natgillin/translations-raw huggingface dataset:
Patients received either 900 mg/day Raxone or placebo for a period of 24 weeks (6 months).
Bolniki so 24 tednov (6 mesecev) prejemali 900 mg zdravila Raxone na dan ali placebo.
- Raxone contains lactose (a type of sugar).
- Zdravilo Raxone vsebuje laktozo (vrsto sladkorja).
Each film-coated tablet contains 150 mg idebenone.
Ena filmsko obložena tableta vsebuje 150 mg idebenona.
If you stop taking Raxone
Če ste prenehali jemati zdravilo Raxone
In the EAP the number of responders increased with longer treatment duration, from 19 out of 62 patients (30.6%) at 6 months to 17 out of 47 patients (36.2%) at 12 months.
(30,6 %) po 6 mesecih do 17 izmed 47 bolnikov (36,2 %) po 12 mesecih.
Idebenone, a short-chain benzoquinone, is an anti-oxidant assumed to be capable of transferring electrons directly to complex III of the mitochondrial electron transport chain, thereby circumventing complex I and restoring cellular energy (ATP) generation under experimental conditions of complex I deficiency.
Idebenon, benzokinon s kratko verigo, je antioksidant, za katerega se predvideva, da elektrone prenaša neposredno v kompleks III mitohondrijske verige za prenos elektronov, pri tem pa obide kompleks I in ponovno vzpostavi ustvarjanje celične energije (ATP) pri eksperimentalnih pogojih pomanjkanja kompleksa I. Podobno lahko idebenon pri LHON prenaša elektrone neposredno v kompleks III verige za prenos elektronov in pri tem obide kompleks I, na katerega vplivajo vse tri primarne mutacije mtDNA, ki povzročajo LHON, kar ponovno vzpostavi ustvarjanje celične ATP.
Raxone contains lactose.
Zdravilo Raxone vsebuje laktozo.
Tablet film-coating: macrogol, poly(vinyl alcohol), talc, titanium dioxide, sunset yellow (E110).
Filmska obloga tablete: makrogol, polivinil alkohol, smukec, titanov dioksid, sončno rumeno barvilo (E110).
Treatment should be initiated and supervised by a physician with experience in LHON.
4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzorovati zdravnik z izkušnjami z LHON.
Bronchitis
- bronhitis
Contains lactose and sunset yellow (E110).
Vsebuje laktozo in sončno rumeno barvilo (E110).
Raxone contains a substance called idebenone.
Zdravilo Raxone vsebuje zdravilno učinkovino, imenovano idebenon.
In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should conduct and submit the results of an external natural history controlled, open-label intervention study to assess the efficacy and safety of Raxone in the treatment of LHON patients, including long-term treatment.
mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate zunanje, nadzorovane, odprte, intervencijske študije pojava in poteka LHON, ki bo ocenila učinkovitost in varnost zdravila Raxone pri zdravljenju bolnikov z LHON, vključno z dolgotrajnim zdravljenjem.
How to take Raxone
Kako jemati zdravilo Raxone
No specific dose adjustment is required for the treatment of LHON in elderly patients.
Pri starejših bolnikih za zdravljenje LHON posebno prilagajanje odmerka ni potrebno.
Fax: +49 (0) 7621 1690 201
Nemčija tel.: +49 (0) 7621 1690 200 faks: +49 (0) 7621 1690 201 e-pošta: office@santhera.com
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, magnesium stearate and colloidal silica.
Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, natrijev karmelozat, premreženi, povidon K25, magnezijev stearat in koloidni silicijev dioksid.
Raxone is not expected to affect your ability to drive or use machines.
Učinek zdravila Raxone na sposobnost vožnje in upravljanja strojev se ne pričakuje.
Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus,
CYP3A4, za katere je znano, da imajo ozek terapevtski indeks, kot so alfentanil, astemizol, terfenadin, cisaprid, ciklosporin, fentanil, pimozid, kinidin, sirolimus, takrolimus ali alkaloidi rženega rožička (ergotamin, dihidroergotamin), pri bolnikih, ki prejemajo idebenon, uporabljati previdno.
The following adverse reactions emerging from clinical trials in LHON patients or reported postmarketing in other indications are tabulated below.
