FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Maltese: Fi provi kliniċi kkontrollati (li damu 4-8 ġimgħat) 52 % tal-pazjenti kkurati bi pregabalin u 38 % talpazjenti fuq il-plaċebo kellhom titjib ta' mill-anqas 50 % fil-punteġġ totali tal-HAM-A mil-linja bażika sal-punt finali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/074-076
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/074-076
English: 6.5 Nature and contents of container PVC/PVDC//Alu blister.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja tal-PVC/PVDC//Alu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/018-029
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/018-029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-056
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/042-056
English: Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Maltese: Pregabalin Sandoz huwa indikat bħala terapija aġġuntiva f'persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: 200 mg capsules Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
Maltese: 200 mg kapsuli Għatu u korp opaki ta' lewn oranġjo ċar, daqs tal-kapsula 1 (19.4 mm x 6.9 mm) mimlija bi trab ta' lewn abjad sa kważi abjad.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/011-017
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/011-017
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Maltese: Kienu msemmija l-episodji li ġejjin: nuqqas ta' rqad, uġigħ ta' ras, dardir, ansjetà, dijarea, sindrome tal-influwenza, nervożità, depressjoni, uġigħ, aċċessjoni, iperidrosi u sturdament, li jindika dipendenza fiżika.
English: The estimated infant dose from breast milk (assuming mean milk consumption of 150 ml/kg/day)of women receiving 300 mg/day or the maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively.
Maltese: Id-doża stmata tat-trabi mill-ħalib tas-sider (jekk wieħed jassumi medja ta' konsum ta' ħalib ta' 150 ml/kg/jum) ta' nisa li kienu qed jirċievu 300 mg/jum jew id-doża massima ta' 600 mg/jum tkun ta' 0.31 jew 0.62 mg/kg/jum, rispettivament.
English: 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
Maltese: Pakketti bil-folji: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) jew 120 (2 x 60) kapsula iebsa Pakketti bil-folji (doża tal-unità): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) jew 210 x 1 (3 x 70) kapsula iebsa.
English: Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules.
Maltese: Folji bid-doża tal-unità 14, 56, 84, 100 jew 210 (3 x 70) kapsula iebsa.
English: Rash papular, urticaria, hyperhidrosis, pruritus
Maltese: Raxx bl-infafet, urtikarja, iperidrosi, ħakk
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/031-033
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/031-033
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/054-056
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/054-056
English: 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.
Maltese: Fi provi kliniċi kkontrollati dwar uġigħ nevrotiku periferali, 35 % tal-pazjenti kkurati bi pregabalin u 18 % tal-pazjenti fuq il-plaċebo kellhom titjib ta' 50 % fil-punteġġ tal-uġigħ.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/063-068
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/063-068
English: Jaundice
Maltese: Suffejra
English: INFORMATION IN BRAILLE Pregabalin Sandoz 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 75 mg
English: 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.
Maltese: Għatu opak aħmar u korp opak ta' lewn isfar fil-kannella ċar, daqs tal-kapsula 0 (21.7 mm x 7.6 mm), mimlija bi trab ta' lewn abjad sa kważi abjad.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 150 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/034-041
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/034-041
English: SK-811 02 Bratislava Tel: + 421 2 48 200 600
Maltese: SK-811 02 Bratislava
English: Unit dose blisters containing 56, 84, 100 or 210 (3 x 70) hard capsules.
Maltese: Folji bid-doża tal-unità 56, 84, 100 jew 210 (3 x 70) kapsula iebsa.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 200 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 300 mg
English: Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Maltese: Folji li fihom 14, 21, 28, 56, 70, 84, 100 jew 120 kapsula iebsa.
English: Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Sandoz GmbH, Biochemiestrasse 10, A-6250
English: OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER
Maltese: KARTUNA TA' BARRA GĦALL-KONTENITUR U TIKKETTA GĦALL-KONTENITUR
English: Fertility
Maltese: Newtropenija
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in tmax to approximately 2.5 hours.
Maltese: Ir-rata ta' assorbiment ta' pregabalin tonqos meta jingħata mal-ikel biex tirriżulta fi tnaqqis ta' madwar 25-30 % fil-Cmax u dewmien fit-tmax ta' madwar 2.5 sigħat.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 100 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 225 mg ta' pregabalin.
English: 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).
Maltese: Ir-riżultati ta' studju ta' 12-il ġimgħa kkontrollat bil-plaċebo ta' 295 pazjent pedjatriku li kellhom bejn 4 u 16-il sena li sar biex jevalwa l-effikaċja u s-sigurtà ta' pregabalin bħala terapija aġġuntiva għall-kura ta' aċċessjonijiet ta' bidu parzjali u studju open label dwar issigurtà li dam sena, li sar fuq 54 pazjent pedjatriku li kellhom minn 3 xhur sa 16-il sena, bl-epilessija, jindikaw li l-avvenimenti avversi ta' deni u infezzjonijiet respiratorji fil-parti ta' fuq, ġew osservati b'mod aktar frekwenti milli fl-istudji li saru fuq l- adulti ta' pazjenti b'epilessija (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 225 mg kapsuli ibsin Pregabalin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/069-073
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/069-073
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 56 x 1 hard capsules
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 70 kapsula iebsa 56 x 1 kapsula iebsa
English: Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Maltese: Folji li fihom 14, 28, 56, 70, 84, 100 jew 120 kapsula iebsa.
English: 21 hard capsules 28 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Maltese: 21 kapsula iebsa 28 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: INFORMATION IN BRAILLE Pregabalin Sandoz 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 25 mg
English: 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.
Maltese: Pakketti bil-folji: 14, 21, 28, 56, 70, 84, 100 jew 120 kapsula iebsa Pakketti bil-folji (doża tal-unità): 14 x 1, 56 x 1, 84 x 1, 100 x 1 jew 210 x 1 (3 x 70) kapsula iebsa.
English: HDPE bottles containing 200 hard capsules.
Maltese: Fliexken tal-HDPE li fihom 200 kapsula iebsa.
English: In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
Maltese: Fl-istudji kliniċi fejn saru testijiet oftalmoloġiċi, l-inċidenza ta' tnaqqis tal-akutezza viżiva u bdil fil-kamp viżwali kienu aktar f'pazjenti fuq kura bi preglabalin milli f'pazjenti fuq plaċebo; linċidenza ta' bdil fundoskopiku kien ogħla minn f'pazjenti ttrattati bi plaċebo (Ara sezzjoni 5.1).
English: Neutropaenia
Maltese: Manifattur
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/081-083
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/081-083
English: INFORMATION IN BRAILLE Pregabalin Sandoz 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 50 mg
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 200 mg kapsuli ibsin Pregabalin
English: 14 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 70 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 120 kapsula iebsa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/053
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/053
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA [For outer carton only]
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM [Għall-kartuna ta' barra biss]
English: White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white coloured powder.
Maltese: Għatu u korp opaki ta' lewn abjad, daqs tal-kapsula 2 (18.0 mm x 6.4 mm), mimlija bi trab ta' lewn abjad sa kważi abjad.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules
Maltese: Pregabalin Sandoz 225 mg kapsuli ibsin
English: Unit dose blisters containing 84 x 1 hard capsules.
Maltese: Folji bid-doża tal-unità 84 x 1 kapsula, iebsa.
English: Blisters containing 21, 28, 84 or 100 hard capsules.
Maltese: Folji li fihom 21, 28, 84 jew 100 kapsula iebsa.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 75 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 100 mg kapsuli ibsin Pregabalin
English: Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests.
Maltese: Pregabalin mhux ġenotossiku skont ir-riżultati ta' sensiela ta' testijiet in vitro u in vivo.
English: If while taking Pregabalin Sandoz you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Maltese: Meta Pregabalin Sandoz tiġi meħuda ma' ċertu mediċini oħra, tista tqawwi l-effetti sekondarji li ntwerew b' dawn ilmediċini u li jinkludu insuffiċjenza respiratorja u koma.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 300 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 150 mg kapsuli ibsin Pregabalin
English: Unit dose blisters containing 84 or 100 hard capsules.
