natgillin/translations-raw huggingface dataset:
Alpivab was shown to reduce the length of time symptoms lasted in patients with influenza.
Zdravilo Alpivab skrajšuje trajanje simptomov pri bolnikih z influenco.
Symptoms took around 2 and a half days (59 hours) to get better in patients taking Alpivab in comparison with just under 3 and a half days (82 hours) in patients taking placebo.
Do izboljšanja simptomov sta pri bolnikih, ki so jemali zdravilo Alpivab, minila približno dva dneva in pol (59 ur), pri bolnikih, ki so jemali placebo, pa skoraj trije dnevi in pol (82 ur).
For the full list of side effects and restrictions with Alpivab, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Alpivab glejte navodilo za uporabo.
How is Alpivab used?
Kako se zdravilo Alpivab uporablja?
How does Alpivab work?
Kako zdravilo Alpivab deluje?
Alpivab is available as a solution to be diluted for infusion (drip) into a vein.
Zdravilo Alpivab je na voljo v obliki raztopine, ki se najprej razredči, nato pa se z infundiranjem (kapalno infuzijo) daje v veno.
The mutual recognition procedure (UK/V/0356/001/MR) started on 26 November 2009.
Postopek medsebojnega priznavanja (UK/V/0356/001/MR) se je začel 26. novembra 2009.
On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by a Concerned Member States, France, that the safety and efficacy of the product had not been sufficiently demonstrated.
Združeno kraljestvo je kot referenčna država članica 2. julija 2010 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na Evropsko agencijo za zdravila zaradi zadržkov, ki jih je izpostavila zadevna država članica Francija, in sicer da varnost in učinkovitost zdravila nista bili zadostno dokazani.
The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combisyn via a mutual recognition procedure in Austria, Belgium, Denmark, Finland, France, Portugal and Spain on the basis of the marketing authorisation granted by the United Kingdom.
Imetnik dovoljenja za promet z zdravilom družba Norbrook Laboratories Ltd je predložila vlogo za zdravilo Combisyn prek postopka medsebojnega priznavanja v Avstriji, Belgiji, na Danskem, Finskem, v Franciji, na Portugalskem in v Španiji na podlagi dovoljenja za promet z zdravilom, ki je bilo odobreno v Združenem kraljestvu.
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Combisyn Lactating Cow Intramammary Suspension is negative, and therefore adopted an opinion on 6 April 2011 recommending the refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation.
CVMP je zato po presoji ocene trenutno razpoložljivih podatkov, ki jo je opravil poročevalec, menil, da je razmerje med koristmi in tveganji za zdravilo Combisyn Lactating Cow Intramammary Suspension negativno, in 6. aprila 2011 sprejel mnenje, v katerem priporoča zavrnitev odobritve dovoljenja za promet z zdravilom in začasen umik obstoječega dovoljenja za promet.
Combisyn is intended for the treatment of mastitis in lactating cows.
Zdravilo Combisyn je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije.
There was disagreement between the Reference Member State and the Concerned Member States on the demonstration of bioequivalence and the adequacy of the proposed withdrawal period.
Referenčna država članica in zadevna država članica se nista strinjali glede dokazov biološke enakovrednosti in ustreznosti predlagane karence.
Combisyn Lactating Cow Intramammary Suspension (Combisyn) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Zdravilo Combisyn Lactating Cow Intramammary Suspension (Combisyn) je intramamarna suspenzija, ki vsebuje amoksicilin, klavulansko kislino in prednizolon.
These effects are more frequent if you also drink alcohol.
Ti učinki so pogostejši, če pijete tudi alkohol.
Wait at least 1 hour until the next meal.
Z naslednjim obrokom počakajte vsaj 1 uro.
This medicine should be taken twice a day.
To zdravilo je treba jemati dvakrat na dan.
The liquid has a sweet taste.
Tekočina je sladkega okusa.
Approximately 2% of the radioactivity was eliminated in the urine.
Približno 2 % radioaktivnosti se je izločilo v urinu.
The 3 studies demonstrated similar survival rates.
