natgillin/translations-raw huggingface dataset:
• Hardening of the skin at the injection site 
• bolečina na mestu injiciranja, • otrdelost kože na mestu injiciranja,
There is no information on administration of AFLUNOV with noninfluenza vaccines. 
Ni podatkov o dajanju cepiva AFLUNOV s cepivi, ki niso namenjena proti gripi.
- Keep this leaflet. 
ga zavrzite.
assays) and reduced seroprotection rates in adults and elderly (≥ 61 years old) subjects with underlying medical or immunosuppressive conditions, suggest that AFLUNOV may not elicit the same level of protection against A/H5N1 strain as compared to healthy adults (see section 4.4). 
V obeh študijah (V87_25 in V87_26) nižje ravni protiteles (izmerjene s testi HI, SRH in MN) in znižane stopnje serozaščite pri odraslih in starejših osebah (starih ≥ 61 let) z osnovnimi bolezenskimi stanji ali zmanjšanim imunskim odzivom kažejo na to, da cepivo AFLUNOV pri teh osebah morda ne vzpostavi enake stopnje zaščite proti sevu A/H5N1 kot pri zdravih odraslih osebah (glejte poglavje 4.4).
How AFLUNOV is given 
Kako se daje cepivo AFLUNOV
Baseline Serostatus 
OVOJNINA ZA BRIZGE
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows: 
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 A/Vietnam/1194/2004, izmerjeno s testi SRH, so bili kot sledi:
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 in the adults measured by SRH assay was as follows: 
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 A/Vietnam/1194/2004 in na H5N1 A/turkey/Turkey/1/2005 pri odraslih, izmerjeno s testom SRH, so bili, kot sledi:
Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows: 
Geometrijska sredina površine*, stopnja serozaščite*, stopnja serokonverzije* in faktor serokonverzije** za protitelo proti HA na H5N1 A/turkey/Turkey/1/2005, izmerjeni s testi SRH 21 dni po 2. odmerku, so bili naslednji:
Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows: 
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelesa proti HA na sev H5N1 A/turkey/Turkey/1/2005 po 2. odmerku pri odraslih, starih od 18 do 60 let, izmerjeno s testoma SRH in HI, so bili, kot sledi:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Talk to your doctor or nurse before having this vaccine 
Pred cepljenjem s tem cepivom se posvetujte z zdravnikom ali medicinsko sestro.
Nausea, aching joints, diarrhoea and loss of appetite were reported very commonly in this population. 
Pri teh bolnikih so zelo pogosto poročali o siljenju na bruhanje, bolečinah v sklepih, driski in izgubi apetita.
Adults from 18 onwards: 
Odrasli, stari 18 let ali več:
Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody 
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelesa proti HA na H5N1 A/Indonesia/5/2005 in A/Vietnam/1194/2004 po 2. odmerku pri odraslih (18-60 let) in starejših (≥ 61 let), izmerjeno s testoma SRH in HI, so bili, kot sledi:
Influenza like illness 
trepetanje gripi podobna bolezen anafilaksa
Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects. 
S 3-tedenskim presledkom so 156 zdravih odraslih oseb cepili z dvema odmerkoma cepiva AFLUNOV.
Study V87P2 Adults booster after 2nd dose 
Študija V87P2 odrasli obnovitev po 2. odmerku
• Nausea 
• krči,
°° GMRs of HI 
** GMR za SRH
Based on humoral immune responses to the vaccine strain A/turkey/Turkey/1/2005 after two doses of AFLUNOV, a protective immune response may not be elicited in all vaccinees. 
Na podlagi humoralnih imunskih odzivov na cepilni sev A/turkey/Turkey/1/2005 po dveh odmerkih cepiva
Name and address of the manufacturers of the biological active substance Seqirus Vaccines Ltd 
Ime in naslov izdelovalcev biološke učinkovine
Study V87P1 Elderly booster after 2nd dose 
Študija V87P1 starejše osebe obnovitev po 2. odmerku
Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c 
Študija V87P11 A/turkey/Turkey/1/2005 21. dni po 2. odmerku N = 132
• Injection site redness 
• pordečeno mesto injiciranja,
Study V87P1 Adults booster after 2nd dose 
Študija V87P1 odrasli obnovitev po 2. odmerku
A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults. 
faze (V87P1) s cepivom AFLUNOV (A/Vietnam/1194/2004).
Adults (19- 60 years)a 
Odrasli (19-60 let)
Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions. 
