natgillin/translations-raw huggingface dataset:
Elevated liver enzymes* 
Poremećaji jetre i žuči Manje često povišene vrijednosti jetrenih enzima*
Red opaque/Red opaque, size “3” hard gelatin capsules, imprinted with ‘PG' on cap and ‘100' on body. 
Tvrde želatinske kapsule s crvenom neprozirnom kapicom i crvenim neprozirnim tijelom, veličine „3“ s otisnutom oznakom „PG“ na kapici i „100“ na tijelu.
Pregabalin Accord 25 mg hard capsules pregabalin 
Pregabalin Accord 25 mg tvrde kapsule pregabalin
Orange opaque/White opaque, size “1” hard gelatin capsules, imprinted with ‘PG' on cap and ‘225' on body. 
Tvrde želatinske kapsule s narančastom neprozirnom kapicom i bijelim neprozirnim tijelom, veličine „1“ s otisnutom oznakom „PG“ na kapici i „225“ na tijelu.
Pregabalin Accord 50 mg hard capsules 
Pregabalin Accord 50 mg tvrde kapsule
- If you get any side effects , talk to your doctor or pharmacist. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Pregabalin Accord 75 mg hard capsules pregabalin 
Pregabalin Accord 75 mg tvrde kapsule pregabalin
White opaque/White opaque, size “2” hard gelatin capsules, imprinted with ‘PG' on cap and ‘150' on body. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i bijelim neprozirnim tijelom, veličine „2“ s otisnutom oznakom „PG“ na kapici i „150“ na tijelu.
• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal. 
• poremećaj pažnje, nespretnost, poremećaj pamćenja, gubitak pamćenja, nevoljno drhtanje
Pregabalin Accord 200 mg hard capsules pregabalin 
Pregabalin Accord 200 mg tvrde kapsule pregabalin
Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness 
Manje često oticanje zglobova, mialgija, trzanje mišića, bol u vratu, ukočenost mišića
White opaque/ White opaque, size “4” hard gelatin capsules imprinted with ‘‘PG' on cap and ‘25' on body. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i bijelim neprozirnim tijelom, veličine „4“ s otisnutom oznakom „PG“ na kapici i „25“ na tijelu.
White opaque/White opaque, size “3” hard gelatin capsules, imprinted with ‘PG' on cap and ‘50' on body. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i bijelim neprozirnim tijelom, veličine „3“ s otisnutom oznakom „PG“ na kapici i „50“ na tijelu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 150 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 150 mg tvrde kapsule}
Pregabalin Accord 50 mg hard capsules pregabalin 
Pregabalin Accord 50 mg tvrde kapsule pregabalin
30 hard capsules 200 hard capsules 
OBLIK I SADRŽAJ 30 tvrdih kapsula
Generalised oedema, face oedema, chest tightness, pain, pyrexia, 
Manje često generalizirani edem, edem lica, stezanje u prsištu, bol, pireksija, žeđ, zimica, astenija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 225 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 225 mg tvrde kapsule}
Adverse drug reactions 
FARMAKOLOŠKA SVOJSTVA
The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence. 
