natgillin/translations-raw huggingface dataset:
The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 48 mg per day.
Farmakokinetika silodozina in njegovih glavnih presnovkov je bila ovrednotena pri odraslih osebah moškega spola z BHP ali brez nje po enkratnem in večkratnem odmerjanju v odmerkih od 0,1 mg do 48 mg na dan. Farmakokinetika silodozina je v celotnem navedenem odmernem intervalu linearna.
Other medicines and Silodosin Recordati
Druga zdravila in zdravilo Silodosin Recordati
The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Druge sestavine zdravila so predgelirani koruzni škrob, manitol (E421), magnezijev stearat, natrijev lavrilsulfat, želatina, titanov dioksid (E171), rumeni železov oksid (E172).
Pregnancy and breast-feeding Not applicable as silodosin is intended for male patients only.
Navedba smiselno ni potrebna, saj je silodozin namenjen samo bolnikom moškega spola.
Orthostatic effects
Ortostatski učinki
The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).
Druge sestavine zdravila so predgelirani koruzni škrob, manitol (E421), magnezijev stearat, natrijev lavrilsulfat, želatina, titanov dioksid (E171).
Ejaculatory disorders, including retrograde ejaculation, anejaculation
vključno z retrogradno ejakulacijo, anejakulacijo erektilna disfunkcija
In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) relative to subjects with normal renal function (n = 8).
V študiji enkratnega odmerka je izpostavitev silodozinu (nevezanemu) pri bolnikih z blago (n = 8) in zmerno (n = 8) okvaro delovanja ledvic v primerjavi z bolniki z normalnim delovanjem ledvic (n = 8) v povprečju vodila v povečanje Cmax (1,6-krat) in AUC (1,7-krat).
Since no data are available in patients with severe hepatic impairment, the use of silodosin in these patients is not recommended (see sections 4.2 and 5.2).
Zaradi pomanjkanja podatkov o bolnikih s hudo okvaro delovanja jeter uporaba silodozina pri teh bolnikih ni priporočljiva (glejte poglavji 4.2 in 5.2).
• Dizziness, including dizziness when standing up (see also above, in this section)
• ohlapna šarenica med operacijo sive mrene (glejte tudi zgoraj v tem poglavju)
The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Uporaba pri bolnikih s hudo okvaro delovanja ledvic (CLCR < 30 ml/min) ni priporočljiva (glejte poglavji 4.4 in 5.2).
No significant reduction in supine blood pressure was observed in all clinical studies conducted with silodosin.
V vseh kliničnih študijah s silodozinom v ležečem položaju niso opazili pomembnega znižanja krvnega tlaka.
No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Pri bolnikih z blago okvaro delovanja ledvic (CLCR ≥ 50 do ≤80 ml/min) prilagoditev odmerka ni potrebna.
If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Če je do zaužitja prišlo pred kratkim, lahko pride v poštev izzvano bruhanje ali izpiranje želodca.
What Silodosin Recordati is and what it is used for
Kaj je zdravilo Silodosin Recordati in za kaj ga uporabljamo
In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during treatment with silodosin (see section 4.8), due to the pharmacodynamic properties of silodosin.
V kliničnih študijah so med zdravljenjem s silodozinom, zaradi farmakodinamičnih lastnosti silodozina, opazili pojavljanje ejakulacije z zmanjšano količino ejakulata ali brez njega (glejte poglavje 4.8).
The use of silodosin in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.2 and 5.2).
Uporaba silodozina pri bolnikih s hudo okvaro delovanja ledvic (CLCR < 30 ml/min) ni priporočljiva (glejte poglavji 4.2 in 5.2).
Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra.
Zdravilo Silodosin Recordati se selektivno veže na receptorje, ki se nahajajo v prostati, mehurju in sečnici.
Syncope Loss of consciousness1
Bolezni živčevja omotica sinkopa izguba zavesti1
Orthostatic hypotension may occasionally lead to syncope (see section 4.4).
Ortostatska hipotenzija občasno lahko vodi v sinkopo
In all studies, patients treated with silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of BPH as compared to placebo as assessed after 12 weeks of treatment.
V vseh študijah so imeli bolniki, zdravljeni s silodozinom, v primerjavi s placebom bolj izraženo izboljšanje iritacijskih in obstrukcijskih simptomov BHP, kar so ocenili po
Silodosin has not been evaluated in patients less than 18 years of age.
