natgillin/translations-raw huggingface dataset:
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 izvedenih za procjenu 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 pireksija i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
25 mg capsules:
25 mg kapsule:
300 mg capsules:
300 mg kapsule:
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 tjedno ispitivanje djelotvornosti i sigurnosti u bolesnika s parcijalnim napadajima, n=295, ispitivanje farmakokinetike i podnošljivosti,
300 mg capsules Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm) filled with white to nearly white coloured powder.
300 mg kapsule Crvena neprozirna kapica i blijedo žuto-smeđe neprozirno tijelo, kapsula veličine 0 (21,7 mm x 7,6 mm), ispunjena bijelim do gotovo bijelim praškom.
150 mg capsules White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm) filled with white to nearly white coloured powder.
150 mg kapsule Bijela neprozirna kapica i tijelo, kapsula veličine 2 (18,0 mm x 6,4 mm), ispunjena bijelim do gotovo bijelim praškom.
NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sandoz
100 mg capsules:
100 mg kapsule:
White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white coloured powder.
Bijela neprozirna kapica i tijelo, kapsula veličine 2 (18,0 mm x 6,4 mm), ispunjena bijelim do gotovo bijelim praškom.
200 mg capsules:
200 mg kapsule:
50 mg capsules:
50 mg kapsule:
Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm), filled with white to nearly white coloured powder.
Crvena neprozirna kapica i blijedo žuto-smeđe neprozirno tijelo, kapsula veličine 0 (21,7 mm x 7,6 mm), ispunjena bijelim do gotovo bijelim praškom.
INFORMATION IN BRAILLE Pregabalin Sandoz 225 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 225 mg
Pharmacotherapeutic group: Anti epileptics, other anti-epileptics ATC code: N03AX16 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].
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/018-029
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/018-029
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/011-017
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/011-017
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
Maize starch
• upala gušterače
Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules.
Blisteri djeljivi na jedinične doze koji sadrže 14, 56, 84, 100 ili 210 (3 x 70) tvrdih kapsula.
Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 56 x 1, 84 x 1 or 100 x 1 hard capsules.
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.
Unit dose blisters containing 56, 84, 100 or 210 (3 x 70) hard capsules.
Blisteri djeljivi na jedinične doze koji sadrže 56, 84, 100 ili 210 (3 x 70) tvrdih kapsula.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/001-010
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/001-010
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/074-076
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/074-076
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/081-083
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/081-083
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/057-062
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/057-062
• There have been reports of kidney failure in some patients when taking pregabalin .
• U nekih je bolesnika pri uzimanju pregabalina prijavljeno zatajenje bubrega.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/054-056
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/054-056
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 150 mg
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz 150 mg
100 mg capsules Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.
100 mg kapsule Crvena neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm x 5,8 mm), ispunjena bijelim do gotovo bijelim praškom.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/063-068
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/063-068
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-052
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/042-052
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules pregabalin
Pregabalin Sandoz 225 mg tvrde kapsule pregabalin
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 225 mg pregabalina.
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Nositelj odobrenja za stavljanje gotovog lijeka u promet Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austrija
Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder.
Crvena neprozirna kapica i bijelo neprozirno tijelo, kapsula veličine 4 (14,3 mm x 5,3 mm), ispunjena bijelim do gotovo bijelim praškom.
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 56 x 1 hard capsules
14 tvrdih kapsula 21 tvrda kapsula 28 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 56 x 1 tvrda kapsula
INFORMATION IN BRAILLE Pregabalin Sandoz 75 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 75 mg
Tlf: + 45 6395 1000
Tel: + 39 02 96541
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/031-033
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/031-033
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.
Blijeda žuto-smeđa neprozirna kapica i tijelo, kapsula veličine 4 (14,3 mm x 5,3 mm), ispunjena bijelim do gotovo bijelim praškom.
14 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules
14 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 120 tvrdih kapsula
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA UMOTANOG
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/085
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/085
Titanium dioxide (E171) Iron oxide yellow (E172)
Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172)
INFORMATION IN BRAILLE Pregabalin Sandoz 150 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 150 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules
Pregabalin Sandoz 225 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules pregabalin
Pregabalin Sandoz 150 mg tvrde kapsule pregabalin
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/069-073
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/069-073
INFORMATION IN BRAILLE Pregabalin Sandoz 200 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 200 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 75 mg pregabalina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 200 mg pregabalina.
INFORMATION IN BRAILLE Pregabalin Sandoz 100 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 100 mg
Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Blijedo narančasta neprozirna kapica i tijelo, kapsula veličine 1 (19,4 mm x 6,9 mm), ispunjena bijelim do gotovo bijelim praškom.
