natgillin/translations-raw huggingface dataset:
Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood.
Zdravilo Inovelon se uporablja za zdravljenje Lennox-Gastautovega sindroma, redke vrste epilepsije, ki običajno prizadene otroke, vendar se lahko nadaljuje tudi v odrasli dobi.
What is happening with Inovelon for the treatment of other diseases?
Kaj to pomeni za nadaljnjo uporabo zdravila Inovelon za zdravljenje drugih bolezni?
The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system.
V študiji so proučevali varnost zdravila Inovelon in njegov učinek na otrokov vedenjski in čustveni razvoj, kot so ga po standardiziranem sistemu točkovanja ocenili bolnikovi starši oziroma skrbniki.
However, the CHMP considered that including the data obtained in these children in Inovelon's product information could help the healthcare professionals who manage them.
Vendar pa je menil, da bi z vključitvijo podatkov, pridobljenih pri teh otrocih, v informacije o zdravilu Inovelon pomagali zdravstvenim delavcem, ki jih vodijo.
While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness.
Študija je sicer pokazala, da je varnost zdravila Inovelon pri otrocih, starih od enega do manj kot štiri leta, skladna z znanim varnostnim profilom pri starejših otrocih, vendar je odbor CHMP zaključil, da je študija premajhna, da bi lahko sprejeli zaključke o učinkovitosti zdravila.
Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome.
Zdravilo Inovelon je bilo dne 20. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje Lennox-Gastautovega sindroma.
Regarding the data that the company used to make predictions for use in children aged 1 to less than 4 years, the CHMP considered that further analyses were needed in order to make dosing recommendations in the younger age group.
V zvezi s podatki, ki jih je družba uporabila pri napovedovanju uporabe pri otrocih, starih od enega do manj kot štiri leta, je odbor CHMP presodil, da so potrebne nadaljnje analize, na podlagi katerih bi lahko oblikovali priporočila za odmerjanje v mlajši skupini.
There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon.
Odobritev ali zavrnitev te vloge nima nobenih posledic za bolnike, ki trenutno sodelujejo ali bodo morda sodelovali v kliničnih preskušanjih zdravila Inovelon.
The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil pregled vloge za razširitev uporabe zdravila Inovelon za zdravljenje epilepsije na otroke, stare od enega do štirih let.
The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment.
Družba je predložila podatke študije, v kateri je 37 otrok, starih od enega do štirih let, z LennoxGastautovim sindromom prejemalo poleg obstoječega zdravila še zdravilo Inovelon ali drugo zdravilo za zdravljenje epilepsije.
What was Inovelon expected to be used for?
Za kaj naj bi se zdravilo Inovelon uporabljalo?
The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years.
Na podlagi trenutno razpoložljivih podatkov je zaključil, da zdravila Inovelon ni mogoče odobriti za bolnike z Lennox-Gastautovim sindromom, mlajše od štirih let.
How does Inovelon work?
Kako zdravilo Inovelon deluje?
and prevents abnormal electrical activity from spreading through the brain.
Tako zmanjša aktivnost možganskih celic in prepreči, da bi se nenormalna električna aktivnost širila po možganih.
What is Inovelon?
Kaj je zdravilo Inovelon?
The company that markets Inovelon applied for it to be used to treat Lennox-Gastaut syndrome in children aged 1 to 4 years.
Družba, ki trži zdravilo Inovelon, je vložila vlogo, na podlagi katere naj bi se zdravilo uporabljalo za zdravljenje Lennox-Gastautovega sindroma pri otrocih, starih od enega do štirih let.
The company also proposed a way to make predictions on the use of Inovelon in children aged between 1 and 4 years based on existing data in patients aged 4 years and older.
Družba je na podlagi obstoječih podatkov pri bolnikih, starejših od štirih let, tudi predlagala način napovedovanja uporabe zdravila Inovelon pri otrocih, starih od enega do štirih let.
There are no consequences on the use of Inovelon in patients with Lennox-Gastaut syndrome aged 4 years and over.
Pri bolnikih z Lennox-Gastautovim sindromom, starejših od štirih let, ni nobenih posledic za uporabo zdravila Inovelon.
This will prevent misuse and help to protect the environment.
To prepreči napačno uporabo in pomaga varovati okolje.
(see section 5.2)
(glejte poglavje 5.2).
• A core text as agreed by the Rapporteur
• osnovno besedilo, kot je bilo dogovorjeno s poročevalcem
If this happens to you, it is not known if your periods will come back.
Če se vam to zgodi, ni znano, ali se vam bodo menstruacije vrnile.
• every month during treatment.
• vsak mesec med zdravljenjem.
