natgillin/translations-raw huggingface dataset:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
The reliever inhalations of BiResp Spiromax should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise.
Inhalacije lijeka BiResp Spiromax za terapiju akutnih pogoršanja astme nužno je uzeti kao odgovor na simptome astme, ali one nisu namijenjene za redovitu profilaksu, npr. prije vježbanja.
Keep the mouthpiece cover closed and use within 6 months of removing from foil wrapping.
Poklopac nastavka za usta držite zatvorenom i upotrijebite unutar 6 mjeseci nakon skidanja folije.
Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Nemojte koristiti BiResp Spiromax 320/9 mikrograma kao „inhalator za brzo ublažavanje simptoma“.
There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.
Nema dostupnih podataka o primjeni kombiniranog lijeka s fiksnom dozom budezonida i formoterolfumarat dihidrata u bolesnika s oštećenom jetrom ili bubrezima.
• an effect on the adrenal gland (a small gland next to the kidney).
• učinak na nadbubrežnu žlijezdu (malu žlijezdu smještenu neposredno pokraj bubrega).
Other medicines and BiResp Spiromax
Drugi lijekovi i BiResp Spiromax
BiResp Spiromax maintenance therapy: BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Terapija održavanja lijekom BiResp Spiromax: BiResp Spiromax uzima se kao redovita terapija održavanja s posebnim inhalatorom koji sadrži brzodjelujući bronhodilatator za hitno simptomatsko liječenje.
Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.
Simptomi supresije nadbubrežne žlijezde mogu biti umor, slabost, želučane tegobe uključujući mučninu, povraćanje, bol i proljev, potamnjela koža i gubitak težine.
Only use BiResp Spiromax in this way if your doctor has told you to. Use your BiResp Spiromax every day.
Primjenjujte BiResp Spiromax na ovaj način samo ako vam je tako odredio vaš liječnik.
Use your BiResp Spiromax every day.
Svakodnevno koristite BiResp Spiromax.
The toxicity observed in animal studies with budesonide and formoterol, given in combination or separately, were effects associated with exaggerated pharmacological activity.
5.3 Neklinički podaci o sigurnosti primjene Toksičnost zabilježena u ispitivanjima na životinjama s budezonidom i formoterolom, davanima kombinirano ili zasebno, bili su učinci povezani s prekomjernom farmakološkom aktivnošću.
However, do not use BiResp Spiromax just before exercise to stop asthma symptoms from happening.
Međutim, nemojte primjenjivati BiResp Spiromax neposredno prije tjelovježbe kako biste spriječili pojavu simptoma.
BiResp Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
BiResp Spiromax nije odgovarajuće liječenje za odraslog bolesnika koji ima samo blagi oblik astme i koji nije zadovoljavajuće kontroliran inhalacijskim kortikosteroidom i ″prema potrebi″ inhalacijskim ß2-adrenoreceptorskim agonistima kratkog djelovanja.
For some patients a maintenance dose of 2 inhalations twice daily may be appropriate.
Za neke bolesnike može biti prikladna doza održavanja od 2 inhalacije dvaput dnevno.
BiResp Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
BiResp Spiromax NIJE indiciran za primjenu u djece s navršenih 12 godina i mlađu niti za adolescente u dobi od 13 do 17 godina.
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of BiResp Spiromax as-needed inhalations.
Pomno praćenje nuspojava ovisnih o primijenjenoj dozi potrebno je u bolesnika koji učestalo uzimaju veliki broj inhalacija lijeka BiResp Spiromax po potrebi.
A lower strength of BiResp Spiromax is available for the maintenance and reliever therapy regimen.
Dostupne su niže doze lijeka BiResp Spiromax za održavanje i brzo simptomatsko liječenje.
Patients should not be initiated on BiResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Bolesnici ne smiju započinjati liječenje lijekom BiResp Spiromax tijekom egzacerbacije, niti tijekom značajnog ili akutnog pogoršanja astme.
Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.
Učinak na gustoću kostiju Mora se uzeti u obzir potencijalne učinke na gustoću kostiju, poglavito u bolesnika koji primaju visoke doze kroz dulje vrijeme, a istodobno imaju čimbenike rizika za osteoporozu.
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time.
Inhalirani kortikosteroidi mogu utjecati na normalno stvaranje steroidnih hormona u Vašem tijelu,
• Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• fenotiazinske antipsihotike (poput klorpromazina i proklorperazina).
1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening.
1 ili 2 inhalacije (potisaka), dvaput dnevno, uzeti ujutro i navečer.
Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of 80 micrograms
Provedena su dva pedijatrijska ispitivanja u trajanju od 12 tjedana u kojima je 265 djece u dobi od 6 do 11 godina bilo liječeno dozom održavanja budezonida/formoterola (2 inhalacije od 80 mikrograma/4,5 mikrograma po inhalaciji dva puta dnevno) i kratkodjelujućim ß2 adrenoreceptorskim agonistom po potrebi.
1 inhalation (actuation), twice a day, taken in the morning and in the evening.
1 inhalacija (potisak), dvaput dnevno, uzeti ujutro i navečer.
If either of these symptoms occur, stop using BiResp Spiromax straightaway and use your ‘reliever inhaler' if you have one.
Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka BiResp Spiromax i primijenite svoj „inhalator za brzo ublažavanje simptoma“, ako ga imate.
Not more than 6 inhalations should be taken on any single occasion.
Odjednom se ne smije primijeniti više od 6 inhalacija.
b) You may be prescribed BiResp Spiromax as your only asthma inhaler.
b) Možda će Vam se propisati BiResp Spiromax kao jedini inhalator za astmu.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of BiResp Spiromax.
Nakon što se postigne kontrola simptoma astme, može se razmotriti postupno smanjenje doze lijeka BiResp Spiromax.
Keep the mouthpiece closed all the time unless you are about to use your inhaler.
Nastavak za usta stalno držite zatvorenim osim ako se ne spremate uzeti inhalaciju.
If patients find the treatment ineffective, or exceed the highest recommended dose of BiResp Spiromax, medical attention must be sought (see section 4.2).
Ako bolesnici smatraju liječenje neučinkovitim ili prekorače najvišu preporučenu dozu lijeka BiResp
In patients using potent CYP3A4 inhibitors, a fixed-dose combination of budesonide and formoterol fumarate dihydrate maintenance and reliever therapy is not recommended.
U bolesnika koji koriste potentne inhibitore CYP3A4 ne preporučuje se terapija održavanja i terapija ublažavanja akutnih simptoma astme kombinacijom fiksne doze budezonida i formoterolfumarat dihidrata.
Preparing your new BiResp Spiromax
Priprema Vašeg novog inhalatora BiResp Spiromax
Budesonide/formoterol maintenance therapy
Astma Terapija održavanja budezonidom/formoterolom
BiResp Spiromax is indicated in adults 18 years of age and older only.
BiResp Spiromax indiciran je samo u odraslih u dobi od 18 godina i starijih.
Your doctor may increase this to 2 inhalations twice a day.
Vaš liječnik ovo može povećati na 2 inhalacije dvaput dnevno.
• inadequate asthma control and in frequent need of a reliever inhaler.
• neadekvatnom kontrolom astme i učestalom primjenom inhalatora za hitno simptomatsko liječenje
BiResp Spiromax 320 micrograms/9 micrograms inhalation powder
BiResp Spiromax 320 mikrograma/9 mikrograma prašak inhalata
Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + as needed
Budezonid/formoterolfumarat dihidrat 160/4,5 µg dvaput dnevno + po potrebi
Patients should be reassessed regularly by their prescriber/health care provider so that the dose of BiResp Spiromax remains optimal.
Bolesnike mora redovito procijenjivati liječnik koji im propisuje lijekove/pružatelj zdravstvene skrbi kako bi doza inhalatora BiResp Spiromax ostala optimalna.
If you forget to use BiResp Spiromax
Ako ste zaboravili primijeniti BiResp Spiromax
Study No.
nije ispitana.
BiResp Spiromax maintenance and reliever therapy: BiResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms.
BiResp Spiromax uzima se kao redovita terapija održavanja i po potrebi u odnosu na simptome.
If you stop using BiResp Spiromax
Ako prestanete primjenjivati BiResp Spiromax
You do not need a separate ‘reliever inhaler' for this.
