natgillin/translations-raw huggingface dataset:
Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in  5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
Pemetrexed/ cisplatin (N = 839)
Organski sistem Pogostnost Dogodek** Pemetreksed/cisplatin N = 839
Pemetrexed/cisplatin
Pemetreksed / cisplatin
Cisplatin Pemetrexed / cisplatin
Cisplatin Pemetreksed / cisplatin
- if you are breast-feeding; you must discontinue breast-feeding during treatment with
- če dojite, morate med zdravljenjem z zdravilom Pemetreksed Lilly dojenje prekiniti.
Pemetrexed Lilly contains sodium
Zdravilo Pemetreksed Lilly vsebuje natrij
EU/1/15/1034/001 EU/1/15/1034/002
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/15/1034/001
Low haemoglobin level (anaemia) Low platelet count
Nizka raven hemoglobina (anemija)
Talk to your doctor or hospital pharmacist before receiving Pemetrexed Lilly.
Pred začetkom uporabe zdravila Pemetreksed Lilly se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio = 0.78,
Od začetka indukcijskega zdravljenja prve izbire s pemetreksedom skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku s pemetreksedom in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95% % CI = 0,64-0,96).
Frequency* Event**
Pogosto Bolezni sečil****
100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Lilly and cisplatin is documented in Table 3.
Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za  CTC stopnjo krvavitve 2.
Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/ radiation therapy.
V kliničnih preskušanjih s pemetreksedom so občasno poročali o ezofagitisu/radiacijskem ezofagitisu.
Pemetrexed Lilly.
Shranjevanje zdravila Pemetreksed Lilly
What Pemetrexed Lilly contains
Kaj vsebuje zdravilo Pemetreksed Lilly
Reconstitute each 100 mg vial with 4.2 mL of 9 mg/mL (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/mL pemetrexed.
100 mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion
Pemetreksed Lilly 100 mg prašek za koncentrat za raztopino za infundiranje
Reconstitute each 500 mg vial with 20 mL of 9 mg/mL (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/mL pemetrexed.
500 mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
PC GC
PC
Package leaflet: Information for the user Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Lilly 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Lilly 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Lilly 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Lilly 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
Common Vomiting Mucositis/ stomatitis
Pogosto Bruhanje Mukozitis/
Abbreviation: CI = confidence interval * p-value refers to comparison between arms.
*p-vrednost se nanaša na primerjavo med vejama zdravljenja.
Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Pemetreksed Lilly 500 mg prašek za koncentrat za raztopino za infundiranje 500-miligramske viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
Hydrochloric acid (for pH adjustment)
6.1 Seznam pomožnih snovi Manitol (E421) klorovodikova kislina (za uravnavanje pH-vrednosti) natrijev hidroksid (za uravnavanje pH-vrednosti)
This overview was last updated in 02-2018.
Povzetek je bil nazadnje posodobljen 02-2018.
The doctor will decide which inhaler the patient should use.
Zdravnik bo presodil, kateri inhalator naj bolnik uporabi.
Further information on Relvar Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Relvar Ellipta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The dose is one inhalation (‘puff') into the mouth once a day at the same time each day.
Odmerek je ena inhalacija (vpih) skozi usta enkrat na dan vedno ob istem času.
The European Medicines Agency concluded that Relvar Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Relvar Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It works on various types of immune cells, blocking the release of substances involved in inflammation.
Deluje na različne vrste imunskih celic, ki blokirajo sproščanje snovi, ki sodelujejo pri vnetju.
In asthma, it is used for regular treatment of patients from 12 years of age:
Pri astmi se uporablja za redno zdravljenje bolnikov, starih 12 let ali več:
Relvar Ellipta received a marketing authorisation valid throughout the EU on 13 November 2013.
Za zdravilo Relvar Ellipta je bilo 13. novembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Relvar Ellipta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Relvar Ellipta?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relvar Ellipta have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Relvar Ellipta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).
Pri KOPB se uporablja pri odraslih, ki imajo poslabšanja bolezni kljub rednemu zdravljenju z bronhodilatatorji (zdravili za širjenje dihalnih poti).
This reduces inflammation in the airways and improves the patient's breathing.
To zmanjša vnetje v dihalih in izboljša bolnikovo dihanje.
Side effects reported with Relvar Ellipta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Relvar Ellipta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Relvar Ellipta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Relvar Ellipta stalno spremljajo.