V87_26, z odraslimi (18-60 let) in starejšimi osebami (≥ 61 let), ki so bile zdrave ali pa so imele osnovna bolezenska stanja ali oslabljen imunski odziv.
Nervous system disorders 
Bolezni živčevja glavobol konvulzije
Injection site swelling, Injection site pain, Injection site induration, Injection site redness, Fatigue 
rdečina na mestu injiciranja, utrujenost ekhimoza na mestu injiciranja, zvišana telesna temperatura, splošno slabo počutje,
Medical conditions 
UPORABO ZDRAVILA
Seroprotection rate (95%CI) ° Seroconversion rate (95%CI) ° Seroconversion factor (95%CI) °° 
(95-odstotni IZ)° Stopnja serokonverzije (95-odstotni IZ)° Faktor serokonverzije (95-odstotni IZ)°°
(A/Vietnam/1194/2004) dose, all vaccine schedule groups after 3 weeks from the 2nd vaccination achieved high levels of antibodies as evaluated with SRH. 
starih 18 do 60 let, kjer je drugi odmerek sledil 1, 2, 3 ali 6 tednov po prvem odmerku cepiva AFLUNOV (A/Vietnam/1194/2004), so vsi režimi cepljenja po 3. tednih po 2. cepljenju dosegli visoke ravni protiteles, ocenjene s SRH.
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities. 
Oslabelost mišic, bolečine v okončinah
Immunocompromised 
Z oslabljenim imunskim odzivom
Non-clinical data obtained with AFLUNOV and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period). 
MF59C.1, na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, lokalnega prenašanja,
Adults (20- 60 years)a 
Odrasli (20-60 le t)*
Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea. 
Prebavne težave, kot so navzea, bruhanje, bolečine v trebuhu in driska
MARKETING AUTHORISATION HOLDER 
Spremljanje v obdobju trženja
How to store AFLUNOV 
Shranjevanje cepiva AFLUNOV
Anti-HA antibody Study V87P12 21 days after 2nd dose N=60 
Študija V87P12 21. dni po 2. odmerku N = 60
The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to AFLUNOV. 
imenovanim Focetria H1N1v, ki je podobno cepivu AFLUNOV.
Suspension for injection in pre-filled syringe. 
suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno-bela tekočina
Other rare side effects observed after routine use: 
Drugi redki neželeni učinki, ki so jih opazili po rutinski uporabi: Spodaj našteti neželeni učinki so se pojavili v dneh ali tednih po cepljenju z drugim cepivom,
a actual age range of population enrolled * Seroprotection: SRH area≥25 mm2 
* izmerjeno s testom SRH; serozaščita: površina SRH ≥ 25 mm2; serokonverzija: površina SRH
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6. 
• če ste imeli kakršno koli alergijsko reakcijo, ki ni bila nenadna, življenje ogrožajoča, na katero koli sestavino cepiva, na jajčne in piščančje beljakovine, na ovalbumin, formaldehid,
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)*** 
(95-% IZ)* Stopnja serokonverzije (95-% IZ)* Faktor serokonverzije (95-% IZ)**
The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly: 
Neželeni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom AFLUNOV v kliničnih študijah: Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov):
Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd 
Ime in naslov izdelovalca, odgovornega za sproščanje serij
There are no data with AFLUNOV using the subcutaneous route of administration. 
Podatkov o subkutani poti uporabe cepiva AFLUNOV ni.
MedDRA System Organ class Very common 
Organski sistem po MedDRA
Clinical trials with AFLUNOV have been conducted with either the former A/Vietnam/1194/2004 (H5N1) (clade 1) or the current A/turkey/Turkey/1/2005 (H5NI) vaccine strain (clade 2.2.1). 
A/Vietnam/1194/2004 (H5N1) ali sedanjim sevom A/turkey/Turkey/1/2005 (H5N1) (gruča 2.2.1).
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66 
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 66
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=128 
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 128
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=69 
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 69
Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=149 
Študija V87P1 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 149
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder 
Imetnik dovoljenja za promet z zdravilom in izdelovalec: Imetnik dovoljenja za promet z zdravilom
• Injection site swelling 
• oteklo mesto injiciranja,
Posology 
sistemom
Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=84a 
Študija V87P1 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 84
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143 
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 143
* measured by SRH assay seroprotection: SRH area ≥25 mm2, seroconversion: SRH area ≥25 mm2 for subjects with a baseline SRH area ≤4 mm2 or a minimum 50% increase in SRH area for subjects with >4 mm2. 