Za to Vam ne treba zaseban 'inhalator za brzo ublažavanje simptoma'.
(A) Using BiResp Spiromax and a separate ‘reliever inhaler'
(A) Primjena lijeka BiResp Spiromax i zasebnog 'inhalatora za brzo ublažavanje simptoma'
When it is appropriate to titrate down to a lower strength than is available for BiResp Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Kad je primjereno titrirati dozu na nižu jačinu od one koja je dostupna u lijeku BiResp Spiromax, potrebna je zamjena s drugim kombiniranim lijekom s fiksnom dozom budezonida i formoterolfumarata, koji sadrži nižu dozu inhalacijskog kortikosteroida.
BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
BiResp Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata
Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
adrenalnu supresiju, zastoj u rastu djece i adolescenata, smanjenje mineralne gustoće kosti, kataraktu i glaukom.
Always keep your ‘reliever inhaler' with you and use it to relieve sudden attacks of breathlessness and wheezing.
Uvijek imajte pri ruci „inhalator za ublažavanje simptoma” i primjenjujte ga za ublažavanje iznenadnih napadaja nedostatka zraka i zviždanja u plućima.
Adults (18 years and older): • 1 inhalation twice a day, taken in the morning and in the evening.
Odrasli (s 18 godina i više) • 1 inhalacija dvaput dnevno, uzeti ujutro i navečer.
1 inhaler containing 120 doses.
1 inhalator sadrži 120 doza.
• cataract (clouding of the lens in the eye)
• očnu mrenu (zamućenje očne leće)
BiResp Spiromax maintenance and reliever therapy should especially be considered for patients with:
Terapiju održavanja i terapiju ublažavanja akutnih simptoma astme lijekom BiResp Spiromax se mora posebno razmotriti u bolesnika s:
Adults (18 years and older): 2 inhalations twice a day, taken in the morning and in the evening
Odrasli (s 18 godina i više) 2 inhalacije dvaput dnevno, uzeti ujutro i navečer.
BiResp Spiromax as your only asthma inhaler.
Primjena lijeka BiResp Spiromax kao Vašeg jedinog inhalatora za astmu.
How to store BiResp Spiromax
Kako čuvati BiResp Spiromax
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands.
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Nizozemska.
Linearity/non-linearity Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.
Sistemska izloženost kako budezonidu tako i formoterolu u linearnoj je korelaciji s primijenjenom dozom.
(B) Using BiResp Spiromax as your only asthma inhaler
(B) Primjena lijeka BiResp Spiromax kao jedinog inhalatora za astmu
Contents of the pack and other information
Sadržaj pakiranja i druge informacije Što BiResp sadrži
How to use BiResp Spiromax
Kako primjenjivati BiResp Spiromax
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
(terfenadin) i tricikličkim antidepresivima može produljiti QTc-interval i povećati rizik od ventrikularnih aritmija.
Close: Breathe out gently and close the mouthpiece cover It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax and not to block the air vents when they are preparing the “Breathe” step.
Također je važno uputiti bolesnike da ne protresaju inhalator prije uporabe i da ne izdišu kroz Spiromax te da ne blokiraju otvore za zrak kod pripreme koraka „Udahnite“.
Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Bočna strana: Svaka primijenjena doza sadrži 320 mikrograma budezonida i 9 mikrograma formoterolfumarat dihidrata.
Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.
Potentni inhibitori CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, pozakonazol, klaritromicin,
2 inhalers each containing 120 doses.
2 inhalatora, svaki sadrži 120 doza.
EXP Use the product within 6 months of removing from foil wrapping.
Rok valjanosti Lijek upotrijebite u roku od 6 mjeseci nakon skidanja folije.
Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Jedna primijenjena doza (doza koja izlazi iz nastavka za usta inhalatora Spiromax) sadrži 320 mikrograma budezonida i 9 mikrograma formoterolfumarat dihidrata.
Package leaflet: Information for the patient BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Uputa o lijeku: Informacije za bolesnika BiResp Spiromax 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
160/4.5 µg bd + formoterol 4.5 µg as needed
µg dvaput dnevno + formoterol 4,5 µg po potrebi
Package leaflet: Information for the patient BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Uputa o lijeku: Informacije za bolesnika BiResp Spiromax 160 mikrograma/4,5 mikrograma, prašak inhalata budezonid/ formoterolfumarat dihidrat
6.3 Shelf life
6.1 Popis pomoćnih tvari laktoza hidrat
If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests.
