natgillin/translations-raw huggingface dataset:
For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% of patients on placebo.
Među bolesnicima u kojih se nije javila somnolencija takvo je poboljšanje zabilježeno u 33% bolesnika liječenih pregabalinom te 18% bolesnika koji su primali placebo.
• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
• neuobičajen osjet mirisa, nemogućnost fokusiranja slike, promijenjena percepcija dubine,
CLcr (ml/min) = [ 1.23 x [140 - age (years)] x weight (kg) ] (x 0.85 for female patients) serum creatinine (µmol/L)
1,23 x [140 - dob (godine)] x težina (kg)
Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to pregabalin and the severity of these effects may be increased when taken together.
Neke nuspojave, poput pospanosti, mogu se javljati češće jer bolesnici s ozljedom leđne moždine možda uzimaju druge lijekove za liječenje, primjerice, boli ili grčeva, koji imaju slične nuspojave kao pregabalin.
In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 7% of the patients on placebo had a 50% improvement in pain score.
U kontroliranom kliničkom ispitivanju u centralnoj neuropatskoj boli je u 22% bolesnika liječenih pregabalinom i 7% bolesnika koji su primali placebo zabilježeno 50%-tno poboljšanje rezultata procjene boli.
• Blurred vision, double vision.
• zamagljen vid, dvoslike
• Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
• suhe oči, oticanje očiju, bol u oku, slabost očiju, suzne oči, nadraženost očiju
In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
U kontroliranim kliničkim ispitivanjima u perifernoj neuropatskoj boli je u 35% bolesnika liječenih pregabalinom i 18% bolesnika koji su primali placebo zabilježeno 50%-tno poboljšanje rezultata procjene boli.
Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder,
Manje često sinkopa, stupor, mioklonus, gubitak svijesti, psihomotorička hiperaktivnost, diskinezija, posturalna omaglica, intencijski tremor, nistagmus, kognitivni poremećaj, slabljenje mentalnih sposobnosti, poremećaj govora, hiporefleksija, hiperestezija, osjećaj žarenja, ageuzija, malaksalost
Pregabalin Accord 25/50/75/100/150/200/225/300mg hard capsules are available in 100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters.
Pregabalin Accord tvrde kapsule od 25/50/75/100/150/200/225/300 mg dostupne su kao 100 x 1 tvrda kapsula u PVC/aluminijskim perforiranim blisterima djeljivim na jedinične doze.
Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at > 2 times the human therapeutic exposure.
U mladih je štakora nakon 1-2 tjedna izloženosti > 2 puta većoj od terapijske izloženosti u ljudi opažena umanjena reakcija straha na akustične podražaje.
These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness.
One uključuju poteškoće sa spavanjem, glavobolju, mučninu, osjećaj tjeskobe, proljev, simptome nalik gripi, konvulzije, nervozu, depresiju, bol, znojenje i omaglicu.
Rhabdomyolysis
Rijetko rabdomioliza
Very rare
Rijetko žutica
• Kidney failure, reduced urine volume, urinary retention.
• zatajenje bubrega, smanjen volumen mokraće, zadržavanje mokraće
HDPE bottle pack should be used within 30 days (for 30's count) and 100 days (for 200's count) after first opening.
Nakon prvog otvaranja HDPE bocu treba iskoristiti u roku od 30 dana (za bocu s 30 kapsula) i 100 dana (za bocu s 200 kapsula).
Pregabalin Accord 25 mg hard capsules Pregabalin Accord 50 mg hard capsules Pregabalin Accord 75 mg hard capsules Pregabalin Accord 100 mg hard capsules Pregabalin Accord 150 mg hard capsules Pregabalin Accord 200 mg hard capsules Pregabalin Accord 225 mg hard capsules Pregabalin Accord 300 mg hard capsules
Pregabalin Accord 25 mg tvrde kapsule Pregabalin Accord 50 mg tvrde kapsule Pregabalin Accord 75 mg tvrde kapsule Pregabalin Accord 100 mg tvrde kapsule Pregabalin Accord 150 mg tvrde kapsule Pregabalin Accord 200 mg tvrde kapsule Pregabalin Accord 225 mg tvrde kapsule Pregabalin Accord 300 mg tvrde kapsule pregabalin
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava Manje često neutropenija
For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Među bolesnicima u kojih se javila somnolencija, udio onih koji su odgovorili na liječenje iznosio je 48% u skupini koja je primala pregabalin te 16% u skupini koja je primala placebo.
• Flushing, hot flushes.
• navale crvenila, navale vrućine
Each capsule is approximately 15.8 mm in length.
Jedna je kapsula duga otprilike 15,8 mm.
Each capsule is approximately 14.4 mm in length.
Jedna je kapsula duga otprilike 14,4 mm.
Ear and labyrinth disorders
Poremećaji uha i labirinta Često vrtoglavica
This medicine is for oral use only.
Ovaj je lijek namijenjen samo za primjenu kroz usta.
225 mg capsules
225 mg kapsule
The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Zabilježeni su sljedeći događaji: nesanica, glavobolja, mučnina, anksioznost, proljev, sindrom nalik gripi, nervoza, depresija, bol, konvulzije, hiperhidroza i omaglica, koji upućuju na fizičku ovisnost.
Each capsule is approximately 21.4 mm in length.
Jedna je kapsula duga otprilike 21,4 mm.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
• suha usta, zatvor, povraćanje, vjetrovi, proljev, mučnina, otečen trbuh
Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses.
Liječenje pregabalinom može započeti dozom od 150 mg na dan, podijeljenom u dvije ili tri doze.
Each capsule is approximately 17.8 mm in length.
Jedna je kapsula duga otprilike 17,8 mm.
After stopping long and short-term Pregabalin Accord treatment, you need to know that you may experience certain side effects.
Morate znati da nakon prekida dugotrajnog i kratkotrajnog liječenja lijekom Pregabalin Accord mogu nastupiti određene nuspojave.
• Increased saliva production, heartburn, numb around mouth.
• pojačano stvaranje sline, žgaravica, utrnulost oko usta
Infections and infestations
Infekcije i infestacije Često nazofaringitis
60 hard capsules
200 tvrdih kapsula
Each capsule is approximately 19.3 mm in length.
Jedna je kapsula duga otprilike 19,3 mm.
The dose range is 150 to 600 mg per day given as two or three divided doses.
Doza se kreće u rasponu od 150 do 600 mg na dan, podijeljeno u dvije ili tri doze.
• Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
• preosjetljivost, oticanje lica, svrbež, koprivnjača, curenje iz nosa, krvarenje iz nosa, kašalj hrkanje
75 mg capsules
75 mg kapsule
Pregabalin Accord 25 mg/ 50 mg/ 75 mg/ 100 mg/ 150 mg/ 200 mg/ 225 mg/ 300 mg hard capsules Capsule content:
Pregabalin Accord 25 mg/ 50 mg/ 75 mg/ 100 mg/ 150 mg/ 200 mg/ 225 mg/ 300 mg tvrde kapsule
100 hard capsules 112 hard capsules 100 x 1 hard capsules
14 tvrdih kapsula 21 tvrda kapsula 56 tvrdih kapsula 60 tvrdih kapsula 84 tvrde kapsule 90 tvrdih kapsula 100 tvrdih kapsula 112 tvrdih kapsula 100 x 1 tvrda kapsula
Ascites, pancreatitis, swollen tongue, dysphagia
Rijetko ascites, pankreatitis, otečen jezik, disfagija
This leaflet was approved in Other sources of information
Drugi izvori informacija
Pregabalin Accord 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Pregabalin Accord 225 mg tvrde kapsule Jedna tvrda kapsula sadrži 225 mg pregabalina.
Pregabalin Accord 25/50/75/100/150/200/225/300mg hard capsules are also available in an HDPE bottle containing 30 or 200 hard capsules.
Pregabalin Accord tvrde kapsule od 25/50/75/100/150/200/225/300 mg dostupne su također u HDPE boci koja sadrži 30 ili 200 tvrdih kapsula.
• Difficulty breathing, dry nose, nasal congestion.
• otežano disanje, suhoća nosne sluznice, začepljen nos
• Painful menstrual periods.
• bolne mjesečnice
• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood,
• promijenjena slika o sebi, nemir, depresija, uznemirenost, promjene raspoloženja, poteškoće u pronalaženju riječi, halucinacije, neuobičajeni snovi, napadaj panike, apatija, agresija, povišeno raspoloženje, slabljenje mentalnih sposobnosti, poteškoće pri razmišljanju, povećanje seksualne želje, tegobe sa spolnom funkcijom uključujući nemogućnost postizanja orgazma, odgođena ejakulacija
Pregabalin Accord 25/50/75/100/150/200/225/300mg hard capsules are available in HDPE bottle containing 30 or 200 hard capsules
Pregabalin Accord tvrde kapsule od 25/50/75/100/150/200/225/300 mg dostupne su u HDPE boci koja sadrži 30 ili 200 tvrdih kapsula.
100 mg capsules
100 mg kapsule
Propylene glycol
• upala gušterače
50 mg capsules
50 mg kapsule
Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles.
Osjet bola može se opisati kao vrućina, žarenje, pulsirajuća bol, sijevajuća bol, probadanje, oštra bol, grčevi, stalna tupa bol, trnci, utrnulost, bockanje.
25 mg capsules
25 mg kapsule
• Muscle cramp, joint pain, back pain, pain in limb.
• grčevi u mišićima, bol u zglobovima, bol u leđima, bol u udovima
Pregabalin Accord 150 mg hard capsules
Pregabalin Accord 150 mg tvrde kapsule
Pregabalin Accord 225 mg hard capsules
Pregabalin Accord 225 mg tvrde kapsule
Pregabalin Accord 75 mg hard capsules
Pregabalin Accord 75 mg tvrde kapsule
• There have been reports of kidney failure in some patients when taking this medicine.
• U nekih je bolesnika pri uzimanju ovog lijeka prijavljeno zatajenje bubrega.
Pregabalin Adverse Drug Reactions System organ class
Tablica 2. Nuspojave pregabalina Organski sustav
Pregabalin Accord 225 mg hard capsules pregabalin
Pregabalin Accord 225 mg tvrde kapsule pregabalin
Orange opaque/Orange opaque, size “1” hard gelatin capsules, imprinted with ‘PG' on cap and ‘200' on body.
Tvrde želatinske kapsule s narančastom neprozirnom kapicom i narančastim neprozirnim tijelom, veličine „1“ s otisnutom oznakom „PG“ na kapici i „200“ na tijelu.
Pregabalin Accord 200 mg hard capsules
Pregabalin Accord 200 mg tvrde kapsule
Each hard capsule contains 100 mg of pregabalin.
Jedna tvrda kapsula sadrži 100 mg pregabalina.
Pregabalin Accord 300 mg hard capsules
Pregabalin Accord 300 mg tvrde kapsule
Each hard capsule contains 75 mg of pregabalin.
Jedna tvrda kapsula sadrži 75 mg pregabalina.
Each hard capsule contains 200 mg of pregabalin.
Jedna tvrda kapsula sadrži 200 mg pregabalina.
Pregabalin Accord 100 mg hard capsules
Pregabalin Accord 100 mg tvrde kapsule
Pregabalin Accord 100 mg hard capsules pregabalin
Pregabalin Accord 100 mg tvrde kapsule pregabalin
Pregabalin Accord 300 mg hard capsules pregabalin
Pregabalin Accord 300 mg tvrde kapsule pregabalin
Each hard capsule contains 300 mg of pregabalin.
Jedna tvrda kapsula sadrži 300 mg pregabalina.
Angioedema, allergic reaction
Rijetko angioedem, alergijska reakcija Poremećaji metabolizma i prehrane Često pojačan tek
Each hard capsule contains 25 mg of pregabalin.
Jedna tvrda kapsula sadrži 25 mg pregabalina.
Each hard capsule contains 225 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 225 mg pregabalina.
Each hard capsule contains 50 mg of pregabalin.
Jedna tvrda kapsula sadrži 50 mg pregabalina.
Each hard capsule contains 150 mg of pregabalin.
Jedna tvrda kapsula sadrži 150 mg pregabalina.
How to store Pregabalin Accord Contents of the pack and other information
Sadržaj pakiranja i druge informacije
Pregabalin Accord 150 mg hard capsules pregabalin
Pregabalin Accord 150 mg tvrde kapsule pregabalin
• Breast pain.
• grlobolja.
Uncommon (may affect up to 1 in 100 people):
Manje česte (mogu se javiti u do 1 na 100 osoba)
Red opaque/White opaque, size “0” hard gelatin capsules, imprinted with ‘PG' on cap and ‘300' on body.
Tvrde želatinske kapsule s crvenom neprozirnom kapicom i bijelim neprozirnim tijelom, veličine „0“ s otisnutom oznakom „PG“ na kapici i „300“ na tijelu.
Red opaque/White opaque, size “4” hard gelatin capsules, imprinted with ‘PG' on cap and ‘75' on body.
Tvrde želatinske kapsule s crvenom neprozirnom kapicom i bijelim neprozirnim tijelom, veličine „4“ s otisnutom oznakom „PG“ na kapici i „75“ na tijelu.
Pregabalin Accord 25 mg hard capsules
Pregabalin Accord 25 mg tvrde kapsule
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.