natgillin/translations-raw huggingface dataset:
En subkutan dosis på 5 mg Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning, til raske voksne resulterer i Cmax- og tmax-værdier i plasma på henholdsvis 72 ± 28 µg/l og 4,0 ± 2,0 timer. 
A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively.
Det skal du vide, før du begynder at bruge Omnitrope Sådan skal du bruge Omnitrope Bivirkninger 
What Omnitrope is and what it is used for What you need to know before you use Omnitrope How to use Omnitrope
En subkutan dosis på 5 mg Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning, til raske voksne resulterer i Cmax- og tmax-værdier i plasma på henholdsvis 74 ± 22 µg/l og 3,9 ± 1,2 timer. 
A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively.
Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat natriumchlorid poloxamer 188 phenol vand til injektionsvæsker 
Omnitrope 15 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat glycin poloxamer 188 phenol vand til injektionsvæsker 
Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning Hver ml opløsning indeholder 10 mg somatropin* (svarende til 30 IE). 
Omnitrope 15 mg/1.5 ml solution for injection Each ml of solution contains 10 mg of somatropin* (corresponding to 30 IU) One cartridge contains 1.5 ml corresponding to 15 mg somatropin* (45 IU).
Sådan skal du bruge Omnitrope 
How to use Omnitrope
Andre indholdsstoffer: dinatriumhydrogenphosphatheptahydrat og natriumdihydrogenphosphatdihydrat, natriumchlorid, poloxamer 188, phenol, vand til injektionsvæsker. 
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Aktivt stof: somatropin 
The active substance of Omnitrope is somatropin.
Omnitrope 5 mg/1,5 ml i en cylinderampul til SurePal 5 er beregnet til flergangsbrug. 
Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Knogler, led, muskler og bindevæv 
Musculoskeletal, Connective Tissue and Bone Disorders
En patron med solvens til Omnitrope 5 mg/ml Et overførselssæt til blanding og overførsel af den tilberedte opløsning til patronen (se instruktion for brug af Pen injektor). 
- a transfer set for mixing and transferring the reconstituted solution back into the cartridge (see Instructions for Use of the pen injector).
- Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat mannitol poloxamer 188 benzylalkohol vand til injektionsvæsker 
- The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Væksthormonmangel Prader-Willis syndrom Turners syndrom Kronisk nedsat nyrefunktion Børn/unge født små i forhold til deres gestationsalder (SGA) 
Growth hormone deficiency Prader-Willi syndrome Turner syndrome
Omnitrope 1,3 mg/ml pulver og solvens til injektionsvæske, opløsning Somatropin 
NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection Somatropin
Omnitrope 15 mg/1,5 ml indeholder: 
What Omnitrope 15 mg/1.5 ml contains
Omnitrope 10 mg/1,5 ml indeholder: 
What Omnitrope 10 mg/1.5 ml contains
Sæt cylinderampullen i Omnitrope Pen ifølge den medfølgende brugsanvisning. 
Disinfect the rubber membrane of the cartridge with a cleansing swab Insert the cartridge into the Omnitrope Pen following the instructions for use provided with the pen.
Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning: 
Omnitrope 5 mg/1.5 ml solution for injection:
- Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat glycin poloxamer 188 phenol vand til injektionsvæsker 
- The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning er en steril, brugsklar injektionsvæske, opløsning til subkutan injektion i en cylinderampul af glas. 
Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
• Ledsmerter 
• Joint pain
- Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat natriumchlorid poloxamer 188 phenol vand til injektionsvæsker 
- The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Det må kun anvendes med Omnitrope Pen L, en injektionsanordning udviklet specielt til brug af Omnitrope 5 mg/ml rekonstitueret injektionsvæske, opløsning. 
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.
Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning 
Omnitrope 10 mg/1.5 ml solution for injection
LÆGEMIDLETS NAVN Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning Somatropin 
NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin
INFORMATION I BRAILLESKRIFT Omnitrope 15 mg/1,5 ml 
INFORMATION IN BRAILLE Omnitrope 15 mg/1.5 ml
LÆGEMIDLETS NAVN Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning Somatropin 
NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin
I andre studier med somatropin vedr. 
some of whom have been treated with somatropin.
LÆGEMIDLETS NAVN Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning Somatropin 
NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin
Omnitrope 5 mg/1,5 ml indeholder: 
What Omnitrope 5 mg/1.5 ml contains
Omnitrope 5 mg/ml pulver og solvens til injektionsvæske, opløsning Somatropin 
NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/ml powder and solvent for solution for injection Somatropin
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED SOLVENS ETIKET 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT CARTRIDGE LABEL
Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/007 
Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning 
Omnitrope 15 mg/1.5 ml solution for injection
En cylinderampul indeholder 1,5 ml svarende til 15 mg somatropin (45 IE). 
One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
En cylinderampul indeholder 1,5 ml svarende til 5 mg somatropin (15 IE). 
One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SOLVENS CYLINDERAMPUL ETIKET 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
INFORMATION I BRAILLESKRIFT Omnitrope 10 mg/1,5 ml 
INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Det bør kun gives med Omnitrope Pen 10, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning. 
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.
INFORMATION I BRAILLESKRIFT Omnitrope 5 mg/1,5 ml 
INFORMATION IN BRAILLE Omnitrope 5 mg/1.5 ml
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/013 
MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/016 
Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Det bør kun gives med Omnitrope Pen 5, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning. 
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.
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/016 
MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
Uåbnet cylinderampul 
Unopened cartridge
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/010 
MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/007 
MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
Det bør kun gives med SurePal 10, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning. 
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.
Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/004 
Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Tilberedning af Omnitrope 
How to store Omnitrope
Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/010 
Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
• Følelsesløshed/prikkende fornemmelse 
• Numbness/tingling
Børn med kronisk nedsat nyrefunktion 
Children with chronic renal (kidney) insufficiency
Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning 
Omnitrope 5 mg/1.5 ml solution for injection
Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/013 
Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Alle patienter, som af ukendt årsag ikke responderer, bør testes for antistoffer mod somatropin. 
Testing for antibodies to somatropin should be carried out in any patient with otherwise unexplained lack of response.
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/004 
MARKETING AUTHORISATION NUMBERS EU/1/06/332/004
Det bør kun gives med SurePal 15, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning. 
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.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 10 mg/1,5 ml Injektionsvæske Somatropin s.c. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 10 mg/1.5 ml Injection
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 15 mg/1,5 ml Injektionsvæske Somatropin s.c. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 15 mg/1.5 ml Injection
MARKEDSFØRINGSTILLADELSESNUMMER EU/1/06/332/001 
MARKETING AUTHORISATION NUMBER EU/1/06/332/001
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/002 
MARKETING AUTHORISATION NUMBERS EU/1/06/332/002
Det bør kun gives med SurePal 5, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning. 
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.
Amning 
Paraesthesia
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 5 mg/ml pulver til injektionsvæske, opløsning. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin
Opbevaringstid efter rekonstitution 
Shelf life after reconstitution
En cylinderampul indeholder 10,0 mg (svarende til 30 IE) somatropin i 1,5 ml. 
Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU) One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
• Udvalget behandlede indbringelsen i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF. 
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
• Udvalget vurderede alle de data, som ansøgeren havde fremsendt, i forhold til indvendingerne vedrørende en mulig alvorlig risiko for folkesundheden. 
• The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Forskel i median VAS-score: 8 mm på dag 3-4 og 4,6 mm på dag 7-8. 
The difference in median VAS score was 8 mm at day 3-4 and 4.6mm at day 7-8.
Studiet var designet og havde styrke til at påvise superioritet med et signifikansniveau på 5 % (ensidet), men det aktuelle krav er nu et signifikansniveau på 2,5 % (ensidet), hvilket studiet ikke opnåede. 
