natgillin/translations-raw huggingface dataset:
The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
Po aspiriranju vsebine viale je treba iglo s filtrom zavreči.
Talk to your doctor before you are given Lucentis.
Preden prejmete zdravilo Lucentis, se posvetujte z zdravnikom.
The marketing authorisation is valid for five years, after which it can be renewed.
Dovoljenje za promet velja pet let, nato ga je mogoče podaljšati.
It is available as pink, round tablets (75 mg).
Na voljo je v obliki okroglih rožnatih tablet (75 mg).
B.V. can be started between a few days and 35 days after the attack;
se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Temu sledi običajni 75-miligramski odmerek enkrat na dan v trajanju najmanj štirih tednov (pri miokardnem infarktu z dvigom spojnice ST) ali največ 12 mesecev (pri sindromu brez dviga spojnice ST).
This means that Clopidogrel Teva Generics B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
• patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
• bolnikom z akutnim koronarnim sindromom, pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov), vključno z bolniki, ki jim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zamašitev).
The standard dose of Clopidogrel Teva Generics B.V. is one 75-mg tablet once a day, taken with or without food.
je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Lahko se uporablja tudi pri bolnikih, pri katerih ni nenormalnega zapisa na EKG-ju, če imajo nestabilno angino pektoris (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez zobca Q.
The full EPAR for Clopidogrel Teva Generics B.V. can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Because Clopidogrel Teva Generics B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This document is a summary of the European public assessment report (EPAR) for Clopidogrel Teva Generics B.V.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel Teva Generics B.V.
Clopidogrel Teva Generics B.V. can be used in patients who are having a heart attack with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG-ju), če zdravnik meni, da jim zdravilo lahko pomaga.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Teva Generics B.V.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel Teva Generics B.V., na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For more information about treatment with Clopidogrel Teva Generics B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
In acute coronary syndrome, Clopidogrel Teva Generics B.V. is used together with aspirin and treatment generally starts with a loading dose of four tablets.
uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih tablet.
Clopidogrel Teva Generics B.V. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
Because Clopidogrel Teva Generics B.V. is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
What are the benefit and risk of Clopidogrel Teva Generics B.V.?
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Teva Generics B.V.
The active substance in Clopidogrel Teva Generics B.V., clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel Teva Generics B.V., klopidogrel, je zaviralec agregacije trombocitov.
Clopidogrel Teva Generics B.V. can be given to the following groups of patients:
se lahko daje naslednjim skupinam bolnikov:
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Generics B.V. to Teva Generics B.V. on 28 October 2010.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Teva Generics B.V., veljavno po vsej Evropski uniji, odobrila družbi Teva Generics B.V.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Generics B.V. has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Teva Generics B.V.
For genetic reasons, some patients may not be able to convert Clopidogrel Teva Generics B.V. as effectively as others, which could reduce their response to the medicine.
pretvarjajo manj učinkovito kot drugi, zaradi česar je njihov odziv na zdravilo manjši.
Clopidogrel Teva Generics B.V. can be started between seven days and six months after the stroke;
se lahko začne jemati sedem dni po napadu do šest mesecev po njem;
Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Plavix, odtehtajo znana tveganja.
Other information about Clopidogrel Teva Generics B.V.:
Druge informacije o zdravilu Clopidogrel Teva Generics B.V.
The Committee recommended that Clopidogrel Teva Generics B.V. be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel Teva Generics B.V.
What is Clopidogrel Teva Generics B.V.?
Kaj je zdravilo Clopidogrel Teva Generics B.V.
Clopidogrel Teva Generics
Zdravilo Clopidogrel Teva
Clopidogrel Teva Generics B.V. is converted into its active form in the body.
se v svojo aktivno obliko pretvori v telesu.
What is Clopidogrel Teva Generics B.V. used for?
Za kaj se zdravilo Clopidogrel Teva Generics B.V.
How has Clopidogrel Teva Generics B.V. been studied?
