natgillin/translations-raw huggingface dataset:
In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
17 Za zmanjšanje tveganja neželenih učinkov, povezanih z jemanjem opioidov, in za opredelitev učinkovitega odmerka je nujno, da bolnike med postopkom titriranja skrbno nadzira zdravstveni delavec.
This medicinal product contains 16 mg sodium per tablet.
To zdravilo vsebuje 16 mg natrija na tableto.
18 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Hkratna uporaba drugih zaviralcev osrednjega živčnega sistema, vključno z drugimi opioidi, sedativi ali hipnotiki, splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholom, lahko poveča pomirjevalne učinke.
Effentora is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
18 Zdravilo Effentora se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili zaviralce monoamin - oksidaze (MAO), saj poročajo o resnih in nepredvidljivih povečanjih učinkov zaviralcev MAO z opioidnimi analgetiki.
The adverse reactions considered to be at least possibly-related to treatment from clinical studies were as follows (frequencies defined as: very common ≥ 1/ 10, common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100; within each frequency grouping, undesirable effects are presented in order of decreasing seriousness):
Neželeni učinki iz kliničnih študij, pri katerih obstaja vsaj možnost, da so povezani z zdravljenjem, so bili naslednji (pogostost opredeljena kot: zelo pogosti ≥1/ 10, pogosti ≥ 1/ 100 do < 1/ 10, občasni ≥ 1/ 1. 000 do < 1/ 100; v vsaki skupini pogostosti so neželeni učinki predstavljeni v padajočem vrstnem redu po resnosti):
19 Investigations
19 Bolezni krvi in limfatičnega sistema
20 Skin and subcutaneous tissue disorders
20 Bolezni mišično - skeletnega sistema in vezivnega tkiva
21 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Za zdravljenje prevelikega odmerka (nezgodnega zaužitja) pri osebi brez predhodnega jemanja opioidov, je treba ustvariti intravenski dostop in dovajati nalokson ali druge opioidne antagoniste, kot je klinično indicirano.
If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
V takem primeru je treba uvesti podporno ventilacijo, opioidni antagonist in kot zadnjo možnost zdravilo za živčno- mišično blokado..
In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p < 0.0001).
V osrednji klinični študiji (študija 1) je bila primarna končna točka povprečni seštevek razlik v skupnem številu intenzivnosti bolečin od apliciranja do vključno 60 minut (SPID60), kar je bilo statistično značilno v primerjavi s placebom (p < 0, 0001).
22 Study 1:
22 Študija 1:
23 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
23 Statistično pomembno izboljšanje razlike v intenzivnosti bolečine so opazili pri zdravilu Effentora v primerjavi s placebom po 10 minutah v študiji 1 in po 15 minutah (najzgodnejše merjenje) v študiji 2.
48% (±31.8%)
48% (± 31, 8%))
The reason of this difference is unknown. ** Data for Tmax presented as median (range).
(razpon)
24 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
24 količina absorpcije fentanila pri zdravilu Effentora med 30% in 50% višja kot pri peroralnem transmukoznem fentanil citratu.
Effentora 400 micrograms buccal tablets
Effentora 400 mikrogramov, bukalne tablete
Each buccal tablet contains 400 micrograms fentanyl (as citrate).
Vsaka bukalna tableta vsebuje 400 mikrogramov fentanila (kot citrata).
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 4”.
Ploske, bele, okrogle prirezane tablete z oznako ‘ C ’ na eni strani in na drugi strani ‘ 4 ’.
28 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.
28 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.
29 Hepatic or renal impairment:
29 Jetrna ali ledvična okvara:
30 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
30 Za zmanjšanje tveganja neželenih učinkov, povezanih z jemanjem opioidov, in za opredelitev učinkovitega odmerka je nujno, da bolnike med postopkom titriranja skrbno nadzira zdravstveni delavec.
31 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Hkratna uporaba drugih zaviralcev osrednjega živčnega sistema, vključno z drugimi opioidi, sedativi ali hipnotiki, splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholom, lahko poveča pomirjevalne učinke.
