FrancophonIA/ELRC3.0 huggingface dataset:
English: Granules For Oral Suspension
Maltese: Granuli Għal Sospensjoni Orali
English: Gastro-Resistant Tablet
Maltese: Pillola Gastroreżistenti
English: Diplococcus Pneumoniae Type I 6000 Milli I.U.
Maltese: Diplococcus Pneumoniae Tip I 6000
English: Streptococcus Agalactiae 1 Giga Units Tablet, Haemophilus Influenzae 1.5 Giga Units Tablet, Staphylococcus Aureus 1 Giga Units Tablet, Streptococcus Pneumoniae 1 Giga Units Tablet
Maltese: Streptococcus Agalactiae 1 Unità Giga Pillola, Haemophilus Influenzae 1.5 Unitajiet Giga Pillola, Staphylococcus Aureus 1 Unità Giga Pillola, Streptococcus Pneumoniae 1 Unità Giga Pillola
English: Nasal Drops, Suspension
Maltese: Taqtir tal-Ħalq, Sospensjoni
English: Lysatum Bacteriale Mixtum 3mg Tablet
Maltese: Lysatum Bacteriale Mixtum 3mg Pillola
English: Haemophilus Influenzae Type B (Hib) 1.25 Giga Cells / 50mg, Branhamella Catarrhalis Lysate 1.25 Giga Cells / 50mg, Klebsiella Pneumoniae (Inactivated) 1.25 Giga Cells / 50mg, Staphylococcus Aureus Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pneumoniae Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pyogenes Inactivated Bacteria 1.25 Giga Cells / 50mg
Maltese: Haemophilus Influenzae Tip B (Hib) 1.25 Ċelloli Giga / 50mg, Lisat ta' Branhamella Catarrhalis 1.25 Ċelloli Giga / 50mg, Klebsiella Pneumoniae (Inattivat) 1.25 Ċelloli Giga / 50mg, Staphylococcus Aureus Batterja Inattivati 1.25 Ċelloli Giga / 50mg, Streptococcus Pneumoniae Batterja Inattivati 1.25 Ċelloli Giga / 50mg, Streptococcus Pyogenes Batterja Inattivati 1.25 Ċelloli Giga / 50mg
English: Tablet, Staphylococcus Aureus 6000 Milli I.U.
Maltese: Pillola, Staphylococcus Aureus 6000
English: Lysatum Bacteriale Mixtum 3.5mg Capsule
Maltese: Lysatum Bacteriale Mixtum 3.5mg Kapsula
English: Haemophilus Influenzae Type B (Hib) 0.625 Giga Cells / 25mg, Branhamella Catarrhalis Lysate 0.625 Giga Cells / 25mg, Klebsiella Pneumoniae (Inactivated) 0.625 Giga Cells / 25mg, Staphylococcus Aureus Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pneumoniae Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pyogenes Inactivated Bacteria 0.625 Giga Cells / 25mg
Maltese: Haemophilus Influenzae Tip B (Hib) 0.625 Ċelloli Giga / 25mg, Lisat ta' Branhamella Catarrhalis 0.625 Ċelloli Giga / 25mg, Klebsiella Pneumoniae (Inattivat) 0.625 Ċelloli Giga / 25mg, Staphylococcus Aureus Batterja Inattivati 0.625 Ċelloli Giga / 25mg, Streptococcus Pneumoniae Batterja Inattivati 0.625 Ċelloli Giga / 25mg, Streptococcus Pyogenes Batterja Inattivati 0.625 Ċelloli Giga / 25mg
English: Lysatum Bacteriale Mixtum 7mg Capsule
Maltese: Lysatum Bacteriale Mixtum 7mg Kapsula
English: Broncho-Vaxom Lysatum Bacteriale Mixtum 7mg Capsule
Maltese: Broncho-Vaxom Lysatum Bacteriale Mixtum 7mg Kapsula
English: Proteoglycanes Of Klebsiella Pneumoniae 1.125mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70% Rna) 0.75mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet
Maltese: Proteoglikani ta' Klebsiella Pneumoniae 1.125mg Qartas, Frazzjonijiet Ribożomali (Ribożomi b'Titer ta' 70% Rna) 0.75mg Qartas, Ribożomi Ta' Haemophilus Influenzae 5 Unitajiet Qartas, Ribożomi Ta' Streptococcus Pneumoniae 30 Unità Qartas, Frazzjonijiet Ribożomali ta' Klebsiella Pneumoniae 35 Unità Qartas, Ribożomi Minn Streptococcus Pyogenes Gropp A 30 Unità Qartas
English: Tablet, Streptococcus Pyogenes 6000 Milli I.U.
