natgillin/translations-raw huggingface dataset:
On 7 April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due 
Dne 7. aprila 2005 sta FDA (Food and Drug Administration) in EMEA zaradi podatkov o hudih kožnih reakcijah zahtevali, da podjetje Pfizer prostovoljno umakne zdravilo Bextra (valdekoksib) iz prometa.
- Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking, - Addition of a warning for prescribers to consider discontinuation of therapy if during treatment, patients deteriorate in any of the organ system functions described, - Addition of a warning for prescribers to exercise caution when prescribing NSAIDs, including celecoxib, in combination with ACE inhibitors or angiotensin II receptor antagonists, 
Spremembe informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo kot sledi: - dodani sta kontraindikaciji Potrjena ishemična srčna bolezen in/ali cerebrovaskularno obolenje ter Periferna arterijska bolezen, - dodana je kratka informacija o kardiovaskularnih izsledkih v PreSAP (Učinkovitost in varnost celekoksiba (SC-58635) pri preprečevanju posameznih kolorektalnih adenomnih polipov) in APC (Preprečevanje posameznih kolorektalnih adenomov s celekoksibom); vključiti strožje besedilo v zvezi s skupinami za kardiovaskularna tveganja, - dodano je opozorilo za bolnike z dejavniki tveganja za srčne bolezni, kot so hipertenzija, hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje, - dodano je opozorilo za predpisovalce zdravila, naj preučijo možnost prekinitve zdravljenja, če se med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov, - dodano je opozorilo za predpisovalce zdravila, naj bodo previdni pri predpisovanju neselektivnih nesteroidnih protivnetnih zdravil (non-steroidal anti-inflammatory drugs, NSAIDs), vključno s celekoksibom, v kombinaciji z zaviralci ACE ali antagonisti receptorjev
- the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction. 
- novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom, - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases 
Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi:
EU/1/06/335/001 Valtropin 15 mg/1.5 ml Powder and solvent for solution for injection (multi-use) 
EU/1/06/335/001 Valtropin 5 mg/1,5 ml Prašek in vehikel za raztopino za injiciranje (večkratna uporaba)
Powder: 5 mg Solvent: 1.5 ml 
Prašek: 5 mg Vehikel: 1,5 ml
Powder: vial (glass) Solvent: pre-filled syringe (glass) 
Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
1 vial + 1 pre-filled syringe l t o r 
1 viala + 1 napolnjena injekcijska brizga o ā
Strength Pharmaceutical Form Route of administration 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
Gastro-Resistant Tablet 
Gastrorezistentna tableta
Suspension For Injection 
Raztopina za injiciranje
Granules In Sachet 
Granule v vrečici
Powder For Oral Suspension 
Prašek za peroralno suspenzijo
Oral Drops, Suspension 
Kapljice za nos, suspenzija
Tablet 
Podjezična tableta
Streptococcus Agalactiae 1000 Mega Units Tablet, Haemophilus Influenzae 1500 Mega Units Tablet, Staphylococcus Aureus 1000 Mega Units Tablet, Streptococcus Pneumoniae 1000 Mega Units Tablet 
Streptococcus Agalactiae 1000 mega enot/tableto, Haemophilus Influenzae 1500 mega enot/tableto, Staphylococcus Aureus 1000 mega enot/tableto, Streptococcus Pneumoniae 1000 mega enot/tableto
Lysatum Bacteriale Mixtum 3mg Tablet 
Lysatum bacteriale mixtum 3 mg tableta
Granules For Oral Suspension 
Granule za peroralno suspenzijo
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 
Streptococcus Agalactiae 1 giga enot/tableto, Haemophilus Influenzae 1,5 giga enot/tableto, Staphylococcus Aureus 1 giga enot/tableto, Streptococcus Pneumoniae 1 giga enot/tableto
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 
Haemophilus Influenzae tip B (Hib) 1,25 giga celic/50 mg, lizat bakterije Branhamella Catarrhalis 1,25 giga celic/50 mg, Klebsiella Pneumoniae (inaktivirana) 1,25 giga celic/50 mg, inaktivirana bakterija Staphylococcus Aureus 1,25 giga celic/50 mg, inaktivirana bakterija Streptococcus Pneumoniae 1,25 giga celic/50 mg, inaktivirana bakterija Streptococcus Pyogenes 1,25 giga celic/50 mg
Nasal Use 
Nazalna uporaba
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 
Haemophilus Influenzae tip B (Hib) 0,625 giga celic/25 mg, lizat bakterije Branhamella Catarrhalis 0,625 giga celic/25 mg, Klebsiella Pneumoniae (inaktivirana) 0,625 giga celic/25 mg, inaktivirana bakterija Staphylococcus Aureus 0,625 giga celic/25 mg, inaktivirana bakterija Streptococcus Pneumoniae 0,625 giga celic/25 mg, inaktivirana bakterija Streptococcus Pyogenes 0,625 giga celic/25 mg
Lysatum Bacteriale Mixtum 3.5mg Capsule 
Lysatum bacteriale mixtum 3,5 mg kapsula
Lysatum Bacteriale Mixtum 7mg Capsule 
Lysatum bacteriale mixtum 7 mg kapsula
Lyophilized Bacterial Lysates 7mg Tablet 
Liofilizirani bakterijski lizati 7 mg tableta
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.