FrancophonIA/ELRC3.0 huggingface dataset:
English: Ewopharma AG Representative Office Tel: + 40 377 881 045
Maltese: Ewopharma AG pārstāvniecība Tel: + 371 66 16 40 32
English: 104 Week 28.4% 28.1% 46.6% <0.001 <0.001 0.864 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il-persentaġġ ta' pazjenti li ma avvanzatilhomx il-marda (bidla mil-linja bażi fit-tibdil tal-Puteġġ Totali Sharp ≤ 0.5) kien sinifikament ogħla bit-terapija kombinata ta' adalimumab/methotrexate (63.8% u 61.2% rispettivament) meta pparagunat ma' kura b' methotrexate waħdu (37.4% u 33.5% rispettivament, p<0.001) u kura b'adalimumab waħdu (50.7%,
English: Imraldi 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Maltese: Imraldi 40 mg soluzzjoni għall-injezzjoni f'kunjett hija fornuta bħala soluzzjoni ta' 0.8 mL ċara u bla kulur.
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/ml during the induction period.
Maltese: F'pazjenti li għandhom kolite ulċerattiva, d-doża kbira ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 µg/mL matul il-perijodu tal-bidu .
English: Paraesthesias (including hypoesthesia), migraine, nerve root compression Uncommon Cerebrovascular accident1),
Maltese: Parasteżija (inkluża ipoestesija), emigranja, tagħfis fuq l-għerq tan-nerv
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Maltese: Rigward it-teħid flimkien ta' Imraldi ma' mediċini antirewmatiċi minbarra methotrexate li jaffettwaw il-proċess tal-mard, ara sezzjoni 4.4 u 5
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51 %) were in remission at week 52.
Maltese: Fi studju UC-II, min dawk il-pazjenti ttrattati b'adalimumab u li kellhom titjib kliniku f'ġimgħa 8, 21/41 (51 %) kellhom ukoll titjib kliniku f'ġimgħa 52.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Maltese: Id-dejta disponibbli tissuġġerixxi li r-rispons kliniku huwa normalment milħuq fi żmien 12il ġimgħa ta' trattament.
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ±
Maltese: Tfal u żgħażagħ minn 4 sa 17-il sena li jiżnu 30 kg jew aktar Id-doża rrakkomandata ta' Imraldi hija doża inizjali ta' 40 mg, segwita b' 40 mg wara ġimgħa li tibda l-ewwel doża.
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥40 kg, and 80 mg and 40 mg, respectively, for subjects <40 kg.
Maltese: Is-suġġetti kollha ngħataw kura tal-bidu open-label b'doża fuq bażi tal-linja bażi tal-piż tal-ġisem tagħhom: 160 mg f'Ġimgħa 0 u 80 mg f'Ġimgħa 2 għal suġġetti ≥ 40 kg, u 80 mg u 40 mg, rispettivament, għal suġġetti < 40 kg.
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg The recommended dose of Imraldi is an initial dose of 20 mg, followed by 20 mg one week later.
Maltese: Tfal u żgħażagħ minn 4 sa 17-il sena li jiżnu minn 15 kg sa inqas 30 kg Id-doża rrakkomandata ta' Imraldi hija doża inizjali ta' 20 mg, segwita b'20 mg wara ġimgħa li tibda l-ewwel doża.
English: In RA studies I-IV, adalimumab -treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Maltese: Fi Studi RA minn I-IV, pazjenti kkurati b'adalimumab laħqu risponsi statistikament sinifikanti għallACR 20 u 50 sa minn ġimgħa jew tnejn wara li nbdiet il-kura, meta pparagunati mal-plaċebo.
English: The usual dose of Imraldi is 40 mg every other week with methotrexate.
Maltese: Id-doża ta' Imraldi normalment hija 40 mg ġimgħa iva u ġimgħa le b'methotrexate.
English: years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Maltese: Studju RA I evalwa 271 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18-il sena, ma kinux irrispondew għal kura b'mill-inqas mediċina waħda anti-rewmatika li taffetwa l-proċess tal-mard u li kellhom effikaċja insuffiċjenti b'methotrexate f'dożi minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil-ġimgħa, u li d-doża ta' methotrexate tagħhom baqgħet kostanti minn 10 sa 25 mg fil-ġimgħa.
English: Paediatric ulcerative colitis
Maltese: Sarcoidosis infjammazzjoni vaskulari
English: Imraldi Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Maltese: Doża ta' Imraldi għal Pazjenti Pedjatriċi bil-Psorjasi tal-Plakka Piż tal-Pazjent
English: Imraldi is used to treat moderate to severe plaque psoriasis in adults.