Kako se zdravilo Clopidogrel Teva Generics B.V.
How is Clopidogrel Teva Generics B.V. used?
Kako je bilo zdravilo Clopidogrel Teva Generics B.V.
How does Clopidogrel Teva Generics B.V. work?
Kako zdravilo Clopidogrel Teva Generics B.V.
Why has Clopidogrel Teva Generics B.V. been approved?
Zakaj je bilo zdravilo Clopidogrel Teva Generics B.V.
The European Commission issued a decision on 26 May 2009.
Evropska komisija je odločbo izdala 26. maja 2009.
Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev zaradi različnih odločitev, ki so jih sprejele države članice.
Ref. EMEA/CHMP/335293/2009 EMEA/H/A-30/1000
EMEA/CHMP/335293/2009 EMEA/H/A-30/1000
London, 28 May 2009 Doc.
London, 28. maja 2009 Sklic dok.
In addition, before prescribing higher strengths of Diovan Comp, doctors should consider that in most patients maximal effects are observed within four weeks, but in some patients four to eight weeks treatment may be required.
Poleg tega morajo zdravniki pred predpisovanjem večjih jakosti zdravila Diovan Comp upoštevati, da se pri večini bolnikov največji učinki pokažejo v štirih tednih, pri nekaterih pa mora zdravljenje trajati štiri do osem tednov.
The Committee also removed a contraindication for women who are breastfeeding because it considered that the amount of hydrochlorothiazide found in breast milk was very low.
Odbor je izbrisal tudi kontraindikacijo za matere, ki dojijo, saj se šteje, da je količina hidroklorotiazida v materinem mleku zelo majhna.
Diovan Comp and associated names are authorised in the EU via national procedures.
Zdravilo Diovan Comp in z njim povezana imena so v EU odobreni z nacionalnimi postopki.
Questions and answers on the referral for Diovan Comp and associated names tablets containing valsartan (80, 160 or 320 mg) and hydrochlorothiazide (12.5 or 25 mg)
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Diovan Comp in z njim povezana imena tablete, ki vsebujejo valsartan (80, 160 ali 320 mg) in hidroklorotiazid (12,5 ali 25 mg)
Why was Diovan Comp reviewed?
Zakaj je bilo zdravilo Diovan Comp pregledano?
Diovan Comp is used to treat patients with hypertension (high blood pressure), and is also available in the EU under other trade names: Co-Angiosan, Co-Angiosane, Co-Dalzad, Co-Diovan, Co-Diovane, Co-Novasan, Co-Novocard, Cordinate Plus, Corixil, Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten Plus, Nazzec, Provas Comp, Provas Plus, and Valsartan/Hydroklortiazide.
Zdravilo Diovan Comp se uporablja za zdravljenje bolnikov s hipertenzijo (visokim krvnim tlakom) in je v EU na voljo tudi pod drugimi imeni: Co-Angiosan, Co-Angiosane, Co-Dalzad, Co-Diovan, Co-Diovane, Co-Novasan, Co-Novocard, Cordinate Plus, Corixil, Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten Plus, Nazzec, Provas Comp, Provas Plus in Valsartan/Hydroklortiazide.
The new wording also means that in all member states Diovan Comp will also be used in patients previously treated with hydrochlorothiazide.
Novo besedilo pomeni tudi, da se bo v vseh državah članicah zdravilo Diovan Comp uporabljalo tudi pri bolnikih, predhodno zdravljenih s hidroklorotiazidom.
The European Medicines Agency (EMEA) has completed a review of Diovan Comp and associated names.
Evropska agencija za zdravila (EMEA) je zaključila pregled zdravila Diovan Comp in z njim povezanih imen.
Valsartan works by blocking the effect of angiotensin II.
Valsartan deluje z zaviranjem učinka angiotenzina II.
It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Deluje s povečanjem izločanja seča, zmanjšanjem količine tekočine v krvi in znižanjem krvnega tlaka.
Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.” The Committee noted that some contra-indications that were included in the SPC in some member states could be removed, as they were now covered by the harmonised wording.
neodzivna hipokaliemija, hiponatriemija, hiperkalciemija in simptomatska hiperurikemija.“ Odbor je ugotovil, da se lahko nekatere kontraindikacije iz povzetka glavnih značilnosti zdravila v nekaterih državah članicah izbrišejo, ker jih sedaj zajema usklajeno besedilo.
The CHMP agreed on a harmonised indication (the disease for which the medicine may be used): “Treatment of essential hypertension in adults.
CHMP je odobril usklajeno indikacijo (bolezen, za katero se zdravilo lahko uporablja): “Zdravljenje esencialne hipertenzije pri odraslih bolnikih.
The new wording clarifies the possible interactions with Diovan Comp, and identifies which interactions are linked to each, or to both, active substances.
Novo besedilo pojasnjuje možne interakcije z zdravilom Diovan Comp ter opredeljuje, katere interakcije so povezane s posamezno zdravilno učinkovino ali obema zdravilnima učinkovinama.
The contraindications removed were: hepatic encephalopathy, biliary obstruction, gout and Addison's disease.
Izbrisane kontraindikacije so: jetrna encefalopatija, biliarna obstrukcija, protin in Addisonova bolezen.
What is Diovan Comp?
Kaj je zdravilo Diovan Comp?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan Comp in the European Union (EU) and the European Economic Area (EEA).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) in v Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Diovan Comp.
Diovan Comp contains two active substances, valsartan and hydrochlorothiazide.
Zdravilo Diovan Comp vsebuje dve zdravilni učinkovini, valsartan in hidroklorotiazid.
This has led to differences in the way the medicine can be used in the different member states where the medicine is marketed, as reflected in the Summaries of Product Characteristics (SPCs), labelling and package leaflets.
To je v različnih državah članicah, kjer je zdravilo v prometu, privedlo do razhajanj glede uporabe zdravila, kot je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo.
Valsartan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Valsartan spada v razred zdravil, imenovanih antagonisti receptorjev angiotenzina II, ki pomagajo pri nadzorovanju visokega krvnega tlaka.
4.2 Posology and method of administration
4.2 Odmerjanje in pot uporabe
The Committee also harmonised the SPC section on interactions with other medicines.
Odbor je uskladil tudi poglavje povzetka glavnih značilnosti zdravila o medsebojnem delovanju z drugimi zdravili.
The CHMP discussed the use of Diovan Comp in patients previously treated with other angiotensin II receptor antagonists and agreed that the switch to Diovan Comp should only be for patients previously treated with valsartan.
CHMP je razpravljal o uporabi zdravila Diovan Comp pri bolnikih, predhodno zdravljenih z drugimi antagonisti receptorjev angiotenzina II, in sprejel sklep, da na zdravilo Diovan Comp lahko preidejo le bolniki, ki so bili predhodno zdravljeni z valsartanom.
The CHMP harmonised the SPC section on special warnings and included warnings about photosensitivity and problems with the function of the parathyroid glands in patients taking ‘thiazide' diuretics such as hydrochlorothiazide.
CHMP je uskladil poglavje povzetka glavnih značilnosti zdravila o posebnih opozorilih ter dodal opozorila o občutljivosti na svetlobo in težavah z delovanjem obščitničnih žlez pri bolnikih, ki jemljejo „tiazidne“ diuretike, med katere spada hidroklorotiazid.
The CHMP discussed how Diovan Comp, which is a fixed-dose combination of two active substances, should be introduced in to the treatment of patients whose blood pressure is not controlled with either of the active substances used alone.
CHMP je razpravljal o načinu uvedbe zdravila Diovan Comp, ki je fiksna kombinacija odmerkov dveh zdravilnih učinkovin, v zdravljenje bolnikov, pri katerih krvnega tlaka ne moremo nadzorovati s posamezno uporabo teh dveh zdravilnih učinkovin.
