FrancophonIA/ELRC3.0 huggingface dataset:
English: Statistically significant reductions in white blood cell (WBC) count were observed in the controlled studies at 24 hours post-injection, from a mean value of 8.9 to a mean value of 8.0 (× 103/mm3), but remained within the normal range, and returned to their pre-injection values by the time of the next measurement at 10 days.
Maltese: Kien hemm nuqqas fic-celluli bojod tad-demm (white blood cells WBC) 24 siegha wara l-injezzjoni minn medja ta' 8.9 ghal 8.0 (x 103/mm3) imma baqghu fin-normal u gew lura ghal li kienu 10 ijiem wara l-injezzjoni.
English: 4.9 Overdose
Maltese: .2 Inkompatibilitajiet
English: LeukoScan is contraindicated in pregnancy.
Maltese: Leukoscan huwa ippreparat ghal injezzjoni wahda.
English: Store in a refrigerator (2°C-8°C).
Maltese: Zomm f'temperatura bejn 2°C u 8°C.
English: Lactation
Maltese: Treddigh
English: The product is more sensitive (93.9% vs. 80.6%), but less specific (51.6% vs. 72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis.
Maltese: 6%) imma inqas specifiku (51.6% vs 72.9%) f'pazjenti diabetici b'ulceri f'riglejhom milli f'pazjenti b'infezzjonijiet fl-ghadam it-twal.
English: For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv.
Maltese: Ghal hafna mill-investigazzjonijiet tal-medicina nuklejari, id-dosa hija inqas minn 20 mSv.
English: In 49.7% of the patients, LeukoScan was presumed to provide clinical benefit not achievable by other available diagnostic imaging methods, with the potential that the diagnosis could have been made by LeukoScan alone in 70.3% of the patients.
Maltese: Jidher ukoll illi Leukoscan ta' informazzjoni li ma setghux jaghtu metodi ohrajn u d-dijanjosi setghat saret bil-Leukoscan wahdu fi 70.3% tal-pazjenti.
English: The effect on lymphocyte
Maltese: QABEL MA TUZA LEUKOSCAN
English: Average Dose µGy/MBq
Maltese: Oqgħod attent ħafna b'Leukoscan
English: For diagnostic nuclear medicine investigations, the current evidence suggests that the adverse effects will occur with low frequency because of the low radiation doses incurred.
Maltese: Ghal investigazzjonijiet tal-medicina nuklejari, jidher illi effetti mhux mixtieqa jigru b'frekwenza baxxa minhabba id-dosa baxxa ta' radjazzjoni.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Maltese: Leukoscan 0.31 mg, trab ghal soluzzjoni ghall-injezzjoni (sulesomab)
English: Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein.
Maltese: Ftit minuti wara li il-Leukoscan jithallat mas-sustanza radjuattiva technetium, it-tabib itik l-injezzjoni.
English: EXPIRY DATE
Maltese: Iz-zieda
English: Planar imaging in all views necessary to adequately visualise the affected area at 1-8 h post-injection with at least 500 k counts or ten minutes per view should be made.
Maltese: Ritratti planari huma necessjari biew jigu viswalizzati il-partijiet li qed jigu studjati u ghandhom jittiehdu mill inqas 500 elf kolp jew ghaxar minuti kul ritratt.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Maltese: STRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI
English: Name and address of the manufacturer(s) of the biological active substance(s) Immunomedics, Inc.
Maltese: Immunomedics, Inc.
English: Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [99mTc].
Maltese: Ezatt qabel l-uzu, il-kontenut tal-fjala jigu rikonstitwiti fil-forma ta' Leukoscan (Tc99m).
English: (77.5% vs. 75.8%, respectively).
Maltese: Minkejja dan, l-akkuratezza hija simili fiz-zewg gruppi (77.5% vs 75.8%).
English: The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection.
Maltese: L-antibody jorbot ma wicc ic-celluli bojod tad-demm li jkunu fil-parti infettata.
English: LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Maltese: Leukoscan qatt ma ntuza ghad-dijanjosi ta' infezzjoni f'pazjenti bl-anemija mediterranja.
English: Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended.
Maltese: Matrix ta' 128 x 128 huwa rrakomandat
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Quality control
Maltese: GĦAMLA KWALITATTIVA
English: Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
Maltese: Ghal dan il-prodott mediku, id-doza ekwivalenti effettiva ghal attivita' somministrata ta' 750MBq hija tipikament 7.7 mSv f'persuna li tizen 70 kg Technetium (tc99m) jiddisintegra b'emissjoni ta' raggi gamma b'energija ta' 140 keV u half life ta' 6 sieghat ghal technetium (tc99) li huwa stabbli.
