natgillin/translations-raw huggingface dataset:
This medicinal product contains 24 vol% ethanol (alcohol), i. e. up to 6 g per dose consumed over a 1.5 – hour period (12 g loading dose consumed over a 3-hour period); this is equivalent to 144 ml beer (288 ml beer for the loading dose) or 60 ml wine (120 ml wine for the loading dose).
Zdravilo vsebuje 24 volumskih odstotkov etanola (alkohola), tj. do 6 g na odmerek, prejet v obdobju 1, 5 ur (12 g na polnilni odmerek, prejet v obdobju 3 ur); to ustreza 144 ml piva (288 ml piva na polnilni odmerek) ali 60 ml vina (120 ml vina na polnilni odmerek).
Harmful for those suffering from alcoholism.
Etanol lahko škoduje osebam z alkoholizmom.
To be taken into account in pregnant or breast-feeding women, children, and in high-risk groups such as those with liver disease or epilepsy.
To je treba upoštevati tudi pri nosečnicah in doječih ženskah, otrocih in zelo ogroženih skupinah, npr. bolnikih z boleznijo jeter ali epilepsijo.
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Količina alkohola v tem zdravilu lahko okvari vašo sposobnost upravljanja vozil in strojev.
HOW TO USE ECALTA
KAKO UPORABLJATI ZDRAVILO ECALTA
This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Infundiranje bo trajalo vsaj 1, 5 ure za vzdrževalni odmerek in 3 ure za polnilni odmerek.
If a dose of ECALTA has been forgotten
Če je bil odmerek zdravila ECALTA pozabljen
Effects when treatment with ECALTA is stopped
Če ste prenehali uporabljati zdravilo ECALTA
23 You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
23 Ko bo zdravnik prekinil vaše zdravljenje z zdravilom ECALTA, to ne bi smelo imeti nobenih posledic.
Like all medicines, ECALTA can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ECALTA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common side effects (likely to occur in fewer than 1 in 10 patients):
Pogosti neželeni učinki (ki se lahko pojavijo pri manj kot 1 od 10 bolnikov):
- Disorder of blood clotting system
- motnje v sistemu strjevanja krvi
- Low blood potassium (hypokalaemia)
- nizka raven kalija v krvi (hipokaliemija)
- Convulsion (seizure)
- konvulzije (napadi krčev)
- Flushing
- zardevanje
- Diarrhoea, vomiting, nausea
- driska, bruhanje, slabost s siljenjem na bruhanje
- Changes in blood tests of liver function
- spremembe v izvidih krvnih preiskav delovanja jeter
- Rash, pruritis (itching)
- izpuščaj, pruritus (srbenje)
- Changes in blood tests of kidney function
- spremembe v izvidih krvnih preiskav delovanja ledvic
Uncommon side effects (likely to occur in fewer than 1 in 100 patients):
Občasni neželeni učinki (ki se lahko pojavijo pri manj kot 1 od 100 bolnikov):
- High blood sugar
- visoka raven sladkorja v krvi
- High blood pressure
- visok krvni tlak
- Hot flush
- navali vročine
- Stomach pain
- bolečine v želodcu
- Abnormal flow of bile from the gallbladder into the intestine (cholestasis)
- nenormalnosti pri iztekanju žolča iz žolčnika v črevo (holestaza)
- Hives
- koprivnica
- Pain at injection site
- bolečina na mestu injiciranja
If any of the side effects you experience are severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE ECALTA
SHRANJEVANJE ZDRAVILA ECALTA
Do not use ECALTA after the expiry date which is stated on the label.
Zdravila ECALTA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The expiry data refers to the last day of that month.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Do not store ECALTA above 25ºC.
Shranjujte pri temperaturi do 25 °C.
The reconstituted solution should not be stored above 25ºC.
Rekonstituirano raztopino shranjujte pri temperaturi do 25 °C.
The infusion solution should not be stored above 25ºC.
Raztopino za infundiranje shranjujte pri temperaturi do 25 °C.
- The active substance is anidulafungin.
- Zdravilna učinkovina je anidulafungin.
Each vial with powder contains 100 mg anidulafungin.
Ena viala s praškom vsebuje 100 mg anidulafungina.
