natgillin/translations-raw huggingface dataset:
The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA arm over the placebo arm (n = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001). 
Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v skupini z zdravilom ALIMTA glede na skupino s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI: 0,490,73, p < 0,00001).
Children and adolescents There is no relevant use of ALIMTA in the paediatric population 
Zdravilo Alimta ni primerno za uporabo pri pediatrični populaciji.
If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs) 
Če doživite nenadno težko dihanje, močno bolečino v prsih ali kašelj s krvavim izmečkom
Gemcitabine + cisplatin 
ALIMTA + Cisplatin Gemcitabin + Cisplatin
ALIMTA 100 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 100 mg of pemetrexed. 
ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I z gumijasto zaporko, ki vsebuje 100 mg pemetrekseda.
The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002). 
Študija je dosegla svoj primarni ciljni učinek in dokazala statistično pomembno izboljšanje preživetja brez napredovanja bolezni v skupini, ki je prejemala zdravilo ALIMTA, v primerjavi s skupino, ki je prejemala placebo (n = 472, neodvisno pregledana populacija; mediano 3,9 meseca in 2,6 meseca) (razmerje tveganja=0,64, 95 % CI = 0,51-0,81, p = 0,0002).
For Precautions to be taken before handling or administering ALIMTA, see section 6.6. 
Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila ALIMTA glejte poglavje 6.6.
**According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2. 
**V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), alopecija mora biti poročana kot stopnja 1 ali 2.
ALIMTA 500 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 500 mg of pemetrexed. 
ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I z gumijasto zaporko, ki vsebuje 500 mg pemetrekseda.
Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy. 
Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
Common Taste disturbance Eye disorders Common Conjunctivitis 
Bolečina v prsnem košu Mišična oslabelost Konjunktivitis (vnetje očesa)
All Grades toxicity 
Toksičnost vseh stopenj
From the start of ALIMTA plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the ALIMTA arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96). 
Od začetka indukcijskega zdravljenja prve izbire z zdravilom ALIMTA skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku ALIMTA in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95% % CI = 0,64-0,96).
MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/290/001
For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the ALIMTA arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001). 
Za bolnike z NSCLC , ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za skupino z zdravilom ALIMTA in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95% CI: 0,37-0,60, p = 0,00001).
Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy. 
Nekateri bolniki so med prejemanjem zdravila ALIMTA, običajno v kombinaciji z drugim zdravilom proti raku, doživeli srčno kap, možgansko kap ali "manjšo kap".
EXP Read the leaflet for the shelf life of the reconstituted product. 
EXP: Za informacije o roku uporabnosti pripravljenega zdravila preberite navodilo za uporabo.
ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium). 
ALIMTA 100 mg: Vsaka viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2. 
***V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), motnje okusa in alopecija morata biti poročana kot stopnja 1 ali 2.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/002 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/290/002
Table 2 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b Dose of ALIMTA (mg/m2) 
Preglednica 2 - Preglednica za prilagajanje odmerkov zdravila ALIMTA (kot edine učinkovine ali v kombinaciji) in cisplatina - Nehematološke toksičnostia, b
If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive ALIMTA. 
Če imate ali ste imeli težave z ledvicami, se pogovorite z zdravnikom ali bolnišničnim farmacevtom,
Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by glomerular filtration. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pemetreksed se izloča predvsem preko ledvic nespremenjen s tubulno sekrecijo in v manjšem obsegu z glomerulno filtracijo.
ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed 
ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
Talk to your doctor or hospital pharmacist before receiving ALIMTA. 
Pred začetkom uporabe zdravila ALIMTA se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
ALIMTA at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma. 
500 mg/m2 pri 64 bolnikih z malignim plevralnim mezoteliomom, ki predhodno še niso prejemali kemoterapije.
8.3 months for patients treated with ALIMTA (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288). 
v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali metastatskim NSCLC po predhodni kemoterapiji, je pokazala mediano časa preživetja 8,3 mesece pri bolnikih, zdravljenih z zdravilom ALIMTA (Populacija z namenom zdraviti n = 283), in 7,9 mesecev pri bolnikih, zdravljenih z docetakselom (NZ n = 288).
Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) 
Kolitis (vnetje sluznice debelega črevesa, ki ga lahko spremlja krvavitev iz črevesa ali danke) Intersticijska pljučnica (vnetje pljučnih mešičkov) Edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino)
The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of ALIMTA plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the ALIMTA arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95% CI = 0.47-0.74). 
Za naključno izbrane bolnike, merjeno od začetka zdravljenja z zdravilom ALIMTA in indukcijskim zdravljenjem prve izbire s cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala zdravilo ALIMTA, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59 95 % CI = 0,47-0,74).
ALIMTA 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium). 
ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation ALIMTA maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation) 
Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja z zdravilom ALIMTA v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
Constipation Common Dyspepsia 
Zelo pogosto Diareja Bruhanje
Low haemoglobin level (anaemia) Low platelet count 
Nizko število belih krvnih celic Nizka raven hemoglobina (anemija) Nizko število trombocitov Diareja
ALIMTA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium). 
ALIMTA 500 mg: Vsaka viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease. 
Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje AST, povišanje ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjuktivitis in znižanje očistka kreatinina.
Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the ALIMTA arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002). 
Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za skupino z zdravilom ALIMTA in 13,6 mesecev za skupino s placebom (razmerje tveganja = 0,71, 95% CI: 0,56-0,88, p = 0,002).
White to either light yellow or green-yellow lyophilised powder. 
Bel do svetlorumen ali zelenorumen liofilizirani prašek.
ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion 
ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje
Hypernatraemia - increased sodium in blood Inflammation of the skin, mainly of the lower limb with swelling, pain and redness 
Vnetje kože, večinoma spodnjih okončin, z otekanjem, bolečino in pordelostjo
95 % CI for median 
Mediana (m) 95 % IZ za mediano
Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain. 
Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: odpoved ledvic, okužbo, pireksijo, febrilno nevtropenijo, povišane AST, ALT in GGT, koprivnico in bolečino v prsnem košu.
Preparation and administration precautions 
Previdnostni ukrepi pri pripravi in dajanju
ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed 
ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the ALIMTA arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002). 
Mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 481) je bila 15,5 mesecev za skupino z zdravilom ALIMTA in 10,3 mesecev za skupino s placebom (razmerje tveganja = 0,70, 95% CI: 0,56-0,88, p = 0,002).
Rash Alopecia 
Alopecija
ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 
ALIMTA je indicirana kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
Common Leukocytes decreased 
Pogosto Znižani levkociti
Breast-feeding must be discontinued during ALIMTA treatment. 
Dojenje morate med zdravljenjem z zdravilom ALIMTA prekiniti.
Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent. 
Občasno so v kliničnih študijah pemetrekseda, običajno ob sočasnem dajanju z drugo citotoksično učinkovino, poročali o resnih srčnožilnih in možganskožilnih dogodkih, vključno z miokardnim infarktom, angino pektoris, cerebrovaskularnim insultom in prehodnimi ishemičnimi atakami.
Nervous system disorders 
Celotni sistemski očistek pemetrekseda je
In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4). 
Ker ni podatkov o možnem medsebojnem delovanju pemetrekseda in NSAID-ov z daljšimi razpolovnimi časi, denimo, piroksikama ali rofekoksiba, moramo sočasno dajanje NSAID-ov s pemetreksedom pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic prekiniti vsaj za 5
EMPHACIS, a multicentre, randomised, single-blind phase 3 study of ALIMTA plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with ALIMTA and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone. 
EMPHACIS, multicentrična, randomizirana, enojno slepa študija faze 3 zdravila ALIMTA skupaj s cisplatinom v primerjavi s cisplatinom pri bolnikih z malignim plevralnim mezoteliomom, ki v preteklosti še niso prejemali kemoterapije, je pokazala, da so imeli bolniki, zdravljeni z zdravilom
Women must use effective contraception during treatment with ALIMTA. 
ALIMTA morajo ženske uporabljati učinkovito metodo kontracepcije.
CLASSIFICATION FOR SUPPLY 
SEZNAM POMOŽNIH SNOVI
Treatment with ALIMTA should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed. 
100 % predhodnega odmerka 50 % predhodnega odmerka a *Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) Zdravljenje z zdravilom ALIMTA moramo prekiniti, če bolnik izkusi kakršnokoli hematološko ali nehematološko toksičnost stopnje 3 ali 4 po 2 znižanjih odmerka ali nemudoma, če opazimo nevrološko toksičnost stopnje 3 ali 4.
SPECIAL STORAGE CONDITIONS 
POSEBNA NAVODILA ZA SHRANJEVANJE 10.
Inflammation of the lining of the oesophagus (gullet) has been experienced with ALIMTA/ radiation therapy. 
V kliničnih preskušanjih s pemetreksedom so občasno poročali o ezofagitisu/radiacijskem ezofagitisu.
Irritation of the skin and itching Chest pain 
Odpoved ledvic Draženje kože in srbenje
NAME OF THE MEDICINAL PRODUCT ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed 
IME ZDRAVILA IN POT(I) UPORABE ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium). 
ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
NAME OF THE MEDICINAL PRODUCT ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed 
IME ZDRAVILA IN POT(I) UPORABE ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration. 
Videz parenteralnih zdravil je treba pred dajanjem vizualno pregledati, da ne vsebujejo trdnih delcev ali da nimajo spremenjene barve.
A multicentre, randomised, open label phase 3 study of ALIMTA versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 
Multicentrična, randomizirana, odprta študija faze 3 zdravila ALIMTA skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč
What ALIMTA looks like and contents of the pack ALIMTA is a powder for concentrate for solution for infusion in a vial. 
ALIMTA je prašek za koncentrat za raztopino za infundiranje v viali.
The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel. 
od 265 bolnikov, ki so jih naključno razporedili, da so prejemali eno učinkovino pemetreksed z dopolniloma folno kislino in vitaminom B12, ter pri 276 bolnikih, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, docetaksel.
Haemoglobin decreased 
Znižani trombociti
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5). 
naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAID), denimo, ibuprofena in acetilsalicilne kisline (> 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
Common Vomiting Mucositis/ stomatitis 
Pogosto Bruhanje Mukozitis/S tomatitis
Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased 
Znižan hemoglobin 26,2 Znižani trombociti
Package leaflet: Information for the user ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed 
Navodilo za uporabo ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed. 
100 mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
See section 4. 
Priloga IV
Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed. 
100-mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
Common Constipation 
Pogosto Konjunktivitis
Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed. 
500 mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
Any Grade 3 or 4 toxicities except mucositis 
Katerekoli toksičnosti stopnje 3 ali
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes. 
100 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje brez konzervansa, damo jo kot intravensko infuzijo, ki teče 10 minut.
Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed. 
500-mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
Constipation 
luščenje
All grades toxicity 
Toksičn ost vseh stopenj
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium). 
Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
Time to treatment failure (months) (95 % CI) 
Čas do neuspeha zdravljenja (meseci)
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). 
To pomeni, da je kljub pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da se na navedeni način varno uporabljajo že vsaj 30 let (najmanj 15 let tudi v EU).
Hop strobile EMA/304459/2016 
Cvet navadnega hmelja EMA/304459/2016
Hop strobile medicines should only be used in adults and adolescents over the age of 12 years. 
Zdravila, ki vsebujejo cvet navadnega hmelja, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
Hop strobile is the common name for the flowers of the plant Humulus lupulus L. 
Cvet navadnega hmelja je splošno ime za cvetove rastline Humulus lupulus L.
This summary is not intended to provide practical advice on how to use medicines containing hop strobile. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo cvet navadnega hmelja.
The HMPC conclusions only cover hop strobile preparations which are obtained by comminuting (reducing into tiny pieces) or by drying and powdering the flowers or as dry or liquid extracts. 
Zaključki odbora HMPC zajemajo samo pripravke s cvetom navadnega hmelja, ki se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) ali s sušenjem in drobljenjem cvetov v prah ter kot suhi ali tekoči ekstrakti.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of hop strobile. 
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo cveta navadnega hmelja.
The solvent is then partially or completely evaporated to obtain a dry extract. 
Topilo se nato delno ali v celoti odpari, s čimer se pridobi suhi ekstrakt.