Te tri študije so pokazale podobne deleže preživetja.
Most patients completely recover after appropriate measures are taken.
Večina bolnikov si po vpeljavi ustreznih ukrepov popolnoma opomore.
blindness not known:
slepota ni znano:
To date, no other relevant epidemiological data are available.
Do sedaj ni na voljo drugih relevantnih epidemioloških podatkov.
It is not known exactly how often these side effects occur.
Ni natančno znano, kako pogosto se pojavijo ti neželeni učinki.
The recommended initial doses presented below are intended to act solely as a guideline.
Spodaj navedeni priporočeni začetni odmerki se upoštevajo le kot smernice.
Schisandra sphenanthera.
Schisandre sphenanthere.
It could potentially influence the health of the baby or adversely influence the course of the pregnancy.
To bi lahko vplivalo na zdravje otroka ali negativno vplivalo na potek nosečnosti.
Infections including opportunistic infections
Okužbe, vključno z oportunističnimi okužbami
Stir, or swirl gently until the granules have been suspended completely.
Mešajte ali nežno vrtinčite, dokler zrnca niso povsem suspendirana.
Suspend the granules in water.
Zrnca suspendirajte v vodi.
Place the cup with water on a stable surface.
Posodico z vodo postavite na stabilno površino.
When treating rejection, these same doses may be used.
Pri zdravljenju zavrnitve se lahko uporabijo enaki odmerki.
Dose adjustments should be made to ensure that similar systemic exposure is maintained.
Odmerek je treba prilagajati, da se zagotovi vzdrževanje podobne sistemske izpostavljenosti.
During treatment, careful monitoring with EBV-PCR is recommended.
Med zdravljenjem je priporočljivo skrbno nadziranje z EBV-PCR.
Date of first authorisation: 15 May 2009 Date of latest renewal: 17 Feb 2014
Datum zadnjega podaljšanja: 17 februar 2014
Modigraf reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Zdravilo Modigraf omeji obrambni mehanizem vašega telesa (imunski sistem), ki ne bo tako dober pri premagovanju okužb.
Modigraf is used in adults and children.
Zdravilo Modigraf se uporablja pri odraslih in otrocih.
If you follow these instructions, you will get the right amount of granules from the sachet.
Ob upoštevanju teh navodil boste iz vrečk dobili pravo količino zrnc.
No studies on the effects of tacrolimus (Modigraf) on the ability to drive and use machines have been performed.
Študij o vplivu takrolimusa (Modigraf) na sposobnost vožnje in upravljanja s stroji niso izvedli.
An updated RMP should be submitted
Posodobljen je treba RMP predložiti:
In case of sun exposure, wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
V primeru izpostavljenosti soncu nosite primerna zaščitna oblačila in uporabljajte sredstva za sončenje z visokim zaščitnim faktorjem.
Children and adolescents will receive doses of Modigraf calculated in the same way as adults.
Otroci in mladostniki bodo prejeli odmerke zdravila Modigraf izračunane na enak način kot pri odraslih.
Your doctor will tell you exactly how many sachets to take.
Zdravnik vam bo natančno povedal, koliko vrečk morate jemati.
If you have forgotten to take your Modigraf, wait until it is time for the next dose, and then continue as before.
Če ste pozabili vzeti zdravilo Modigraf, počakajte do naslednjega odmerka, in nadaljujte kot običajno.
Your doctor will advise you on the number of sachets that you need to open and the volume of water that is required to make a suspension.
Vaš zdravnik vam bo povedal, koliko vrečk morate odpreti in koliko vode potrebujete za pripravo suspenzije.
Rinse the glass or cup once with the same amount of water and drink this, too.
Z enako količino vode enkrat sperite kozarec ali lonček, ter spijte tudi to vodo.
In systemic circulation only one of the inactive metabolites is present at low concentrations.
V sistemskem obtoku je v nizki koncentraciji prisoten le eden od neaktivnih presnovkov.
Data on oral bioavailability of Modigraf in other indications is not available.
