natgillin/translations-raw huggingface dataset:
Blood pressure and heart rate increase upon discontinuation of Intuniv Blood pressure and pulse may increase following discontinuation of Intuniv. 
Zvišanje krvnega tlaka in pospešitev srčnega utripa ob prekinitvi zdravljenja z zdravilom Intuniv Po prekinitvi zdravljenja z zdravilom Intuniv se lahko krvni tlak zviša in srčni utrip pospeši.
Intuniv contains the active substance guanfacine. 
Zdravilo Intuniv vsebuje zdravilno učinkovino gvanfacin.
What Intuniv contains 
Kaj vsebuje zdravilo Intuniv
Patients treated with CYP3A4 and CYP3A5 inhibitors/inducers CYP3A4/5 inhibitors have been shown to have a significant effect on the pharmacokinetics of guanfacine when co-administered. 
Dokazali so, da zaviralci CYP3A4/5 signifikantno vplivajo na farmakokinetiko gvanfacina, če jih dajemo skupaj z njim.
Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate). 
Ena 4 mg tableta vsebuje 50,42 mg laktoze (v obliki monohidrata).
CYP3A4 inducers 
Spodbujevalci CYP3A4
• feeling dizzy when standing up (postural dizziness) 
• omedlevica pri vstajanju (posturalna omotica),
• pale skin colour (pallor) 
• bledica kože,
Intuniv 1 mg pack sizes: 7 or 28 tablets. 
Velikosti pakiranja zdravila Intuniv 1 mg: 7 ali 28 tablet.
Intuniv 2 mg pack sizes: 7, 28 or 84 tablets. 
Velikosti pakiranja zdravila Intuniv 2 mg: 7, 28 or 84 tablet.
Talk to your doctor or pharmacist before taking this medicine if: 
Pred začetkom jemanja zdravila Intuniv se posvetujte z zdravnikom ali s farmacevtom, če:
• indigestion (dyspepsia) 
• prebavne motnje (dispepsija),
• feeling tired (fatigue) 
• utrujenost,
Other CYP3A4 inducers may have a comparable effect, see table 3 for a list of examples of CYP3A4/5 inducers, this list is not definitive. 
Glejte preglednico 3 za seznam primerov spodbujevalcev CYP3A4/5; ta seznam ni dokončen.
Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate). 
Ena 2 mg tableta vsebuje 44,82 mg laktoze (v obliki monohidrata).
What Intuniv is used for 
Za kaj zdravilo Intuniv uporabljamo
Each 1 mg tablet contains 22.41 mg of lactose (as monohydrate). 
Ena 1 mg tableta vsebuje 22,41 mg laktoze (v obliki monohidrata).
What Intuniv is 
Kaj je zdravilo Intuniv
7.14mm round, white to off-white tablets debossed with ‘1MG' on one side and ‘503' on the other side. 
Okrogle, bele do belkaste tablete, 7,14 mm v premeru, z vtisnjenim napisom ‘1MG' na eni strani in ‘503' na drugi strani.
Study (SPD503-315) was a 41 week long term maintenance of efficacy study which included an open-label phase (up to 13 weeks) followed by double-blind, placebo-controlled, randomised-withdrawal phase (up to 26 weeks), conducted in paediatric patients (children and adolescents aged 6-17 years old inclusive) (n=526 in the open-label phase and n=315 in the double-blind randomised-withdrawal phase) to assess the efficacy, safety, and tolerability of once-daily dosing with guanfacine (children: 1-4 mg/day, adolescents:1-7 mg/day) in the treatment of ADHD. 
Študija (SPD503-315) je bila 41-tedenska študija dolgoročnega vzdrževanja učinkovitosti, v katero je bila vključena odprta faza (do 13 tednov), ki ji je sledila dvojno slepa, s placebom kontrolirana faza randomizirane odtegnitve (do 26 tednov), opravljena pri pediatričnih bolnikih (otroci in mladostniki,
How to store Intuniv 
Shranjevanje zdravila Intuniv
Rare (≥1/10,000 to <1/1,000) 
Naslednje opredelitve veljajo za uporabljeno terminologijo v zvezi s pogostnostjo: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000);
12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG' on one side and ‘503' on the other side. 