Uporaba silodozina pri bolnikih, mlajših od 18 let, ni bila ovrednotena.
This is because some patients treated with this kind of medicine experienced a loss of muscle tone in the iris (the coloured circular part of the eye) during such a surgery.
ki so bili zdravljeni s to vrsto zdravil, med takšno operacijo izgubili mišični tonus v šarenici
Discontinuing treatment with an α1-blocker 1-2 weeks prior to cataract surgery has been recommended, but the benefit and duration of stopping the therapy prior to cataract surgery has not yet been established.
Prekinitev zdravljenja z zaviralcem α1 receptorjev 1-2 tedna pred operacijo sive mrene je priporočljiva,
Silodosin Recordati is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Za kaj uporabljamo zdravilo Silodosin Recordati Zdravilo Silodosin Recordati se pri odraslih moških uporablja za zdravljenje simptomov mokrenja, ki so povezani z nenevarnim povečanjem prostate (hiperplazijo prostate), kot na primer:
In patients with severe renal impairment administration of Silodosin Recordati is not recommended.
Pri bolnikih s hudo okvaro delovanja ledvic uporaba zdravila Silodosin Recordati ni priporočljiva.
Libido decreased
Psihiatrične motnje zmanjšan libido
Tachycardia1 Palpitations1
Srčne bolezni tahikardija1
The capsule should not be broken or chewed but swallowed whole, preferably with a glass of water.
treba je pogoltniti celo, najbolje s kozarcem vode.
The exposure to the main metabolite in plasma, silodosin glucuronide (KMD-3213G), at steady-state is about 3-fold that of the parent substance.
Izpostavitev glavnemu presnovku v plazmi, glukuronidnemo konjugatu silodozina (KMD-3213G), je v stanju dinamičnega ravnotežja približno trikrat večja od izpostavitve izhodiščni učinkovini.
Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.
ampak pogoltnite celo, najbolje s kozarcem vode.
IFIS has been reported during cataract surgery (see section 4.4).
Medoperacijski sindrom ohlapne šarenice (IFIS) Poročali so, da je pri operacijah sive mrene prišlo do sindroma IFIS (glejte poglavje 4.4).
When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, an increase in silodosin AUC of approximately 30% was observed, but Cmax and half-life were not affected.
Ob sočasni uporabi silodozina in zmernih zaviralcev CYP3A4 kot je diltiazem so opazili približno 30% porast AUC silodozina, Cmax in razpolovna doba pa se nista spremenila.
In an interaction study, a 3.7-fold increase in maximum silodosin plasma concentrations and a 3.1-fold increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent CYP3A4 inhibitor (ketoconazole 400 mg).
V študiji medsebojnega delovanja so ob sočasni uporabi močnega zaviralca CYP3A4 (ketokonazol 400 mg) opazili 3,7-kratno zvečanje najvišjih plazemskih koncentracij silodozina in 3,1-kratno zvišanje izpostavljenosti silodozinu (tj. AUC).
The recommended dose is one capsule of Silodosin Recordati 8 mg daily.
Priporočeni odmerek je ena kapsula zdravila Silodosin Recordati 8 mg na dan.
Skin rash1, Pruritus1
Bolezni kože in podkožja kožni izpuščaj1, pruritus1
• Abnormal results of liver function tests
• nenormalni rezultati jetrnih testov • nizek krvni tlak
What Silodosin Recordati looks like and contents of the pack
Izgled zdravila Silodosin Recordati in vsebina pakiranja
Very common
izjemno visoko.
No dose adjustment is required for patients with mild to moderate hepatic impairment.
Pri bolnikih z blago do zmerno okvaro delovanja jeter prilagoditev odmerka ni potrebna.
Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects.
4.9 Preveliko odmerjanje Uporaba silodozina je bila pri zdravih moških ovrednotena vse do odmerka 48 mg/dan.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalneg a prostora nosna kongestija
Very common side effects (may affect more than 1 in 10 people)
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
You may take your capsule later the same day if you have forgotten to take it earlier.
Če ste pozabili vzeti zdravilo Silodosin Recordati Če ste tekom dneva pozabili vzeti kapsulo, jo vzemite pozneje istega dne.
Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥ 13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Score; izhodiščna vrednost ≥ 13) je v dveh s placebom nadzorovanih kliničnih študijah Faze III v Združenih državah Amerike in v eni s placebom in z učinkovino nadzorovani klinični študiji, izpeljani v Evropi, prejemalo 8 mg silodozin enkrat na dan.
• Nausea
• slabost
INFORMATION IN BRAILLE silodosin recordati 4 mg
PODATKI V BRAILLOVI PISAVI silodosin recordati 4 mg
The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled.
Uvajanje zdravljenja s silodozinom pri bolnikih, ki čakajo na operacijo sive mrene, ni priporočljivo.
INFORMATION IN BRAILLE silodosin recordati 8 mg
PODATKI V BRAILLOVI PISAVI silodosin recordati 8 mg
Silodosin Recordati 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Silodosin Recordati 8 mg trde kapsule Ena trda kapsula vsebuje 8 mg silodozina.
Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • hiter ali nereden srčni utrip (imenovan palpitacije)
Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Zdravilo Silodosin Recordati 4 mg so rumene, neprozorne, trde želatinske kapsule, velikost 3 (približno 15,9 mm x 5,8 mm).
Each capsule contains 4 mg of silodosin.
Ena kapsula vsebuje 4 mg silodozina.
The recommended dose is one capsule of Silodosin Recordati 8 mg per day by oral administration.
Priporočeni odmerek je ena kapsula zdravila Silodosin Recordati 8 mg enkrat na dan peroralno (zaužita skozi usta).
Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Zdravilo Silodosin Recordati 8 mg so bele, neprozorne, trde želatinske kapsule, velikost 0 (približno 21,7 mm x 7,6 mm).
Each capsule contains 8 mg of silodosin.
Ena kapsula vsebuje 8 mg silodozina.
Please inform your doctor if you are planning to have children.
Obvestite svojega zdravnika, če menite, da zdravilo vpliva na vaše spolno življenje.
Silodosin Recordati 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm).
Silodosin Recordati 4 mg trde kapsule Rumena, neprozorna, trda želatinska kapsula velikosti 3 (približno 15,9 mm x 5,8 mm).
Silodosin Recordati 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm).
Silodosin Recordati 8 mg trde kapsule Bela, neprozorna, trda želatinska kapsula velikosti 0 (približno 21,7 mm x 7,6 mm).
Not known (frequency cannot be estimated from the available data) • Floppy pupil during cataract surgery (see also above, in this section)
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
Steady state levels of digoxin, a substrate of P-glycoprotein, were not significantly affected by co-administration with silodosin 8 mg once daily.
Digoksin Sočasna uporaba 8 mg silodozina enkrat na dan ni imela pomembnejšega vpliva na koncentracijo digoksina, substrata za P-glikoprotein, v stanju dinamičnega ravnovesja.
Dialysis is unlikely to be of significant benefit since silodosin is highly (96.6%) protein bound.
(96,6%) silodozina na beljakovine je malo verjetno, da bi bila dializa zelo koristna.
• Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings and precautions”)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) • nenormalna ejakulacija (izliv sperme) (pri spolnem odnosu se izlije manj ali nič sperme, glejte poglavju »Opozorila in previdnostni ukrepi«)
EU/1/18/1343/001 EU/1/18/1343/002 EU/1/18/1343/003 EU/1/18/1343/004 EU/1/18/1343/005 EU/1/18/1343/006 EU/1/18/1343/007 EU/1/18/1343/008 EU/1/18/1343/009 EU/1/18/1343/010 EU/1/18/1343/011 EU/1/18/1343/012
EU/1/18/1343/006 EU/1/18/1343/007 EU/1/18/1343/008 EU/1/18/1343/009 EU/1/18/1343/010 EU/1/18/1343/011 EU/1/18/1343/012
If you become dizzy or feel weak, tell your doctor straight away.
Če postanete omotični ali šibki,
How to take Silodosin Recordati
Kako jemati zdravilo Silodosin Recordati
Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists, ATC code: G04CA04.
oznaka ATC: G04CA04.
If you have moderate kidney problems, your doctor will start Silodosin Recordati with caution and possibly with a lower dose (see section 3 “Dose”).
Recordati previdno in morda z nižjim odmerkom (glejte poglavje 3 »Odmerek«).
