natgillin/translations-raw huggingface dataset:
Repaglinide Accord can also be given with metformin, another medicine for diabetes.
Zdravilo Repaglinide Accord se lahko uporablja tudi skupaj z metforminom, drugim zdravilom za zdravljenje sladkorne bolezni.
• If you exercise more than usual
• če jeste več kot ponavadi,
Do not use Repaglinide Accord after the expiry date which is stated on the carton bottle label and blister after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in foliji pretisnega omota poleg oznake »Upor.
Patients can be transferred directly from other oral hypoglycaemic medicinal products to repaglinide.
Bolnike je mogoče na repaglinid prevesti neposredno z drugih peroralnih antidiabetikov.
• The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to
• Zdravnik lahko odmerek zviša do 4 mg, ki ga vzemite tik pred ali do 30 minut pred glavnimi obroki.
Repaglinide Accord is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
Zdravilo Repaglinide Accord uporabljamo za obvladovanje sladkorne bolezni tipa 2 pri odraslih kot dodatek k dieti in telesni dejavnosti: zdravljenje je treba uvesti, če samo z dieto, telesno dejavnostjo in zmanjšanjem telesne mase vrednosti sladkorja v krvi ni mogoče nadzirati (ali znižati).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2011
Datum prve odobritve: 22. december 2011 Datum zadnjega podaljšanja: 19. september 2016
Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.
Uporaba repaglinida je indicirana tudi v kombinaciji z metforminom pri odraslih s sladkorno boleznijo tipa 2 diabetesom mellitusom, pri katerih glikemija samo z metforminom ni zadovoljivo urejena.
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Accord.
Če jemljete gemfibrozil (zdravilo za zdravljenje zvišane vrednosti maščob v krvi), zdravila Repaglinide Accord ne smete jemati.
Allergy is very rare (may affect up to 1 in 10,000 patients).
Alergija je zelo redka (lahko se pojavi pri največ 1 od 10.000 bolnikov).
Aluminium/aluminium blister in packs containing 30, 90, 120, 180 or 270 tablets.
Pretisni omot (aluminij/aluminij) v pakiranjih, ki vsebujejo 30, 90, 120, 180 ali 270 tablet.
Repaglinide Accord should be taken with caution.
V tem primeru morate zdravilo Repaglinide Accord uporabljati previdno.
Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the active substance.
Repaglinid se hitro absorbira iz prebavil, zato se koncentracija zdravilne učinkovine v plazmi hitro zveča.
No clinical studies have been conducted in patients with hepatic insufficiency.
Pri bolnikih z jetrno insuficienco klinične študije niso bile izvedene.
If you forget to take Repaglinide Accord
Če ste pozabili vzeti zdravilo Repaglinide Accord
If you stop taking Repaglinide Accord
Če prenehate jemati zdravilo Repaglinide Accord
How to store Repaglinide Accord Contents of the pack and other information
Shranjevanje zdravila Repaglinide Accord Vsebina pakiranja in dodatne informacije
Seven days pre-treatment with rifampicin (600 mg), followed by co-administration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Pri sedemdnevnem predzdravljenju z rifampicinom (v odmerku 600 mg) in kasnejšemu dodatku repaglinida (v enkratnem odmerku 4 mg) sedmi dan, se je vrednost AUC znižala za 50 % (kombinirani učinek indukcije in inhibicije).
Alcohol can change the ability of Repaglinide Accord to reduce the blood sugar.
Zdravilo Repaglinide Accord skupaj z alkoholom Alkohol lahko spremeni sposobnost zdravila Repaglinide Accord, da zniža vrednost krvnega sladkorja.
Repaglinide Accord is available in the following pack sizes: 30, 90, 120, 180 or 270 tablets in blisters
Repaglinide Accord je na voljo v štirih velikostih pretisnih omotov: 30, 90, 120, 180 ali 270 tablet.
Repaglinide pharmacokinetics are characterised by low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and is highly bound to plasma proteins in humans (greater than
Za farmakokinetiko repaglinida je značilen majhen volumen porazdelitve (30 l), kar je v skladu s porazdelitvijo v znotrajcelični tekočini, vezava na plazemske proteine pri človeku pa je obsežna (več kot 98 %).
