natgillin/translations-raw huggingface dataset:
In addition, data on the misuse of modafinil by university students, currently being collected, will be analysed once available.
Analizirani bodo tudi podatki o zlorabi modafinila med univerzitetnimi študenti, ki se trenutno še zbirajo in še niso na voljo.
• Doctors should also be aware of the safety profile of modafinil-containing medicines, and they should monitor their patients appropriately.
• Zdravniki morajo biti pozorni tudi na varnostni profil zdravil, ki vsebujejo modafinil, in ustrezno spremljati bolnike.
Looking at the safety data, the Committee noted that modafinil is strongly linked to a risk of serious, life-threatening skin reactions, and this risk appears higher in children.
Ob pregledu varnostnih podatkov je Odbor menil, da je modafinil močno povezan s tveganjem resnih, smrtno nevarnih kožnih reakcij in zdi se, da je to tveganje večje pri otrocih.
In addition the Committee also recommended that modafinil-containing medicines not be used in patients with uncontrolled hypertension or irregular heart beat.
Odbor je tudi priporočil, da se zdravila, ki vsebujejo modafinil, ne uporabljajo pri bolnikih z nenadzorovano hipertenzijo ali nerednim srčnim utripom.
• There is no need for patients to stop treatment with modafinil immediately, but patients who wish to stop can do so at any time.
• Takojšnje prenehanje zdravljenja z modafinilom ni potrebno; če pa želijo, lahko bolniki zdravljenje kadar koli prekinejo.
This led to an update of the product information for modafinil-containing medicines across Europe to strengthen the warnings about these risks.
Posledično so po vsej Evropi posodobili informacije o zdravilih za zdravila, ki vsebujejo modafinil, da bi okrepili opozorila o teh tveganjih.
The CHMP also recommended further changes to the product information to ensure that the medicines are used appropriately, and asked the manufacturers to put in place risk minimisation measures.
CHMP je priporočil tudi dodatne spremembe informacij o zdravilu za zagotovitev pravilne uporabe zdravila in izdelovalce zaprosil, da vzpostavijo ukrepe za zmanjševanje tveganja.
• Doctors prescribing modafinil-containing medicines should keep in mind the change in the indication: modafinil is only indicated to treat narcolepsy.
• Zdravniki, ki predpisujejo zdravila, ki vsebujejo modafinil, ne smejo pozabiti na spremembe indikacij: modafinil je indiciran le za zdravljenje narkolepsije.
Modafinil-containing medicines are used in patients who suffer from excessive sleepiness.
Zdravila, ki vsebujejo modafinil, se uporabljajo pri bolnikih, ki imajo težave s pretirano zaspanostjo.
Looking at the data from the clinical trials, the Committee noted that the effectiveness of modafinil in narcoleptic patients had been shown.
Ob pregledu podatkov iz kliničnih preskušanj je Odbor ugotovil, da je bila učinkovitost modafinila pri bolnikih z narkolepsijo dokazana.
The Committee also noted the increased risk of serious life-threatening skin reactions with modafinil in children and advised against its use in children.
Odbor je izpostavil tudi povečano tveganje resnih, smrtno nevarnih kožnih reakcij pri uporabi modafinila pri otrocih in odsvetoval uporabo pri otrocih.
Excessive sleepiness can be caused by narcolepsy, a disease that causes the person to fall asleep during the day, or it can be due to disturbed night-time sleeping patterns leading to daytime sleepiness.
Čezmerno zaspanost lahko povzroča narkolepsija, bolezen, zaradi katere posameznik podnevi zaspi, ali pa je posledica motenih vzorcev nočnega spanja, kar povzroča zaspanost podnevi.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of modafinil-containing medicines continue to outweigh their risks only in the treatment of narcolepsy.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo modafinil, še vedno odtehtajo z njimi povezana tveganja le pri zdravljenju narkolepsije.
• Modafinil should no longer be used to treat: Obstructive sleep apnoea; Shift work sleep disorder; Idiopathic hypersomnia.
• Modafinil se ne sme več uporabljati za zdravljenje: obstruktivne apneje med spanjem, motnje spanja zaradi izmenskega dela, idiopatske hipersomnije.
The Committee also noted a link between modafinil and psychiatric adverse reactions, such as suicidal thoughts, depression, psychotic episodes, and between modafinil and cardiovascular adverse reactions, such as hypertension (high blood pressure) and irregular heart beat.