proljev, sindrom nalik gripi, konvulzije, nervoza, depresija, bol, hiperhidroza i omaglica, koji upućuju na fizičku ovisnost.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 75 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 75 mg tvrde kapsule}
Nervous system disorders Very Common 
Poremećaji imunološkog sustava Manje često preosjetljivost
Nasopharyngitis 
Prijavljivanje nuspojava
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 100 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 100 mg tvrde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 300 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 300 mg tvrde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 200 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 200 mg tvrde kapsule}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 25 mg hard capsules} 
{Naljepnica za HDPE bocu (30, 200) za 25 mg tvrde kapsule}
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.} 
{Kutija s blisterima (14, 21, 56, 60, 70, 84, 90, 100 i 112) i perforiranim blisterima djeljivima na jedinične doze (100) za 75 mg tvrde kapsule}
Tabulated list of adverse reactions 
Tablični sažetak nuspojava
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} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 70, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 75 mg tvrde kapsule - PVC/aluminij}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 50 mg hard capsules } 
{Naljepnica za HDPE bocu (30, 200) za 50 mg tvrde kapsule}
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 
OZNAČIVANJE I UPUTA O LIJEKU
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.} 
{Kutija s blisterima (14, 21, 56, 60, 84, 90, 100 i 112) i perforiranim blisterima djeljivima na jedinične doze (100) za 150 mg tvrde 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.} 
{Kutija s blisterima (14, 21, 56, 60, 84, 90, 100 i 112) i perforiranim blisterima djeljivima na jedinične doze (100) za 225 mg tvrde 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 225 mg hard capsules - PVC/Aluminium} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 225 mg tvrde 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 300 mg hard capsules - PVC/Aluminium} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 300 mg tvrde kapsule - PVC/aluminij}
Method of administration 
Režim doziranja
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.} 
{Kutija s blisterima (14, 21, 56, 60, 84, 90, 100 i 112) i perforiranim blisterima djeljivima na jedinične doze (100) za 300 mg tvrde 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} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 50 mg tvrde 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 100 mg hard capsules- PVC/Aluminium} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 100 mg tvrde 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 25mg hard capsules - PVC/Aluminium} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 25 mg tvrde 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.} 
{Kutija s blisterima (14, 21, 56, 60, 84, 90, 100 i 112) i perforiranim blisterima djeljivima na jedinične doze (100) za 100 mg tvrde 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 50 mg hard capsules.} 
{Kutija s blisterima (14, 21, 56, 60, 84, 90, 100 i 112) i perforiranim blisterima djeljivima na jedinične doze (100) za 50 mg tvrde kapsule}
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} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 150 mg tvrde 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 25 mg hard capsules.} 
{Kutija s blisterima (14, 21, 56, 60, 84, 90, 100 i 112} i perforiranim blisterima djeljivima na jedinične doze (100) za 25 mg tvrde kapsule.}
Jaundice 
Dojenje
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 200 mg hard capsules - PVC/Aluminium} 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {Blister (14, 21, 56, 60, 84, 90, 100 i 112) i perforirani blister djeljiv na jedinične doze (100) za 200 mg tvrde kapsule - PVC/aluminij}
1 pre-filled syringe with safety device 
1 štrcaljka s uloškom sa sigurnosno m napravom
1 pre-filled syringe 
1 štrcaljka s uloškom
● At the request of the European Medicines Agency; 
• na zahtjev Europske agencije za lijekove;
These medicinal products should be avoided whenever possible. 
Te bi lijekove trebalo izbjegavati kad god je to moguće.
OTHER Week 1, Week 2 
DRUGO 1. tjedan, 2. tjedan
● Risk Management Plan (RMP) 
• Plan upravljanja rizikom (RMP)
Children and adolescents Do not give Esbriet to children and adolescents under the age of 18. 
Esbriet se ne smije davati djeci i adolescentima mlađima od 18 godina.
Esbriet with food and drink 
Esbriet s hranom i pićem
● Additional risk minimisation measures 
• Dodatne mjere minimizacije rizika
These findings are not considered relevant to humans. 
Ti se nalazi ne smatraju značajnima za ljude.
If you forget a dose, take it as soon as you remember. 
Ako zaboravite uzeti dozu lijeka, uzmite je čim se sjetite.
Stop taking Esbriet and tell your doctor immediately 
Prestanite uzimati Esbriet i odmah obavijestite svog liječnika
Be careful if you have to take part in activities where you have to be alert and co-ordinated. 
Budite oprezni ako morate sudjelovati u aktivnostima koje zahtijevaju koncentraciju i koordinaciju.
● This medicine has been prescribed for you only. 
• Ovaj je lijek propisan samo Vama.
Date of latest renewal: 08 September 2015 
Datum posljednje obnove odobrenja: 8. rujna 2015.