≥ 25 mm2 za osebe s površino SRH ≤ 4 mm2 ob izhodišču ali z vsaj 50 % povečanjem površine
Immune system disorders 
Limfadenopatija Bolezni imunskega sistema
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=210b 
Študija V87P13 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 210
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=197 
Študija V87P13 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 197
Cardiac disorders Palpitation, tachycardia. 
Palpitacije, tahikardija Bolezni dihal Kašelj
• Vomiting 
• mravljinčenje,
Immunocompromised N=139 
sistemom N = 139
They should not be used during pregnancy and breastfeeding. 
Ne smejo se uporabljati med nosečnostjo in dojenjem.
This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU. 
To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njihovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
Castor oil medicines should only be used in adults, and should not be taken for longer than one week without medical supervision. 
Zdravila, ki vsebujejo ricinusovo olje, se smejo uporabljati samo pri odraslih in se brez zdravniškega nadzora ne smejo uporabljati več kot en teden.
This means that the oil is extracted from the seeds by crushing and pressing them without heating. 
To pomeni, da se olje ekstrahira iz semen tako, da se semena brez segrevanja zdrobijo in stisnejo.
Castor oil EMA/108531/2016 
Ricinusovo olje EMA/108531/2016
This summary is not intended to provide practical advice on how to use medicines containing castor oil. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo ricinusovo olje.
Castor oil is the common name for the oil obtained from the seeds of the plant Ricinus communis L. The HMPC conclusions only cover castor oil preparations which are obtained by ‘cold expression' of the seeds. 
Ricinusovo olje je splošno ime za olje, pridobljeno iz semen rastline Ricinus communis L. Zaključki odbora HMPC zajemajo samo pripravke z ricinusovim oljem, ki se pridobivajo s „hladnim iztiskanjem“ semen.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of castor oil. 
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo ricinusovega olja.
Herbal medicines containing these castor oil preparations are usually available in solid or liquid forms to be taken by mouth. 
Zdravila rastlinskega izvora, ki vsebujejo te pripravke z ricinusovim oljem, so navadno na voljo v trdni ali tekoči obliki za jemanje skozi usta.
What is castor oil? 
Kaj je ricinusovo olje?
Castor oil medicines should not be taken in case of obstruction or narrowing of the gut, atony (loss of normal movement in the gut muscle), appendicitis (inflammation of the appendix, a small organ connected to the bowel), inflammatory diseases of the colon (the lower part of the bowel), unexplained abdominal pain and severe dehydration. 
Zdravila, ki vsebujejo ricinusovo olje, se ne smejo uporabljati pri črevesni zapori ali zožitvi, atoniji (izgubi normalnega gibanja črevesnih mišic), apendicitisu (vnetju slepiča, majhnega organa, povezanega s črevesjem), vnetni bolezni debelega črevesa (spodnjega dela črevesa), nepojasnjeni bolečini v trebuhu in hudi dehidraciji.
Further information on the risks associated with castor oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo ricinusovo olje, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
How does castor oil work as a medicine? 
Kako ricinusovo olje deluje kot zdravilo?
In its assessment, the HMPC considered two clinical studies which showed a laxative effect for castor oil medicines in constipated patients. 
V svoji oceni je odbor HMPC upošteval dve klinični študiji, ki sta pokazali, da imajo zdravila, ki vsebujejo ricinusovo olje, pri bolnikih z zaprtjem odvajalni učinek.
Castor oil 
Ricinusovo olje
In one of the studies the effects of castor oil capsules were similar to those of senna capsules (another herbal preparation commonly used to treat constipation). 
V eni od študij so bili učinki ricinusovega olja podobni učinkom kapsul sene (drugega pripravka rastlinskega izvora, ki se pogosto uporablja za zdravljenje zaprtosti).
This increases the water content of stools, making them softer and easier to pass. 
S tem se poveča vsebnost vode v blatu, zato blato postane mehkejše in se lažje odvaja.
The HMPC conclusions on the use of these castor oil medicines as laxatives are based on their ‘wellestablished use'. 
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo ricinusovo olje, kot odvajal temeljijo na njihovi „dobro uveljavljeni medicinski uporabi“.
These include nausea, vomiting abdominal (belly) pain and severe diarrhoea. 
Ti vključujejo slabost, bruhanje, bolečine v trebuhu in hudo drisko.
Castor oil preparations may also be found in combination with other herbal substances in some herbal medicines. 
Pripravki z ricinusovim oljem so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
Any applications for the licensing of medicines containing castor oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC. 