Effentora is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
31 Zdravilo Effentora se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili zaviralce monoamin - oksidaze (MAO), saj poročajo o resnih in nepredvidljivih povečanjih učinkov zaviralcev MAO z opioidnimi analgetiki.
32 Investigations
32 Bolezni krvi in limfatičnega sistema
33 Skin and subcutaneous tissue disorders
33 Bolezni mišično - skeletnega sistema in vezivnega tkiva
34 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Za zdravljenje prevelikega odmerka (nezgodnega zaužitja) pri osebi brez predhodnega jemanja opioidov, je treba ustvariti intravenski dostop in dovajati nalokson ali druge opioidne antagoniste, kot je klinično indicirano.
35 Study 1:
35 Študija 1:
36 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
36 Statistično pomembno izboljšanje razlike v intenzivnosti bolečine so opazili pri zdravilu Effentora v primerjavi s placebom po 10 minutah v študiji 1 in po 15 minutah (najzgodnejše merjenje) v študiji 2.
37 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
37 količina absorpcije fentanila pri zdravilu Effentora med 30% in 50% višja kot pri peroralnem transmukoznem fentanil citratu.
Effentora 600 micrograms buccal tablets
Effentora 600 mikrogramov, bukalne tablete
Each buccal tablet contains 600 micrograms fentanyl (as citrate).
Vsaka bukalna tableta vsebuje 600 mikrogramov fentanila (kot citrata).
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 6”.
Ploske, bele, okrogle prirezane tablete z oznako ‘ C ’ na eni strani in na drugi strani ‘ 6 ’.
41 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.
41 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.
42 Hepatic or renal impairment:
42 Jetrna ali ledvična okvara:
43 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
43 Za zmanjšanje tveganja neželenih učinkov, povezanih z jemanjem opioidov, in za opredelitev učinkovitega odmerka je nujno, da bolnike med postopkom titriranja skrbno nadzira zdravstveni delavec.
44 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Hkratna uporaba drugih zaviralcev osrednjega živčnega sistema, vključno z drugimi opioidi, sedativi ali hipnotiki, splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholom, lahko poveča pomirjevalne učinke.
Effentora is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
44 Zdravilo Effentora se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili zaviralce monoamin - oksidaze (MAO), saj poročajo o resnih in nepredvidljivih povečanjih učinkov zaviralcev MAO z opioidnimi analgetiki.
45 Investigations
45 Bolezni krvi in limfatičnega sistema
46 Skin and subcutaneous tissue disorders
46 Bolezni mišično - skeletnega sistema in vezivnega tkiva
47 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Za zdravljenje prevelikega odmerka (nezgodnega zaužitja) pri osebi brez predhodnega jemanja opioidov, je treba ustvariti intravenski dostop in dovajati nalokson ali druge opioidne antagoniste, kot je klinično indicirano.
48 Study 1:
48 Študija 1:
49 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
49 Statistično pomembno izboljšanje razlike v intenzivnosti bolečine so opazili pri zdravilu Effentora v primerjavi s placebom po 10 minutah v študiji 1 in po 15 minutah (najzgodnejše merjenje) v študiji 2.
50 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
50 količina absorpcije fentanila pri zdravilu Effentora med 30% in 50% višja kot pri peroralnem transmukoznem fentanil citratu.
Effentora 800 micrograms buccal tablets
Effentora 800 mikrogramov, bukalne tablete
Each buccal tablet contains 800 micrograms fentanyl (as citrate).
Vsaka bukalna tableta vsebuje 800 mikrogramov fentanila (kot citrata).
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 8”
Ploske, bele, okrogle prirezane tablete z oznako ‘ C ’ na eni strani in na drugi strani ‘ 8 ’.
54 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.
54 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.
