natgillin/translations-raw huggingface dataset:
So in the hypothetical scenario of a difference in the amount of produced saliva this would not impact on the absorbed amount of the active substance.
V hipotetičnem scenariju različnih količin nastale sline to ne bi vplivalo na absorbirano količino učinkovine.
On the top of that, flurbiprofen is a highly permeable and passively absorbed drug of which the permeability is not altered by a difference in concentration.
Poleg tega je flurbiprofen močno permeabilno in pasivno absorbirano zdravilo, katerega permeabilnost se zaradi razlike v koncentraciji ne spremeni.
The therapeutic equivalence has been claimed to be demonstrated based on in-vitro data only.
Terapevtska enakovrednost naj bi bila dokazana samo na podlagi podatkov in vitro.
The proposed indication is ‘pain relief of mild to moderate symptoms of acute sore throat'.
Predlagana indikacija je „lajšanje bolečin pri blagih do zmernih simptomih akutnega vnetja žrela“.
The proposed indication is short-term symptomatic relief of sore throat.
Predlagana indikacija je kratkotrajno lajšanje simptomov vnetega žrela.
Literature data (Radkova et al., 2017, Imai et al., 1988) demonstrate that different formulations of flurbiprofen (spray and lozenges) displayed comparable efficacy and safety profiles, despite the lack of cycloextrins from lozenges, and were also taken into consideration.
Podatki iz literature (Radkova idr., 2017, Imai idr., 1988) dokazujejo, da različne formulacije flurbiprofena (pršilo in pastile) kažejo primerljiva profila učinkovitosti in varnosti, kljub odsotnosti ciklodekstrinov v pastilah, kar je bilo tudi upoštevano.
The CHMP considered that the removal of the mint flavour is considered clinically irrelevant in this specific case.
Odbor CHMP je menil, da je odstranitev arome mete v tem primeru klinično nepomembna.
• 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;
ii) the amount of cyclodextrins: the amount of cyclodextrins is lower in the test product compared to this of the reference medicinal product;
(ii) količino ciklodekstrinov: količina ciklodekstrinov v testnem zdravilu je manjša od njihove količine v referenčnem zdravilu;
The CHMP considered that the noted differences between the reference and test product are minor and the applicant has sufficiently demonstrated why these differences do not affect the local efficacy, safety or the systemic absorption of the product.
Odbor CHMP je ocenil, da so opažene razlike med referenčnim in testnim zdravilom zanemarljive in da je predlagatelj zadovoljivo dokazal, zakaj te razlike ne vplivajo na lokalno učinkovitost, varnost ali sistemsko absorpcijo zdravila.
If bioequivalence has been established among such different formulations, the minor differences in the present case will not affect the pharmacokinetic and clinical profile of the test product.
Če je bila bioekvivalenca dokazana med temi različnimi formulacijami, manjše razlike v tem primeru ne bodo vplivale na farmakokinetični in klinični profil testnega zdravila.
Moreover, it was emphasised that the originator has demonstrated bioequivalence between the oromucosal spray (Strefen Direct 8,75 mg Oromucosal spray) and lozenges (Strepflam 8,75 mg Lozenges), for which more significant formulation differences exist.
Poudarili so tudi, da je originator dokazal bioekvivalenco oralnega pršila (Strefen Direct 8,75 mg oralno pršilo) in pastil (Strepflam 8,75 mg pastile), med katerima obstajajo pomembnejše razlike v formulaciji.
During the decentralised procedure (DCP) and the CMDh procedure, the RMS (ES) considered that the above mentioned differences were minor and without a clinical impact on the efficacy and safety of the test product.
Med decentraliziranim postopkom in postopkom skupine CMDh je referenčna država članica (ES) menila, da so zgoraj navedene razlike manjše ter nimajo kliničnega vpliva na učinkovitost in varnost testnega zdravila.
The originator product is Strepflam 8.75 Lozenges by Crookes Healthcare/Reckitt Benckiser Healthcare, which has been registered since June 2001.
Originatorsko zdravilo je zdravilo Strepflam 8,75 mg pastile podjetja Crookes Healthcare/Reckitt Benckiser Healthcare, ki je registrirano od junija 2001.
No clinical studies have been contacted and instead the applicant requested a biowaiver.
Klinične študije niso bile opravljene; namesto tega je predlagatelj zaprosil za izvzetje iz obveznosti izvedbe študij biološke enakovrednosti.