Ovalne, zelene tablete, velike 12,34 mm x 6,10 mm, z vtisnjenim napisom ‘4MG' na eni strani in ‘503' na drugi strani.
Adjustments in the dose of valproic acid and Intuniv may be indicated when coadministered. 
Pri sočasnem dajanju valproične kisline in zdravila Intuniv bo mogoče treba prilagoditi njuna odmerka.
Intuniv 4 mg pack sizes: 28 or 84 tablets. 
Velikosti pakiranja zdravila Intuniv 4 mg: 28 or 84 tablet.
EU/1/15/1040/003 7 prolonged-release tablets EU/1/15/1040/004 28 prolonged-release tablets EU/1/15/1040/005 84 prolonged-release tablets 
EU/1/15/1040/003 7 tablet s podaljšanim sproščanjem EU/1/15/1040/004 28 tablet s podaljšanim sproščanjem EU/1/15/1040/005 84 tablet s podaljšanim sproščanjem
Rifampicin 
Gvanfaci n
• feeling (nausea) or being sick (vomiting) 
• siljenje na bruhanje (navzea) ali bruhanje,
EU/1/15/1040/001 7 prolonged-release tablets EU/1/15/1040/002 28 prolonged-release tablets 
EU/1/15/1040/001 7 tablet s podaljšanim sproščanjem EU/1/15/1040/002 28 tablet s podaljšanim sproščanjem
Intuniv 1mg prolonged-release tablets Intuniv 2mg prolonged-release tablets Intuniv 3mg prolonged-release tablets Intuniv 4mg prolonged-release tablets 
Zmerni zaviralci CYP3A4/5 Močni zaviralci CYP3A4/5 Spodbujevalci CYP3A4 aprepitant boceprevir bosentan atazanavir kloramfenikol karbamazepin ciprofloksacin klaritromicin efavirenz krizotinib indinavir etravirin diltiazem itrakonazol modafinil eritromicin ketokonazol nevirapin flukonazol posakonazol okskarbazepin fosamprenavir ritonavir fenobarbital imatinib sakvinavir fenitoin verapamil subokson primidon sok grenivke telaprevir rifabutin telitromicin rifampicin šentjanževka
Intuniv 3 mg pack sizes: 28 or 84 tablets. 
Velikosti pakiranja zdravila Intuniv 3 mg: 28 or 84 tablet.
• The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on one side and 503 on the other side. 
• 1 mg tablete s podaljšanim sproščanjem so okrogle in bele, trde tablete, z vtisnjenim napisom 1MG na eni strani in 503 na drugi strani.
Intuniv 2 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine. 
Intuniv 2 mg tableta Ena tableta vsebuje 2 mg gvanfacina v obliki gvanfacinijevega klorida
Intuniv 4 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine. 
Intuniv 4 mg tableta Ena tableta vsebuje 4 mg gvanfacina v obliki gvanfacinijevega klorida.
• chest pain 
• bolečina v prsih,
Blood pressure and pulse should be monitored when reducing the dose or discontinuing Intuniv. 
Ob zmanjšanju odmerka ali prekinitvi zdravljenja z zdravilom Intuniv je treba spremljati krvni tlak in srčni utrip.
Weight Group Week 1 Week 2 Week 3 Week 4 25 kg and up 
skupina glede na telesno maso a teden teden teden teden teden teden teden
• Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine 
• Ena 4 mg tableta vsebuje 4 mg gvanfacina v obliki gvanfacinijevega klorida.
EU/1/15/1040/008 28 prolonged-release tablets EU/1/15/1040/009 84 prolonged-release tablets 
EU/1/15/1040/008 28 tablet s podaljšanim sproščanjem EU/1/15/1040/009 84 tablet s podaljšanim sproščanjem
• Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine 
• Ena 2 mg tableta vsebuje 2 mg gvanfacina v obliki gvanfacinijevega klorida.
Skin and subcutaneous tissue disorders Rash 
Bolezni kože in podkožja izpuščaj pogosti pruritus občasni
• The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on one side and 503 on the other side. 
• 3 mg tablete s podaljšanim sproščanjem so okrogle in zelene, trde tablete, z vtisnjenim napisom 3MG na eni strani in 503 na drugi strani.
• The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one side and 503 on the other side. 
• 4 mg tablete s podaljšanim sproščanjem so ovalne in zelene, trde tablete, z vtisnjenim napisom 4MG na eni strani in 503 na drugi strani.
Uncommon: may affect up to 1 in 100 people 
Občasni: lahko se pojavijo pri največ 1 od 100 bolnikov
• Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine 
• Ena 1 mg tableta vsebuje 1 mg gvanfacina v obliki gvanfacinijevega klorida.
Intuniv 3 mg tablet 7.94mm round, green tablets debossed with ‘3MG' on one side and ‘503' on the other side. 
Okrogle, zelene tablete, 7,94 mm v premeru, z vtisnjenim napisom ‘3MG' na eni strani in ‘503' na drugi strani.
Intuniv 3 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine. 
Intuniv 3 mg tableta Ena tableta vsebuje 3 mg gvanfacina v obliki gvanfacinijevega klorida
• The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one side and 503 on the other side. 
• 2 mg tablete s podaljšanim sproščanjem so ovalne in bele, trde tablete, z vtisnjenim napisom 2MG na eni strani in 503 na drugi strani.
12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG' on one side and “503” on the other side. 
Ovalne, bele do belkaste tablete, velike 12,34 mm x 6,10 mm, z vtisnjenim napisom ‘2MG' na eni strani in ‘503' na drugi strani.
• wetting yourself (enuresis) 
• močenje postelje (enureza),
58.5 kg and above 
58,5 kg in več največji odmerek = 7 mg
EU/1/15/1040/006 28 prolonged-release tablets EU/1/15/1040/007 84 prolonged-release tablets 
EU/1/15/1040/006 28 tablet s podaljšanim sproščanjem EU/1/15/1040/007 84 tablet s podaljšanim sproščanjem
• Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine 
• Ena 3 mg tableta vsebuje 3 mg gvanfacina v obliki gvanfacinijevega klorida.
Ciprofloxacin, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampicin, telithromycin 
ciprofloksacin, kloramfenikol, klaritromicin, eritromicin, rifabutin, rifampicin, telitromicin bakterijskih okužb flukonazol, itrakonazol, posakonazol glivičnih okužb krizotinib, imatinib raka diltiazem, verapamil bolezni srca in žilja boceprevir, telaprevir virusnega hepatitisa subokson odvisnosti od substanc bosentan bolezni srca in žilja (npr. zoženja krvnih žil v pljučih)
Methacrylic acid-Ethyl acrylate copolymer Lactose monohydrate Povidone 
Žilne bolezni hipotenzija pogosti ortostatska hipotenzija pogosti bledica občasni hipertenzija redki hipertenzivna encefalopatija zelo redki
Intuniv 3 mg prolonged-release tablets Guanfacine 
Intuniv 3 mg tablete s podaljšanim sproščanjem gvanfacin
Intuniv 2 mg prolonged-release tablets Guanfacine 
Intuniv 2 mg tablete s podaljšanim sproščanjem gvanfacin
Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine. 
Ena tableta vsebuje 2 mg gvanfacina v obliki gvanfacinijevega klorida.
Intuniv 1 mg prolonged-release tablets 
Intuniv 1 mg tablete s podaljšanim sproščanjem gvanfacin
Intuniv 4 mg prolonged-release tablets Guanfacine 
Intuniv 4 mg tablete s podaljšanim sproščanjem gvanfacin
Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine. 
Ena tableta vsebuje 1 mg gvanfacina v obliki gvanfacinijevega klorida.
Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine. 
Ena tableta vsebuje 3 mg gvanfacina v obliki gvanfacinijevega klorida.
Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine. 
Ena tableta vsebuje 4 mg gvanfacina v obliki gvanfacinijevega klorida.
• feeling agitated 
• slabo počutje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
Izgled zdravila Intuniv in vsebina pakiranja
What is colistin? 
Kaj je kolistin?
14 July 2016 
14. julij 2016
The European Commission issued a decision on 14 July 2016. 
Evropska komisija je sklep izdala 14. julija 2016.
This advice critically reviewed information on 
V okviru priprave mnenja so kritično pregledali informacije o uporabi
Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats. 
Kolistin se uporablja za zdravljenje in preprečevanje bolezni, ki jih povzročajo občutljive bakterije (npr. Escherichia coli) pri prašičih, perutnini, kuncih, govedu, ovcah in kozah.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/111) 
Izid postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/111)
the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health and the possible impact on human and animal health. 
kolistina pri živalih za proizvodnjo živil v EU, njegov učinek na razvoj odpornosti proti tej kategoriji protimikrobnih sredstev pri bakterijskih vrstah, ki so pomembne za zdravje ljudi in živali, in morebiten vpliv na zdravje ljudi in živali.
2 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information. 
2, ki omejuje indikacije, ciljne živalske vrste in trajanje zdravljenja za zadevna zdravila ter s katerim je bilo v informacije o zdravilu dodano opozorilo o preudarni uporabi.
Colistin belongs to the polymyxin group of antibiotics. 
Kolistin je antibiotik iz skupine polimiksinov.
Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure. 
V tem napotitvenem postopku v skladu s členom 35 so bili predloženi pravno zaščiteni podatki, znanstvene reference in strokovna poročila, ki podpirajo nekatere indikacije za nekatera izmed zdravil, ki jih zajema ta postopek.
The CVMP was requested to review the marketing authorisations and the available data in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health. 
Odbor CVMP je bil zaprošen za pregled dovoljenj za promet z zdravili in razpoložljivih podatkov, da se zagotovi odgovorna uporaba snovi na področju zdravstvenega varstva živali in zmanjša možnost prihodnjega tveganja za javno zdravje.
These include veterinary medicinal products containing combinations of colistin with 14 different antimicrobial substances, belonging to different classes e.g. β-lactams, tetracyclines, macrolides, sulfonamides and trimethoprim (see Annex I on the 'All documents' tab). 
Mednje spadajo zdravila za uporabo v veterinarski medicini, ki vsebujejo kombinacije kolistina s 14 različnimi protimikrobnimi sredstvi iz različnih skupin antibiotikov, npr. beta-laktami, tetraciklini, makrolidi, sulfonamidi in trimetoprim (glejte Prilogo I na zavihku »Vsi dokumenti«).
In addition, the marketing authorisation holders were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products 
Poleg tega so bili imetniki dovoljenj za promet z zdravilom pozvani, naj utemeljijo prednosti uporabe kombiniranih zdravil s kolistinom pred uporabo monoterapije pri zdravljenju ustreznih stanj, zlasti z upoštevanjem smernice CVMP o farmacevtskih proizvodih s fiksno kombinacijo
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally EMA/461505/2016 
Vprašanja in odgovori glede zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje EMA/461505/2016
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je splošno razmerje med tveganji in koristmi za navedena zdravila negativno, ker nimajo kliničnega pomena in ker prekomerno izpostavljanje kolistinu zaradi porasti pojavljanja odpornosti proti njem lahko predstavlja nevarnost za zdravje živali in ljudi.
Why were veterinary medicinal products containing colistin in combination with other antimicrobial substances reviewed? 
Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi?
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally 
Vprašanja in odgovori glede zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje
CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf 
Smernica CVMP o farmacevtskih proizvodih s fiksno kombinacijo (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
On 4 May 2015, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally. 
Evropska komisija je 4. maja 2015 sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje.
Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf 
Uporaba zdravil s kolistinom pri živalih v Evropski uniji: razvoj odpornosti in možnega vpliva na zdravje ljudi in živali (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm 
Sklep Komisije o dovoljenjih za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo „kolistin“, za peroralno dajanje v skladu s členom 35 Direktive 2001/82/ES Evropskega parlamenta in Sveta ((2015)1916 z dne 16. marca 2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally. 
Evropska agencija za zdravila (agencija) je 21. aprila 2016 zaključila pregled učinkovitosti vseh zdravil za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje, in odpornosti proti njim.
Request for scientific advice on the impact on public health and animal health of the use of antibiotics in animals, answer to the first request from the European Commission (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf 
Zahteva za znanstveno mnenje o vplivu uporabe antibiotikov pri živalih na javno zdravje in zdravje živali, odgovor na prvi poziv Evropske komisije (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
Therefore the CVMP recommended that all marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn. 
Zato je odbor CVMP priporočil umik dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje.
Combinations of colistin with other antimicrobials are available for group treatments of gastro-intestinal and respiratory infections in food-producing animals in different European Member States. 
V določenih državah članicah EU so za zdravljenje skupin okužb prebavil in dihal pri živalih za proizvodnjo živil na voljo kombinacije kolistina z drugimi protimikrobnimi sredstvi.
The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU). 
Odbor CVMP je priporočil, da se po vsej Evropski uniji (EU) umaknejo vsa dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin, v kombinaciji z drugimi protimikrobnimi sredstvi za peroralno dajanje.
Based on the evaluation of the currently available data, the CVMP concluded that no benefit could be demonstrated when using colistin combination products instead of monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even limited use of colistin combination products was considered unnecessary. 
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP zaključil, da ni mogoče dokazati prednosti uporabe kombiniranih zdravil s kolistinom namesto monoterapije.
The final opinion was converted into a Decision by the European Commission on 13 April 2007. 
Evropska komisija je končno mnenje spremenila v Odločbo dne 13. aprila 2007.
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions. 
Arbitražni postopek se je začel 27. julija 2006 s sprejetjem seznama vprašanj.
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated”. 
Dokazano je bilo zmanjšanje pogostosti vretenčnih zlomov, ne pa tudi nevretenčnih zlomov“.
The Marketing Authorisation Holder provided written explanations on 19 October 2006. 
Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 19. oktobra 2006.
In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS): Belgium, Greece and Denmark. 
Pri ponovni uporabi postopka medsebojnega priznavanja, ki se je začel 11. oktobra 2005, je bila vloga predložena zadevnim državam članicam: Belgiji, Grčiji in Danski.
Significant difference has been identified with regard to the indication for treatment of osteoporosis in men and this was considered to be of serious public health concern. 
Pomembne razlike so bile ugotovljene v zvezi z indikacijo za zdravljenje osteoporoze pri moških, kar predstavlja resne pomisleke v zvezi z javnim zdravjem.
The Rapporteur was Dr. Tomas Salmonson and Co-Rapporteur(s) was Dr. Frits Lekkerkerker. 
Poročevalec je bil dr. Tomas Salmonson, soporočevalec pa dr. Frits Lekkerkerker.
The CHMP considered that the benefit/risk ratio was considered to be favourable in the following indication: “Treatment of osteoporosis in men at increased risk of fracture. 
CHMP je menil, da je razmerje med koristmi in tveganji ugodno za naslednjo indikacijo: „Zdravljenje osteoporoze pri moških s povišanim tveganjem za zlome.
Sweden referred the reasons for disagreement to the EMEA on 10 July 2006. 
Švedska je Evropski agenciji za zdravila dne 10. julija 2006 predložila razloge za nesoglasje.
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral, should not prevent the granting of a Marketing Authorisation for Alendronate HEXAL and associated names. 
Med svojim zasedanjem januarja 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora sprejel mnenje, da zadržki, ki so sprožili napotitev v skladu s členom 29, ne bi smeli preprečiti podelitve dovoljenja za promet za zdravilo Alendronat HEXAL in z njim povezana imena.