natgillin/translations-raw huggingface dataset:
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
Haemophilus Influenzae tip B (Hib) 50,2 AGU/ml, Klebsiella Pneumoniae 39,8 AGU/ml, Staphylococcus Aureus 79,6 AGU/ml, Streptococcus Pneumoniae 63,2 AGU/ml, Streptococcus Pyogenes 126,2 AGU/ml, Moraxella Catarrhalis 39,9 AGU/ml
Broncho-Vaxom Lysatum Bacteriale Mixtum 7mg Capsule
Broncho-Vaxom Lysatum bacteriale mixtum 7 mg kapsula
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
Escherichia Coli (inaktivirana) 20 mega celic/ml, Klebsiella Pneumoniae (inaktivirana) 10 mega celic/ml, inaktivirana bakterija Staphylococcus Aureus 50 mega celic/ml, inaktivirana bakterija Staphylococcus Epidermidis 50 mega celic/ml, inaktivirana bakterija Streptococcus Salivarius 10 mega celic/ml, inaktivirana bakterija Streptococcus Pneumoniae 10 mega celic/ml, inaktivirana bakterija Streptococcus Pyogenes 10 mega celic/ml, inaktivirana bakterija Haemophilus Influenzae 10 mega celic/ml, inaktivirana bakterija Corynebacterium Pseudodiphtheriticum 20 mega celic/ml, inaktivirana bakterija Moraxella Catarrhalis 10 mega celic/ml
Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule
Broncho-Vaxom Liofilizirani bakterijski lizati 3,5 mg kapsula
Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet
Broncho-Vaxom Liofilizirani bakterijski lizati 3,5 mg vrečica
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
Escherichia Coli (inaktivirana) 2 mega celic/ml, Klebsiella Pneumoniae (inaktivirana) 1 mega celic/ml, inaktivirana bakterija Staphylococcus Aureus 5 mega celic/ml, inaktivirana bakterija Staphylococcus Epidermidis 5 mega celic/ml, inaktivirana bakterija Streptococcus Salivarius 1 mega celic/ml, inaktivirana bakterija Streptococcus Pneumoniae 1 mega celic/ml, inaktivirana bakterija Streptococcus Pyogenes 1 mega celic/ml, inaktivirana bakterija Haemophilus Influenzae 1 mega celic/ml, inaktivirana bakterija Corynebacterium Pseudodiphtheriticum 2 mega celic/ml, inaktivirana bakterija Moraxella Catarrhalis 1 mega celic/ml
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
Escherichia Coli (inaktivirana) 200 mega celic/ml, Klebsiella Pneumoniae (inaktivirana) 100 mega celic/ml, inaktivirana bakterija Staphylococcus Aureus 500 mega celic/ml, inaktivirana bakterija Staphylococcus Epidermidis 500 mega celic/ml, inaktivirana bakterija Streptococcus Salivarius 100 mega celic/ml, inaktivirana bakterija Streptococcus Pneumoniae 100 mega celic/ml, inaktivirana bakterija Streptococcus Pyogenes 100 mega celic/ml, inaktivirana bakterija Haemophilus Influenzae 100 mega celic/ml, inaktivirana bakterija Corynebacterium Pseudodiphtheriticum 200 mega celic/ml, inaktivirana bakterija Moraxella Catarrhalis 100 mega celic/ml
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
Proteoglikani bakterije Klebsiella Pneumoniae 1,125 mg vrečica, ribosomske frakcije (ribosomi s titrom 70 % RNK) 0,75 mg vrečica, ribosomi bakterije Haemophilus Influenzae 5 enot/vrečico, ribosomi bakterije Streptococcus Pneumoniae 30 enot/vrečico, ribosomske frakcije bakterije Klebsiella Pneumoniae 35 enot/vrečico, ribosomi iz bakterije Streptococcus Pyogenes skupina A 30 enot/vrečico
Lysatum Bacteriale Mixtum 3.5mg Sachet
Lysatum bacteriale mixtum 3,5 mg vrečica
Lyophilised, Standardised Bacterial Extract 7mg Capsule
Liofiliziran, standardiziran bakterijski izvleček 7 mg kapsula
Bacterial Lysate 3mg Tablet
Bakterijski lizat 3 mg tableta
Broncho-Vaxom Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Broncho-Vaxom Liofiliziran, standardiziran bakterijski izvleček 3,5 mg kapsula
Standardized Lyophylisate Of Bacterial Lysates 7mg Capsule
Standardizirani liofilizat bakterijskih lizatov 7 mg kapsula
Nasal Drops, Suspension
Peroralne kapljice, raztopina
Standardized Lyophylisate Of Bacterial Lysates 3.5mg Capsule
Standardizirani liofilizat bakterijskih lizatov 3,5 mg kapsula
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
Glicin 43 mg tableta, Haemophilus Influenzae tip B (Hib) 6 giga organizmov/tableto, Klebsiella Ozaenae 6 giga organizmov/tableto, Klebsiella Pneumoniae 6 giga organizmov/tableto, Neisseria Catarrhalis 6 giga organizmov tableto, Staphylococcus Aureus 6 giga organizmov/tableto, Streptococcus Pneumoniae 6 giga organizmov/tableto, Streptococcus Pyogenes 6 giga organizmov/tableto, Streptococcus Oralis 6 giga organizmov/tableto, liofilizirani bakterijski lizati 50 mg tableta