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.
Numerisk set er eksponeringen for Spraygel lavere end for Emulgel, og dens betydning for effekten kan ikke fastslås nøjagtigt. 
Numerically, the exposure of Spraygel is lower than Emulgel and its impact on efficacy cannot be ascertained accurately.
Den kvalitetsrelaterede sammenligning er baseret på sammensætning, graden af ionisering og det aktive stofs fuldstændige opløselighed. 
The qualitative comparison is based on composition, degree of ionization and complete solubility of active substance.
Studiet kan dog godt anses for at understøtte, at Spraygel har gavnlig aktivitet, i forbindelse med denne bibliografi-baserede ansøgning. 
However, the study can be considered supportive of efficacy to infer that Spraygel has beneficial activity in the context of this bibliographic application.
Studiet kan imidlertid ikke anses for at give bekræftende evidens for Spraygels virkning, da det primære effektmål ikke valideres, og da den statistiske analyse ikke opfylder de regulatoriske krav. 
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.
MIKA Pharma GmbH har anmodet om, at den markedsføringstilladelse for Diclofenac Sodium Spray Gel 4 %, som Det Forenede Kongerige udstedte i 2001, og som efterfølgende blev udstedt af Østrig, Estland, Ungarn, Irland, Letland, Litauen og Slovenien, også anerkendes i Tyskland, Italien og Spanien som led i "anden bølge" af en gensidig anerkendelsesprocedure. 
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).
De fleste af dataene er sammenligninger på tværs af studier, hvor der er anvendt forskellige doser og metoder; der kan således ikke drages solide konklusioner ud fra disse sammenligninger. 
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.
Den systemiske eksponering er dog så lav, at den bivirkningsprofil, der ses ved oralt eller på anden vis systemisk administrerede NSAID'er, ikke er problematisk. 
However, the systemic exposure is low enough that the adverse event profile seen with oral or other systemically administered NSAIDs is not problematic.
Klinisk farmakologi 
Clinical Pharmacology
Ansøgeren medsendte en gennemgang af Predel 2013-studiet [før publicering benævnt studie 9702SUV], der undersøgte virkningen af Spraygel ved akut ankelskade. 
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.
• Udvalget vurderede, at de samlede indsendte data godtgjorde virkningen af det omhandlede lægemiddel, herunder anknytningen til litteraturen, navnlig hvad angår eksisterende data om topiske diclofenac-formuleringer, herunder Voltarol Emulgel-formuleringer. 
• 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.
Dag 60 i CMDh-proceduren var den 29. marts 2018, og da to medlemsstater har givet udtryk for betænkelighed vedrørende en mulig alvorlig risiko for folkesundheden relateret til manglende effekt af den omhandlede spraygel 4 % og utilstrækkelig anknytning til litteraturen, navnlig hvad angår andre topiske diclofenac-formuleringer (herunder Voltarol Emulgel), for hvilke det anerkendes, at der foreligger tilstrækkelig evidens for virkning og sikkerhed, indledte referencemedlemsstaten (Det Forenede Kongerige) den 5. april 2018 en indbringelsesprocedure i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF, og anmodede CHMP om at vurdere de fremsatte indvendinger vedrørende en mulig alvorlig risiko for folkesundheden. 
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.
Det materiale, som ansøgeren har indsendt i forbindelse med indbringelsesproceduren, omfatter data fra litteraturen og drøftelser af kvalitet, klinisk farmakologi, klinisk virkning og klinisk sikkerhed. 
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.
Den ansøgning, der er omfattet af denne indbringelsesprocedure, angår således en gentagen gensidig anerkendelsesprocedure (UK-H-0563-001-E-002) for diclofenacnatrium-hudspray 4 %, opløsning (PL 18017/0006) med Det Forenede Kongerige som referencemedlemsstat og Italien, Spanien og Tyskland som berørte medlemsstater. 
