natgillin/translations-raw huggingface dataset:
a Analysis treats patients who withdrew as non-responder b ≥70% reduction from baseline in TAC at Month 6 (28-day period) c 0 to 4 HDDs/month at Month 6 (28-day period)
a analizirani zdravljeni bolniki, ki so prekinili sodelovanje v študiji zaradi ne-odziva b ≥ 70 % zmanjšanje od izhodišča v TAC pri 6. mesecu (28-dnevno obdobje) c 0 to 4 HDDs/mesec pri 6. mesecu 6 (28-dnevno obdobje)
Few cases of side effects of seeing, hearing or sensing things that are not there or feeling detached from oneself have been reported.
Poročali so o nekaj primerih stranskih učinkov kot so videnje, slišanje ali občutenje stvari, ki jih ni ali občutek odmaknjenosti od sebe.
Caution should be exercised if Selincro is prescribed to patients with current psychiatric comorbidity such as major depressive disorder.
Potrebna je previdnost pri predpisovanju zdravila Selincro bolnikom s sočasno prisotnimi psihiatričnimi obolenji kot je velika depresivna motnja.
Limited data are available for Selincro in the 1-month run-out period.
Omejeni podatki so na voljo za zdravilo Selincro v enomesečnem zaključnem obdobju.
Patients for whom recent use of opioids is suspected.
Bolniki, pri katerih obstaja sum nedavne uporabe opioidov.
There is limited experience in patients with a history of seizure disorders, including alcohol withdrawal seizures.
Izkušnje so omejene pri bolnikih z epileptičnimi motnjami v anamnezi, vključno z epileptičnimi napadi v sklopu odtegnitve od alkohola.
In patients with moderate hepatic impairment, exposure increased 2.9 times for AUC and 1.7 times for Cmax, while oral clearance decreased by approximately 60%.
Pri bolnikih z zmerno okvaro jeter se je izpostavljenost povečala za 2,9-krat za AUC in 1,7-krat za Cmax, peroralni očistek pa se je zmanjšal za okoli 60 %.
Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).
Bolniki z nedavnim akutnim sindromom odtegnitve od alkohola (ki vključujejo halucinacije, epileptične napade in alkoholni delirij) v anamnezi.
A study with IV administration suggested that there were no relevant changes in the pharmacokinetics in the elderly as compared to non-elderly adults (see sections 4.2 and 4.4).
Študija z intravenskim vnosom je pokazala, da ni pomembnih sprememb v farmakokinetiki pri starejših v primerjavi z drugimi odraslimi (glejte poglavji 4.2 in 4.4).
Caution is advised if Selincro is co-administered with a potent UGT2B7 inhibitor (see section 4.5).
Potrebna je previdnost, če zdravilo Selincro sočasno uporabljamo z močnim zaviralcem UGT2B7 (glejte poglavje 4.5).
The most common adverse reactions were nausea, dizziness, insomnia, and headache.
Najpogostejši neželeni učinki so bili slabost, omotica, nespečnost in glavobol.
The film-coated tablet should not be divided or crushed because nalmefene may cause skin sensitisation when in direct contact with the skin (see section 5.3).
Filmsko obložene tablete ne smete razpolavljati ali drobiti, saj lahko nalmefen pri neposrednem stiku s kožo povzroči preobčutljivost kože (glejte poglavje 5.3).
- This medicine does not require any special storage conditions.
- Za shranjevanje tega zdravila niso potrebna posebna navodila.
No specific study with oral dosing has been conducted in patients ≥65 years of age.
Pri bolnikih, starih 65 let ali več, ni bila opravljena nobena posebna študija s peroralnimi odmerki.
Post-hoc efficacy analysis in patients who maintained a high or very high DRL at randomisation In Study 1, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (50% versus 32%, respectively).
Post hoc analiza učinkovitosti pri bolnikih, ki so ohranili visoko ali zelo visoko DRL pri randomizaciji V študiji 1 je bil delež bolnikov, ki so prekinili sodelovanje v študiji večji v Selincro skupini kot v placebo skupini (50 % proti 32 %, glede na vrstni red).
Film-coated tablet (tablet) White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with “S” on one side
Bela, ovalna, bikonveksna, 6,0 mm x 8,75 mm filmsko obložena tableta z vtisnjeno oznako "S" na eni strani.
In Study 2, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (30% versus 28%, respectively).
V študiji 2 je bil delež bolnikov, ki so prekinili sodelovanje v študiji večji v Selincro skupini kot v placebo skupini (30 % proti 28 %, glede na vrstni red).
