natgillin/translations-raw huggingface dataset:
It is advised not to drink alcohol while taking Pregabalin Sandoz GmbH.
Preporučuje se da ne pijete alkohol dok uzimate lijek Pregabalin Sandoz GmbH.
Your doctor will prescribe Pregabalin Sandoz GmbH for you to help treat your epilepsy when your current treatment is not controlling your condition.
Liječnik će Vam propisati lijek Pregabalin Sandoz GmbH za liječenje epilepsije kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom.
Pregabalin Sandoz GmbH 25 mg hard capsules Pregabalin Sandoz GmbH 50 mg hard capsules Pregabalin Sandoz GmbH 75 mg hard capsules Pregabalin Sandoz GmbH 100 mg hard capsules Pregabalin Sandoz GmbH 150 mg hard capsules Pregabalin Sandoz GmbH 200 mg hard capsules Pregabalin Sandoz GmbH 225 mg hard capsules Pregabalin Sandoz GmbH 300 mg hard capsules Pregabalin
Pregabalin Sandoz GmbH 25 mg tvrde kapsule Pregabalin Sandoz GmbH 50 mg tvrde kapsule Pregabalin Sandoz GmbH 75 mg tvrde kapsule Pregabalin Sandoz GmbH 100 mg tvrde kapsule Pregabalin Sandoz GmbH 150 mg tvrde kapsule Pregabalin Sandoz GmbH 200 mg tvrde kapsule Pregabalin Sandoz GmbH 225 mg tvrde kapsule Pregabalin Sandoz GmbH 300 mg tvrde kapsule pregabalin
Pregabalin Sandoz GmbH may produce dizziness, sleepiness and decreased concentration.
Pregabalin Sandoz GmbH može izazvati omaglicu, pospanost i smanjenu koncentraciju.
When taken with certain other medicines, Pregabalin Sandoz GmbH may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Kada se uzima s nekim drugim lijekovima, Pregabalin Sandoz GmbH može pojačati nuspojave tih lijekova, uključujući zatajenje disanja i komu.
Epilepsy: Pregabalin Sandoz GmbH is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Epilepsija: Pregabalin Sandoz GmbH se koristi za liječenje nekih oblika epilepsije (parcijalnih napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Pregabalin Sandoz GmbH je indiciran kao dodatna terapija u odraslih osoba s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
For three times a day take Pregabalin Sandoz GmbH once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Ako lijek Pregabalin Sandoz GmbH uzimate tri puta na dan, uzmite jednu dozu ujutro, jednu dozu poslijepodne te jednu navečer, svakoga dana otprilike u isto vrijeme.
Generalised Anxiety Disorder: Pregabalin Sandoz GmbH is used to treat Generalised Anxiety Disorder (GAD).
Generalizirani anksiozni poremećaj: Pregabalin Sandoz GmbH se koristi za liječenje generaliziranog anksioznog poremećaja (GAP).
What Pregabalin Sandoz GmbH contains - The active substance is pregabalin.
Što Pregabalin Sandoz GmbH sadrži - Djelatna tvar je pregabalin.
Pregabalin Sandoz GmbH may be taken with oral contraceptives.
Pregabalin Sandoz GmbH se može uzimati s oralnim kontraceptivima.
Very common: may affect more than 1 in 10 people
Vrlo česte: mogu se javiti u više od 1 na 10 osoba:
Pregabalin Sandoz GmbH may be taken with or without food.
Način primjene Pregabalin Sandoz GmbH se može uzimati s hranom ili bez nje.
• There have been reports of heart failure in some patients when taking pregabalin ; these patients were mostly elderly with cardiovascular conditions.
• U nekih je bolesnika pri uzimanju pregabalina prijavljeno zatajenje srca; radilo se uglavnom o starijim bolesnicima s postojećim bolestima srca i krvožilja.
What Pregabalin Sandoz GmbH is and what it is used for
Što je Pregabalin Sandoz GmbH i za što se koristi
The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3(aminomethyl)-5-methylhexanoic acid].
Djelatna tvar je pregabalin, analog gama-aminomaslačne kiseline [(S)-3-(aminometil)-5-metilheksanoična kiselina].
Do not stop taking Pregabalin Sandoz GmbH unless your doctor tells you to.
Nemojte prestati uzimati lijek Pregabalin Sandoz GmbH ako Vam to ne kaže liječnik.
Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Sandoz GmbH pripada skupini lijekova koji se koriste za liječenje epilepsije i generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
: + 359 2 970 47 47 regaffairs.bg@sandoz.com
Teл.: + 359 2 970 47 47 regaffairs.bg@sandoz.com regaff.belgium@sandoz.com
Pregabalin Sandoz GmbH may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Pregabalin Sandoz GmbH može izazvati omaglicu i somnolenciju te tako utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
Talk to your doctor or pharmacist before taking Pregabalin Sandoz GmbH.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Sandoz GmbH.
Pregabalin Sandoz GmbH may have minor or moderate influence on the ability to drive and use machines.
Pregabalin Sandoz GmbH može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Sandoz d.o.o.
Hrvatska Sandoz d.o.o.
For twice a day take Pregabalin Sandoz GmbH once in the morning and once in the evening, at about the same time each day.
Ako lijek Pregabalin Sandoz GmbH uzimate dva puta na dan, uzmite jednu dozu ujutro te jednu navečer, svakoga dana otprilike u isto vrijeme.
Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Sandoz GmbH je indiciran za liječenje generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise
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,
After stopping long and short-term Pregabalin Sandoz GmbH treatment, you need to know that you may experience certain side effects.
Morate znati da nakon prekida dugotrajnog i kratkotrajnog liječenja lijekom Pregabalin Sandoz GmbH mogu nastupiti određene nuspojave.
What Pregabalin Sandoz GmbH looks like and contents of the pack 25 mg capsules Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm) filled with white to nearly white coloured powder.
Kako Pregabalin Sandoz GmbH izgleda i sadržaj pakiranja 25 mg kapsule Blijedo žuto-smeđa neprozirna kapica i tijelo, kapsula veličine 4 (14,3 mm x 5,3 mm), ispunjena bijelim do gotovo bijelim praškom.
Withdrawal of concomitant antiepileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Nema dovoljno podataka za ukidanje istodobno primijenjenih antiepileptika nakon što je dodavanjem pregabalina postignuta kontrola napadaja, a u cilju monoterapije pregabalinom.
Rare: may affect up to 1 in 1,0000 people
Rijetke: mogu se javiti u do 1 na 1000 osoba:
The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (see section 4.4).
U liječenju centralne neuropatske boli uzrokovane ozljedom leđne moždine zabilježena je povećana incidencija nuspojava općenito te nuspojava SŽS-a, a osobito somnolencije (vidjeti dio 4.4).
What you need to know before you take Pregabalin Sandoz GmbH
Što morate znati prije nego počnete uzimati Pregabalin Sandoz GmbH
Marketing Authorisation Holder Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Nositelj odobrenja za stavljanje gotovog lijeka u promet Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austrija
Dizziness, somnolence, headache
omaglica, omamljenost, glavobolja
The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis (see sections 4.2, 5.1 and 5.2).
Najčešći štetni događaji zabilježeni u 12 tjednom ispitivanju liječenja pregabalinom bile su somnolencija, pireksija, infekcija gornjih dišnih puteva, povećani apetit, povećana težina i nazofaringitis (vidjeti dijelove 4.2, 5.1 i 5.2).
Other medicines and Pregabalin Sandoz GmbH Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus placebo) and 22.6% of those receiving placebo.
Najmanje 50%-tno smanjenje parcijalnih napadaja od početka ispitivanja imalo je 40,6% ispitanika liječenih pregabalinom u dozi od 10 mg / kg na dan (p = 0,0068 naspram placeba), 29,1% ispitanika liječenih pregabalinom 2,5 mg / kg na dan (p = 0,2600 naspram placeba) i 22,6% onih koji su primali placebo.
The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy.
Sigurnosni profil pregabalina zabilježen u tri pedijatrijska ispitivanja u bolesnika s parcijalnim napadajima sa sekundarnom generalizacijom ili bez nje (12 tjedano ispitivanje djelotvornosti i sigurnosti u bolesnika s parcijalnim napadajima, n=295(ispitivanje farmakokinetike i podnošljivosti, n=65; jednogodišnje otvoreno ispitivanje praćenja sigurnosti, n=54) bio je sličan onome zapaženom u ispitivanjima u odraslih bolesnika s epilepsijom.
Adverse reactions in patients with spinal cord injury The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury.