Odbor je izpostavil tudi povezavo med modafinilom in neželenimi psihiatričnimi učinki, kot so samomorilne misli, depresija, psihotične epizode, ter med modafinilom in srčno-žilnimi neželenimi učinki, kot sta hipertenzija (visok krvni tlak) in neredni srčni utrip.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of modafinil-containing medicines continue to outweigh their risks but that their use should be restricted to the treatment of narcolepsy.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravil, ki vsebujejo modafinil, še vedno odtehtajo z njimi povezana tveganja, vendar je treba njihovo uporabo omejiti samo na zdravljenje narkolepsije.
The Committee looked at all the data from the clinical trials of modafinil in narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and at articles from the published literature.
Odbor je preučil vse podatke iz kliničnih preskušanj modafinila pri narkolepsiji, obstruktivni apneji med spanjem, motnji spanja zaradi izmenskega dela in idiopatski hipersomniji ter članke iz objavljene literature.
• Patients who are receiving modafinil-containing medicines should contact their doctors at a convenient time to check that they should continue receiving it.
• Bolniki, ki prejemajo zdravila, ki vsebujejo modafinil, naj se v ustreznem času oglasijo pri zdravniku in preverijo, ali lahko nadaljujejo zdravljenje s tem zdravilom.
This can be seen in people who work a shift-pattern or in those who suffer from obstructive sleep apnoea (a condition in which pauses in breathing occur repeatedly during the night, disturbing sleep).
To je mogoče opaziti pri ljudeh, ki delajo v izmenah, in pri posameznikih z obstruktivno apnejo med spanjem (bolezen, pri kateri se ponoči med spanjem neprestano ponavljajo premori pri dihanju, ki motijo spanje).
For obstructive sleep apnoea (including in patients with excessive sleepiness despite correctly using a Continuous Positive Airway Pressure machine), shift-work sleep disorder and idiopathic hypersomnia, the CHMP concluded that the data on the effectiveness were not sufficient to outweigh the risks, and that therefore the benefit-risk balance was negative.
CHMP je menil, da podatki o učinkovitosti pri obstruktivni apneji med spanjem (vključno z bolniki, ki trpijo za čezmerno zaspanostjo kljub pravilni uporabi aparata za stalni pozitivni tlak v dihalnih poteh), motnji spanja zaradi izmenskega dela in idiopatski hipersomniji niso zadostni, da bi odtehtali tveganja, zato je bilo razmerje med koristmi in tveganji negativno.
The CHMP also reviewed all the side effects reported with modafinil-containing medicines.
CHMP je pregledal tudi vse neželene učinke, o katerih so poročali pri zdravilih, ki vsebujejo modafinil.
The CHMP has also asked the companies that make modafinil-containing medicines to put in place measures to minimise the risks.
CHMP je družbe, ki izdelujejo zdravila, ki vsebujejo modafinil, tudi pozval, da vzpostavijo ukrepe za zmanjševanje tveganja.
The PhVWP also asked the companies that make modafinil-containing medicines to provide all information they had to assess if further measures were needed.
Delovna skupina za farmakovigilanco je družbe, ki izdelujejo zdravila, ki vsebujejo modafinil, zaprosila tudi, da predložijo vse razpoložljive informacije za oceno, ali so potrebni dodatni ukrepi.
In 2007, the CHMP's Pharmacovigilance Working Party (PhVWP) reviewed the safety of modafinilcontaining medicines because of concerns that the medicines were associated with serious psychiatric disorders (suicidal thoughts, mania and symptoms of psychosis such as delusion) and with skin reactions, including severe reactions such as Stevens-Johnson syndrome, a life-threatening type of allergic reaction affecting the skin and mucous membranes.
(samomorilne misli, manija in simptomi psihoze, kot so blodnje) in kožnimi reakcijami, vključno z resnimi reakcijami, kot je Stevens-Johnsonov sindrom, smrtno nevarna vrsta alergijske reakcije, ki vpliva na kožo in sluznico.
This plan should address the following:
Plan mora vsebovati:
Training for the patients will be via a healthcare professional.
Izobraževanje bolnikov bo potekalo preko zdravstvenih delavcev.
¾ The Member States must ensure that the education plans for health care professionals and patients contain the measures to minimise the risks as detailed below,
¾ Države članice morajo zagotoviti, da načrti izobraževanja zdravstvenih delavcev in bolnikov vsebujejo spodaj navedena merila za zmanjnševanje tveganja:
• An educational plan for patients, which is aimed at risk minimisation and to support safe and effective use for the product.