Maltese: Pillola, Streptococcus Pyogenes 6000
English: Lysatum Bacteriale Mixtum 3.5mg Sachet
Maltese: Lysatum Bacteriale Mixtum 3.5mg Qartas
English: Escherichia Coli (Inactivated) 2 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 1 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 5 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 5 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 1 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 1 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 2 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 1 Mega Cells / Ml
Maltese: 2 Ċelloli Mega / Ml, Klebsiella Pneumoniae (Inattivat) Ċellola 1 Mega / Ml, Staphylococcus Aureus Batterja Inattivati 5 Ċelloli Mega / Ml, Staphylococcus Epidermidis Batterja Inattivati 5 Ċelloli Mega / Ml, Streptococcus Salivarius Batterja Inattivati Ċellola 1 Mega / Ml, Streptococcus Pneumoniae Batterja Inattivati Ċellola 1 Mega / Ml, Streptococcus Pyogenes Batterja Inattivati Ċellola 1 Mega / Ml, Haemophilus Influenzae Batterja Inattivati Ċellola 1 Mega / Ml, Corynebacterium Pseudodiphtheriticum Batterja Inattivati 2 Ċelloli Mega / Ml, Moraxella Catarrhalis Batterja Inattivati Ċellola 1 Mega / Ml
English: Tablet, Streptococcus Viridans 6000 Milli I.U.
Maltese: Pillola, Streptococcus Viridans 6000
English: Abiogen Pharma S.P.A.
Maltese: Abiogen Pharma
English: Oral Powder
Maltese: Trab Orali
English: Annex I List of nationally authorised medicinal products
Maltese: Lista tal-prodotti mediċinali awtorizzati b'mod nazzjonali
English: Haemophilus Influenzae Type B (Hib) 50.2agu/Ml, Klebsiella Pneumoniae 39.8agu/Ml, Staphylococcus Aureus 79.6agu/Ml, Streptococcus Pneumoniae 63.2agu/Ml, Streptococcus Pyogenes 126.2agu/Ml, Moraxella Catarrhalis 39.9agu/Ml
Maltese: Haemophilus Influenzae Tip B (Hib) 50.2agu/Ml, Klebsiella Pneumoniae 39.8agu/Ml, Staphylococcus Aureus 79.6agu/Ml, Streptococcus Pneumoniae 63.2agu/Ml, Streptococcus Pyogenes 126.
English: Luxembourg Daiichi Sankyo Europe Gmbh
Maltese: Il-Lussemburgu Daiichi Sankyo Europe Gmbh
English: Lyophilized Bacterial Lysates 7mg Tablet
Maltese: Lisati Batteriċi Lijofilizzati 7mg Pillola
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet
Maltese: Broncho-Vaxom Lisati Batteriċi Lijofilizzati 3.5mg Qartas
English: Oral Drops, Suspension
Maltese: Sospensjoni Orali
English: Tablet, Neisseria Catarrhalis 6000 Milli I.U.
Maltese: Pillola, Neisseria Catarrhalis 6000
English: Glycine 43mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Viridans 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50mg Tablet
Maltese: Glycine 43mg Pillola, Haemophilus Influenzae Tip B (Hib) 6 Organiżmi Giga Pillola, Klebsiella Ozaenae 6 Organiżmi Giga Pillola, Klebsiella Pneumoniae 6 Organiżmi Giga Pillola, Neisseria Catarrhalis 6 Organiżmi Giga Pillola, Staphylococcus Aureus 6 Organiżmi Giga Pillola, Streptococcus Pneumoniae 6 Organiżmi Giga Pillola, Streptococcus Pyogenes 6 Organiżmi Giga Pillola, Streptococcus Viridans 6 Organiżmi Giga Pillola, Lisati Batteriċi Lijofilizzati 50mg Pillola
English: Glycine 43mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Oralis 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50mg Tablet
Maltese: Glycine 43mg Pillola, Haemophilus Influenzae Tip B (Hib) 6 Organiżmi Giga Pillola, Klebsiella Ozaenae 6 Organiżmi Giga Pillola, Klebsiella Pneumoniae 6 Organiżmi Giga Pillola, Neisseria Catarrhalis 6 Organiżmi Giga Pillola, Staphylococcus Aureus 6 Organiżmi Giga Pillola, Streptococcus Pneumoniae 6 Organiżmi Giga Pillola, Streptococcus Pyogenes 6 Organiżmi Giga Pillola, Streptococcus Oralis 6 Organiżmi Giga Pillola, Lisati Batteriċi Lijofilizzati 50mg Pillola
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule
Maltese: Broncho-Vaxom Lisati Batteriċi Lijofilizzati 3.5mg Kapsula
English: Bacterial Lysate 3mg Tablet
Maltese: Lisat Batteriku 3mg Pillola
English: Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml
Maltese: Ċellola Mega / Ml, Streptococcus Salivarius Batterja Inattivati 10 Ċelloli Mega / Ml, Streptococcus Pneumoniae Batterja Inattivati 10 Ċelloli Mega / Ml, Streptococcus Pyogenes Batterja Inattivati 10 Ċelloli Mega / Ml, Haemophilus Influenzae Batterja Inattivati 10 Ċelloli Mega / Ml, Corynebacterium Pseudodiphtheriticum Batterja Inattivati 20
English: Powder For Oral Suspension
Maltese: Trab Għal Sospensjoni Orali