V spodnji preglednici so povzeti neželeni učinki, ki so se pojavili med kliničnimi preskušanji pri bolnikih z LHON ali v obdobju trženja pri drugih indikacijah.
Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gammalutamyltransferase increased, blood bilirubin increased, hepatitis
Bolezni jeter, žolčnika in žolčevodov zvišana raven alanin-aminotransferaze, zvišana raven aspartat-aminotransferaze, zvišana raven alkalne fosfataze v krvi, zvišana raven laktat-dehidrogenaze v krvi, zvišana raven gama-glutamiltransferaze, zvišana raven bilirubina v krvi, hepatitis neznana
- LHON can lead to loss of eyesight due to the inactivity of cells responsible for vision.
- Zaradi neaktivnosti celic, odgovornih za vid, lahko LHON povzroči izgubo vida.
Endpoint (ITT)
Opazovani dogodek (ITT)
feeling restless, lacking energy - nausea, vomiting, loss of appetite, stomach ache - high levels of some liver enzymes in the body which mean you have liver problems - shown in tests, high levels of “bilirubin” - this can make your skin and the whites of your eyes look yellow, hepatitis - rash, itching - pain in extremity - high levels of nitrogen in the blood - shown in tests change in urine colour - generally feeling unwell
omotica, glavobol, nemir, pomanjkanje energije, - siljenje na bruhanje, bruhanje, izguba teka, bolečina v želodcu, - visoke ravni nekaterih jetrnih encimov v telesu, kar pomeni, da imate težave z jetri (kar se ugotovi s preiskavami), visoke ravni »bilirubina« (kar lahko obarva kožo in beločnice rumeno),
Your doctor will check your eye-sight before you start taking this medicine and then at regular visits while you are taking it.
Pred začetkom jemanja tega zdravila in ob rednih obiskih med njegovim jemanjem bo zdravnik preverjal vid.
Name and address of the manufacturer responsible for batch release
A. IPROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
In RHODOS and the EAP in LHON, a total of 3 patients between the ages of 9 and 11 years and 27 patients between the ages of 12 and 17 years received idebenone at 900 mg/day for up to 33 months.
V študiji RHODOS in EAP pri LHON so 3 bolniki, stari od 9 do 11 let, in 27 bolnikov, starih od 12
Best recovery of VA (mean ± SE; 95%CI)
(povprečje ± SE; 95-% IZ)
Clinical safety and efficacy of idebenone in LHON have been assessed in one double-blind, randomised, placebo-controlled study (RHODOS).
randomizirani, s placebom nadzorovani študiji (RHODOS).
Main secondary endpoint: Change in best VA (mean ± SE; 95% CI)
Glavni sekundarni opazovani dogodek: sprememba najboljše VA
Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
agitacija, diskinezija, hiperkinezija, poriomanija, omotica, glavobol, nemir, stupor neznana
Raxone 150 mg film-coated tablets idebenone
Raxone 150 mg filmsko obložene tablete idebenon
Therefore, caution should be exercised when prescribing Raxone to patients with hepatic or renal impairment.
Kadar se zdravilo Raxone predpiše bolnikom z jetrno ali ledvično okvaro, je treba biti previden.
Raxone 150 mg film-coated tablets
Raxone 150 mg filmsko obložene tablete
- Raxone contains a colourant called “sunset yellow” (also called E110).
- Zdravilo Raxone vsebuje barvilo, imenovano »sončno rumeno« (tj. E110).
CARTONS/ HDPE BOTTLE LABEL
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLE/OZNAKA NA VSEBNIKU IZ HDPE
Idebenone may inhibit P-glycoprotein (p-gp) with possible exposure increases of e.g. dabigatran etexilate, digoxin or aliskiren.
Idebenon lahko zavira P-glikoprotein (p-gp) z morebitnim povečanjem izpostavljenosti npr.
Raxone contains lactose and sunset yellow (E110)
Zdravilo Raxone vsebuje laktozo in sončno rumeno barvilo (E110).
What you need to know before you take Raxone Do not take Raxone if you are allergic to idebenone or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na idebenon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Common (may affect up to 1 in 10 people): - diarrhoea (mild to moderate that usually does not require discontinuation of treatment) - back pain
- driska (blaga do zmerna, ki navadno ne zahteva prekinitve zdravljenja),
Back pain
- bolečina v hrbtu.
