natgillin/translations-raw huggingface dataset:
One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
En vložek vsebuje 1,5 ml, kar ustreza 15 mg somatropina (45 i.e.).
What Omnitrope 10 mg/1.5 ml contains
Omnitrope 10 mg/1,5 ml
Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Zdravilo Omnitrope 5 mg/1,5 ml v vložku za injekcijski peresnik SurePal 5 je namenjeno za večkratno uporabo.
It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml reconstituted solution for injection.
Uporablja se lahko samo z Omnitrope Pen L, pripravi za injiciranje, narejeni posebej za uporabo pripravljene raztopine za injiciranje Omnitrope 5 mg/ml.
It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml powder and solvent for solution for injection.
Dajati se sme samo z napravo za injiciranje zdravila Omnitrope Pen 5, narejeno posebej za uporabo z zdravilom Omnitrope 5 mg/ml prašek in vehikel za injiciranje.
Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Omnitrope 10 mg/1,5 ml raztopina za injiciranje EU/1/06/332/007
Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Pri tem so vrednosti perifernega hormona ščitnice ostale v priporočenih mejah za zdrave ljudi.
What Omnitrope 15 mg/1.5 ml contains
Omnitrope 15 mg/1,5 ml
Use only clear solution.
Uporabljajte samo bistro raztopino.
The content must be clear and colourless after reconstitution.
Po pripravi mora biti vsebina bistra in brezbarvna.
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2 - 0.5 mg per day.
Pomanjkanje rastnega hormona pri odraslih bolnikih Pri bolnikih, ki po PRH v otroštvu nadaljujejo zdravljenje z rastnim hormonom, je priporočeni odmerek za ponovno jemanje 0,2 - 0,5 mg na dan. Odmerek je treba postopoma večati ali manjšati v skladu z individualnimi potrebami bolnika, ki jih določa koncentracija IGF-I.
The reconstituted solution should be administered using sterile, disposable syringes.
Pripravljeno raztopino je treba dajati s pomočjo sterilne injekcijske brizge za enkratno uporabo.
Talk to your doctor before using Omnitrope.
Pred začetkom uporabe zdravila Omnitrope se posvetujte z zdravnikom.
NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin
Omnitrope 10 mg/1,5 ml raztopina za injiciranje somatropin
Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only.
Zdravilo Omnitrope 10 mg/1,5 raztopina za injiciranje se uporablja samo z napolnjenim injekcijskim peresnikom SurePal 10.
MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/016
Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Omnitrope 10 mg/1,5 ml raztopina za injiciranje EU/1/06/332/016
• Joint pain
• bolečine mišic
What Omnitrope 5 mg/1.5 ml contains
Omnitrope 5 mg/1,5 ml
MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/013
It has to be administered using sterile, disposable pen needles.
Uporablja naj se s sterilnimi iglami za enkratno uporabo, ki so namenjene za injekcijske peresnike.
Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Omnitrope 5 mg/1,5 ml raztopina za injiciranje EU/1/06/332/004
Omnitrope 10 mg/1.5 ml solution for injection
Omnitrope 10 mg/1,5 ml raztopina za injiciranje
How to store Omnitrope
Shranjevanje zdravila Omnitrope
MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/010
NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin
Omnitrope 15 mg/1,5 ml raztopina za injiciranje somatropin
It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Uporablja se lahko samo z Omnitrope Pen 5, pripomočku za injiciranje, narejeni posebej za uporabo raztopine za injiciranje Omnitrope 5 mg/1,5 ml.
Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only.
Zdravilo Omnitrope 5 mg/1,5 raztopina za injiciranje se uporablja samo z napolnjenim injekcijskim peresnikom SurePal 5.
Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Omnitrope 15 mg/1,5 ml raztopina za injiciranje EU/1/06/332/010
MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/007
It should only be administered with SurePal 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Dajati se sme samo s peresnikom SurePal 10, pripomočkom za injiciranje, narejenim posebej za uporabo z zdravilom Omnitrope 10 mg/1,5 ml raztopina za injiciranje.
Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only.
Zdravilo Omnitrope 15 mg/1,5 raztopina za injiciranje se uporablja samo z napolnjenim injekcijskim peresnikom SurePal 15.
It should only be administered with SurePal 15, an injection device specifically developed for use with Omnitrope 15 mg/1.5 ml solution for injection.
Dajati se sme samo s peresnikom SurePal 15, pripomočkom za injiciranje, narejenim posebej za uporabo z zdravilom Omnitrope 15 mg/1,5 ml raztopina za injiciranje.
Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Omnitrope 5 mg/1,5 ml raztopina za injiciranje EU/1/06/332/013
It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Uporablja se lahko samo z Omnitrope Pen 10, pripomočku za injiciranje, narejeni posebej za uporabo raztopine za injiciranje Omnitrope 10 mg/1,5 ml.
NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin
Omnitrope 5 mg/1,5 ml raztopina za injiciranje somatropin
MARKETING AUTHORISATION NUMBER EU/1/06/332/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/06/332/001
Collect necessary items before you begin: - a vial with Omnitrope 5 mg/ml powder for solution for injection.
Preden začnete, si pripravite vse potrebno: - vialo s praškom za raztopino za injiciranje zdravila Omnitrope
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C - 8°C).
Zdravilo shranjujte in prevažajte na hladnem (2 C - 8 C).
MARKETING AUTHORISATION NUMBERS EU/1/06/332/004
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/004
MARKETING AUTHORISATION NUMBERS EU/1/06/332/002
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/002
It should only be administered with SurePal 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Dajati se sme samo s peresnikom SurePal 5, pripomočkom za injiciranje, narejenem posebej za uporabo z zdravilom Omnitrope 5 mg/1,5 ml raztopina za injiciranje.
Musculoskeletal , Connective Tissue and Bone Disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija*
Omnitrope 5 mg/1.5 ml solution for injection
Omnitrope 5 mg/1,5 ml raztopina za injiciranje
The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
Pri bolnikih z začetkom PRH v odrasli dobi je treba zdravljenje začeti z majhnim odmerkom - 0,15 do 0,3 mg na dan. Nato se ga postopno, v skladu z bolnikovimi individualnimi potrebami, ki jih določa koncentracija IGF-I, povečuje.
Dose recommendations in paediatric patients Indication mg/kg body weight dose per day mg/m² body surface area dose per day
Indikacija mg/kg telesne mase dnevni odmerek mg/m telesne površine dnevni odmerek pomanjkanje rastnega hormona Prader-Willijev sindrom Turnerjev sindrom kronična ledvična insuficienca otroci/mladostniki, ki so se za svojo gestacijsko starost rodili majhni (MGS)
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo:
Always inject Omnitrope exactly as your doctor has told you.
Pri injiciranju zdravila Omnitrope natančno upoštevajte zdravnikova navodila.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON LABEL
OZNAKA NA ZUNANJI OVOJNINI
Disinfect the rubber membrane of the cartridge with a cleansing swab Insert the cartridge into SurePal following the instructions for use provided with the pen.
Vložek vstavite v injekcijski peresnik SurePal po priloženih navodilih za uporabo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin
Omnitrope 5 mg/ml prašek in vehikel za raztopino za injiciranje somatropin
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
• odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES,
Particularly the endpoint of main interest which is pain.
Končna točka v središču zanimanja je bolečina.
The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Informacije o zdravilu ostajajo take, kot so v končni različici, doseženi v postopku skupine za usklajevanje, kakor je navedeno v Prilogi III k mnenju odbora CHMP.
The study was designed and powered to demonstrate superiority with a significant level of 5% one-sided, but the current requirement is now that a significance level of 2.5% one-sided, which the study could not reach.
Študija je bila zasnovana in oblikovana za prikaz superiornosti s stopnjo značilnosti 5 % enostransko, vendar se trenutno zahteva stopnja značilnosti 2,5 % enostransko, česar pa v študiji ni bilo mogoče doseči.
An effect was seen on the critical secondary endpoint of spontaneous pain visual analogue scale (VAS).
Učinek je bil opažen na kritični sekundarni končni točki spontane bolečine glede na vizualno analogno lestvico (VAS).
However, this study cannot be considered to provide confirmatory evidence on efficacy of Spraygel as the primary endpoint is not validated and statistical analysis does not meet regulatory requirements.
Vendar pa ta študija ne more z gotovostjo potrditi učinkovitosti gela v pršilu, saj primarna končna točka ni potrjena, statistična analiza pa ne izpolnjuje regulativnih zahtev.
Numerically, the exposure of Spraygel is lower than Emulgel and its impact on efficacy cannot be ascertained accurately.
Izpostavljenost gela v pršilu je številčno nižja kot pri emulgelu, njenega vpliva na učinkovitost pa ni mogoče natančno ugotoviti.
MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain as part of a “second wave” Mutual recognition procedure (MRP).