English: Proteoglycanes Of Klebsiella Pneumoniae 1.125mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet
Maltese: Proteoglikani Ta' Klebsiella Pneumoniae 1.125mg Qartas, Ribożomi Ta' Haemophilus Influenzae 5 Unitajiet Qartas, Ribożomi Ta' Streptococcus Pneumoniae 30 Unità Qartas, Frazzjonijiet Ribożomali
English: Escherichia Coli (Inactivated) 200 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 100 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 500 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 500 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 100 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 100 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 200 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 100 Mega Cells / Ml
Maltese: Ċellola Mega / Ml, Streptococcus Salivarius Batterja Inattivati 100 Ċellola Mega / Ml, Streptococcus Pneumoniae Batterja Inattivati 100 Ċellola Mega / Ml, Streptococcus Pyogenes Batterja Inattivati 100 Ċellola Mega / Ml, Haemophilus Influenzae Batterja Inattivati 100 Ċellola Mega / Ml, Corynebacterium Pseudodiphtheriticum Batterja Inattivati 200 Ċellola Mega / Ml, Moraxella Catarrhalis Batterja Inattivati 100 Ċellola Mega / Ml
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7mg Capsule
Maltese: Lisat Batteriku Mnixxef bil-Friża (Lijofilizzat), Standardizzat 7mg Kapsula
English: Broncho-Vaxom Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Maltese: Broncho-Vaxom Estratt Batteriku Lijofilizzat Standardizzat 3.5mg Kapsula
English: Lyophilized Bacterial Lysates 3.5mg Capsule
Maltese: Lisati Batteriċi Lijofilizzati 3.5mg Kapsula
English: Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 GigaCells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Oralis 6GigaCells Tablet
Maltese: Haemophilus Influenzae 6 Ċelloli Giga Pillola, Klebsiella Ozaenae 6 Ċelloli Giga Pillola, Klebsiella Pneumoniae 6 Ċelloli Giga Pillola, Neisseria Catarrhalis 6 Ċelloli Giga Pillola, Staphylococcus Aureus 6 Ċelloli Giga Pillola, Streptococcus Pneumoniae 6 Ċelloli Giga Pillola, Streptococcus Pyogenes 6 Ċelloli Giga Pillola, Streptococcus Oralis 6 Ċelloli Giga Pillola
English: Broncho Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Maltese: Broncho Vaxom Lisati Batteriċi Lijofilizzati 7mg Kapsula
English: Bacterial Lysate 7mg Capsule
Maltese: Lisati Batteriċi Lijofilizzati 7mg Kapsula
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule
Maltese: Lisat Batteriku Mnixxef bil-Friża (Lijofilizzat), Standardizzat 3.5mg Kapsula
English: Bacterial Lysate 3.5mg Capsule
Maltese: Lisat Batteriku 3.5mg Kapsula
English: Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 Giga Cells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Viridans 6 Giga Cells Tablet
Maltese: Haemophilus Influenzae 6 Ċelloli Giga Pillola, Klebsiella Ozaenae 6 Ċelloli Giga Pillola, Klebsiella Pneumoniae 6 Ċelloli Giga Pillola, Neisseria Catarrhalis 6 Ċelloli Giga Pillola, Staphylococcus Aureus 6 Ċelloli Giga Pillola, Streptococcus Pneumoniae 6 Ċelloli Giga Pillola, Streptococcus Pyogenes 6 Ċelloli Giga Pillola, Streptococcus Viridans 6 Ċelloli Giga Pillola
English: Granules For Oral Solution
Maltese: Granuli Għal Soluzzjoni Orali
English: Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Maltese: Lijofilizzat Standardizzat ta' Lisati Batteriċi 3.5mg Kapsula
English: Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units
Maltese: Unitajiet Qartas, Ribożomi Ta' Streptococcus Pneumoniae 3 Unitajiet Qartas, Frazzjonijiet Ribożomali Ta' Klebsiella Pneumoniae 3.5 Unitajiet Qartas, Ribożomi Minn Streptococcus Pyogenes Grupp A 3 Unitajiet Qartas
English: Broncho-Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Maltese: Broncho-Vaxom Lisati Batteriċi Lijofilizzati 7mg Kapsula
English: Lyophilised, Standardised Bacterial Extract 7mg Capsule
Maltese: Lijofilizzat Standardizzat ta' Lisati Batteriċi 7mg Kapsula
English: Powder For Oral Solution
Maltese: Trab Għal Soluzzjoni Orali
English: Lyophilized Bacterial Lysates 3.5mg Sachet
Maltese: Lisati Batteriċi Lijofilizzati 3.5mg Qartas
English: 3 inhalers (3 x 30 doses) (multipack)
Maltese: Folja (Alu) 3 inalaturi (3 x 30 doża) (pakkett multiplu)
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (UE) Isem (ivvintat) Qawwa
English: 18 June 2012
Maltese: 18 ta' Ġunju 2012
English: Febantel is a probenzimidazole.
