natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
Incruse Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni
A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Incruse Ellipta (-4.69 units, p<0.001) in the 24-week study.
V 24tedenski študiji so z zdravilom Incruse Ellipta v primerjavi s placebom ugotovili večje izboljšanje v spremembi celotnega seštevka SGRQ od izhodišča (-4,69 enote, p < 0,001∗).
Incruse Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12week pivotal study.
Od izhodišča je zdravilo Incruse Ellipta v primerjavi s placebom v 12-tedenski ključni študiji po 12 tednih doseglo statistično značilno večje izboljšanje uteženega povprečnega FEV1 v obdobju od 0 do 6 ur po uporabi odmerka (166 ml, p < 0,001).
Elderly patients
Druge posebne skupine bolnikov
Similarly, a greater proportion of patients achieved 1 unit TDI focal score for Incruse Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Podobno je v 24-tedenskih študiji po 24 tednih dosegel ≥ 1 enoto fokalnega seštevka TDI večji delež bolnikov z zdravilom Incruse Ellipta (53 %) kot s placebom
Talk to your doctor before using this medicine: if you have asthma (Don't use Incruse Ellipta to treat asthma) if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom: če imate astmo (ne uporabljajte zdravila Incruse Ellipta za zdravljenje astme),
What Incruse Ellipta is and what it is used for
Kaj je zdravilo Incruse Ellipta in za kaj ga uporabljamo Kaj je zdravilo Incruse Ellipta
1 inhaler of 7 doses.
1 inhalator s 7 odmerki 1 inhalator s 30 odmerki.
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Incruse Ellipta inhaler:
Če se vam takoj po uporabi inhalatorja Incruse Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
1 inhaler of 30 doses.
prašek za inhaliranje, odmerjeni 1 inhalator s 30 odmerki
• Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
• Položite ustnik čvrsto med ustnici .
STATEMENT OF ACTIVE SUBSTANCE(S) Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
En oddani odmerek vsebuje 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida).
A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Incruse Ellipta (1.0 units, p<0.001) in the 24-week study.
V 24-tedenski študiji so z zdravilom Incruse Ellipta v primerjavi s placebom ugotovili statistično značilno izboljšanje fokalnega seštevka TDI po 24 tednih (1,0 enota, p < 0,001).
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Incruse Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij (umeklidinijev bromid)
What Incruse Ellipta is used for
Za kaj se uporablja zdravilo Incruse Ellipta
Your Incruse Ellipta inhaler carton contains
Škatla vašega zdravila Incruse Ellipta vsebuje
The “Discard by” date should be written on the inhaler label in the space provided.
V predvideni prostor na nalepki inhalatorja je potrebno vpisati datum "Zavrzite do".
Similarly, a greater proportion of patients achieved at least the MCID for Incruse Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Podobno je v 24-tedenskih študiji po 24 tednih vsaj minimalno klinično pomembno razliko s 55 mikrogrami zdravila Incruse Ellipta dosegel večji delež bolnikov (44 %) kot s placebom (34 %).
Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
Zdravila Incruse Ellipta ne smete uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
INFORMATION IN BRAILLE incruse ellipta
Shranjevanje zdravila Incruse Ellipta
Excipient with known effect:
Izidi glede na simptome Težko dihanje:
• eye pain
• suha usta,
Incruse Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Zdravilo Incruse Ellipta je tudi statistično značilno izboljšalo zdravstveno kakovost življenja, merjeno z vprašalnikom SGRQ (St. George's Respiratory Questionnaire).
METHOD AND ROUTE(S) OF ADMINISTRATION Once daily.
za 24 ur po uporabi enkrat na dan.
NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Incruse Ellipta 55 µg prašek za inhaliranje umeklidinij (umeklidinijev bromid)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
To ustreza odmerjenemu odmerku 62,5 mikrograma umeklidinija (kar ustreza 74,2 mikrograma umeklidinijevega bromida).
What Incruse Ellipta looks like and contents of the pack Incruse Ellipta is an inhalation powder, pre-dispensed.
Zdravilo Incruse Ellipta je prašek za inhaliranje, odmerjeni.