Nalmefene is an opioid system modulator with a distinct μ, δ, and κ receptor profile.
Nalmefen je modulator opioidnega sistema z značilnimi profilom delovanja na receptorjih μ, δ in κ.
Occupancy data obtained in a PET study after single and repeated daily dosing with 18.06 mg nalmefene show 94% to 100% receptor occupancy within 3 hours after dosing, which suggests that nalmefene readily crosses the blood-brain barrier.
Podatki o zasedenosti receptorjev, ki so bili pridobljeni v študiji s pozitronsko emisijsko tomografije (PET) po enkratnem in ponovljenem dnevnem odmerku 18,06 mg nalmefena, kažejo 94 % do 100 % zasedenost receptorjev v 3 urah po vnosu odmerka, kar kaže na to, da nalmefen dobro prehaja skozi krvno-možgansko pregrado.
For the inactive major metabolite nalmefene 3-O-glucuronide, the AUC and Cmax were up to 5.1 times and 1.8 times higher in patients with severe renal impairment, respectively (see sections 4.3 and 4.4).
Za glavni neaktivni metabolit nalmefena 3-O-glukuronid je bila pri bolnikih s hudo okvaro ledvic AUC do 1,8-krat večja in Cmax do 5,1-krat večja (glejte poglavji 4.3 in 4.4).
The side effects reported with Selincro were mainly mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
Neželeni učinki, o katerih so poročali pri uporabi zdravila Selincro, so bili v glavnem blagi ali zmerni, pojavili pa so se na začetku zdravljenja in trajali nekaj ur ali dni.
If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
Če ste začeli piti alkohol, ne da bi vzeli zdravilo Selincro, morate vzeti eno tableto v najkrajšem možnem času.
Caution should be exercised when prescribing Selincro to patients with elevated ALAT or ASAT (>3 times ULN) as these patients were excluded from the clinical development programme.
Potrebna je previdnost pri predpisovanju zdravila Selincro bolnikom s povišano vrednostjo alanin aminotransferaze (ALAT) ali aspartat aminotransferaze (ASAT) (> 3-kratna zgornja meja normalnih vrednosti (ULN - Upper Limit of Normal), saj so bili ti bolniki izključeni iz programa kliničnega razvoja.
Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies.
V kliničnih študijah so poročali o zmedenosti ter redkeje o halucinacijah in disociaciji.
In patients with mild hepatic impairment, exposure increased 1.5 times and oral clearance decreased by approximately 35%.
Pri bolnikih z blago okvaro jeter se je izpostavljenost povečala za 1,5-krat, peroralni očistek pa se je zmanjšal za okoli 35 %.
From distribution, metabolism, and excretion data, it appears that nalmefene has a high hepatic extraction ratio.
Podatki o porazdelitvi, presnovi in izločanju kažejo, da ima nalmefen visoko jetrno ekstrakcijsko razmerje.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Odločite se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Selincro, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
If the patient has started drinking alcohol without taking Selincro, the patient should take one tablet as soon as possible.
Če je bolnik začel piti alkohol, ne da bi vzel zdravilo Selincro, mora vzeti eno tableto v najkrajšem možnem času.
Pharmacokinetic data after oral administration of nalmefene to patients with severe hepatic impairment are not available (see sections 4.3 and 4.4).
Farmakokinetični podatki po peroralnem vnosu nalmefena pri bolnikih s hudo okvaro jeter niso na voljo (glejte poglavja 4.3 in 4.4.
You may experience acute opioid withdrawal symptoms (such as feeling sick, vomiting, shakiness, sweating and anxiety) - if you experience, or suspect you are experiencing opioid withdrawal symptoms - if your liver or kidney function is poor - if you are experiencing or have recently experienced several alcohol withdrawal symptoms
Pojavijo se lahko akutni opioidni odtegnitveni simptomi (kot so slabost, bruhanje, tresenje, potenje in tesnoba) - če se pojavijo ali sumite, da so se pojavili odtegnitveni simptomi pri odvisnosti od opoidov - če imate oslabljeno delovanje jeter ali ledvic - če imate ali ste pred kratkim doživeli več odtegnitvenih simptomov od alkohola (kot so videnje,
If you take more Selincro than you should
Če ste vzeli večji odmerek zdravila Selincro, kot bi smeli
Selincro is not for patients for whom the treatment goal is immediate abstinence.
Zdravilo Selincro ni primerno za bolnike, katerih cilj je takojšnja vzpostavitev abstinence od alkohola.
In fertility studies in rats, no effects were observed for nalmefene on fertility, mating, pregnancy, or sperm parameters.