Many of these genes are involved in proliferation, survival, and differentiation.
Številni od teh genov so vključeni v proliferacijo, preživetje in diferenciacijo.
Date of latest renewal: 26 May 2016
Datum zadnjega podaljšanja: 26. maj 2016
• National specific requirements as agreed with the National Competent Authority regarding:
• nacionalno specifične zahteve, dogovorjene s pristojnim nacionalnim organom, glede:
Hard capsule (capsule).
Trda kapsula (kapsula).
The recommended dose is one capsule each day.
Priporočeni odmerek je ena kapsula vsak dan.
Please refer to these documents for further information.
Prosimo, poglejte ta dokumenta za nadaljnje informacije.
Talk to your doctor if you wish to have children in the future.
Posvetujte se z zdravnikom, če želite v prihodnosti imeti otroke.
Objective response was defined as a complete or partial response determined on two consecutive assessments separated by at least 4 weeks.
Objektivni odziv je bil opredeljen kot popoln ali delen odziv, določen na dveh zaporednih ocenjevanjih, med katerima so minili vsaj 4 tedni.
• a sexually mature female who
spolno zrelo žensko, ki
Each pack contains one bottle.
Vsako pakiranje vsebuje eno plastenko.
Key data are summarised in Table 2:
Ključni podatki so povzeti v preglednici 2.
The size of the capsule is ‘Size 1' (dimensions 19.0 x 6.6 mm).
Velikost kapsule je "Velikost 1" (dimenzije 19,0 x 6,6 mm).
• you think your contraception has failed for any reason,
• mislite, da je kontracepcija zaradi kakršnega koli razloga odpovedala,
Patients should be instructed never to give this medicinal product to another person.
Bolnikom je treba naročiti, da tega zdravila nikoli ne dajo drugim osebam.
(18.1, NE)
(18,1; N.o.)
You must follow the contraception advice described in this leaflet.
Upoštevajte nasvete o kontracepciji, opisane v tem navodilu.
This interaction is not expected to be clinically significant.
Ni pričakovati, da bi bila ta interakcija klinično pomembna.
IRF-Assessed
ocena IRF
Pregnancy tests should have a minimum sensitivity of 25 mIU/mL as per local availability.
Testi nosečnosti morajo imeti minimalno občutljivost 25 mi.e./ml, v skladu z lokalno dostopnostjo.
Frequencies are defined as:
Pogostnosti so opredeljene takole:
The PRAC therefore recommends that the Product Information should be updated accordingly.
PRAC zato priporoča, da se informacije o zdravilu ustrezno posodobijo.
• Information on the recommended forms of contraception both for women and men
• informacije o priporočenih oblikah kontracepcije za ženske in moške
Very rare ( < 1/10,000)
Zelo redki (< 1/10.000)
It is used when the cancer:
To zdravilo se uporabi, če se je rak:
This is because it is not known if it is safe or effective in this age group.
Ni namreč znano, ali je to zdravilo v tej starostni skupini varno ali učinkovito.
Effects on specific enzymes and transporters
Učinki na specifične encime in prenašalce
• loss of water from the body (dehydration),
• izguba vode iz telesa (dehidracija),
Four patients were excluded from the figure: 3 patients with stable disease were assessed by non-target lesions only and 1 patient was unevaluable.
Štirje bolniki niso vključeni v sliko: 3 bolniki s stabilno boleznijo so bili ocenjeni samo po neciljnih lezijah, 1 bolnik pa ni bil ocenljiv.
No correlative histopathologic changes were observed.
Prav tako niso opazili korelacijskih histopatoloških sprememb.
Carcinogenicity studies were performed in mice and rats.
Študije kancerogenosti so izvedli na miših in podganah.
You must also use one barrier method, such as:
Uporabljati morate tudi enega od pregradnih načinov, na primer:
• you stop using contraception,
• prenehate uporabljati kontracepcijo,
Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Skrbno preberite in sledite navodilom iz knjižice za bolnike in opozorilne kartice, ki vam ju je dal vaš zdravnik.
• Information for men
• Informacije za moške
• pain (in general) or pain in your arms, legs,
• bolečina (na splošno) ali bolečine v rokah, nogah,
Do not take this medicine if any of the above apply to you.
Ne vzemite tega zdravila, če kaj od naštetega velja za vas.
Do not stop taking this medicine without talking to your doctor first as this could make your treatment less effective.
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom, sicer lahko postane vaše zdravljenje manj učinkovito.
Although the number of identified cases is limited, the reactions are serious and the association with vismodegib is plausible.
Kljub majhnemu številu ugotovljenih primerov so reakcije resne in povezanost z vismodegibom verjetna.