The Committee, as a consequence, considers that the benefit-risk balance of Flurbiprofen Geiser 8,75 mg oromucosal 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 Flurbiprofen Geiser 8,75 mg oralno pršilo, raztopina, in povezanih imen pozitivno, zato priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.
The test product has some quantitative and qualitative differences with the reference product, namely;
Testno zdravilo ima nekaj kvantitativnih in kvalitativnih razlik v primerjavi z referenčnim zdravilom, in sicer:
The reference medicinal product was Strefen Direct 8,75 mg Oromucosal spray (UK/H/5072/001).
Referenčno zdravilo je bilo zdravilo Strefen Direct 8,75 mg oralno pršilo (UK/H/5072/001).
Flurbiprofen belongs to the non-steroidal anti-inflammatory class of medicines (NSAID) which have analgesic, antipyretic, and anti-inflammatory properties.
Flurbiprofen spada v razred nesteroidnih protivnetnih zdravil (NSAID), ki imajo analgetične, antipiretične in protivnetne lastnosti.
The application for Strefen Direct 8,75 mg Oromucosal spray was made under Article 8(3) of Directive 2001/83/EC.
Vloga za zdravilo Strefen Direct 8,75 mg oralno pršilo je bila predložena v skladu s členom 8(3) Direktive 2001/83/ES.
Second, flurbiprofen is moderately bound to the cyclodextrins and the release of the active substance is immediate when it comes in contact with the buccal membrane.
Drugič, flurbiprofen se zmerno veže na ciklodekstrin in učinkovina se sprosti takoj, ko pride v stik z ustno sluznico.
The assessment was performed having in mind that this was this is a hybrid application under Article 10(3) of Directive 2001/83/EC.
Pri oceni se je upoštevalo, da je šlo za hibridno vlogo v skladu s členom 10(3) Direktive 2001/83/ES.
Based on the in-vitro tests, equivalence has been shown between the reference and the test products with respect to the following quality attributes: amount of active substance in each dose, the particle size, the plume geometry and the spray pattern.
Na podlagi preskusov in vitro je bila dokazana enakovrednost referenčnega in testnega zdravila, kar zadeva naslednje kakovostne lastnosti: količina učinkovine v posameznem odmerku, velikost delcev, geometrija izpusta in vzorec pršenja.
Overall summary of the scientific evaluation by the CHMP Flurbiprofen Geiser 8,75 mg oromucosal spray, is a non-steroidal anti-inflammatory (NSAID) with analgesic, antipyretic, and anti-inflammatory properties.
Splošni povzetek znanstvenega vrednotenja odbora CHMP Zdravilo Flurbiprofen Geiser 8,75 mg oralno pršilo je nesteroidno protivnetno zdravilo (NSAID) z analgetičnimi, antipiretičnimi in protivnetnimi lastnostmi.
i) the concentration: 17.16 mg/ml in the test medicinal product versus 16.20 mg/ml in the reference product;
(i) koncentracijo: 17,16 mg/ml v testnem zdravilu v primerjavi s 16,20 mg/ml v referenčnem zdravilu;
The application was submitted under Article 10(3) of Directive 2001/83/EC.
Vloga je bila predložena v skladu s členom 10(3) Direktive 2001/83/ES.
The saliva secretion does not play a relevant contribution in the in-vivo performance of the buccal spray since most of the content of the spray is swallowed as a consequence of gag the reflex caused by the impact of the spray in the throat, without any time to be affected by the secretion of saliva.
Izločanje sline ne prispeva pomembno k delovanju ustnega pršila in vivo, saj večino vsebine pršila pogoltnemo, in sicer zaradi refleksa bruhanja, ki ga povzroči pršilo v grlu, pri tem pa ni časa, da bi pršilo vplivalo na izločanje sline.
Results from the in-vitro tests performed by the applicant have shown equivalence in the critical quality attributes that were tested (single actuation content, droplet size distribution, drug small particles, spray pattern, plum geometry and priming), suggesting that the quantitative and qualitative differences between the reference and the test medicinal products do not affect the deposition of the spray in the site of action (the buccal cavity).
Rezultati preskusov in vitro, ki jih je opravil predlagatelj, so pokazali enakovrednost preskušanih ključnih kakovostnih lastnosti (vsebnost ob enkratni sprožitvi, porazdelitev velikosti kapljic, majhni delci zdravila, vzorec razpršitve, geometrija izpusta in aktivacija), kar kaže, da kvantitativne in kvalitativne razlike med referenčnim in testnim zdravilom ne vplivajo na odlaganje pršila na mesto delovanja (ustna votlina).
