natgillin/translations-raw huggingface dataset:
These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines).
Med tovrstna zdravila sodijo: substance, ki se uporabljajo pri zdravljenju duševnih bolezni (antipsihotiki, hipnotiki, anksiolitiki/sedativi, antidepresivi), močna protibolečinska zdravila (narkotični analgetiki), zdravila za zdravljenje epileptičnih napadov oz. konvulzij (antiepileptična zdravila), anestetiki in zdravila za zdravljenje alergij (sedativni antihistaminiki).
The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis).
Odmerek brez učinka na poporodni razvoj je bil 1 mg/kg/dan (kar ustreza 0,5-kratniku MRHD, izračunano v mg/m2).
The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis).
Odmerek brez učinka na rast podganjih mladičev je bil 10 mg/kg (kar ustreza 5-kratniku MRHD, izračunano v mg/m2).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Meda AB
Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data)
Pogostnosti so definirane kot: 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)
Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).
Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (zlato črnilo SB-3002): šelak, amonijev hidroksid, rumeni železov oksid (E172).
What Sonata contains
Kaj vsebuje zdravilo Sonata
C. OTHER CONDITIONS AND REQUIREMENTS OF THE D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Attention to airway patency and supportive management of ventilation and haemodynamics are usually sufficient.
Običajno zadošča skrb za prehodnost dihalnih poti in zagotavljanje podpore dihanju in hemodinamiki.
Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”.
Izgled zdravila Sonata in vsebina pakiranja Sonata 5 mg trde kapsule, ki vsebujejo svetlo moder prašek, imajo svetlo rjav pokrovček in belo telo z zlatim odtisom »5 mg«.
The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Druge sestavine so mikrokristalna celuloza, predgeliran škrob, silicijev dioksid, natrijev lavrilsulfat, magnezijev stearat, laktoza monohidrat, indigo karmin (E132), titanov dioksid (E171).
Talk to your doctor or pharmacist before taking Sonata.
Pred začetkom jemanja zdravila Sonata se posvetujte z zdravnikom ali farmacevtom.
Reproductive system and breast disorders Common:
Motnje reprodukcije in dojk Pogosto:
Zaleplon has not been adequately studied in patients with severe renal impairment.
Zaleplona niso ustrezno testirali pri bolnikih s hudo ledvično okvaro.
anaphylactic/anaphylactoid reactions
anafilaktične / anafilaktoidne reakcije
The majority of the faecal recovery consists of 5-oxo-zaleplon.
Večino količine zdravila, izločene v blato, sestavlja 5-okso-zaleplon.
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
Če se razvije odvisnost, se lahko pri nenadni prekinitvi zdravljenja pojavijo odtegnitveni simptomi.
In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects.
Pri bolnikih z blago do zmerno ledvično okvaro farmakokinetski profil zaleplona ni pomembno drugačen kot pri zdravih osebah, zato pri teh bolnikih odmerka ni treba prilagajati.
Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk (see section 4.5).
To tveganje povečuje tudi sočasna uporaba zaleplona z alkoholom in drugimi zaviralci osrednjega živčevja (glejte poglavje 4.5).
If you experience these events, contact your doctor immediately.
Če se vam zgodi kaj takega, se nemudoma posvetujte z zdravnikom.
If you are in any doubt about whether you have any of these conditions, do ask your doctor.
Če sumite, da imate morda katero izmed zgoraj navedenih bolezni, se posvetujte s svojim zdravnikom.
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon.
Po zaužitju prvega ali kakšnega poznejšega odmerka sedativov/hipnotikov, vključno z zaleplonom, so poročali o primerih angioedema jezika, glotisa ali larinksa.
Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (rožnato črnilo SW-1105): šelak, titanov dioksid (E171), amonijev hidroksid, rdeči železov oksid (E172), rumeni železov oksid (E172).
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Pogosti neželeni učinki: dremavost/zaspanost, težave s spominom, občutki kot so mravljinci, npr. v okončinah (parestezije), boleča menstruacija.
MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/102/001-003
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Ti dogodki se lahko pojavijo tako pri bolnikih, ki sedativa/hipnotika prej še nikoli niso vzeli, kot tudi pri tistih, ki ga že jemljejo.
In line with effects observed with other compounds binding to benzodiazepine receptors, reversible increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral administration of high multiples of the maximum human therapeutic dose.
Reverzibilno povečanje mase jeter in nadledvičnih žlez pri podganah in psih je bilo opaženo šele po večkratni peroralni uporabi visokih večkratnikov največjega terapevtskega odmerka za ljudi, kar je v skladu z učinki drugih zdravil, ki se vežejo na benzodiazepinske receptorje.
MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/102/004-006
If you have any further questions, please consult your doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
S-170 73 Solna
S-170 09 Solna Švedska
This medicine has been prescribed for you.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations.
Sočasno odmerjanje zdravila Sonata z zdravili, ki vplivajo na izoencim CYP3A4, lahko povzroči spremembe koncentracije zaleplona v plazmi (glejte poglavje 4.5).
Severe renal impairment
Huda ledvična okvara
Uncommon:
Pogosto:
Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
V kontroliranih raziskavah za merjenje odstotka trajanja spanja v posameznih fazah spanja se je izkazalo, da zdravilo Sonata ohrani faze spanja.
Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate.
Sestavine ovojnice kapsule: želatina, titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), črni železov oksid (E172) in natrijev lavrilsulfat.
Psychiatric disorders Uncommon:
Psihiatrične motnje Občasno:
How to store Sonata
Shranjevanje zdravila Sonata
The active substance in each Sonata hard capsule is zaleplon 10 mg.
Zdravilna učinkovina: v eni trdi kapsuli Sonata je 10 mg zaleplona.
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see section 4.4).
prekinitev terapije lahko povzroči odtegnitvene simptome ali povratni fenomen (glejte poglavje 4.4).
If you experience any of these events, contact your doctor immediately.
Če pri sebi opazite kaj od naštetega, se nemudoma posvetujte z zdravnikom.
The active substance in each Sonata hard capsule is zaleplon 5 mg.
Zdravilna učinkovina: v eni trdi kapsuli Sonata je 5 mg zaleplona.
As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3.
Ker je očistek zdravila zmanjšan, morate bolnike z blago do zmerno jetrno okvaro zdraviti z zdravilom Sonata
MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/102/004 7 kapsul
amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Glejte tudi spodaj pod amnezijo amnezija, parestezije, zaspanost ataksija/nekoordiniranost gibov, vrtoglavica, zmanjšana koncentracija, parosmija; motnje govora (dizartrija,
Excipient with known effect: Lactose monohydrate 54 mg. For the full list of excipients, see section 6.1.
Pomožne snovi z znanim učinkom: 54 mg laktoze monohidrata
An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting.
Alergijska reakcija lahko obsega izpuščaj, srbenje, oteženo dihanje ali otekanje obraza, ustnic, žrela ali jezika ali slabost in bruhanje Če pri sebi opazite kaj od naštetega, se nemudoma posvetujte z zdravnikom.
Chromaturia (bluegreen urine discolouration) has been reported with zaleplon overdose.
Pri prevelikem odmerjanju zaleplona so poročali o kromaturiji (modro-zelena obarvanost urina).
Sonata 5 mg hard capsules zaleplon
Sonata 5 mg trde kapsule zaleplon
Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Pri bolnikih, ki po tistem, ko vzamejo sedativ/hipnotik, niso povsem budni, so poročali še o drugih vrstah kompleksnega vedenja (npr. priprava in uživanje hrane, telefoniranje ali spolno občevanje).
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character, and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents.
Reakcije kot so nemir, vznemirjenost, razdražljivost, popustitev zavor, agresivnost, nenormalno mišljenje, zablode, bes, nočne more, občutki depersonalizacije, halucinacije, psihoza, neprimerno vedenje, ekstrovertnost, ki se zdi pretirana, ter druge neželene vedenjske reakcije se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks.
Po nekajtedenski zaporedni uporabi lahko nastopi zmanjšanje uspavalnega učinka kratkotrajno delujočih benzodiazepinov in njim sorodnih učinkovin.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/102/001 7 kapsul
Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
Sestavine ovojnice kapsule: želatina, titanov dioksid (E171) in natrijev lavrilsulfat.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.V tem primeru ne smete jemati zdravila Sonata, saj ni na voljo dovolj kliničnih podatkov za oceno varnosti jemanja zdravila Sonata med nosečnostjo.
EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules
EU/1/99/102/003 14 kapsul
• Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Sonata.
besnost, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, in drugi vedenjski učinki pri uporabi katerih koli zdravil, ki spadajo med uspavala, tudi zdravila Sonata.
EU/1/99/102/005 10 capsules EU/1/99/102/006 14 capsules
EU/1/99/102/006 14 kapsul
Severe respiratory insufficiency
Hude težave z dihanjem
Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Pri bolnikih z blago do zmerno ledvično okvaro torej ni treba prilagajati odmerka.
NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules
IME ZDRAVILA Sonata 10 mg trde kapsule
NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules
IME ZDRAVILA Sonata 5 mg trde kapsule
Therapy of overdose
Zdravljenje prevelikega odmerjanja
Sonata 10 mg hard capsules zaleplon
Sonata 10 mg trde kapsule zaleplon
Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate,
Ovojnica kapsule: želatina titanov dioksid (E171) natrijev lavrilsulfat
Sleep apnoea syndrome
Sindrom apneje v spanju
Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Jedro kapsule: mikrokristalna celuloza predgeliran škrob silicijev dioksid natrijev lavrilsulfat magnezijev stearat laktoza monohidrat indigo karmin (E132) titanov dioksid (E171)
Do not go unaccompanied to seek medical help.
Če rabite zdravniško pomoč, obiščite zdravnika s spremstvom.
In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and decreased growth and physical development, were observed in the offspring of females treated with doses of ≥7 mg/kg/day that did not elicit maternal toxicity.
V študiji prenatalnega in postnatalnega razvoja pri podganah so pri potomcih samic, zdravljenih z odmerkom
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon.
Vsaka kapsula vsebuje 5 mg zaleplona.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon.
Vsaka kapsula vsebuje 10 mg zaleplona.
Rebound insomnia and anxiety
Povrnitev nespečnosti in tesnoba
Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1.
Pomožne snovi z znanim učinkom: 49 mg laktzoze monohidrata
NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules zaleplon
IME ZDRAVILA Sonata 5 mg trde kapsule zaleplon
NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules zaleplon
IME ZDRAVILA Sonata 10 mg trde kapsule zaleplon
Hepatic impairment
Očesne bolezni
If you have any further questions, ask your doctor or pharmacist.
V primeru dodatnih vprašanj se posvetujte z zdravnikom ali farmacevtom.
Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate,
Ovojnica kapsule: želatina titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Pri jemanju sedativov/hipnotikov, vključno z zaleplonom, so poročali o hudih anafilaktičnih/anafilaktoidnih reakcijah.
Ear and labyrinth disorders Uncommon:
Ušesne bolezni,vključno z motnjami labirinta Občasno:
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
zabloda, bes, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, ter drugi vedenjski učinki se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
CZ 100 10 Praha 10
7 trdih kapsul 10 trdih kapsul 14 trdih kapsul
There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug.
Po uporabi enkratnega odmerka (10 mg oziroma 50 mg) posameznega zdravila ne pride do farmakokinetičnih interakcij med zaleplonom in difenhidraminom.
Elderly
Presnova
Skin and subcutaneous tissue disorders Uncommon:
Bolezni kože in podkožja
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
PRETISNI OMOTI S 5 MG KAPSULAMI
capsule, hard
kapsula, trda
Invented name Strength
Izmišljeno ime
Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Priloga I Seznam izmišljenih imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
Pharmaceutical Form Route of administration
Farmacevtska oblika Pot uporabe
Ikelan solution for injection or infusion 50mg/5ml injection
Ikelan solution for injection or infusion 50mg/5ml injekcija intramuskularna in intravenska uporaba
LOFTON 150 mg/ml gotas orales en solución oral drops solution
LOFTON 150 mg/ml gotas orales en solución peroralne kapljice, raztopina
LOFTON 150 mg comprimidos recubiertos coated tablet
LOFTON 150 mg comprimidos recubiertos obložena tableta
INTRAVENOUS INFUSION, INTRAVENOUS INJECTION, INTRAMUSCULAR
INTRAVENSKO INFUNDIRANJE, INTRAVENSKO INJICIRANJE, INTRAMUSKULARNA UPORABA
SOLUTION FOR INJECTION
RAZTOPINA ZA INJICIRANJE
LOFTYL 50 mg/5 ml, solution injectable
LOFTYL 50 mg/5 ml, solution injectable 50 mg/5 ml raztopina za injiciranje intramuskularna in intravenska uporaba
BUFLOMEDIL SANDOZ 150 mg, comprimé 150 mg
BUFLOMEDIL SANDOZ 150 mg, comprimé 150 mg tableta
solution for injection intramuscular and intravenous use
raztopina za injiciranje intramuskularna in intravenska uporaba
oral drop, solution
peroralne kapljice, raztopina
BUFLOMEDIL ARROW 150 mg, comprimé 150 mg
BUFLOMEDIL ARROW 150 mg, comprimé 150 mg tableta
Buvasodil film coated tablets
Buvasodil filmsko obložene tablete peroralna uporaba
BUFLOMEDIL CRISTERS 150 mg, comprimé
BUFLOMEDIL CRISTERS 150 mg, comprimé tableta
BUFLOMEDIL ACTAVIS 150 mg, comprimé
BUFLOMEDIL ACTAVIS 150 mg, comprimé tableta
BUFLOMEDIL ZYDUS 150 mg, comprimé
BUFLOMEDIL ZYDUS 150 mg, comprimé tableta
CONTROLLED RELEASE TABLET
TABLETA S PRIREJENIM SPROŠČANJEM
Buflomedil-CT 50mg/5ml Ampullen
Buflomedil-CT 50mg/5ml Ampullen 50mg / 5ml raztopina za injiciranje, raztopina za infundiranje intravenska in intramuskularna uporaba
BUFLOMEDIL RPG 150 mg, comprimé
BUFLOMEDIL RPG 150 mg, comprimé tableta
Complamin Buflomedil Injekt
Complamin Buflomedil Injekt raztopina za injiciranje intravenska in intramuskularna uporaba
coated tablet
OBLOŽENA TABLETA peroralna uporaba
Pharmaceutical Form Route of Administration
Farmacevtska oblika Pot uporabe
Content Package size
Velikost pakiranja
EU Number
Številka EU Zaščiteno ime
Packaging
Ovojnina
Content (concentration)
Pot uporabe Stična ovojnina Vsebina (koncentracija)
MA (EU) number (Invented) name Strength
Številka (EU) dovoljenja za promet
Immediate Packaging
Stična ovojnina Velikost pakiranja e
The main areas harmonised include:
Med glavnimi usklajenimi področji so:
Other changes
Druge spremembe
Outcome of a procedure under Article 30 of Directive 2001/83/EC
Izid postopka po členu 30 Direktive 2001/83/ES
22 May 2012
22. maj 2012
The amended information to doctors and patients is available here.
Spremenjene informacije za zdravnike in bolnike so na voljo tukaj.
The European Commission issued a decision on 22 May 2012.
Evropska komisija je sklep izdala dne 22. maja 2012.
Why was Femara reviewed?
Zakaj je bilo zdravilo Femara pregledano?
The CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4.
CHMP je menil, da je ustreznejša vključitev zadevnih opozoril v poglavje 4.4.
Femara is authorised in the EU via national procedures.
Zdravilo Femara so odobrili v EU z nacionalnimi postopki.
On 15 March 2012, the European Medicines Agency completed a review of Femara.
Evropska agencija za zdravila je 15. marca 2012 dokončala pregled zdravila Femara.
Femara is marketed in all EU Member States and is also available under other trade names: Femar, Fémara, and Loxifan.
Zdravilo Femara se trži v vseh državah članicah EU in je na voljo tudi pod drugimi tržnimi imeni: Femar, Fémara in Loxifan.
What is Femara?
Kaj je zdravilo Femara?
On 31 August, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Femara in the EU.
Evropska komisija je 31. avgusta zadevo napotila na CHMP z namenom uskladitve dovoljenj za promet z zdravilom Femara v EU.
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)
Vprašanja in odgovori o zdravilu Femara in povezanih imenih (letrozol, 2,5 mg tablete)
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EMA/180824/2012
Vprašanja in odgovori o zdravilu Femara in povezanih imenih (letrozol, 2,5 mg tablete) EMA/180824/2012
The company that markets these medicines is Novartis.
Ta zdravila trži farmacevtska družba Novartis.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je treba uskladiti informacije o predpisovanju zdravila Femara v Evropski uniji (EU).
The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation) and 4.8 (side effects).
CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjema 4.6 (nosečnost in dojenje) in 4.8 (neželeni učinki).
After reviewing the available data supporting the medicine's use, the CHMP agreed that Femara should be used in postmenopausal women for the following:
Po pregledu razpoložljivih podatkov, ki podpirajo uporabo zdravila, je CHMP soglašal, da se sme zdravilo Femara uporabljati pri ženskah po menopavzi za naslednje indikacije:
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je povzročilo razlike med državami članicami glede načina, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravilo trži.
Femara is a medicine that contains the active substance letrozole.
Femara je zdravilo, ki vsebuje zdravilno učinkovino letrozol.
Having harmonised the indications, the CHMP also harmonised recommendations on the doses, duration of treatment and use of Femara in patients with reduced kidney or liver function.
Po uskladitvi indikacij je CHMP uskladil tudi priporočila o odmerkih, trajanju zdravljenja in uporabi zdravila Femara pri bolnicah z zmanjšanim delovanjem ledvic ali jeter.