA VAI PLĀKSNĪTES Blisters 500 mg apvalkotajām tabletēm
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more The initial therapeutic dose is 500 mg twice daily.
Latvian: Papildterapija pieaugušajiem (≥18 gadiem) un pusaudžiem (vecumā no 12 līdz17 gadiem), kuru ķermeņa masa ir 50 kg vai lielāka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA Kartona kastīte 250 mg apvalkotajām tabletēm pudelītē
English: Each tablet contains 750 mg levetiracetam.
Latvian: Katra apvalkotā tablete satur 750 mg levetiracetāma (Levetiracetamum).
English: Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets
Latvian: EU/1/11/713/042 60 x 1 tabletes
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA Kartona kastīte 500 mg apvalkotajām tabletēm pudelītē
English: EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets
Latvian: EU/1/11/713/038 30 tabletes EU/1/11/713/039 100 tabletes EU/1/11/713/040 200 tabletes
English: EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
Latvian: EU/1/11/713/001 20 tabletes EU/1/11/713/002 30 tabletes EU/1/11/713/003 50 tabletes EU/1/11/713/004 60 tabletes EU/1/11/713/005 100 tabletes EU/1/11/713/006 120 tabletes EU/1/11/713/007 200 tabletes
English: Each tablet contains 500 mg levetiracetam.
Latvian: Katra apvalkotā tablete satur 500 mg levetiracetāma (Levetiracetamum).
English: Each film-coated tablet contains 500 mg levetiracetam.
Latvian: Katra apvalkotā tablete satur 500 mg levetiracetāma.
English: Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets
Latvian: EU/1/11/713/043 60 x 1 tabletes
English: EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
Latvian: EU/1/11/713/021 20 tabletes EU/1/11/713/022 30 tabletes EU/1/11/713/023 50 tabletes EU/1/11/713/024 60 tabletes EU/1/11/713/025 100 tabletes EU/1/11/713/026 120 tabletes EU/1/11/713/027 200 tabletes
English: EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
Latvian: EU/1/11/713/011 20 tabletes EU/1/11/713/012 30 tabletes EU/1/11/713/013 50 tabletes EU/1/11/713/014 60 tabletes EU/1/11/713/015 100 tabletes EU/1/11/713/016 120 tabletes EU/1/11/713/017 200 tabletes
English: Each film-coated tablet contains 750 mg levetiracetam.
Latvian: Katra apvalkotā tablete satur 750 mg levetiracetāma.
English: EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
Latvian: EU/1/11/713/031 20 tabletes EU/1/11/713/032 30 tabletes EU/1/11/713/033 50 tabletes EU/1/11/713/034 60 tabletes EU/1/11/713/035 100 tabletes EU/1/11/713/036 120 tabletes EU/1/11/713/037 200 tabletes
English: Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets
Latvian: EU/1/11/713/041 60 x 1 tabletes
English: 30 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Latvian: ZĀĻU FORMA UN SATURS 30 apvalkotās tabletes 100 apvalkotās tabletes 200 apvalkotās tabletes
English: Each film-coated tablet contains 250 mg levetiracetam.
Latvian: Katra apvalkotā tablete satur 250 mg levetiracetāma.
English: Levetiracetam Actavis 1,000 mg film-coated tablets
Latvian: Levetiracetam Actavis 1000 mg apvalkotās tabletes
English: Levetiracetam Actavis 250 mg film-coated tablets Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Latvian: Ovālas, gaiši zilas, 13,6 x 6,4 mm, ar marķējumu “L” vienā pusē un “250” otrā pusē.
English: 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
Latvian: (0,035 līdz 0,07 ml/kg) divas reizes dienā
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Latvian: 7 līdz 14 mg/kg (0,07 10 līdz 20 mg/kg (0,10 līdz 0,20
English: Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam
Latvian: Levetiracetam Actavis 1000 mg tabletes Levetiracetamum
English: Pack sizes
Latvian: Nazofaringīt s
English: Levetiracetam Actavis 750 mg film-coated tablets
Latvian: Levetiracetam Actavis 750 mg apvalkotās tabletes
English: Add-on therapy for infants aged from 1 month to less than 6 months
Latvian: Papildterapija zīdaiņiem vecumā no1 mēneša līdz 6 mēnešu vecumam Šķīdums iekšķīgai lietošanai ir piemērots lietošanai zīdaiņiem.
English: Levetiracetam Actavis 500 mg film-coated tablets
Latvian: Levetiracetam Actavis 500 mg apvalkotās tabletes
English: Cough
Latvian: Klepus
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Latvian: 7 līdz 14 mg/kg (0,07
English: Pancytopenia, neutropenia, agranulocytosis
Latvian: panikas lēkmes, emocionāla labilitāte/garastāvokļ a svārstības, ažitācija
English: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Latvian: Papildterapija mioklonisko krampju ārstēšanā pieaugušajiem un pusaudžiem, kuri vecāki par 12
English: Ref. EMEA/554626/2009 EMEA/H/C/1025
Latvian: EMA/554626/2009 EMEA/H/C/1025
English: London, 24 September 2009 Doc.