With regards to the different concentration (17.16 mg/ml vs. 16.20 mg/ml), it was noted that that due to the different sprayed volumes (0.17 mL vs. 0.18 mL), the delivered dose is eventually the same.
Kar zadeva različno koncentracijo (17,16 mg/ml v primerjavi s 16,20 mg/ml), je bilo ugotovljeno, da je zaradi različnih volumnov pršenja (0,17 ml v primerjavi z 0,18 ml) dani odmerek praktično enak.
The present referral was triggered on the grounds that the waiver for clinical studies is not in line with the “Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract” (CPMP/EWP/239/95 Rev.1) and that the differences may impact on the clinical performance of the test product.
Trenutna napotitev je bila sprožena z utemeljitvijo, da izvzetje iz obveznosti izvedbe kliničnih študij ni v skladu s Smernicami o študijah enakovrednosti za dokaz terapevtske enakovrednosti lokalno uporabljenih, lokalno delujočih zdravil v prebavnem traktu (CPMP/EWP/239/95 Rev.1) in da bi razlike lahko vplivale na klinično učinkovitost testnega zdravila.
i) different concentration: 17.16 mg/ml in the test product versus 16.20 mg/ml in the reference product (0.096% difference of content of drug substance in weight/volume)
(i) drugačno koncentracijo: 17,16 mg/ml v testnem zdravilu v primerjavi s 16,20 mg/ml v referenčnem zdravilu (0,096-odstotna razlika vsebnosti snovi v zdravilu v masi/prostornino)
Acknowledging that deviations from the guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) could be accepted if they are justified appropriately and having reviewed all the data submitted and the responses submitted by the applicant, the CHMP considered that the waiver of the clinical trials to demonstrate therapeutic equivalence has been adequately substantiated.
Odbor CHMP je s priznanjem, da je odstopanja od Smernic o študijah enakovrednosti za dokaz terapevtske enakovrednosti lokalno uporabljenih, lokalno delujočih zdravil v prebavnem traktu (CPMP/EWP/239/95 Rev.1) mogoče sprejeti, če so ustrezno utemeljena, ter po pregledu vseh predloženih podatkov in odgovorov predlagatelja menil, da je bilo izvzetje iz obveznosti izvedbe kliničnega preskušanja za dokaz terapevtske enakovrednosti zadostno utemeljeno.
On the other hand, the waiver of clinical studies supporting equivalent efficacy and safety has been questioned by one of the CMS (NL) because the difference in concentration of the active substance, the qualitative difference in flavours and the quantitative difference in cyclodextrins that in their view could potentially have an impact on the efficacy and the safety of the medicinal product.
Po drugi strani pa je ena od zadevnih držav članic (NL) izrazila dvome glede izvzetja iz obveznosti izvedbe kliničnih študij v podporo enakovredni učinkovitosti in varnosti, saj bi lahko po njenem mnenju razlika v koncentraciji učinkovine, kvalitativna razlika v aromah in kvantitativna razlika v ciklodekstrinih vplivale na učinkovitost in varnost zdravila.
Differences with respect to the reference medicinal product are possible in the context of a hybrid application, as long as these differences do not affect the therapeutic equivalence between the reference and the test products.
Razlike glede na referenčno zdravilo so mogoče v okviru hibridne vloge, če te razlike ne vplivajo na terapevtsko enakovrednost referenčnega in testnega zdravila.
In addition, published evidence underline that completely different formulations of flurbiprofen (e.g. lozenge, granules and spray) applied to the oral cavity has demonstrated bioequivalence.
Poleg tega objavljeni dokazi kažejo, da je bila bioekvivalenca dokazana za popolnoma različne formulacije (npr. pastile, zrnca in pršilo), ki se uporabljajo v ustni votlini.
Differences with respect to the reference medicinal product are possible, as long as it is demonstrated that these differences do not affect the therapeutic equivalence between the reference and the test product.
Razlike glede na referenčno zdravilo so mogoče, če se dokaže, da ne vplivajo na terapevtsko enakovrednost referenčnega in testnega zdravila.
According to the Guideline on the equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) preclinical and clinical trials are considered necessary in order to bridge the test to the reference medicinal product in case the definition of a generic medicinal product is not met.
Skladno s Smernicami o študijah enakovrednosti za dokaz terapevtske enakovrednosti lokalno uporabljenih, lokalno delujočih zdravil v prebavnem traktu (CPMP/EWP/239/95 Rev.1) so potrebna predklinična in klinična preskušanja za premostitev preskušanja glede na referenčno zdravilo, če opredelitev generičnega zdravila ni izpolnjena.
submitted an application under the decentralised procedure for Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names (ES/H/0552/001/DC).
Predlagatelj, podjetje Geiser Pharma S.L., je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Flurbiprofen Geiser 8,75 mg oralno pršilo, raztopina, in povezanimi imeni po decentraliziranem postopku (ES/H/0552/001/DC).
For this application, in order to demonstrate therapeutic equivalence, the applicant has submitted invitro studies.
Pri tej vlogi je za dokaz terapevtske enakovrednosti predlagatelj predložil študije in vitro.
iii) the flavours: in the test product one flavour is employed (cherry) instead of two flavours employed in the reference medicinal product (cherry and mint)
(iii) arome: v testnem zdravilu je uporabljena ena aroma (aroma češnje), v referenčnem pa dve (aroma češnje in mete).
ii) lower amount of cyclodextrins iii) one flavour less: in the test product one flavour is employed (cherry) instead of two flavours employed in the reference product (cherry and mint)
(iii) eno aromo manj: v testnem zdravilu je uporabljena ena aroma (aroma češnje), v referenčnem pa dve (aroma češnje in mete)
Before opening: 30 months.
Pred odprtjem: 30 mesecev.
Date of first authorisation: 07 October 2002 Date of latest renewal: 18 September 2007
Datum prve odobritve: 7. oktober 2002 Datum zadnjega podaljšanje: 18. september 2007
The warning signs appear gradually.
Opozorilni znaki se pojavijo postopoma.
See also Serious allergic reactions above.
Glejte tudi podpoglavje Resna alergijska reakcija zgoraj.
How and where to inject
Kako in kje injicirati
This is especially important if you take more than one type of insulin.
To je zlasti pomembno, če uporabljate več kot eno vrsto insulina.
Seek medical advice immediately:
Nemudoma poiščite zdravniško pomoč:
Careful monitoring is recommended.
Priporočljivo je skrbno nadziranje.
They must not give you any food or drink, because you may choke.
Ne smejo vam dajati hrane ali pijače, ker se lahko zadušite.
• If signs of allergy spread to other parts of your body.
• če se znaki alergije razširijo na druge dele telesa,
Reactions usually resolve in a few days to a few weeks.
Reakcije običajno minejo v nekaj dneh do nekaj tednih.
Further important information
Dodatne pomembne informacije
This will make sure you get the full dose.
Tako zagotovite, da boste dobili celoten odmerek.
These reactions are usually of a transitory nature.
Te reakcije so običajno prehodne.
Onset of action is within ½ hour, reaches a maximum effect within 2-8 hours and the entire duration of action is up to 24 hours.
Delovati začne v 1/2 ure, največji učinek doseže v 2-8 urah, celotni čas delovanja pa je do 24 ur.
If not, change the needle and repeat the procedure no more than 6 times.
Če se ne, zamenjajte iglo in ponovite postopek, vendar ne več kot 6-krat.
Ask your doctor about this.
O tem se posvetujte z zdravnikom.
The potency of human insulin is expressed in international units.
Moč humanega insulina izražamo v mednarodnih enotah.
Warning signs of high blood sugar:
Opozorilni znaki visokega krvnega sladkorja:
► If it has not been stored correctly or if it has been frozen, see section 5.
► če zdravilo ni bilo pravilno shranjeno ali je zmrznilo, glejte poglavje 5,
You should always measure your blood sugar regularly.
Redno si morate meriti sladkor v krvi.
• You will hear a click for every single unit dialled.
• Za vsako posamezno nastavljeno enoto boste slišali klik.
This makes it easier to resuspend.
Tako ga boste lažje resuspendirali.
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Če se na zdravljenje z glukagonom ne odzovete, bo potrebno zdravljenje v bolnišnici.
The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day.
Potreba posameznega bolnika po insulinu je običajno od 0,3 do 1,0 mednarodne enote/kg/dan.
12 units
12 enot
Resuspend according to instructions
Resuspendirajte v skladu z navodili.
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
► To so lahko znaki zelo resnega stanja, ki ga imenujemo diabetična ketoacidoza (kopičenje kisline v krvi, ker telo razgrajuje maščobe namesto sladkorja).
After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9).
Po ureditvi bolnikove glukoze v krvi je treba razmisliti o prilagoditvi odmerka (glejte poglavji 4.8 in 4.9).
Your medicine might be harmful to their health.
Vaše zdravilo bi drugim lahko škodilo.
The maximum plasma concentration of the fast-acting insulin is reached within 1.5-2.5 hours after subcutaneous administration.
Največja koncentracija hitro delujočega insulina v plazmi je dosežena v 1,5 do 2,5 ure po subkutani aplikaciji.
Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Prvi simptomi hiperglikemije se običajno razvijejo postopoma, v času nekaj ur ali dni.
If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious.
Če dobite glukagon, boste potrebovali glukozo ali sladek prigrizek, takoj ko se zaveste.
Otherwise the liquid may leak out, which can cause inaccurate dosing.
V nasprotnem primeru lahko tekočina izteka, kar pa lahko povzroči netočno odmerjanje.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar.
Ustreznim osebam povejte, da imate sladkorno bolezen in kakšne so lahko posledice, vključno s tveganjem, da se zaradi nizkega krvnega sladkorja lahko tudi onesvestite (izgubite zavest).
Severe low blood sugar can lead to unconsciousness.
Zelo nizek krvni sladkor lahko povzroči nezavest.
You can select doses from 1 to 60 units in increments of 1 unit.
Izberete lahko odmerke od 1 do 60 enot v koraku po 1 enoto.
These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Takšne reakcije namreč lahko postanejo hujše ali spremenijo absorpcijo insulina, če ga injicirate na takšno mesto.
If they do not disappear, or if they spread throughout your body, talk to your doctor immediately.
Če ne minejo ali se razširijo po telesu, se nemudoma posvetujte z zdravnikom.
• Anabolic steroids (such as testosterone)
• anabolne steroide (kot je testosteron),
Premixed insulin medicinal products are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired.
Mešane insuline običajno uporabljamo enkrat ali dvakrat na dan, če želimo doseči hiter začetni učinek skupaj s podaljšanim učinkom.
• Drink alcohol, see Actraphane with alcohol in section 2.
• če pijete alkohol, glejte podpoglavje Zdravilo Actraphane skupaj z alkoholom v poglavju 2.
You can also report side effects via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Once empty, it must be disposed of.
Ko so prazni, jih morate zavreči.
Measure your blood sugar if possible and rest.
Če je mogoče, si izmerite vrednost krvnega sladkorja in počivajte.
Use in special patient groups
Uporaba pri posebnih skupinah bolnikov
• Other medicines for the treatment of diabetes
• druga zdravila za zdravljenje sladkorne bolezni,
• If you have frequent hypoglycaemia.
• če imate pogoste hipoglikemije,
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done.
Ne prenehajte uporabljati insulina, ne da bi se pogovorili z zdravnikom, ki vam bo povedal, kaj je potrebno storiti.
Pull the needle out of the vial.
Iglo izvlecite iz viale.
• Eat too little or miss a meal.
• če premalo jeste ali izpustite obrok,
If you suspect that the cartridge is damaged, take it back to your supplier.
Če sumite, da je vložek poškodovan, ga vrnite dobavitelju.
The pharmacokinetics of insulin medicinal products are therefore affected by significant intra- and inter-individual variation.
Na farmakokinetiko insulinskih zdravil torej vplivajo znatne intra- in interindividualne razlike.
See Effects from diabetes in section 4.
Glejte podpoglavje Učinki zaradi sladkorne bolezni v poglavju 4.
Trials have indicated a t½ of about 5-10 hours.
Preskušanja so pokazala, da t1/2 znaša približno 5-10 ur.
To avoid injection of air and ensure proper dosing:
Da boste preprečili injiciranje zraka in zagotovili pravilno odmerjanje:
Withdraw the needle from the skin then release the pressure on the push-button.
Izvlecite iglo iz kože in nato spustite potisni gumb.
These usually disappear after a few weeks of taking your insulin.
Običajno minejo po nekaj tednih uporabe insulina.
Dispose of it carefully.
Pazljivo jo zavrzite.
Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Alkohol lahko poveča ali zmanjša hipoglikemični učinek insulina.
You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
Insulina nikoli ne smete injicirati neposredno v veno (intravensko) ali mišico (intramuskularno).
Each vial has a protective, tamper-proof plastic cap.
Vsaka viala ima zaščitno, varovalno plastično zaporko.
Let them know that if you pass out, they must turn you on your side and get medical help straight away.
Povejte jim, da vas morajo v primeru, da se onesvestite, položiti na bok in nemudoma poiskati zdravniško pomoč.
*Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
*Humani insulin je pridobljen iz Saccharomyces cerevisiae s tehnologijo rekombinantne DNA.
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.