How to take Repaglinide Accord
Kako jemati zdravilo Repaglinide Accord
4.4 Special warnings and precautions for use General
4.4 Posebna opozorila in previdnostni ukrepi
• Sympathomimetics (used to treat asthma)
• simpatikomimetike (uporabljamo jih za zdravljenje astme),
HDPE bottle containing 100 tablets in packs of 1 bottle.
Pakiranje v eni HDPE plastenki, ki vsebuje 100 tablet.
Repaglinide Accord should not be taken if you have a severe liver disease (see Do not take Repaglinide Accord).
Bolniki s hudo boleznijo jeter zdravila Repaglinide Accord ne smejo jemati (glejte odstavek Ne jemljite zdravila Repaglinide Accord).
Repaglinide Accord 0.5 mg tablets Repaglinide Accord 1 mg tablets Repaglinide Accord 2 mg tablets Repaglinide
Repaglinide Accord 0,5 mg tablete Repaglinide Accord 1 mg tablete Repaglinide Accord 2 mg tablete repaglinid
OTHER SPECIAL WARNINGS, IF NECESSARY EXPIRY DATE
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Upor.
• Severe liver problems, abnormal liver function such as increased liver enzymes in your blood.
• motnje vida • hude težave z jetri, moteno delovanje jeter, zvišana koncentracija jetrnih encimov v krvi
Isolated cases of increased liver enzymes have been reported during treatment with repaglinide.
Med zdravljenjem z repaglinidom so poročali o posameznih primerih zvišanja vrednosti jetrnih encimov.
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed.
Kombinacija z insulinom NPH (Neutral Protamine Hagedorn) ali s tiazolidindioni
The active substance is repaglinide.
Zdravilna učinkovina je repaglinid.
The resulting increased calcium influx induces insulin secretion from the β-cell.
Vtok kalcija se zato zveča in to sproži izločanje insulina iz celic .
Abnormal hepatic function, increased liver enzymes
Moteno delovanje jeter, zvišana vrednost jetrnih encimov
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide.
Pri sočasni uporabi repaglinida in drugih učinkovin, ki se presnavljajo s CYP3A4, kot so cimetidin, nifedipin, estrogen ali simvastatin, se farmakokinetične lastnosti repaglinida niso pomembneje spremenile.
Method of administration Repaglinide should be taken before main meals (i.e. preprandially).
Način uporabe Bolnik mora repaglinid vzeti pred glavnimi obroki (tj. predprandialno).
Patients receiving other oral hypoglycaemic medicinal products
Bolniki, ki se zdravijo z drugimi peroralnimi antidiabetiki
• If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
• jemljete gemfibrozil (zdravilo za zdravljenje zvišane vrednosti maščob v krvi).
• If you take too much Repaglinide Accord
• če ste vzeli prevelik odmerek zdravila Repaglinide Accord,
What you need to know before you take Repaglinide Accord Do not take Repaglinide Accord
Kaj morate vedeti, preden boste vzeli zdravilo Repaglinide Accord
What Repaglinide Accord contains
Kaj vsebuje zdravilo Repaglinide Accord
• If you take too little Repaglinide Accord
• če ste vzeli premajhen odmerek zdravila Repaglinide Accord,
• Gemfibrozil (used to treat high blood fats)
• gemfibrozil (zdravilo za zdravljenje zvišane vrednosti maščob v krvi),
Your blood sugar may get too high (hyperglycaemia).
V primeru prekomernega zvišanja vrednosti krvnega sladkorja Krvni sladkor se vam lahko tudi preveč zviša (to imenujemo hiperglikemija).
You may get a hypo (short for hypoglycaemia) if your blood sugar gets too low.
V primeru pojava hipe (nizka vrednost krvnega sladkorja) Če se vam krvni sladkor prekomerno zniža, lahko doživite hipo (hipa je okrajšava za hipoglikemijo in pomeni simptome nizkega krvnega sladkorja).
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets
IME ZDRAVILA Repaglinide Accord 0,5 mg tablete repaglinid
MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/743/005
You should not take Repaglinide Accord if you are pregnant or you are planning to become pregnant.
Če ste noseči ali nameravate zanositi, zdravila Repaglinide Accord ne smete jemati.