Maltese: Febantel huwa probenzimidazole.
English: Opinion following an Article 34
Maltese: Opinjoni skont riferiment tal-Artikolu 34
English: referral for Milaxyn Plus,
Maltese: għal Milaxyn
English: The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Dr Michael HolzhauserAlberti bħala relatur u lil Dr David Murphy bħala korelatur.
English: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus (and associated names) are veterinary medicinal products as tablets for dogs containing 50 mg praziquantel, 50 mg pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg of febantel.
Maltese: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus u Prazitel Plus (u ismijiet assoċjati) huma prodotti mediċinali veterinarji bħal pilloli għall-klieb li fihom 50 mg praziquantel, 50 mg pyrantel (ekwivalenti għal 144 mg pyrantel embonate) u 150 mg ta' febantel.
English: Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative.
Maltese: Praziquantel huwa derivattiv pyrazinoisoquinoline parzjalment idroġenat Pyrantel embonate (pamoate) huwa derivattiv tetrahydropyrimidine.
English: International non-proprietary name (inn): Praziquantel, pyrantel and febantel
Maltese: Praziquantel, pyrantel u febantel
English: Written explanations were provided by the marketing authorisation holder on 2 December 2011.
Maltese: Id-detentur tal-awtorizzazzjoni għattqegħid fis-suq ipprovda l-ispjegazzjonijiet bil-miktub fit-2 ta' Diċembru 2011.
English: Opinion following an Article 34F F referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names EMA/289985/2012
Maltese: Opinjoni skont riferiment tal-Artikolu 34F F għal Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus u Prazitel Plus u ismijiet assoċjatiDenominazzjoni Komuni Internazzjonali (inn):
English: Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names
Maltese: Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus u Prazitel Plus u ismijiet assoċjatiDenominazzjoni Komuni Internazzjonali (inn):
English: These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes.
Maltese: Dawn il-prodotti mediċinali veterinarji huma maħsuba għat-trattament ta' diversi infezzjonijiet parassitiċi fil-klieb ikkawżati minn nematodji u ċċestodji.
English: Due to the divergent national decisions taken by Member States regarding the indications and use in pups less than 9 weeks of age and dogs weighing less than 2.5 kg concerning the authorisations of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names, on 22 July 2011 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the above mentioned divergences.
Maltese: Minħabba deċiżjonijiet nazzjonali diverġenti meħuda mill-Istati Membri dwar l-indikazzjonijiet u l-użu ta' dawn il-prodotti mediċinali fi frieħ li għandhom inqas minn 9 ġimgħat u klieb li l-piż tagħhom huwa inqas minn 2.5 kg dwar l-awtorizzazzjonijiet ta' Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus u ismijiet assoċjati, fit-22 ta' Lulju Franza rreferiet il-kwistjoni lisCVMP skont l-Artikolu 34 (1) tad-Direttiva 2001/82/KE, sabiex issolvi d-diverġenzi msemmija hawn fuq.
English: terms of the marketing authorisations for Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) and the maintenance of the marketing authorisations for Prazitel Plus, Exitel Plus and Cazitel Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0241-0243/001/MR).