Podjetje MIKA Pharma GmbH je zahtevalo, da se dovoljenje za promet z zdravilom Diclofenac Sodium Spray Gel 4 %, ki ga je leta 2001 izdalo Združeno kraljestvo, pozneje pa tudi Avstrija, Estonija, Madžarska, Irska, Latvija, Litva in Slovenija, prizna tudi v Nemčiji, Italiji in Španiji kot del „drugega vala“ postopka z medsebojnim priznavanjem (MRP).
Clinical Pharmacology
Klinična farmakologija
The applicant included a review of the Predel 2013 study [previously pre-publication known as Study 9702SUV] on the efficacy of Spraygel in acute ankle injury.
Predlagatelj je vključil pregled študije Predel 2013 (prej predhodna objava, imenovana Študija 9702SUV) o učinkovitosti gela v pršilu pri akutni poškodbi gležnja.
The qualitative comparison is based on composition, degree of ionization and complete solubility of active substance.
Primerjava kakovosti temelji na sestavi, stopnji ionizacije in popolni topnosti učinkovine.
The difference in median VAS score was 8 mm at day 3-4 and 4.6mm at day 7-8.
Mediana vrednost vizualne analogne lestvice (VAS) je bila 3. in 4. dan 8 mm, 7. in 8. dan pa 4,6 mm.
All these studies provide evidence on modest efficacy for authorised topical diclofenac formulations of which the most robust is study Predel 2012 with Emulgel,.
Vse omenjene študije dokazujejo zmerno učinkovitost odobrenih topičnih formulacij diklofenaka, najzanesljivejša pa je študija emulgela Predel 2012.
The applicant's submissions as part of the referral procedure incorporates literature data and discussions on Quality, Clinical Pharmacology, Clinical Efficacy and Clinical Safety aspects.
Predlagatelj je v okviru napotitvenega postopka predložil podatke iz literature in razprav o kakovosti, klinični farmakologiji, klinični učinkovitosti in klinični varnosti.
The applicant has also reviewed the available published clinical trial literature on topical diclofenac which includes a study on effects of Emulgel on Joint Pain (Predel 2012), study on DHEP (Diclofenac hydroxyethylpyrrolidine plaster), Heparin plaster or placebo plaster (Constantino C et al. 2011) and an uncontrolled study on DHEP gel.
Predlagatelj je pregledal tudi razpoložljivo objavljeno literaturo o kliničnem preskušanju topičnega diklofenaka, ki vključuje študijo o učinkih emulgela na bolečine v sklepih (Predel 2012), študijo o DHEP (obližu z diklofenak hidroksietilpirolidinom), obližu s heparinom ali obližu s placebom (Constantino C. et al. 2011) in nekontrolirano študijo o gelu DHEP.
The original application in 2000 under Article 4.8 (a) (II) of Directive 65/65/EEC - bibliographic for new pharmaceutical form and strength, was supported with published literature on efficacy of topical diclofenac as well as data from pharmacokinetics and a clinical study (9702 SUV) of the proposed 4% cutaneous spray formulation.
Prvotni vlogi iz leta 2000 v skladu s členom 4(8)(a)(ii) Direktive 65/65/EGS - bibliografskim podatkom za novo farmacevtsko obliko in jakost, so bili priloženi objavljena literatura o učinkovitosti topičnega diklofenaka ter podatki iz farmakokinetike in klinične študije (9702 SUV) predlagane formulacije 4-odstotnega dermalnega pršila.
However, the systemic exposure is low enough that the adverse event profile seen with oral or other systemically administered NSAIDs is not problematic.
Sistemska izpostavljenost je vseeno dovolj nizka, da profil neželenega dogodka kot pri peroralnih ali drugih sistemsko danih nesteroidnih protivnetnih zdravilih (NSAID) ni problematičen.
The only intra-study comparative data that is available is from study Martin et al. 1997 which indicated that the systemic absorption is comparable for Spraygel and Emulgel, but a conclusion on equivalence - and clinical relevance of systemic absorption - cannot be drawn.
Edini razpoložljivi primerjalni podatki znotraj ene študije izhajajo iz študije Martin et al. 1997, ki so pokazali, da je sistemska absorpcija gela v pršilu primerljiva z emulgelom, vendar pa ni mogoče podati zaključkov o enakovrednosti in klinični ustreznosti sistemske absorpcije.
• The Committee was of the view that the totality of data submitted justified the efficacy of the applied medicinal product as well as the bridging to the literature, in particular to existing data on topical diclofenac formulations including Voltarol Emulgel formulations.