Raxone may make your urine become reddish brown.
Zdravilo Raxone lahko urin obarva rdečerjavo.
- Tell your doctor if your urine changes colour.
- Če opazite spremembo barve urina, o tem obvestite zdravnika.
Depending on the time since symptom onset and the proportion of RGCs already affected, idebenone can promote recovery of vision in patients who experience vision loss.
Idebenon lahko spodbuja vračanje vida pri bolnikih z izgubo vida, kar je odvisno od časa od pojava simptomov in deleža prizadetih RGC.
Blood cholesterol increased, blood triglycerides increased
Presnovne in prehranske motnje zvišana raven holesterola v krvi, zvišana raven trigliceridov v krvi neznana
Talk to your doctor before you stop taking this medicine.
Preden prenehate jemati to zdravilo, se posvetujte z zdravnikom.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone K25
Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karmelozat, premreženi povidon K25 magnezijev stearat koloidni silicijev dioksid
Nausea, vomiting, anorexia, dyspepsia
Bolezni prebavil driska pogosti navzeja, bruhanje, anoreksija, dispepsija neznana
Titanium dioxide Sunset yellow FCF (E110)
Obloga makrogol 3350 polivinil alkohol smukec titanov dioksid sončno rumeno barvilo FCF (E110)
movements that you cannot control, a tendency to wonder away, feeling dizzy, headache,
(halucinacije), občutek vzburjenja, nenadzorovani gibi, nagnjenost k brezciljnem beganju,
How to store Raxone
Shranjevanje zdravila Raxone
Preferred Term
Organski sistem Prednostni izraz
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj zelo pogosti
Tell your doctor if you are taking, have recently taken or might take any other medicines, especially any of the following: - antihistamines to treat allergies (astemizole, terfenadine) - to treat heartburn (cisapride) - to treat muscle and speech tics associated with Tourette syndrome (pimozide) - to treat hearth rhythm disorders (quinidine) - to treat migraine (dihydroergotamine, ergotamine) - to put you to sleep called “anaesthetics” (alfentanil) - to treat inflamation in rheumatoid arthritis and psoriasis (cyclosporine) - to prevent the rejection of an organ transplant (sirolimus, tacrolimus) - to treat strong pain called “opioids” (fentanyl)
ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, predvsem naslednja zdravila: - antihistaminiki za zdravljenje alergij (astemizol, terfenadin), - za zdravljenje zgage (cisaprid),
Package leaflet: Information for the user Raxone 150 mg film-coated tablets idebenone
Navodilo za uporabo Raxone 150 mg filmsko obložene tablete idebenon
If you are breast-feeding your doctor will discuss with you whether to stop breast-feeding or to stop taking the medicine.
ali morate prekiniti dojenje ali prenehati uporabljati to zdravilo.
Unknown frequency (frequency cannot be estimated from the available data): - bronchitis - changes in blood test results: low level of white blood cells, or low level of red blood cells, or low level of platelets - increased cholesterol or fat in the blood -shown in tests - fits, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited,
- zvišana raven holesterola ali maščob v krvi, kar se ugotovi s preiskavami, - epileptični napadi, občutek zmedenosti, vidno in slušno zaznavanje stvari, ki niso resnične
Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia
Bolezni krvi in limfatičnega sistema agranulocitoza, anemija, levkocitopenija, trombocitopenija, nevtropenija neznana
See section 4.
(Preglednica 1).
- Raxone film-coated tablets are orange, round tablets of 10 mm diameter, engraved with the
- Filmsko obložene tablete zdravila Raxone so oranžne, okrogle tablete s premerom 10 mm ter logotipom Santhera na eni strani in »150« na drugi - Zdravilo Raxone je na voljo v plastenkah.
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije splošno slabo počutje neznana
Azotaemia, chromaturia
- nazofaringitis (prehlad), - kašelj.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj, pruritus neznana
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v hrbtu pogosti bolečina v udu neznana
Very common (may affect more than 1 in 10 people): - nasopharyngitis (cold) - cough
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
- Raxone is supplied in white plastic bottles.
- Zdravilo Raxone lahko prehaja v materino mleko.
These reactions are usually short lived and go away within 5 to 15 days but could last up to 49 days.