Response assessment was based on a composite endpoint defined as above.
Ocena odziva je temeljila na sestavljenem cilju preskušanja, kot je opredeljen zgoraj.
Erivedge can also affect how some other medicines work.
Zdravilo Erivedge lahko prav tako vpliva na delovanje drugih zdravil.
Contraception - for men and women
Kontracepcija - za moške in ženske
• Erivedge can be taken with or without food.
• Zdravilo Erivedge lahko vzamete s hrano ali brez nje.
• loss of taste,
• izguba okusa,
• surgical sterilisation.
• kirurško sterilizacijo.
The capsules must not be opened, to avoid unintended exposure to patients and health care providers.
Kapsul ne smemo odpreti, da preprečimo nenamerno izpostavljenost bolnikov in zdravstvenega osebja.
In particular, tell your doctor if you take any of the following medicines:
Še posebno pomembno je, da svojemu zdravniku poveste, če jemljete katero od naslednjih zdravil:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/848/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET) EU/1/13/848/001
PHARMACEUTICAL FORM AND CONTENTS 28 capsules
FARMACEVTSKA OBLIKA IN VSEBINA 28 kapsul
Reversibility of fertility impairment is unknown.
Reverzibilnost okvare plodnosti ni znana.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2013
Datum prve odobritve: 12. julij 2013
• The need to provide comprehensive advice and counselling to patients
• potreba po zagotovitvi izčrpnih informacij in svetovanju bolnikom
As a result, your skin cancer may shrink.
Zaradi tega se kožni rak lahko zmanjša.
Induction could lead to decreases in systemic exposure of the contraceptive steroids and thereby reduced contraceptive efficacy.
Spodbujanje lahko vodi v zmanjšanje sistemske izpostavljenosti kontraceptivnim steroidom in zmanjšanje učinkovitosti kontracepcije.
Time to maximum tumour reduction
Čas do največjega zmanjšanja tumorjev
The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) as summarised in Table 2.
Primarni cilj preskušanja je bil delež objektivnega odziva (ORR - objective response rate), kakor ga je ocenila neodvisna ustanova za pregled (IRF - independent review facility), kot je povzeto v preglednici 2.
Note: Tumour size is based on sum of longest dimensions of target lesions.
Opomba: Velikost tumorja temelji na seštevku najdaljših dimenzij ciljnih lezij.
The median duration of treatment was 12.9 months (range 0.7 to 47.8 months).
Mediana trajanja zdravljenja je bila 12,9 meseca (razpon: od 0,7 do 47,8 meseca).
Prescriptions of Erivedge should be limited to 28 days of treatment and continuation of treatment requires a new prescription.
Recepti za zdravilo Erivedge morajo biti omejeni na 28 dni zdravljenja, za nadaljevanje zdravljenja je potreben nov recept.
Erivedge must not be used during pregnancy.
Zdravila Erivedge se ne sme uporabljati med nosečnostjo.
The median age of the efficacy evaluable population was 62 years (46 % were at least 65 years old), 61 % male and 100 % White.
Mediana starosti bolnikov, primernih za oceno učinkovitosti, je bila 62 let (46 % bolnikov je bilo starih vsaj 65 let), 61 % je bilo moških in 100 % belcev.
This damage can change how certain proteins in these cells work and the damaged cells become cancerous and begin to grow and divide.
Okvara lahko spremeni delovanje nekaterih beljakovin v teh celicah in okvarjene celice se spremenijo v rakave in začnejo rasti ter se deliti.
• Check list for healthcare professional ensuring that patients receive the appropriate counselling
• Kontrolni seznam za zdravstvene delavce, ki zagotavlja, da bolniki prejmejo ustrezno svetovanje
• Information on the disposal of unwanted medication
• Informacijo glede odstranjevanja neuporabljenega zdravila
• He must always use the recommended contraception (see the ‘Contraception' section below and section 4.6),
• mora vedno uporabljati priporočeno kontracepcijo (glejte spodnji odstavek ‘Kontracepcija' in poglavje 4.6);
Similar findings were not observed after a 16 week recovery period.
Po 16-tedenskem okrevanju podobnih učinkov niso opazili.
This can happen even after stopping Erivedge.
To se lahko zgodi tudi po prenehanju jemanja zdravila Erivedge.
You must not become pregnant while taking this medicine (see section 2, “Do not take Erivedge” and “Pregnancy, breast-feeding and fertility”).
Med jemanjem tega zdravila ne smete zanositi (glejte poglavje 2, Ne jemljite zdravila Erivedge in Nosečnost, dojenje in plodnost).
