natgillin/translations-raw huggingface dataset:
Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Nizozemska in Nemčija sta menili, da odobritev dovoljenja za promet z zdravilom predstavlja morebitno resno tveganje za javno zdravje;
Overall summary of the scientific evaluation of Methylphenidate Hexal and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Methylphenidate Hexal in povezanih imen (glejte Prilogo I)
The major concern raised by Germany could not be solved during the CMD(h) referral, and the issue was therefore referred to the CHMP.
Glavnega pomisleka, ki sta ga izpostavili Nemčija in Nizozemska, med napotitvenim postopkom skupine CMD(h) ni bilo mogoče odpraviti, zato je bila zadeva posredovana odboru CHMP.
The application for Methylphenidate Hexal is therefore based on bioequivalence studies between the applied and the reference product.
Uporaba zdravila Methylphenidate Hexal temelji na študijah biološke enakovrednosti med uporabljenim in referenčnim zdravilom.
• The Committee is of the opinion that bioequivalence was demonstrated under fasting conditions for the immediate and prolonged release phases and under fed conditions for the prolonged release phase.
• odbor meni, da je bila biološka enakovrednost pri pogojih na tešče dokazana za fazi s takojšnjim in podaljšanim sproščanjem ter pri pogojih na poln želodec za fazo s podaljšanim sproščanjem;
However, the Committee is of the opinion that the observed deviation is attributed to variability between subjects and to physiological conditions after intake of a high fat meal and this does not translate into differences in quality between Methylphenidate Hexal and the reference formulations.
Vendar odbor meni, da je opaženi odklon posledica variabilnosti med preskušanci in fiziološkega stanja po vnosu obroka z veliko vsebnostjo maščobe, kar ne pomeni razlik v kakovosti med zdravilom Methylphenidate Hexal in referenčnimi formulacijami;
Regarding the results obtained in the fed study (2009-18-PRT-2) it was shown that when compared to the fasting study several subjects did not have a biphasic profile but a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Na podlagi rezultatov, pridobljenih v študiji pri pogojih na poln želodec (2009-18-PRT-2), so pokazali, da v primerjavi s študijo pri pogojih na tešče mnogi preskušanci niso imeli dvofaznega profila, ampak neprekinjen profil brez zgodnje največje koncentracije, pri čemer so se koncentracije metilfenidata povečevale z nerednim časovnim zamikom.
• The Committed reviewed all the data submitted by the applicant in order to support the bioequivalence between Methylphenidate Hexal 18 mg, 36 mg, 54 mg prolonged release tablets and the reference product.
• odbor je pregledal vse podatke, ki jih je predlagatelj predložil v podporo biološki enakovrednosti med zdravilom Methylphenidate Hexal 18 mg, 36 mg, 54 mg tablete s podaljšanim sproščanjem in referenčnim zdravilom;
Methylphenidate Hexal's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Formulacija zdravila Methylphenidate Hexal je zasnovana z zunanjo oblogo, ki vsebuje del s takojšnjim sproščanjem, ta del pa obkroža jedro s podaljšanim sproščanjem (osmotsko nadzorovanim).
Methylphenidate Hexal which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Zdravilo Methylphenidate Hexal, ki vsebuje zdravilno učinkovino metilfenidatijev klorid, je osmozno nadzorovana, filmsko obložena tableta s podaljšanim sproščanjem z dvoplastnim jedrom.
Waiver of studies under fed conditions for the 18 mg and 36 mg strengths The bioequivalence under fed conditions has only been studied in the 54 mg strength.
Opustitev študij pri pogojih na poln želodec za jakosti 18 mg in 36 mg Biološka enakovrednost pri pogojih na poln želodec je bila preučevana samo z jakostjo 54 mg.
The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Hexal 18mg, 36mg, 54mg tablets is a generic application in accordance with the Article 10.1 of the Directive 2001/83/EC.
Vloga za pridobitev dovoljenja za promet z zdravilom Methylphenidate Hexal 18 mg, 36 mg, 54 mg tablete za večkratno uporabo s postopkom z medsebojnim priznavanjem je generična vloga v skladu s členom 10.1 Direktive 2001/83/ES.
The fed study failed to fulfil the standard acceptance criteria for bioequivalence for the immediaterelease phase (AUC(0-2h) and Cmax(0-2h)).
Študija pri pogojih na poln želodec ni izpolnila standardnih meril za sprejemljivost biološke enakovrednosti za fazo s takojšnjim sproščanjem (AUC (0-2h) in Cmax(0-2h)).
Methylphenidate Hexal (18 mg, 36 mg and 54 mg) is indicated in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged between 6 and 18 years old once daily in the morning and can be taken with or without food.
Zdravilo Methylphenidate Hexal (18 mg, 36 mg in 54 mg) je indicirano za zdravljenje motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD) pri otrocih, starih od 6 do 18 let.