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
Glicin 43 mg tableta, Haemophilus Influenzae tip B (Hib) 6 giga organizmov/tableto, Klebsiella Ozaenae 6 giga organizmov/tableto, Klebsiella Pneumoniae 6 giga organizmov/tableto, Neisseria Catarrhalis 6 giga organizmov/tableto, Staphylococcus Aureus 6 giga organizmov/tableto, Streptococcus Pneumoniae 6 giga organizmov/tableto, Streptococcus Pyogenes 6 giga organizmov/tableto, Streptococcus Viridans 6 giga organizmov/tableto, liofilizirani bakterijski lizati 50 mg tableta
Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Liofiliziran, standardiziran bakterijski izvleček 3,5 mg kapsula
Bacterial Lysate 3.5mg Capsule
Bakterijski lizat 3,5 mg kapsula
Broncho Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Broncho Vaxom Liofilizirani bakterijski lizati 7 mg kapsula
Lyophilized Bacterial Lysates 7mg Capsule
Liofilizirani bakterijski lizati 7 mg kapsula
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
Proteoglikani bakterije Klebsiella Pneumoniae 1,125 mg vrečica, ribosomi bakterije Haemophilus Influenzae 5 enot/vrečico, ribosomi bakterije Streptococcus Pneumoniae 30 enot/vrečico, ribosomske frakcije bakterije Klebsiella Pneumoniae 35 enot/vrečico, ribosomi iz bakterije Streptococcus Pyogenes skupina A 30 enot/vrečico
Lyophilized Bacterial Lysates 3.5mg Capsule
Liofilizirani bakterijski lizati 3,5 mg kapsula
Broncho-Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Broncho-Vaxom Liofilizirani bakterijski lizati 7 mg kapsula
Oral Suspension Sublingual Use
Peroralni prašek Peroralna uporaba
Membranes Fractions Of Klebsiella Pneumoniae 15 Units / Ml, Ribosomes Of Haemophilus Influenzae 0.5 Units / Ml, Ribosomes Of Streptococcus Pneumoniae 3 Units / Ml, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units / Ml, Ribosomes From Streptococcus Pyogenes Group A 3 Units / Ml
Membranske frakcije bakterije Klebsiella Pneumoniae 15 enot/ml, ribosomi bakterije Haemophilus Influenzae 0,5 enote/ml, ribosomi bakterije Streptococcus Pneumoniae 3 enote/ml, ribosomske frakcije bakterije Klebsiella Pneumoniae 3,5 enote/ml, ribosomi iz bakterije Streptococcus Pyogenes skupina A 3 enote/ml
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
Haemophilus Influenzae 6 giga celic/tableto, Klebsiella Ozaenae 6 giga celic/tableto, Klebsiella Pneumoniae 6 giga celic/tableto, Neisseria Catarrhalis 6 giga celic/tableto, Staphylococcus Aureus 6 giga celic/tableto, Streptococcus Pneumoniae 6 giga celic/tableto, Streptococcus Pyogenes 6 giga celic/tableto, Streptococcus Oralis 6 giga celic/tableto
Bacterial Lysate 7mg Capsule
Bakterijski lizat 7 mg kapsula
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
Haemophilus Influenzae 6 giga celic/tableto, Klebsiella Ozaenae 6 giga celic/tableto, Klebsiella Pneumoniae 6 giga celic/tableto, Neisseria Catarrhalis 6 giga celic/tableto, Staphylococcus Aureus 6 giga celic/tableto, Streptococcus Pneumoniae 6 giga celic/tableto, Streptococcus Pyogenes 6 giga celic/tableto, Streptococcus Viridans 6 giga celic/tableto
Lyophilized Bacterial Lysates 3.5mg Sachet
Liofilizirani bakterijski lizati 3,5 mg vrečica
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
Membranske frakcije bakterije Klebsiella Pneumoniae 15 enot, ribosomi bakterije Haemophilus Influenzae 0,5 enote, ribosomi bakterije Streptococcus Pneumoniae 3 enote, ribosomske frakcije bakterije Klebsiella Pneumoniae 3,5 enote, ribosomi iz bakterije Streptococcus Pyogenes skupina A 3 enote
Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet
Membranske frakcije bakterije Klebsiella Pneumoniae 15 enot/tableto, ribosomi bakterije Haemophilus Influenzae 0,5 enote/tableto, ribosomi bakterije Streptococcus Pneumoniae 3 enote/tableto, ribosomske frakcije bakterije Klebsiella Pneumoniae 3,5 enote/tableto, ribosomi iz bakterije Streptococcus Pyogenes skupina A 3 enote/tableto
Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet
Membranske frakcije bakterije Klebsiella Pneumoniae 15 enot/tableto, ribosomi bakterije Haemophilus Influenzae 0,5 enote/tableto, ribosomi bakterije Streptococcus Pneumoniae 3 enote, ribosomske frakcije bakterije Klebsiella Pneumoniae 3,5 enote/tableto, ribosomi iz bakterije Streptococcus Pyogenes skupina A 3 enote/tableto
Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7mg Capsule
Standardizirani bakterijski lizat, posušen z zamrzovanjem (liofiliziran) 7 mg kapsula
Granules For Oral Solution
Granule za peroralno raztopino
Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule
Standardizirani bakterijski lizat, posušen z zamrzovanjem (liofiliziran) 3,5 mg kapsula
Membranes Fractions Of Klebsiella Pneumoniae 15 Units Sachet, Ribosomes Of Haemophilus Influenzae 0.5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 3 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Sachet
Membranske frakcije bakterije Klebsiella Pneumoniae 15 enot/vrečico, ribosomi bakterije Haemophilus Influenzae 0,5 enote/vrečico, ribosomi bakterije Streptococcus Pneumoniae 3 enote/vrečico, ribosomske frakcije bakterije Klebsiella Pneumoniae 3,5 enote/vrečico, ribosomi iz bakterije Streptococcus Pyogenes skupina A 3 enote/vrečico
18 June 2012
18. junij 2012
The final opinion was converted into a Decision by the European Commission on 18 June 2012.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 18. junija 2012.
The referral procedure started on 14 September 2011.
Napotitveni postopek se je začel 14. septembra 2011.
Written explanations were provided by the marketing authorisation holder on 2 December 2011.
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil dne 2. decembra 2011.
These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes.
Ta zdravila za uporabo v veterinarski medicini so namenjena zdravljenju različnih parazitskih okužb pri psih, ki jih povzročajo nematode (ogorčice) in cestode (trakulje).
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, package leaflet and labelling in the Annex III.
Seznam zadevnih imen proizvodov je naveden v Prilogi I. Znanstveni zaključki so skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, podani v Prilogi II, navodilo za uporabo in označevanje pa v Prilogi III.
International non-proprietary name (inn): Praziquantel, pyrantel and febantel
Mednarodno nelastniško ime (INN): prazikvantel, pirantelij in febantel
Febantel is a probenzimidazole.
Febantel je pro-benzimidazol.
Pyrantel embonate (pamoate) is a tetrahydropyrimidine derivative.
Pirantelijev embonat (pamoat) je derivat tetrahidropirimidina.
Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative.
Prazikvantel je delno hidrogenizirani derivat pirazinoizokvinolina.
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.
Zaradi različnih nacionalnih odločitev držav članic glede indikacij in uporabe pri kužkih, mlajših od 9 tednov, in pri psih, ki tehtajo manj kot 2,5 kg, glede odobritev zdravil Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus in povezanih imen, je Francija 22. julija 2011 zadevo napotila na CVMP v skladu s členom 34(1) Direktive 2001/82/ES, da bi razrešila zgoraj omenjena razhajanja.
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.
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus (ter povezana imena) so zdravila za uporabo v veterinarski medicine v obliki tablet za pse, ki vsebujejo 50 mg prazikvantela, 50 mg pirantelija (kar je enako 144 mg pirantelijevega embonata) in 150 mg febantela.
Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus and associated names (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) remains positive subject to variation of the marketing authorisations in accordance with the recommended changes to the product information.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je splošno razmerje med koristmi in tveganji za zdravila Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus in povezana imena (odobrena s postopkom medsebojnega priznavanja št. IE/V/0272-0275/001/MR) ostaja pozitivno pod pogojem, da se dovoljenje za promet z zdravilom spremeni v skladu s priporočenimi spremembami
Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names
za zdravila Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus ter povezana imena
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).
