natgillin/translations-raw huggingface dataset:
Each film-coated tablet (tablet) contains 5 mg of linagliptin
Ena filmsko obložena tableta (tableta) vsebuje 5 mg linagliptina.
Metformin: co-administration of multiple daily doses of 10 mg linagliptin with 850 mg metformin, an OCT substrate, had no relevant effect on the pharmacokinetics of metformin in healthy volunteers.
Metformin: večkratno sočasno dajanje dnevnih odmerkov linagliptina po 10 mg z 850 mg metformina, substrata za OCT, pri zdravih prostovoljcih ni vplivalo na farmakokinetiko metformina.
Sulphonylureas: co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide.
Sulfonilsečnine: pri sočasnem večkratnem dajanju peroralnih odmerkov linagliptina po 5 mg in enkratnega peroralnega odmerka glibenklamida (gliburida) po 1,75 mg sta se za 14 % zmanjšali AUC in Cmax glibenklamida, kar ni veljalo za klinično pomembno.
Linagliptin also provided significant improvements in fasting plasma glucose (FPG), and a greater proportion of patients achieved a target HbA1c of < 7.0%, compared to placebo.
Linagliptin je hkrati pomembno izboljšal tudi vrednost glukoze v plazmi na tešče, poleg tega je v primerjavi s placebom več bolnikov doseglo ciljno vrednost HbA1c < 7,0 %.
Treatment with once daily linagliptin at 5 mg provided a significant improvement in HbA1c (-0.69% change compared to placebo), in patients with baseline HbA1c of approximately 8%.
Pri zdravljenju z enim odmerkom linagliptina po 5 mg na dan se je pri bolnikih z izhodiščno vrednostjo HbA1c približno 8 % le-ta pomembno izboljšala (za -0,69 % v primerjavi s placebom).
Digoxin: co-administration of multiple daily doses of 5 mg linagliptin with multiple doses of 0.25 mg digoxin had no effect on the pharmacokinetics of digoxin in healthy volunteers.
Digoksin: sočasno večkrat dnevno dajanje odmerkov linagliptina po 5 mg in več odmerkov digoksina po 0,25 mg pri zdravih prostovoljcih ni vplivalo na farmakokinetiko digoksina.
Metformin: co-administration of multiple three times daily doses of 850 mg metformin with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy volunteers.
Metformin: pri sočasnem dajanju večkratnih odmerkov metformina po 850 mg, trikrat na dan, in 10 mg linagliptina, enkrat na dan, pri zdravih prostovoljcih ni bilo klinično pomembnih sprememb farmakokinetike linagliptina.
Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Znižanje je bilo večje pri bolnikih z višjo izhodiščno ravnijo HbA1c.
What you need to know before you take Trajenta Do not take Trajenta - if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section
• če ste alergični na linagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin.
Zato je pri uporabi kombinacije linagliptina in sulfonilsečnine in/ali insulina potrebna previdnost.
The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at >900 times the human exposure.
Odmerek, pri katerem še ni opaziti toksičnega učinka na plodnost, zgodnji razvoj zarodka in teratogenost pri podganah, 900-krat presega mejo izpostavljenosti za človeka.
Linagliptin as monotherapy in patients ineligible for metformin The efficacy and safety of linagliptin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Monoterapija z linagliptinom pri bolnikih, za katere metformin ni primerno zdravilo Učinkovitost in varnost monoterapije z linagliptinom so ocenjevali v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 24 tednov.
The efficacy and safety of the addition of linagliptin 5 mg to insulin alone or in combination with metformin and/or pioglitazone has been evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Linagliptin kot dodatno zdravilo ob zdravljenju z insulinom Učinkovitost in varnost dodajanja linagliptina v odmerkih po 5 mg k zdravljenju s samim insulinom ali v kombinaciji z metforminom in/ali pioglitazonom so ocenili v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 24 tednov.
No dosage adjustment for linagliptin is proposed for diabetic patients with mild, moderate or severe hepatic impairment.
Za bolnike s sladkorno boleznijo z blago, zmerno ali hudo jetrno okvaro ni predvideno prilagajanje odmerka.
Linagliptin also showed significant improvements in fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG) compared to placebo.