Maltese: Folji bid-doża tal-unità 84 jew 100 kapsula iebsa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 25 mg pregabalin.
English: How to store Pregabalin Sandoz
Maltese: Mediċini oħra u Pregabalin Sandoz
English: 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.
Maltese: Pakketti bil-folji: 14, 28, 56, 70, 84, 100 jew 120 kapsula iebsa Pakketti bil-folji (doża tal-unità): 56 x 1, 84 x 1 jew 100 x 1 kapsula iebsa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 200 mg ta' pregabalin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 50 mg pregabalin.
English: 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.
Maltese: Għatu u korp opaki ta' lewn isfar fil-kannella ċar, daqs tal-kapsula 4 (14.3 mm x 5.3 mm), mimlija bi trab ta' lewn abjad sa kważi abjad.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz is taken together with medicines containing:
Maltese: Il-livell ta' sturdament, irqad u konċentrazzjoni mnaqqsa jista' jiżdied jekk Pregabalin Sandoz jittieħed ma' mediċini li fihom:
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
Maltese: Billi t-tneħħija ta' pregabalin hija direttament proporzjonali mat-tneħħija talkreatinina (ara sezzjoni 5.2), it-tnaqqis fid-doża f'pazjenti b'funzjoni renali kompromessa jrid ikun individwalizzat skont it-tneħħija tal-kreatinina (CLcr), kif indikat f'Tabella 1 stabbilit billi tintuża lformula li ġejja:
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 50 mg kapsuli ibsin Pregabalin
English: It is advised not to drink alcohol while taking Pregabalin Sandoz.
Maltese: Huwa rakkomandat li wieħed ma jixrobx alkoħol waqt li jkun qed jieħu Pregabalin Sandoz.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules pregabalin
Maltese: Pregabalin Sandoz 25 mg kapsuli ibsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules
Maltese: Pregabalin Sandoz 200 mg kapsuli ibsin
English: • The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Maltese: • Id-doża, li tiġi aġġustata għalik u għall-kondizzjoni tiegħek, ġeneralment tkun bejn 150 mg u
English: ul.
Maltese: L/kg.
English: 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
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 70 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 120 kapsula iebsa 14 x 1 kapsula iebsa 56 x 1 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: Pregabalin Sandoz may produce dizziness, sleepiness and decreased concentration.
Maltese: Pregabalin Sandoz hu disponibbli fil-preżentazzjonijiet li ġejjin:
English: There are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Maltese: Tnaqqis fil-funzjoni gastrointestinali fil-parti t'isfel Kien hemm rapporti ta' episodji assoċjati mal-funzjoni gastrointestinali fil-parti t'isfel (eż. imblukkar tal-intestini, ileus paralitiku, stitikezza) fl-esperjenza ta' wara t-tqegħid fis-suq, meta pregabalin ġie mogħti flimkien ma' mediċini li għandhom potenzjal li jikkawżaw stitikezza, bhal analġesiċi opjojd.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 100 mg ta' pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules
Maltese: Pregabalin Sandoz 100 mg kapsuli ibsin
English: Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 hard capsules Container packs: 200 hard capsules
Maltese: Pakketti bil-folji: 14, 21, 28, 56, 84 jew 100 kapsula iebsa Pakketti bil-folji (doża tal-unità): 84 x 1 kapsula iebsa.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules
Maltese: Pregabalin Sandoz 150 mg kapsuli ibsin
English: • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
Maltese: • Bidla fil-mod kif tħares lejk innifsek, irrekwitezza, depressjoni, aġitazzjoni, bidliet fil-burdata, diffikulta' biex issib il-kelma, alluċinazzjonijiet, ħolm anormali, attakk ta' paniku, apatja, agressjoni, burdata ta' entużjażmu, indeboliment mentali, diffikulta' biex taħseb, żieda flinteress sesswali, problemi fil-funzjoni ta' natura sesswali li jinkludu inkapaċità li tilħaq orgażmu, dewmien fl-ejakulazzjoni.
English: Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.
Maltese: Folji li fihom 14, 21, 28, 56, 84 jew 100 kapsula iebsa.
English: 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
Maltese: 14-il kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 70 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 120 kapsula iebsa 56 x 1 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 75 mg ta' pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules
Maltese: Pregabalin Sandoz 75 mg kapsuli ibsin
English: 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
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 70 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 120 kapsula iebsa 56 x 1 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules.
Maltese: Pakketti bil-folji: 14, 21, 28, 56, 84 jew 100 kapsula ibsin Pakketti bil-folji (doża tal-unità): 84 x 1 jew 100 x 1 kapsula iebsa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 150 mg ta' pregabalin.
English: For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% of patients on placebo.
Maltese: Fil-każ tal-pazjenti li ma esperjenzawx ngħas, dan it-titjib kien osservat fi 33 % tal-pazjenti kkurati bi pregabalin u fi 18 % talpazjenti fuq il-plaċebo.
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Maltese: Edema periferali, edema, mixja anormali, waqgħat, sensazzjoni ta' wieħed fis-sakra, għeja,
English: Treatment of central neuropathic pain due to spinal cord injury In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
Maltese: Kura ta' uġigħ nevrotiku ċentrali minħabba leżjoni fil-korda spinali Fil-kura ta' uġigħ nevrotiku ċentrali minħabba leżjoni fil-korda spinali l-inċidenza ta' reazzjonijiet avversi b'mod ġenerali, reazzjonijiet avversi tas-sistema nervuża ċentrali u b'mod speċjali tan-ngħas żdiedet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TAL-IPPAKKJAR TA' BARRA FUQ MULTIPACKS IMKEBBIN ĠO FOLJA (INKLUŻ IL- KAXXA BLU)
English: 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.
Maltese: Għatu opak aħmar u korp opak abjad, daqs tal-kapsula 4 (14.3 mm x 5.3 mm), mimlija bi trab ta' lewn abjad sa kważi abjad.
English: 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.
Maltese: Għatu opak ta' lewn oranġjo ċar u korp opak abjad, daqs tal-kapsula 1 (19.4 mm x 6.9 mm), mimlija bi trab ta' lewn abjad sa kważi abjad.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules
Maltese: Pregabalin Sandoz 300 mg kapsuli ibsin
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 84 x 1 kapsula iebsa
English: 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
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 300 mg ta' pregabalin.
English: Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain
Maltese: Axxite, pankreatite, ilsien minfuħ, disfaġja Disturbi fil-fwied u fil marrara
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Sandoz than you should.
Maltese: Tista' tħossok bi ngħas, konfuż, aġitat, jew bla kwiet jekk tieħu Pregabalin Sandoz aktar milli suppost.
English: Epilepsy: Pregabalin Sandoz is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Maltese: Pregabalin Sandoz tintuża sabiex tiġi kkurata ċerta forma ta' epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl-adulti.
English: EU/1/15/1011/011-017 EU/1/15/1011/085
Maltese: EU/1/15/1011/085
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules
Maltese: Pregabalin Sandoz 25 mg kapsuli ibsin
English: • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances
Maltese: • Tibdil fir-riżultati elettriċi (ECG) tal-qalb li jirrifletttu disturbi fir-ritmu tal-qalb.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/030
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/030
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/084
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/084
English: It may harm them,
Maltese: L-effett ta' l-ikel fuq l-assorbiment mhux magħruf.
English: Immedica Pharma AB SE-113 29 Stockholm Sweden
Maltese: Immedica Pharma AB SE-113 29 Stockholm
English: Tablet.
Maltese: Pilloli.
English: Common: Depression, irritability
Maltese: Komuni: Dipressjoni, irritabilità
English: 250 tablets 500 tablets
Maltese: 250 pillola 500 pillola
English: AMMONAPS 500 mg tablets.
Maltese: AMMONAPS 500 mg pilloli.