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.
Alle disse studier giver evidens for en beskeden virkning ved godkendte topiske diclofenac-formuleringer, idet det mest robuste studie er Predel 2012-studiet af Emulgel. 
All these studies provide evidence on modest efficacy for authorised topical diclofenac formulations of which the most robust is study Predel 2012 with Emulgel,.
De eneste tilgængelige komparative data fra ét og samme studie kommer fra studiet Martin et al. 1997, og de viste, at den systemiske absorption er sammenlignelig for Spraygel og Emulgel, men der kan ikke drages nogen konklusion om ækvivalens, endsige den kliniske relevans af den systemiske absorption. 
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.
Samlet resumé af CHMP's videnskabelige vurdering Sammenfattende kan det siges, at den videnskabelige evidens samlet set viser, at Diclofenac Sodium Spray Gel 4 % har en acceptabel sikkerheds- og virkningsprofil. 
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.
Ansøgeren har også gennemgået den tilgængelige litteratur om publicerede kliniske forsøg med topisk diclofenac, der omfatter et studie af Emulgel-anvendelse ved ledsmerter (Predel 2012), et studie af brugen af diclofenac-hydroxyethylpyrrolidin-plaster (DHEP-plaster), heparin-plaster eller placeboplaster (Constantino C et al. 2011) samt et ukontrolleret studie af DHEP-gel. 
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.
Ikke desto mindre er der på tværs af studierne konsistent rapporteret om målbare niveauer af diclofenac efter anvendelse af spraygelen, både ved systemisk eksponering og topisk eksponering på indvirkningsstedet (subkutant væv og muskelvæv). 
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.
Selvom styrken af den omhandlede hudspray er 4 %, sammenholdt med 1 % eller 2 % for Emulgel, er denne højere styrke i hudsprayen designet til at levere samme mængde diclofenac til det lokale væv som Emulgel. 
Although the strength of the proposed cutaneous spray is 4% as compared to the Emulgel which is 1% or 2%, this difference in the cutaneous spray was designed to deliver a similar amount of diclofenac to local tissues as the Emulgel.
Den oprindelige ansøgning i 2000, der blev indsendt i henhold til artikel 4, stk. 8, litra a), nr. ii), i direktiv 65/65/EØF (bibliografisk dokumentation for ny lægemiddelform og styrke), var understøttet af publiceret litteratur vedrørende virkningen af topisk diclofenac samt af farmakokinetiske data og data fra et klinisk studie (9702 SUV) af den omhandlede hudsprayformulering 4 %. 
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.
Der sås en effekt, hvad angår det kritiske sekundære effektmål (spontane smerter målt på en VASskala). 
An effect was seen on the critical secondary endpoint of spontaneous pain visual analogue scale (VAS).
Det væsentligste effektmål var graden af smerte. 
Particularly the endpoint of main interest which is pain.
Udvalget finder følgelig, at benefit/risk-forholdet for hudsprayen Diclofenac Sodium Spray Gel 4 %, opløsning, og relaterede navne er positivt, og anbefaler derfor udstedelse af markedsføringstilladelse for de lægemidler, der er anført i bilag I til CHMP's udtalelse. 
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.
Farmakokinetiske data for plasma og væv ved brug af den omhandlede spraygel hos raske forsøgspersoner samt hos patienter med akut inflammation er blevet sammenlignet med dataene for Voltaren Sodium Gel og Voltaren Emulgel. 
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.
Det vurderes navnlig, at anvendelsen af topiske NSAID'er og det faktum, at de erstatter orale og andre systemisk administrerede NSAID'er, i betydeligt omfang bidrager til patienternes trivsel, jf. de tilgængelige sikkerhedsdata, hvilket understøtter en markant lavere risiko for potentielt alvorlige bivirkninger sammenholdt med systemisk administrerede diclofenac-holdige produkter. 
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.