U liječenju centralne neuropatske boli uzrokovane ozljedom leđne moždine zabilježena je povećana incidencija nuspojava općenito te nuspojava središnjeg živčanog sustava, a osobito somnolencije.
Pregabalin Sandoz GmbH is for oral use only.
Pregabalin Sandoz GmbH je namijenjen samo za peroralnu primjenu.
In the 12-week placebo-controlled study, paediatric patients were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
U 12 tjednom placebom kontroliranom ispitivanju pedijatriski pacijenti su dobivali pregabalin u dozi od 2,5 mg / kg na dan (maksimalno 150 mg na dan), pregabalin 10 mg / kg na dan (maksimalno 600 mg na dan) ili placebo.
Cases of misuse, abuse and dependece have been reported.
Pogrešna primjena, potencijal za zlouporabu ili ovisnost Prijavljeni su slučajevi pogrešne primjene, zlouporabe lijeka i ovisnosti o lijeku.
If you stop taking Pregabalin Sandoz GmbH
Ako prestanete uzimati lijek Pregabalin Sandoz GmbH
Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Rezultati 12tjednog placebom kontroliranog ispitivanja koje je provedeno u 295 pedijatrijskih bolesnika u dobi od 4 do 16 godina radi procjene djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina starosti s epilepsijom ukazuju da su štetni događaji pireksije i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
You should take Pregabalin Sandoz GmbH in addition to your current treatment.
Lijek Pregabalin Sandoz GmbH morate uzimati kao dodatak postojećim lijekovima.
Common: may affect up to 1 in 10 people
Česte: mogu se javiti u do 1 na 10 osoba:
Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 hard capsules.
Blister pakiranja: 14, 21, 28, 56, 84 ili 100 tvrdih kapsula Blister pakiranja (djeljiva na jedinične doze): 84 x 1 tvrda kapsula.
Uncommon: may affect up to 1 in 100 people
Manje česte: mogu se javiti u do 1 na 100 osoba:
How to take Pregabalin Sandoz GmbH
Kako uzimati Pregabalin Sandoz GmbH
There have been postmarketing reports of congestive heart failure in some patients receiving pregabalin.
Kongestivno zatajenje srca Nakon stavljanja lijeka u promet u nekih bolesnika koji su primali pregabalin prijavljeno je kongestivno zatajenje srca.
If you forget to take Pregabalin Sandoz GmbH
Ako ste zaboravili uzeti lijek Pregabalin Sandoz GmbH
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/011-017
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/011-017
Urinary incontinence, dysuria
Nuspojava ageuzija, malaksalost
Unit dose blisters containing 56, 84 (2 x 42), 100 (2 x 50) or 210 (3 x 70) hard capsules.
Blisteri djeljivi na jedinične doze koji sadrže 561, 84 (2 x 42), 100 (2 x 50) ili 210 (3 x 70) tvrdih kapsula.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/001-010
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/001-010
Stevens Johnson syndrome, cold sweat Musculoskeletal and connective tissue disorders Common
Stevens-Johnsonov sindrom, hladan znoj Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često grčevi u mišićima, artralgija, bol u leđima, bol u udovima, cervikalni
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/057-062
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/057-062
How to store Pregabalin Sandoz GmbH
Kako čuvati Pregabalin Sandoz GmbH
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/074-076
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/074-076
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/063-068
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/063-068
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/018-029
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/018-029
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 225 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 225 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/042-052
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/042-052
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/031-033
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/031-033
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/054-056
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/054-056
Blister packs (unit dose): 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Blister pakiranja (djeljiva na jedinične doze): 84 x 1 ili 100 x 1 tvrda kapsula.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/081-083
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/081-083
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/034-041
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/034-041
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/085
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/085
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/053
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/053
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 225 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 225 mg tvrde kapsule pregabalin
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 150 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 150 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 150 mg tvrde kapsule pregabalin
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 200 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 200 mg
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 75 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 75 mg
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 300 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 300 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 225 mg hard capsules
Pregabalin Sandoz GmbH 225 mg tvrde kapsule
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/069-073
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/069-073
Very rare: may affect up to 1 in 10,000 people
Vrlo rijetke: mogu se javiti u manje odo 1 na 10 000 osoba zatajenje jetre hepatitis (upala jetre)
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 300 mg
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz GmbH 300 mg
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 100 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 100 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/084
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/084
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 150 mg
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz GmbH 150 mg
Dose regimen
Nuspojava spazam
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules
Pregabalin Sandoz GmbH 200 mg tvrde kapsule
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz GmbH 75 mg
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz GmbH 75 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 200 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 200 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 150 mg hard capsules
Pregabalin Sandoz GmbH 150 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules
Pregabalin Sandoz GmbH 300 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 300 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 300 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules
Pregabalin Sandoz GmbH 75 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules
Pregabalin Sandoz GmbH 100 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 75 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 75 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 100 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 100 mg tvrde kapsule pregabalin
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 25 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 25 mg
INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 50 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz GmbH 50 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/030
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1012/030
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules
Pregabalin Sandoz GmbH 25 mg tvrde kapsule
Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules Not all pack sizes may be marketed.
Blister pakiranja: 14, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula Blister pakiranja (djeljiva na jedinične doze): 56 x 1, 84 x 1 ili 100 x 1 tvrda kapsula.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 25 mg tvrde kapsule pregabalin
MARKETING AUTHORISATION HOLDER Sandoz GmbH
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sandoz GmbH
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules
Pregabalin Sandoz GmbH 50 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 50 mg hard capsules pregabalin
Pregabalin Sandoz GmbH 50 mg tvrde kapsule pregabalin
EU/1/15/1012/084
EU/1/15/1012/001-010 EU/1/15/1012/084
Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Blister pakiranja: 14, 21, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula.
1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Rezultati 12tjednog placebom kontroliranog istraživanja koje je porovedeno u 295 pedijatrijskih bolesnika u dobi od 4 do 16 godina radi procjene djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina starosti s epilepsijom ukazuju da su štetni događaji pireksije i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
Congestive heart failure
Oštećenje bubrega
Εθνική Οδός No 1 (12ο km) Μεταμόρφωση GR-144 51 Αθήνα Τηλ: +30 210 2811712
National Road No 1 (12th klm) GR-144 51, Metamorphosis, Αthens Greece
Elimination
Režim doziranja
Blister packs: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules Blister packs (unit dose): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules Container packs: 100, 200 or 250 hard capsules
Blister pakiranja: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) ili 120 (2 x 60) tvrdih kapsula.
EU/1/15/1012/085
EU/1/15/1012/011-017 EU/1/15/1012/085
Pregabalin Sandoz GmbH is available in the following presentations: PVC/PVDC//Alu blisters packed in carton.
Pregabalin Sandoz GmbH je dostupan u sljedećim oblicima pakiranja:
00351 Helsinki, Finland
00351 Helsinki, Finska
00 Praha 6, Czech
00 Prag 6, Češka
Budapest, Hungary
Budimpešta, Mađarska
1831 Diegem, Belgium
1831 Diegem, Belgija
167 14 Bromma, Sweden
167 14 Bromma, Švedska
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Dodatak I Popis zaštićenih imena, farmaceutskih oblika, doza lijekova, putova primjene, nositelja odobrenja za stavljanje lijeka u promet u državama članicama
Tatoiou Street 14671 Nea Erythrea, Greece
Tatoiou Street 14671 Nea Erythrea, Grčka
Slotsmarken 13, 2970 Hoersholm, Denmark
Slotsmarken 13, 2970 Hoersholm, Danska
Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands
Kampenringweg 45 D-E, 2803 PE Gouda,
France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France
Francuska sanofi-aventis France 1-13 Bd Romain Rolland 75014 Pariz, Francuska
Denmark sanofi-aventis Denmark A/S
Danska sanofi-aventis Denmark A/S
Finland sanofi-aventis Oy Huopalahdentie 24 PL 22
Finska sanofi-aventis Oy Huopalahdentie 24 PL 22
Republic
Republika
Slovak Republic sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovak Republic
Slovačka Republika sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovačka Republika
Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
Austrija sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Beč, Austrija
Bulgaria sanofi-aventis Bulgaria EOOD
Bugarska sanofi-aventis Bulgaria EOOD
Netherlands sanofi-aventis Netherlands BV.
Nizozemska sanofi-aventis Netherlands BV.
One Onslow Street, Guildford Surrey, GU1 4YS, United Kingdom
One Onslow Street, Guildford Surrey, GU1 4YS, Ujedinjeno Kraljevstvo
Norway sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325
Norveška sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325 Lysaker, Norveška
Hungary sanofi-aventis Zrt.
Mađarska sanofi-aventis Zrt.