Linagliptin je pomembno izboljšal tudi raven glukoze v plazmi na tešče in 2 uri po jedi v primerjavi s placebom.
Gastrointestinal disorders Pancreatitis rare #
Bolezni prebavil pankreatitis redko zaprtje občasno
The observed difference in HbA1c over placebo was0.72% after 52 weeks.
Po 52 tednih je bila opažena razlika v vrednosti HbA1c v primerjavi s placebom -0,72 %.
• Trajenta 5 mg tablets are 8 mm diameter round, light red film-coated tablets debossed with
• Zdravilo Trajenta 5 mg tablete imajo premer 8 mm, so okrogle, svetlo rdeče filmsko obložene z oznako D5 na eni strani in logom Boehringer Ingelheim na drugi strani.
rare
pogosto
Linagliptin alone showed a comparable incidence of hypoglycaemia to placebo.
Pri samostojni uporabi linagliptina je bila pojavnost hipoglikemije podobna kot pri placebu.
The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo.
Pojavnost hipoglikemije je bila pri zdravljenju z linagliptinom podobna kot pri placebu.
Urticaria*
redko urtikarija*
Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
V študiji, v kateri so primerjali učinkovitost in varnost dodajanja linagliptina v odmerkih po 5 mg ali glimepirida (povprečni odmerek 3 mg) pri bolnikih z nezadostno urejeno glikemijo z monoterapijo z metforminom, je bilo srednje znižanje vrednosti HbA1c -0,16 % pri linagliptinu (s srednjo izhodiščno vrednostjo HbA1c 7,69 %) in -0,36 % pri glimepiridu (s srednjo povprečno vrednostjo 7,69 %) s srednjo razliko zdravljenja 0,20 % (97,5-odstotni interval zaupanja: 0,09, 0,299).
How to store Trajenta
Shranjevanje zdravila Trajenta
Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
Pomembno je izboljšal tudi raven glukoze v plazmi na tešče v primerjavi s placebom.
Your blood sugar levels may increase when you stop taking Trajenta.
Če zdravilo Trajenta prenehate jemati, se vam lahko zviša raven krvnega sladkorja.
Therefore, no dosage adjustment of linagliptin is necessary in patients with any degree of renal insufficiency.
Zato bolnikom s katero koli stopnjo ledvične odpovedi odmerka linagliptina ni treba prilagajati.
NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets linagliptin
IME ZDRAVILA Trajenta 5 mg tablete linagliptin
Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes.
Nekaj bolnikov je imelo med jemanjem zdravila Trajenta, samega ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vnetje trebušne slinavke (pankreatitis; pogostnost redka, pojavi se lahko pri največ 1 od 1.000 bolnikov).
Linagliptin provided significant improvements in HbA1c (-0.59 % change compared to placebo after 12 weeks), from a mean baseline HbA1c of 8.2%.
Linagliptin je pomembno izboljšal HbA1c (po 12 tednih -0,59 % sprememba v primerjavi s placebom) v primerjavi s srednjo izhodiščno vrednostjo HbA1c, ki je bila 8,2 %.
What Trajenta contains - The active substance is linagliptin
• Učinkovina je linagliptin.
Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Odmerka linagliptina ni treba prilagajati na podlagi indeksa telesne mase (ITM), ker ni klinično pomembno vplival na farmakokinetiko linagliptina, kar je pokazala populacijska farmakokinetična analiza podatkov I. in II.
Linagliptin provided significant improvements in HbA1c (-0.64 % change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Linagliptin je pomembno izboljšal HbA1c (-0,64 % v primerjavi s placebom po 24 tednih) v primerjavi z njeno srednjo izhodiščno vrednostjo, ki je bila 7,8 %.
In the placebo-controlled studies 4.9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Neželeni učinek hipoglikemijo je v s placebom nadzorovanih študijah med zdravljenjem z linagliptinom imelo 4,9 % bolnikov.
II data.
faze.
Linagliptin provided significant improvements in HbA1c (-0.65% compared to placebo) from a mean baseline HbA1c of 8.3%.
Linagliptin je pomembno izboljšal HbA1c (-0,65 % v primerjavi s placebom), in sicer glede na srednjo izhodiščno vrednost HbA1c 8,3 %.