• Načrt izobraževanja bolnikov, katerega cilj je zmanjšanjšati tveganje in podpirati varno in učinkovito uporabo zdravila.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI JIH MORAJO IZPOLNITI DRŽAVE ČLANICE
• An educational plan for physicians and health care providers, which is aimed at risk minimisation and to support safe and effective use for the product.
• Načrt izobraževanja zdravnikov in drugih zdravstvenih delavcev, katerega cilj je zmanjšanjšati tveganje in podpirati varno in učinkovito uporabo zdravila.
Invented name Strength Pharmaceutical Form Route of Administration
Številka EU Izmišljeno imejakost farmacevtska oblika ovojnina vsebina velikost pakiranja
5 pre-filled syringes
5 nepolnjenih injekcijskih brizg
Subcutaneous use
pot uporabe
No specific measures are usually required.
Običajno posebni ukrepi niso potrebni.
Before you start
Preden začnete
Do not use any other sort of water.
Ne uporabljajte druge vrste vode.
If blood appears:
Če se pojavi kri:
(See next section ‘How much to use').
(glejte naslednje poglavje 'Koliko zdravila uporabiti').
Your doctor will tell you the exact date and time.
Zdravnik vam bo povedal točen datum in uro.
Wash your hands • It is important that your hands and the things you use are as clean as possible.
Umijte si roke • Pomembno je, da so vaše roke in stvari, ki jih uporabljate, kar se da čiste.
• This medicine is only for you - do not let anyone else use it.
• To zdravilo je le za vas - ne dovolite, da bi ga uporabil kdo drug.
Lay out everything you need on a clean surface:
Vse, kar potrebujete, položite na čisto površino:
Unopened vial: 2 years
Neodprta viala: 2 leti.
Your doctor or nurse will show you how to prepare and inject the medicine.
Zdravnik ali medicinska sestra vam bosta pokazala, kako pripraviti in injicirati zdravilo.
• Hold the syringe in one hand - like you would hold a pencil.
• Brizgo držite v eno roki - kot bi držali svinčnik.
DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
DATUM ZADNJE REVIZIJE BESEDILA {DD/MM/LLLL}
If blood appears, follow Step 5 below.
Če se pojavi kri, sledite navodilom v 5. koraku spodaj.
Do not use this medicine if you notice that the white powder in the vial has changed in appearance.
Ne uporabljajte tega zdravila, če opazite, da se je belemu prašku v viali spremenil videz.
You can choose to inject every morning or every evening.
Zdravilo lahko injicirate vsako jutro ali vsak večer.
It stops eggs being released straight away.
Preprečuje takojšnje sproščanje jajčec.
The adverse reactions reported below are classified according to frequency of occurrence as follows: 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).
Poročani neželeni učinki so v nadaljevanju razvrščeni po pogostnosti, kot sledi: 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
Cetrorelix is not to be used in the presence of any of the conditions listed below:
Cetroreliksa se ne sme uporabljati v prisotnosti katerega od spodaj navedenih stanj:
It is best to use the medicine at the same time each day, leaving 24 hours between each dose.
Najbolje je vzeti zdravilo vsak dan ob istem času tako, da je razmak med posameznimi odmerki 24 ur.
Based on your ovarian response, your doctor may decide to start on another day.
Na podlagi odziva vaših jajčnikov se lahko zdravnik odloči za začetek na drug dan.
Luteal phase support should be given according to the reproductive medical centre´s practice.
Podpora lutealne faze mora potekati v skladu z ustaljeno prakso zdravstvenega centra za reprodukcijo.
• Turn the vial upside down.
• Vialo obrnite navzdol.
The effect of the medicine will last for longer.
Delovanje zdravila bo podaljšano.
Administration in the morning
Uporaba zjutraj
• Before starting to use this medicine, please read these instructions the whole way through first.
• Preden začnete uporabljati to zdravilo, najprej v celoti preberite ta navodila.
This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins
Ta dogodek moramo upoštevati kot intrinzično tveganje postopka stimulacije z gonadotropini.
The onset of suppression is virtually immediate and is maintained by continuous treatment, without initial stimulatory effect.
Supresija je takojšnja in se vzdržuje s stalnim zdravljenjem, brez začetnega stimulativnega učinka.
Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
Preveliko odmerjanje lahko pri človeku povzroči podaljšano delovanje, vendar je malo verjetno, da bi bilo povezano z akutnimi toksičnimi učinki.
Distribution The volume of distribution (Vd) is 1.1 L x kg
Porazdelitev Volumen porazdelitve (Vd) je 1,1 l x kg
You may be having a possible serious, life-threatening allergic reaction to the medicine.
Morda boste imeli hude, življenjsko nevarne alergijske reakcije na zdravilo.
Repeated ovarian stimulation procedure
Ponovljen postopek ovarijske stimulacije
• wash your hands and start again with a new vial and pre-filled syringe.
• Umijte si roke in začnite znova z novo vialo in napolnjeno brizgo.
Your doctor will carefully look at the benefits and risks for you, if you need to have Cetrotide during more than one cycle.
Vaš zdravnik bo pozorno preučil koristi in tveganja v primeru, da bi morali zdravilo Cetrotide prejemati v več kot enem ciklusu.
Therefore, cetrorelix should be used in repeated cycles only after a careful benefit/risk evaluation.
Zato smemo cetroreliks uporabiti v večkratnih ciklusih samo po natančni oceni razmerja koristi/tveganja.
- The other ingredients are:
• Druge sestavine zdravila so:
• if you have severe kidney disease.
• če imate hudo ledvično bolezen.
Do not use Cetrotide if any of the above applies to you.
Ne uporabljajte zdravila Cetrotide če katera od zgornjih navedb velja za vas.
Remove from the refrigerator approximately 30 minutes before use.
Iz hladilnika ga vzemite približno 30 minut pred uporabo.
Children and adolescents Cetrotide is not indicated for the use in children and adolescents.
Otroci in mladostniki Zdravilo Cetrotide ni indicirano za uporabo pri otrocih in mladostnikih.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 April 1999
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 13. april 1999 Datum zadnjega podaljšanja: 13. april 2009
• Use each needle, vial and syringe only once.
• Vsako iglo, vialo in injekcijsko brizgo uporabite le enkrat.
• Do not touch the grey needle and do not let the needle touch any surface.
• Sive igle se ne dotikajte in ne dovolite, da bi se z iglo dotaknili katere koli površine.
However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.
Vendar možnosti medsebojnega delovanja z gonadotropini ali zdravili, ki pri občutljivih posameznikih lahko sprožijo sproščanje histamina, ni mogoče popolnoma izključiti.
This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed.
To lahko pomeni, da so se jajčniki prekomerno odzvali na zdravljenje in da so se razvile velike ovarijske ciste.
If you look from the side through the gap in the rubber stopper, you can control the movement of the needle and the liquid.
Če od strani pogledate skozi režo v gumijastem zamašku, lahko nadzorujete gibanje igle in tekočine.
In case you pulled out the plunger with the plunger stopper by mistake, make sure to discard the dose as sterility will be lost, and prepare a new dose (and restart from step 1).
V primeru, da ste bat z batnim zamaškom pomotoma izvlekli, zagotovite, da bo odmerek zavržen, ker ne bo več sterilen, in pripravite nov odmerek (in ponovno začnite s 1. korakom).
Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Po prvi uporabi je priporočljivo, da bolnica ostane pod zdravniškim nadzorom še 30 minut, da se prepričamo, da nima alergijske/psevdoalergijske reakcije na injekcijo.
Absorption The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Absorpcija Absolutna biološka uporabnost cetroreliksa po subkutani uporabi je približno 85 %.
It should be removed from the refrigerator approximately 30 minutes before use.
Iz hladilnika ga je treba vzeti približno 30 minut pred uporabo.
• If you forget a dose, inject it as soon as you remember and talk to your doctor.
• Če ste pozabili uporabiti odmerek zdravila, si ga injicirajte takoj ko se spomnite in se posvetujte z zdravnikom.
• There will be a rubber stopper underneath - keep this in the vial.
• Pod njim bo gumijasti zamašek - obdržite ga v viali.
The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Prevalenca prirojenih okvar po uporabi tehnik asistirane reprodukcije (ART) z antagonisti GnRH ali brez njih je morda malenkost višja kot po spontanih zanositvah, čeprav ni jasno, ali je to povezano z dejavniki, ki so lastni neplodnosti para ali postopkom ART.
There is limited experience up to now with the administration of cetrorelix during a repeated ovarian stimulation procedure.