On 27 May 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diovan Comp and associated names in the EU and the EEA.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Diovan Comp in z njim povezanimi imeni v EU in EGP, je dne 27. maja 2008 zadevo napotila na CHMP.
patients whose blood pressure is not adequately controlled on valsartan or hydrochlorotiazide monotherapy”
Zdravilo Diovan Comp fiksna kombinacija odmerkov je indicirano za bolnike, pri katerih krvnega tlaka ne moremo zadostno nadzorovati z monoterapijo z valsartanom ali hidroklorotiazidom”
Company responses provided on: 27 October 2008, 16 February 2009 Opinion date:
27. oktober 2008, 16. februar 2009
In particular, the CHMP agreed that patients not adequately controlled with valsartan or hydrochlorothiazide can be switched directly to Diovan Comp as long as the new treatment is in line with the recommended dosages for the individual active substances.
CHMP je priporočil besedilo poglavja o odmerjanju z natančnejšimi navodili o prehodu na zdravilo Diovan Comp. CHMP se je še zlasti strinjal, da lahko bolniki, katerih krvni tlak ni bil zadostno nadzorovan z valsartanom ali hidroklorotiazidom, neposredno preidejo na zdravilo Diovan Comp, če je novo zdravljenje skladno s priporočenimi odmerki posameznih zdravilnih učinkovin.
The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used): Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients.
CHMP je odobril tudi usklajeno besedilo kontraindikacij (okoliščin, v katerih se zdravilo ne sme uporabiti): preobčutljivost za valsartan, hidroklorotiazid, druga iz sulfonamidov pridobljena zdravila ali katerokoli pomožno snov zdravila; drugo in tretje trimesečje nosečnosti (poglavje 4.4 in 4.6); huda okvara jeter, biliarna ciroza ali holestaza; huda okvara ledvic (očistek kreatinina <30 ml/min), anurija;.
Diovan Comp was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Diovan Comp potrebno usklajevanje.
Dr Liv Mathiesen (Norway)
dr Liv Mathiesen (Norveška) Datum začetka napotitvenega postopka: junij 2008 Odgovori družbe, poslani dne:
(Invented) Name
Izmišljeno ime Ime
This approach has generally been accepted and supported by other EU and non-EU authorities as well.
Ta pristop so na splošno sprejeli in podprli tudi drugi pristojni organi EU in izven EU.
The legal basis for this application refers to: Article 10(1) of Directive 2001/83/EC, as amended.
Pravna podlaga za to vlogo se nanaša na: člen 10(1) Direktive 2001/83/ES, kakor je bila spremenjena.
This can be possibly attributed to different algorithms/specifications of the model or similar reasons.
To lahko pripišemo različnim algoritmom/specifikacijam modela ali podobnim razlogom.
Local tolerance
Lokalna toleranca
The results the Applicant obtained for the treatment effect using this model are as follows:
Rezultati, ki jih je pridobil predlagatelj za učinek zdravljenja s tem modelom, so naslednji:
Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Ker do 60. dne ni bilo doseženega soglasja, je bil postopek napoten na CHMP.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTRIX AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA FENTRIX IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
For this reason, it was considered reliable to assume that further investigations would not substantially add to this favourable safety profile and should hence be avoided for reasons of animal welfare as has been common practice in other European procedures in the past.
Zaradi tega se je za zanesljivo štela domneva, da nadaljnje raziskave ne bi bistveno prispevale k temu ugodnemu varnostnemu profilu in se jim je treba posledično izogniti v dobrobit živali, kar je bila običajna praksa v drugih evropskih postopkih v preteklosti.
It was therefore argued that this could not be used as supportive of a similar safety profile as required by the guideline.
Zato so ugovarjale, da tega ni mogoče uporabiti v podporo podobnemu varnostnemu profilu, kar zahtevajo smernice.