- The other ingredients are
• Pomožne snovi so:
If you get any side effects talk to your doctor, pharmacist or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PERFORATED)
PRETISNI OMOTI (PERFORIRANI)
Bullous pemphigoid rare #
občasno bulozni pemfigoid redko
Linagliptin provided significant improvements in HbA1c, (-0.57% change compared to placebo), from a mean baseline HbA1c of 8.09%.
Linagliptin je pomembno izboljšal HbA1c (-0,57 % v primerjavi s placebom) glede na njegovo srednjo izhodiščno vrednost 8,09 %.
Linagliptin also showed significant improvements in patients fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG), compared to placebo.
Poleg tega je pomembno izboljšal raven glukoze v plazmi na tešče in 2 uri po jedi v primerjavi s placebom.
Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Linagliptin je pomembno izboljšal HbA1c (-0,62 % v primerjavi s placebom) glede na njegovo srednjo izhodiščno vrednost 8,14 %.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of linagliptin.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg linagliptina.
Linagliptin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Linagliptin je pomembno izboljšal HbA1c (-0,64 % v primerjavi s placebom) glede na njegovo srednjo izhodiščno vrednost 8 %.
The observed incidence of hypoglycaemia in patients treated with linagliptin was higher than placebo, due to an increase in asymptomatic hypoglycaemic events.
Pojavnost hipoglikemije je bila zaradi povečanja števila nesimptomatskih hipoglikemičnih dogodkov večja med bolniki, ki so jemali linagliptin, kot med bolniki, ki so jemali placebo.
Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450 times human exposure.
Pri opicah vrste Cynomolgus so se pri izpostavljenosti, ki je bila več kot 450-krat večja kot pri človeku, pokazali kot tarčni organi za toksične učinke: jetra, ledvice, želodec, reproduktivni organi, priželjc, vranica in limfni vozli.
This summary was last updated in 01-2019.
Povzetek je bil nazadnje posodobljen 01-2019.
What measures are being taken to ensure the safe and effective use of Ravicti?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ravicti?
The European Medicines Agency decided that the benefits of Ravicti are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Ravicti večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The company that markets Ravicti will set up a registry of patients to obtain further information on the long-term benefits and safety of the medicine.
Družba, ki trži zdravilo Ravicti, bo vzpostavila register bolnikov za pridobivanje dodatnih informacij o dolgoročnih koristih in varnosti zdravila.
Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila: ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
Regular blood tests are needed to adjust the dose.
Za prilagoditev odmerka so potrebne redne krvne preiskave.
Since proteins are a source of nitrogen, Ravicti must be used together with a special low-protein diet, and sometimes with dietary supplements (depending on the daily protein intake needed for growth and development).
Ker so beljakovine vir dušika, je treba zdravilo Ravicti uporabljati skupaj s posebno dieto z nizko vsebnostjo beljakovin in včasih s prehranskimi dopolnili (odvisno od dnevnega vnosa beljakovin, potrebnih za rast in razvoj).
The main measure of effectiveness was the change in the blood level of ammonia after 4 weeks of treatment.
Glavno merilo učinkovitosti je bila sprememba ravni amoniaka v krvi po štirih tednih zdravljenja.
Data from additional studies showed a similar effect in children treated with Ravicti from birth.
Podatki iz podobnih študij so pokazali podoben učinek pri otrocih, ki so bili z zdravilom Ravicti zdravljeni od rojstva.
However, further data on the long-term safety of Ravicti are awaited.
Vendar pa se nadaljnji podatki o dolgoročni varnosti zdravila Ravicti še pričakujejo.
Other information about Ravicti
Druge informacije o zdravilu Ravicti
What is Ravicti and what is it used for?
Kaj je zdravilo Ravicti in za kaj se uporablja?
The total daily dose of Ravicti should be divided into equal amounts and given with each meal.
Skupni dnevni odmerek zdravila Ravicti je treba razdeliti na enake količine in jih zaužiti ob vsakem obroku.
Why is Ravicti authorised in the EU?
Zakaj je zdravilo Ravicti odobreno v EU?
Patients with urea cycle disorders are not able to get rid of waste nitrogen from the body because they lack some liver enzymes.
Bolniki z motnjami cikla sečnine ne morejo odvajati odpadnega dušika iz telesa, ker jim primanjkuje nekaterih jetrnih encimov.