270 capsules 
270 kapsula
Do not drink grapefruit juice whilst taking this medicine. 
Nemojte piti sok od grejpfruta dok uzimate ovaj lijek.
(sunrise; morning dose) 
(svitanje; jutarnja doza)
More than 170 patients have been investigated in open studies for more than five years and some for up to 10 years. 
Više od 170 bolesnika ispitano je u otvorenim ispitivanjima tijekom više od pet godina, dok su neka ispitivanja trajala do 10 godina.
● loss of appetite 
• gubitak apetita
Your doctor will monitor your weight whilst you are taking this medicine. 
Liječnik će Vam kontrolirati tjelesnu težinu dok uzimate ovaj lijek.
Component of a multipack, can't be sold separately 
Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno
which may make you more sensitive to sunlight. 
Vas mogu učiniti osjetljivijima na sunčevu svjetlost.
In some situations, your doctor may advise you to stop taking Esbriet. 
U nekim će Vam situacijama liječnik možda savjetovati da prestanete uzimati Esbriet.
A risk to the breastfed infant cannot be excluded. 
Ne može se isključiti rizik za dojenče.
● difficulty sleeping 
• tegobe sa spavanjem
It is important that you have these regular blood tests for as long as you are taking Esbriet. 
Važno je da redovito obavljate krvne pretrage dokle god uzimate Esbriet.
4 years for blisters. 
4 godine za blistere.
Other medicines and Esbriet 
Drugi lijekovi i Esbriet
● changes in taste 
• promjene osjeta okusa
Each dose should be separated by at least 3 hours. 
Razmak između pojedinih doza treba iznositi najmanje 3 sata.
● blood tests may show increased levels of liver enzymes 
• krvne pretrage mogu pokazati povišene razine jetrenih enzima
Treatment was administered three times daily for 52 weeks. 
Liječenje se primjenjivalo triput na dan tijekom 52 tjedna.
Pirfenidone binds to human plasma proteins, primarily to serum albumin. 
Pirfenidon se vezuje za proteine u ljudskoj plazmi, prvenstveno za serumski albumin.
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. 
U slučaju sumnje na predoziranje, potrebno je osigurati potpornu medicinsku skrb, uključujući praćenje vitalnih znakova i strog nadzor kliničkog statusa bolesnika.
● Physician information (safety checklists) 
• Informacije za liječnike (kontrolni popisi za provjeru sigurnosti)
Decline of ≥10% or death 
Pad od ≥10% ili smrt
This is especially important if you are taking the following medicines, as they may change the effect of Esbriet. 
To je osobito važno ako uzimate neki od sljedećih lijekova, jer oni mogu promijeniti učinak lijeka Esbriet.
Three of the Phase 3 studies (PIPF-004, PIPF-006, and PIPF-016) were multinational, and one (SP3) was conducted in Japan. 
Tri od tih ispitivanja faze 3 (PIPF-004, PIPF-006 i PIPF-016) bila su multinacionalna, a jedno (SP3) je provedeno u Japanu.
1 What Esbriet is and what it is used for 
Što je Esbriet i za što se koristi
● Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps). 
• Bolesnicima se savjetuje da izbjegavaju ili ograniče izlaganje izravnoj sunčevoj svjetlosti (uključujući lampe za sunčanje).
Rare side effects (may affect up to 1 in 1,000 people): ● blood tests may show decrease in white blood cells. 
Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba): • krvne pretrage mogu pokazati smanjen broj bijelih krvnih stanica
Rarely these have been associated with concomitant elevations in total serum bilirubin. 
Ta su povišenja rijetko bila povezana s istodobnim povišenjem ukupnog serumskog bilirubina.
5-Carboxy-Pirfenidone 
5-karboksi-pirfenidon
What Esbriet contains 
Što Esbriet sadrži
Recommendations in case of ALT/AST elevations 
Preporuke u slučaju porasta ALT-a/AST-a
3 years for bottles. 
3 godine za boce.
Your medicine will usually be given to you in increasing doses as follows: 
Doza lijeka obično će se povećavati na sljedeći način:
Cigarette smoking can reduce the effect of Esbriet. 
Pušenje cigareta može smanjiti učinak lijeka Esbriet.
● You should not take other medicines, such as tetracycline antibiotics (such as doxycycline), 
• Ne smijete uzimati druge lijekove, kao što su tetraciklinski antibiotici (npr. doksiciklin), koji
● You should stop smoking before and during treatment with Esbriet. 
• Prestanite pušiti prije i tijekom liječenja lijekom Esbriet.
If symptoms continue, see your doctor. 
Ako simptomi potraju, obratite se svom liječniku.
<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. 
rijetko (≥1/10 000 i <1/1000), nepoznato (ne može se procijeniti iz dostupnih podataka)] navedene su u padajućem nizu prema ozbiljnosti.
The exposure to pirfenidone in smokers was 50% of that observed in non-smokers. 
Izloženost pirfenidonu u pušača iznosila je 50% izloženosti uočene kod nepušača.
If you take more Esbriet than you should 
Ako uzmete više lijeka Esbriet nego što ste trebali
In both studies, treatment was administered three times daily for a minimum of 72 weeks. 
U oba se ispitivanja liječenje primjenjivalo triput na dan tijekom najmanje 72 tjedna.
4 years for bottles. 
4 godine za boce.
Reports of anaphylactic reactions have also been received. 
Osim toga, prijavljene su i anafilaktičke reakcije.
2 What you need to know before you take Esbriet 
Što morate znati prije nego počnete uzimati Esbriet
21 tablets 42 tablets) 90 tablets 180 tablets 
21 tableta 42 tablete 90 tableta 180 tableta
Keep this leaflet. 
• Sačuvajte ovu uputu.
What Esbriet looks like and contents of the pack 
Kako Esbriet izgleda i sadržaj pakiranja
● Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken. 
• Bolesnike treba upozoriti da je poznato da je Esbriet povezan s pojavom reakcija fotoosjetljivosti i da stoga treba poduzeti preventivne mjere.
Patients with angioedema or severe allergic reactions should be managed according to standard of care. 
Bolesnike s angioedemom ili teškim alergijskim reakcijama treba zbrinuti u skladu sa standardnim liječenjem.
These are rare side effects. 
To su rijetke nuspojave.
● skin reactions after going out in the sun or using sunlamps 
• kožne reakcije nakon izlaska na sunce ili nakon korištenja lampi za sunčanje • mučnina
The bottle pack contains 270 capsules. 
Pakiranje u boci sadrži 270 kapsula.
Roche Pharma AG Emil-Barell-Str. 1 
Roche Pharma AG Emil-Barell-Strasse 1
There is limited clinical experience with overdose. 
Kliničko iskustvo s predoziranjem je ograničeno.
The capsules contain a white to pale yellow powder. 
Kapsule sadrže bijeli do blijedožuti prašak.
Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects). 
Svakodnevno koristite sredstva za zaštitu od sunca te pokrijte ruke, noge i glavu kako biste smanjili izlaganje sunčevoj svjetlosti (pogledajte dio 4: Moguće nuspojave).
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). 
Stoga bi bolesnici trebali znati kako reagiraju na ovaj lijek prije nego što započnu aktivnosti koje zahtijevaju koncentraciju ili koordinaciju (vidjeti dio 4.7).
This makes it hard for your lungs to work properly. 
To otežava normalan rad Vaših pluća.
Elderly No dose adjustment is necessary in patients 65 years and older (see section 5.2). 
Nije potrebno prilagođavati dozu u bolesnika u dobi od 65 i više godina (vidjeti dio 5.2).
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). 
Toksikološka ispitivanja utjecaja na reprodukciju nisu pokazala neželjene učinke na plodnost mužjaka i ženki niti na postnatalni razvoj mladunčadi štakora, a nisu primijećeni ni znakovi teratogenosti u štakora (1000 mg/kg/dan) ni kunića (300 mg/kg/dan).