For more information about using Relvar Ellipta, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Relvar Ellipta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Relvar Ellipta
Druge informacije o zdravilu Relvar Ellipta
An overview of Relvar Ellipta and why it is authorised in the EU
Pregled zdravila Relvar Ellipta in zakaj je odobreno v EU
More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma.
Resnejši neželeni učinki vključujejo pljučnico in zlome (opaženi pri 1 od 10 bolnikov), o katerih so pogosteje poročali pri bolnikih s KOPB kot pri bolnikih z astmo.
The most common side effects with Relvar Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Najpogostejša neželena učinka zdravila Relvar Ellipta (ki se lahko pojavita pri več kot 1 od 10 bolnikov) sta glavobol in nazofaringitis (vnetje nosu in žrela).
Relvar Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Relvar Ellipta je inhalator za zdravljenje astme in kronične obstruktivne pljučne bolezni (KOPB).
What benefits of Relvar Ellipta have been shown in studies?
Kakšne koristi zdravila Relvar Ellipta so se pokazale v študijah?
Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Zdravilo Relvar Ellipta je na voljo v obliki inhalatorja v dveh jakostih (92/22 mg in 184/22 mg).
It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Pritrdi se na receptorje beta2 v dihalih in povzroči, da se mišice dihal sprostijo in razširijo, kar bolniku olajša dihanje.
A fourth study in 1,522 patients showed that Relvar Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
V četrti študiji pri 1 522 bolnikih so dokazali, da je zdravilo Relvar Ellipta enako učinkovito kot drugo zdravilo, ki vsebuje kortikosteroid (flutikazonpropionat) in dolgotrajno delujoč agonist adrenergičnih receptorjev beta2 (salmeterol).
Why is Relvar Ellipta authorised in the EU?
Zakaj je bilo zdravilo Relvar Ellipta odobreno v EU?
Vilanterol is a long-acting beta-2 agonist.
Vilanterol je dolgodelujoči agonist adrenergičnih receptorjev beta2.
Regarding its safety, the most frequent side effects reported with Relvar Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
V zvezi z varnostjo so bili najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Relvar Ellipta, podobni tistim, ki so jih opazili pri drugih načinih zdravljenja KOPB in astme; pri bolnikih s KOPB so opazili povečano pojavnost pljučnice.
These patients were already well controlled with the comparator medicine and Relvar Ellipta treatment was able to maintain their FEV1.
Bolezen pri teh bolnikih je že bila dobro obvladovana s primerjalnim zdravilom in pri zdravljenju z zdravilom Relvar Ellipta se je vrednost FEV1 ohranila.
What are the risks associated with Relvar Ellipta?
Kakšna tveganja so povezana z zdravilom Relvar Ellipta?
In a third study, fewer patients taking Relvar Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
V tretji študiji je imelo manj bolnikov, ki so jemali zdravilo Relvar Ellipta z jakostjo 92/22 mg, po enem letu zdravljenja vsaj eno resno poslabšanje bolezni v primerjavi z bolniki, ki so jemali samo flutikazonfuroat (13 % v primerjavi s 16 %).
What is Relvar Ellipta and what is it used for?
Kaj je zdravilo Relvar Ellipta in za kaj se uporablja?
In two further studies, Relvar Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.
V dveh drugih študijah je zdravilo Relvar Ellipta zmanjšalo število poslabšanj bolezni za od 13 do 34 % več kot samostojno zdravljenje z vilanterolom.
Relvar Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Zdravilo Relvar Ellipta vsebuje dve učinkovini, ki različno delujeta za izboljšanje dihanja pri bolnikih z astmo in KOPB.
Relvar Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Zdravilo Relvar Ellipta z jakostjo 184/22 mg je prav tako povečalo FEV1 za 193 ml v primerjavi s flutikazonfuroatom in za 210 ml v primerjavi z drugim inhalatorjem, ki vsebuje flutikazonpropionat.
The first study showed that Relvar Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Relvar Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
V prvi študiji so dokazali, da je zdravilo Relvar Ellipta z jakostjo 92/22 mg povečalo povprečno vrednost FEV1 za 115 ml v primerjavi s placebom, v drugi študiji pa, da je zdravilo Relvar Ellipta z jakostjo 184/22 mg povečalo povprečno vrednost FEV1 za 131 ml v primerjavi s placebom.