No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose.
Pri odmerku, 4-krat višjem od terapevtskega odmerka, niso opazili vpliva na AUC ali
The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Inhalator Ellipta sestavljajo sivo ohišje, svetlo zelen pokrovček ustnika in števec odmerkov.
No effect of verapamil was observed on umeclidinium bromide Cmax.
Učinkovina je umeklidinijev bromid.
Use this medicine for as long as your doctor recommends.
Zdravilo bo učinkovito le, dokler ga uporabljate.
Marketing Authorisation Holder
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Do not drive or use any tools or machines until you know how ARICLAIM affects you.
Ne vozite in ne upravljajte z orodji ali stroji, dokler ne veste, kako zdravilo ARICLAIM vpliva na vas.
The starting and recommended maintenance dose is 60 mg daily with or without food.
Začetni in priporočeni vzdrževalni odmerek je 60 mg enkrat na dan s hrano ali brez nje.
Some patients who stop taking ARICLAIM suddenly have had symptoms such as:
Nekateri bolniki, ki so nenadoma prenehali jemati zdravilo ARICLAIM, so imeli simptome, kot so:
There are no adequate data on the use of duloxetine in pregnant women.
Nimamo zadostnih podatkov o uporabi duloksetina pri nosečnicah.
DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Ne prenehajte jemati svojih kapsul, če vam ni tako svetoval vaš zdravnik, tudi če se bolje počutite.
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARICLAIM, you should see your doctor.
Ta zdravila povečajo tveganje za neželene učinke; če se pojavi kakršenkoli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom ARICLAIM, obiščite svojega zdravnika.
• depression, anxiety and urinary incontinence
• depresije, anksioznosti in urinske inkontinence
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
• falls (mostly in elderly people), fatigue
• padci (predvsem pri starejših) utrujenost
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 August 2004
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11. avgust 2004
Date of latest renewal: 24 June 2009
Datum podaljšanja dovoljenja za promet: 24. junij 2009
ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo ARICLAIM naj se v nosečnosti uporablja le, če možna korist upravičuje možno tveganje za plod.
The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1).
Terapevtsko korist je treba redno ponovno ocenjevati (vsaj enkrat na vsake tri mesece) (glejte poglavje
Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Zdravniki bi morali bolnike vzpodbuditi k poročanju, če so kadarkoli imeli žalostne misli ali občutke ali simptome depresije.
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanje in samomorilnosti (s samomorom povezani dogodki).
There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
V prizadetem področju lahko pride do izgube zaznavanja, ali občutki, denimo dotik, toplota, mraz ali pritisk povzročijo bolečino.)
Taking a MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects.
Jemanje MAOI skupaj z mnogimi zdravili na recept, vključno z zdravilom ARICLAIM, lahko povzroči resne ali celo smrtno nevarne neželene učinke.
What ARICLAIM is and what it is used for
KAJ JE ZDRAVILO ARICLAIM IN ZA KAJ GA UPORABLJAMO
You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Zdravilo ARICLAIM lahko uporabljate le po tem, ko ste se o možnih koristih in morebitnih možnih tveganjih za vašega nerojenega otroka pogovorili s svojim zdravnikom.
The European Medicines Agency has waived the obligation to submit the results of studies with ARICLAIM in all subsets of the paediatric population in the treatment of diabetic neuropathic pain.
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom ARICLAIM za vse skupine pediatrične populacije pri zdravljenju bolečine diabetične nevropatije.
To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.
Morda se boste lažje spomnili vzeti zdravilo ARICLAIM, če ga boste jemali vsak dan ob istih urah.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoze-izomaltaze ne smejo jemati tega zdravila.
The usual dose of ARICLAIM is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Običajen odmerek zdravila ARICLAIM je 60 mg enkrat na dan, za vas ustrezen odmerek pa vam bo predpisal vaš zdravnik.
What ARICLAIM is and what it is used for What you need to know before you take ARICLAIM
Kaj je zdravilo ARICLAIM in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ARICLAIM
In people with diabetic neuropathic pain it can take some weeks before you feel better.
Pri večini bolnikov z bolečino pri diabetični nevropatiji traja nekaj tednov, preden se vaše počutje izboljša.
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
Ti simptomi običajno niso resni in v nekaj dneh izzvenijo, vendar se posvetujte s svojim zdravnikom,
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines., including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Do not stop taking ARICLAIM, or change your dose, without talking to your doctor.
Ne prenehajte jemati zdravila ARICLAIM in ne spreminjajte odmerka, ne da bi se posvetovali s svojim zdravnikom.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
• Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking ARICLAIM.
• Obvestite svojega zdravnika, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo ARICLAIM.
Your doctor should decide whether you can take ARICLAIM with other medicines.
Vaš zdravnik se mora odločiti, ali lahko jemljete zdravilo ARICLAIM z drugimi zdravili.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
Dolgoročni učinki zdravila ARICLAIM na varnost glede rasti, dozorevanja in kognitivnega ter vedenjskega razvoja v tej starostni skupini tudi še niso bili ugotovljeni.
• Ariclaim may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
• Ariclaim lahko povzroči tudi neželene učinke, ki se jih morda ne zavedate, kot povišanje jetrnih encimov ali krvnega nivoja kalija, kreatinske fosfokinaze, sladkorja ali holesterola.
If your doctor has prescribed ARICLAIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Če je vaš zdravnik predpisal zdravilo ARICLAIM bolniku, mlajšemu od 18 let, in se želite o tem pogovoriti,
If you take ARICLAIM near the end of your pregnancy, your baby might have some symptoms when it is born.
Če zdravilo ARICLAIM jemljete proti koncu nosečnosti, se lahko po rojstvu pri vašem otroku pojavijo nekateri simptomi.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking ARICLAIM.
Svojega zdravnika obvestite, če se kateri od zgoraj naštetih simptomov pri bolniku, mlajšemu od 18 let, ki jemlje zdravilo ARICLAIM, pojavi ali poslabša.
If your doctor thinks that you no longer need ARICLAIM he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Če bo vaš zdravnik menil, da zdravila ARICLAIM ne potrebujete več, vam bo naročil/naročila, da pred prenehanjem zdravljenja 2 tedna postopoma znižujte svoj odmerek.
Contents of the pack and other information What ARICLAIM contains
VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo ARICLAIM
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions:
Poglavitno sestavino zdravila ARICLAIM, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni:
Use in children and adolescents under 18 years of age ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
Uporaba pri otrocih in mladostnikih, mlajših od 18 let Zdravila ARICLAIM pri zdravljenju otrok in mladostnikov, mlajših od 18 let, ne smemo uporabljati.
ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system.
Zdravilo ARICLAIM zviša nivo serotonina in noradrenalina v živčnem sistemu.
The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
zmanjšanje bolečine so 50 % oziroma 26 %.
INFORMATION IN BRAILLE ARICLAIM 60 mg
PODATKI V BRAILLOVI PISAVI ARICLAIM 60 mg
However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Vendar je bila večina najpogostejših neželenih učinkov blagih do zmernih, navadno so se pojavili na začetku zdravljenja in večina jih je tekom nadaljevanja zdravljenja izzvenela.
If you take more ARICLAIM than you should
Če ste vzeli večji odmerek zdravila ARICLAIM, kot bi smeli
Other medicines and ARICLAIM
Druga zdravila in zdravilo ARICLAIM:
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• nočno potenje, koprivnica, hladen znoj, občutljivost na sončno svetlobo, povečano nagnjenje k
Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence).
Duloksetin se pod različnimi zaščitenimi imeni uporablja za več indikacij (zdravljenje bolečine zaradi diabetične nevropatije, velikih depresivnih motenj, generalizirane anksiozne motnje in stresne urinske inkontinence).
− are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
- ste alergični (preobčutljivi) na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v
Do not take more than the daily amount of ARICLAIM that has been prescribed for you in one day.
Ne zaužijte več zdravila ARICLAIM v enem dnevu, kot vam je bilo predpisano.
When stopping treatment with ARICLAIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Ob prenehanju zdravljenja z zdravilom ARICLAIM je treba odmerek zdravila v obdobju najmanj enega do dveh tednov postopoma zmanjševati, da zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4.4 in 4.8).
ARICLAIM should normally not be used for children and adolescents under 18 years.
Zdravila ARICLAIM pri otrocih in mladostnikih, mlajših od 18 let, običajno ne uporabljamo.
How to take ARICLAIM
KAKO JEMATI ZDRAVILO ARICLAIM
ARICLAIM is indicated in adults.
Zdravilo ARICLAIM je indicirano za zdravljenje odraslih.
ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still.
Zdravilo ARICLAIM lahko povzroči občutek nemira ali nezmožnosti sedenja ali stanja pri miru.
ARICLAIM is available in 2 strengths: 30 mg and 60 mg.
Zdravilo ARICLAIM je na voljo v dveh jakostih: 30 in 60 mg.
Talk with your doctor about how long you should keep taking ARICLAIM.
S svojim zdravnikom se pogovorite o tem, kako dolgo boste jemali zdravilo ARICLAIM.
• menopausal symptoms, abnormal production of breast milk in men or women
• nenormalen vonj urina menopavzalni simptomi, nenormalno nastajanje mleka v dojkah pri moških in ženskah
Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medicinal product.
Čeprav zdravilo ARICLAIM ni indicirano za zdravljenje depresije, njegova zdravilna učinkovina (duloksetin) obstaja tudi kot antidepresiv.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI),, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
Zdravilo ARICLAIM 30 mg je na voljo v pakiranju po 7, 28 in 98 kapsul.
If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Če bolnik med zdravljenjem z zdravilom ARICLAIM postane agitiran ali razvije simptome depresije, se je treba posvetovati s specialistom, depresija je namreč resno bolezensko stanje.
If you forget to take ARICLAIM
Če ste pozabili vzeti zdravilo ARICLAIM
ARICLAIM may be associated with sedation and dizziness.
Zdravilo ARICLAIM je lahko povezano s sedacijo in omotico.
ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Zdravilo ARICLAIM je treba pri bolnikih z manijo v anamnezi ali z diagnozo bipolarne motnje in/ali epileptičnimi napadi uporabljati previdno.
Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Vsaka kapsula zdravila ARICLAIM vsebuje pelete duloksetinijevega klorida z oblogo za zaščito pred želodčno kislino.
What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule.
Izgled zdravila ARICLAIM in vsebina pakiranja Zdravilo ARICLAIM je trda gastrorezistentna kapsula.
Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Zato je pri jemanju zdravila ARICLAIM v kombinaciji z drugimi centralno delujočimi zdravili ali snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.
Care should be taken if you drink alcohol while you are being treated with ARICLAIM.
Bodite posebej previdni, če med zdravljenjem z zdravilom ARICLAIM pijete alkohol.
ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
Zdravilo ARICLAIM 60 mg je na voljo v pakiranjih po 28 in 98 kapsul.
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Učinkovitost duloksetina kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12-tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom pri odraslih (starih od 22 do 88 let), ki so imeli bolečino zaradi diabetične nevropatije vsaj 6 mesecev.
If you stop taking ARICLAIM
Če ste prenehali jemati zdravilo ARICLAIM
The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied.
Pediatrična populacija Varnost in učinkovitost duloksetina za zdravljenje bolečine periferne diabetične nevropatije nista bili dokazani.
ARICLAIM may make you feel sleepy or dizzy.
Zdravilo ARICLAIM lahko vpliva, da se počutite zaspani ali omotični.
The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Uvedba zdravljenja z zdravilom ARICLAIM je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4.4 in 4.8).
ARICLAIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Zdravila ARICLAIM ne smemo uporabljati v kombinaciji s fluvoksaminom, ciprofloksacinom ali enoksacinom (tj. močnimi zaviralci CYP1A2), saj kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4.5).
Hyponatraemia has been reported when administering ARICLAIM, including cases with serum sodium lower than 110 mmol/l.
Ob dajanju zdravila ARICLAIM so poročali o hiponatriemiji, vključno s primeri, ko je bila serumska koncentracija natrija pod 110 mmol/l.