• odbor je menil, da vsi predloženi podatki utemeljujejo učinkovitost uporabljenega zdravila in povezovanje z literaturo, zlati z obstoječimi podatki o topičnih formulacijah diklofenaka, vključno s formulacijami zdravila Voltarol Emulgel.
The application subject to this referral therefore concerns a repeat-use mutual recognition procedure (UK-H-0563-001-E-002) for Diclofenac sodium 4% cutaneous spray, solution (PL 18017/0006) with UK as RMS and which involves Italy, Spain, Germany as Concerned Member States.
Vloga, ki je predmet te napotitve, zato upošteva postopek ponovne uporabe medsebojnega priznavanja (UK-H-0563-001-E-002) za zdravilo Diclofenac Sodium Spray Gel 4 %, dermalno pršilo, raztopina (PL 18017/0006), v katerem je referenčna država članica Združeno kraljestvo, in ki kot zadevne države članice vključuje Italijo, Španijo in Nemčijo.
Most of the data are cross-study comparisons which are affected by different doses and methods and so no robust conclusions can be drawn from these cross-study comparisons.
Večina podatkov izhaja iz medštudijskih primerjav z različnimi odmerki in potmi uporabe, zato na njihovi podlagi ni mogoče podati trdnih zaključkov.
Day 60 of the CMDh procedure was on 29 March 2018, and since two Member States raised concerns regarding potential serious risk to public health (PSRPH) related to lack of efficacy for the specific 4% spraygel product and inadequate bridging to literature, in particular with other topical diclofenac formulations (including Voltarol Emulgel) for which it was acknowledged that there was adequate evidence of efficacy and safety, the Reference Member State (UK) triggered on 5 April 2018 a referral under Article 29(4) of Directive 2001/83/EC, requesting the CHMP to assess the impact of the objections raised that constitute a potential serious risk to public health.
Ker sta dve državi članici izrazili zaskrbljenost zaradi možnega resnega tveganja za javno zdravje (PSRPH), povezanega s pomanjkanjem učinkovitosti zadevnega 4-odstotnega gela v pršilu in neustreznega povezovanja z literaturo, zlasti drugimi formulacijami topičnega diklofenaka (vključno z zdravilom Voltarol Emulgel), za katere so bili ugotovljeni zadostni dokazi za učinkovitost in varnost, je referenčna država članica (Združeno kraljestvo) 5. aprila 2018 sprožila napotitveni postopek skladno s členom 29(4) Direktive 2001/83/ES in od odbora CHMP zahtevala, da oceni vpliv izraženih pomislekov, ki predstavljajo možno resno tveganje za javno zdravje.
The plasma and tissue pharmacokinetic (PK) data of SprayGel in healthy volunteers, and patients with acute inflammation, are compared to those of Voltaren Sodium Gel and Voltaren Emulgel.
Farmakokinetične podatke o gelu v pršilu v plazmi in tkivu zdravih prostovoljcev in bolnikov z akutnim vnetjem so primerjali s podatki o zdravilih Voltaren Sodium Gel in Voltaren Emulgel.
However, the study can be considered supportive of efficacy to infer that Spraygel has beneficial activity in the context of this bibliographic application.
Kljub temu pa opravljena študija dokazuje učinkovitost, na podlagi katere lahko sklepamo, da je gel v pršilu koristen v okviru bibliografske aplikacije.
The Committee, as a consequence, considers that the benefit-risk balance of Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Odbor zato ocenjuje, da je razmerje med tveganji in koristmi zdravila Diclofenac Sodium Spray Gel 4 %, dermalno pršilo, raztopina, in povezanih imen ugodno in zato priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.
The CHMP agreed that topical NSAIDs, including Diclofenac Sodium Spray Gel 4 %, have a proven safety record over many more than 10 years, which is supported by their low systemic bioavailability compared to e.g. oral pharmaceutical forms.
Odbor CHMP se je strinjal, da topična nesteroidna protivnetna zdravila (NSAID), vključno z zdravilom Diclofenac Sodium Spray Gel 4 %, že več kot deset let veljajo za varna, o čemer priča tudi njihova nizka sistemska biološka razpoložljivost v primerjavi z na primer peroralnimi farmacevtskimi oblikami.
Nevertheless, it is consistently seen across studies that measurable levels of diclofenac have been reported after application of the spraygel both in systemic exposure and topical exposure (subcutaneous tissue and muscle tissue) at the site of action.
Vseeno pa različne študije dosledno kažejo na to, da po aplikaciji gela v pršilu tako pri sistemski izpostavljenosti kot tudi topični izpostavljenosti (podkožno tkivo in mišično tkivo) poročajo o merljivih koncentracijah diklofenaka na mestu aplikacije.