V študijah o vplivu na sposobnost razmnoževanja pri podganah niso zasledili nobenih vplivov nalmefena na plodnost, sposobnost razmnoževanja, nosečnost ali parametre semena.
Management of an overdose should be observational and symptomatic.
V primeru prevelikega odmerjanja je treba bolnika opazovati in zdraviti simptomatsko.
Selincro is not recommended if you are pregnant.
Zdravilo Selincro ne uporabljajte, če ste noseči.
Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate).
Ena filmsko obložena tableta vsebuje 18,06 mg nalmefena (v obliki nalmefenijevega klorida dihidrata).
Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination)
Halucinacije (vključno s slušnimi, tipnimi, vidnimi halucinacijami in halucinacijami telesnega občutka) Disociacija
Selincro contains lactose
Zdravilo Selincro vsebuje laktozo
Conversely, concomitant administration with a UGT inducer (for example, dexamethasone, phenobarbital, rifampicin, omeprazole) may potentially lead to subtherapeutic nalmefene plasma concentrations.
Nasprotno, lahko sočasno uporaba UGT induktorjev (npr. deksametazon, fenobarbital, rifampicin, omeprazol) privede do subterapevtskih koncentracij nalmefena v plazmi.
Administration of a single oral dose of nalmefene 18.06 mg to patients with mild, moderate or severe renal impairment, classified using the estimated glomerular filtration rate, resulted in an increased exposure to nalmefene relative to that in healthy subjects.
Enkratni odmerek nalmefena 18,06 mg je pri bolnikih z blago, zmerno ali hudo okvaro ledvic, razvrščenih na podlagi ocene hitrosti glomerulne filtracije, povzročil povečano izpostavljenost nalmefenu v primerjavi z zdravimi osebami.
Caution should be exercised when prescribing Selincro to patients ≥65 years of age (see sections 4.2 and 5.2).
Potrebna je previdnost pri predpisovanju zdravila Selincro bolnikom, starim 65 let ali več (glejte poglavji 4.2 in 5.2).
Elderly (≥65 years of age) No dose adjustment is recommended for this patient population (see sections 4.4 and 5.2).
Starejši (≥65 let) Za to skupino bolnikov ni priporočenega prilaganja odmerka (glejte poglavji 4.4 in 5.2).
The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days).
Večina teh učinkov je bila blagih ali zmernih, povezanih z začetkom zdravljenja in kratkotrajnih (od nekaj ur do nekaj dni).
Microcrystalline cellulose Lactose, anhydrous Crospovidone, type A Magnesium stearate
Jedro tablete mikrokristalna celuloza brezvodna laktoza krospovidon tipa A magnezijev stearat
Titanium dioxide (E171)
Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171)
What Selincro looks like and contents of the pack
Izgled zdravila Selincro in vsebina pakiranja
If you forget to take Selincro
Če ste pozabili vzeti zdravilo Selincro
Other side effects (cannot be estimated from the available data) - seeing, hearing or sensing things that are not there - feeling detached from oneself - swelling of face, lips, tongue or throat - hives - itching - rash - redness of skin - muscle pain - prolonged erection (priapism)
Drugi neželeni učinki (ni mogoče oceniti iz razpoložljivih podatkov): - videnje, slišanje ali občutenje stvari, ki jih ni - občutek odmaknjenosti od sebe - otekanje obraza, ustnic, jezika ali grla
The nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, or carcinogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti ali kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
Angioedema Urticaria Pruritus Rash
Angioedem Urtikarija Pruritus Izpuščaj Eritem
- Selincro is for oral use.
- Zdravilo Selincro je za peroralno uporabo.
Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.
O uporabi zdravila Selincro pri bolnikih, starih 65 let ali več, z odvisnostjo od alkohola, so na voljo omejeni klinični podatki.
The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.
Večina teh učinkov je bila blagih ali zmernih, povezanih z začetkom zdravljenja in kratkotrajnih.
If you are breast-feeding, you and your doctor should make a decision whether to discontinue breastfeeding or to discontinue Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to you.
Če dojite, se morate vi in vaš zdravnik odločiti med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Selincro, pri čemer je treba pretehtati prednost dojenja za otroka in prednost zdravljena za vas.
Hepatic impairment
Omotica Glavobol
If you stop taking Selincro
Če ste prenehali jemati zdravilo Selincro
The tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.
Jedro tablete: mikrokristalna celuloza, brezvodna laktoza, krospovidon tipa A, magnezijev stearat.
