natgillin/translations-raw huggingface dataset:
Nervous system disorders 
MedDRA organski sistem
No dose adjustment is needed in patients with mild to moderate hepatic impairment. 
Bolniki z jetrno okvaro Pri bolnikih z blago do zmerno jetrno okvaro odmerka ni potrebno prilagajati.
in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. 
• miokloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z juvenilno mioklonično epilepsijo.
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 
leta starosti z juvenilno mioklonično epilepsijo primarno generaliziranih tonično-kloničnih napadov (veliki napadi, vključno z izgubo zavesti) pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo (vrsta epilepsije, ki je genetskega izvora)
One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam. 
Ena tableta zdravila Levetiracetam Actavis 750 mg vsebuje 750 mg levetiracetama.
The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, using the following formula: 
CLcr v ml/min je pri odraslih in mladostnikih, s telesno maso 50 kg in več, mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) po formuli: [140 - starost (leta)] x masa (kg) CLcr (ml/min) = ------------------------------------------------------------- (x 0,85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl) CLcr je prilagojen na telesno površino (BSA-»body surface area«) na sledeč način:
- If you get any side effects talk to your doctor or pharmacist. 
− Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily 
3,5 do 7 mg/kg (0,035 do 0,07 ml/kg) dvakrat na dan
An oral solution is the formulation to use in infants. 
Peroralna raztopina je farmacevtska oblika, ki je prilagojena za uporabo pri dojenčkih.
Each film-coated tablet contains 1,000 mg levetiracetam. 
Ena filmsko obložena tableta vsebuje 1000 mg levetiracetama.
A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. 
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
The risk of anorexia is higher when levetiracetam is coadministered with topiramate. 
Opis izbranih neželenih učinkov Tveganje za pojav anoreksije je večje pri sočasni uporabi levetiracetama in topiramata.
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended. 
(1) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 750 mg. (2) Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
(3) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam. 
(3) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 15 mg/kg (0,15 ml/kg).
Levetiracetam Actavis 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam. 
Levetiracetam Actavis 750 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 750 mg levetiracetama.
Each tablet contains 1,000 mg levetiracetam. 
Ena tableta vsebuje 1000 mg levetiracetama.
7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily 
7 do 21 mg/kg (0,07 do 0,21 ml/kg) dvakrat na dan
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. 
Levetiracetam Actavis 750 mg filmsko obložene tablete so: ovalne, oranžne, velike 19,0 x 9,3 mm z oznako “L” na eni strani in “750” na drugi strani.
CLcr (ml/min/1.73 m 
(ml/min/1,73m2)
3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily 
3,5 do 10,5 mg/kg (0,035 do 0,105 ml/kg) dvakrat na dan
Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis) 
preobčutljivost (vključno z angioedemom in anafilakso)
250 mg tablet: Indigo carmine (E132). 
250 mg tableta: indigotin (E132) 500 mg tableta: rumeni železov oksid (E172), indigotin (E132)
Levetiracetam Actavis 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam. 
Levetiracetam Actavis 250 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
• partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age; 
• napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih,
Levetiracetam Actavis 750 mg film-coated tablets Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side. 
Levetiracetam Actavis 750 mg filmsko obložene tablete Ovalne, oranžne, velike 19.0 x 9.3 mm z oznako “L” na eni strani in “750” na drugi strani.
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. 
Priporočeni začetni odmerek je 250 mg dvakrat na dan, ki ga po dveh tednih povečamo na začetni terapevtski odmerek 500 mg dvakrat na dan. Odmerek se lahko poveča za 250 mg dvakrat na dan vsaka dva tedna glede na klinični odziv.
Levetiracetam Actavis 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam. 
Levetiracetam Actavis 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
This is related to the decrease in renal function in this population (see section 4.2). 
11 ur) (glejte poglavje 4.2).
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. 
Levetiracetam Actavis 250 mg filmsko obložene tablete Ovalne, svetlo modre, velike 13.6 x 6.4 mm z oznako “L” na eni strani in “250” na drugi strani.
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. 
Levetiracetam Actavis 250 mg filmsko obložene tablete so: ovalne, svetlo modre, velike 13,6 x 6,4 mm z oznako “L” na eni strani in “250” na drugi strani.
Levetiracetam Actavis 1,000 mg film-coated tablets Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side. 
Levetiracetam Actavis 1.000 mg filmsko obložene tablete Ovalne, bele, velike 19.0 x 10.0 mm z oznako “L” na eni strani in “1000” na drugi strani.