Therefore the CHMP agreed by majority, that the benefit-risk balance of Diclofenac Sodium Spray Gel 4 % is favourable.
Zato je odbor CHMP z večino sprejel ugotovitev, da je razmerje med tveganji in koristmi zdravila Diclofenac Sodium Spray Gel 4 % ugodno.
Nevertheless, while it is acknowledged that the efficacy of Emulgel cannot be directly attributed to Diclofenac Sodium Spray Gel 4 %, it is also reasonable to infer that Diclofenac Sodium Spray Gel 4 % has a beneficial effect based on the supportive Predel 2013 study, PK comparisons and cross-study comparisons in a similar range as seen for other topical diclofenac products.
Čeprav je ugotovljeno, da učinkovitosti emulgela ne moremo neposredno pripisati zdravilu Diclofenac Sodium Spray Gel 4 %, pa lahko na podlagi podporne študije Predel 2013, farmakokinetičnih primerjav in medštudijskih primerjav utemeljeno sklepamo, da ima zdravilo Diclofenac Sodium Spray Gel 4 % koristne učinke v podobnem obsegu kot druga topična zdravila z diklofenakom.
In particular their use and substitution for oral and other systemically administered NSAIDS makes a major contribution to patient well-being in view of the available safety data, which supports a markedly lower risk of potentially serious adverse events compared to systemically administered diclofenac containing products.
Glede na razpoložljive podatke o varnosti je glavni prispevek k dobremu počutju bolnikov zlasti njihova uporaba in nadomestek za peroralna in druga sistemsko dana nesteroidna protivnetna zdravila (NSAID), s čimer pripomorejo k izrazito manjšem tveganju za morebitne resne neželene dogodke v primerjavi s sistemsko danimi zdravili, ki vsebujejo diklofenak.
Overall summary of the scientific evaluation by the CHMP In summary, when taken together the totality of scientific evidence supports that Diclofenac Sodium Spray Gel 4 % has an acceptable safety and efficacy profile.
Splošni povzetek znanstvenega vrednotenja odbora CHMP Če povzamemo, skupek znanstvenih dokazov potrjuje sprejemljivo varnost in učinkovitost uporabe zdravila Diclofenac Sodium Spray Gel 4 %.
Further as the systemic and topical exposure data of Emulgel is available for comparison to Spraygel, the Marketing Authorisation Holder bridged the efficacy of Emulgel to Spraygel based on a cross-study comparison of the efficacy endpoints, which are however confounded by differences in study methods and populations.
Ker so podatki o sistemski in topični izpostavljenosti pri emulgelu na voljo za primerjavo z gelom v pršilu, je imetnik dovoljenja za promet z zdravilom na podlagi medštudijske primerjave končnih točk učinkovitosti, ki so sicer zavajajoče zaradi razlik v uporabljenih metodah in populacijah, povezal učinkovitost emulgela z učinkovitostjo gela v pršilu.
The Committee considered the available data submitted in support of the use of Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names , which included a comparison of quality aspects in relation to authorised topical diclofenac products, and literature covering pharmacokinetic (local and systemic) as well as efficacy and safety data.
• odbor je obravnaval vse podatke, ki jih je v povezavi s pomisleki, izraženimi kot možno resno tveganje za javno zdravje, predložil predlagatelj; odbor je obravnaval razpoložljive podatke, predložene v podporo uporabi zdravila Diclofenac Sodium Spray Gel 4 %, dermalno pršilo, raztopina, in povezanih imen, ki so vključevali primerjavo kakovosti v povezavi z odobrenimi zdravili s topičnim diklofenakom ter literaturo, ki obsega tako farmakokinetične (lokalne in sistemske) podatke kot tudi podatke o učinkovitosti in varnosti,
The defined primary endpoint response, expressed as a decrease in swelling of at least 50% during 10 days of treatment for the ‘Full Analysis Set' (FAS), was reached in 87/97 patients treated with diclofenac spray gel (89.7%) compared to
tj. primarna končna točka, opredeljena kot zmanjšanje otekline za vsaj 50 % v desetih dneh zdravljenja celotne skupine bolnikov (FAS), je bila dosežena pri 87 od 97 bolnikov (89,7 %), zdravljenih z gelom v pršilu, ki vsebuje diklofenak, v primerjavi s 74 od 94 bolnikov (78,7 %), zdravljenih s placebom; p = 0,0292 (en krak) in p = 0,0467 (dva kraka).