Podatki o biološki uporabnosti zdravila Modigraf pri drugih indikacijah niso na voljo.
toxic epidermal necrolysis (Lyell's syndrome)
toksična epidermalna nekroliza (Lyellova bolezen)
Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Primerjavo v literaturi objavljenih koncentracij ter individualnih vrednosti v klinični praksi je treba previdno oceniti in poznati uporabljene metode.
If the physical appearance has changed from the normal white granules, or if dose instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Če se je spremenil fizični videz tega zdravila , ki so normalno bela zrnca, ali so se spremenila navodila za jemanje, se čimprej pogovorite z zdravnikom ali s farmacevtom, da zagotovite, da imate pravo zdravilo.
In general children need higher doses per kg of body weight to achieve the same effective levels in the blood as adults.
Na splošno otroci potrebujejo večje odmerke na kg telesne mase za doseganje enake učinkovitosti v krvi kot odrasli.
How to prepare the Modigraf sachets for use?
Kako pripraviti vrečke zdravila Modigraf za uporabo?
Not known (frequency cannot be estimated from the available data): Abnormality of the optic nerve (optic neuropathy)
Ni znano (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo): - prizadetost vidnega živca (nevropatija vidnega živca)
This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Ta pristop je namenjen bolnikom brez okvar organov (npr. okvara ledvic).
Elderly patients There is no evidence currently available to indicate that dosing should be adjusted in older people.
Starejši ljudje Trenutno ni dokazov, da bi bila pri starejših ljudeh potrebna prilagoditev odmerjanja.
Investigations very common:
Preiskave zelo pogosti:
Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Jemanje je treba začeti v roku petih dni po koncu operacije, takoj ko se bolnikovo stanje stabilizira.
You will need to take Modigraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Zdravilo Modigraf boste morali jemati vsak dan, dokler potrebujete imunosupresijo za preprečitev zavrnitve presajenega organa.
< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po pogostnosti takole: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Modigraf with food and drink
Zdravilo Modigraf skupaj s hrano in pijačo
If you need to have any vaccinations, please tell your doctor before.
Če morate opraviti cepljenje s katerimkoli cepivom, to prej povejte zdravniku.
Absorption of tacrolimus is variable.
Absorpcija takrolimusa je variabilna.
Children and adolescents may experience the same side effects as adults.
Otroci in mladostniki Pri otrocih in mladostnikih se lahko pojavijo enaki neželeni učinki kot pri odraslih.
Severe effects may occur, including allergic and anaphylactic reactions (a very serious type of allergic reaction with fainting and difficulty breathing, which needs immediate medical attention).
Pojavijo se lahko resni neželeni učinki, vključno z alergijskimi in anafilaktičnimi reakcijami (zelo hud tip alergijske reakcije z omedlevanjem in težkim dihanjem, ki zahteva takojšnjo zdravniško pomoč).
Certain combinations of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the risks of these effects (see section 4.5).
Določene kombinacije takrolimusa z zdravili, za katere je znano, da imajo nefrotoksične ali nevrotoksične učinke, lahko povečajo tveganje za te učinke (glejte poglavje 4.5).
Materials containing polyvinyl chloride (PVC) should not be used (see section 6.2).
Ne uporabljajte materialov, ki vsebujejo polivinilklorid (PVC) (glejte poglavje 6.2).
Other medicines and Modigraf
Druga zdravila in zdravilo Modigraf
The required dose is calculated from the weight of the patient, using the minimum number of sachets possible.
Potrebni dnevni odmerek se preračuna iz bolnikove telesne mase, in tako, da se uporabi najmanjše možno število vrečk.
Pour the prescribed volume of water (at room temperature) into a glass or cup, up to a maximum of 50 ml.
Predpisano količino vode (pri sobni temperaturi) zlijte v kozarec ali lonček, vendar ne več kot 50 ml.
Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE).
Vrečke so iz plasti polietilen tereftalata (PET), aluminija (Al) in polietilena.
Carefully open the prescribed number of sachets, e.g. with a pair of scissors at the point indicated with an arrow.
Previdno odprite predpisano število vrečk, npr. s škarjami, na mestu, označenem s puščico.