The repeat-use MRP was closed on day 210, with Germany which did not agree with the conclusions of the RMS's assessment report and which raised a potential serious risk to public health (PSRPH).
Postopek z medsebojnim priznavanjem za večkratno uporabo se je končal 210. dan, pri čemer se je večina zadevnih držav članic strinjala z zaključki poročila o oceni referenčne države članice, z izjemo Nemčije in Nizozemske, ki sta izpostavili morebitno resno tveganje za javno zdravje.
The results showed that bioequivalence was demonstrated for the studies under fasted conditions between Methylphenidate Hexal (18mg, 36mg, 54mg) and the reference product for the immediate and prolonged release phase.
Rezultati so pokazali, da je bila biološka enakovrednost med zdravilom Methylphenidate Hexal (18 mg, 36 mg, 54 mg) in referenčnim zdravilom dokazana pri študijah pri pogojih na tešče za fazi s takojšnjim ter podaljšanim sproščanjem.
the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Methylphenidate Hexal and associated names (see Annex I).
• odbor meni, da je opustitev študij manjših jakosti (18 mg in 36 mg) pri pogojih na poln želodec upravičena; je odbor CHMP priporočil odobritev dovoljenj za promet z zdravilom, pri katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot v končnih različicah, pripravljenih med postopkom skupine za usklajevanje, kot je navedeno v Prilogi III za zdravilo Methylphenidate Hexal in povezana imena (glejte Prilogo I).
The marketing authorisation holder is Eisai Ltd.
Imetnik dovoljenja za promet je Eisai Ltd.
Further information on Panretin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Panretin so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• other treatments (radiotherapy or chemotherapy) are not suitable, and
• druge oblike zdravljenja (radioterapija ali kemoterapija) niso primerne in
It may be used after this period but only on lesions that are responding to treatment.
Lahko se uporablja tudi po tem obdobju, vendar le pri lezijah, ki se odzivajo na zdravljenje.
Around 35% and 37% of the patients using Panretin responded to treatment compared with 18% and 7% of the patients using placebo.
Na zdravljenje se je odzvalo približno 35 in 37 % bolnikov, ki so uporabljali zdravilo Panretin, v primerjavi z 18 in 7 % bolnikov, ki so uporabljali placebo.
• the skin is not broken and the lesions are not swollen,
• koža ni počila in lezije niso otekle;
The main measure of effectiveness was the proportion of patients
Glavno merilo učinkovitosti je bil
• treatment for visceral (internal) Kaposi's sarcoma is not needed.
• zdravljenje visceralnega (internega) Kaposijevega sarkoma ni potrebno.
Panretin should be used for up to 12 weeks.
Zdravilo Panretin se uporablja do 12 tednov.
Panretin received a marketing authorisation valid throughout the EU on 11 October 2000.
Za zdravilo Panretin je bilo 11. oktobra 2000 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Panretin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Panretin večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
• the lesions have not responded to HIV treatment,
• se lezije niso odzvale na zdravljenje HIV;
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Panretin have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Panretin upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
It must not be used to treat lesions that are close to areas affected by other skin disorders.
Ne sme se uporabljati za zdravljenje lezij v bližini površin, ki so jih prizadele druge kožne bolezni.
Other information about Panretin
Druge informacije o zdravilu Panretin
who responded to treatment.
delež bolnikov, ki so se odzvali na zdravljenje.
What measures are being taken to ensure the safe use of Panretin?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Panretin?
Panretin is used when:
Zdravilo Panretin se uporablja, kadar:
Panretin is available as a gel to be applied to the skin lesions twice a day, using enough gel to cover each lesion with a generous coating and then leaving it to dry for three to five minutes before covering with clothing.
Zdravilo Panretin je na voljo kot gel, ki ga bolniki nanesejo na kožne lezije dvakrat dnevno, pri čemer je treba uporabiti dovolj gela, da prekrijejo vsako lezijo z obilnim nanosom, in počakati tri do pet minut, da se posuši, preden lezije prekrijejo z obleko.
The most common side effects with Panretin (which may affect more than 1 patient in 10) are rash, pruritus (itching), skin disorders (cracking, scabbing, crusting, draining, oozing) and pain (burning, soreness).
Najpogostejši neželeni učinki zdravila Panretin (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so izpuščaj, pruritus (srbenje), bolezni kože (pokanje kože, nastajanje krast, krastavost, izločanje tekočine, izcedki) in bolečina (pekoča bolečina, občutljivost).
As for all medicines, data on the use of Panretin are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Panretin stalno spremljajo.
Side effects reported with Panretin are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Panretin, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Panretin have been shown in studies?
Kakšne koristi zdravila Panretin so se pokazale v študijah?