55 Hepatic or renal impairment:
55 Jetrna ali ledvična okvara:
56 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
56 Za zmanjšanje tveganja neželenih učinkov, povezanih z jemanjem opioidov, in za opredelitev učinkovitega odmerka je nujno, da bolnike med postopkom titriranja skrbno nadzira zdravstveni delavec.
57 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Hkratna uporaba drugih zaviralcev osrednjega živčnega sistema, vključno z drugimi opioidi, sedativi ali hipnotiki, splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholom, lahko poveča pomirjevalne učinke.
Effentora is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
57 Zdravilo Effentora se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili zaviralce monoamin - oksidaze (MAO), saj poročajo o resnih in nepredvidljivih povečanjih učinkov zaviralcev MAO z opioidnimi analgetiki.
The adverse reactions considered to be at least possibly-related to treatment from clinical studies were as follows (frequencies defined as: very common ≥ 1/ 10, common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100; within each frequency grouping, undesirable effects are presented in order of decreasing seriousness):
Neželeni učinki iz kliničnih študij, pri katerih obstaja vsaj možnost, da so povezani z zdravljenjem, so bili naslednji (pogostost opredeljena kot: zelo pogosti ≥1/ 10, pogosti ≥1/ 100 do < 1/ 10, občasni ≥ 1/ 1. 000 do < 1/ 100; v vsaki skupini pogostosti so neželeni učinki predstavljeni v padajočem vrstnem redu po resnosti):
58 Investigations
58 Bolezni krvi in limfatičnega sistema
59 Skin and subcutaneous tissue disorders
59 Bolezni mišično - skeletnega sistema in vezivnega tkiva
60 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Za zdravljenje prevelikega odmerka (nezgodnega zaužitja) pri osebi brez predhodnega jemanja opioidov, je treba ustvariti intravenski dostop in dovajati nalokson ali druge opioidne antagoniste, kot je klinično indicirano.
61 Study 1:
61 Študija 1:
62 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
62 Statistično pomembno izboljšanje razlike v intenzivnosti bolečine so opazili pri zdravilu Effentora v primerjavi s placebom po 10 minutah v študiji 1 in po 15 minutah (najzgodnejše merjenje) v študiji 2.
63 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
63 količina absorpcije fentanila pri zdravilu Effentora med 30% in 50% višja kot pri peroralnem transmukoznem fentanil citratu.
Subsequently, fentanyl is redistributed between the deep tissue compartment (muscle and fat) and the plasma.
Plastificiran aluminijev pretisni omot PVC/ Al folija/ poliamid/ PVC s pokrovom iz papirja/ poliestra.
Norfentanyl is not pharmacologically active in animal studies.
Pretisni omoti so pakirani v kartonih s po 4 ali 28 posamičnimi tabletami.
5.3 Preclinical safety data
Na trgu ni vseh navedenih pakiranj.
PHARMACEUTICAL PARTICULARS
65 6. 6 Posebni varnostni ukrepi za odstranjevanje
Armagh BT63 5UA United Kingdom
Armagh BT63 5UA Velika Britanija
Medicinal product subject to restricted and special medical prescription.
Izdaja zdravila je le pod omejenimi pogoji in na recept.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO RABO ZDRAVILA
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za trženje mora zagotoviti, da je farmakovigilančni sistem, opisan v različici 1. 2, predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za trženje, izgrajen in da deluje pred in med tem, ko je izdelek na trgu.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt obvladovanja tveganj Imetnik dovoljenja za promet se obvezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1. 2 načrta za obvladovanje tveganja (RMP), z dne 10. avgusta 2006, predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme obvladovanja tveganja za zdravila za uporabo v humani medicini je treba posodobljen načrt obvladovanja tveganja predložiti hkrati z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Posodobljen načrt obvladovanja tveganja je treba predložiti tudi • ob prejemu novih informacij, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja • v roku 60 dni po doseženem pomembnem mejniku (pri farmakovigilanci ali zmanjševanju tveganja) • na zahtevo Evropske agencije za zdravila (EMEA)
Effentora 100 micrograms buccal tablets Fentanyl
Effentora 100 mikrogramske bukalne tablete Fentanil
Each buccal tablet contains 100 micrograms fentanyl (as citrate)
Vsaka bukalna tableta vsebuje 100 mikrogramov fentanila (kot citrata)
For oromucosal use.