System organ class
Študija Skupina
NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 8 mg hard capsules silodosin
IME ZDRAVILA Silodosin Recordati 8 mg trde kapsule silodozin
Silodosin Recordati 8 mg hard capsules Silodosin Recordati 4 mg hard capsules silodosin
Silodosin Recordati 4 mg trde kapsule Silodosin Recordati 8 mg trde kapsule
Ask your doctor whether or not you should postpone or temporarily stop taking Silodosin Recordati when undergoing cataract surgery.
Če se pripravljate na operacijo sive mrene, vprašajte svojega zdravnika, če lahko odložite začetek jemanja ali začasno prenehate z jemanjem zdravila Silodosin Recordati.
NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules silodosin
IME ZDRAVILA Silodosin Recordati 4 mg trde kapsule silodozin
For this purpose Silodosin Recordati 4 mg hard capsules are available.
ta namen je na voljo zdravilo Silodosin Recordati 4 mg trde kapsule.
Injury, poisoning and procedural complication
Pošk odbe in zastrupitve in zapleti pri posegih medoperacijs ki sindrom ohlapne šarenice
Abnormal liver function tests1
Bolezni jeter, žolčnika in žolčevodov nenormalni rezultati jetrnih testov1
QUALITATIVE AND QUANTITATIVE COMPOSITION Silodosin Recordati 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Silodosin Recordati 4 mg trde kapsule Ena trda kapsula vsebuje 4 mg silodozina.
IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α1-blockers or previously treated with α1-blockers.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Medoperacijski sindrom ohlapne šarenice (IFIS - Intraoperative Floppy Iris Syndrome) Med operacijo sive mrene so pri nekaterih bolnikih, ki so bili sočasno ali predhodno zdravljeni z zaviralci α1 receptorjev, opazili IFIS (različica sindroma majhne zenice).
What Silodosin Recordati contains
Kaj vsebuje zdravilo Silodosin Recordati
BATCH NUMBER Lot
Izde lovale c
Immune system disorders
Bolezni imunskega sistema alergijske reakcije,
How to store Silodosin Recordati
Shranjevanje zdravila Silodosin Recordati
Study Treatment arm
NAČIN IZDAJANJA ZDRAVILA
4.4 Special warnings and precautions for use
4.2 Odmerjanje in način uporabe
Reproductive system and breast disorders
Motnje reproduk cije in dojk motnje ejakulacije,
If you feel that your sexual life is affected, please tell your doctor.
Če nameravate imeti otroke, o tem obvestite svojega zdravnika.
What Silodosin Recordati is
Kaj je zdravilo Silodosin Recordati
• The treatment with Silodosin Recordati may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
(zmanjšanje količine sperme, izločene pri spolnem odnosu), kar lahko začasno prizadene moško plodnost.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg silodosin.
Ena trda kapsula vsebuje 4 mg silodozina.
- This medicine has been prescribed for you personally and you should not pass it on to others.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Date of first authorisation: 24 January 2003 Date of renewal: 20 May 2008
Datum prve pridobitve dovoljenja za promet: 24. januar 2003 Datum podaljšanja dovoljenja za promet: 20. maj 2008
No specific interaction studies have been performed.
Specifične raziskave interakcij niso bile opravljene.
The tablet can be divided into equal halves.
Tableto je možno razdeliti v dve enaki polovici.
EU/1/02/246/001 (15 dispersible tablets) EU/1/02/246/002 (60 dispersible tablets) EU/1/02/246/003 (5 dispersible tablets)
EU/1/02/246/001 (15 disperzibilnih tablet) EU/1/02/246/002 (60 disperzibilnih tablet) EU/1/02/246/003 (5 disperzibilnih tablet)
Do not store above 30C.
Ne shranjujte pri temperaturi nad 30 C.
36 months After first opening of the tablet container: 3 months
36 mesecev Po prvem odprtju vsebnika s tabletami: 3 mesece
Patients suffering from one of these disorders need treatment during the hyperammonaemia crisis.
Bolnike, ki imajo katero od teh bolezni, je treba med hiperamoniemično krizo zdraviti.
The suspension has a slightly acidic taste.
Suspenzija ima rahlo kiselkast okus.
The effects of Carbaglu on pregnancy and the unborn child are not known.
Učinki zdravila Carbaglu na nosečnost in na nerojenega otroka niso znani.
Based on clinical experience, the treatment may be started as early as the first day of life.
Klinične izkušnje kažejo, da se zdravljenje lahko začne že prvi dan po rojstvu.
This disorder persists during the entire life of the affected patient and therefore the need for this treatment is lifelong.
To nepravilnost ima prizadeti bolnik vse življenje, zato je potrebno doživljenjsko zdravljenje.
Reported adverse reactions are listed below, by system organ class and by frequency.
Neželene reakcije, o katerih so poročali, so navedene spodaj po organskih sistemih in po pogostnosti.
- Undesirable effects in organic acidaemia
- Neželeni učinki pri organski acidaemiji
No adverse effects have been observed on male or female fertility.
Opazili niso nikakršnih neugodnih učinkov na plodnost pri moških ali ženskah.
Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four doses to be given before meals or feedings.
Ob upoštevanju farmakokinetičnih podatkov in kliničnih izkušenj je priporočljivo skupni dnevni odmerek razdeliti v dva do štiri odmerke, ki se jih daje pred jedjo oz. hranjenjem.
When the treatment was instituted before any permanent brain damage, patients exhibited normal growth and psychomotor development.
Če se je zdravljenje začelo, še preden je prišlo do trajnih poškodb možganov, so pri bolnikih opazili normalno rast in psihomotorični razvoj.
The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately.
Tablete je treba razpršiti v najmanj 5 do 10 ml vode in jih nato takoj zaužiti.
Animal studies have revealed minimal developmental toxicity (see section 5.3).
Raziskave na živalih so razkrile minimalno toksičnost za razvoj (glejte poglavje 5.3).
After first opening of the tablet container:
Po prvem odprtju vsebnika s tabletami:
Protein binding has not been determined.
Vezave na beljakovine niso ugotavljali.
The tablets are white and elongated with three score marks and engraved on one side.
Tablete so bele in podolgovate, s tremi oznakami vrednosti in vgravirane na eni strani.
These symptoms resolved once the dose was reduced.
Ti znaki so po zmanjšanju odmerka izginili.
Patients with this rare disorder are not able to eliminate nitrogen waste, which builds up after eating protein.
Bolniki s to redko boleznijo ne morejo izločati odpadnega dušika, ki se kopiči po zaužitju proteinov.
Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Amonijak je še posebej toksičen za možgane in lahko v hudih primerih privede do izgube zavesti in kome.
Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in your blood.
Vaš zdravnik bo določil odmerek, ki je za vas primeren za vzdrževanje normalne ravni amoniaka v krvi.
• Common: increased sweating
• pogosti: zvečano znojenje
Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05
Farmakoterapevtska skupina: aminokisline in njihovi derivati; oznaka ATC: A16AA05
It is suggested that depending on its activity, the intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a variable extent of metabolism of the molecule.
Domnevajo, da črevesna bakterijska flora lahko odvisno od svoje aktivnosti prispeva k začetku procesa degradacije in s tem povzroči spremenljivost obsega presnove molekule.
The maternal systemic exposures after 500 and 2000 mg/kg/day were twenty five times and seventy times the expected human exposure.
Sistemska izpostavljenost mater pri odmerkih 500 oziroma 2000 mg/kg/dan je bila petindvajsetkrat oziroma sedemdesetkrat večja od pričakovane izpostavljenosti ljudi.
Like all medicines, Carbaglu can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Carbaglu neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
As very few data on the safety of carglumic acid are available, systematic surveillance of liver, renal, cardiac functions and haematological parameters is recommended.
Ker je na razpolago zelo malo podatkov o varnosti kargluminske kisline, je priporočljivo sistematično preverjati delovanje jeter, ledvic in srca ter hematološke parametre.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA)http://www.ema.europa.eu/.
Their range was consistent with those measured in healthy adults, even in newborn infants.
Njihove vrednosti so bile celo pri novorojenčkih primerljive s tistimi, ki so jih izmerili pri zdravih odraslih.
Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Ne jemljite zdravila Carbaglu, če ste alergični (preobčutljivi) na kargluminsko kislino ali katerokoli sestavino zdravila Carbaglu.
Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/ml.
Ne glede na višino dnevnega odmerka so se vrednosti v 15 urah počasi znižale na raven okrog 100 ng/ml.
Discard 3 months after first opening.
Zavrzite 3 mesece po prvem odpiranju.
Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
V drugih raziskavah na podganah, ki so jih izvajali pod različnimi eksperimentalnimi pogoji, so dobili povečano raven amoniaka (stradanje, dieta brez proteina ali visoko-proteinska dieta).