English: The radiolabelled product should not contain more than 10% free technetium.
Maltese: M'ghandux ikun hemm izjed minn 10% mhux marbut.
English: After radiolabelling the antibody and diluting a 10 µl sample with 1.5 ml saline, immediately determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent.
Maltese: Wara li jigi ppreparat, il-purezza radjukimika ghandha tigi ddeterminata b' Instant Thin Layer Chromatography fuq gel tas-silica fuq fiibri tal-hgieg.
English: LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic
Maltese: Leukoscan jintuza biex jittiehdu ritratti biex tigi ddterminata il-post u l-estent ta' infezzjoni/infjammazzjoni fl-ghadam it-twal f'pazjenti b'infezzjoni fl-ghadam, inkluz dawk il-pazjenti li ghandhom problemi f'riglejhom minhabba l-mard tad-dijabete.
English: This medicine
Maltese: U KWANTITATTIVA
English: LeukoScan is not expected to bind to leukocytes in patients with paroxysmal nocturnal hemoglobinuria.
Maltese: VO4D Fil-kwantitajiet li tintuza, Leukoscan ma tidhirx li ghandha effett farmakodinamiku.
English: 15 September 2017 EMA/589782/2017 EMEA/H/C/4419
Maltese: 15 ta' Settembru 2017 EMA/589782/2017
English: What is Tigecycline Accord?
Maltese: X'inhu Tigecycline Accord?
English: Tigecycline Accord is an antibiotic medicine that contains the active substance tigecycline.
Maltese: Tigecycline Accord huwa mediċina antibijotika li fiha s-sustanza attiva tigeċiklina.
English: The active substance in Tigecycline Accord and Tygacil, tigecycline, is one of a group of antibiotics called ‘glycylcyclines'.
Maltese: Is-sustanza attiva f'Tigecycline Accord u Tygacil, it-tigeċiklina, hija waħda minn grupp ta' antibijotiċi msejħa ‘gliċilċiklini'.
English: Tigecycline Accord was developed as a ‘generic medicine'.
Maltese: Tigecycline Accord kien żviluppat bħala ‘mediċina ġenerika'.
English: On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.
Maltese: Fit-12 ta' Settembru 2017, Accord Healthcare Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Tigecycline Accord, għall-kura ta' ċerti infezzjonijiet ikkumplikati.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Tygacil, and did not need to be repeated for Tigecycline Accord.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi approvati bil-mediċina ta' referenza, Tygacil, u ma kellhomx għalfejn jiġu ripetuti għal Tigecycline Accord.
English: Tigecycline Accord was expected to be used to treat adults and children older than 8 years with complicated infections of the skin and soft tissue (the tissue below the skin), except foot infections in people with diabetes.
Maltese: Tigecycline Accord kien mistenni li jintuża għall-kura ta' adulti u ta' tfal ta' aktar minn 8 snin b'infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab (it-tessut ta' taħt il-ġilda), minbarra infezzjonijiet fis-saqajn f'persuni bid-dijabete.
English: It was intended for use only when other antibiotics were not suitable.
Maltese: Kien maħsub biex jintuża biss meta antibijotiċi oħra ma jkunux adattati.
English: The CHMP's main concern was lack of compliance with Good Manufacturing Practice (GMP) by the manufacturing site for the medicine's active substance.
Maltese: It-tħassib ewlieni tas-CHMP kien in-nuqqas ta' konformità mal-Prassi Tajba ta' Manifattura (GMP) missit tal-manifattura għas-sustanza attiva tal-mediċina.
English: There was no need for ‘bioequivalence' studies to investigate whether Tigecycline Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' ‘bijoekwivalenza' biex jiġi investigat jekk Tigecycline Accord jiġix assorbit b'mod simili bħall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fiddemm.
English: Because the medicine blocks the production of new proteins, the bacteria cannot multiply and they eventually die.
Maltese: Minħabba li l-mediċina timblokka lproduzzjoni ta' proteini ġodda, il-batterji ma jkunux jistgħu jimmultiplikaw u eventwalment imutu.
English: What was Tigecycline Accord expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Tigecycline Accord?
English: 1407 София
Maltese: 1407 София Teл.:
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Maltese: *Żieda fl- alanine aminotransferase (ALT) u żieda fl- aspartate aminotransferase (AST).
English: 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
Maltese: Pregabalin Sandoz GmbH 25 mg kapsuli ibsin Pregabalin Sandoz GmbH 50 mg kapsuli ibsin Pregabalin Sandoz GmbH 75 mg kapsuli ibsin Pregabalin Sandoz GmbH 100 mg kapsuli ibsin Pregabalin Sandoz GmbH 150 mg kapsuli ibsin Pregabalin Sandoz GmbH 200 mg kapsuli ibsin Pregabalin Sandoz GmbH 225 mg kapsuli ibsin Pregabalin Sandoz GmbH 300 mg kapsuli ibsin Pregabalin
English: Container packs: 200 hard capsules
Maltese: Pakketti bil-kontenituri: 200 kapsula iebsa
English: Εθνική Οδός No 1 (12ο km) Μεταμόρφωση GR-144 51 Αθήνα Τηλ: +30 210 2811712
Maltese: Εθνική Οδός No 1 (12ο km) Μεταμόρφωση GR-144 51
English: Creatinine clearance (CLcr) (mL/min)
Maltese: Tneħħija tal- krejatinina (CLcr) (mL/min)
English: Rīga, LV1010 Tel: + 371 67892006
Maltese: Tel: + 371 67892006
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva gћas-sustanza attiva jew gћal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules.
Maltese: U KONTENUT Multipack: 210 x 1 (3 pakketti ta' 70 x 1) kapsuli ibsin.
English: Rare: may affect up to 1 in 1,0000 people
Maltese: Rari: jistgħu jaffettwaw sa persuna 1 minn kull 1,000
English: • When Pregabalin Sandoz GmbH is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Maltese: • Meta Pregabalin Sandoz GmbH tkun qed tittieħed ma' mediċini oħrajn li jikkawżaw listitikezza (bħal ċerti tipi ta' mediċini li jingħataw għall-uġigħ) jista' jkun possibli li jkun hemm problemi gastroinestinali (eż. stitikezza, imsaren imblukkati jew paralizzati).
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Maltese: Is-sustanza attiva, pregabalin, hija gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
English: HDPE bottles containing 100, 200 or 250 hard capsules.
Maltese: Pakketti bil-kontenituri: 100, 200 jew 250 kapsula iebsa.
English: The active substance, pregabalin, is a gamma-aminobutyric- acid analogue [(S)-3-(aminomethyl-5-methylhexanoic acid].
Maltese: Is-sustanza attiva, pregabalin, hija gamma-aminobutyric-acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
English: Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Maltese: Billi pregabalin jitneħħa fil-parti l-kbira mhux mibdul fl-awrina, jgħaddi minn metaboliżmu negliġibbli fin-nies (< 2 % ta' doża tkun irkuprata fl-awrina bħala metaboliti), ma jostakolax ilmetaboliżmu tal-mediċina in vitro, u ma jeħilx mal-proteini tal-plasma, mhux probabbli li jipproduċi, jew ikun suġġett għal, interazzjonijiet farmakokinetiċi.
English: Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Maltese: L-amministrazzjoni ta' pregabalin mal-kontraċettivi orali norethisterone u/jew ethinyl oestradiol ma tinfluwenzax il-farmakokinetika stabbli ta' xi waħda mis-sustanzi.
English: • Hepatitis (inflammation of the liver).
Maltese: • Insuffiċjenza tal-fwied • Epatite (infjammazzjoni tal-fwied).
English: Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Sandoz GmbH huwa indikat għall-kura tad-Disturb ta' Ansjetà Ġeneralizzata (GADGeneralised Anxiety Disorder) f'persuni adulti.
English: Österreich Sandoz GmbH Biochemiestr.
Maltese: Sandoz GmbH Biochemiestrasse 10
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz GmbH normally except if you have problems with your kidneys.
Maltese: Jekk int pazjent anzjan ('il fuq minn 65 sena), inti għandek tieħu Pregabalin Sandoz GmbH b'mod normali ħlief jekk ikollok problemi bil-kliewi.
English: 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.
Maltese: Il-persentaġġ ta' suġġetti li kellhom tal-inqas tnaqqis ta' 50% fl-aċċessjonijiet ta' bidu parzjali kkomparat mal-linja bażi kien ta' 40.6% mis-suġġetti kkurati bi pregabalin 10mg/kg/jum (p=0.0068 kontra l-plaċebo), 29.1% ta' suġġetti kkurati b'pregabalin 2.5mg/kg/jum (p=0.2600 kontra l-plaċebo) u 22.6% ta' dawk li kienu qed jirċievu l-plaċebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/001-010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/001-010
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Maltese: Kura kontra l-epilessija, kura oħra kontra l-epilessija Kodiċi ATC:
English: Withdrawal symptoms
Maltese: Rappurtar tal-effetti sekondarji
English: [For outer carton only]
Maltese: [Għall-kartuna ta'barra biss]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/011-017
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/011-017
English: Pregabalin Sandoz GmbH may be taken with oral contraceptives.
Maltese: Pregabalin Sandoz GmbH jista' jittieħed ma' kontraċettivi orali.
English: Jaundice
Maltese: BŻONN
English: 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.
Maltese: Il-profil tas-sigurtà ta' pregabalin osservat fi tliet studji pedjatriċi f'pazjenti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja (studju ta' 12-il ġimgħa dwar l-effikaċja u s-sigurtà f'pazjenti b'aċċessjonijiet ta' bidu parzjali, n = 295; studju farmakokinetiku u tollerabilità, n = 65; u studju dwar is-sigurtà open label follow on, n = 54, li dam sena) kien simili għal dik osservata flistudji fuq l-adulti ta' pazjenti b'epilessija.
English: 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).
Maltese: L-avvenimenti avversi l-aktar komuni li ġew osservati flistudju ta' 12-il ġimgħa b'kura bi pregabalin kienu ngħas, deni, infezzjoni fl-apparat respiratorju ta' fuq, żieda fl-aptit, żieda fil-piż, u nasofarinġite (ara sezzjonijiet 4.2, 5.1 u 5.2).
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: 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: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/057-062
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/057-062
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/042-052
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/042-052
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/074-076
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/074-076
English: 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).
Maltese: L-inċidenza ta' reazzjonijiet avversi b'mod ġenerali, reazzjonijiet avversi relatati mas-sistema nervuża ċentrali u b'mod speċjali n-ngħas żdiedet fil-kura ta' uġigħ newropatiku ċentrali dovut għal korriment tal-korda spinali (ara sezzjoni 4.4).
English: Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Maltese: Pregabalin Sandoz GmbH huwa indikat bħala terapija aġġuntiva f'persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/018-029
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/018-029
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 225 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 225 mg
English: Unit dose blisters containing 84 x 1 hard capsules.
Maltese: Folji bid-doża tal-unità 84 x 1 kapsula iebsa.
English: Marketing Authorisation Holder Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Sandoz GmbH, Biochemiestrasse 10, A-6250
English: 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.
Maltese: Fl-istudju kkontrollat bi plaċebo ta' 12-il ġimgħa, il-pazjenti pedjatriċi ġew assenjati għal pregabalin 2.5 mg/kg/jum (massimu, 150 mg/jum), pregabalin 10 mg/kg/jum (massimu, 600 mg/jum), jew ilplaċebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/018-033
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/018-033
English: How to take Pregabalin Sandoz GmbH
Maltese: Tiħux Pregabalin Sandoz GmbH:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/063-068
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/063-068
English: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain.
Maltese: Il-farmakokinetiċi stabbli ta' pregabalin huma simili f'voluntiera b'saħħithom, f'pazjenti bl-epilessija li jkunu qegħdin jieħdu mediċina kontra l-epilessija u pazjenti b'uġigħ kroniku.
English: Camberley, GU16 7SR, UK Tel: + 44 1276 698020 uk.regaffairs@sandoz.com
Maltese: United Kingdom Sandoz Limited Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/031-033
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/031-033
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/054-056
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/054-056
English: Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules Blister packs (unit dose): 84 x 1 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: If while taking Pregabalin Sandoz GmbH you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Maltese: Meta Pregabalin Sandoz GmbH tiġi meħuda ma' ċertu mediċini oħra, tista tqawwi l-effetti sekondarji li ntwerew b' dawn il-mediċini u li jinkludu insuffiċjenza respiratorja u koma.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/069-083
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/069-083
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 75 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/069-073
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/069-073
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 200 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 300 mg
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 150 mg
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz GmbH is taken together with medicines containing:
Maltese: Il-livell ta' sturdament, irqad u konċentrazzjoni mnaqqsa jista' jiżdied jekk Pregabalin Sandoz GmbH jittieħed ma' mediċini li fihom:
English: What is in this leaflet:
Maltese: Disturb ta' Ansjetà Ġeneralizzata:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/081-083
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/081-083
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz GmbH 100 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/034-041
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1012/034-041
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: 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.