Do danes imamo le omejene izkušnje z uporabo cetroreliksa pri ponovljenem postopku ovarijske stimulacije.
You then start using Cetrotide a few days later.
Nato nekaj dni kasneje začnete uporabljati zdravilo Cetrotide.
• LH stimulates ovulation during your menstrual cycle.
• LH stimulira ovulacijo med menstrualnim ciklusom.
• During pregnancy and lactation.
• Med nosečnostjo in dojenjem.
Pregnancy and breast-feeding Cetrotide is not intended to be used during pregnancy and lactation (see section 4.3).
Nosečnost in dojenje Zdravilo Cetrotide ni namenjeno za uporabo v času nosečnosti in dojenja (glejte poglavje 4.3).
This is because if the eggs are released too early (premature ovulation) it may not be possible for your doctor to collect them.
Če se jajčeca sprostijo prezgodaj (prezgodnja ovulacija), jih vaš zdravnik morda ne bo mogel odvzeti.
Cetrotide should only be prescribed by a specialist experienced in this field.
Zdravilo Cetrotide sme predpisovati samo specialist z izkušnjami na tem področju.
After reconstitution: use immediately
Po rekonstituciji: uporabite takoj.
Cetrotide is one of the medicines used during ‘assisted reproductive techniques' to help you get pregnant.
Zdravilo Cetrotide je eno od zdravil, ki se uporablja pri 'tehnikah asistirane reprodukcije', s katerimi vam pomagajo zanositi.
The start of Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.
Začetek zdravljenja z zdravilom Cetrotide se lahko zakasni, če ni rasti folikla, vendar klinične izkušnje temeljijo na začetku uporabe zdravila Cetrotide na 5. ali 6. dan stimulacije.
• In the powder: mannitol.
• V prašku: manitol.
Pregnancy and breast-feeding Do not use Cetrotide if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Nosečnost in dojenje Zdravila Cetrotide ne uporabljajte, če ste noseči, menite, da bi lahko bili noseči ali če dojite.
Additionally, for each vial the pack contains:
Pakiranje za vsako vialo vsebuje še:
In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of Cetrotide 0.25 mg.
V kliničnih študijah so te učinke opazili s pogostnostjo 9,4 % po več injekcijah zdravila Cetrotide 0,25 mg.
An OHSS should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.
OHSS moramo zdraviti simptomatsko, npr. s počitkom, intravenskimi elektroliti/koloidi in heparinsko terapijo.
To reduce skin irritation, select a different part of your belly each day.
Da bi zmanjšali draženje kože, vsak dan izberite drug predel na trebuhu.
EXP After reconstitution, use immediately.
EXP Po rekonstituciji uporabite takoj.
This is when your follicles develop too much and become large cysts.
To je stanje, ko se folikli preveč razvijejo in postanejo velike ciste.
Pharmacotherapeutic group: anti-gonadotropin-releasing hormones, ATC code: H01CC02.
Farmakoterapevtska skupina: antagonisti gonadotropin sproščajočih hormonov, oznaka ATC: H01CC02.
Take care not to pull out completely the plunger with the attached plunger stopper.
Bodite previdni, da bata s pritrjenim batnim zamaškom ne izvlečete v celoti.
In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.
V kliničnih študijah so zdravilo Cetrotide uporabljali s humanim menopavznim gonadotropinom (HMG), vendar pa omejene izkušnje z rekombinantnim folikle stimulirajočim hormonom (FSH) kažejo podobno učinkovitost.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/100/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/100/001
• Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino ali kateri koli strukturni analog gonadotropin sproščajočega hormona (GnRH), eksogene peptidne hormone ali katero koli pomožno snov, navedeno v poglavju 6.1.
This means that Cetrotide stops the chain of events that leads to an egg being released from your ovary.
To pomeni, da zdravilo Cetrotide blokira verigo dogodkov, zaradi katerih se jajčece sprosti iz jajčnika.
Do not freeze or place next to the freezer compartment or a freezer pack.
Ne zamrzujte in ne dajajte v bližino zamrzovalnega predala ali zamrzovalnega vložka.
• If no blood appears, slowly push the plunger in to inject your medicine.
• Če se kri ne pojavi, bat počasi potiskajte navzdol, da injicirate zdravilo.
• if you are allergic to cetrorelix or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na cetroreliks ali katero koli sestavino tega zdravila (navedeno v poglavju 6),