Each film-coated tablet contains 750 mg levetiracetam. 
Ena filmsko obložena tableta vsebuje 750 mg levetiracetama.
Levetiracetam Actavis 500 mg film-coated tablets Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side. 
Levetiracetam Actavis 500 mg filmsko obložene tablete Ovalne, rumene, velike 17.1 x 8.1 mm z oznako “L” na eni strani in “500” na drugi strani.
(2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam. 
(2) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 10,5 mg/kg (0,105 ml/kg).
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. 
Levetiracetam Actavis 500 mg filmsko obložene tablete so: ovalne, rumene, velike 17,1 x 8,1 mm z oznako “L” na eni strani in “500” na drugi strani.
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation 
nespečnost, živčnost/razdražljivost poskus samomora, razmišljanje o samomoru, psihotične motnje, nenormalno vedenje, halucinacije, jeza, stanje zmedenosti,
Each tablet contains 500 mg levetiracetam. 
Ena tableta vsebuje 500 mg levetiracetama.
basis) and 1,200 mg/kg/day for fetuses. 
1800 mg/kg/dan.
Povidone 
Odvajala
Levetiracetam Actavis 1,000 mg film-coated tablets 
Levetiracetam Actavis 1.000 mg filmsko obložene tablete
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. 
Levetiracetam Actavis 1000 mg filmsko obložene tablete so: ovalne, bele, velike 19,0 x 10,0 mm z oznako “L” na eni strani in “1000”na drugi strani.
Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets 
Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/042 60 x 1 tablet
Each tablet contains 250 mg levetiracetam. 
Ena tableta vsebuje 250 mg levetiracetama.
Each film-coated tablet contains 500 mg levetiracetam. 
Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets 
Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/043 60 x 1 tablet
Contact your doctor if you have missed one or more doses. 
Če ste pozabili vzeti zdravilo Levetiracetam Actavis Če pozabite vzeti enega ali več odmerkov, se posvetujte s svojim zdravnikom.
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). 
Pri bolnikih, ki so se zdravili z antiepileptiki (vključno z levetiracetamom), so poročali o samomoru,
Each film-coated tablet contains 250 mg levetiracetam. 
Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets 
EU/1/11/713/018 30 tablet EU/1/11/713/019 100 tablet EU/1/11/713/020 200 tablet
Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets 
Perforiranem pretisnem omotu za enkratni odmerek: EU/1/11/713/041 60 x 1 tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers 
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 1000 mg filmsko obložene tablete
Talk to your doctor before taking Levetiracetam Actavis 
Pred začetkom jemanja zdravila Levetiracetam Actavis se posvetujte s svojim zdravnikom.
INFORMATION IN BRAILLE 17. 
NAVODILA ZA UPORABO 16.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers 
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 750 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers 
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 250 mg filmsko obložene tablete
EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets 
EU/1/11/713/028 30 tablet EU/1/11/713/029 100 tablet EU/1/11/713/030 200 tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers 
PODATKI NA ZUNANJI OVOJNINI Škatla za vsebnik za tablete za 500 mg filmsko obložene tablete
EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets 
EU/1/11/713/008 30 tablet EU/1/11/713/009 100 tablet EU/1/11/713/010 200 tablet
How to store Levetiracetam Actavis 
Shranjevanje zdravila Levetiracetam Actavis
EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets 
EU/1/11/713/038 30 tablet EU/1/11/713/039 100 tablet EU/1/11/713/040 200 tablet
Levetiracetam Actavis 500 mg film-coated tablets 
Levetiracetam Actavis 500 mg filmsko obložene tablete
7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily 
7 do 14 mg/kg (0,07 do 0,14 ml/kg) enkrat na dan (2) (4)
Each tablet contains 750 mg levetiracetam. 
Ena tabletavsebuje 750 mg levetiracetama.
- Keep this leaflet. 
− Navodilo shranite.
Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172) 
sončno rumeno (E110) rdeči železov oksid (E172)
Levetiracetam Actavis 750 mg film-coated tablets 
Levetiracetam Actavis 750 mg filmsko obložene tablete
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. 