Odbor je zato 7. marca 2012 sprejel pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet za zdravila Milaxyn Plus, Strantel Plus, Prazical Plus in Voxical Plus (ter povezana imena) (odobrena s postopkom medsebojnega priznavanja št. IE/V/02720275/001/MR) ter ohranitev dovoljenj za promet z zdravili Prazitel Plus, Exitel Plus in Cazitel Plus (ter povezana imena) (odobrena s postopkom medsebojnega priznavanja št. IE/V/0241-0243/001/MR).
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
Mnenje v zvezi z napotitvijo v skladu s členom 34F F za zdravila Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus ter povezana imena stran 2/2
• it is used in children and adolescents aged 6-17 years.
• uporablja se pri otrocih in mladostnikih, starih 6-17 let.
Abuse, misuse, and diversion
Napačna uporaba, zloraba in preusmeritev
• it is not indicated in all children with ADHD.
• ni indicirano pri vseh otrocih z ADHD.
• it is used only after when another medicine called methylphenidate was not sufficiently effective.
• uporablja se le, če drugo zdravilo, imenovano metilfenidat, ni bilo dovolj učinkovito.
A comprehensive treatment programme typically includes psychological, educational and social measures.
Obširni program zdravljenja običajno vključuje psihološke, izobraževalne in socialne ukrepe.
WHAT DEXAMED IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO DEXAMED IN ZA KAJ GA UPORABLJAMO Za kaj se uporablja
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.
Diagnozo je treba postaviti v skladu s kriteriji DSM-5 ali smernicami ICD-10; temeljiti mora na podlagi obširne multidisciplinarne ocene bolnika.
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
Opomba: Spremembe se vključijo v veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so končne različice, dosežene v postopku koordinacijske skupine
4.1 Therapeutic indications [The wording of this section should read as follows]
4.1 Terapevtske indikacije [Besedilo tega poglavja naj se glasi kot sledi]
Dexamfetamine possesses a high potential to cause dependency and has been/is frequently abused.
Deksamfetamin ima visok potencial za povzročanje odvisnosti in so ga/ga pogosto zlorabljajo.
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.
Deksamfetamin ni indiciran pri vseh otrocih z ADHD; odločitev o uporabi deksamfetamina mora temeljiti na zelo temeljiti oceni resnosti in kroničnosti otrokovih simptomov ob upoštevanju otrokove starosti in možnosti za napačno uporabo, zlorabo, ali preusmeritev uporabe.
Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Zdravljenje mora potekati pod nadzorom specialista vedenjskih motenj pri otrocih in/ali mladostnikih.
[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).
Tveganje je na splošno večje za hitrodelujoče stimulante, kot za ustrezna dolgodelujoča zdravila (glejte poglavje 4.1).
Dexamed is used to treat attention-deficit/hyperactivity disorder (ADHD).
Zdravilo Dexamed se uporablja za zdravljenje motnje pomanjkljive pozornosti s hiperaktivnostjo (ADHD, attention-deficit/hyperactivity disorder).
• It should be used as part of a treatment programme which typically includes psychological,
• uporablja se kot del programa zdravljenja, ki običajno vključuje psihološke, izboraževalne in socialne ukrepe.
[These bullet points should read as follows]
[Te točke morajo biti navedene kot sledi]
Package leaflet: Information for the patient Dexamed 5 mg tablets
Navodilo za uporabo Dexamed 5 mg tablete deksamfetaminijev sulfat
[The following wording should be added at the end of this section]
[Spodnje besedilo se doda na koncu tega poglavja]
Amendments to the summary of product characteristics and package leaflet
Spremembe povzetka glavnih značilnosti zdravila in navodila za uporabo
[The wording below should be deleted]
[Naslednje besedilo se briše]
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.
Deksamfetamin je indicirano kot del obširnega programa zdravljenja motnje pomanjkljive pozornosti s hiperaktivnostjo (ADHD, attention deficit/hyperactivity disorder) pri otrocih in mladostnikih, starih 6 do
[The below wording should be inserted at the top of the document]
[Spodnje besedilo se vstavi na začetku tega dokumenta]
What it is used for
NAVODILO ZA UPORABO
This summary was last updated in 09-2007.
Povzetek je bil nazadnje posodobljen 09-2007.
The marketing authorisation holder is Glaxo Group Ltd.
Imetnik dovoljenja za promet z zdravilom je družba Glaxo Group Ltd.
The dose may be adjusted, depending on body weight.
Odmerek se lahko prilagodi, odvisno od telesne mase.