Ravicti is available as a liquid (1.1 g/ml) to be taken by mouth, or given through a tube that goes from the nose to the stomach or through the belly into the stomach.
Zdravilo Ravicti je na voljo kot tekočina (1,1 g/ml), ki se jemlje peroralno ali se jo dovaja po cevki, ki poteka skozi nos do želodca oziroma skozi trebuh v želodec.
An overview of Ravicti and why it is authorised in the EU
Pregled zdravila Ravicti in zakaj je odobreno v EU
Additionally, the Agency considered that since Ravicti is available as a liquid this could make the medicine more palatable especially for children, compared with other medicines available as granules to be added to food; the liquid formulation also facilitates giving it through a tube to patients unable to swallow.
Agencija je poleg tega menila, da bi bilo lahko zdravilo Ravicti, ker je na voljo v obliki tekočine, bolj všečno predvsem otrokom, v primerjavi z drugimi razpoložljivimi zdravili, ki so na voljo v obliki zrnc, ki se dodajajo živilom; tekoča formulacija pa omogoča tudi dajanje prek cevke bolnikom, ki ne morejo požirati.
As for all medicines, data on the use of Ravicti are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ravicti stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ravicti have also 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 Ravicti upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Side effects reported with Ravicti are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ravicti, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Ravicti, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ravicti glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Ravicti (glycerol phenylbutyrate)
Ravicti (glicerol fenilbutirat)
Ravicti is used in patients who lack one or more of the following enzymes: carbamoyl phosphate synthase-I, ornithine carbamoyltransferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I and ornithine translocase.
Zdravilo Ravicti se uporablja pri bolnikih, ki jim manjka eden ali več naslednjih encimov: karbamoilfosfat sintetaza-I, ornitin karbamoiltransferaza, argininosukcinat sintetaza, argininosukcinat liaza, arginaza I in ornitin translokaza.
The study showed that Ravicti was at least as effective as the comparator in controlling the blood level of ammonia: the estimated average ammonia level was about 870 micromoles per litre in patients treated with Ravicti, compared with about 980 micromoles per litre in patients treated with sodium phenylbutyrate.
Študija je pokazala, da je zdravilo Ravicti pri uravnavanju ravni amoniaka v krvi vsaj tako učinkovito kot primerjalno zdravilo: povprečna raven amoniaka je bila ocenjena na približno 870 mikromolov na liter pri bolnikih, ki so se zdravili z zdravilom Ravicti, v primerjavi s približno 980 mikromoli na liter pri bolnikih, ki so se zdravili z natrijevim fenilbutiratom.
The most common side effects with Ravicti (which may affect more than 1 in 20 people) are diarrhoea, flatulence (passing gas), headache, decreased appetite, vomiting, tiredness, feeling sick and abnormal skin smell.
Najpogostejši neželeni učinki zdravila Ravicti (ki se lahko pojavijo pri več kot 1 od 20 oseb) so driska, flatulenca (vetrovi), glavobol, zmanjšan apetit, bruhanje, utrujenost, slabost in nenormalen vonj kože.
What benefits of Ravicti have been shown in studies?
Kakšne koristi je zdravilo Ravicti izkazalo v študijah?
What are the risks associated with Ravicti?
Kakšna tveganja so povezana z zdravilom Ravicti?
The side effects of Ravicti affect mainly the gut and are considered manageable.
Neželeni učinki zdravila Ravicti vplivajo predvsem na črevesje in veljajo za obvladljive.
It can only be obtained with a prescription and should be prescribed by a doctor who has experience in treating patients with urea cycle disorders.
Izdaja zdravila je le na recept, predpiše pa ga lahko le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami cikla sečnine.
Ravicti is a medicine used to manage urea cycle disorders in adults and children, when the diseases cannot be managed by changes in diet alone.
Ravicti je zdravilo, ki se uporablja za obvladovanje motenj cikla sečnine pri odraslih in otrocih, kadar bolezni ni mogoče obvladovati samo s spreminjanjem prehrane.
Urea cycle disorders are rare, and Ravicti was designated an ‘orphan medicine' (a medicine used in rare diseases) for several forms of the disease on 10 June 2010.
Motnje cikla sečnine so redke, zato je bilo zdravilo Ravicti 10. junija 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za več oblik bolezni.