- The other ingredients are
- Pomožne snovi so
24 Powder: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment)
Prašek: fruktoza, manitol, polisorbat 80, vinska kislina, natrijev hidroksid (za prilagoditev pH), klorovodikova kislina (za prilagoditev pH)
Solvent: ethanol anhydrous, water for injections
Vehikel: brezvodni etanol, voda za injekcije
ECALTA is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion and 1 vial of 30 ml solvent.
Zdravilo ECALTA je na voljo v škatli, ki vsebuje 1 vialo s 100 mg praška za koncentrat za raztopino za infundiranje in 1 vialo s 30 ml vehikla.
The powder for concentrate for solution for infusion is white to off-white.
Prašek za koncentrat za raztopino za infundiranje je bele do kremaste barve.
The solvent is a clear colourless solution.
Vehikel je bistra in brezbarvna raztopina.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
< -------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
< -------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
The reconstitution time can be up to 5 minutes.
Rekonstituirana
The reconstituted solution should be clear and free from visible particulates.
26 raztopina mora biti bistra in brez vidnih delcev.
26 Dilution and infusion Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion obtaining an anidulafungin concentration of 0.36 mg/ ml.
Razredčenje in infundiranje Aseptično prenesite vsebino rekonstituirane viale/ rekonstituiranih vial v intravensko vrečko (ali steklenico), ki vsebuje bodisi natrijev klorid 9 mg/ ml (0, 9%) za infundiranje bodisi glukozo 50 mg/ ml (5%) za infundiranje, da boste dobili koncentracijo anidulafungina 0, 36 mg/ ml.
Effentora is a medicine containing the active substance fentanyl.
Effentora je zdravilo, ki vsebuje zdravilno učinkovino fentanil.
It is available as buccal tablets (tablets that dissolve in the mouth), containing 100, 200, 400, 600 or 800 micrograms of fentanyl.
Na voljo je v obliki bukalnih tablet (tablete, ki se raztopijo v ustih), ki vsebujejo 100, 200, 400, 600 ali 800 mikrogramov fentanila.
Effentora is used to treat ‘ breakthrough’ pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain. ‘ Breakthrough pain’ is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
O „ prebijajoči bolečini “ govorimo, ko bolnik občuti nenadno dodatno bolečino kljub potekajočemu zdravljenju z zdravili za lajšanje bolečin.
Treatment with Effentora should be initiated and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.
Zdravljenje z zdravilom Effentora je treba uvesti in ga izvajati pod vodstvom zdravnika, ki ima izkušnje z opioidnim zdravljenjem rakavih bolnikov.
The tablets should be removed from the packaging immediately before being placed between the gum and the cheek at the back of the mouth.
Tablete je treba vzeti iz ovojnine tik preden jo vstavimo med dlesen in lice v zadnjem delu ustne votline.
The tablet usually dissolves in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream.
Tableta se običajno raztopi v 14 do 25 minutah, pri čemer sprošča zdravilno učinkovino, ki se absorbira neposredno v krvni obtok.
After 30 minutes, any pieces of the tablet remaining can be swallowed with a glass of water.
Če so po 30 minutah v ustih še ostanki tablete, se jih lahko pogoltne s kozarcem vode.
The tablets should not be broken or crushed, and they should not be sucked, chewed or swallowed whole.
Tablet se ne sme lomiti ali drobiti, kakor tudi ne sesati, žvečiti ali pogoltniti cele.
Patients should not eat or drink anything while the tablet is in the mouth.
Bolniki ne smejo s tableto v ustih niti jesti niti piti.
When a patient starts to take Effentora, the doctor will need to work out the appropriate individual dose that will provide adequate pain relief for the patient with few side effects.
Ko bolnik začne jemati zdravilo Effentora, mora zdravnik ugotoviti ustrezen individualni odmerek, ki bo zagotavljal primerno lajšanje bolečine in imel za bolnika malo neželenih učinkov.
The usual starting dose is one 100 microgram tablet, but this can be increased until the appropriate maintenance dose is found.
Običajen začetni odmerek je 100 mikrogramska tableta, ki pa ga je mogoče zviševati, dokler ni določen ustrezen vzdrževalni odmerek.