Three studies in over 3,200 patients showed that Relvar Ellipta improves breathing and reduces flareups in patients with asthma.
Tri študije pri več kot 3 200 bolnikih so pokazale, da zdravilo Relvar Ellipta izboljša dihanje in zmanjša število poslabšanj pri bolnikih z astmo.
Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flareups of symptoms in patients with COPD.
Štiri študije pri več kot 5 500 bolnikih so pokazale, da zdravilo Relvar Ellipta izboljša dihanje in zmanjša število poslabšanj simptomov pri bolnikih s KOPB.
Relvar Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD.
Zdravilo Relvar Ellipta izboljša dihanje in zmanjša število poslabšanj simptomov pri bolnikih z astmo in KOPB.
In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
V dveh študijah je zdravilo Relvar Ellipta z jakostjo 92/22 mg povečalo volumen zraka, ki ga bolnik lahko izdihne v eni sekundi (FEV1), za 36 ml v primerjavi s samostojnim flutikazonfuroatom in za 172 ml v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
• whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting
• katerih simptomi niso obvladovani z inhalacijskim kortikosteroidom in inhalacijskim kratkodelujočim agonistom adrenergičnih receptorjev beta2;
For the full list of side effects of Relvar Ellipta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Relvar Ellipta, glejte navodilo za uporabo.
Relvar Ellipta contains the active substances fluticasone furoate and vilanterol.
Zdravilo Relvar Ellipta vsebuje učinkovini flutikazonfuroat in vilanterol.
• whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting
• katerih simptomi so ustrezno obvladovani z inhalacijskimi kortikosteroidi in dolgotrajno delujočim agonistom adrenergičnih receptorjev beta2.
How is Relvar Ellipta used?
Kako se zdravilo Relvar Ellipta uporablja?
How does Relvar Ellipta work?
Kako zdravilo Relvar Ellipta deluje?
Relvar Ellipta can only be obtained with a prescription.
Predpisovanje in izdaja zdravila je le na recept.
The applicant presented data from one main study involving 167 patients who underwent vascular surgery.
Predlagatelj je predstavil podatke iz ene glavne študije, v katero je bilo vključenih 167 bolnikov, ki so imeli vaskularni kirurški poseg.
The Committee was concerned that the main study had not been carried out in accordance with the guidelines for Good Clinical Practice (GCP).
Odbor je izrazil zaskrbljenost, da glavna študija ni bila izvedena v skladu s smernicami dobre klinične prakse.
The main measure of effectiveness was the ability to stop bleeding during a 10-minute observation period, after applying the method to stop the bleeding.
Glavno merilo učinkovitosti je bila zmožnost zaustavitve krvavitve med 10-minutnim obdobjem opazovanja po uporabi metode za zaustavitev krvavitve.
When applied to a moist surface, the thrombin is activated and cuts fibrinogen up into smaller units called fibrin.
Ko ju nanesemo na vlažno površino, se trombin aktivira in pretvori fibrinogen v manjše enote, imenovane fibrini.
VeraSeal is a medicine that contains the active substances human fibrinogen and human thrombin.
VeraSeal je zdravilo, ki vsebuje zdravilni učinkovini humani fibrinogen in humani trombin.
The active substances in VeraSeal, human fibrinogen and human thrombin, are natural proteins in the blood and are obtained from blood donors.
Zdravilni učinkovini v zdravilu VeraSeal, humani fibrinogen in humani trombin, sta naravni beljakovini v krvi in se pridobivata iz darovane krvi.
There are no consequences for patients in the three ongoing clinical trials.
Umik nima nobenih posledic za bolnike, ki sodelujejo v treh tekočih kliničnih preskušanjih.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
It was to be available as two separate solutions that are mixed together to prepare a sealant that is applied to the surface of blood vessels.
Na voljo naj bi bilo v obliki dveh ločenih raztopin, ki se zmešata za pripravo lepila, ki se nanese na površino krvnih žil.
Findings from a GCP inspection of the study sites raised serious questions about the data from the main study submitted in support of the application.
Ugotovitve pri pregledu dobre klinične prakse na mestih izvajanja študije so vzbudile resne pomisleke o podatkih v glavni študiji, predloženi v podporo vlogi.
On 29 September 2015, Instituto Grifols S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for marketing authorisation of VeraSeal, which was intended to help stop bleeding during vascular (blood vessel) surgery when standard surgical methods for controlling bleeding are insufficient.
Družba Instituto Grifols S.A. je 29. septembra 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom VeraSeal, namenjenim pomoči pri ustavljanju krvavitve med vaskularnim kirurškim posegom (posegom na ožilju), kadar standardne kirurške metode za obvladovanje krvavitev ne zadoščajo.
In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to not being able to gather the additional data required by the CHMP, including data from three ongoing clinical studies with the product, within the available timeframe.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da vlogo umika, ker ni bila zmožna zbrati dodatnih podatkov, ki jih je od nje zahteval CHMP, vključno s podatki iz treh tekočih kliničnih preskušanj z zdravilom, v času, ki ga je imela na voljo.
The fibrin then aggregates (sticks together) and forms fibrin clots on the surface of blood vessels.
Fibrini se nato združijo (medsebojno zlepijo) in ustvarijo fibrinske strdke na površini krvnih žil.
The company informed the CHMP that there are currently no ongoing compassionate use programmes for VeraSeal.
Družba je obvestila CHMP, da se trenutno ne izvaja noben program sočutne uporabe zdravila VeraSeal.
This helps prevent bleeding and seals the blood vessels.
To pomaga preprečiti krvavenje in zatesniti krvne žile.
What was VeraSeal expected to be used for?
Za kaj naj bi se zdravilo VeraSeal uporabljalo?
VeraSeal was expected to be used to help stop bleeding during vascular surgery when standard surgical methods for controlling bleeding are insufficient.
Zdravilo VeraSeal naj bi se uporabljalo za pomoč pri ustavljanju krvavitve med vaskularnim kirurškim posegom, kadar standardne kirurške metode za obvladovanje krvavitev ne zadoščajo.
How is VeraSeal expected to work?
Kako naj bi zdravilo VeraSeal delovalo?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had concerns and was of the provisional opinion that VeraSeal could not have been approved to help stop bleeding during vascular surgery.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila VeraSeal ni mogoče odobriti za pomoč pri ustavljanju krvavitve med vaskularnim kirurškim posegom.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for VeraSeal.
Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo VeraSeal.
What is VeraSeal?
Kaj je zdravilo VeraSeal?
applying manual pressure (a standard way of stopping bleeding during surgery).
V tej študiji so krvavitev med posegom obvladovali bodisi z nanosom zdravila VeraSeal bodisi z ročnim pritiskom (standardnim načinom za zaustavitev krvavitve med
This summary was last updated in 05-2008.
Povzetek je bil nazadnje posodobljen 05-2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Pelzont to Merck Sharp & Dohme Ltd. on 3 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Pelzont, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 14. julija 2008.
It is taken by mouth, with food, in the evening or before going to bed.
Zdravilo se jemlje peroralno, s hrano, zvečer ali pred spanjem.
Other information about Pelzont:
Druge informacije o zdravilu Pelzont:
Pelzont is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Zdravilo Pelzont ni priporočeno za zdravljenje otrok, starih manj kot 18 let, saj ni zadostnih informacij o varnosti in učinkovitosti v tej skupini.
In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
Pri večjih odmerkih zmanjša ravni maščobe v krvi preko mehanizma, ki ga še ne razumemo popolnoma.
The tablets must be swallowed whole, and should not be split, broken, crushed or chewed.
Tableto je treba pogoltniti celo, ne sme se je prelomiti, zlomiti, zdrobiti ali zgristi.
The starting dose of Pelzont is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Začetni odmerek zdravila Pelzont je ena tableta enkrat dnevno štiri tedne, nato pa se odmerek poveča na dve tableti enkrat dnevno.
The Committee recommended that Pelzont be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pelzont odobri dovoljenje za promet.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PELZONT EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PELZONT Povzetek EPAR za javnost
Laropiprant blocks the receptors to which PGD2 normally attaches.
Laropiprant blokira receptorje, na katere se običajno veže PGD2.
Primary means that the hypercholesterolaemia does not have any identifiable cause.
Primarna pomeni, da za hiperholesterolemijo ni nobenega znanega vzroka.
The effects of Pelzont were first tested in experimental models before being studied in humans.
Učinki zdravila Pelzont so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.