For this same reason Ravicti must not be used to treat acute hyperammonaemia as more rapidly acting treatments are needed in these cases.
Zdravilo Ravicti se zato ne sme uporabljati za zdravljenje akutne hiperamoniemije, saj so v teh primerih potrebna hitrejša zdravljenja.
Ravicti must not be used to treat acute hyperammonaemia (sudden rise of blood ammonia levels).
Zdravilo Ravicti se ne sme uporabljati za zdravljenje akutne hiperamoniemije (nenadnega zvišanja ravni amoniaka v krvi).
In the body, waste nitrogen is turned into ammonia, which is harmful when it accumulates.
V telesu se odpadni dušik spremeni v amoniak, ki je ob nakopičenju škodljiv.
The dose of Ravicti depends on the patient's diet, height and weight.
Odmerek zdravila Ravicti je odvisen od bolnikove prehrane, telesne višine in mase.
This removal of proteins decreases the levels of nitrogen in the body, reducing the amount of ammonia produced.
Z odstranitvijo beljakovin se zmanjša količina dušika v telesu, s tem pa se zmanjša količina proizvedenega amoniaka.
Ravicti is effective in reducing the blood level of ammonia in patients with urea cycle disorders.
Zdravilo Ravicti je učinkovito pri zniževanju ravni amoniaka v krvi pri bolnikih z motnjami cikla sečnine.
Phenylacetate attaches to the amino acid glutamine found in proteins to form a substance that the kidneys can remove from the body.
Fenilacetat se veže na aminokislino glutamin, prisotno v beljakovinah, in tvori snov, ki jo lahko ledvice odstranijo iz telesa.
For the full list of side effects and restrictions with Ravicti, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ravicti glejte navodilo za uporabo.
Ravicti received a marketing authorisation valid throughout the EU on 27 November 2015 Further information on Ravicti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ravicti
Nadaljnje informacije za zdravilo Ravicti so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ravicti
How is Ravicti used?
Kako se zdravilo Ravicti uporablja?
Ravicti may be a life-long treatment unless the patient has a successful liver transplant.
Bolnik se mora zdraviti z zdravilom Ravicti celo življenje, razen v primeru uspešne presaditve jeter.
How does Ravicti work?
Kako zdravilo Ravicti deluje?
Ravicti has been compared with sodium phenylbutyrate (another medicine used to treat urea cycle disorders) in a study involving 88 adults with urea cycle disorders.
Zdravilo Ravicti so v študiji, v kateri je sodelovalo 88 odraslih z motnjami cikla sečnine, primerjali z natrijevim fenilbutiratom (drugim zdravilom, ki se uporablja za zdravljenje motenj cikla sečnine).
The active substance in Ravicti, glycerol phenylbutyrate, is converted to phenylacetate in the body.
Učinkovina zdravila Ravicti, glicerol fenilbutirat, se v telesu pretvori v snov, imenovano fenilacetat.
Ravicti contains the active substance glycerol phenylbutyrate.
Zdravilo Ravicti vsebuje učinkovino glicerol fenilbutirat.
Ravicti is a sustained-release medicine, meaning the active substance is released throughout the day.
Zdravilo Ravicti je zdravilo s podaljšanim sproščanjem, kar pomeni, da se učinkovina sprošča čez cel dan. Zaradi tega je nadzor nad ravnijo amoniaka v krvi skozi cel dan boljši.
The European Commission granted a marketing authorisation valid throughout the European Union for Orphacol on 12 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Orphacol, veljavno po vsej Evropski uniji, odobrila 12. septembra 2013.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove podatke in ustrezno posodobila ta povzetek.
This is a summary of the European public assessment report (EPAR) for Orphacol.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Orphacol.
This means that because the disease is rare, it has not been possible to obtain complete information about Orphacol.
Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti popolnih informacij o njem.
It must not be taken by patients already taking phenobarbital, a medicine used to treat epilepsy.
Ne sme se uporabljati pri bolnikih, ki že jemljejo fenobarbital, zdravilo za zdravljenje epilepsije.
Orphacol has been authorised under ‘exceptional circumstances'.
Zdravilo Orphacol je pridobilo dovoljenje za promet v „izjemnih okoliščinah‟.