The majority of these reactions were mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
Večina teh učinkov je bila blagih ali zmernih, pojavili pa so se na začetku zdravljenja in so trajali nekaj ur do nekaj dni.
Nornalmefene is further converted to nornalmefene 3-O-glucuronide and nornalmefene 3O-sulphate.
3-O-glukuronid in nornalmefen 3-O-sulfat.
Administration of a single dose of nalmefene 18.06 mg to patients with mild or moderate hepatic impairment increased exposure relative to that in healthy subjects.
Pri enkratnem odmerku nalmefena 18,06 mg pri bolnikih z blago ali zmerno okvaro jeter se je izpostavljenost povečala podobno kot pri zdravih osebah.
How to take Selincro
Kako jemati zdravilo Selincro
(such as seeing, hearing or sensing things that are not there, seizures and shakiness)
slišanje ali občutenje stvari, ki jih ni, epileptični napadi in tresenje)
Adverse reactions such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur following administration of nalmefene (see section 4.8).
Po dajanju nalmefena se lahko pojavijo neželeni učinki, kot so motnje pozornosti, nenormalno počutje, navzea, omotica, somnolenca, nespečnost in glavobol (glejte poglavje 4.8).
Selincro 18 mg film-coated tablets
Selincro 18 mg filmsko obložene tablete
- Do not use this medicine after the expiry date (EXP) that is printed on the blister and carton.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
Selincro 18 mg film-coated tablets nalmefene
Selincro 18 mg filmsko obložene tablete nalmefen
Both studies were randomised, double-blind, parallel-group and placebo-controlled, and after 6 months of treatment, patients who received Selincro were re-randomised to receive either placebo or Selincro in a 1-month run-out period.
Šest mesecev po zdravljenju so bili bolniki, ki so prejemali zdravilo Selincro, ponovno randomizirani in so mesec dni prejemali bodisi placebo bodisi zdravilo Selincro.
Selincro contains the active substance nalmefene.
Zdravilo Selincro vsebuje zdravilno učinkovino nalmefen.
The patient's response to treatment and the need for continued pharmacotherapy should be evaluated on a regular
Odziv bolnika na zdravljenje in potrebo po nadaljnji farmakoterapiji je treba ovrednotiti na redni (npr. mesečni) osnovi (glejte poglavje 5.1).
reduced sense of touch - racing heart, a sensation of a rapid, forceful, or irregular beating of the heart - vomiting, dry mouth, diarrhoea - excessive sweating - muscle spasms - feeling of exhaustion, weakness, discomfort or uneasiness, feeling strange - weight loss
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov) - izguba apetita - težave s spanjem, zmedenost, občutek nemira, zmanjšana spolna sla - zaspanost, trzanje telesa, manjša zbranost, nenavaden občutek na koži, kot sta zbadanje in mravljinčenje, zmanjšana občutljivost na dotik - hitro bitje srca, občutek hitrega, silovitega, ali nepravilnega bitja srca - bruhanje, suha usta, driska - prekomerno potenje - mišični krči - občutek izčrpanosti, slabost, nelagodje, nenavadno počutje - zmanjšanje telesne mase
- Each film-coated tablet contains 18.06 milligram nalmefene (as hydrochloride dihydrate) - The other ingredients are:
- Ena filmsko obložena tableta vsebuje 18,06 miligrama nalmefena (v obliki nalmefenijevega klorida dihidrata).
The TAC was 102 g/day at baseline in the Selincro group (n=171) and 99 g/day at baseline in the placebo group (n=167).
V izhodišču je bila TAC 102 g/dan v Selincro skupini (n=171) in 99 g/dan v placebo skupini (n=167).
The TAC was 100 g/day at baseline in the Selincro group (n=141) and 101 g/day at baseline in the placebo group (n=42).
V izhodišču je bila TAC 100 g/dan v Selincro skupini (n=141) in 101 g/dan v placebo skupini (n=42).
double-blind, parallel-group, placebo-controlled 1-year study.
Učinkovitost zdravila Selincro je bila prav tako ocenjena v randomizirani, dvojno slepi, z vzporednima skupinama in s placebom nadzorovani enoletni študiji.
The TAC was 113 g/day at baseline in the Selincro group (n=148) and 108 g/day at baseline in the placebo group (n=155).
V izhodišču je bila TAC 113 g/dan v Selincro skupini (n=148) in 108 g/dan v placebo skupini (n=155).
The following side effects have been reported with Selincro:
Pri uporabi zdravila Selincro so poročali o naslednjih neželenih učinkih:
There seems to be a small impairment in cognitive and psychomotor performance after administration of nalmefene.