Vaš liječnik će možda zatražiti da redovito obavljate krvne pretrage.
This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
To odgovara odmjerenoj dozi od 400 mikrograma budezonida i 12 mikrograma formoterolfumarat dihidrata.
BiResp Spiromax is indicated for use in adults 18 years of age and older only.
Primjena lijeka BiResp Spiromax indicirana je samo za odrasle u dobi od 18 i više godina.
160/4.5 µg bd + terbutaline 0.4 mg as needed a
µg dvaput dnevno + terbutalin 0,4 mg po potrebi a
BiResp Spiromax pharmacokinetic profile
Farmakokinetički profil lijeka BiResp Spiromax
Patients should be advised to always have BiResp Spiromax available for rescue use.
Bolesnike se mora savjetovati da uvijek imaju dostupan
BiResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
BiResp Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat Za inhaliranje.
What you need to know before you use BiResp Spiromax Do not use BiResp Spiromax if:
Nemojte primjenjivati BiResp Spiromax ako:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze,
For BiResp Spiromax there are two treatment approaches:
Dva su pristupa liječenju lijekom BiResp Spiromax:
The effects include: changes in bone mineral density (thinning of the bones) cataract (clouding of the lens in the eye) glaucoma (increased pressure in the eye) a slowing of the rate of growth of children and adolescents an effect on the adrenal gland (a small gland next to the kidney).
• usporavanje brzine rasta u djece i adolescenata • učinak na nadbubrežnu žlijezdu (malu žlijezdu smještenu neposredno pokraj bubrega).
If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using BiResp Spiromax.
Ako se bilo što od gore navedenog odnosi na Vas ili niste sigurni, prije uporabe lijeka BiResp
BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat Za inhaliranje.
3 inhalers each containing 60 doses.
2 inhalatora, svaki sadrži 60 doza 3 inhalatora, svaki sadrži 60 doza
BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
BiResp Spiromax je indiciran u redovitom liječenju astme kad je primjereno kombinirano liječenje (inhalacijskim kortikosteroidom i dugodjelujućim agonistima ß2-adrenergičkih receptora): -u bolesnika u kojih astma nije zadovoljavajuće kontrolirana inhalacijskim kortikosteroidima i „prema potrebi“ inhalacijskim kratkodjelujućim agonistima ß2-adrenergičkih receptora.
Inhalation powder 1 inhaler containing 60 doses.
1 inhalator sadrži 60 doza.
Adults (18 years and older): 2 inhalations twice daily
Odrasli (s 18 godina i stariji): 2 inhalacije dvaput dnevno Posebne populacije:
In 2 other studies with patients seeking medical attention due to acute asthma symptoms, budesonide/formoterol provided rapid and effective relief of bronchoconstriction similar to salbutamol and formoterol.
budezonid/formoterol omogućio je brzo i učinkovito ublažavanje bronhokonstrikcije slično salbutamolu i formoterolu.
Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Mogući sistemski učinci uključuju Cushingov sindrom, Cushingoidna obilježja, adrenalnu supresiju,
If you stop using BiResp SpiromaxDo not stop using your inhaler without telling your doctor first.
Nemojte prekinuti s primjenom inhalatora bez prethodnog javljanja liječniku.
BiResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 160 μg/4,5 μg prašak inhalata budezonid/formoterolfumarat dihidrat
BiResp Spiromax maintenance therapy
Terapija održavanja lijekom BiResp Spiromax
Using BiResp Spiromax and a separate ‘reliever inhaler'.
pročitajte odjeljak pod naslovom (A) Primjena lijeka BiResp Spiromax i zasebnog 'inhalatora za brzo ublažavanje simptoma'.