In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.
V tem primeru je začetni peroralni odmerek takrolimusa 2 do 4 mg na dan, uporabljen v kombinaciji z mofetilijevim mikofenolatom in kortikosteroidi ali v kombinaciji s sirolimusom in kortikosteroidi.
Clinical efficacy and safety of tacrolimus administered twice daily in other primary organ transplantation
Objavljene študije o klinični učinkovitosti in varnosti jemanja takrolimusa dvakrat dnevno pri primarnih presaditvah drugih organov
What Modigraf is and what it is used for
Kaj je zdravilo Modigraf in za kaj ga uporabljamo
Packs containing 50 sachets are available.
Na voljo je pakiranje s 50 vrečkami.
Tacrolimus treatment can be considered in pregnant women, when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
Zdravljenje s takrolimusom pride v poštev tudi pri nosečnicah, če ni varnejše alternative in če pričakovana korist opravičuje možno tveganje za plod.
However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output).
Vendar je zaradi nefrotoksičnega potenciala takrolimusa priporočljivo skrbno nadziranje delovanja ledvic (vključno z rednim določanjem koncentracije kreatinina v serumu, izračunavanjem očistka kreatinina in nadziranjem izločanja urina).
Pain in extremity has been described in a number of published case reports as part of CalcineurinInhibitor Induced Pain Syndrome (CIPS).
Bolečina v okončini je bila opisana v številnih objavljenih poročilih o primerih kot del bolečinskega sindroma, izzvanega z zaviralci kalcinevrina (CIPS - Calcineurin-Inhibitor Induced Pain Syndrome).
An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
Objavljena je bila tudi alternativna strategija, pri kateri je bil takrolimus uveden v roku 12 ur po presaditvi.
Stopping your treatment with Modigraf may increase the risk of rejection of your transplanted organ.
Prekinitev zdravljenja z zdravilom Modigraf lahko poveča tveganje za zavrnitev presajenega organa.
In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
V praksi so zdravljenje s takrolimusom začenjali od 12 do 24 ur po ukinitvi ciklosporina.
Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Farmakoterapevtska skupina: imunosupresivi, zaviralci kalcinevrina, oznaka ATC: L04AD02
Pack size: carton box containing 50 sachets.
Velikost pakiranja: kartonasta škatla s 50 vrečkami.
The other metabolites have only weak or no immunosuppressive activity.
Ostali presnovki imajo le šibko imunosupresivno delovanje ali ga sploh nimajo.
Modigraf 1 mg granules for oral suspension EU/1/09/523/002
Modigraf 1 mg zrnca za peroralno suspenzijo EU/1/09/523/002
The incidences of acute rejection were numerically lower with tacrolimus in all 3 studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Incidenca akutnih zavrnitev je bila v vseh treh študijah številčno manjša s takrolimusom in v eni od teh študij so poročali o značilno manjši incidenci obliteracijskega bronhiolitisa pri uporabi takrolimusa.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving tacrolimus.
Ker ni mogoče izključiti škodljivih učinkov na novorojenčka, ženske med zdravljenjem s takrolimusom ne smejo dojiti.
If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Modigraf may need to be reduced.
Če se pojavijo znaki toksičnosti, na primer resni neželeni učinki (glejte poglavje 4.8), bo odmerek zdravila Modigraf morda treba zmanjšati.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''EXP''.
From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Modigraf.
Zdravnik vam bo od časa do časa moral narediti preiskave krvi, urina, srca in vida, da bo določil pravi odmerek zdravila Modigraf.
Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Kontroliranje najnižje koncentracije v polni krvi zato omogoča dobro oceno sistemske izpostavljenosti.
If you take Modigraf during pregnancy, it may pass into your baby through the placenta.
Če jemljete zdravilo Modigraf med nosečnostjo, lahko ta preide skozi posteljico v vašega otroka.
Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions.
Ventrikularno hipertrofijo ali hipertrofijo septuma, opisani kot kardiomiopatije, so opazili v redkih primerih.
It is normal that some granules stay behind; the sachet was designed that way.