Maltese: Imraldi huwa intenzjonat għall-kura ta' psorijasi tal-plakka moderata sa severa fl-adulti.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated patients.
Maltese: Il-proporzjon ta' pazjenti li waqt il-porzjoni kontrollata double-blind fl-istudji pivitali ma baqgħux jieħdu l-kura minħabba effetti avversi kien ta' 5.9% għall-pazjenti li kienu qegħdin jieħdu adalimumab u 5.4% għal pazjenti kkurati b'mod kontrollat.
English: Imraldi is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: Imraldi huwa indikat għat-trattament tal-marda attiva ta' Crohn (Crohn's diease) minn moderata sa severa fit-tfal (minn 6 snin 'il fuq) li ma kellhomx rispons kif mistenni għall-kura konvenzjonali inkluż terapija ta' nutrizzjoni primarja u kortikosterojde u/jew immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: Aftokratoros Nikolaou 2 Athens 17671
Maltese: Alapis ABEE Aftokratoros Nikolaou 2 Athens 17671
English: Kuhloweg 37
Maltese: KG Kuhloweg 37
English: FI-02200 Espoo,
Maltese: FI-02200
English: Sanofi-Aventis Zrt Tó utca 1-5, 1045 Budapest Hungary
Maltese: Sanofi-Aventis Zrt Tó utca 1-5, 1045
English: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Maltese: Orion Corporation, Orionintie 1, FI-02200
English: FERRO SACCARATO FME
Maltese: FERRO SACCARATO
English: Denmark Orion Corporation, Orionintie 1,
Maltese: Id-Danimarka Orion Corporation, Orionintie 1,
English: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
Maltese: Sandoz GmbH Biochemiestrasse 10 A-6250
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande,
Maltese: Farmoz - Sociedade Técnico Medicinal, S.A.
English: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy sodium ferric gluconate complex
Maltese: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy
English: Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351 Greece
Maltese: Alexander 121, Agia Varvara, 12351 Greece
English: Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex
Maltese: Il-Ġermanja Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany
English: Target Pharma Ltd Menandrou 54 Athens 10431
Maltese: Target Pharma Ltd Menandrou 54
English: PHARMABIDE LTD 20, Lakonias str, 15234 Halandri Athens - Greece
Maltese: LTD 20, Lakonias str, 15234
English: Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
Maltese: Karbossimaltożju Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
English: 92931 Paris La Défense Cedex
Maltese: TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex
English: IRON SUCROSE PHARMABIDE 20 MG/ML
Maltese: IRON SUCROSE PHARMABIDE 20
English: VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France
Maltese: VIFOR France SA 123 Rue Jules Guesde 92200
English: Concentrate for solution for infusion/solution for injection
Maltese: PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie
English: Luxembourg Medice Arzneimittel Pütter GmbH & Co KG
Maltese: Il-Lussemburgu Medice Arzneimittel Pütter GmbH & Co
English: FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
Maltese: INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħataw, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl
English: Lek Pharmaceuticals d.d.
Maltese: Alet Pharmaceuticals M.
English: 4230 Skaelskoer Denmark
Maltese: Alternova A/S Lodshusvej 11 4230 Skaelskoer Denmark
English: Germany Medice Arzneimittel Pütter GmbH & Co KG
Maltese: Medice Arzneimittel Pütter GmbH & Co
English: 14KM National Highway Athens-Lamia Kifissia 14564
Maltese: Uni-Pharma Kleon Tseitis Pharmaceutical Laboratories 14KM National Highway Athens-Lamia Kifissia 14564
English: Jerndextran "Pharmacosmos" 50mg/ml
Maltese: Jerndextran "Pharmacosmos"
English: Genericos Espanoles Laboratorio S.A.Cólquide, 6 - Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain
Maltese: Genericos Espanoles Laboratorio S.A.Cólquide, 6 - Portal 2,
English: Rafarm AEBE Korinthou 12, N. Psychiko, 15451 Greece
Maltese: Rafarm AEBE Korinthou 12, N.
