natgillin/translations-raw huggingface dataset:
• If you have been prescribed BiResp Spiromax as your only inhaler, read the section called (B) Using
• Če vam je zdravilo BiResp Spiromax zdravnik predpisal kot edini inhalator, preberite poglavje
• Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• antipsihotična fenotiazinska zdravila (npr. klorpromazin in proklorperazin).
Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Ne uporabljajte inhalatorja BiResp Spiromax 320/9 mikrogramov kot olajševalca.
BiResp Spiromax is not intended for the initial management of asthma.
Zdravilo BiResp Spiromax ni primerno za začetno zdravljenje astme.
µg bd + terbutaline 0.4 mg as needed Salmeterol/fluticasone 2 x 25/125 µg bd + terbutaline 0.4 mg as needed
1103 125 0,23b budezonid/formoterolijev fumarat dihidrat 320/9 µg 2-krat na dan + terbutalin 0,4 mg po potrebi salmeterol/flutikazon 2×25/125 µg 2-krat na dan + terbutalin 0,4 mg po potrebi
Swensweg 5, 2031GA Haarlem The Netherlands
Swensweg 5, 2031 GA Haarlem Nizozemska
Method of administration Inhalation use.
Način uporabe za inhaliranje
BiResp Spiromax is indicated for use in adults 18 years of age and older only.
Zdravilo BiResp Spiromax je namenjeno izključno za uporabo pri odraslih osebah, starih 18 let in več.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Občasni modrice
If you forget to use BiResp Spiromax
Če ste pozabili uporabiti zdravilo BiResp Spiromax
Bronchospasm
Redki bronhospazem
Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + as needed
Študija mesecev budezonid/formoterolijev fumarat dihidrat 160 µg /4,5 µg 2-krat na dan + po potrebi
BiResp Spiromax is indicated in adults 18 years of age and older only.
Zdravilo BiResp Spiromax je indicirano izključno pri odraslih, starih 18 let in več.
BiResp Spiromax maintenance and reliever therapy: BiResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms.
Zdravilo BiResp Spiromax za vzdrževalno in olajševalno zdravljenje: Zdravilo BiResp Spiromax se uporablja za vzdrževalno zdravljenje in hkrati kot olajševalec po potrebi, ko se pojavijo simptomi.
Patients should be advised to have their rescue inhaler available at all times, either BiResp Spiromax (for asthma patients using BiResp Spiromax as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using BiResp Spiromax as maintenance therapy only).
Bolnikom svetujte, naj imajo inhalator z olajševalcem vedno pri roki, bodisi BiResp Spiromax (za bolnike z astmo, ki uporabljajo zdravilo BiResp Spiromax za vzdrževalno in olajševalno zdravljenje),
1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening.
1 ali 2 vdiha (sprožitvi) dvakrat na dan, uporabi se zjutraj in zvečer.
Hospitalisation/emergency room treatment or treatment with oral steroids b
Opredeljeno kot bolnišnično zdravljenje, urgentno zdravljenje ali pa kot zdravljenje s peroralnimi steroidi.
BiResp Spiromax maintenance and reliever therapy should especially be considered for patients with:
Vzdrževalno in olajševalno zdravljenje z zdravilom BiResp Spiromax je primerno predvsem za bolnike:
Hypokalaemia
Redki hipokaliemija
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.
Ko je inhalator poln, kaže kazalnik 120 inhalacij in se konča z 0 (nič) inhalacijami, ko je prazen.
BiResp Spiromax is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Zdravilo BiResp Spiromax NI namenjeno za uporabo pri otrocih, starih 12 let in manj, ali mladostnikih, starih od 13 do 17 let.
If you stop using BiResp Spiromax
Če ste prenehali uporabljati zdravilo BiResp Spiromax
What BiResp Spiromax looks like and contents of the pack
Izgled zdravila BiResp Spiromax in vsebina pakiranja
Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Bolezni imunskega sistema Redki takojšnje in zapoznele preobčutljivostne reakcije npr. eksantem, urtikarija, pruritus, dermatitis,
(B) Using BiResp Spiromax as your only asthma inhaler
(B) Uporaba zdravila BiResp Spiromax kot edinega inhalatorja za astmo
Patients should be advised to always have BiResp Spiromax available for rescue use.