● Esbriet can cause weight loss. 
• Esbriet može uzrokovati gubitak tjelesne težine.
However, existing data suggest that pirfenidone exerts both antifibrotic and anti-inflammatory properties in a variety of in vitro systems and animal models of pulmonary fibrosis (bleomycin- and transplant-induced fibrosis). 
Međutim, dosadašnji podaci upućuju na to da pirfenidon ima antifibrozirajuća i protuupalna svojstva u različitim in vitro sustavima i životinjskim modelima plućne fibroze (fibroza inducirana bleomicinom i transplantacijom).
PVC/Aclar (PCTFE) aluminium foil blister Pack sizes 
PVC/Aclar (PCTFE) blister od aluminijske folije
Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone. 
Nuspojave su bile blage, prolazne i u skladu s najčešće prijavljivanim nuspojavama za pirfenidon.
The physician information should encourage the prescribers to report serious adverse reactions and clinically significant ADRs of special interest including: 
Informacije za liječnike trebaju potaknuti liječnike koji propisuju ovaj lijek da prijave ozbiljne nuspojave i klinički značajne nuspojave od posebnog interesa, uključujući:
Your medicine is provided in either a 2-week treatment initiation pack, a 4-week treatment pack or in a bottle. 
Lijek dolazi u pakiranju za 2-tjedni početak liječenja, u pakiranju za 4-tjedno liječenje ili u boci.
PHARMACEUTICAL FORM AND CONTENTS Hard capsule 
OBLIK I SADRŽAJ Tvrda kapsula
Following single dose administration of pirfenidone in healthy older adults, the mean apparent terminal elimination half-life was approximately 2.4 hours. 
Nakon primjene jednokratne doze pirfenidona u zdravih starijih odraslih ispitanika, srednja vrijednost prividnog terminalnog poluvijeka eliminacije iznosila je približno 2,4 sata.
Severe photosensitivity reactions are uncommon. 
Teške reakcije fotoosjetljivosti su manje česte.
If symptoms continue, patients may be instructed to interrupt treatment for one to two weeks to allow symptoms to resolve. 
Ako su simptomi i dalje prisutni, bolesniku se može savjetovati da privremeno prekine liječenje na jedan do dva tjedna, dok se simptomi ne povuku.
● There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter. 
• Potrebno je pratiti nalaze testova jetrene funkcije prije početka liječenja lijekom Esbriet i u redovitim intervalima nakon toga.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 February 2011 
Datum prvog odobrenja: 28. veljače 2011.
As a precautionary measure, it is preferable to avoid the use of Esbriet if you are pregnant, planning to become pregnant, or think you might be pregnant as the potential risks to the unborn child are unknown. 
Kao mjera opreza, savjetuje se da izbjegavate primjenu lijeka Esbriet ako ste trudni, ako namjeravate zatrudnjeti ili ako mislite da biste mogli biti trudni jer mogući rizici za nerođeno dijete nisu poznati.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
Esbriet should be used with caution when ciprofloxacin is used at a dose of 250 mg or 500 mg once or two times a day. 
Esbriet treba primjenjivati uz oprez kada se ciprofloksacin primjenjuje u dozi od 250 mg ili 500 mg jedanput ili dvaput na dan.
There are no data from the use of Esbriet in pregnant women. 
Nema podataka o primjeni lijeka Esbriet u trudnica.
Population pharmacokinetic analyses from 4 studies in healthy subjects or subjects with renal impairment and one study in patients with IPF showed no clinically relevant effect of age, gender or body size on the pharmacokinetics of pirfenidone. 
Populacijske farmakokinetičke analize podataka iz 4 ispitivanja provedena u zdravih osoba ili osoba s oštećenjem funkcije bubrega i jednog ispitivanja provedenog u bolesnika s IPF-om nisu pokazale klinički značajan utjecaj dobi, spola ni tjelesne veličine na farmakokinetiku pirfenidona.