natgillin/translations-raw huggingface dataset:
White opaque/White opaque, size “2” hard gelatin capsules, imprinted with ‘PG' on cap and ‘150' on body.
Neprozorne bele/neprozorne bele trde želatinske kapsule velikosti “2”, ki imajo na pokrovčku natisnjeno oznako “PG”, na telesu pa “150”.
Reduced lower gastrointestinal tract function
Redki zmanjšanje števila levkocitov
White opaque/White opaque, size “3” hard gelatin capsules, imprinted with ‘PG' on cap and ‘50' on body.
Neprozorne bele/neprozorne bele trde želatinske kapsule velikosti “3”, ki imajo na pokrovčku natisnjeno oznako “PG”, na telesu pa “50”.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 150 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 150 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 150 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 150 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 75 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 75 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 75 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 75 mg trde kapsule}
White opaque/White opaque, size “4” hard gelatin capsules, imprinted with ‘PG' on cap and ‘25' on body.
Neprozorne bele/neprozorne bele trde želatinske kapsule velikosti “4”, ki imajo na pokrovčku natisnjeno oznako “PG”, na telesu pa “25”.
Pregabalin Accord 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Pregabalin Accord 25 mg trde kapsule Ena trda kapsula vsebuje 25 mg pregabalina.
Angioedema, allergic reaction
Redki angioedem, alergična reakcija Presnovne in prehranske motnje Pogosti zvečanje apetita
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 225 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 225 mg trde kapsule}
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 70, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules - PVC/Aluminium}
{Pretisni omot (14,21, 56, 60, 70, 84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 75 mg trde kapsule - PVC/aluminij}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 225 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 225 mg trde kapsule}
Immune system disorders
Bolezni imunskega sistema Občasni preobčutljivost
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 70, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules.}
{Škatla s pretisnim omotom (14, 21, 56, 60, 70, 84, 90, 100 in112) in perforiranim pretisnim omotom za enkratni odmerek (100) za 75 mg trde kapsule.}
You may feel sleepy, confused, agitated, or restless as a result of taking more this medicine than you should.
Če ste vzeli večji odmerek tega zdravila, kot bi smeli, se lahko počutite zaspani, zmedeni, tesnobni ali nemirni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 100 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 100 mg trde kapsule}
• Increased saliva production, heartburn, numb around mouth.
• močnejše slinjenje, zgaga, otrplost okrog ust
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 100 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 100 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 200 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 200 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 200 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 200 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 225 mg hard capsules.}
{Škatla s pretisnim omotom (14, 21, 56, 60, 84, 90, 100 in 112) in perforiranim pretisnim omotom za enkratni odmerek (100) za 225 mg trde kapsule.}
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 300 mg hard capsules - PVC/Aluminium}
{Pretisni omot (14,21, 56, 60, 84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 300 mg trde kapsule - PVC/Aluminium}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 150 mg hard capsules.}
{Škatla s pretisnim omotom (14, 21, 56, 60, 84, 90, 100 in 112) in perforiranim pretisnim omotom za enkratni odmerek (100) za 150 mg trde kapsule.}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 300 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 300 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 50 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 50 mg trde kapsule}
White opaque/ White opaque, size “4” hard gelatin capsules imprinted with ‘‘PG' on cap and ‘25' on body.
Neprozorne bele/neprozorne bele trde želatinskekapsule velikosti “4”, ki imajo na pokrovčkunatisnjeno oznako “PG”, na telesu pa “25”.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 300 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 300 mg trde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 300 mg hard capsules.}
{Škatla s pretisnimi omoti (14, 21, 56, 60, 84, 90, 100 in112) in perforiranim pretisnim omotom za enkratni odmerek (100) za 300 mg trde kapsule.}
Pregabalin Accord 75 mg/ 100 mg/ 200 mg/ 225 mg/ 300 mg hard capsules Capsule shell:
Pregabalin Accord 75 mg/100 mg/200 mg/225 mg/300 mg trde kapsule Ovojnica kapsule: želatina titanov dioksid (E171) natrijev lavrilsulfat
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 50 mg hard capsules }
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 50 mg trde kapsule}
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 50 mg hard capsules - PVC/Aluminium}
{Pretisni omot (14, 21, 56,60, 84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 50 mg trde kapsule - PVC/aluminij}
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 225 mg hard capsules - PVC/Aluminium}
{Pretisni omot (14,21, 56, 60, 84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 225 mg trde kapsule - PVC/aluminij}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 50 mg hard capsules.}
{Škatla s pretisnim omotom (14, 21, 56, 60, 84, 90, 100 in 112) in perforirani pretisni omot za enkratni odmerek (100) za 50 mg trde kapsule.}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules.}
{Škatla s pretisnim omotom (14, 21, 56, 60, 84, 90, 100 in 112) in perforiranim pretisnim omotom za enkratni odmerek (100) za 25 mg trde kapsule.}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 25 mg hard capsules}
{Škatla za plastenke iz polietilena visoke gostote(30, 200) za 25 mg trde kapsule}
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 25mg hard capsules - PVC/Aluminium}
{Pretisni omot (14, 21, 56,60, 84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 25 mg trde kapsule- PVC/aluminij}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 25 mg hard capsules}
{Oznaka za plastenke iz polietilena visoke gostote(30, 200) za 25 mg trde kapsule}
Pregabalin Accord 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin For the full list of excipients, see section 6.1.
Pregabalin Accord 300 mg trde kapsule Ena trda kapsula vsebuje 300 mg pregabalina.
Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Redki izguba vida, keratitis, oscilopsija, spremenjeno vidno zaznavanje globine, midriaza, strabizem, občutek svetlosti pri gledanju Ušesne bolezni, vključno z motnjami labirinta Pogosti vrtoglavica
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack (14, 21, 56, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 150 mg hard capsules - PVC/Aluminium}
{Pretisni omot (14,21, 56, 60,84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 150 mg trde kapsule - PVC/aluminij}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 100 mg hard capsules.}
{Škatla s pretisnim omotom (14, 21,56, 60, 84, 90, 100 in 112) in perforirani pretisni omot za enkratni odmerek (100) za 100 mg trde kapsule.}
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 100 mg hard capsules- PVC/Aluminium}
{Pretisni omot (14, 21,56, 60, 84, 90, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 100 mg trde kapsule - PVC/aluminij}
Invented name Strength Pharmaceutical form
Izmišljeno ime Jakost Farmacevtska oblika
1 pre-filled syringe with safety device
1 napolnjen a injekcijska brizga z varnostno napravo
1 pre-filled syringe
1 napolnjen a injekcijska brizga
● At the request of the European Medicines Agency;
• na zahtevo Evropske agencije za zdravila;
These findings are not considered relevant to humans.
Ti izsledki se ne štejejo kot pomembni za ljudi.
OTHER Week 1, Week 2
DRUGI PODATKI 1. teden, 2. teden
Children and adolescents Do not give Esbriet to children and adolescents under the age of 18.
Otroci in mladostniki Zdravila Esbriet ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
These medicinal products should be avoided whenever possible.
Če je le mogoče, se je treba tem zdravilom izogibati.
(sunrise; morning dose)
(vzhod; jutranji odmerek)
If you forget a dose, take it as soon as you remember.
Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite.
● Additional risk minimisation measures
• Dodatni ukrepi za zmanjševanje tveganj
(sun; daytime dose) and (moon; evening dose).
(sonce; dnevni odmerek) in (luna; večerni odmerek).
A risk to the breastfed infant cannot be excluded.
Tveganja za dojenega otroka ni možno izključiti.
The safety of Esbriet has been evaluated in clinical studies including 1,650 volunteers and patients.
Varnost zdravila Esbriet je bila ovrednotena v kliničnih študijah, ki so vključevale 1650 prostovoljcev in bolnikov.
Recommendations in case of ALT/AST elevations
Priporočila v primeru zvišanja vrednosti ALT/AST
More than 170 patients have been investigated in open studies for more than five years and some for up to 10 years.
V odprtih študijah so preučevali več kot 170 bolnikov več kot pet let, nekatere tudi do
● changes in taste
• spremembe okusa,
● difficulty sleeping
• težave s spanjem,
● blood tests may show increased levels of liver enzymes
• preiskave krvi lahko kažejo povišane ravni jetrnih encimov,
Be careful if you have to take part in activities where you have to be alert and co-ordinated.
Pri dejavnostih, pri katerih morate biti pozorni in pri katerih je potrebna koordinacija, bodite previdni.
● if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na pirfenidon ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Rare side effects (may affect up to 1 in 1,000 people): ● blood tests may show decrease in white blood cells.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): • krvne preiskave lahko pokažejo zmanjšanje števila belih krvnih celic.
Decline of ≥10% or death
Zmanjšanje za ≥ 10 % ali smrt
Reports of anaphylactic reactions have also been received.
Prejeli so tudi poročila o anafilaktičnih reakcijah.
Cigarette smoking can reduce the effect of Esbriet.
Kajenje cigaret lahko zmanjša učinek zdravila Esbriet.
Therefore, patients should know how they react to this medicinal product before they engage in activities requiring mental alertness or coordination (see section 4.7).
Bolniki morajo zato vedeti, kakšen je njihov odziv na to zdravilo, preden se začnejo ukvarjati z dejavnostmi, ki zahtevajo mentalno pozornost ali koordinacijo (glejte poglavje 4.7).
Your medicine will usually be given to you in increasing doses as follows:
Zdravilo boste običajno prejeli v odmerkih, ki se bodo povečevali, kot je opisano:
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Adverse reactions from post-marketing experience are also listed in Table 1.
Neželeni učinki iz izkušenj v obdobju trženja so prav tako navedeni v preglednici 1.
Doses above 2403 mg/day are not recommended for any patient (see section 4.9).
Odmerki, večji od 2403 mg/dan, niso priporočljivi pri nobenem bolniku (glejte poglavje 4.9).
● feeling weak or feeling low in energy
• občutek oslabelosti ali občutek pomanjkanja energije,
As it is unknown whether Esbriet passes into breast milk, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding if you decide to do so.
Ker ni znano, ali zdravilo Esbriet prehaja v materino mleko, se bo zdravnik z vami pogovoril o tveganjih in koristih jemanja tega zdravila med dojenjem, če se boste odločili dojiti.
Date of latest renewal: 08 September 2015
Datum prve odobritve: 28. februar 2011 Datum zadnjega podaljšanja: 8. september 2015
Pirfenidone binds to human plasma proteins, primarily to serum albumin.
Porazdelitev Pirfenidon se veže na beljakovine človeške plazme, predvsem na serumski albumin.
There are no data from the use of Esbriet in pregnant women.
Ni podatkov o uporabi zdravila Esbriet pri nosečnicah.
Treatment was administered three times daily for 52 weeks.
Zdravilo so dajali trikrat na dan 52 tednov.
The overall mean binding ranged from 50% to 58% at concentrations observed in clinical studies (1 to 100 μg/ml).
Skupna povprečna vezava je znašala od 50 % do 58 % pri koncentracijah, kakršne so opazovali v kliničnih študijah (od 1 do 100 μg/ml).
Do not drink grapefruit juice whilst taking this medicine.
Med jemanjem tega zdravila ne pijte grenivkinega soka.
This is especially important if you are taking the following medicines, as they may change the effect of Esbriet.
To je še posebej pomembno, če jemljete spodaj našteta zdravila, saj lahko spremenijo učinek zdravila
Esbriet with food and drink
Zdravilo Esbriet skupaj s hrano in pijačo
Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.
Zdravnik vam lahko zmanjša odmerek, če se pojavijo neželeni učinki, kot so težave z želodcem, kožne reakcije na sončno svetlobo ali ultravijolične svetilke ali večje spremembe jetrnih encimov.
Following single dose administration of pirfenidone in healthy older adults, the mean apparent terminal elimination half-life was approximately 2.4 hours.
Po uporabi enega odmerka pirfenidona pri zdravih starejših odraslih je bila navidezna povprečna končna eliminacijska razpolovna doba približno 2,4 ure.
Each dose should be separated by at least 3 hours.
Med dvema odmerkoma naj minejo vsaj 3 ure.
If symptoms continue, patients may be instructed to interrupt treatment for one to two weeks to allow symptoms to resolve.
Če simptomi ne izginejo, se lahko bolnikom naroči, naj za teden ali dva prekinejo zdravljenje, da simptomi izginejo.
Stop taking Esbriet and tell your doctor immediately
Zdravilo Esbriet prenehajte jemati in nemudoma obvestite zdravnika:
Dose reduction due to side effects
Zmanjšanje odmerka zaradi neželenih učinkov
In both studies, treatment was administered three times daily for a minimum of 72 weeks.
V obeh se je zdravilo dajalo trikrat na dan najmanj 72 tednov.
In the event of a suspected overdose, supportive medical care should be provided including monitoring of vital signs and close observation of the clinical status of the patient.
Ob sumu na preveliko odmerjanje je treba nuditi podporno zdravstveno nego, ki mora vključevati tudi spremljanje življenjskih znakov in skrbno spremljanje kliničnega stanja bolnika.
Rarely these have been associated with concomitant elevations in total serum bilirubin.
Redko so bile povezane s sočasnim skupnim zvišanjem bilirubina v serumu.
Median (25th-75th)
mediana (25.-75.)
It is important that you have these regular blood tests for as long as you are taking Esbriet.
Pomembno je, da redne preiskave krvi opravljate, dokler jemljete zdravilo Esbriet.
Reproductive toxicology studies demonstrated no adverse effects on male and female fertility or postnatal development of offspring in rats and there was no evidence of teratogenicity in rats (1,000 mg/kg/day) or rabbits (300 mg/kg/day).
Reproduktivne toksikološke raziskave so dokazale, da pri podganah ni neželenih učinkov na plodnost samcev in samic ali postnatalni razvoj mladičev, prav tako pa ni dokazov za teratogenost pri podganah (1000 mg/kg/dan) ali kuncih (300 mg/kg/dan).
● Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
• Bolnikom je treba svetovati, da se izogibajo izpostavljenosti neposredni sončni svetlobi ali jo zmanjšajo (vključno z ultravijoličnimi svetilkami).
<1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data)] the adverse reactions are presented in order of decreasing seriousness.
< 1/100), redki (≥ 1/10.000 do < 1/1.000), neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov)] pa so navedeni po padajoči resnosti.
The exposure to pirfenidone in smokers was 50% of that observed in non-smokers.
Izpostavljenost pirfenidonu je bila pri kadilcih enaka 50 % izpostavljenosti, ki so jo opazili pri nekadilcih.
Decline of ≥10% or death or lung transplant
Zmanjšanje za ≥ 10 % ali smrt ali presaditev pljuč
● Abnormal liver function tests
• nenormalne rezultate testov delovanja jeter
The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Kontrolni seznam za zagotavljanje varne uporabe zdravila Esbriet mora vsebovati naslednje ključne elemente v zvezi z delovanjem jeter in preobčutljivostjo na svetlobo:
Smoking has the potential to induce hepatic enzyme production and thus increase medicinal product clearance and decrease exposure.
Kajenje lahko sproži tvorjenje jetrnih encimov in tako poveča očistek zdravila in zmanjša izpostavljenost.
In clinical studies, most patients who experienced dizziness had a single event, and most events resolved, with a median duration of 22 days.
V kliničnih študijah je večina bolnikov, ki so doživeli omotico, to doživela samo enkrat, najpogosteje pa so ti dogodki izginili po povprečno 22 dneh.
Three of the Phase 3 studies (PIPF-004, PIPF-006, and PIPF-016) were multinational, and one (SP3) was conducted in Japan.
Tri od študij faze III (PIPF-004, PIPF-006 in PIPF-016) so bile mednarodne, eno (SP3) pa so izvedli na
1 What Esbriet is and what it is used for
Kaj je zdravilo Esbriet in za kaj ga uporabljamo
The physician information should encourage the prescribers to report serious adverse reactions and clinically significant ADRs of special interest including:
Informacije za zdravnike naj spodbudijo zdravnike, ki predpisujejo zdravilo, da bodo poročali o resnih neželenih učinkih in klinično pomembnih neželenih učinkih posebnega pomena, kar vključuje:
270 capsules
270 kapsul.
Patients with angioedema or severe allergic reactions should be managed according to standard of care.
Bolnike z angioedemom ali hudimi alergijskimi reakcijami je treba obravnavati v skladu s standardno nego.
Component of a multipack, can't be sold separately
Sestavnih delov skupnega pakiranja ni mogoče prodajati posebej
When tested under UV exposure pirfenidone was positive in a photoclastogenic assay in Chinese hamster lung cells.
Pri preskušanju pod ultravijolično svetlobo je bil pirfenidon pozitiven pri testu foto-klastogenosti v pljučnih celicah kitajskega hrčka.
Physicians should monitor patient's weight, and when appropriate encourage increased caloric intake if weight loss is considered to be of clinical significance.
Zdravniki naj spremljajo bolnikovo telesno maso in ga po potrebi vzpodbujajo k povečanju vnosa kalorij, kadar je izguba telesne mase klinično pomembna.
The dose of pirfenidone may be reduced to 3 capsules/day (1 capsule three times a day).
Odmerek pirfenidona se lahko zmanjša na 3 kapsule/dan (ena kapsula trikrat na dan).
If symptoms continue, see your doctor.
Če simptomi ne izginejo, obiščite zdravnika.
Esbriet may cause dizziness and fatigue, which could have a moderate influence on the ability to drive or use machines, therefore patients should exercise caution when driving or operating machinery if they experience these symptoms.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Esbriet lahko povzroči omotico in utrujenost, ki imata lahko zmeren vpliv na sposobnost vožnje in upravljanja strojev, zato morajo biti bolniki v primeru teh simptomov previdni, če vozijo ali upravljajo stroje.
The majority of pirfenidone is excreted as the 5-carboxy-pirfenidone metabolite (>95% of that recovered), with less than 1% of pirfenidone excreted unchanged in urine.
Večina pirfenidona se izloči kot presnovek 5-karboksi-pirfenidona (> 95 % izločenega), manj kot 1 % pirfenidona v seču pa se izloči nespremenjeno.
The results of mechanistic studies indicate that the occurrence of uterine tumours is probably related to a chronic dopamine-mediated sex hormone imbalance involving a species specific endocrine mechanism in the rat which is not present in humans.
Rezultati študij delovanja kažejo, da je pojavnost tumorjev na maternici verjetno povezana s kroničnim neravnovesjem spolnih hormonov, ki ga prenaša dopamin in pri podganah vključuje za to živalsko vrsto specifičen mehanizem endokrinega sistema, ki ga pri ljudeh ni.
In repeated dose toxicity studies increases in liver weight were observed in mice, rats and dogs; this was often accompanied by hepatic centrilobular hypertrophy.
V raziskavah toksičnosti pri ponavljajočih se odmerkih so pri miših, podganah in psih opazili povečanje jeter, ki ga je pogosto spremljala centrolobularna hipertrofija jeter.
● Any other clinically significant ADRs based on the judgment of the prescriber
• katerekoli druge klinično pomembne neželene učinke po presoji zdravnika, ki predpiše zdravilo