natgillin/translations-raw huggingface dataset:
EU/2/10/115/016 (90 mg, 3 tablets) EU/2/10/115/017 (90 mg, 6 tablets) EU/2/10/115/018 (140 mg, 3 tablets) EU/2/10/115/019 (140 mg, 6 tablets) EU/2/10/115/020 (180 mg, 3 tablets) EU/2/10/115/021 (180 mg, 6 tablets) EU/2/10/115/011 (270 mg, 3 tablets) EU/2/10/115/001 (270 mg, 6 tablets) EU/2/10/115/012 (425 mg, 3 tablets) EU/2/10/115/003 (425 mg, 6 tablets) EU/2/10/115/013 (665 mg, 3 tablets) EU/2/10/115/005 (665 mg, 6 tablets) EU/2/10/115/014 (1040 mg, 3 tablets) EU/2/10/115/007 (1040 mg, 6 tablets) EU/2/10/115/015 (1620 mg, 3 tablets) EU/2/10/115/009 (1620 mg, 6 tablets)
EU/2/10/115/016 (90 mg, 3 tablete) EU/2/10/115/017 (90 mg, 6 tablet) EU/2/10/115/018 (140 mg, 3 tablete) EU/2/10/115/019 (140 mg, 6 tablet) EU/2/10/115/020 (180 mg, 3 tablete) EU/2/10/115/021 (180 mg, 6 tablet) EU/2/10/115/011 (270 mg, 3 tablete) EU/2/10/115/001 (270 mg, 6 tablet) EU/2/10/115/012 (425 mg, 3 tablete) EU/2/10/115/003 (425 mg, 6 tablet) EU/2/10/115/013 (665 mg, 3 tablete) EU/2/10/115/005 (665 mg, 6 tablet) EU/2/10/115/014 (1040 mg, 3 tablete) EU/2/10/115/007 (1040 mg, 6 tablet) EU/2/10/115/015 (1620 mg, 3 tablete) EU/2/10/115/009 (1620 mg, 6 tablet)
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45-70 mg/kg bodyweight for dogs:
Zdravilo za uporabo v veterinarski medicini se daje v skladu s spodnjo tabelo, da se zagotovi odmerek 45-70 mg/kg telesne mase pri psih.
The mean Tmax for spinosyns A and D ranged from 2-4 hours and the mean elimination half-life ranged from 127.5 to 162.6 hours and 101.3 to 131.9 hours respectively.
2-4 ure, medtem ko je bil razpon srednjega razpolovnega časa izločanja od 127,5 do 162,6 ur za spinosin A in 101,3 do 131,9 ur za spinosin D. Vrednosti AUC in Cmax so bile višje pri nahranjenih kot pa pri teščih psih in so naraščale približno linearno z naraščanjem stopenj odmerka v nameravanem razponu terapevtskega odmerka.
Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Heinz-Lohmann-Str. 4
Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet 1 x 665 mg tablet 1 x 1040 mg tablet 1 x 1620 mg tablet 1 x 1620 mg tablet + 1 x 665 mg tablet 2 x 1620 mg tablets
Število tablet in jakost tablete (mg spinosada) 1 x 90 mg tableta 1 x 140 mg tableta 1 x 180 mg tableta 1 x 270 mg tableta 1 x 425 mg tableta 1 x 665 mg tableta 1 x 1040 mg tableta 1 x 1620 mg tableta 1 x 1620 mg tableta + 1 x 665 mg tableta 2 x 1620 mg tableta
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Special warnings for each target species:
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako živalsko vrsto:
Tan to brown, or speckled with embedded darker particles, round, flat, bevelled edge tablets plain on one side and debossed with a number and a line above on the other side:
Svetlorjave do rjave ali lisaste z vgrajenimi temnejšimi delci, okrogle, ploščate tablete s prirezanimi robovi, na eni strani brez vtisa, na drugi strani pa z vtisom številke in črto nad njo:
Also noted were diffuse hepatocellular hypertrophy in males and females, and this finding correlated with higher pooled mean liver weights.
Pri samcih in samicah so opazili tudi difuzno hipertrofijo jetrnih celic, kar je bilo povezano s povečano maso jeter.
The safety of spinosad in pregnant cats (queens) has not been evaluated.
Pri brejih mačkah varnost spinosada ni bila ocenjena.
Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet †Cats over 8.5 kg: give the appropriate combination of tablets.
Število tablet in jakost tablete (mg spinosada) 1 x 90 mg tableta 1 x 140 mg tableta 1 x 180 mg tableta 1 x 270 mg tableta 1 x 425 mg tableta
In cats, a commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.