Normalno je, da nekaj zrnc ostane v vrečki; vsebina vrečk je temu prilagojena.
The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Ledvice in pankreas sta bila primarna organa, prizadeta v študijah toksičnosti pri podganah in pavianih.
Overall, the safety profile of oral tacrolimus in these published studies appeared to be similar to what was reported in the large studies, where tacrolimus was used as primary treatment in liver, kidney and heart transplantation.
V celoti so bile varnostne značilnosti takrolimusa v peroralni obliki v teh objavljenih študijah podobne tistemu, kar je znano iz velikih študij, v katerih so takrolimus v peroralni obliki uporabljali kot primarno zdravljenje po presaditvi jeter, ledvic in srca.
- The other ingredients are: lactose monohydrate, hypromellose (E464) and croscarmellose sodium (E468).
- Druge sestavine zdravila so: laktoza monohidrat, hipromeloza (E464) in premrežen natrijev karmelozat (E468).
febrile neutropenia
febrilna nevtropenija
The half-life in paediatric transplant patients averages approximately 12 hours.
Povprečen razpolovni čas pri pediatričnih bolnikih s presadki je približno 12 ur.
Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9-12 months).
Glede na to je treba zelo ogrožene bolnike, še posebej male otroke in tiste, ki se zdravijo z intenzivno imunosupresijo, nadzorovati s preiskavami, kot sta ehokardiografija ali EKG, in sicer pred presaditvijo in po njej (npr. uvodoma po 3 mesecih in potem pri 9-12 mesecih).
Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Imunosupresivi lahko poslabšajo odziv na cepljenje, zato je cepljenje med zdravljenjem s takrolimusom lahko manj učinkovito.
If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Če se ugotovi prisotnost PRES, je potreben ustrezen nadzor krvnega tlaka in krčev ter takojšnja prekinitev sistemske uporabe takrolimusa.
The use of live attenuated vaccines should be avoided (see section 4.4).
Izogniti se je treba uporabi živih oslabljenih cepiv (glejte poglavje 4.4).
Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Modigraf.
Pri tej skupini bolnikov je pred začetkom zdravljenja z zdravilom Modigraf treba izvesti serološko testiranje na EBV-VCA.
Tacrolimus may prolong the QT interval and may cause Torsades de Pointes.
Takrolimus lahko podaljša interval QT in lahko povzroči Torsades de Pointes.
Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Evidentno je bilo zmanjšanje AUC (27 %) in Cmax (50 %) ter povečanje tmax (173 %) v polni krvi.
Gently tap on the closed end of the sachet and pour the contents of each sachet into the glass or cup containing the water.
Narahlo udarite po zaprtem delu vrečke in stresite vsebino vsake vrečke v kozarec ali lonček z vodo.
In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy.
V celoti je 34 bolnikov prešlo s ciklosporina na takrolimus, le 6 bolnikov na takrolimusu pa je potrebovalo drugo terapijo.
Limited data from organ transplant recipients show no evidence of an increased risk of adverse reactions on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Omejeni podatki prejemnic presajenih organov ne kažejo, da bi med zdravljenjem s takrolimusom obstajalo večje tveganje za neželene učinke na potek in izid nosečnosti v primerjavi z drugimi imunosupresivnimi zdravili.
Tell your doctor immediately if during treatment you suffer from: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Nemudoma obvestite zdravnika, če se vam med zdravljenjem pojavijo: težave z vidom, npr. zamegljen vid, spremembe barvnega vida, težave pri videnju podrobnosti ali zožitev vidnega polja.
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms.
Te okužbe so pogosto povezane z visoko skupno obremenitvijo z imunosupresivi in lahko vodijo do resnih ali smrtno nevarnih stanj, kar morajo zdravniki upoštevati pri diferencialni diagnostiki pri bolnikih, ki se zdravijo z imunosupresivi in ki imajo oslabljeno delovanje jeter ali ledvic ali nevrološke simptome.
Tacrolimus is not compatible with PVC (polyvinylchloride) plastics.
Takrolimus ni kompatibilen z umetnimi masami iz polivinilklorida (PVC).