Vismodegib is present in semen.
Vismodegib je prisoten v semenu.
Usually this type of lesion appears on sun-damaged skin, remains local and can be cured.
Ponavadi ta vrsta lezije nastane na koži, poškodovani zaradi sonca, ostane lokalizirana in se lahko pozdravi.
Four patients did not have lesion measurements and were not included in the plot.
Štirje bolniki niso imeli meritev lezij in niso bili vključeni v diagram.
• abnormal hair growth,
• nenormalna rast dlak,
Dedicated studies to assess the potential of vismodegib to affect post-natal development have not been performed.
Usmerjenih študij za oceno možnega vpliva vismodegiba na postnatalni razvoj niso izvedli.
Erivedge may affect a woman's ability to have children.
Zdravilo Erivedge lahko poslabša zmožnost žensk, da bi imele otroke.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden boste vzeli to zdravilo.
• Swallow the capsule whole with a drink of water.
• Kapsulo zaužijte celo z nekaj vode.
Educational material
Izobraževalno gradivo
• Requirements in the event of pregnancy
• Zahteve v primeru nosečnosti
In particular, caution should be exercised if vismodegib is administered in combination with any statin.
Še posebno je potrebna previdnost, če vismodegib dajemo skupaj s katerim koli statinom.
Concomitant administration should be performed with caution and a dose adjustment may be necessary.
Sočasno jih je treba dajati s previdnostjo in morda bo potrebna prilagoditev odmerka.
Frequency not known
Neznana pogostnost
More information on the issues above is found in the sections “Pregnancy, breast-feeding and fertility” and “Contraception - for men and women”.
Več informacij glede zgoraj omenjenega lahko najdete v poglavjih Nosečnost, dojenje in plodnost ter Kontracepcija - za moške in ženske.
Based on population pharmacokinetic analysis of combined data from 121 males and 104 females, gender did not appear to affect the pharmacokinetics of vismodegib.
Glede na populacijsko farmakokinetično analizo kombiniranih podatkov 121 moških in 104 žensk spol ni vplival na farmakokinetiko vismodegiba.
The safety and efficacy of Erivedge in children and adolescents aged below 18 years have not been established.
Varnost in učinkovitost zdravila Erivedge pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
Of a total number of 138 patients in 4 clinical trials of Erivedge in advanced basal cell carcinoma, approximately 40 % of patients were ≥ 65 years old and no overall differences in safety and efficacy were observed between these patients and younger patients.
Od celotnega števila 138 bolnikov v 4 kliničnih preskušanjih zdravila Erivedge pri napredovalem bazalnoceličnem karcinomu je bilo približno 40 % bolnikov starih 65 let ali več; v celoti med temi bolniki in mlajšimi bolniki niso opazili nobenih razlik v varnosti in učinkovitosti.
• Do not crush, open or chew the capsule, to avoid unintended exposure to the capsule contents.
• Kapsule ne drobite, odpirajte ali žvečite, da se izognete nenamerni izpostavljenosti vsebini kapsul.
Method of recommended contraception: Talk to your doctor about the best two contraception methods for you.
Priporočeni načini kontracepcije: z zdravnikom se posvetujte o tem, katera kontracepcijska metoda je za vas najprimernejša.
• changes in blood tests, which include increased values in liver tests or increased values in creatine phosphokinase (a protein mainly from muscle).
• spremembe v krvnih preiskavah, ki vključujejo zvišane vrednosti jetrnih testov ali zvišane vrednosti kreatin-fosfokinaze (beljakovine, ki se večinoma nahaja v mišicah).
Embryo-foetal death or severe birth defects
Embrio-fetalna smrt ali hude prirojene napake
Vismodegib inhibits UGT2B7 in vitro and it may not be excluded that inhibition can take place in vivo in the intestine.
Vismodegib zavira UGT2B7 in vitro in ni mogoče izključiti, da inhibicija lahko poteka tudi in vivo v črevesju.
Erivedge can cause bones to stop growing and lead to premature onset of puberty (before age 8 years in girls or age 9 years in boys).
da kosti prenehajo rasti, in vodi v prezgodnji nastop pubertete (pred 8 letom pri deklicah in pred 9 letom pri dečkih).
The median duration of treatment for all patients was 8.6 months (range 0 to
Mediana trajanja zdravljenja vseh bolnikov je bila 8,6 meseca (razpon od 0 do
• The need for adequate contraception and definition of adequate contraception
• Potrebo po ustrezni kontracepciji in definicijo ustrezne kontracepcije
• if you are allergic to vismodegib or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na vismodegib ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
It cannot be excluded that vismodegib may increase the exposure to substrates of OATP1B1, e.g. bosentan, ezetimibe, glibenclamide, repaglinide, valsartan and statins.