Za oralno uporabo.
Keep out of the reach and sight of children.
Zdravilo shranjujte zunaj dosega in pogleda otrok!
Cephalon Europe, 5 rue Charles Martigny, 94700 Maisons-Alfort, France
Cephalon Europe, 5 rue Charles Martigny, 94700 Maisons- Alfort, Francija
BN:
ŠS:
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 PODATKI NA ZUNANJI OVOJNINI
Effentora 200 micrograms buccal tablets Fentanyl
Effentora 200 mikrogramske bukalne tablete Fentanil
Each buccal tablet contains 200 micrograms fentanyl (as citrate)
Vsaka bukalna tableta vsebuje 200 mikrogramov fentanila (kot citrata)
4 buccal tablets 28 buccal tablets
4 bukalnih tablet 28 bukalnih tablet
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
76 PODATKI NA ZUNANJI OVOJNINI
Effentora 400 micrograms buccal tablets Fentanyl
Effentora 400 mikrogramske bukalne tablete Fentanil
Each buccal tablet contains 400 micrograms fentanyl (as citrate)
Vsaka bukalna tableta vsebuje 400 mikrogramov fentanila (kot citrata)
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
79 PODATKI NA ZUNANJI OVOJNINI
Effentora 600 micrograms buccal tablets Fentanyl
Effentora 600 mikrogramske bukalne tablete Fentanil
Each buccal tablet contains 600 micrograms fentanyl (as citrate)
Vsaka bukalna tableta vsebuje 600 mikrogramov fentanila (kot citrata)
Effentora 800 micrograms buccal tablets Fentanyl
Effentora 800 mikrogramske bukalne tablete Fentanil
Each buccal tablet contains 800 micrograms fentanyl (as citrate)
Vsaka bukalna tableta vsebuje 800 mikrogramov fentanila (kot citrata)
86 PACKAGE LEAFLET:
86 NAVODILO ZA UPORABO:
INFORMATION FOR THE USER Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets Fentanyl
Effentora 100 mikrogramske bukalne tablete Effentora 200 mikrogramske bukalne tablete Effentora 400 mikrogramske bukalne tablete Effentora 600 mikrogramske bukalne tablete Effentora 800 mikrogramske bukalne tablete Fentanil
Do not pass it on to others.
Njim bi lahko celo škodovalo,
their symptoms are the same as yours.
čeprav imajo znake bolezni, podobne vašim.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v
tell your doctor or pharmacist.
tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Effentora is and what it is used for 2.
Kaj je zdravilo Effentora in za kaj ga uporabljamo 2.
Before you use Effentora 3.
Kaj morate vedeti, preden boste uporabili zdravilo Effentora 3.
How to use Effentora 4.
Kako uporabljati zdravilo Effentora 4.
How to store Effentora 6.
Shranjevanje zdravila Effentora 6.
WHAT EFFENTORA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EFFENTORA IN ZA KAJ GA UPORABLJAMO
Effentora is a pain-relieving medicine known as an opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their constant (around-the-clock) cancer pain.
Effentora je zdravilo za lajšanje bolečine, znano kot opioid, ki se uporablja za zdravljenje prebijajoče bolečine pri odraslih bolnikih s karcinomom, ki že jemljejo druga opioidna zdravila za lajšanje stalne (24- urne) bolečine zaradi karcinoma.
BEFORE YOU USE EFFENTORA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO EFFENTORA
Do not use Effentora if: • You have not been using a prescribed opioid pain medicine every day on a regular schedule, for at least a week, to control your persistent pain.
Ne uporabljajte zdravila Effentora: • Za nadzor svoje stalne bolečine niste uporabljali predpisanega opioidnega zdravila proti bolečinam vsak dan po rednem režimu.