Maltese: Għaldaqstant, is-CVMP adotta opinjoni pożittiva fis-7 ta' Marzu 2012 u rrakkomanda varjazzjonijiet għat-termini għall-awtorizzazzjonijiet għat-tqegħid fis-suq għal Milaxyn Plus, Strantel Plus, Prazical Plus u Voxical Plus (u ismijiet assoċjati) (awtorizzati permezz tal-Proċedura ta' Rikonoxximent Reċiproku Nru IE/V/0272-0275/001/MR) u għaż-żamma tal-awtorizzazzjonijiet għattqegħid fis-suq ta' Prazitel Plus, Exitel Plus u Cazitel Plus (u ismijiet assoċjati) (awtorizzati permezz talProċedura ta' Rikonoxximent Reċiproku Nru IE/V/0241-0243/001/MR) Il-lista ta' ismijiet tal-prodott ikkonċernati hija mogħtija fl-Anness I.
English: Abuse, misuse, and diversion
Maltese: Abbuż, użu ħażin, u diverżjoni
English: Package leaflet: Information for the patient Dexamed 5 mg tablets
Maltese: Dexamed 5 mg pilloli
English: A comprehensive treatment programme typically includes psychological, educational and social measures.
Maltese: Programm ta' kura komprensiva tipikament tinkludi miżuri psikoloġiċi, edukattivi u soċjali.
English: educational and social measures.
Maltese: edukattivi u soċjali.
English: Dexamfetamine is indicated as part of a comprehensive treatment programme for attentiondeficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate.
Maltese: Dexamfetamine hu indikat bħala parti minn programm ta' kura komprensiva għal disturb ta' nuqqas ta' attenzjoni/attività eċċessiva (ADHD) fi tfal u adolexxenti li jkollhom minn 6 sa 17-il sena meta r-rispons għal kura fil-passat b'methylphenidate jiġi kkunsidrat li kien klinikament inadegwat.
English: PACKAGE LEAFLET
Maltese: TAL-PRODOTT
English: • it is used in children and adolescents aged 6-17 years.
Maltese: • jintuża fit-tfal u adolexxenti li jkollhom 6-17-il sena.
English: POSSIBLE SIDE EFFECTS
Maltese: SEKONDARJI POSSIBBLI
English: Dexamfetamine possesses a high potential to cause dependency and has been/is frequently abused.
Maltese: Dexamfetamine għandu potenzjal qawwi li jikkawża dipendenza u kien/jiġi abbużat b'mod frekwenti.
English: Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient.
Maltese: DSM-5 jew il-linji gwida f'ICD-10 u għandha tiġi bbażata fuq evalwazzjoni multidixxiplinarja komprensiva tal-pazjent appoġġjata minn stimi differenti.
English: Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age and potential for abuse, misuse or diversion.
Maltese: Dexamfetamine mhuwiex indikat fit-tfal kollha b'ADHD u d-deċiżjoni għall-użu ta' dexamfetamine trid tiġi bbażata fuq evalwazzjoni bir-reqqa ħafna tas-severità u l-kroniċità tas-sintomi tat-tifel/tifla fir-rigward tal-età tat-tifel/tifla u l-potenzjal għal abbuż, użu ħażin jew diverżjoni.
English: • it is used only after when another medicine called methylphenidate was not sufficiently effective.
Maltese: • jintuża biss wara li mediċina oħra msejħa methylphenidate ma kinitx effettiva biżżejjed.
English: • It should be used as part of a treatment programme which typically includes psychological,
Maltese: • Għandu jintuża bħala parti minn programm ta' kura li tipikament jinkludi miżuri psikoloġiċi,
English: Note: These amendments are to be incorporated to the valid Summary of Product Characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure
Maltese: Nota: Dawn l-emendi għandhom jiġu inkorporati mas-Sommarju tal-Karatteristiċi tal-Prodott, tikkettar u l-fuljett ta' tagħrif, li huma l-verżjonijiet finali li nkisbu matul il-Proċedura ta' grupp ta' koordinament
English: [The following sentence should be added in its place] The risk is generally greater for short acting stimulants than for corresponding long-acting products (see section 4.1).
Maltese: Ir-riskju hu ġeneralment ikbar għal stimulanti li jaġixxu għal ħin qasir milli għal prodotti korrispondenti li jaġixxu għal ħin twil (ara sezzjoni 4.1).
English: Dexamed is used to treat attention-deficit/hyperactivity disorder (ADHD).
Maltese: [Dawn il-bullet points għandhom jaqraw kif ġej] Dexamed jintuża biex jikkura disturb ta' nuqqas ta' attenzjoni/attività eċċessiva (ADHD).
English: Dexamfetamine sulphate [The below wording should be inserted at the top of the document]
Maltese: Dexamfetamine sulphate
English: SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: WHAT DEXAMED IS AND WHAT IT IS USED FOR
Maltese: X'INHU DEXAMED
English: • it is not indicated in all children with ADHD.
Maltese: • mhuwiex indikat fit-tfal kollha bl-ADHD.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati