natgillin/translations-raw huggingface dataset:
In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
V primerjalnih skupinah je dodatek sulfonilsečnine metforminu povzročil povprečno povečanje telesne mase za 1,3 kg in dodatek metformina sulfonilsečnini povprečno zmanjšanje telesne teže za 1,0 kg.
In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
V PROaktivni študiji, ki ocenjuje kardiovaskularni izid, je bilo 5.238 bolnikov s sladkorno boleznijo tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju, v trajanju do 3,5 let.
Do not use this medicine after the expiry date which is stated on the carton and the blister pack after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu, poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Ker obstaja možnost povečanja od odmerka odvisnih neželenih učinkov, bo morda ob sočasnem dajanju gemfibrozila potrebno znižati odmerek pioglitazona.
See section 2 “Glustin contains lactose monohydrate”.
Glejte poglavje 2 “Zdravilo Glustin vsebuje laktozo monohidrat”.
What you need to know before you take Glustin Do not take Glustin:
Kaj morate vedeti, preden boste vzeli zdravilo Glustin
If you stop taking Glustin
Če ste prenehali jemati zdravilo Glustin
Blood and lymphatic system disorders anaemia common
Bolezni krvi in limfatičnega sistema anemija
as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
kot dvojno peroralno zdravljenje v kombinaciji: - z metforminom pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku metformina v monoterapijis sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu dovoljenemu odmerku sulfonilsečnine v monoterapiji.
Frequencies are defined as: 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); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Neželeni učinki, o katerih so poročali večkrat (> 0,5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po skupinah organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III
Če upoštevamo aktivnost, koncentracije in vezavo na beljakovine, je delež učinkovitosti pioglitazona in presnovka M-III enak.
Reproductive system and breast disorders erectile dysfunction common
Motnje reprodukcije in dojk erektilna disfunkcija
This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na sposobnost upravljanja vozil strojev, vendar pa bodite pozorni v primeru pojava težav z vidom.
You may take your tablets with or without food.
Zdravilo Glustin skupaj s hrano in pijačo Tablete lahko jemljete skupaj s hrano ali brez nje.
No dose adjustment is necessary in patients with impaired renal function (creatinine clearance >4 mL/min) (see section 5.2).
Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina > 4 ml/min) odmerka ni treba prilagajati (glejte poglavje 5.2).
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
Pri nekaterih bolnikih z dolgotrajno sladkorno boleznijo tipa 2 in srčno boleznijo ali predhodno kapjo se je pri zdravljenju z zdravilom Glustin in insulinom pojavilo srčno popuščanje.
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glustin.
Obstaja povečana možnost zanositve, saj se vam pri jemanju zdravila Glustin ovulacija lahko povrne.
common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
povišana vrednost keratin fosfokinaze v krvi povišana vrednost laktatne dehidrogenaze občasni povišana vrednost alanin amino transferaze7
- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
kot monoterapija - pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) nezadostno nadzorovanih z dieto in gibanjem, pri katerih je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren.
4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
4 Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8.100 bolnikov v skupini, zdravljeni s pioglitazonom in 7.400 v skupini, zdravljeni s primerjalnim zdravilom, ki so trajale do 3,5 let.
The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Običajni začetni odmerek je ena 15 miligramska ali 30-miligramska tableta pioglitazona enkrat na dan.
Glustin contains pioglitazone.
Zdravilo Glustin vsebuje pioglitazon.
Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Presnovne in prehranske motnje hipoglikemija občasni zelo pogosti povečan apetit občasni
Each tablet contains 114.51 mg of lactose monohydrate (see section 4.4).
Ena tableta vsebuje 114,51 mg laktoze monohidrata (glejte poglavje 4.4).
How to take Glustin
Kako jemati zdravilo Glustin
Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4).
Ena tableta vsebuje 92,87 mg laktoze monohidrata (glejte poglavje 4.4).
Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4).
Ena tableta vsebuje 76,34 mg laktoze monohidrata (glejte poglavje 4.4).
Blurred vision due to swelling (or fluid) at the back of the eye has also been reported in patients taking Glustin (frequency cannot be estimated from the available data).
Pri bolnikih, ki so jemali zdravilo Glustin, so poročali tudi o zamegljenem vidu zaradi otekanja (ali tekočine) očesnega ozadja (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Bladder Cancer
Rak sečnega mehurja
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5)
Poročali so, da sočasno dajanje pioglitazona z gemfibrozilom (zaviralcem citokroma P450 2C8) ali z rifampicinom (induktorjem citokroma P450 2C8) poviša oziroma zniža plazemsko koncentracijo pioglitazona (glejte poglavje 4.5).
Your blood sugar will be checked, and your dose of Glustin may need to be changed.
Odmerek zdravila Glustin bo morda treba spremeniti.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5 x upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih s povišanimi izhodiščnimi ravnmi jetrnih encimov (ALT > 2,5-kratna zgornja meja normalnih vrednosti) ali s kakršnimi koli drugimi znaki jetrne bolezni, zdravljenja s pioglitazonom ne smemo začeti.
Glustin should be used every day to work properly.
Za pravilno delovanje morate zdravilo Glustin jemati vsak dan.
Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Infekcijske in parazitske bolezni okužba zgornjih dihal bronhitis sinuzitis občasni občasni občasni občasni
Glustin contains lactose monohydrate
Zdravilo Glustin vsebuje laktozo monohidrat
Glustin 15 mg tablets Glustin 30 mg tablets Glustin 45 mg tablets
IME ZDRAVILA Glustin 15 mg tablete Glustin 30 mg tablete Glustin 45 mg tablete
- The active substance in Glustin is pioglitazone.
Zdravilna učinkovina zdravila Glustin je pioglitazon.
Frequency of adverse reactions of pioglitazone by treatment regimen Monotherapy
Pogostnost neželenih učinkov pioglitazona glede na režim zdravljenja
Glustin may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Zdravilo Glustin se lahko uporablja kot samostojno zdravilo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in s telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) okužba dihal motnje vida povečanje telesne mase odrevenelost občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje sinusov (sinuzitis)
If you experience this side effect, talk to your doctor as soon as possible.
Če opazite ta neželeni učinek, se čim prej posvetujte z zdravnikom.
Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Prav tako se čim prej posvetujte z zdravnikom, če ste imeli zamegljen vid že prej, pa se vam je stanje poslabšalo.
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8.100 s pioglitazonom in 7.400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3,5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Glustin.
Pri bolnikih, ki so jemali zdravilo Glustin, so poročali o alergijskih reakcijah z neznano pogostnostjo (iz razpoložljivih podatkov je ni mogoče oceniti).
- you are breast-feeding or if you are planning to breast-feed your baby.
če dojite ali nameravate dojiti.
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) rak sečnega mehurja občasni občasni občasni občasni
Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Bolezni živčevja hipestezija glavobol občasni omotica nespečnost občasni občasni občasni občasni
Glustin tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
However, certain medicines are especially likely to affect the amount of sugar in your blood: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these.
rifampicin (uporablja se za zdravljenje tuberkuloze in drugih okužb) Obvestite zdravnika ali farmacevta, če jemljete katero od teh zdravil.
Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Glustin in combination with insulin.
Pri bolnikih, ki so jemali zdravilo Glustin v kombinaciji z insulinom, so zelo pogosto (pri več kot 1 od 10 bolnikov) poročali o lokalnem otekanju (edemih).
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Glustin.
Pri bolnikih, ki so jemali zdravilo Glustin, so občasno (pri največ 1 od 100 bolnikov) poročali o pojavu raka sečnega mehurja.
Glustin 30 mg
PODATKI V BRAILLOVI PISAVI Glustin 30 mg
How to store Glustin
Shranjevanje zdravila Glustin
Glustin 30 mg tablets are white to off-white, round, flat tablets marked “30” on one face, “AD4” on the other.
Tablete zdravila Glustin 30 mg so bele do sivobele barve, okrogle, ploščate, z oznako “30” na eni in “AD4” na drugi strani.
- Glustin 45 mg tablets are white to off-white, round, flat tablets marked “45” on one face, “AD4” on the other.
Tablete zdravila Glustin 45 mg so bele do sivobele barve, okrogle, ploščate, z oznako “45” na eni in “AD4” na drugi strani.
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Pri bolnikih s sladkorno boleznijo tipa 2 se izboljša urejenost glikemije tako na tešče kot po obrokih.
EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010 EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
Each Glustin 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Ena 30-miligramska tableta Glustin vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Glustin and have also been reported in male patients (frequency cannot be estimated from the available data) taking Glustin.
O zlomih so poročali tudi pri bolnikih, ki so se zdravili z zdravilom Glustin (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Glustin 45 mg
PODATKI V BRAILLOVI PISAVI Glustin 45 mg
Glustin 30 mg tablets pioglitazone
IME ZDRAVILA Glustin 30 mg tablete pioglitazon
Each Glustin 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Ena 45-miligramska tableta Glustin vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
EU/1/00/151/009 14 tablets EU/1/00/151/010 28 tablets EU/1/00/151/020 30 tablets EU/1/00/151/011 50 tablets EU/1/00/151/012 56 tablets EU/1/00/151/021 84 tablets EU/1/00/151/022 90 tablets EU/1/00/151/013 98 tablets
EU/1/00/151/009 14 tablet EU/1/00/151/010 28 tablet EU/1/00/151/020 30 tablet EU/1/00/151/011 50 tablet EU/1/00/151/012 56 tablet EU/1/00/151/021 84 tablet EU/1/00/151/022 90 tablet EU/1/00/151/013 98 tablet
Glustin 45 mg tablets pioglitazone
IME ZDRAVILA Glustin 45 mg tablete pioglitazon
Glustin 15 mg tablets pioglitazone
IME ZDRAVILA Glustin 15 mg tablete pioglitazon
The tablets are white to off-white, round, flat and marked ‘45' on one face, ‘AD4' on the other.
Tablete so bele ali skoraj bele barve, okrogle, ploščate, z oznako ‘45' na eni in AD4 na drugi strani.
EU/1/00/151/008 14 tablets EU/1/00/151/004 28 tablets EU/1/00/151/017 30 tablets EU/1/00/151/005 50 tablets EU/1/00/151/024 56 tablets EU/1/00/151/018 84 tablets EU/1/00/151/019 90 tablets EU/1/00/151/006 98 tablets
EU/1/00/151/008 14 tablet EU/1/00/151/004 28 tablet EU/1/00/151/017 30 tablet EU/1/00/151/005 50 tablet EU/1/00/151/024 56 tablet EU/1/00/151/018 84 tablet EU/1/00/151/019 90 tablet EU/1/00/151/006 96 tablet
If you stop using Glustin, your blood sugar may go up.
Če zdravilo Glustin prenehate jemati, se lahko raven krvnega sladkorja zviša, zato se pred prekinitvijo zdravljenja najprej posvetujte z zdravnikom.
- Glustin 15 mg tablets are white to off-white, round, convex tablets marked “15” on one face, “AD4” on the other.
Tablete zdravila Glustin 15 mg so bele do sivobele barve, okrogle, izbočene, z oznako “15” na eni in “AD4” na drugi strani.
EU/1/00/151/007 14 tablets EU/1/00/151/001 28 tablets EU/1/00/151/014 30 tablets EU/1/00/151/002 50 tablets EU/1/00/151/023 56 tablets EU/1/00/151/015 84 tablets EU/1/00/151/016 90 tablets EU/1/00/151/003 98 tablets
EU/1/00/151/007 14 tablet EU/1/00/151/001 28 tablet EU/1/00/151/014 30 tablet EU/1/00/151/002 50 tablet EU/1/00/151/023 56 tablet EU/1/00/151/015 84 tablet EU/1/00/151/016 90 tablet EU/1/00/151/003 98 tablet
Each Glustin 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Ena 15-miligramska tableta Glustin vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
The tablets are white to off-white, round, flat and marked ‘30' on one face, ‘AD4' on the other.
Tablete so bele ali skoraj bele barve, okrogle, ploščate, z oznako ‘30' na eni in AD4 na drugi strani.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Če se telesna masa poveča, o tem obvestite zdravnika.
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
The tablets are white to off-white, round, convex and marked ‘15' on one face, ‘AD4' on the other.
Tablete so bele ali skoraj bele barve, okrogle, izbočene, z oznako ‘15' na eni in AD4 na drugi strani.
Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Glustin in combination with insulin.
Pri bolnikih, ki so jemali zdravilo Glustin v kombinaciji z insulinom, so pogosto (pri največ 1 od 10 bolnikov) poročali o pojavu srčnega popuščanja.
MANUFACTURER'S BATCH NUMBER
ŠTEVILKA SERIJE Lot
Glustin 15 mg
PODATKI V BRAILLOVI PISAVI Glustin 15 mg
nausea or vomiting).
težave s spanjem (nespečnost)
14 January 2013
14. januar 2013
The European Commission issued a decision on 14 January 2013.
Evropska komisija je sklep izdala 14. januarja 2013.
Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom).
(„zadevne države članice“, v tem primeru Belgija, Bolgarija, Ciper, Nemčija, Grčija, Malta, Portugalska, Romunija in Združeno kraljestvo).
It controls many body functions, mainly to do with growth and energy.
Ščitnica nadzira številne telesne funkcije, predvsem funkcije, povezane z rastjo in energijo.
This could potentially lead to medication errors and pose a risk to public health.
To bi lahko pripeljalo do napak pri uporabi zdravila in pomenilo tveganje za javno zdravje.
This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned
To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Nizozemska) ovrednoti zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih državah članicah
However, the Member States were not able to reach an agreement and the Dutch agency referred the matter to the CHMP for arbitration on 26 January 2012.
Vendar države članice niso mogle doseči soglasja, zato je nizozemska agencija 26. januarja 2012 zadevo napotila odboru CHMP v arbitražni postopek.
It was to be available as oral drops (100 microgram/ml).
Zdravilo naj bi bilo na voljo v obliki peroralnih kapljic (100 mikrogramov/ml).
On 18 October 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levothyroxine Alapis.
Evropska agencija za zdravila je 18. oktobra 2012 zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) glede izdaje dovoljenj za promet z zdravilom Levothyroxine Alapis.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and the marketing authorisation cannot be granted in the Netherlands or in the following EU Member States: Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agencije je ugotovil, da koristi zdravila Levothyroxine Alapis ne odtehtajo z njim povezanih tveganj ter da dovoljenja za promet ni mogoče izdati na Nizozemskem ali v naslednjih državah članicah EU: v Belgiji, Bolgariji, na Cipru, v Nemčiji, Grčiji, na Malti, Portugalskem, v Romuniji in Združenem kraljestvu.
Since the solution is highly concentrated and the active substance highly potent, there was an unacceptable risk of serious medication errors.
Ker je raztopina visoko koncentrirana in zdravilna učinkovina zelo potentna, obstaja nesprejemljivo tveganje za napake pri uporabi zdravila.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that there was a risk that the dropper used for delivery might deliver variable doses, and that large numbers of drops might be hard to count.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvenih razprav v Odboru, se je ta strinjal, da obstaja pri uporabi kapalke za odmerjanje tveganje za spremenljivo odmerjanje in da se lahko pri štetju tako velikega števila kapljic pojavijo napake.
In addition there were concerns over the safety of the combined long-term use of the ingredients ethanol and propylene glycol at the proposed concentrations, particularly in children.
Poleg tega so izrazili tudi pomisleke glede varnosti dolgotrajne kombinirane uporabe sestavin etanol in propilenglikol pri predlaganih koncentracijah, zlasti pri otrocih.
Therefore the CHMP concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.
Odbor CHMP je zato zaključil, da koristi zdravila Levothyroxine Alapis ne odtehtajo z njim povezanih tveganj in da se dovoljenje za promet z zdravilom ne sme izdati v zadevnih državah članicah.
• conditions in which the thyroid gland is underactive (hypothyroidism, including diffuse non-toxic goitre) and so does not make enough thyroxine for the body's needs;
• stanj, pri katerih je delovanje ščitnice zmanjšano (hipotiroidizem, vključno z difuzno netoksično golšo) in se zato ne proizvede dovolj tiroksina za potrebe telesa;
Thyroxine is normally produced in the body by the thyroid gland in the neck.
Tiroksin v telesu običajno proizvaja žleza ščitnica v vratu.
Levothyroxine Alapis was intended to be used to treat:
Zdravilo Levothyroxine Alapis je bilo namenjeno za zdravljenje:
• thyroid cancer.
• raka ščitnice.