Bolnikom je treba svetovati, da naj imajo zdravilo BiResp Spiromax vedno na razpolago za hitro obvladanje simptomov.
Lactose monohydrate.
Zelo redki hiperglikemija
Patients should be reminded to take their BiResp Spiromax maintenance dose as prescribed, even when asymptomatic.
Bolnike je treba opozoriti, naj uporabljajo vzdrževalni odmerek zdravila BiResp Spiromax skladno z navodili zdravnika, tudi če nimajo simptomov.
If either of these symptoms occur, stop using BiResp Spiromax straightaway and use your 'reliever inhaler' if you have one.
Če se pojavi kateri od teh simptomov, takoj nehajte uporabljati inhalator BiResp Spiromax in uporabite svoj
In animal studies formoterol has caused adverse reactions in reproduction studies at very high systemic exposure levels (see section 5.3).
V študijah vpliva na sposobnost razmnoževanja pri živalih je formoterol pri zelo veliki sistemski izpostavljenosti zdravilu povzročil nekatere neželene učinke (glejte poglavje 5.3).
In pharmacokinetic studies with and without a charcoal blockage, BiResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
Prolongation of QTc-interval
Zelo redki angina pektoris podaljšanje intervala QTc
Only use BiResp Spiromax in this way if your doctor has told you to. Use your BiResp Spiromax every day.
Zdravilo BiResp Spiromax uporabljajte na ta način le, če vam je tako naročil zdravnik.
BiResp Spiromax contains lactose
Zdravilo BiResp Spiromax vsebuje laktozo.
Patients should take 1 additional inhalation as needed in response to symptoms.
Ob pojavu simptomov naj bolniki po potrebi naredijo še 1 dodaten vdih.
b) You may be prescribed BiResp Spiromax as your only asthma inhaler.
b) Lahko vam predpišejo inhalator BiResp Spiromax kot edini inhalator za zdravljenje astme.
Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
supraventrikularna tahikardija, ekstrasistole
BiResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Mehanizem delovanja in farmakodinamični učinki Zdravilo BiResp Spiromax vsebuje učinkovini formoterol in budezonid, ki imata različna mehanizma delovanja, njuni učinki pri zmanjšanju pogostnosti poslabšanj astme pa so aditivni.
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.
Ko je inhalator poln, kaže kazalnik 60 inhalacij in se konča z 0 (nič) inhalacijami, ko je prazen.
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.
Zdravljenje z zdravilom BiResp Spiromax ni ustrezno pri odraslih bolnikih z blago obliko astme, ki ni ustrezno nadzorovana z inhalacijskim kortikosteroidi in inhalacijskimi kratkodelujočimi agonisti adrenergičnih adrenoreceptorjev β2, ki se uporabljajo po potrebi.
How to use BiResp Spiromax
Kako uporabljati zdravilo BiResp Spiromax
Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Cushingov sindrom, Cushingoidne značilnosti, supresijo nadledvične žleze, upočasnitev rasti pri otrocih in mladostnikih, zmanjšanje kostne mineralne gostote, katarakto in glavkom.
BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
tem primeru je treba zdravljenje z zdravilom BiResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja (glejte poglavje 4.4).
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
Adults (18 years and older): • 1 inhalation twice a day, taken in the morning and in the evening.
Odrasli (18 let in več) 1 vdih (sprožitev) dvakrat na dan, uporabi se zjutraj in zvečer.
Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using BiResp Spiromax due to the lactose excipient.
Bolnikom svetujte tudi, naj si po inhaliranju sperejo usta z vodo (glejte poglavje 4.4).
Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Občasni agresija, psihomotorična hiperaktivnost,
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).
katarakta (motnost očesne leče), glavkom (zvišan tlak v očesu), upočasnjena rast pri otrocih in mladostnikih, vpliv na nadledvično žlezo (majhna žleza nad ledvico).