Cellulose, microcrystalline (E460) Calcium hydrogen phosphate, anhydrous Maize starch
6.1 Seznam pomožnih snovi celuloza, mikrokristalna (E460) brezvodni kalcijev hidrogenfosfat koruzni škrob povidon glicerin magnezijev stearat meglumin poloksamer 188
Repaglinide Accord 0.5 mg: Each tablet contains 0.5 mg repaglinide Repaglinide Accord 1 mg: Each tablet contains 1 mg repaglinide Repaglinide Accord 2 mg: Each tablet contains 2 mg repaglinide The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, meglumine, poloxamer 188, povidone, glycerin, magnesium stearate, yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets.
Pomožne snovi so: mikrokristalna celuloza (E460), brezvodni kalcijev hidrogenfosfat, koruzni škrob, meglumin, poloksamer 188, povidon, glicerin, magnezijev stearat, rumeni železov oksid (E172) v 1mg tabletah in rdeči železov oksid (E172) samo v 2-mg tabletah.
NAME OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Accord
MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/010
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/743/010
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets
IME ZDRAVILA Repaglinide Accord 2 mg tablete Repaglinid
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets
IME ZDRAVILA Repaglinide Accord 1 mg tablete repaglinid
The Repaglinide Accord 2 mg tablet is peach coloured, round, biconvex with beveled edge, with inscription 'R' on one side and plain on other side, may have mottled appearance
Repaglinide Accord 2 mg tablete so breskove barve, okrogle, izbočene s poševnim robom, brez prevleke, z vtisnjenim “R” na eni strani in brez oznake na drugi, in so lahko pikčastega izgleda
The Repaglinide Accord 1 mg tablet is light yellow to yellow round, biconvex, with beveled edge, with inscription 'R' on one side and plain on other side, may have mottled appearance.
Repaglinide Accord 1 mg tablete so svetlo rumene do rumene barve, okrogle, izbočene s poševnim robom, brez prevleke, z vtisnjenim “R” na eni strani in brez oznake na drugi, in so lahko pikčastega izgleda.
What Repaglinide Accord looks like and contents of the pack The Repaglinide Accord 0.5 mg tablet is white to off white, round, biconvex, with beveled edge, with inscription ‘R' on one side and plain on other side.
Repaglinide Accord 0,5 mg tablete so belo sive, okrogle, izbočene s poševnim robom, brez prevleke in imajo na eni strani vtisnjen “R“ in na drugi so brez napisa.
• Acute coronary syndrome (but it may not be due to the medicine).
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • akutni koronarni sindrom (ki pa ni nujno povezan z uporabo zdravila)
It has not been studied in these age groups.
Uporaba zdravila Repaglinide Accord ni priporočljiva, saj njegova uporaba v teh starostnih skupinah ni bila raziskana.
MARKETING AUTHORISATION NUMBER EU/1/11/743/015
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/743/015
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
PRILOGA II A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Light yellow to yellow colored, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side, may have mottled appearance.
Tablete repaglinida so svetlo rumene do rumene barve, okrogle, izbočene s poševnim robom, brez prevleke, z vtisnjenim “R” na eni strani in brez oznake na drugi, in so lahko pikčastega izgleda.
White to off white, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side.
Tablete repaglinida so belo sive, okrogle, izbočene s poševnim robom, brez prevleke in imajo na eni strani vtisnjen “R“ in na drugi so brez napisa.
You should not take Repaglinide Accord if you are breast-feeding.
Ne jemljite zdravila Repaglinide Accord, če:
However, the benefit risk profile remains to be established when comparing to other combination therapies.
Preskušanja s kombiniranim zdravljenjem z insulinom NPH ali s tiazolidindioni so bila izvedena, vendar pa je treba profil koristi in tveganj v primerjavi z drugimi kombiniranimi zdravljenji še ugotoviti.
GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE
PODATKI V BRAILLOVI PISAVI
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 0.5 mg of repaglinide.
PODATKI, KI MORAJO BITI NAVEDENI NA NEPOSREDNEM OMOTU HDPE STEKLENICA IME ZDRAVILA Repaglinide Accord 0,5 mg tablete Repaglinid NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 0,5 mg repaglinida SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA Tableta 100 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Possible interactions should therefore be taken into account by the physician:
Na presnovo repaglinida lahko vplivajo številna zdravila, zato mora zdravnik upoštevati možne interakcije.