The patient should be monitored carefully while the dose is increased.
Bolnikovo stanje je treba med povečevanjem odmerka skrbno spremljati.
The final individual dose must include no more than two tablets, but it can be adjusted if a patient consistently has more than four episodes of breakthrough pain per day.
Končni individualni odmerek ne sme vključevati več kot dve tableti, vendar ga je mogoče prilagajati, če ima bolnik kontinuirano več kot štiri epizode prebijajoče bolečine na dan.
Doses above 800 micrograms have not been tested.
Odmerki nad 800 mikrogramov niso bili testirani.
There must be a gap of at least four hours between treating each episode of pain.
Med zdravljenjem dveh epizod bolečine morajo preteči vsaj štiri ure.
See the Package Leaflet for further information.
Za več informacij glejte navodilo za uporabo.
The active substance in Effentora, fentanyl, is an opioid (a strong painkiller that is related to morphine).
Fentanil, zdravilna učinkovina v zdravilu Effentora, je opioid (močno zdravilo za lajšanje bolečin, sorodno morfinu).
It is a well-known substance, which has been used to control pain for many years.
Gre za dobro znano učinkovino, ki se že leta uporablja za nadzor bolečin.
In 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Pri 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. zdravilu Effentora se fentanil daje v obliki bukalne tablete, tako da se absorbira skozi sluznico ust.
Effentora, fentanyl is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth.
Ko prispe v krvni obtok, deluje na receptorje v možganih in hrbtenjači ter tako preprečuje bolečino.
Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out.
Ker je fentanil v uporabi že veliko let, je družba predstavila podatke iz znanstvene literature, poleg tega pa tudi podatke iz študij, ki jih je izvedla sama.
The effectiveness of Effentora in treating breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids.
Učinkovitost zdravila Effentora pri zdravljenju prebijajoče bolečine so preučevali v dveh glavnih študijah s skupno 150 odraslimi rakavimi bolniki, ki so jemali opioide.
The first study included 72 patients and the second included 78.
Prva študija je vključevala 72 bolnikov, druga pa 78.
In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet).
V obeh študijah je bil vsak bolnik zdravljen v času desetih posameznih epizod prebijajoče bolečine: pri sedmih od vseh epizod je vsak bolnik prejel zdravilo Effentora, pri ostalih treh epizodah pa je vsak bolnik prejel placebo (zdravilo brez zdravilne učinkovine).
The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet.
Glavno merilo učinkovitosti je bila sprememba intenzivnosti bolečine v prvih 30 ali 60 minutah po prejemu tablete.
Each patient ranked their pain intensity on an 11-point scale.
Vsak bolnik je intenzivnost bolečine ocenjeval na 11- točkovni lestvici.
Effentora was more effective than placebo in reducing pain in both studies.
Zdravilo Effentora se je v obeh študijah izkazalo za učinkovitejše od placeba pri zmanjševanju bolečine.
In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo.
V prvi študiji se je intenzivnost bolečine v povprečju zmanjšala za 3, 2 točki 30 minut po jemanju zdravila Effentora oziroma za 2, 0 točke po jemanju placeba.
In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.
V drugi študiji se je intenzivnost bolečine zmanjšala za 9, 7 točke 60 minut po uporabi zdravila Effentora oziroma za 4, 9 točke po uporabi placeba.
The most common side effects with Effentora (seen in more than 1 patient in 10) are dizziness, nausea (feeling sick) and reactions at the site of application including pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots.
Najpogostejši neželeni stranski učinki pri zdravilu Effentora (opaženi pri več kot 1 bolniku izmed 10) so bili omotica, navzeja (slabost) in reakcije na mestu aplikacije, kot npr. bolečina, razjede, draženje, neobičajni občutki, odrevenelost, pordelost, otekanje in madeži.
Effentora can also cause the side effects typically seen with other opioids, but these tend to decrease or stop with continued use.
Zdravilo Effentora lahko povzroči tudi neželene stranske učinke, značilne za druge opioide, vendar pa se ti s trajanjem uporabe zmanjšujejo oziroma prenehajo.
The most serious of these are respiratory depression (slow or shallow breathing), circulatory depression (slow heart beat), hypotension (low blood pressure) and shock (insufficient blood flow to the tissues).