Te reakcije so običajno kratkotrajne in izginejo v petih do 15 dneh, lahko pa trajajo do 49 dni.
In case of eye contact the affected area should be rinsed immediately with water.
V primeru stika z očmi je treba prizadeto področje nemudoma izprati z vodo.
The full EPAR for Zeleris can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Zeleris je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Other information about Zeleris:
Druge informacije o zdravilu Zeleris:
Zeleris should not be administered by pregnant women.
Zdravila Zeleris ne smejo dajati nosečnice.
The European Commission granted a marketing authorisation valid throughout the EU for Zeleris on 15 May 2017.
Evropska komisija je dovoljenje za promet z zdravilom Zeleris, veljavno po vsej Evropski uniji, izdala 15/05/2017.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zeleris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Zeleris večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Zeleris.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zeleris.
During injection of this product animals may show signs of moderate pain, such as movement of the head or neck.
Med injiciranjem tega zdravila lahko živali kažejo znake zmerne bolečine, npr. s premikanjem glave ali vratu.
Cattle weighing more than 150 kg will need to have the dose divided and injected at more than one site.
Pri govedu, ki tehta več kot 150 kg, je treba odmerek razdeliti in ga injicirati na več kot enem mestu.
It is not intended to provide practical advice on how to use Zeleris.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The withdrawal period for meat from cattle treated with Zeleris is 56 days.
Karenca za meso goveda, zdravljenega z zdravilom Zeleris, je 56 dni.
What benefits of Zeleris have been shown in studies?
Kakšne koristi je zdravilo Zeleris izkazalo v študijah?
What is Zeleris and what is it used for?
Kaj je zdravilo Zeleris in za kaj se uporablja?
Meloxicam belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Meloksikam spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
Florfenicol is a broad-spectrum antibiotic which stops bacteria from growing by blocking the activity of ribosomes, the part of the bacterial cells where proteins are produced.
Florfenikol je antibiotik širokega spektra, ki zaustavlja rast bakterij tako, da blokira aktivnost ribosomov, tj. delov bakterijske celice, v katerih nastajajo beljakovine.
What are the risks associated with Zeleris?
Kakšna tveganja so povezana z zdravilom Zeleris?
As Zeleris contains an antibiotic it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Ker zdravilo Zeleris vsebuje antibiotik, je pomembno natančno slediti napotkom v navodilu za uporabo, da se razvoj odpornosti na antibiotike zmanjša na najnižjo možno raven.
People who are hypersensitive (allergic) to florfenicol, meloxicam or any of the other ingredients of the medicine should avoid contact with Zeleris.
Osebe, ki so preobčutljive za (alergične na) florfenikol, meloksikam ali katero koli drugo sestavino zdravila, se morajo stiku z zdravilom Zeleris izogibati.
The most common side effects with Zeleris (which may affect more than 1 in 10 animals) are reactions at the injection site (mostly swelling, hardness, heat and pain) after injection under the skin.
Najpogostejši neželeni učinki zdravila Zeleris (ki lahko prizadenejo več kot 1 od 10 živali) so reakcije na mestu injiciranja (najpogostejše so otekanje, otrdelost, vročina in bolečina) po injiciranju pod kožo.
Zeleris is a veterinary medicine used to treat cattle with bovine respiratory disease (BRD, a condition affecting the lungs) associated with a high temperature, which is due to the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Zeleris je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje dihalnih obolenj goveda (BRD, bolezni, ki prizadene pljuča), povezane z visoko telesno temperaturo, ki jo povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
Why is Zeleris approved?
Zakaj je bilo zdravilo Zeleris odobreno?
The medicine can only be obtained with a prescription and is available as a solution for injection.
Izdaja in predpisovanje zdravila je le na recept, na voljo pa je v obliki raztopine za injiciranje.
Zeleris was as effective as florfenicol alone in improving signs of the disease (based on behaviour and breathing) on day 7.
Zdravilo Zeleris je bilo pri izboljšanju znakov bolezni (glede na vedenje in dihanje) sedmega dne enako učinkovito kot samo florfenikol.
Zeleris must not be given to bulls intended for breeding nor to animals with impaired liver, heart or kidney function, bleeding disorders or with gut ulceration.
Zdravila Zeleris se ne sme dajati bikom, namenjenim vzreji, in živalim z okvarjenim delovanjem jeter, srca ali ledvic, motnjami strjevanja krvi ali ulceracijo črevesja.
The dose depends on the animal's weight and is given by injection under the skin in the neck area.
Odmerek je odvisen od telesne mase živali in se daje z injekcijo v podkožje na predelu vratu.
In a field study 329 calves with bovine respiratory disease and a body temperature of 40˚C or higher were treated either with Zeleris or florfenicol alone.
V terenski študiji je bilo samo z zdravilom Zeleris ali samo s florfenikolom zdravljenih 329 telet z dihalnim obolenjem in s telesno temperaturo, ki je znašala 40 ˚C ali več.
The medicine is not authorised for use in cows producing milk for human consumption.
Zdravilo ni odobreno za uporabo pri kravah, katerih mleko je namenjeno prehrani ljudi.
A success rate of 67% was achieved with Zeleris compared to 65% for florfenciol.
V primerjavi z uspešnostjo zdravljenja s florfenikolom, ki je znašala 65 %, je uspešnost zdravljenja z zdravilom Zeleris znašala 67 %.
In addition, in the first 48 hours after the injection, Zeleris was more effective than florfenicol alone in reducing the body temperature to below 39.5˚C.
Poleg tega je bilo zdravilo Zeleris pri zniževanju telesne temperature na raven, nižjo od 39,5 ˚C, v prvih 48 urah po injiciranju bolj učinkovito od samostojno danega florfenikola.
How is Zeleris used?
Kako se zdravilo Zeleris uporablja?
Safety information has been included in the summary of product characteristics and the package leaflet for Zeleris, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
For practical information about using Zeleris, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Zeleris naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Zeleris contains the active substances florfenicol and meloxicam.
Vsebuje zdravilni učinkovini florfenikol in meloksikam.
For more information about treatment with Zeleris, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Zeleris naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
How does Zeleris work?
Kako zdravilo Zeleris deluje?
It should also not be used in pregnant cows which are intended to produce milk for human consumption within two months of calving.
Dva meseca pred telitvijo se zdravila ne sme dajati brejim kravam, katerih mleko je namenjeno prehrani ljudi.
• if you are more than 3 months pregnant.
• ak ste tehotná dlhšie 3 mesiace.
See also information under the heading “Do not take Kinzalkomb”.
Pozri tiež informácie v časti „Neužívajte Kinzalkomb“.
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
• Druhý a tretí trimester gravidity (pozri časti 4.4 a 4.6).
4.1 Therapeutic indications
4.1 Terapeutické indikácie
(It is also better to avoid Kinzalkomb in early pregnancy - see pregnancy section.)
(Vhodnejšie je vyhnúť sa užívaniu Kinzalkombu vo včasnom štádiu tehotenstva - pozri časť Tehotenstvo a dojčenie)
• if you have severe kidney disease.
• keď máte závažné ochorenie obličiek
The European Medicines Agency has waived the obligation to submit the results of studies with Kinzalkomb in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Európska agentúra pre lieky udelila výnimku z povinnosti predložiť výsledky štúdií s Kinzalkombom vo všetkých podskupinách pediatrickej populácie pre hypertenziu (informácie o použití v pediatrickej populácii, pozri časť 4.2).
• if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
• ak ste alergický na telmisartan alebo na ktorúkoľvek z ďalších zložiek tohto lieku (uvedených v časti 6)
C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
C značeného telmisartanu, glukorunid predstavuje asi 11 % meranej rádioaktivity v plazme.
- Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
- ochorenie systémový lupus erythematosus (nazývaný tiež „lupus“ alebo „SLE“)choroba, kde imunitný systém napadá telo.
Microcrystalline cellulose Povidone (K25)
Mikrokryštalická celulóza Povidón (K25)
- Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
- zvýšená hladina aldosterónu (zadržiavanie vody a solí v tele popri nerovnováhe rôznych krvných minerálov).
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
• ak ste alergický na hydrochlorotiazid alebo na niektorý z ďalších derivátov sulfonamidu
Calcium supplements and/or vitamin D supplements.
- výživové doplnky s obsahom vápnika a/alebo vitamínu D.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 April 2002
DÁTUM PRVEJ REGISTRÁCIE/PREDĹŽENIA REGISTRÁCIE Dátum prvej registrácie: 19.