Latvian: Londona, 2009. gada 24. septembris Atsauces dok.
English: The letter from the company notifying the European Medicines Agency of the withdrawal of the application is available here.
Latvian: Uzņēmuma vēstule, kurā tas informēja Eiropas Zāļu aģentūru par pieteikuma atsaukšanu, ir atrodama šeit.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Latvian: Pēc CHMP atzinuma saņemšanas Eiropas Komisijai lēmuma izsniegšanai par šo atzinumu parasti ir nepieciešami apmēram divi mēneši.
English: The Committee was also concerned over the way the company had measured the levels of impurities in the medicine.
Latvian: Komitejai bija bažas arī par veidu, kādā uzņēmums bija mērījis zāļu piemaisījumu līmeni.
English: What is Ramvocid?
Latvian: Kas ir Ramvocid?
English: It contains the active substance oritavancin.
Latvian: Tas satur aktīvo vielu oritavancīnu.
English: Questions and answers on the withdrawal of the marketing authorisation application for Ramvocid oritavancin
Latvian: Jautājumi un atbildes par reģistrācijas apliecības pieteikuma atsaukšanu zālēm Ramvocid oritavancīns
English: Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Latvian: Šūnu sieniņa un membrāna kopā veido barjeru starp baktēriju šūnu saturu un ārējo vidi.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Latvian: ”Komplicētas” nozīmē, ka infekcija ir grūti ārstējama, jo tā ir izplatījusies dziļāk zemādas audos, iespējams, ka ir nepieciešama ķirurģiska iejaukšanās, vai arī pacientam ir citas slimības, kas, iespējams, var ietekmēt pacienta atbildes reakciju uz ārstēšanu.
English: The company presented results from one main study involving 1,267 patients with complicated skin and soft tissue infections.
Latvian: Uzņēmums iesniedza viena pamatpētījuma rezultātus, kurā bija iesaistīti 1267 pacienti ar komplicētām ādas un mīksto audu infekcijām.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Latvian: To skaitā ir baktērijas Staphylococcus aureus (tai skaitā pret meticilīnu rezistenti baktēriju veidi, ko dēvē par „MRSA”) un Streptococcus pyogenes.
English: The main measure of effectiveness was the number of patients who were cured after treatment.
Latvian: Galvenais iedarbīguma rādītājs bija izārstēto pacientu skaits terapijas beigās.
English: Patients were given either Ramvocid for seven days or vancomycin with or without cephalexin (other antibiotic medicines) for between 10 and 14 days.
Latvian: Pacienti septiņas dienas lietoja vai nu Ramvocid, vai 10 līdz 14 dienas vankomicīnu vienu pašu vai kombinācijā ar cefaleksīnu (citu antibiotiku).
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramvocid?
Latvian: Kādas sekas atsaukums radīs pacientiem, kas piedalās Ramvocid klīniskajos pētījumos vai zāļu eksperimentālās lietošanas programmās?
English: The CHMP was concerned that the company had not provided enough evidence to support the use of Ramvocid to treat complicated skin and soft tissue infections at the dose proposed, particularly in patients with MRSA.
Latvian: CHMP bija bažas, ka uzņēmums nav sniedzis pietiekami daudz pierādījumu, lai pamatotu Ramvocid ierosinātās devas lietošanu komplicētu ādas un mīksto audu infekciju ārstēšanai, jo īpaši MRSA pacientiem.
English: Ramvocid is a powder to be made up into a solution for infusion (drip into a vein).
Latvian: Ramvocid ir pulveris, no kura gatavo šķīdumu infūzijai (ievadīšanai vēnā pa pilienam).
English: By disrupting this barrier, oritavancin is expected to kill the bacteria that are causing the infection.
Latvian: Paredzams, ka, noārdot šo barjeru, oritavancīns iznīcinās infekciju izraisošās baktērijas.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ramvocid could not have been approved for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Latvian: Pamatojoties uz izskatītajiem datiem un uzņēmuma atbildēm uz CHMP jautājumiem, atsaukšanas brīdī CHMP bija daži iebildumi un tobrīd atzina, ka Ramvocid nevar apstiprināt grampozitīvu baktēriju izraisītu komplicētu ādas un mīksto audu infekciju ārstēšanai.
English: The effects of Ramvocid were first tested in experimental models before being studied in humans.
Latvian: Pirms uzsākt pētījumus ar cilvēkiem, Ramvocid iedarbību pārbaudīja eksperimentālos modeļos.
English: The active substance in Ramvocid, oritavancin, is an antibiotic that belongs to the group ‘lipoglycopeptides'.
Latvian: Ramvocid aktīvā viela oritavancīns ir antibiotika, kas pieder lipoglikopeptīdu grupai.
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Latvian: Paredzams, ka zāles iedarbosies divējādi: neļaujot baktērijām veidot šūnu sieniņas un noārdot šūnu membrānas.