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo ricinusovo olje, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Information on the use and licensing of castor oil medicines in EU Member States should be obtained from the relevant national authorities. 
Za informacije o uporabi in registraciji zdravil, ki vsebujejo ricinusovo olje, v državah članicah EU se obrnite na pristojni nacionalni organ.
Further information on the HMPC assessment of castor oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o oceni zdravil, ki vsebujejo ricinusovo olje, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC concluded that these castor oil preparations can be used for short term as laxatives for occasional constipation. 
Odbor HMPC je zaključil, da se lahko ti pripravki, ki vsebujejo ricinusovo olje, uporabljajo kratkotrajno kot odvajalo pri občasni zaprtosti.
How are castor oil medicines approved in the EU? 
Kako so zdravila, ki vsebujejo ricinusovo olje, odobrena v EU?
When ingested, castor oil is broken down into ricinoleic acid which works by reducing absorption of fluid and salts in the small intestine (the upper part of the bowel). 
Ob zaužitju se ricinusovo olje razgradi v ricinoleinsko kislino, ki zmanjšuje absorpcijo tekočin in soli v tankem črevesu (zgornjem delu črevesja).
What evidence supports the use of castor oil medicines? 
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo ricinusovo olje?
Other information about castor oil medicines 
Druge informacije o zdravilih, ki vsebujejo ricinusovo olje
Detailed instructions on how to take castor oil medicines and who can use them can be found in the package leaflet that comes with the medicine. 
Podrobna navodila o jemanju zdravil, ki vsebujejo ricinusovo olje, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
What are the risks associated with castor oil medicines? 
Kakšna tveganja so povezana z zdravili, ki vsebujejo ricinusovo olje?
For more information about treatment with castor oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravili, ki vsebujejo ricinusovo olje, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using castor oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist. 
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
In addition, castor oil stimulates movement in the intestines which will help to pass the stools. 
Poleg tega ricinusovo olje spodbuja gibanje črevesa, zato je odvajanje blata lažje.
Member States when evaluating applications for the licensing of herbal medicines containing castor oil. 
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo ricinusovo olje.
Side effects have been reported with castor oil. 
Pri uporabi ricinusovega olja so poročali o neželenih učinkih.
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/498/002 Thymanax 
Jakost Farmacevtska oblika Pot uporabe
Conclusions presented by the European Medicines Agency on: 
Sklepne ugotovitve, ki jih je predstavila Evropska agencija za zdravila, o:
<Similarity> 
<podobnosti>
<Derogation> 
<odstopanju>
<the holder of the marketing authorisation for <authorised orphan medicinal product> has given his consent to the applicant.> 
<imetnik dovoljenja za promet z <odobrenim zdravilom siroto> je dal svoje soglasje predlagatelju.>
<one-year <marketing protection><data exclusivity>> 
<enoletni <tržni zaščiti> <ekskluzivnosti podatkov>>
Conditional marketing authorisation 
pridobitvi pogojnega dovoljenja za promet z zdravilom
CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER <PODOBNOSTI IN ODSTOPANJU> <IN> <ZAHTEVKU ZA ENOLETNO <TRŽNO ZAŠČITO> <EKSKLUZIVNOST PODATKOV>>, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
<the holder of the marketing authorisation for <authorised orphan medicinal product> is unable to supply sufficient quantities of the medicinal product> <and> 
<imetnik dovoljenja za promet z <odobrenim zdravilom siroto> ni sposoben dobavljati zadostnih količin zdravila>; <in>
[For Art 14(11)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report. 
[For Art 14(11)] <Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe člena 14(11) Uredbe (ES) št. 726/2004, in meni, da nova terapevtska indikacija prinaša pomembno klinično korist v primerjavi z obstoječimi terapijami, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
<the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and> 
<predlagatelj je v svoji vlogi lahko utemeljil, da je zdravilo, čeprav je podobno <odobrenemu zdravilu siroti>, varnejše, učinkovitejše ali kako drugače klinično boljše (kot je opredeljeno v členu 3 Uredbe Komisije (ES) št. 847/2000) za isto terapevtsko indikacijo>; <in>
<The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No. 141/2000 and <Article 3 of Commission Regulation (EC) No 847/2000> [only for the superiority derogation] the following derogation
 laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report : 
<Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da v skladu s členom 8 Uredbe (ES) št. 141/2000 in <členom 3 Uredbe Komisije (ES) št. 847/2000> [only for the superiority derogation] velja(-jo) naslednje(-a) odstopanje(-a), določeno(-a) v členu 8(3) iste uredbe, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila: