natgillin/translations-raw huggingface dataset:
Just take the next dose at the scheduled time and continue as normal.
Naslednji odmerek vzemite ob načrtovanem času, nato pa nadaljujte kot običajno.
No interaction studies have been performed.
Študij medsebojnega delovanja niso izvajali.
After first opening: 18 weeks.
Po prvem odprtju: 18 tednov.
Physicians should periodically assess the need for continued treatment.
Zdravniki morajo redno ocenjevati potrebo po nadaljevanju zdravljenja.
However, treatment with Constella can be safely stopped at any time.
Vendar pa lahko zdravljenje z zdravilom Constella varno prekinete kadar koli.
Date of first authorisation: 26 November 2012 Date of latest renewal: 28 August 2017
Datum prve odobritve: 26. november 2012 Datum zadnjega podaljšanja: 28.
A risk to the newborns/infants cannot be excluded.
Tveganja za novorojenčka/dojenčka ne moremo izključiti.
For age related information, please see sections 4.2., 4.4., and 4.8.
Za informacije, povezane s starostjo, glejte poglavja 4.2., 4.4. in 4.8.
- if you or your doctor know that you have a blockage in your stomach or bowels.
- če vi ali vaš zdravnik veste, da imate blokado v želodcu ali črevesju.
- The other ingredients are :
Druge sestavine zdravila so:
The active metabolite was not detected in any of the 162 patients at any time point.
Aktivnega presnovka ni bilo v nobeni časovni točki mogoče zaznati pri nobenem od 162 bolnikov.
• feeling lightheaded after standing up quickly
• občutek vrtoglavice, če hitro vstanete
LS: Least Square CSBM: Complete Spontaneous Bowel Movement
LS: najmanjši kvadrat CSBM: popolne spontane defekacije
Approximately half of the diarrhoea episodes started within the first week of treatment.
Približno polovica epizod driske se je začela v prvem tednu zdravljenja.
Component of a multipack, can't be sold separately.
Del velikega pakiranja; ne sme se prodajati ločeno.
Side effects with frequency not known (frequency cannot be estimated from the available data):
Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
Bloating (11-point NRS)
Napenjanje (11točkovni NRS)
As GC-C receptor is known to be overexpressed at early ages, children younger than 2 years may be particularly sensitive to linaclotide effects.
Ker je znano, da so receptorji GC-C v mladih letih čezmerno izraženi, so lahko otroci do 2. leta starosti še posebej občutljivi na učinke linaklotida.
Take special care if you are older than 65 years, as there is a higher risk you experience diarrhoea.
Zlasti bodite pazljivi, če ste starejši od 65 let, saj obstaja večja verjetnost za pojav driske.
Main secondary efficacy parameters
Glavni parametri sekundarne učinkovitosti
Because these other diseases may have the same symptoms as IBS, it is important that you report any change or irregularity in symptoms to your doctor promptly.
Ker imajo lahko omenjene druge bolezni enake simptome kot sindrom razdražljivega črevesja, je pomembno, da o vseh spremembah ali nepravilnostih simptomov takoj poročate svojemu zdravniku.
What you need to know before you take Constella 3.
Kaj morate vedeti, preden boste uporabili zdravilo Constella 3.
In the second clinical study (study 2), 800 patients were treated for 12 weeks, and then re-randomised for an additional 4 weeks treatment period.
V drugi klinični študiji (študija 2) so 800 bolnikov zdravili 12 tednov, nato pa so jih znova randomizirali za dodatno 4-tedensko obdobje zdravljenja.
The safety and efficacy of Constella in children aged 0 to18 years have not yet been established.
Varnost in učinkovitost zdravila Constella pri otrocih, starih od 0 do 18 let, nista bili dokazani.
These effects were reached at 1 week and sustained over the entire treatment periods.
Ti učinki so se pokazali v 1. tednu in so se ohranili skozi celotno obdobje zdravljenja.
In cases of severe or prolonged diarrhoea, absorption of other oral medicinal products may be affected.
V primeru hude ali dolgotrajnejše driske se lahko pojavi vpliv na absorpcijo drugih peroralnih zdravil.
This medicinal product should not be used in children and adolescents (see sections 4.4 and 5.1).
Zdravila se ne sme uporabljati pri otrocih in mladostnikih (glejte poglavji 4.4 in 5.1).
Do not use this medicine if you notice any signs of damage to the bottle or any change in the appearance of the capsules.
Ne uporabljate tega zdravila, če opazite kakršne koli znake poškodb plastenke ali spremembe v izgledu kapsul.
If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
Če ste imeli zelo hudo drisko, kontracepcijska tabletka morda ne bo delovala pravilno, zato priporočamo uporabo dodatne kontracepcijske metode.
The efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Zmanjša se lahko učinkovitost peroralnih kontracepcijskih sredstev, zato priporočamo uporabo dodatne kontracepcijske metode za preprečitev morebitne neuspešnosti peroralne kontracepcije (glejte navodila za predpisovanje peroralnih kontracepcijskih sredstev).
Pharmacotherapeutic group: Drugs for constipation, other drugs for constipation, ATC Code: A06AX04
Farmakoterapevtska skupina: zdravila proti zaprtju, druga zdravila proti zaprtju, oznaka ATC: A06AX04
Once the bottle is opened, the capsules should be used within 18-weeks.
Po prvem odprtju plastenke je treba kapsule uporabiti v 18 tednih.
Linaclotide has been shown not to cause rebound effect when the treatment was stopped after 3 months continuous treatment.
Pokazalo se je, da linaklotid ne povzroči povratnega (rebound) učinka, če so zdravljenje zaustavili po 3-mesečnem neprekinjenem zdravljenju.
The majority of reported cases of diarrhoea were mild (43%) to moderate (47%); 2% of treated patients experienced severe diarrhoea.
Večina poročanih primerov driske je bila blagih (43 %) do zmernih (47 %); 2 % zdravljenih bolnikov sta imela hudo drisko.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after ¨EXP¨.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake »EXP«.
Other common adverse reactions (>1%) were abdominal pain, abdominal distension and flatulence.
Druge pogoste neželene reakcije (> 1 %) so bile abdominalne bolečine, abdominalna distenzija in flatulenca.
• stomach flu (viral gastroenteritis)
• trebušna gripa (virusni gastroenteritis)
It is unknown whether linaclotide is excreted in human milk.
Ni znano, ali se linaklotid izločajo v materino mleko.
What you need to know before you take Constella Do not take Constella - if you are allergic to linaclotide or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste uporabili zdravilo Constella Ne jemljite zdravila Constella: če ste alergični na linaklotid ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
An overdose may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product, mainly diarrhoea.
Preveliko odmerjanje lahko povzroči simptome, ki so pretirani znani farmakodinamični učinki zdravila, v glavnem driska.
Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Constella in this age group has not been established.
Zdravila ne dajajte otrokom in mladostnikom do 18. leta starosti, ker varnost in učinkovitost zdravila Constella v tej starostni skupini nista bili dokazani.
• lack of control over passing stools (faecal incontinence)
• pomanjkanje nadzora uhajanja blata (fekalna inkontinenca)
The characteristics of the patient population included in Phase 3 clinical trials were as follows: mean age of 43.9 years [range 18 - 87 years with 5.3% ≥ 65 years of age], 90.1% female.
Lastnosti populacije bolnikov, vključenih v klinična preskušanja 3. faze, so: povprečna starost 43,9 let [razpon 18-87 let s 5,3 % ≥ 65 let starosti], 90,1 % žensk.
The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Constella in one or more subsets of the paediatric population in functional constipation (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Constella za eno ali več podskupin pediatrične populacije s funkcionalnim zaprtjem (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
CSBM/week
CSBM/teden 0,2
IBS is a common gut disorder.
IBS je pogosta motnja črevesja.
Treatment with linaclotide also resulted in significant improvements in validated and disease-specific Quality of Life measure (IBS-QoL; p<0.0001), and EuroQoL (p = 0.001).
Zdravljenje z linaklotidom je povzročilo tudi znatno izboljšanje validiranih in za bolezen specifičnih meril kakovosti življenja (IBS-QoL; p < 0,0001) in EuroQoL (p = 0,001).
Constella should not be used in children and adolescents as it has not been studied in this population.
Zdravilo Constella se ne sme uporabljati pri otrocih in mladostnikih, ker zdravila pri tej populaciji še niso preučili.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Constella therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Potrebno se je odločiti, ali prekiniti dojenje ali prekiniti/prenehati z zdravljenjem z zdravilom Constella, pri čemer je treba pretehtati tako prednosti dojenja za otroka kot tudi prednosti zdravljenja za mater.
Take also special care if you have severe or prolonged diarrhoea and an additional disease, such as high blood pressure, previous disease of the heart and blood vessels (e.g. such as previous heart attacks) or diabetes.
Poleg tega bodite posebej pozorni, če imate hudo ali dolgotrajnejšo drisko ter dodatno bolezen, kot so visok krvni tlak, predhodno bolezen srca in ožilja (npr. predhodne srčne kapi) oziroma sladkorna bolezen.
The diarrhoea resolved within seven days in about one third of patients, however 80 patients (50%) experienced diarrhoea with a duration of more than 28 days (representing 9.9% of all patients treated with linaclotide).
Driska je pri približno eni tretjini bolnikov izzvenela v sedmih dneh, vendar pa je imelo 80 bolnikov (50 %) drisko, ki je trajala več kot 28 dni (kar predstavlja 9,9 % vseh bolnikov, zdravljenih z linaklotidom).
Because of the higher risk of diarrhoea seen in the clinical trials (see section 4.8), special attention should be given to these patients and the treatment benefitrisk ratio should be carefully and periodically assessed.
Zaradi visokega tveganja za pojav driske, ki so ga opazili pri kliničnih preskušanjih (glejte poglavje 4.8), je treba tem bolnikom posvetiti posebno pozornost, skrbno in redno pa je treba ocenjevati tudi razmerje med koristmi in tveganji zdravljenja.
In both studies, these improvements were seen by week 1 and sustained over the entire treatment periods (Figures 1 and 2).
V obeh študijah so izboljšanje opazili že v prvem tednu, nato pa so se ohranilo v celotnem obdobju zdravljenja (1. in 2. slika).
What Constella is and what it is used for 2.
Kaj je zdravilo Constella in za kaj ga uporabljamo 2.
There are limited data in elderly patients (see section 5.1).
Pri starejših bolnikih so podatki omejeni (glejte poglavje 5.1).
The efficacy of linaclotide has been established in double-blind placebo-controlled studies for up to 6 months.
Učinkovitost linaklotida je bila ugotovljena v dvojno slepih, s placebom kontroliranih študijah, ki so trajale do 6 mesecev.
If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.
Če se pri bolnikih v 4 tednih simptomi ne izboljšajo, jih je treba ponovno pregledati in razmisliti o koristih in tveganjih nadaljevanja zdravljenja.
Hypersensitivity to linaclotide or to any of the excipients listed in section 6.1.
Preobčutljivost na linaklotid ali katero koli pomožno snov, navedeno v poglavju 6.1.
The following adverse reactions were reported in controlled clinical studies at the recommended dose of 290 micrograms per day with frequencies corresponding to: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to < 1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
V nadzorovanih kliničnih študijah so ob uporabi priporočenega odmerka 290 mikrogramov na dan poročali o spodnjih neželenih učinkih z naslednjimi pogostnostmi: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If you have not experienced improvement in your symptoms after 4 weeks of treatment, you should contact your doctor.
Če po 4 tednih zdravljenja ni znakov izboljšanja, se posvetujte z zdravnikom.
The potential inhibitory activity of linaclotide and its active primary metabolite MM-419447 on the human efflux transporters BCRP, MRP2, MRP3, and MRP4 and the human uptake transporters OATP1B1, OATP1B3, OATP2B1, PEPT1 and OCTN1 was investigated in vitro.
Morebitna zaviralna aktivnost linaklotida in njegovega primarnega presnovka MM-419447 na izločevalne prenašalce pri človeku BCRP, MRP2, MRP3 in MRP4 privzemne prenašalce pri človeku OATP1B1, OATP1B3, OATP2B1, PEPT1 in OCTN1 je bila raziskana in vitro.
Do not take this medicine if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor advises you to do so.
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, ne jemljite tega zdravila, razen če vam tako naroči vaš zdravnik.
For elderly patients, although no dose adjustment is required, the treatment should be carefully monitored and periodically re-assessed (see section 4.4).
Kljub temu, da odmerka pri starejših bolnikih ni potrebno spreminjati, je treba pozorno spremljati zdravljenje in ga občasno ponovno oceniti (glejte poglavje 4.4).
Make sure you drink plenty of fluids to replace the water and electrolytes like potassium lost from the diarrhoea.
Pijte veliko tekočine, da nadomestite izgubo vode in elektrolitov, kot je kalij, ki se pojavi zaradi driske.
In a study in healthy volunteers receiving a single dose of 2,897 micrograms (up to 10-fold the recommended therapeutic dose) the safety profile in these subjects was consistent with that in the overall population, with diarrhoea being the most commonly reported adverse event.
Pri študiji z zdravimi prostovoljci, ki so prejeli en odmerek 2.897 mikrogramov (do 10kratnik priporočenega terapevtskega odmerka), je bil varnostni profil teh oseb skladen s profilom celotne zdravljene populacije, pri kateri so o driski poročali kot o najpogostejšem neželenem učinku.
It is expected that linaclotide is negligibly or not systemically distributed.
Pričakovati je, da je sistemska porazdelitev linaklotida neznatna ali da je ni.
Do not store above 30ºC.
Shranjujte pri temperaturi do 30 C.
The recommended dose is one capsule (290 micrograms) once daily.
Priporočen odmerek je ena kapsula (290 mikrogramov) enkrat na dan.
Your doctor has given this medicine to you after excluding other diseases, especially of your bowels and concluding that you suffer from IBS with constipation.
Vaš zdravnik vam je dal to zdravilo, ko je izključil druge bolezni, še posebej črevesne bolezni, in je zaključil, da imate sindrom razdražljivega črevesja z zaprtostjo.
As a precautionary measure, it is preferable to avoid the use of Constella during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Constella bolje izogibati.
Gender is not expected to have any impact on dosing.
Ni pričakovati, da bi starost vplivala na odmerjanje.
There is limited amount of data from the use of linaclotide in pregnant women.
Podatki o uporabi linaklotida pri nosečnicah so omejeni.
Clinical studies to determine the impact of age and gender on the clinical pharmacokinetics of linaclotide have not been conducted because it is rarely detectable in plasma.
Kliničnih študij za ugotavljanje vpliva starosti in spola na klinično farmakokinetiko linaklotida niso izvedli, saj je v plazmi le redko zaznaven.
EXP Once opened, use within 18 weeks.
EXP Po prvem odprtju vsebino porabite v 18 tednih.
The capsule should be taken at least 30 minutes before a meal (see section 4.5).
Kapsulo je treba vzeti vsaj 30 minut pred obrokom (glejte poglavje 4.5).
In general, linaclotide is minimally detectable in plasma following therapeutic oral doses and therefore standard pharmacokinetic parameters cannot be calculated.
Na splošno je linaklotid v plazmi po terapevtskem peroralnem odmerku minimalno zaznaven, zato standardnih farmakokinetičnih parametrov ni mogoče izračunati.
The effect of linaclotide and its metabolites to inhibit the common intestinal enzymes (CYP2C9 and CYP3A4) and liver enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) or to induce liver enzymes (CYP1A2, 2B6, and 3A4/5) was investigated in vitro.
Učinek linaklotida in njegovih presnovkov pri zaviranju pogostih črevesnih encimov (CYP2C9 in CYP3A4) ter jetrnih encimov (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4) ali na indukcijo jetrnih encimov (CYP1A2, 2B6 in 3A4/5) so preučili in vitro.
If you are breast-feeding, do not take Constella unless your doctor advises to do so.
Če dojite, ne jemljite zdravila Constella, razen če vam tako naroči vaš zdravnik.
Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family.
Linaklotid je sintetični peptid s 14 aminokislinami, ki so strukturno sorodne endogeni gvanilin peptidni družini.
Fertility Animal studies indicate that there is no effect on male or female fertility.
Plodnost Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja pri moških ali ženskah.
Keep the canisters in the bottle.
Vsebnike pustite v plastenki.
Following single doses of up to 966 micrograms and multiple doses up to 290 micrograms of linaclotide, there were no detectable plasma levels of parent compound or the active metabolite (des-tyrosine).
Po enkratnemu odmerku do 966 mikrogramov in večkratnih odmerkih do 290 mikrogramov linaklotida v plazmi ni bilo zaznavnih ravni prvotne spojine ali aktivnega presnovka (des-tirozina).
Unopened bottle for 10 capsules: 2 years.
V zaprti plastenki, ki vsebuje 10 kapsul: 2 leta.
Should prolonged (e.g. more than 1 week) or severe diarrhoea occur, medical advice should be sought and temporary discontinuation of linaclotide until diarrhoea episode is resolved may be considered.
Če se pojavi dolgotrajna (tj. več kot 1 teden) ali huda driska, mora bolnik poiskati zdravniški nasvet; v poštev pride začasna prekinitev jemanja linaklotida, dokler epizoda driske ni zaključena.
Special populations Patients with renal or hepatic impairment
Posebne skupine bolnikov Bolniki z okvaro ledvic ali jeter
Linaclotide is a Guanylate Cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities.
Linaklotid je agonist receptorja gvanilat ciklaze-C (GC-C) z visceralnim analgetičnim in sekretornim delovanjem.
Clinically meaningful response in overall IBS-QoL (> 14 points difference) was achieved in 54% of linaclotide treated patients vs. 39% in placebo treated patients.
Klinično pomemben odziv celokupnega IBS-QoL (> 14 točk razlike) je bil dosežen pri 54 % bolnikov, zdravljenih z linaklotidom, v primerjavi z 39 % bolnikov, zdravljenih s placebom.
LS mean difference
Povprečna razlika LS
Constella has no or negligible influence on the ability to drive and use machines.
Zdravilo Constella nima vpliva oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
As linaclotide is rarely detectable in plasma following therapeutic doses, standard distribution studies have not been conducted.
Ker se linaklotid po uporabi terapevtskih odmerkov redko zazna v plazmi, standardnih študij porazdelitve niso izvajali.
• low level of potassium in your blood
• nizka raven kalija v krvi
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted as required.
Pri prevelikem odmerku je treba bolnike zdraviti simptomatično in uvesti podporne ukrepe.
If you forget to take Constella
Če ste pozabili vzeti zdravilo Constella
• bleeding from the bowel or rectum including bleeding from piles/haemorrhoids
• krvavenje iz črevesja ali danke, vključno s krvavenjem hemeroidov
The capsule should be taken 30 minutes before a meal (see section 4.2).
Kapsulo je treba vzeti vsaj 30 minut pred obrokom (glejte poglavje 4.2).
Microcrystalline cellulose Hypromellose 4-6 mPa's - substitution type 2910 Calcium chloride dihydrate Leucine
Vsebina kapsule mikrokristalna celuloza hipromeloza 4-6 mPa - substitucijski tip 2910 kalcijev klorid dihidrat levcin
In one clinical study (study 1), 804 patients were treated with Constella 290 micrograms or placebo once daily for 26 weeks.
V eni klinični študiji (študija 1) so 802 bolnika 26 tednov zdravili z zdravilom Constella 290 mikrogramov ali s placebom enkrat na dan.
Results of this study showed that neither peptide is an inhibitor of the common efflux and uptake transporters studied at clinically relevant concentrations.
Rezultati te študije so pokazali, da noben od peptidov ne zavira splošnih izločevalnih in privzemnih prenašalcev, kar so preučili pri klinično relevantnih koncentracijah.
Additional caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with cardiovascular (CV) diseases, diabetes, hypertension), and electrolyte control should be considered.
Pri bolnikih, ki so nagnjeni k motnjam ravnovesja vode ali elektrolitov (tj. starostniki, bolniki z boleznimi srca in ožilja, sladkorno boleznijo, hipertenzijo) morate razmisliti o nadzorovanju elektrolitov.
The most frequently reported adverse reaction associated with Constella therapy was diarrhoea, mainly mild to moderate in intensity, occurring in less than 20% of patients.
Neželeni učinek, o katerem so pri zdravljenju z zdravilom Constella najpogosteje poročali, je bila v glavnem blaga do zmerno huda driska, ki se je pojavila pri manj kot 20 % bolnikov.
Other signs and symptoms of IBS-C including bloating, complete spontaneous bowel movement (CSBM) frequency, straining, stool consistency, were improved in linaclotide treated patients vs. placebo (p<0.0001) as shown in the following table.
Drugi znaki in simptomi sindroma razdražljivega črevesja z zaprtostjo, vključno z napenjanjem, pogostnostjo popolne spontane defekacije (CSBM - complete spontaneous bowel movement), naporom, konsistenco blata, so se izboljšali pri bolnikih, zdravljenih z linaklotidom v primerjavi s placebom (p<0,0001), kot je prikazano v spodnji tabeli.
In rare and more severe cases, this may - as a consequence - lead to the occurrence of dehydration, hypokalaemia, blood bicarbonate decrease, dizziness, and orthostatic hypotension.
V redkih in hudih primerih lahko to povzroči dehidracijo, hipokaliemijo, znižane ravni hidrogenkarbonata v krvi, omotico in ortostatsko hipotenzijo.
In those patients in whom diarrhoea led to discontinuation, it resolved after a few days of discontinuing treatment.
Pri teh bolnikih je driska izzvenela nekaj dni po prekinitvi zdravljenja.
Diarrhoea is normally short lived; however, if you experience severe or prolonged diarrhoea (passing frequent or watery stools for 7 days or more) and feel lightheaded, dizzy or faint, stop taking Constella and contact your doctor.
Driska je običajno kratkotrajna, če pa se pojavi huda ali dolgotrajna driska (pogosto ali tekoče blato, ki traja 7 dni ali več) in imate občutek vrtoglavice, ste omotični ali omedlite, prenehajte jemati zdravilo Constella in se posvetujte s svojim zdravnikom.