Repaglinide Accord with alcohol
Shranjevanje zdravila Repaglinide Accord
Peach colored, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side, may have mottled appearance.
Tablete repaglinida so breskove barve, okrogle, izbočene s poševnim robom, brez prevleke, z vtisnjenim “R” na eni strani in brez oznake na drugi, in so lahko pikčastega izgleda
Talk to your doctor before taking Repaglinide Accord
Pred začetkom jemanja zdravila Repaglinide Accord se posvetujte s svojim zdravnikom:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide.
PODATKI, KI MORAJO NAVEDENI NEPOSREDNO NA OMOTU HPDE STEKLENICA IME ZDRAVILA Repaglinide Accord 2 mg tablete repaglinid NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 2 mg repaglinida SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA Tableta 100 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Povidone
Starostniki
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide.
PODATKI, KI MORAJO BITI NAVEDENI NA NEPOSREDNEM OMOTU HDPE STEKLENICA IME ZDRAVILA Repaglinide Accord 1 mg tablete Repaglinid NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 1 mg repaglinida SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA Tableta 100 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Abdominal pain, diarrhoea Common Vomiting, constipation
Bolezni prebavil bolečina v trebuhu, driska pogosti bruhanje, zaprtost zelo redki navzea neznana
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 0.5 mg of repaglinide.
PODATKI NA ZUNANJI OVOJNINI HDPE STEKLENICA IME ZDRAVILA Repaglinide Accord 0,5 mg tablete Repaglinid NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 0,5 mg repaglinida SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA Tableta 100 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Glycerin
• driska
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide LIST OF EXCIPIENTS
PODATKI NA ZUNANJI OVOJNINI HDPE STEKLENICA IME ZDRAVILA Repaglinide Accord 1 mg tablete repaglinid NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 1 mg repaglinida SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA Tableta 100 tablet POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Be aware that the desired effect is not achieved if you stop taking Repaglinide Accord.
Vedite, da s prenehanjem jemanja zdravila Repaglinide Accord izgubite želeni učinek na znižanje krvnega sladkorja.
Take special care with [product name]
Bodite posebno pozorni pri uporabi [ime zdravila]
“Lisuride is an ergot derivative.
„Lizurid je derivat ergota.
If you experience any one of these symptoms you must tell your doctor immediately.”
Če opazite enega od teh znakov, morate to takoj povedati svojemu zdravniku.«
During treatment your physician will pay special attention to any signs which may be related to fibrotic reactions.
Med zdravljenjem bo vaš zdravnik posebej pozoren na vse znake, ki bi lahko bili povezani s fibroznimi reakcijami.
Before treatment your physician may check whether your heart, lungs and kidneys are in good condition.
Pred zdravljenjem lahko zdravnik preveri, ali so vaše srce, pljuča in ledvice v dobrem stanju.
Section 2 “Before you take [product name]”: Do not take [product name] if you:
Poglavje 2 “Kaj morate vedeti, preden boste vzeli [ime zdravila]”: Zdravila [ime zdravila] ne jemljite, če:
If necessary he/she will have an echocardiogram taken.
Če je potrebno, bo naredil ehokardiogram.
If fibrotic reactions occur treatment will have to be discontinued.”
Če pride do fibroznih reakcij, bo treba zdravljenje prekiniti."
Section 4 “Possible side effects”:
Poglavje 4 „Možni neželeni učinki“:
“- If you have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.
„- Če imate ali ste imeli fibrozno reakcijo (brazgotinsko tkivo), ki vpliva na vaše srce, pljuča ali trebušni predel.
4.3 Contraindications:
4.3 Kontraindikacije:
“For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
„Za dolgoročno zdravljenje: dokazi srčne valvulopatije, določeni z ehokardiografijo pred zdravljenjem."
Since these changes are of insidious onset, patient should be monitored throughout the treatment, paying special attention to the appearance of signs and symptoms suggestive of an inflammatory disorder of a fibrotic or serous type.
Ker so te spremembe lahko začetek zahrbtne bolezni, je pri teh bolnikih potreben stalen nadzor med zdravljenjem in posebna pozornost glede pojava znakov in simptomov, ki kažejo na fibrozno ali serozno vnetno spremembo.
If a fibrotic disorder is suspected, the treatment should be halted and the diagnosis confirmed by performance of appropriate tests such as erythrocyte sedimentation rate, determination of serum creatinine and diagnostic imaging procedures (e.g. chest X-ray, echocardiography).”
Pri sumu na fibrozo je treba zdravljenje prenehati in diagnozo potrditi z ustreznimi preiskavami kot so hitrost sedimentacije eritrocitov, določitev vrednosti kreatinina v serumu in z diagnostičnim slikanjem (npr. rentgensko slikanje prsnega koša, ehokardiografija).“
To ensure recognition of retroperitoneal fibrosis at early reversible stage it is recommended that its manifestations (e.g. back pain, oedema of the lower limbs, impaired kidney function) should be watched in this category of patients.
Da bi lahko prepoznali retroperitonealno fibrozo v zgodnjem reverzibilnem stadiju, se priporoča pri tej skupini bolnikov spremljanje njenih znakov (npr. bolečine v hrbtu, edemi spodnjih okončin, oslabljena ledvična funkcija).
4.8 Undesirable effects: The following should be included under Cardiac disorders:
4.8 Neželeni učinki Pod srčne bolezni je treba dodati naslednje besedilo:
Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of bromocriptine therapy should be contemplated.
Bolnike z nepojasnjenimi plevropulmonalnimi boleznimi je treba skrbno pregledati in razmisliti o prekinitvi zdravljenja z bromokriptinom.
Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of dihydroergocryptine therapy should be contemplated.
Bolnike z nepojasnjenimi plevropulmonalnimi boleznimi je treba skrbno pregledati in premisliti o prekinitvi zdravljenja z dihidroergokriptinom.
4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of maximum dose to 30 mg/day.
Najvišji dnevni odmerek je omejen na 30 mg/dan.
“Very rare: pericarditis, and pericardial effusion.
„Zelo redki: perikarditis in perikardialni izliv.
After prolonged use of ergot derivatives, including lisuride inflammatory changes of a fibrotic type have been detected with serous disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusions and retroperitoneal fibrosis.
Po dolgotrajni uporabi derivatov ergota, vključno z lizuridom, so opazili fibrozne vnetne spremembe s hudimi motnjami kot so plevritis, plevralni izliv, plevralna fibroza, pljučna fibroza, perikarditis, perikardialni izliv in retroperitonealna fibroza.
Bromocriptine medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.”
Z zdravljenje z bromokriptinom je treba prenehati, če v retroperitonealnem prostoru ugotovimo fibrozne spremembe ali če sumimo nanje.«
The early symptoms of these effects on the heart may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs.
Zgodnji simptomi teh učinkov so lahko eden ali več od naslednjih: težave z dihanjem, zasoplost, bolečine v prsih ali hrbtu in otekle noge.
He/she will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started.
Pred začetkom zdravljenja bo naredil tudi ehokardiogram (ultrazvočni test srca).
The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs.
Zgodnji znaki so lahko eden ali več od naslednjih: težko dihanje, kratka sapa, bolečine v prsih ali hrbtu in otečene noge.
In patients treated with ergot derivates cardiac valvulopathy (including regurgitation) has been reported.”
Pri bolnikih, zdravljenimi z derivati ergota, so poročali o okvari srčnih zaklopk (vključno z regurgitacijo).“
If necessary he/she will have an echocardiogram taken (an ultrasound test of your heart).
Po potrebi bo naredil ehokardiogram (ultrazvočno preiskavo srca).
“-will be treated with [product name] for a long period andhave or had fibrotic reactions (scar tissue) affecting your heart.”
„- se boste z zdravilom [ime zdravila] zdravili dolgo časa in imate oziroma ste imeli fibrozne reakcije (brazgotinsko tkivo), ki vplivajo na vaše srce."
Particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported in rare cases.
Zlasti pri dolgotrajnem zdravljenju in zdravljenju z visokimi odmerki so v redkih primerih poročali o retroperitonealni fibrozi.
Dihydroergocryptine medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.”
Z jemanjem dihidroergokriptina je treba prenehati, če se diagnosticirajo ali obstaja sum na fibrozne spremembe v retroperitonealnem predelu.”