Pri mačkaj je neželeni učinek, ki so ga pogosto opazili, bruhanje, ki se pojavi v prvih 48 urah po dajanju zdravila in ga najverjetneje povzroči lokalni učinek na tanko črevo.
Faecal excretion accounted for the vast majority of metabolites in cats.
Velika večina presnovkov se je pri mačkah izločila z blatom.
In dogs, a commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.
Pri psih je neželeni učinek, ki so ga pogosto opazili, bruhanje, ki se pojavi v prvih 48 urah po dajanju zdravila in ga najverjetneje povzroči lokalni učinek na tanko črevo.
INDICATION(S) For the treatment and prevention of flea infestations.
Zdravljenje in preprečevanje infestacij z bolhami.
Tan to brown, or speckled, round, flat, bevelled edge tablets, plain on one side and debossed with a number underlined as listed below on the other:
Svetlorjave do rjave ali lisaste, okrogle, ploščate tablete s prirezanimi robovi, na eni strani brez vtisa, na drugi strani pa z vtisom številke, kot je navedeno spodaj:
Comfortis 90 mg spinosad 90 mg Comfortis 140 mg spinosad 140 mg Comfortis 180 mg spinosad 180 mg Comfortis 270 mg spinosad 270 mg Comfortis 425 mg spinosad 425 mg Comfortis 665 mg spinosad 665 mg Comfortis 1040 mg spinosad 1040 mg Comfortis 1620 mg spinosad 1620 mg
Comfortis 90 mg 90 mg spinosada Comfortis 140 mg 140 mg spinosada Comfortis 180 mg 180 mg spinosada Comfortis 270 mg 270 mg spinosada Comfortis 425 mg 425 mg spinosada Comfortis 665 mg 665 mg spinosada Comfortis 1040 mg 1040 mg spinosada Comfortis 1620 mg 1620 mg spinosada
Comfortis 90 mg chewable tablets for dogs and cats Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs
Comfortis 90 mg žvečljive tablete za pse in mačke Comfortis 140 mg žvečljive tablete za pse in mačke Comfortis 180 mg žvečljive tablete za pse in mačke Comfortis 270 mg žvečljive tablete za pse in mačke Comfortis 425 mg žvečljive tablete za pse in mačke Comfortis 665 mg žvečljive tablete za pse
Bioavailability was shown to be approximately 100%, with maximum plasma concentrations attained approximately 4-12 hours post treatment, and with half-lives of spinosyn A and spinosyn D ranging between 5 days and 20 days in cats dosed at 50-100 mg spinosad/kg bodyweight.
Ugotovljeno je bilo, da je biološka razpoložljivost približno 100 %, največja plazemska koncentracija pa se je pojavila v 4-12 urah po zdravljenju.
Comfortis 665 mg 665 mg spinosad Comfortis 1040 mg 1040 mg spinosad Comfortis 1620 mg 1620 mg spinosad
Comfortis 270 mg 270 mg spinosada Comfortis 425 mg 425 mg spinosada Comfortis 665 mg 665 mg spinosada Comfortis 1040 mg 1040 mg spinosada Comfortis 1620 mg 1620 mg spinosada
− common (more than 1 but less than 10 animals in 100 animals)
- pogosti (pojavijo se pri 1 do 10 živali od 100 živali)
− rare (more than 1 but less than 10 animals in 10,000 animals)
- redki (pojavijo se pri 1 do 10 živali od 10.000 živali)
Comfortis 90 mg chewable tablets for dogs and cats Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs Comfortis 1040 mg chewable tablets for dogs Comfortis 1620 mg chewable tablets for dogs
Comfortis 90 mg žvečljive tablete za pse in mačke Comfortis 140 mg žvečljive tablete za pse in mačke Comfortis 180 mg žvečljive tablete za pse in mačke Comfortis 270 mg žvečljive tablete za pse in mačke Comfortis 425 mg žvečljive tablete za pse in mačke Comfortis 665 mg žvečljive tablete za pse Comfortis 1040 mg žvečljive tablete za pse Comfortis 1620 mg žvečljive tablete za pse
The primary biliary, faecal and urinary metabolites in both the rat and the dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and Ndemethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and also to a lesser extent in the urine.
Glavne presnovke v žolču, blatu in urinu pri podganah in psih so opredelili kot demetilirane spinosine, glutationske konjugate starševskih spojin in
Comfortis 90 mg 90 mg spinosad Comfortis 140 mg 140 mg spinosad Comfortis 180 mg 180 mg spinosad Comfortis 270 mg 270 mg spinosad Comfortis 425 mg 425 mg spinosad
Comfortis 90 mg 90 mg spinosada Comfortis 140 mg 140 mg spinosada Comfortis 180 mg 180 mg spinosada
Tan to brown, or speckled, round, flat, bevelled edge tablets, plain on one side and debossed with a number as listed below on the other:
Svetlorjave do rjave ali lisaste, okrogle, ploščate tablete s prirezanimi robovi, na eni strani brez vtisa,
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali)
− uncommon (more than 1 but less than 10 animals in 1,000 animals)
- občasni (pojavijo se pri 1 do 10 živali od 1.000 živali)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODATKI NA ZUNANJI OVOJNINI Zunanja kartonska škatla
Outer carton
Pretisni omot
This effect was also maintained in the long-term.
Ta učinek se je ohranjal tudi dolgoročno.
Regarding safety, in overall it was considered acceptable.
Kar zadeva varnost, je bilo ocenjeno, da je ta sprejemljiva.
Another study showed maintenance of this effect for 24 months.
Z drugo študijo je bilo dokazano vzdrževanje tega učinka v obdobju 24 mesecev.
The European Commission granted a marketing authorisation valid throughout the European Union for Xadago on 24 February 2015.
Evropska komisija je dovoljenje za promet z zdravilom Xadago, veljavno po vsej Evropski uniji, izdala 24. februarja 2015.
Treatment should be started at a dose of 50 mg a day and the doctor may increase the dose up to 100 mg a day based on patient's need.
Zdravljenje je treba začeti z odmerkom 50 mg na dan, zdravnik pa lahko odmerek glede na bolnikove potrebe poveča na največ 100 mg.
What measures are being taken to ensure the safe and effective use of Xadago?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xadago?
The full EPAR and risk management plan summary for Xadago can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Xadago sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Xadago.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xadago.
Xadago is available as tablets (50 and 100 mg) and can only be obtained with a prescription.
Zdravilo Xadago je na voljo v obliki tablet (50 mg in 100 mg) in se izdaja le na recept.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xadago's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Xadago večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What is Xadago and what is it used for?
Kaj je zdravilo Xadago in za kaj se uporablja?
A risk management plan has been developed to ensure that Xadago is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Xadago je bil pripravljen načrt obvladovanja tveganj.
Other information about Xadago
Druge informacije o zdravilu Xadago
What benefits of Xadago have been shown in studies?
Kakšne koristi je zdravilo Xadago izkazalo v študijah?
Xadago was also investigated as an add-on to treatment in 2 studies in patients with early Parkinson's disease without fluctuations, but these studies did not show a clear benefit and the company did not pursue this use as part of the application.
Zdravilo Xadago so kot dodatek k zdravljenju preučevali tudi v dveh študijah z bolniki s Parkinsonovo boleznijo v zgodnji fazi brez nihanj, vendar ti študiji nista izkazali jasne koristi in družba se ni odločila za uveljavljanje te uporabe v okviru te vloge.
What are the risks associated with Xadago?
Kakšna tveganja so povezana z zdravilom Xadago?
It blocks the enzyme monoamine oxidase type B (which breaks down dopamine), thereby helping to restore dopamine levels in the brain and improving the patient's symptoms.
Safinamid zavira encim monoaminooksidaza tipa B (ki razgrajuje dopamin), s čimer prispeva k ponovni vzpostaviti ustrezne ravni dopamina v možganih in izboljša bolnikove simptome.
The most common side effects with Xadago (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), dyskinesia (difficulty controlling movement), somnolence (sleepiness), dizziness, headache, worsening of existing Parkinson's disease, cataract (clouding of the lens), orthostatic hypotension (drop in blood pressure when standing up), nausea (feeling sick) and falls.
Najpogostejši neželeni učinki zdravila Xadago (ki lahko prizadenejo največ 1 osebo od 10) so nespečnost, diskinezija (težave pri nadzoru gibov), somnolenca (zaspanost), omotica, glavobol, poslabšanje obstoječe Parkinsonove bolezni, katarakta (zameglitev očesne leče), ortostatska hipotenzija (upad krvnega tlaka ob vstajanju v pokončen položaj), navzeja (slabost) in padci.
Why is Xadago approved?
Zakaj je bilo zdravilo Xadago odobreno?
In patients with Parkinson's disease, certain cells in the brain that produce dopamine die, and as dopamine is involved in controlling movement, the patient's movement worsens over time.
Pri bolnikih s Parkinsonovo boleznijo določene celice v možganih, ki tvorijo dopamin, odmrejo in ker dopamin sodeluje pri nadzoru gibanja, se bolnikova sposobnost gibanja sčasoma poslabša.
For more information about treatment with Xadago, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xadago preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In both studies, 6 months treatment with Xadago increased the time during the day during which patients were ‘on' and able to move by 30-60 minutes when compared with placebo.
V obeh študijah je 6-mesečno zdravljenje z zdravilom Xadago v primerjavi s placebom za 30 do 60 minut tekom dneva podaljšalo čas „vklopa“, ko so se bolniki lahko gibali.
The active substance in Xadago, safinamide, is a ‘monoamine oxidase-B (MAO-B) inhibitor'.
Zdravilna učinkovina zdravila Xadago, safinamid, je zaviralec monoaminooksidaze tipa B (MAO-B).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xadago, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Xadago must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines, or in patients with certain conditions affecting the eyes.
Zdravila Xadago ne smejo uporabljati bolniki s hudo okvaro jeter, bolniki, ki se zdravijo s petidinom ali drugimi zaviralci monoaminooksidaze (MAO), ter bolniki, ki imajo določena očesna obolenja.
These fluctuations occur when the effect of levodopa wears off and the patient suddenly switches from being ‘on' and able to move about to being ‘off' and having difficulty moving about.
Do teh nihanj pride, ko učinek levodope pojenja, zaradi česar bolnik doživlja nenadne preskoke med stanjem „vklopa“, ko se lahko giblje, in stanjem „izklopa“, ko ima z gibanjem težave.
For practical information about using Xadago, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Xadago naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Xadago contains the active substance safinamide.
Zdravilo Xadago vsebuje zdravilno učinkovino safinamid.
Xadago is a medicine used to treat Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscular stiffness.
Zdravilo Xadago se uporablja za zdravljenje Parkinsonove bolezni, tj. napredujoče okvare možganov, ki povzroča tresavico, upočasnjeno izvajanje gibov in okorelost mišic.
It is not intended to provide practical advice on how to use Xadago.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects reported with Xadago, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xadago, glejte navodilo za uporabo.
It is used in addition to levodopa (a medicine commonly used to treat the symptoms of Parkinson's disease) either alone or in combination with other medicines for Parkinson's, in patients with mid- to late-stage Parkinson's disease who are having ‘motor fluctuations'.
Uporablja se kot dodatek k levodopi (zdravilu, ki se običajno uporablja za zdravljenje simptomov Parkinsonove bolezni), bodisi samostojno ali v kombinaciji z drugimi zdravili za zdravljenje Parkinsonove bolezni pri bolnikih z motoričnimi nihanji v srednji do pozni fazi bolezni.
Xadago, as an add-on treatment to levodopa with or without other medicines for Parkinson's disease, has been compared with placebo (a dummy treatment) in two main studies involving 1,218 patients with late stage Parkinson's disease who experienced fluctuations.
Zdravilo Xadago so kot dodatek k levodopi ob sočasni uporabi drugih zdravil za Parkinsonovo bolezen ali brez njih primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katere je bilo vključenih 1 218 bolnikov s Parkinsonovo boleznijo v pozni fazi, pri katerih je prihajalo do nihanj.
How is Xadago used?
Kako se zdravilo Xadago uporablja?
How does Xadago work?
Kako zdravilo Xadago deluje?
The Committee concluded that the effect of Xadago on the daily time that patients lived without motor symptoms was of clinical relevance, also taking into account the response reported in the literature for other Parkinson's medicines.
Ob upoštevanju poročil o odzivu na druga zdravila za zdravljenje Parkinsonove bolezni v literaturi je zaključil, da je učinek zdravila Xadago na čas, ki ga bolnik dnevno preživi brez motoričnih simptomov, klinično pomemben.
Do not take two doses at the same time.
Ne vzemite dveh odmerkov hkrati.
The usual dose is one tablet each day.
Običajni odmerek je ena tableta vsak dan.
The label on the carton will tell you how many tablets you should take and when.
Na nalepki na škatli bo napisano, koliko tablet morate vzeti in kdaj.
Be especially careful when you take you first start taking the tablets.
Bodite posebno previdni ob začetku jemanja tablet.
The majority of the adverse reactions were transient.
Večina neželenih učinkov je bilo prehodnih.
However, if you miss a dose, just take it as soon as you remember.
Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
The tablets should be swallowed whole with a glass of water.
Tablete je treba pogoltniti cele s kozarcem vode.
Taking other medicines You should always tell your doctor about any medicines you are taking.
Jemanje drugih zdravil Vedno obvestite zdravnika o vseh zdravilih, ki jih jemljete.
Pharmcom Oy Keijumaki 6B 30 02130 Espoo Finland
Pharmcom Oy Keijumaki 6B 30 02130 Espoo Finska
• Other medicines used in the treatment of high blood pressure
• druga zdravila za zdravljenje visokega krvnega tlaka;
The prolonged-release tablets should not be chewed, divided or crushed.
Tablete s podaljšanim sproščanjem se ne smejo žvečiti, prepoloviti ali zdrobiti.
Ratiopharm Hungaria Kft. Uzoki utca 36/a 1145 Budapest, Hungary Tel: 0036 1 2732730
Ratiopharm Hungaria Kft. Uzoki utca 36/a 1145 Budapest, Madžarska Tel: 0036 1 2732730
They are available in PVC/PVDC/aluminium blisters packs of 28 tablets [20, 30, 50, 98, 100 and 500 tablets].
Na voljo so v pretisnih omotih iz PVC/PVDC/aluminija z 28 tabletami [20, 30, 50, 98, 100 in 500 tabletami].
Frequencies are defined as very common (≥1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10
Pogostost je opredeljena 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).
The prostate gland is just underneath the bladder in men.
Prostata leži pod mehurjem pri moških.
Do not crush or chew the tablets.
Tablet ne zdrobite ali žvečite.
Adults and the elderly:
Odrasli in starejši bolniki:
Take this leaflet and any left-over tablets with you, so the doctor knows what you have taken.
S seboj vzemite to navodilo in morebitne preostale tablete, da bo zdravnik vedel, kaj ste vzeli.
• if you are allergic to doxazosin or to any of the ingredients listed above
• če ste alergični na doksazosin ali katero koli zgoraj navedeno sestavino zdravila;
• if you suffer from kidney problems, overflow incontinence (you do not feel the urge to urinate) or anuria (your body is not producing any urine)
• če imate težave z ledvicami, prelivno inkontinenco (ne čutite potrebe po uriniranju) ali anurijo (vaše telo ne proizvaja urina);
• if you suffer from liver problems
• če imate težave z jetri;
CHMP was of the opinion that the bioequivalence was sufficiently established after single dose administration in two different bioequivalence studies (study 463/04 and 1995/04-05) and after multiple dose administration (study 5208/02-3) according to the CHMP guidelines.
CHMP je menil, da je bila bioekvivalenca po uporabi enega odmerka zadostno dokazana v dveh različnih bioekvivalenčnih raziskavah (raziskavi 463/04 in 1995/04-05) in po uporabi večkratnega odmerka (raziskava 5208/02-3) v skladu s smernicami CHMP.
The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-blockers.
Zdravilna učinkovina v tabletah, doksazosin, spada v skupino zdravil, znanih kot alfa-blokatorji.
A dosage regime of 82 mg/kg/day (8 times the human exposure) was associated with reduced foetal survival.
Odmerki 82 mg/kg/dan (8kratna izpostavljenost pri človeku) so bili povezani z zmanjšanim preživetjem fetusov.
There are no adequate data from the use of doxazosin prolonged release tablets in pregnant women.
Ni zadostnih podatkov o uporabi tablet doksazosina s podaljšanim sproščanjem pri nosečnicah.
89079 Ulm, Germany Tel: 0049 731 40202
89079 Ulm, Nemčija Tel: 0049 731 40202
If you take too many tablets, the most likely symptoms would be a feeling of light-headedness or dizziness due to a fall in blood pressure.
Če vzamete preveč tablet, sta najverjetnejša simptoma občutek omotice ali vrtoglavice zaradi znižanja krvnega tlaka.
This includes any medicines you have bought for yourself, as well as those prescribed for you by a doctor.
Obvestiti ga morate o vseh zdravilih, ki ste jih kupili sami, in zdravilih, ki vam jih je predpisal zdravnik.
Very rare: increase of serum creatinine.
Zelo redki: zvišanepovečane vrednosti kreatinina v serumu
Fax: 00358 94524872
Faks: 00358 94524872
Contact your nearest casualty department or tell your doctor or pharmacist immediately.
Takoj obiščite najbližji nezgodni oddelek ali obvestite zdravnika ali farmacevta.
• if you suffer from acute heart disease such as pulmonary oedema or heart failure
• če imate akutno srčno bolezen, kot je pljučni edem ali srčna odpoved;
Animal studies have shown reduced foetal survival at high doses (see section 5.3).
Študije na živalih so pri visokih odmerkih pokazale zmanjšano preživetje fetusov (glejte poglavje 5.3).