FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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)
Slovenian: (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)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Razlike glede na referenčno zdravilo so mogoče v okviru hibridne vloge, če te razlike ne vplivajo na terapevtsko enakovrednost referenčnega in testnega zdravila.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Razlike glede na referenčno zdravilo so mogoče, če se dokaže, da ne vplivajo na terapevtsko enakovrednost referenčnega in testnega zdravila.
English: 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.
Slovenian: 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.
English: submitted an application under the decentralised procedure for Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names (ES/H/0552/001/DC).
Slovenian: 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).
English: For this application, in order to demonstrate therapeutic equivalence, the applicant has submitted invitro studies.
Slovenian: Pri tej vlogi je za dokaz terapevtske enakovrednosti predlagatelj predložil študije in vitro.
English: 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)
Slovenian: (iii) arome: v testnem zdravilu je uporabljena ena aroma (aroma češnje), v referenčnem pa dve (aroma češnje in mete).
English: 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)
Slovenian: (iii) eno aromo manj: v testnem zdravilu je uporabljena ena aroma (aroma češnje), v referenčnem pa dve (aroma češnje in mete)
English: Before opening: 30 months.
Slovenian: Pred odprtjem: 30 mesecev.
English: Date of first authorisation: 07 October 2002 Date of latest renewal: 18 September 2007
Slovenian: Datum prve odobritve: 7. oktober 2002 Datum zadnjega podaljšanje: 18. september 2007
English: The warning signs appear gradually.
Slovenian: Opozorilni znaki se pojavijo postopoma.
English: See also Serious allergic reactions above.
Slovenian: Glejte tudi podpoglavje Resna alergijska reakcija zgoraj.
English: How and where to inject
Slovenian: Kako in kje injicirati
English: This is especially important if you take more than one type of insulin.
Slovenian: To je zlasti pomembno, če uporabljate več kot eno vrsto insulina.
English: Seek medical advice immediately:
Slovenian: Nemudoma poiščite zdravniško pomoč:
English: Careful monitoring is recommended.
Slovenian: Priporočljivo je skrbno nadziranje.
English: They must not give you any food or drink, because you may choke.
Slovenian: Ne smejo vam dajati hrane ali pijače, ker se lahko zadušite.
English: • If signs of allergy spread to other parts of your body.
Slovenian: • če se znaki alergije razširijo na druge dele telesa,
English: Reactions usually resolve in a few days to a few weeks.
Slovenian: Reakcije običajno minejo v nekaj dneh do nekaj tednih.
English: Further important information
Slovenian: Dodatne pomembne informacije
English: This will make sure you get the full dose.
Slovenian: Tako zagotovite, da boste dobili celoten odmerek.
English: ATC code: A10AD01.
Slovenian: A10AD01.
English: These reactions are usually of a transitory nature.
Slovenian: Te reakcije so običajno prehodne.
English: 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.
Slovenian: Delovati začne v 1/2 ure, največji učinek doseže v 2-8 urah, celotni čas delovanja pa je do 24 ur.
English: If not, change the needle and repeat the procedure no more than 6 times.
Slovenian: Če se ne, zamenjajte iglo in ponovite postopek, vendar ne več kot 6-krat.
English: Ask your doctor about this.
Slovenian: O tem se posvetujte z zdravnikom.
English: The potency of human insulin is expressed in international units.
Slovenian: Moč humanega insulina izražamo v mednarodnih enotah.
English: Warning signs of high blood sugar:
Slovenian: Opozorilni znaki visokega krvnega sladkorja:
English: ► If it has not been stored correctly or if it has been frozen, see section 5.
Slovenian: ► če zdravilo ni bilo pravilno shranjeno ali je zmrznilo, glejte poglavje 5,
English: You should always measure your blood sugar regularly.
Slovenian: Redno si morate meriti sladkor v krvi.
English: • You will hear a click for every single unit dialled.
Slovenian: • Za vsako posamezno nastavljeno enoto boste slišali klik.
English: This makes it easier to resuspend.
Slovenian: Tako ga boste lažje resuspendirali.
English: If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Slovenian: Če se na zdravljenje z glukagonom ne odzovete, bo potrebno zdravljenje v bolnišnici.
English: The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day.
Slovenian: Potreba posameznega bolnika po insulinu je običajno od 0,3 do 1,0 mednarodne enote/kg/dan.
English: 12 units
Slovenian: 12 enot
English: Resuspend according to instructions
Slovenian: Resuspendirajte v skladu z navodili.
English: ► 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).
Slovenian: ► To so lahko znaki zelo resnega stanja, ki ga imenujemo diabetična ketoacidoza (kopičenje kisline v krvi, ker telo razgrajuje maščobe namesto sladkorja).
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9).
Slovenian: Po ureditvi bolnikove glukoze v krvi je treba razmisliti o prilagoditvi odmerka (glejte poglavji 4.8 in 4.9).
English: Your medicine might be harmful to their health.
Slovenian: Vaše zdravilo bi drugim lahko škodilo.
English: The maximum plasma concentration of the fast-acting insulin is reached within 1.5-2.5 hours after subcutaneous administration.
Slovenian: Največja koncentracija hitro delujočega insulina v plazmi je dosežena v 1,5 do 2,5 ure po subkutani aplikaciji.
English: Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Slovenian: Prvi simptomi hiperglikemije se običajno razvijejo postopoma, v času nekaj ur ali dni.
English: If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious.
Slovenian: Če dobite glukagon, boste potrebovali glukozo ali sladek prigrizek, takoj ko se zaveste.
English: Otherwise the liquid may leak out, which can cause inaccurate dosing.
Slovenian: V nasprotnem primeru lahko tekočina izteka, kar pa lahko povzroči netočno odmerjanje.
English: 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.
Slovenian: 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).
English: Severe low blood sugar can lead to unconsciousness.
Slovenian: Zelo nizek krvni sladkor lahko povzroči nezavest.
English: You can select doses from 1 to 60 units in increments of 1 unit.
Slovenian: Izberete lahko odmerke od 1 do 60 enot v koraku po 1 enoto.
English: These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Slovenian: Takšne reakcije namreč lahko postanejo hujše ali spremenijo absorpcijo insulina, če ga injicirate na takšno mesto.
English: If they do not disappear, or if they spread throughout your body, talk to your doctor immediately.
Slovenian: Če ne minejo ali se razširijo po telesu, se nemudoma posvetujte z zdravnikom.
English: • Anabolic steroids (such as testosterone)
Slovenian: • anabolne steroide (kot je testosteron),
English: Premixed insulin medicinal products are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired.
Slovenian: Mešane insuline običajno uporabljamo enkrat ali dvakrat na dan, če želimo doseči hiter začetni učinek skupaj s podaljšanim učinkom.
English: • Drink alcohol, see Actraphane with alcohol in section 2.
Slovenian: • če pijete alkohol, glejte podpoglavje Zdravilo Actraphane skupaj z alkoholom v poglavju 2.
English: 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.
Slovenian: 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.
English: Once empty, it must be disposed of.
Slovenian: Ko so prazni, jih morate zavreči.
English: Measure your blood sugar if possible and rest.
Slovenian: Če je mogoče, si izmerite vrednost krvnega sladkorja in počivajte.
English: Use in special patient groups
Slovenian: Uporaba pri posebnih skupinah bolnikov
English: • Other medicines for the treatment of diabetes
Slovenian: • druga zdravila za zdravljenje sladkorne bolezni,
English: • If you have frequent hypoglycaemia.
Slovenian: • če imate pogoste hipoglikemije,
English: Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done.
Slovenian: Ne prenehajte uporabljati insulina, ne da bi se pogovorili z zdravnikom, ki vam bo povedal, kaj je potrebno storiti.
English: Pull the needle out of the vial.
Slovenian: Iglo izvlecite iz viale.
English: • Eat too little or miss a meal.
Slovenian: • če premalo jeste ali izpustite obrok,
English: If you suspect that the cartridge is damaged, take it back to your supplier.
Slovenian: Če sumite, da je vložek poškodovan, ga vrnite dobavitelju.
English: The pharmacokinetics of insulin medicinal products are therefore affected by significant intra- and inter-individual variation.
Slovenian: Na farmakokinetiko insulinskih zdravil torej vplivajo znatne intra- in interindividualne razlike.
English: See Effects from diabetes in section 4.
Slovenian: Glejte podpoglavje Učinki zaradi sladkorne bolezni v poglavju 4.
English: Trials have indicated a t½ of about 5-10 hours.
Slovenian: Preskušanja so pokazala, da t1/2 znaša približno 5-10 ur.
English: To avoid injection of air and ensure proper dosing:
Slovenian: Da boste preprečili injiciranje zraka in zagotovili pravilno odmerjanje:
English: Withdraw the needle from the skin then release the pressure on the push-button.
Slovenian: Izvlecite iglo iz kože in nato spustite potisni gumb.
English: These usually disappear after a few weeks of taking your insulin.
Slovenian: Običajno minejo po nekaj tednih uporabe insulina.
English: Dispose of it carefully.
Slovenian: Pazljivo jo zavrzite.
English: Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Slovenian: Alkohol lahko poveča ali zmanjša hipoglikemični učinek insulina.
English: You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
Slovenian: Insulina nikoli ne smete injicirati neposredno v veno (intravensko) ali mišico (intramuskularno).
English: Each vial has a protective, tamper-proof plastic cap.
Slovenian: Vsaka viala ima zaščitno, varovalno plastično zaporko.
English: Let them know that if you pass out, they must turn you on your side and get medical help straight away.
Slovenian: Povejte jim, da vas morajo v primeru, da se onesvestite, položiti na bok in nemudoma poiskati zdravniško pomoč.
English: *Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Slovenian: *Humani insulin je pridobljen iz Saccharomyces cerevisiae s tehnologijo rekombinantne DNA.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Slovenian: Iz nezavesti se boste zbudili prej, če dobite injekcijo hormona glukagona od osebe, ki ga zna uporabljati.
English: Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours.
Slovenian: Zdravilo Actraphane začne sladkor v krvi zniževati približno 30 minut po uporabi, njegov učinek pa traja približno 24 ur.
English: Draw into the syringe the same amount of air as the dose of insulin you are going to inject.
Slovenian: V brizgo potegnite enako količino zraka, kot je odmerek insulina, ki ga boste injicirali.
English: Pull off the pen cap (see A).
Slovenian: Snemite pokrovček peresnika (glejte sliko A).
English: • Repeatedly inject less insulin than you need.
Slovenian: • če si večkrat zapored injicirate manj insulina, kot ga potrebujete,
English: This reduces the risk of contamination, infection,
Slovenian: Tako zmanjšate tveganje za kontaminacijo,
English: If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death.
Slovenian: Če dolgotrajno in hudo znižanje krvnega sladkorja ni ustrezno zdravljeno, lahko povzroči okvaro možganov (prehodno ali trajno) in celo smrt.
English: This should be kept in mind if treatment with the combination of pioglitazone and Actraphane is considered.
Slovenian: To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Actraphane.
English: Before opening: Store in a refrigerator (2°C - 8°C).
Slovenian: Pred odprtjem: shranjujte v hladilniku (2 °C - 8 °C).
English: Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Slovenian: Huda hipoglikemija lahko povzroči nezavest in/ali konvulzije ter ima lahko za posledico prehodno ali trajno okvaro možganov ali celo smrt.
English: • If you find it hard to recognise hypoglycaemia.
Slovenian: • če hipoglikemije težko prepoznate.
English: This is called acute painful neuropathy and is usually transient.
Slovenian: Pojav imenujemo akutna boleča nevropatija in je običajno prehoden.
English: Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
Slovenian: Ne uporabljajte merila preostanka, ker kaže samo, koliko insulina je približno še ostalo v injekcijskem peresniku.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Slovenian: • Hude hipoglikemije, ko je bolnik nezavesten, se lahko zdravi z glukagonom (0,5 do 1 mg), ki ga intramuskularno ali subkutano aplicira ustrezno podučena oseba, ali z glukozo, ki jo intravensko aplicira zdravstveni delavec.