Panretin must not be used in people who may be hypersensitive (allergic) to retinoids in general, alitretinoin, or any of the other ingredients.
Zdravila Panretin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) retinoide na splošno, alitretinoin ali katero koli drugo sestavino zdravila.
An overview of Panretin and why it is authorised in the EU
Pregled zdravila Panretin in zakaj je odobreno v EU
Why is Panretin authorised in the EU?
Zakaj je bilo zdravilo Panretin odobreno v EU?
Panretin must also not be used in women who are pregnant or who are planning a pregnancy, or who are breast-feeding.
Zdravila Panretin ne smejo uporabljati nosečnice in ženske, ki načrtujejo nosečnost, ter doječe matere.
For more information about using Panretin, see the package leaflet or contact a doctor or pharmacist.
Za več informacij glede uporabe zdravila Panretin glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Panretin, alitretinoin, is an anticancer agent that belongs to the group ‘retinoids', substances that are derived from vitamin A. The exact way alitretinoin works in Kaposi's sarcoma is unknown.
Učinkovina v zdravilu Panretin, alitretinoin, je protirakava snov, ki spada v skupino „retinoidov“, snovi, pridobljenih iz vitamina A. Točen način delovanja alitretinoina pri Kaposijevem sarkomu ni znan.
Panretin was compared with placebo (a dummy treatment) in two 12-week studies involving a total of 402 patients with Kaposi's sarcoma.
Zdravilo Panretin so primerjali s placebom (zdravilom brez učinkovine) v dveh 12-tedenskih študijah, v katerih sta sodelovala skupno 402 bolnika s Kaposijevim sindromom.
What is Panretin and what is it used for?
Kaj je zdravilo Panretin in za kaj se uporablja?
What are the risks associated with Panretin?
Kakšna tveganja so povezana z zdravilom Panretin?
Panretin can only be obtained with a prescription and treatment should be started and maintained by a doctor with experience in treating Kaposi's sarcoma.
Predpisovanje in izdaja zdravila Panretin je le na recept, zdravljenje pa mora uvesti in vzdrževati zdravnik z izkušnjami z zdravljenjem Kaposijevega sarkoma.
Panretin is a medicine used to treat the skin lesions seen in AIDS patients with Kaposi's sarcoma (a type of skin cancer).
Zdravilo Panretin se uporablja za zdravljenje kožnih lezij, ki se pojavijo pri bolnikih z aidsom, ki imajo Kaposijev sarkom (vrsto kožnega raka).
A patient was considered to have responded to treatment if their lesions reduced in area or flattened by a certain amount depending on the type of lesions.
Če so se pri bolniku lezije po površini zmanjšale ali sploščile za določeno količino glede na vrsto lezije, se je štelo, da se je bolnik odzval na zdravljenje.
For the full list of all side effects reported with Panretin, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Panretin, glejte navodilo za uporabo.
How does Panretin work?
Kako zdravilo Panretin deluje?
Panretin was more effective than placebo at treating Kaposi's sarcoma.
Zdravilo Panretin je bilo pri zdravljenju Kaposijevega sindroma učinkovitejše od placeba.
Healthy skin around the lesion should be avoided.
Bolniki gela ne smejo nanašati na zdravo kožo okrog lezij.
How is Panretin used?
Kako se zdravilo Panretin uporablja?
Depending on each lesion's response to treatment, the number of applications can be increased to three or four times a day.
Število nanosov gela se lahko poveča na od tri- do štirikrat dnevno, odvisno od odziva posamezne lezije na zdravljenje.
Before opening: 2 years.
Pred odprtjem: 2 leti
These reactions are usually of a transitory nature.
Te reakcije so ponavadi prehodne narave.
Careful monitoring is recommended.
Priporočljivo je natančno spremljanje.
ATC code: A10AD05.
Oznaka ATC: A10AD05.
They must not give you any food or drink because you may choke.
Ne smejo vam dajati hrane ali pijače, ker se lahko zadušite.
Elderly (≥65 years old)
Starejši bolniki (≥ 65 let)
Dose adjustments can be made once a week until target HbA1c is reached.
Odmerek je mogoče prilagajati enkrat na teden, dokler ni dosežen ciljni HbA1c.
Normally, this soon disappears.
Običajno to kmalu mine.
Date of last renewal: 2 July 2010
Datum zadnjega podaljšanja: 2. julij 2010
If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Če je potrebna prilagoditev odmerka, jo je mogoče narediti pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
You should always measure your blood sugar regularly.
Redno si morate meriti krvni sladkor.
Intramuscular administration should be avoided.
Intramuskularnemu apliciranju se je treba izogibati.
This makes it easier to resuspend.
To vam bo olajšalo resuspendiranje.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi odsotnosti študij kompatibilnosti zdravila ne smete mešati z drugimi zdravili.
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done.
Ne prenehajte uporabljati vašega insulina, ne da bi se pogovorili z zdravnikom, ki vam bo povedal, kaj je potrebno storiti.
If convenient, the gluteal or deltoid region may be used.
Če je prikladno, je mogoče uporabiti tudi glutealni ali deltoidni predel.
The dose should not be increased if hypoglycaemia occurred within these days.
Odmerka ne smete povečati, če se je v teh dneh pojavila hipoglikemija.
The duration of action is up to 24 hours (Figure 1).
Trajanje delovanja je do 24 ur (slika 1).
The duration of action is 14 to 24 hours (Figure 1).
Trajanje delovanja je 14 do 24 ur (slika 1).
• Whenever the risk management system is modified, especially as the results of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
► 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.
► If you are ill, carry on taking your insulin and consult your doctor.
► če ste bolni; insulin uporabljajte še naprej in se posvetujte s svojim zdravnikom,
The maximum effect is exerted between 1 and 4 hours after injection.
Največji učinek doseže od 1 do 4 ure po injekciji.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Po porodu se potreba po insulinu hitro vrne na raven pred nosečnostjo.
The following titration guideline is recommended for dose adjustments:
Za prilagajanje odmerka so priporočene naslednje smernice:
Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly).
Insulina si nikoli ne injicirajte neposredno v veno (intravensko) ali mišico (intramuskularno).
After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and
Po ureditvi bolnikove glukoze v krvi je treba razmisliti o prilagoditvi odmerka (glejte poglavja 4.2, 4.8
Do not soak, wash or lubricate it as it may damage the pen.
Ne namakajte, ne umivajte in ne mažite ga, ker ga s tem lahko poškodujete.
Warning signs of high blood sugar:
Opozorilni znaki zvišanega krvnega sladkorja
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 August 2000
Datum prve odobritve: 1. avgust 2000
This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Ta začne delovati hitro in tako omogoča uporabo bližje obroku (od nič do 10 minut od obroka) kot topni humani insulin.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Skupine pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar.
V 10 minutah po injiciranju pojejte obrok ali prigrizek, da se izognete nizkemu krvnemu sladkorju.
If you take more insulin than you should
Če ste uporabili več insulina, kot bi smeli
You must use the pen as described in the Instructions for use.
Injekcijski peresnik morate uporabljati, kot je opisano v navodilih za uporabo.
This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Tako lahko zmanjšate tveganje za nastanek zatrdlin in ugreznjenosti kože (glejte poglavje 4, Možni neželeni učinki).
► Withdraw the needle from the skin, then release the pressure on the push-button.
► Izvlecite iglo iz kože in nato spustite potisni gumb.
You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it.
Iz nezavesti se boste zbudili prej, če dobite injekcijo hormona glukagona od osebe, ki ga zna uporabljati.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Prilagoditev odmerka je lahko potrebna tudi v primeru večje telesne aktivnosti bolnika, spremenjene običajne prehrane ali med sočasnimi boleznimi.
Anaphylactic reactions:
Anafilaktične reakcije:
This should be kept in mind if treatment with the combination of pioglitazone and NovoMix is considered.
To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila NovoMix.
EXP During use: Use within 4 weeks
Uporabno do: Med uporabo: porabite v 4 tednih.
Rare - Peripheral neuropathy (painful neuropathy)
Redko - periferna nevropatija (boleča nevropatija)
For patients with an HbA1c higher than 8% a dose reduction should be considered.
Pri bolnikih z vrednostjo HbA1c višjo od 8 % je treba presoditi o zmanjšanju odmerka.
• 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.
• Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti 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.
Adverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart.
Neželeni učinki, opaženi pri bolnikih, ki uporabljajo zdravilo NovoMix, so v glavnem posledica farmakološkega učinka insulina aspart.
• Complete the other stages of injection without delay.
• Brez odlašanja opravite vse ostale korake za injiciranje.
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Neustrezno odmerjanje ali prekinitev zdravljenja, posebno pri sladkorni bolezni tipa 1, lahko vodi v hiperglikemijo in diabetično ketoacidozo.
The adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Neželeni učinki, navedeni spodaj, temeljijo na podatkih iz kliničnih preskušanj in so razvrščeni po MedDRA pogostnosti in organskih sistemih.
Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.
Sladkorna bolezen je bolezen, pri kateri vaše telo ne tvori dovolj insulina, da bi uravnalo koncentracijo sladkorja v krvi.
The insulin will work more quickly if you inject around the waist.
Insulin bo deloval hitreje, če ga injicirate v predelu trebuha.
During use or when carried as a spare: The product can be stored for a maximum of 4 weeks.
Med uporabo in ko se zdravilo uporablja kot rezerva: zdravilo je lahko shranjeno največ 4 tedne.