Pri 72,2 % bolnikov, ki so se zdravili z levetiracetamom, in 45,2 % bolnikov, ki so prejemali placebo,
Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention 
glavobol konvulzije, motnje ravnotežja, omotica, letargija, tremor amnezija, oslabljen spomin, poslabšana koordinacija/ataksija, parestezija, motnje pozornosti horeoatetoza, diskinezija, hiperkinezija, motnje hoje, encefalopatija
Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000 
Levetiracetam Actavis 1.000 mg filmsko obložene tablete krospovidon povidon brezvodni koloidni silicijev dioksid magnezijev stearat polivinilalkohol, delno hidroliziran makrogol 4000 smukec titanov dioksid (E171)
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 
EU/1/11/713/001 20 tablet EU/1/11/713/002 30 tablet EU/1/11/713/003 50 tablet EU/1/11/713/004 60 tablet EU/1/11/713/005 100 tablet EU/1/11/713/006 120 tablet EU/1/11/713/007 200 tablet
7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily 
7 do 14 mg/kg (0,07 do 0,21 ml/kg) dvakrat na dan
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 
EU/1/11/713/021 20 tablet EU/1/11/713/022 30 tablet EU/1/11/713/023 50 tablet EU/1/11/713/024 60 tablet EU/1/11/713/025 100 tablet EU/1/11/713/026 120 tablet EU/1/11/713/027 200 tablet
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers 
Nalepka za vsebnik za tablete za 250 mg filmsko obložene tablete IME ZDRAVILA
Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 1000 mg filmsko obložene tablete levetiracetam
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 
EU/1/11/713/011 20 tablet EU/1/11/713/012 30 tablet EU/1/11/713/013 50 tablet EU/1/11/713/014 60 tablet EU/1/11/713/015 100 tablet EU/1/11/713/016 120 tablet EU/1/11/713/017 200 tablet
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 
EU/1/11/713/031 20 tablet EU/1/11/713/032 30 tablet EU/1/11/713/033 50 tablet EU/1/11/713/034 60 tablet EU/1/11/713/035 100 tablet EU/1/11/713/036 120 tablet EU/1/11/713/037 200 tablet
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers 
Nalepka za vsebnik za tablete za 750 mg filmsko obložene tablete IME ZDRAVILA
Infants 6 to 23 months, children and adolescents weighing less than 50 kg 
(od 12 do 17 let), težke manj kot 50 kg
Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 500 mg filmsko obložene tablete levetiracetam
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers 
Nalepka za vsebnik za tablete za 1000 mg filmsko obložene tablete IME ZDRAVILA
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers 
Nalepka za vsebnik za tablete za 500 mg filmsko obložene tablete IME ZDRAVILA
A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day. 
Peri- in postnatalne razvojne študije z levetiracetamom pri podganah so izvedli pri odmerkih od 70,
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 
3600 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) in pri zarodkih 1200 mg/kg/dan.
Levetiracetam Actavis 250 mg, 500 mg and 1,000 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets. 
Velikosti pakiranj: Levetiracetam Actavis 250 mg, 500 mg in 1.000 mg filmsko obložene tablete
Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 750 mg filmsko obložene tablete levetiracetam
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; 
• kot dopolnilo drugim protiepileptičnim zdravilom za zdravljenje: parcialnih napadov z generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti miokloničnih napadov (kratki, nenadni trzaji mišice ali skupine mišic) pri bolnikih od 12.
Levetiracetam Actavis 250 mg film-coated tablets 
Levetiracetam Actavis 250 mg filmsko obložene tablete
Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 250 mg filmsko obložene tablete levetiracetam
Hepatic impairment 
Ušesne bolezni,
Children (4 to 12 years) 
Dojenčki od 6. do 23. meseca,
5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily 
5 do 10 mg/kg (0,05 do 0,10 ml/kg) dvakrat na dan končna ledvična odpoved bolniki na dializi
Following single dose administration (20 mg/kg) of a 100 mg/ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing. 
(od 1 meseca do 4 let) se je levetiracetam hitro absorbiral in plazemska koncentracija je bila dosežena približno 1 uro po odmerku.
Completed suicide, personality disorder, thinking abnormal, delirium 
napad panike, čustvena labilnost/nihanja v razpoloženju, agitacija samomor, osebnostne motnje, motnje mišljenja, delirij
Ref. EMEA/554626/2009 EMEA/H/C/1025 
: EMA/554626/2009 EMEA/H/C/1025
London, 24 September 2009 Doc. 
London, 24. septembra 2009 Sklic dok.
The letter from the company notifying the European Medicines Agency of the withdrawal of the application is available here. 