English: The suspension is cloudy, white and aqueous.
Slovenian: Suspenzija je motna, bela in vodna.
English: This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis.
Slovenian: To lahko vodi v zelo visok krvni sladkor (hudo hiperglikemijo) in ketoacidozo.
English: A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Slovenian: Predlagana so številna mesta razcepa (hidrolize) na molekuli humanega insulina, nobeden od presnovkov, nastalih po razcepu, pa ni aktiven.
English: Some conditions and activities can affect your need for insulin.
Slovenian: Nekatera stanja in dejavnosti lahko vplivajo na potrebo telesa po insulinu.
English: The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Slovenian: Trajanje delovanja se razlikuje in je odvisno od odmerka, mesta injiciranja, krvnega pretoka, temperature in stopnje telesne dejavnosti.
English: Actraphane dosing is individual and determined in accordance with the needs of the patient.
Slovenian: Odmerjanje zdravila Actraphane je individualno in odvisno od potreb posameznega bolnika.
English: Do not change your insulin unless your doctor tells you to.
Slovenian: Ne spreminjajte svojega insulina, če vam tega ne naroči zdravnik.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Slovenian: Prehod bolnika na zdravljenje z drugo vrsto ali znamko insulina mora potekati pod skrbnim zdravniškim nadzorom.
English: Animal reproduction studies with human insulin have not revealed any adverse effects on fertility.
Slovenian: Študije vplivov humanega insulina na sposobnost razmnoževanja pri živalih ne kažejo nobenih neželenih učinkov na plodnost.
English: If there is not enough insulin left, use a new one.
Slovenian: Če v vložku ni ostalo dovolj insulina, uporabite novega.
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dose.
Slovenian: Zaradi spremembe jakosti, znamke (izdelovalec), vrste, izvora (živalski insulin, humani insulin ali analog insulina) in/ali načina izdelave (rekombinantna DNA v primerjavi z insulinom živalskega izvora) bo odmerek insulina morda treba spremeniti.
English: The symptoms of hypoglycaemia usually occur suddenly.
Slovenian: Simptomi hipoglikemije se običajno razvijejo nenadoma.
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label: - If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Slovenian: Izdelovalca je mogoče ugotoviti po serijski številki, natisnjeni na škatli in nalepki: - Če sta drugi in tretji znak S6, P5, K7, R7, VG, FG ali ZF, je izdelovalec Novo Nordisk A/S,
English: This may reduce the risk of developing lumps or skin pitting, see section 4.
Slovenian: Na ta način se zmanjša tveganje za nastanek zatrdlin ali ugreznjenosti kože (glejte poglavje 4).
English: There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
Slovenian: Med nosečnostjo ni omejitev za zdravljenje sladkorne bolezni z insulinom, saj insulin ne prehaja placentne pregrade.
English: If it is not in perfect condition when you get the vial, return the vial to your supplier.
Slovenian: Če zaporka ni v povsem brezhibnem stanju ko vialo dobite, vialo vrnite dobavitelju;
English: No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Slovenian: Ugotovili niso nobene izrazite vezave na beljakovine v plazmi, razen na krožeča protitelesa proti insulinu (če so prisotna).
English: Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Slovenian: Oktreotid in lanreotid (uporabljamo ju za zdravljenje akromegalije, redke hormonske motnje, ki se običajno pojavi pri odraslih srednjih let in je posledica čezmernega nastajanja rastnega hormona v hipofizi) lahko zvišata ali znižata vrednost krvnega sladkorja.
English: If you do not treat it, this could lead to diabetic coma and eventually death.
Slovenian: Če se stanja ne zdravi, lahko povzroči diabetično komo in se konča s smrtjo.
English: • Sulfonamides (used to treat infections).
Slovenian: • sulfonamide (uporabljamo jih za zdravljenje okužb).
English: The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Slovenian: Končni razpolovni čas je odvisen od hitrosti absorpcije iz podkožnega tkiva.
English: • Get an infection and/or a fever.
Slovenian: • če se pojavi okužba in/ali zvišana telesna temperatura,