Najresnejši neželeni učinki so respiratorna depresija (počasno ali plitvo dihanje), depresija obtočil (počasno utripanje srca), hipotenzije (nizek krvni tlak) in šok (nezadosten dovod krvi v tkiva).
Patients should be closely monitored for these side effects.
Bolnike je treba glede teh stranskih učinkov skrbno spremljati.
For the full list of all side effects reported with Effentora, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Effentora, glejte navodilo za uporabo.
It should also not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression, or who have a severe disease involving obstruction of the lungs.
Zdravila Effentora ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) fentanil ali katero koli drugo sestavino zdravila Prav tako ga ne smejo uporabljati bolniki, ki še ne jemljejo opioidov za vzdrževanje nadzora nad bolečino, kakor tudi ne tisti, ki imajo resno respiratorno depresijo ali hudo obstruktivno bolezen (zaporo) pljuč.
Effentora should be used with caution in patients who have moderate or severe problems with their liver or kidneys.
Zdravilo Effentora je treba pri bolnikih, ki imajo zmerne ali resne težave z jetri ali ledvicami, uporabljati previdno.
The Committee for Medicinal Products for Human Use (CHMP) decided that Effentora’ s benefits are greater than its risks for the treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Effentora pri zdravljenju prebijajoče bolečine pri odraslih rakavih bolnikih, ki že prejemajo opioidno terapijo za kronično bolečino pri raku, večje od z njim povezanih tveganj.
The Committee recommended that Effentora be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Effentora odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Effentora?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Effentora?
The company that makes Effentora will provide educational materials to make sure that healthcare workers are aware of the fact that the medicine could be abused.
Družba, ki izdeluje zdravilo Effentora, bo priskrbela izobraževalno gradivo, s katerim bo zagotovila, da se zdravstveni delavci zavedajo možnosti zlorabe zdravila.
The company will also remind healthcare workers about how the medicine should be used safely and the risks of accidental exposure to fentanyl.
Družba bo tudi opomnila zdravstvene delavce o varnem načinu jemanja in tveganjih v primeru nenamerne izpostavitve fentanilu.
Other information about Effentora:
Druge informacije o zdravilu Effentora:
The European Commission granted a marketing authorisation valid throughout the European Union for Effentora to Cephalon Europe on 4 April 2008.
Evropska komisija je dovoljenje za promet z zdravilom Effentora, veljavno po vsej Evropski uniji, odobrila družbi Cephalon Europe dne 4 aprila 2008.
The full EPAR for Effentora can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Effentora je na voljo tukaj.
Route of Administration
EU/ 1/ 08/ 441/ 001
Package size
Oralna uporaba
EU/ 1/ 08/ 441/ 001 EU/ 1/ 08/ 441/ 002 EU/ 1/ 08/ 441/ 003 EU/ 1/ 08/ 441/ 004 EU/ 1/ 08/ 441/ 005 EU/ 1/ 08/ 441/ 006 EU/ 1/ 08/ 441/ 007 EU/ 1/ 08/ 441/ 008 EU/ 1/ 08/ 441/ 009 EU/ 1/ 08/ 441/ 010
EU/ 1/ 08/ 441/ 002
Effentora Effentora Effentora Effentora Effentora Effentora Effentora Effentora Effentora Effentora
Pretisni omot (PVC/ alu/ poliamid/ PVC)
100 micrograms 100 micrograms 200 micrograms 200 micrograms 400 micrograms 400 micrograms 600 micrograms 600 micrograms 800 micrograms 800 micrograms
Pretisni omot (PVC/ alu/ poliamid/ PVC)
Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet Buccal tablet
Pretisni omot (PVC/ alu/ poliamid/ PVC)
Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use Oromucosal use
Pretisni omot (PVC/ alu/ poliamid/ PVC)
Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC) Blister (PVC/ alu/ polyamid/ PVC)
Pretisni omot (PVC/ alu/ poliamid/ PVC)
4 tablets 28 tablets 4 tablets 28 tablets 4 tablets 28 tablets 4 tablets 28 tablets 4 tablets 28 tablets
Pretisni omot (PVC/ alu/ poliamid/ PVC)
Effentora 100 micrograms buccal tablets
Effentora 100 mikrogramov, bukalne tablete
Each buccal tablet contains 100 micrograms fentanyl (as citrate).