Dopis, s katerim družba Evropsko agencijo za zdravila obvešča o umiku vloge, je na voljo tukaj.
Questions and answers on the withdrawal of the marketing authorisation application for Ramvocid oritavancin 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ramvocid oritavancin
The main measure of effectiveness was the number of patients who were cured after treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba po koncu zdravljenja ozdravljena.
The company presented results from one main study involving 1,267 patients with complicated skin and soft tissue infections. 
Družba je predstavila rezultate glavne študije, ki je vključevala 1 267 bolnikov z zapletenimi okužbami kože ali mehkega tkiva.
The effects of Ramvocid were first tested in experimental models before being studied in humans. 
Učinki zdravila Ramvocid so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
‘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. 
„Zapleteno“ pomeni, da je okužbo težko zdraviti, ker je razširjena v tkiva globoko pod kožo, ker je morda potrebna operacija ali ker ima bolnik še druga stanja, ki utegnejo vplivati na zdravljenje.
Patients were given either Ramvocid for seven days or vancomycin with or without cephalexin (other antibiotic medicines) for between 10 and 14 days. 
Bolniki so dobivali bodisi 7 dni zdravilo Ramvocid ali med 10 in 14 dni vankomicin z cefaleksinom (drugim antibiotikom) ali brez njega.
The Committee was also concerned over the way the company had measured the levels of impurities in the medicine. 
Odbor prav tako ni bil zadovoljen z načinom, kako je družba merila ravni nečistoč v zdravilu.
These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes. 
Med temi bakterijami sta tudi Staphylococcus aureus (vključno z obliko, odporno na meticilin, znano kot „MRSA“) in Streptococcus pyogenes.
By disrupting this barrier, oritavancin is expected to kill the bacteria that are causing the infection. 
Z oviranjem delovanja te pregrade naj bi oritavancin uničil bakterije, ki povzročajo okužbo.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramvocid? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ramvocid?
Ramvocid was to be used when the infection was caused by a group of bacteria known as ‘Grampositive' bacteria. 
Zdravilo Ramvocid naj bi se uporabljalo, kadar je okužbo povzročila skupina bakterij, znana kot Gram pozitivne bakterije.
It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes. 
Zdravilo naj bi delovalo na dva načina, in sicer naj bi preprečevalo bakterijam izgradnjo celičnih sten in oviralo delovanje njihovih celičnih membran.
What is Ramvocid? 
Kaj je zdravilo Ramvocid?
The active substance in Ramvocid, oritavancin, is an antibiotic that belongs to the group ‘lipoglycopeptides'. 
Zdravilna učinkovina zdravila Ramvocid, oritavancin, je antibiotik, ki spada v skupino lipoglikopeptidov.
The company informed the CHMP that, at the time of the withdrawal, there were no patients in clinical trials or compassionate use programmes for Ramvocid. 
Družba je obvestila CHMP, da v času umika vloge ni bilo bolnikov, ki bi sodelovali v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ramvocid.
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. 
CHMP je imel zadržke, ker družba ni zagotovila zadostnih dokazov v podporo uporabi zdravila Ramvocid za zdravljenje zapletenih okužb kože in mehkega tkiva s predlaganim odmerkom, zlasti pri bolnikih z MRSA.
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. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Ramvocid ni mogoče odobriti za zdravljenje zapletenih okužb kože in mehkega tkiva, ki jih povzročijo Gram pozitivne bakterije.
Ramvocid was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin. 
Zdravilo Ramvocid naj bi se uporabljalo za zdravljenje odraslih z zapletenimi okužbami kože in podkožnih „mehkih tkiv“.
On 20 August 2009, Targanta Netherlands B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramvocid, for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria. 
je dne 20. avgusta 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ramvocid, namenjenim zdravljenju zapletenih okužb kože in mehkega tkiva, ki jih povzročajo Gram pozitivne bakterije.
What was Ramvocid expected to be used for? 
Za kaj naj bi se zdravilo Ramvocid uporabljalo?
Ramvocid is a powder to be made up into a solution for infusion (drip into a vein). 
Zdravilo Ramvocid je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
How is Ramvocid expected to work? 
Kako naj bi zdravilo Ramvocid delovalo?
14 June 2010 
14. junij 2010
The final opinion was converted into a Decision by the European Commission on 14 June 2010. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 14. junija 2010.
The referral procedure started on 11 February 2009. 
Napotitveni postopek se je začel 11. februarja 2009.