Po jemanju nalmefena pride do manjšega poslabšanja kognitivnih in psihomotoričnih sposobnosti.
Selincro is not recommended during pregnancy.
Zdravila Selincro ne uporabljajte pri nosečnicah.
Side effects such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur when beginning Selincro treatment.
Na začetku zdravljenja z zdravilom Selincro se lahko pojavijo neželeni učinki, kot so motnje pozornosti, nenormalno počutje, siljenje na bruhanje, omotica, somnolenca (otopelost), nespečnost in glavobol.
What Selincro contains
Kaj vsebuje zdravilo Selincro
For the patients who continued in the study and provided efficacy data at 1 year, the TAC was 24 g/day in the Selincro group (n=78) and 47 g/day in the placebo group (n=29).
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 1. letu, je bila TAC 24 g/dan v Selincro skupini (n=78) in 47 g/dan v placebo skupini (n=29).
For HDDs there were 23 days/month at baseline in the Selincro group (n=171) and 23 days/month at baseline in the placebo group (n=167).
V izhodišču je bilo HDDs 23 dni/mesec v Selincro skupini (n=171) in 23 dni/mesec v placebo skupini (n=167).
Selincro is for oral use.
Zdravilo Selincro je namenjeno peroralni uporabi.
For HDDs there were 23 days/month at baseline in the Selincro group (n=148) and 22 days/month at baseline in the placebo group (n=155).
V izhodišču je bilo HDDs 23 dni/mesec v Selincro skupini (n=148) in 22 dni/mesec v placebo skupini (n=155).
No dose adjustment is recommended for patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Za bolnike z blago do zmerno okvaro jeter ni priporočenega prilagajanja odmerka (glejte poglavji 4.4 in 5.2).
For HDDs there were 19 days/month at baseline in the Selincro-group (n=141) and19 days/month at baseline in the placebo group (n=42).
V izhodišču je bilo HDDs 19 dni/mesec v Selincro skupini (n=141) in 19 dni/mesec v placebo skupini (n=42).
For patients with mild, moderate or severe renal impairment the AUC for nalmefene was 1.1 times, 1.4 times and 2.4 times higher, respectively.
AUC za nalmefen je bila 1,1-krat večja za bolnike z blago okvaro ledvic, 1,4-krat večja za bolnike z zmerno okvaro ledvic in 2,4-krat večja za bolnike s hudo okvaro ledvic.
For the patients who continued in the study and provided efficacy data at 1 year, the number of HDDs was 5 days/month in the Selincro group (n=78) and 10 days/month in the placebo group (n= 29).
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 1. letu, je bilo število HDDs 5 dni/mesec v Selincro skupini (n=78) in 10 dni/mesec v placebo skupini (n=29).
For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 40 g/day in the Selincro-group (n=85) and 57 g/day in the placebo group (n=114).
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bila TAC 40 g/dan v Selincro skupini (n=85) in 57 g/dan v placebo skupini (n=114).
For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 10 days/month in the Selincro group (n=103) and 12 days/month in the placebo group (n=111).
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bilo število HDDs 10 dni/mesec v Selincro skupini (n=103) in 12 dni/mesec v placebo skupini (n=111).
For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 44 g/day in the Selincro group (n=103) and 52 g/day in the placebo group (n=111).
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bila TAC 44 g/dan v Selincro skupini (n=103) in 52 g/dan v placebo skupini (n=111).
Restlessness
Nespečnost
For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 9 days/month in the Selincro group (n=85) and 14 days/month in the placebo group (n=114).
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bilo število HDDs 9 dni/mesec v Selincro skupini (n=85) in 14 dni/mesec v placebo skupini (n=114).
Fatigue Asthenia
Utrujenost Astenija
Nalmefene was shown to have skin sensitisation potential in the Local Lymph Node Assay in mice after topical application.
Lokalna analiza limfnih vozlov pri miših je pokazala, da ima nalmefen potencial za povzročanje preobčutljivosti kože po topikalni uporabi.
How to store Selincro
Shranjevanje zdravila Selincro
Opioid administration
Uporaba opioidov
Comorbidity
Komorbidnost
Tablet coating
filmsko obložena tableta (tableta)
Sleep disorder
Ledvična okvara
Dissociation
Odmerjanje
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zdravljenje raka.
This means that Topotecan Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU).
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU).
This is repeated every 21 days for six courses or until the disease gets worse.
To ponavljamo na vsakih 21 dni, vsega skupaj šestkrat ali dokler se stanje bolezni ne poslabša.