Vsaka bukalna tableta vsebuje 100 mikrogramov fentanila (kot citrata).
Each tablet contains 8 mg of sodium.
Vsaka tableta vsebuje 8 mg natrija.
Buccal tablet.
Bukalne tablete.
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 1”.
Ploske, bele, okrogle prirezane tablete z oznako ‘ C ’ na eni strani in na drugi strani ‘ 1 ’.
Effentora should be individually titrated to an “ effective” dose that provides adequate analgesia and minimises undesirable effects.
Zdravilo Effentora je treba titrirati individualno do ‘ učinkovitega ’ odmerka, ki daje ustrezne analgetične rezultate in zmanjšuje neželene učinke na najmanjšo možno mero.
Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio.
Titriranje pri bolnikih, ki so jemali drugo zdravilo s fentanilom Zaradi različnih absorpcijskih profilov zdravila ni dovoljeno menjati v razmerju 1:
If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Ob menjavi dosedanjega peroralnega zdravila s fentanil citratom z zdravilom Effentora je potrebno neodvisno titriranje odmerka z zdravilom Effentora, saj se biološka razpoložljivost med zdravili znatno razlikuje.
2 Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
2 Način titriranja Če se med titriranjem ustrezen analgetični učinek ne doseže v 30 minutah po začetku apliciranja ene tablete, se lahko uporabi druga tableta zdravila Effentora enake jakosti.
During titration, multiple tablets may be used: up to four 100 micrograms or up to four 200 micrograms tablets may be used to treat a single episode of BTP during dose titration according to the following schedule: • If the initial 100 micrograms tablet is not efficacious, the patient can be instructed to treat the next episode of BTP with two 100 micrograms tablets.
Med titriranjem je možno uporabiti več tablet: do štiri 100- mikrogramske ali do štiri 200 - mikrogramske tablete se lahko uporabijo za zdravljenje ene epizode PBB med titriranjem odmerka po naslednjem režimu: • Če začetna 100- mikrogramska tableta ne učinkuje, dajte bolniku navodila, da za naslednjo epizodo PBB uporabi dve 100- mikrogramski tableti.
If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 200 micrograms tablet of Effentora. • If a single 200 micrograms tablet of Effentora (or two 100 micrograms tablets) is not considered to be efficacious the patient can be instructed to use two 200 micrograms tablets (or four 100 micrograms tablets) to treat the next episode of BTP.
Če se oceni, da ta odmerek učinkuje, se lahko zdravljenje naslednjih epizod PBB nadaljuje z eno 200- mikrogramsko tableto zdravila Effentora. • Če se oceni, da ena 200- mikrogramska tableta zdravila Effentora (ali dve 100- mikrogramski tableti) ni dovolj učinkovita, dajte bolniku navodila, da za zdravljenje naslednje epizode PBB uporabi dve 200- mikrogramski tableti (ali štiri 100- mikrogramske tablete).
If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 400 micrograms tablet of Effentora. • For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used.
Če se oceni, da ta odmerek učinkuje, se lahko zdravljenje naslednjih epizod PBB nadaljuje z eno 400- mikrogramsko tableto zdravila Effentora. • Za titriranje do 600 mikrogramov in 800 mikrogramov se uporabljajo 200- mikrogramske tablete.
Generally, the maintenance dose of Effentora should be increased when a patient requires more than one dose per BTP episode for several consecutive BTP episodes.
Na splošno velja, da je treba vzdrževalni odmerek zdravila Effentora dvigovati pri bolnikih, kjer je za več zaporednih epizod PBB potreben več kot en odmerek na epizodo PBB.
Dose readjustment of Effentora and/ or of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
Ponovna prilagoditev odmerka zdravila Effentora in/ ali osnovne opioidne terapije je morda potrebna pri bolnikih, ki doživijo več kot štiri epizode PBB v 24 urah.
Effentora should be immediately discontinued if no longer required.
Zdravljenje z zdravilom Effentora je treba prekiniti takoj, ko ni več potrebno.