21 hard capsules 28 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
21 tvrda kapsula 28 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Crvena neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm x 5,8 mm), ispunjena bijelim do gotovo bijelim praškom.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/053
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/053
INFORMATION IN BRAILLE Pregabalin Sandoz 300 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 300 mg
Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 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.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 150 mg pregabalina.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/034-041
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/034-041
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules
Pregabalin Sandoz 200 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules
Pregabalin Sandoz 150 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules pregabalin
Pregabalin Sandoz 200 mg tvrde kapsule pregabalin
INFORMATION IN BRAILLE Pregabalin Sandoz 25 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 25 mg
Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Blijedo narančasta neprozirna kapica i bijelo neprozirno tijelo, kapsula veličine 1 (19,4 mm x 6,9 mm), ispunjena bijelim do gotovo bijelim praškom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 25 mg pregabalina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 300 mg pregabalina.
• Flushing, hot flushes.
• crvenilo uz osjećaj vrućine, navale vrućine
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/084
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/084
Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.
Blisteri koji sadrže 14, 21, 28, 56, 84 ili 100 tvrdih kapsula.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules pregabalin
Pregabalin Sandoz 300 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules pregabalin
Pregabalin Sandoz 100 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules
Pregabalin Sandoz 75 mg tvrde kapsule
• 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, drhtanje (tremor),
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules
Pregabalin Sandoz 100 mg tvrde kapsule
INFORMATION IN BRAILLE Pregabalin Sandoz 50 mg
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Sandoz 50 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 100 mg pregabalina.
Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Blisteri koji sadrže 14, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula.
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules
Pregabalin Sandoz 300 mg tvrde kapsule
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 300 mg 17.
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz 300 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules pregabalin
Pregabalin Sandoz 75 mg tvrde kapsule pregabalin
Pregabalin Sandoz is available in the following presentations: PVC/PVDC//Alu blisters packed in carton.
Pregabalin Sandoz je dostupan u sljedećim oblicima pakiranja:
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules pregabalin
Pregabalin Sandoz 25 mg tvrde kapsule pregabalin
Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16 The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Farmakoterapijska skupina: Antiepileptici, ostali antiepileptici; ATK oznaka: N03AX16
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of pregabalin.
TVARI Jedna tvrda kapsula sadrži 50 mg pregabalina.
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Blisteri koji sadrže 14, 21, 28, 56, 70, 84, 100 ili 120 tvrdih kapsula.
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 75 mg 17.
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz 75 mg
Blister packs: 21, 28, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules Not all pack sizes may be marketed.
Blister pakiranja: 21, 28, 84 ili 100 tvrdih kapsula Blister pakiranja (djeljiva na jedinične doze): 84 x 1 ili 100 x 1 tvrda kapsula.
Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Svijetložuta neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm x 5,8 mm), ispunjena bijelim do gotovo bijelim praškom.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/030
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1011/030
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules
Pregabalin Sandoz 25 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg hard capsules
Pregabalin Sandoz 50 mg tvrde kapsule
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 25 mg 17.
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz 25 mg
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules
14 tvrdih kapsula 21 tvrda kapsula 28 tvrdih kapsula 56 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 84 x 1 tvrda kapsula
NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg hard capsules pregabalin
Pregabalin Sandoz 50 mg tvrde kapsule pregabalin
Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders Uncommon
Krvožilni poremećaji Manje često hipotenzija, hipertenzija, navale vrućine, crvenilo uz osjećaj vrućine, hladnoća perifernih dijelova tijela Poremećaji dišnog sustava, prsišta i sredoprsja Manje često dispneja, epistaksa, kašalj, kongestija nosa, rinitis, hrkanje, suhoća nosa
What you need to know before you take Pregabalin Sandoz 3.
Što je Pregabalin Sandoz i za što se koristi Što morate znati prije nego počnete uzimati Pregabalin Sandoz Kako uzimati Pregabalin Sandoz Moguće nuspojave
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 tvrdih kapsula 21 tvrda kapsula 28 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 120 tvrdih kapsula 14 x 1 tvrda kapsula 56 x 1 tvrda kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 tvrdih kapsula 21 tvrda kapsula 28 tvrdih kapsula 56 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
14 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 tvrdih kapsula 28 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 120 tvrdih kapsula 56 x 1 tvrda kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
INFORMATION IN BRAILLE Outer carton: Pregabalin Sandoz 50 mg 17.
16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Pregabalin Sandoz 50 mg
Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules.
Blister pakiranja (djeljiva na jedinične doze): 14 x 1, 56 x 1, 84 x 1, 100 x 1 ili 210 x 1 (3 x 70) tvrda kapsula.
14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
14 tvrdih kapsula 21 tvrda kapsula 28 tvrdih kapsula 56 tvrdih kapsula 70 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 120 tvrdih kapsula 56 x 1 tvrda kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
Nasopharyngitis
S Danmörk
In small children this can be 4 to 6 times per day.
U male djece to može biti 4 do 6 puta na dan.
Increased weight.
Povećanje težine.
Immedica Pharma AB SE-113 29 Stockholm Sweden
Immedica Pharma AB SE-113 29 Stockholm Švedska
You should take a dose as soon as possible with your next meal.
Što prije biste trebali uzeti dozu sa sljedećim obrokom.