1 inhalation twice daily
vdiha dvakrat na dan.
• Low levels of potassium in your blood.
Redki: nizka koncentracija kalija v krvi,
BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje
Your doctor may increase this to 2 inhalations twice a day.
Zdravnik vam lahko poveča uporabo na 2 vdiha dvakrat na dan.
BiResp Spiromax 320 micrograms/9 micrograms inhalation powder
BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje
Inhalation powder
OVOJNINAH INHALATOR
Not more than 6 inhalations should be taken on any single occasion.
Naenkrat ne smejo narediti več kot 6 vdihov.
Patients should be reassessed regularly by their prescriber/health care provider so that the dose of BiResp Spiromax remains optimal.
Zdravljenje bolnikov mora redno ovrednotiti zdravnik, ki predpisuje zdravilo, tako da odmerek zdravila BiResp Spiromax ostane optimalen.
Adults (18 years and older)
Priporočeni odmerek: Odrasli (18 let in več)
• cataract (clouding of the lens in the eye)
• katarakta (motnost očesne leče),
BiResp Spiromax maintenance therapy
Zdravilo BiResp Spiromax za vzdrževalno zdravljenje
• Steroid tablets that you take by mouth (such as prednisolone).
• steroidne tablete za peroralno uporabo (npr. prednizolon).
Start
Začetek:
Study 6 months
6.3 Rok uporabnosti
Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems including nausea, vomiting, pain and diarrhoea,
Simptomi slabšega delovanja nadledvične žleze so lahko utrujenost, šibkost, težave z želodcem, vključno z navzeo,
If the patient experiences paradoxical bronchopasm BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
V tem primeru je treba zdravljenje z zdravilom BiResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja.
BiResp Spiromax pharmacokinetic profile
Farmakokinetični profil zdravila BiResp Spiromax
2 inhalers each containing 60 doses.
2 inhalatorja, ki vsebujeta vsak po 60 odmerkov.
Adults (18 years and older): 2 inhalations twice daily
Priporočeni odmerki: Odrasli (18 let in več): 2 vdiha dvakrat na dan
Preparing your new BiResp Spiromax
Priprava novega inhalatorja BiResp Spiromax
BiResp Spiromax maintenance and reliever therapy
Zdravilo BiResp Spiromax za vzdrževalno in olajševalno zdravljenje
2 inhalers each containing 120 doses.
2 inhalatorja, ki vsebujeta vsak po 120 odmerkov.
1 inhalation (actuation), twice a day, taken in the morning and in the evening.
• 1 vdih dvakrat na dan, uporabi se zjutraj in zvečer.
Adults (18 years and older): 1 inhalation twice daily.
Priporočeni odmerki: Odrasli (18 let in več): 1 vdih dvakrat na dan.
Before using your BiResp Spiromax for the first time, you need to prepare it for use as follows:
Preden prvikrat uporabite nov inhalator BiResp Spiromax, ga morate pripraviti za uporabo na naslednji način: • Vrečko iz folije odprite, tako da jo raztrgate na zarezi na vrhu vrečke iz folije, in iz nje vzemite inhalator.
The most common symptoms that may occur after when you use more BiResp Spiromax than you should are trembling, headache or a rapid heartbeat.
Najpogostejši simptomi, ki se lahko pojavijo, če ste uporabili večji odmerek zdravila BiResp
BiResp Spiromax 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema).
Pojavijo se lahko simptomi, kot so zamašen nos ali izcedek iz nosu, šibkost,
Each BiResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
60 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim pokrovčkom ustnika.
BiResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 160 mcg/4,5 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
What you need to know before you use BiResp Spiromax 3.
Kaj je zdravilo BiResp Spiromax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo BiResp Spiromax Kako uporabljati zdravilo BiResp Spiromax
BiResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
Serious asthma-related adverse reactions and exacerbations may occur during treatment with BiResp Spiromax.
Med zdravljenjem z zdravilom BiResp Spiromax se lahko pojavijo resni neželeni učinki, povezani z astmo, in poslabšanje bolezni.
Using BiResp Spiromax and a separate ‘reliever inhaler'.
potem preberite poglavje »(A) Uporaba zdravila BiResp Spiromax in ločenega inhalatorja z olajševalcem«.
Immune system disorders Rare
Zelo redki motnje okušanja
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of BiResp Spiromax as-needed inhalations.
Pri bolnikih, ki pogosto uporabljajo veliko število inhalacij zdravila BiResp Spiromax po potrebi, je treba skrbno nadzorovati z odmerkom povezane neželene učinke.
(A) Using BiResp Spiromax and a separate ‘reliever inhaler'
(A) Uporaba zdravila BiResp Spiromax in ločenega inhalatorja z olajševalcem Zdravilo BiResp Spiromax uporabljajte vsak dan.
How to store BiResp Spiromax
Shranjevanje zdravila BiResp Spiromax
Package leaflet: Information for the patient BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Navodilo za uporabo BiResp Spiromax 320 mikrogramov/9 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
Tell your doctor if you have any of the following while taking BiResp Spiromax they could be symptoms of a lung infection:
• pljučnica (okužba pljuč) pri bolnikih s KOPB (pogost neželen učinek) Svojemu zdravniku morate povedati, če imate med jemanjem zdravila BiResp Spiromax kar koli od naštetega, ker so to lahko simptomi okužbe pljuč:
BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
• Increased mucus production, change in mucus colour
• zvišano telesno temperaturo ali mrzlico, • obilnejše nastajanje sluzi, spremenjeno barvo sluzi,
Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.
Če ste bolni, npr. imate okužbo v prsnem košu ali pred operacijo vam bo zdravnik morda poleg vašega običajnega zdravljenja predpisal še steroide v tabletah.
Package leaflet: Information for the patient BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Navodilo za uporabo BiResp Spiromax 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
BiResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with BiResp Spiromax.
Če po uvedbi zdravila BiResp Spiromax simptomi astme niso nadzorovani ali se poslabšajo, naj bolniki nadaljujejo z zdravljenjem in poiščejo zdravniško pomoč.
EXPIRY DATE
Občasni navzea
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Kljub temu je lahko v določenih omejenih časovnih obdobjih celotni dnevni odmerek 12 vdihov.
Budesonide/formoterol maintenance and reliever therapy
Vzdrževalno in olajševalno zdravljenje astme z budezonidom/formoterolom
N Severe exacerbationsa Events Events/ patient-year
N Huda poslabšanja a
Tachycardia
Občasni tahikardija
Palpitations
Pogosti palpitacije
• If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A)
• Če vam je zdravnik predpisal zdravilo BiResp Spiromax in ločen inhalator z olajševalcem,
Oral solution Neonatal calves less than 12 hours of age
Zdravilo Locatim je peroralna raztopina, ki se jo pridobiva iz kolostruma in se jo daje teletom v prvih 12 urah življenja.
60 ml
Stran 2/2
Packaging Content Package sizeWithdrawal period
Za zdravilo Locatim ni posebnih previdnostnih ukrepov.
Type III glass bottles
Zdravilna učinkovina zdravila so specifični imunoglobulini G (vrsta protiteles) proti adhezinu Escherichia coli F5.
1 bottle Zero days
Obdobje karence je nič dni.
38.5 mcg Powder for concentrate and solution for solution for infusion
38,5 mcg Prašek za koncentrat in raztopina za raztopino za infundiranje
Powder: 38.5 mcg Solution: 10 mL
38,5 mcg Raztopina: 10 ml
1 vial (powder) + 1 vial (solution)
1 viala (prašek) + 1 viala (raztopina)
Intravenous use Powder: vial (glass)
Prašek: viala (steklena) Raztopina: viala (steklena)
Pack size
Prašek:
The companies that market these medicines include Bayer GmbH and Lundbeck A/S.
Družbi, ki tržita ta zdravila, sta Bayer GmbH in Lundbeck A/S.
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.
Zdravilo Saroten in povezana imena (kot sta Redomex in Sarotex) se tržijo v Avstriji, Belgiji, Estoniji, Nemčiji, Grčiji, Luksemburgu,na Cipru, Danskem, Nizozemskem in Švedskem ter tudi na Norveškem.
The European Commission issued a decision on this opinion on 08/05/2017.
Evropska komisija je o tem mnenju izdala odločbo dne 8. maja 2017.
The medicine should not be given to children to treat depression or pain.
Zdravilo se ne sme dajati otrokom za zdravljenje depresije ali bolečin.
Why was Saroten reviewed?
Zakaj je bilo zdravilo Saroten pregledano?
On 23 February 2017, the European Medicines Agency completed a review of Saroten.
Evropska agencija za zdravila je 23. februarja 2017 zaključila pregled zdravila Saroten.
• treatment to prevent migraine.
• zdravljenje za preprečevanje migrene.
Saroten is authorised in the EU via national procedures.
Zdravilo Saroten je bilo v EU odobreno po nacionalnih postopkih.
The Committee agreed that the medicine could also be used in children from 6 years of age to treat nocturnal enuresis.
Odbor se je strinjal, da se zdravilo lahko uporablja tudi za otroke, starejše od 6 let, za zdravljenje nočne enureze.
Amitriptyline is also available in EU countries as generic amitriptyline.
Amitriptilin je v državah EU na voljo tudi kot generični amitriptilin.
Use is not permitted in children less than 6 years of age.
Uporaba zdravila ni priporočljiva pri otrocih, mlajših od 6 let.
Other amendments included the information on interactions with other medicines (4.5), and the list of side effects (4.8).
Druge spremembe so vključevale informacijo o medsebojnem delovanju z drugimi zdravili (poglavje 4.5) in seznam neželenih učinkov (poglavje 4.8).
• the treatment of serious depression (major depressive disorder)
• zdravljenje hude depresije (velike depresivne motnje);
4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for:
4.1 Terapevtske indikacije Odbor CHMP se je strinjal, da se zdravilo Saroten in povezana imena lahko uporabljajo pri odraslih za:
Questions and answers on Saroten and associated names (amitriptyline)
Vprašanja in odgovori o zdravilu Saroten in povezanih imenih (amitriptilin)
The CHMP harmonised the doses to be used in the approved indications.
Odbor CHMP je uskladil odmerke, ki se uporabljajo za odobrene indikacije.
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.
Ne sme se uporabljati pri bolnikih, ki so imeli pred kratkim srčni napad ali imajo motnje električne aktivnosti srca ali srčnega ritma ali zmanjšan pritok krvi v srce, in pri bolnikih s hudim obolenjem jeter.
• treatment to prevent chronic tension-type headache (CTTH)
• zdravljenje za preprečevanje kroničnega glavobola tenzijskega tipa (CTTH);
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 zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju amitriptilina v Evropski uniji (EU).
On 17 December 2015, the Greek medicines regulator, the National Organization for Medicines (EOF), referred the matter to the CHMP in order to harmonise the marketing authorisations for Saroten and associated names in the EU.
Grška regulativna agencija za zdravila, nacionalna organizacija za zdravila (EOF), je 17. decembra 2015 zadevo napotila na odbor CHMP, da bi se uskladila dovoljenja za promet z zdravilom Saroten in povezanimi imeni v EU.
What is Saroten?
Kaj je zdravilo Saroten?
It contains the active substance amitriptyline.
Vsebuje zdravilno učinkovino amitriptilin.
It should only be prescribed by a specialist doctor and should only be used when physical causes of the problem (including conditions such as spina bifida) have been ruled out and when other treatments, including other medicines used for this problem, have not worked.
Zdravilo lahko predpisuje le zdravnik specialist in se lahko uporablja le, kadar so bili fizični vzroki (vključno s stanji, kot je spina bifida) izključeni ter druga zdravljenja in zdravila za zdravljenje tega stanja niso delovala.
• the treatment of neuropathic pain (long-lasting pain caused by nerve damage)
• zdravljenje nevropatske bolečine (dolgotrajne bolečine, ki jo povzroča poškodba živcev);