English: Intermed ABEE Kalyftaki 27 Athens 14564 Greece
Maltese: Intermed ABEE Kalyftaki 27
English: Ferric carboxymaltose
Maltese: Karbossimaltożju ferriku
English: Luxembourg Pharmacosmos A/S Roervangsvej 30
Maltese: Il-Lussemburgu Pharmacosmos A/S Roervangsvej 30
English: Hungary
Maltese: Budapest Hungary
English: Solution for perfusion
Maltese: INYECTABLE O PARA PERFUSIÓN
English: Ireland VIFOR France SA 7-13 Boulevard Paul Emile Victor
Maltese: Ir-Rumanija VIFOR France SA 7-13 Boulevard Paul Emile Victor
English: Solution for infusion
Maltese: FERROLOGIC SOLUTION FOR
English: Ireland Pharmacosmos A/S Roervangsvej 30
Maltese: Ir-Rumanija Pharmacosmos A/S Roervangsvej 30
English: HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION
Maltese: HIERRO SACAROSA NORMON 20 mg/ml SOLUCION
English: Denmark Fresenius Medical Care Nephrologica Deutschland GmbH
Maltese: Id-Danimarka Fresenius Medical Care Nephrologica Deutschland GmbH
English: HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION
Maltese: HIERRO SACAROSA FME 20 mg/ml SOLUCION
English: Sodium ferric gluconate complex
Maltese: Kumpless ta' glukonat ferriku tassodju
English: Denmark Pharmacosmos A/S Roervangsvej 30
Maltese: Il-Ġermanja Pharmacosmos A/S Roervangsvej 30
English: Germany Pharmacosmos A/S Roervangsvei 30
Maltese: Il-Ġermanja Pharmacosmos A/S Roervangsvei 30
English: Luxembourg Fresenius Medical Care Nephrologica Deutschland GmbH
Maltese: Il-Lussemburgu Fresenius Medical Care Nephrologica Deutschland GmbH
English: Combination with CNS depressants
Maltese: Kombinazzjoni ma' depressanti tas-CNS
English: Do not exceed 10mg per 24 hours.
Maltese: Tiħux iktar minn 10mg f'24 siegħa.
English: Other medicines and [Invented name]
Maltese: Mediċini oħra u [Isem ivvintat]
English: • Medicines for epilepsy
Maltese: • Mediċini għall-epilessija
English: In a randomized double-blind trial in 462 non-elderly healthy volunteers with transient insomnia, zolpidem 10mg decreased the mean time to fall asleep by 10 minutes compared to placebo, while for 5mg zolpidem this was 3 minutes.
Maltese: Fi prova double-blind fejn 462 voluntier mhux anzjan f'saħħithom b'insomja temporanja ntgħażlu b'mod każwali, zolpidem 10mg naqqas il-medja tal-ħin biex wieħed jorqod b'10 minuti meta mqabbel ma' plaċebo, filwaqt li għal 5mg zolpidem il-ħin kien 3 minuti.
English: • Medicines for some mental health problems (antipsychotics)
Maltese: • Mediċini għal xi problemi ta' saħħa mentali (antipsikotiċi)
English: The recommended dose per 24 hours is 10 mg of [Invented Name].
Maltese: Id-doża rrakkomandata kull 24 siegħa hija 10 mg ta' [Isem Ivvintat].
English: The randomized trials only showed convincing evidence of efficacy of 10mg zolpidem.
Maltese: Il-provi li saru b'mod kawżali wrew evidenza konvinċenti ta' effikaċja bit-10mg ta' zolpidem biss.
English: Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines.
Maltese: Żieda fl-effett depressiv ċentrali tista' sseħħ f'każijiet ta' użu flimkien ma' mediċini antipsikotiċi (newrolettiċi), ipnotiċi, mediċini kontra l-ansjetà/sedattivi, sustanzi antidepressanti, analġesiċi narkotiċi, mediċini antiepilettiċi, anestetiċi u antiistamini sedattivi.
English: • Medicines for depressions
Maltese: • Mediċini għad-depressjoni
English: In a randomized double-blind trial in 114 non-elderly patients with chronic insomnia, zolpidem 10mg decreased the mean time to fall asleep by 30 minutes compared to placebo, while for 5mg zolpidem this was 15 minutes.
Maltese: Fi prova double-blind fejn 114-il pazjent mhux anzjan b'insomnja kronika ntgħażlu b'mod każwali, zolpidem 10mg naqqas il-medja tal-ħin biex wieħed jorqod bi 30 minuta meta mqabbel mal-plaċebo, filwaqt li għal 5mg zolpidem il-ħin kien 15-il minuta.
English: • Medicines used for anesthesia
Maltese: • Mediċini użati għall-anestesija
English: • Medicines for moderate to severe pain (narcotic analgesics)
Maltese: • Mediċini għal uġigħ minn moderat sa qawwi (analġeżiċi narkotiċi)
English: Also, isolated cases of visual hallucinations were reported in patients taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine.
Maltese: Ukoll, kienu rrappurtati każijiet iżolati ta' alluċinazzjonijiet viżwali f'pazjenti li kienu qed jieħdu zolpidem ma' antidepressanti fosthom bupropion, desipramine, fluoxetine, sertraline u venlafaxine.
English: • zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7);
Maltese: • zolpidem jittieħed f'perjodu ta' inqas minn 8 sigħat qabel wieħed jagħmel l-attivitajiet li jeħtieġu ħeffa mentali (ara sezzjoni 4.7);
English: • as a single intake,
Maltese: • f'darba,
English: In some patients, a lower dose of 5mg could be effective.
Maltese: F'xi pazjenti, doża aktar baxxa ta' 5mg tista' tkun effettiva.
English: • Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives antihistamines) While taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (hallucinations) It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
Maltese: Waqt li tkun qed tieħu zolpidem ma' antidepressanti inkluż bupropion, desipramine, fluoxetine, sertraline u venlafaxine, jista' jkun li inti tara affarijiet li mhumiex vera (alluċinazzjonijiet) Mhuwiex irrakkomandat li tieħu zolpidem ma' fluvoxamine jew ciprofloxacin.
English: When zolpidem was administrated with ranitidine or cimetidine, no significant pharmacokinetic interactions were observed.
Maltese: Meta zolpidem ingħata ma' ranitidine jew cimetidine, ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi sinifikanti.
English: • Medicines for sleep problems (hypnotics)
Maltese: • Mediċini għal problemi tal-irqad (ipnotiċi)
English: Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness and impaired driving the morning after therapy (see section 4.8).
Maltese: Sewwieqa ta' vetturi u persuni li jħaddmu magni għandhom jiġu mwissija li, kif jiġri b'mediċini ipnotiċi oħra, jista' jkun hemm riskju possibbli ta' ħedla, ħin ta' reazzjoni imdewwem, sturdament, ngħas, vista mċajpra/doppja u nuqqas ta' ħeffa mentali u sewqan indebolit l-għodwa ta' wara t-terapija (ara sezzjoni 4.8).
English: Furthermore, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviours (see section 4.4 and 4.5).
Maltese: Barra dan, l-għoti ta' zolpidem mal-alkoħol u depressanti oħra tas-CNS iżid ir-riskju ta' mġiba bħal dawn (ara sezzjoni 4.4 u 4.5).
English: • zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs (see section 4.5).
Maltese: • zolpidem jingħata flimkien ma' dipressanti oħra tas-CNS jew ma' mediċini oħra li jżidu l-livelli ta' zolpidem fid-demm, jew mal-alkoħol jew drogi illegali (ara sezzjoni 4.5).
English: [Invented Name] should be taken:
Maltese: [Isem Ivvintat] għandu jittieħed:
English: Other drugs [When present in the current SmPC, the following sentence should be modified to remove reference to cimetidine]
Maltese: Mediċini oħra [Fejn tkun preżenti fl-SmPC attwali, is-sentenza li ġejja għandha tiġi modifikata biex titneħħa rriferenza għal cimetidine]
English: Next-day psychomotor impairment The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:
Maltese: L-għada li tieħu [Isem ivvintat], ir-riskju ta' indeboliment psikomotorju, inkluż l-indeboliment fil-ħila li ssuq, jista' jiżdied jekk:
English: On the day after taking [Invented Name] (as other hypnotic medicines), you should be aware that:
Maltese: Fil-jum ta' wara li tieħu [Isem Ivvintat] (bħal mediċini ipnotiċi oħra), inti għandek tkun konxju li:
English: • You may feel drowsy, sleepy, dizzy or confused
Maltese: • Tista' tħossok imħeddel/la, bi ngħas, stordut/a jew konfuż/a
English: Therefore, concomitant use of zolpidem with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability (see section 4.4 and section 4.7).
Maltese: Għalhekk, l-użu ta' zolpidem flimkien ma' dawn il-mediċini jista' jżid il-ħedla u l-indeboliment psikomotorju l-jum ta' wara, inkluż l-indeboliment fil-ħila biex issuq (ara sezzjoni 4.4 u sezzjoni 4.7).
English: Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness.
Maltese: Aċċerta ruħek li għandek perjodu ta' mill-inqas 8 sigħat wara li tieħu din il-mediċina qabel ma inti tagħmel attivitajiet li jeħtiġu li tkun pront mentalment.
English: In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8).
Maltese: Sabiex jitnaqqas ir-riskju, il-pazjenti għandhom jaċċertaw ruħhom li se jkunu jistgħu jorqdu mingħajr interruzzjoni għal 8 sigħat sħaħ (ara sezzjoni 4.8).
English: • You take zolpidem while you are already taking another central nervous system depressants or another medicines that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances Take the single intake immediately at bedtime.
Maltese: • Inti tieħu zolpidem waqt li tkun diġà qed tieħu depressanti oħra tas-sistema nervuża ċentrali jew mediċini oħra li jżidu zolpidem fid-demm tiegħek, jew waqt li tixrob l-alkoħol jew waqt li tieħu sustanzi illegali.
English: • just before bedtime
Maltese: • Tista' tkun inqas pront mentalment
English: Do not drink alcohol or take other psychoactive substances while you are taking [Invented Name], as it can increase the above listed effects
Maltese: Tixrobx alkoħol u tiħux sustanzi psikoattivi oħra waqt li tkun qed tieħu [Isem Ivvintat], minħabba li huwa jista' jżid l-effetti elenkati fuq.
English: 16 mg Implant
Maltese: 16 mg Impjant
English: Subcutaneous use vial (glass)
Maltese: Użu għal taħt il-ġilda kunjett (tal-ħġieġ)
English: See sections 4.3, 4.4 and 4.8.
Maltese: Ara sezzjonijiet 4.3, 4.4 u 4.8.
English: Pennsylvania 19486
Maltese: West POINT, Pennsylvania 19486
English: Common (≥1/100 to, <1/10)
Maltese: (≥1/100 sa, <1/10)
English: 69007 Lyon France
Maltese: 69007 LYON
English: Booster:
Maltese: Doża booster:
English: 2031 BN Haarlem The Netherlands
Maltese: 2031 BN Haarlem, L-Olanda
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Maltese: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon
English: Merck Sharp & Dohme B.V. Waaderweg 39, 2031 BN Haarlem The Netherlands
Maltese: MERCK Sharp & Dohme B.V Waaderweg 39, 2031 BN Haarlem L-Olanda
English: Date of last renewal: 17/03/2011
Maltese: Data tal-aħħar tiġdid: 17/03/2011
English: Pack size of 1, 10, 20, 50.
Maltese: Pakkett ta' 1, 10, 20, 50.
English: Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope
Maltese: Parestesija, Paralisi (inkluż paralisi ta' Bell, paralisi tal-wiċċ), Newropatiji periferali (poliradikulonevrite, Sindrome ta' Guillain Barre), Nevrite (tinkludi nevrite ottika), Mjelite (tinkludi mjelite transversa), Enċefalite, Mard ta' demjelinizzazzjoni tas-sistema nervuża, Taħrix tal-isklerożi multipla, Sklerożi multipla, Aċċessjoni, Uġigħ ta' ras, Sturdament, Sinkope
English: Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95 % as compared to the infection rate in untreated historical controls.
Maltese: Fost 130 tarbija mlaqqma, l-effikaċja stmata fil-prevenzjoni ta' infezzjoni kronika b'epatite B kienet ta' 95% meta mqabbla mar-rata ta' infezzjoni f'kontrolli storiċi mhux ikkurati.
English: (see section 6.)
Maltese: (ara sezzjoni 6).
English: Limited
Maltese: Health) Limited
English: Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01
Maltese: Kategorija farmakoterapewtika: anti-infettiv, Kodiċi ATC:
English: In two infant trials using different dosing schedules and concomitant vaccines, the proportion of infants with protective levels of antibodies were 97.5 % and 97.2 % with geometric mean titres of 214 and 297 IU/l, respectively.
Maltese: F'żewġ provi fuq it-trabi blużu ta' skedi differenti ta' dożaġġ u tilqim fl-istess ħin, il-proporzjon ta' trabi b'livelli protettivi ta' antikorpi kienu ta' 97.5% u 97.2% b'titri medji ġeometriċi ta' 214 u 297 IU/l, rispettivament.
English: Ireland Merck Sharp & Dohme Ireland (Human Health)
Maltese: Merck Sharp & Dohme Ireland (Human
English: Tel.: +48.22.549.51.00 msdpolska@merck.com
Maltese: +48.22.549.51.00 msdpolska@merck.com
English: PC SN NN
Maltese: SN NN
English: Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours.
Maltese: Ħruġ multiplu kumulattiv bejn 0°C u 2°C huwa permess ukoll sakemm ilħin totali bejn 0°C u 2°C ma jaqbiżx 72 siegħa.
English: Sodium chloride, borax and water for injections.
Maltese: Sodium chloride, borax u ilma għall-injezzjonijiet.
English: Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa
Maltese: Disturbi fis-sistema immuni Mard tas-serum, Anafilassi, Polyarterite nodosa