Consequently, the requirements set in these regulations have been taken rather as recommendations by European Member States and applicants in the past than absolute requirements.
Posledično so v preteklosti države članice Evropske unije in predlagatelji zahteve v teh pravilih šteli za priporočila in ne kot absolutne zahteve.
Hence, efficacy and systemic tolerability of the active substance remains unaffected.
Zato učinkovitost in sistemska toleranca zdravilne učinkovine ostajata nespremenjeni.
As there is currently no explicit EU guidance available on the evaluation of local tolerability of transdermal systems, and considering previous experience with marketing authorisations of several other transdermal patches in the EU, the CHMP noted that skin tolerability had always been assessed as part of the pharmacokinetic studies.
Ker trenutno ni jasnih smernic EU za vrednotenje lokalne tolerance transdermalnih sistemov in ob upoštevanju preteklih izkušenj z dovoljenji za promet z več drugimi transdermalnimi obliži v EU, je CHMP izpostavil, da se je kožna toleranca vedno vrednotila kot del farmakokinetičnih študij.
Fentanyl is 75-100 times more potent than parenteral morphine.
Fentanil je 75-100-krat močnejši od parenteralnega morfina.
The guideline on non-clinical investigations of local tolerance was developed before the introduction of transdermal systems.
Smernice o nekliničnih raziskavah lokalne tolerance so bile zasnovane pred uvedbo transdermalnih sistemov.
In order to assess the applicability of this objection, the CHMP took into account that the subsequent points:
Za vrednotenje smiselnosti tega ugovora, je CHMP upošteval naslednje točke:
Taking all these aspects into consideration, the CHMP accepted the argument that the available nonclinical data sufficiently demonstrate the comparable local tolerability of Fentrix and Dorogesic.
Ob upoštevanju vseh omenjenih vidikov je CHMP sprejel argument, da razpoložljivi neklinični podatki zadostno dokazujejo primerljivo lokalno toleranco zdravil Fentrix in Dorogesic.
It was therefore argued that specific dermal irritation studies are required according to the guidelines mentioned above.
Zato so ugovarjale, da so potrebne posebne študije draženja kože v skladu z zgoraj omenjenimi smernicami.
Initially, the Applicant submitted the data comparing the adverse events without any statistical analysis and a statistical comparison was requested.
Najprej je predlagatelj predložil podatke o primerjavi neželenih učinkov brez statističnih analiz, zato je bila naročena statistična primerjava.
Skin reactions with a score 1 were not included in the analysis because these are very mild and could be found in any transdermal product in the market.
Kožnih reakcij z rezultatom 1 niso vključili v analizo, ker so zelo blage in jih lahko ugotovimo pri vseh transdermalnih zdravilih v prometu.
Single dose: OR estimate: 5.67, 95 % CI [1.12; 28.78] p = 0.0371 Multiple dose: OR estimate: 1.41, 95 % CI [0.97; 2.05] p = 0.0716
Študija z enim odmerkom: ocena razmerja verjetnosti: 5,67; 95-odstotni IZ [1,12; 28,78] p = 0,0371 Študija z več odmerki: ocena razmerja verjetnosti: 1,41; 95-odstotni IZ [0,97; 2,05] p = 0,0716
The objecting MS were of the view that the study results needed to be reanalysed because initially the irritation data had not been appropriately assessed.
Mnenje nasprotujočih držav članic je bilo, da je treba rezultate študije znova analizirati, ker na začetku podatki o draženju niso bili primerno ovrednoteni.
More importantly, the Applicant reproduced the statistically significant product effect for the single dose study (p= 0.0371), whereas for the multiple dose study the differences were not statistically significant (p=0.0716).
Pomembneje je, da je predlagatelj reproduciral statistično pomemben učinek zdravila v študiji z enim odmerkom (p = 0,0371), vendar razlike v študiji z več odmerki niso bile statistično pomembne (p = 0,0716).