The patient recovered within 48 hours after symptomatic treatment.
Dijete se oporavilo unutar 48 sati nakon simptomatskog liječenja.
What AMMONAPS is and what it is used for
Što je AMMONAPS i za što se koristi
You should take AMMONAPS with each meal or feeding.
AMMONAPS uzimajte uz svaki obrok ili hranjenje.
Make sure that there are at least 3 hours between two doses.
Pazite da razmak između dvije doze bude najmanje 3 sata.
You must follow this diet carefully.
Morate se pažljivo pridržavati tog režima prehrane.
[Justification for not including Braille accepted]
[Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma]
Your doctor will tell you how many tablets you should take.
Liječnik će Vam reći koliko tableta trebate uzimati.
The effect of food on absorption is unknown.
Učinak hrane na apsorpciju nije poznat.
It is important that the diagnosis is made early and treatment is initiated immediately to improve the survival and the clinical outcome.
Važno je dijagnozu postaviti rano i odmah započeti liječenje kako bi se povećali izgledi za preživljavanje i poboljšao klinički ishod.
Your doctor will tell you the amount of granules you should take.
Liječnik će Vam reći koju količinu granula trebate uzimati.
To measure the dose:
Mjerenje doze:
Other medicines and AMMONAPS
Drugi lijekovi i AMMONAPS
Three measuring spoons of different measures are provided.
Priložene su tri odmjerne žlice različitih mjera.
Plasma glutamine should be maintained at levels less than 1,000 µmol/l.
Nivo glutamina u plazmi treba održavati ispod 1000 µmol/l.
The tablets should be taken with a large volume of water.
Tablete treba uzimati s puno vode.
Talk to your doctor before taking AMMONAPS - if you have difficulty swallowing.
Obratite se svom liječniku prije nego uzmete AMMONAPS - ako imate poteškoća s gutanjem.
The safety of this medicinal product for use in human pregnancy has not been established.
Sigurnost ovog lijeka za primjenu u trudnica nije ustanovljena.
These medicines may change the effect of AMMONAPS and you will need more frequent blood controls.
Ovi lijekovi mogu promijeniti djelovanje lijeka AMMONAPS i trebat ćete češće obavljati krvne pretrage.
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGA POSEBNA UPOZORENJA (UKOLIKO JE POTREBNO) ROK VALJANOSTI
Frequency cannot be estimated from the available data
nije moguće odrediti učestalost na temelju dostupnih podataka
If you forget to take AMMONAPS
Ako ste zaboravili uzeti AMMONAPS
One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Slučaj predoziranja dogodio se u petomjesečnog djeteta koje je slučajno primilo jednokratnu dozu od 10 g (1370 mg/kg).
Common: Depression, irritability
Često: depresija, iritabilnost
Haemodialysis or peritoneal dialysis may be beneficial.
Hemodijaliza ili peritonealna dijaliza mogu biti od koristi.
Evaluation of experimental animal studies has shown reproductive toxicity, i.e. effects on the development of the embryo or the foetus.
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, odnosno postojanje učinaka na razvoj embrija i fetusa.
Contents of the pack and other information What AMMONAPS contains
Sadržaj pakiranja i druge informacije Što AMMONAPS sadrži
In the event of an overdose, discontinue the treatment and institute supportive measures.
U slučaju predoziranja, prekinuti liječenje i uvesti suportivne mjere.
Do not use AMMONAPS if you are pregnant, because this medicine can harm your unborn baby.
Ne uzimajte AMMONAPS ako ste trudni, budući da ovaj lijek može naškoditi Vašem nerođenom djetetu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
The volume of distribution of phenylbutyrate is 0.2 l/kg.
Volumen distribucije fenilbutirata je 0,2 l/kg.
Lightly shake the bottle before dispensing.
Prije otvaranja lagano protresite bočicu.
The safety and efficacy of doses in excess of 20 g/day have not been established.
Sigurnost i djelotvornost doza viših od 20 g/dan nije ustanovljena.
Common: Syncope, headache
Često: sinkopa, glavobolja
Ammonaps 500 mg [outer packaging only]
Ammonaps 500 mg [samo na vanjskom pakovanju]
• 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults.
• 9,9 - 13,0 g/m2/dan za djecu težine veće od 20 kg, adolescente i odrasle.
Patients with these rare disorders have a deficiency of certain liver enzymes and are therefore unable to eliminate nitrogen waste.
Bolesnicima s ovim rijetkim poremećajem nedostaju određeni enzimi jetre te stoga ne mogu ukloniti suvišni dušik.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
Where AMMONAPS granules need to be added to food, liquid or water, it is important that it is taken immediately after mixing.
Ako se AMMONAPS granule moraju miješati s hranom, tekućinom ili vodom, važno ih je primijeniti neposredno nakon miješanja.
The safety and efficacy of doses in excess of 20 g/day (40 tablets) have not been established.
Sigurnost i djelotvornost doza viših od 20 g/dan (40 tableta) nije ustanovljena.