• If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A)
• Ako Vam je propisan BiResp Spiromax i zaseban inhalator za brzo ublažavanje simptoma,
Budesonide/Formoterol Furmarate Dihydrate 320/9
Budezonid/formoterol fumaratdihidrat 160/4,5
Powder: 38.5 mcg Solution: 10 mL
Prašak: 38,5 mcg Otopina: 10 ml
38.5 mcg Powder for concentrate and solution for solution for infusion
BLINCYTO 38,5 mcg Prašak za koncentrat i otopina za otopinu za infuziju
Intravenous use Powder: vial (glass)
Intravenska primjena Prašak: bočica (staklo)
1 vial (powder) + 1 vial (solution)
1 bočica (prašak) + bočica (otopina)
The areas harmonised include:
Usklađena područja obuhvaćaju:
The European Commission issued a decision on this opinion on 08/05/2017.
Europska komisija objavila je odluku o tom mišljenju 8.5.2017.
The companies that market these medicines include Bayer GmbH and Lundbeck A/S.
Tvrtke koje stavljaju u promet ove lijekove uključuju Bayer GmbH i Lundbeck A/S.
What is Saroten?
Što je Saroten?
Use is not permitted in children less than 6 years of age.
Nije dopuštena primjena u djece mlađe od 6 godina.
Saroten and associated names (such as Redomex and Sarotex) is marketed in Austria, Belgium, Cyprus, Denmark, Estonia, Germany, Greece, Luxembourg, the Netherlands and Sweden, and also in Norway.
Saroten i povezani nazivi (kao što su Redomex i Sarotex) stavljeni su u promet u Austriji, Belgiji, Cipru, Danskoj, Estoniji, Njemačkoj, Grčkoj, Luksemburgu, Nizozemskoj i Švedskoj, te u Norveškoj.
The medicine should not be given to children to treat depression or pain.
Lijek se ne smije davati djeci za liječenje depresije ili boli.
Why was Saroten reviewed?
Zašto je Saroten ponovno ocjenjivan?
Other amendments included the information on interactions with other medicines (4.5), and the list of side effects (4.8).
Druge izmjene uključuju informacije o interakcijama s drugim lijekovima (4.5.) i popis nuspojava (4.8.).
Saroten is authorised in the EU via national procedures.
Saroten je u zemljama EU-a odobren nacionalnim postupcima.
The CHMP harmonised the doses to be used in the approved indications.
CHMP je uskladio doze koje treba primjenjivati za odobrene indikacije.
Questions and answers on Saroten and associated names (amitriptyline)
Pitanja i odgovori o lijeku Saroten i povezanim nazivima (amitriptilin)
• the treatment of serious depression (major depressive disorder)
• liječenje ozbiljne depresije (ozbiljan depresivni poremećaj)
4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for:
4.1 Terapijske indikacije CHMP se složio da se Saroten i povezani nazivi mogu primjenjivati u odraslih za:
Amitriptyline is also available in EU countries as generic amitriptyline.
Amitriptilin je dostupan u zemljama EU-a i kao generički amitriptilin.
It contains the active substance amitriptyline.
Sadrži djelatnu tvar amitriptilin.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for amitriptyline in the European Union (EU).
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključilo je da postoji potreba za usklađivanjem informacija za propisivanje amitriptilina u Europskoj uniji (EU).
• the treatment of neuropathic pain (long-lasting pain caused by nerve damage)
• liječenje neuropatske boli (dugotrajna bol prouzročena oštećenjem živca)
It must also not be used in patients who have recently had a heart attack or have disorders of the electrical activity or rhythm of the heart or reduced blood flow to the heart muscle, nor in those with severe liver disease.
Također se ne smije primjenjivati u bolesnika koji su nedavno imali srčani udar ili imaju poremećaj električne aktivnosti srca ili srčanog ritma, odnosno ako imaju smanjeni dotok krvi u srčani mišić, ili ako imaju ozbiljnu bolest jetre.
Treatment for depression or chronic pain may take 2 to 4 weeks to start to work, and treatment for depression should be continued for up to 6 months after the patient gets better.
U liječenju depresije ili kronične boli može biti potrebno 2 do 4 tjedna da bi terapija počela djelovati, a liječenje depresije treba nastaviti do 6 mjeseci nakon što se stanje bolesnika poboljša.
The Committee agreed that the medicine could also be used in children from 6 years of age to treat nocturnal enuresis.
Odbor se složio da se lijek smije primjenjivati i u djece u dobi od 6 i više godina za liječenje noćnog mokrenja.