Ni mogoče izključiti, da lahko vismodegib poveča izpostavljenost substratom OATP1B1, npr. bosentanu, ezetimibu, glibenklamidu, repaglinidu, valsartanu in statinom.
Ex vivo plasma protein binding in human patients is > 99 %.
Vezava na plazemske beljakovine ex vivo je bila pri bolnikih > 99 %.
Patients with a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redkimi prirojenimi motnjami, kot so intoleranca za galaktozo, pomanjkanje Lapp laktaze ali malabsorpcija glukoze-galaktoze, ne smejo jemati tega zdravila.
• She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic,
• mora imeti negativen test nosečnosti vsak mesec med zdravljenjem, tudi če je postala amenoreična;
Programme (see sections 4.4 and 4.6).
Erivedge (glejte poglavji 4.4 in 4.6).
Patients with severe renal impairment should be carefully monitored for adverse reactions.
Bolnike s hudo ledvično okvaro je treba skrbno spremljati zaradi možnosti pojava neželenih učinkov.
However, the interaction study was of only 7 days duration and it cannot be excluded that vismodegib upon longer treatment is an inducer of enzymes which metabolise contraceptive steroids.
Študija medsebojnega delovanja je trajala samo 7 dni in ne moremo izključiti, da je pri daljšem zdravljenju vismodegib spodbujevalec encimov, ki presnavljajo kontraceptivne steroide.
• use 2 methods of contraception, one highly effective method and one barrier method (please see the examples below)
• uporabljajte 2 načina kontracepcije, en visokoučinkovit način in en pregradni način (glejte primere spodaj).
This may slow down or stop the growth of the cancer cells, or may kill them.
Tako lahko upočasni ali ustavi rast rakavih celic ali takšne celice uniči.
It may also lead to the death of a baby before it is born or shortly after being born.
Povzroči lahko tudi, da otrok umre, še preden se rodi ali kmalu po rojstvu.
• pain in your chest, back or side,
• bolečina v prsnem košu, hrbtu ali ob strani trupa,
• Description of the pregnancy prevention programme
• opis programa za preprečevanje nosečnosti
Erivedge is unlikely to affect your ability to drive, use any tools or machines.
Ni verjetno, da bi zdravilo Erivedge vplivalo na vašo sposobnost za upravljanje vozil, uporabo orodij ali strojev.
You must stop treatment and inform your doctor straight away if: you miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Zdravljenje morate prekiniti in svojega zdravnika nemudoma obvestiti, če vaša menstruacija zamuja ali mislite, da zamuja, ali je vaša menstrualna krvavitev nenavadna, ali sumite, da ste noseči.
• The active substance is vismodegib.
• Učinkovina je vismodegib.
In vitro, vismodegib is an inhibitor of OATP1B1.
In vitro je vismodegib zaviralec OATP1B1.
In clinical trials, treatment with Erivedge was continued until disease progression or until unacceptable toxicity.
V kliničnih preskušanjih se je zdravljenje z zdravilom Erivedge nadaljevalo do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
Therefore, Erivedge may be taken without regard to meals.
Zato je mogoče zdravilo Erivedge vzeti ne glede na obroke.
CYP2C9 appears to contribute in part to vismodegib metabolism in vivo.
Videti je, da CYP2C9 delno prispeva k presnovi vismodegiba in vivo.
Paediatric population There are insufficient pharmacokinetic data in paediatric patients.
Pediatrična populacija Farmakokinetičnih podatkov za pediatrične bolnike ni dovolj.
• The other ingredients are:
• Pomožne snovi so:
Itraconazole (a strong CYP3A4 inhibitor) 200 mg daily did not influence vismodegib AUC0-24h after 7 days co-treament in healthy volunteers.
Itrakonazol (močan zaviralec CYP3A4) v odmerku 200 mg na dan ni vplival na AUC0-24h po 7 dneh sočasnega dajanja zdravim prostovoljcem.
Talk to your pharmacist or doctor regarding where to return the medicine.
Posvetujte se s farmacevtom ali zdravnikom glede tega, kam lahko vrnete zdravilo.
• The need for monthly pregnancy tests
• potreba po mesečnem opravljanju testov nosečnosti
• The healthcare professional should assess the pregnancy status, counsel the patient on teratogenicity risk and refer the patient to a specialised physician for counselling
• zdravstveni delavec mora oceniti status nosečnosti, svetovati bolniku glede teratogenih tveganj in napotiti bolnika na posvet k zdravniku specialistu