natgillin/translations-raw huggingface dataset:
This became obvious in mutual recognition procedures for other lansoprazole containing products in which the involved member states could not agree on the therapeutic indications and posology because the differences between the national authorisations of the reference product Agopton, Wyeth Lederle Nordiska AB.
To je postalo očitno pri postopkih medsebojnega priznavanja za druge izdelke, ki so vsebovali lansoprazol, pri katerih se dotične države članice zaradi razlik v nacionalnih odobritvah referenčnega zdravila Agopton, Wyeth Lederle Nordiska AB, niso mogle uskladiti glede terapevtskih indikacij in odmerjanj.
The referral procedure started on 17 March 2005.
Napotitveni postopek se je začel dne 17. marca 2005.
During its meeting on 18-21 September 2006 the CHMP, having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/ risk ratio of Agopton and associated names is considered to be positive for the following indications:
Na svojem sestanku v času od 18. do 21. septembra 2006 je CHMP ob upoštevanju poročevalčevega in soporočevalčevega poročila o oceni, znanstvene razprave v Odboru ter pripomb s strani imetnikov dovoljenja za promet z zdravilom, sklenil, da je razmerje med koristmi in tveganji zdravila Agopton in z njim povezanih imen pozitivno v primeru naslednjih indikacij:
• Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H. pylori associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome.
• zdravljenje razjed dvanajstnika in želodca, • zdravljenje refluksnega ezofagitisa, • profilaksa refluksnega ezofagitisa, • eradikacija Helicobacter pylori (H. pylori) pri sočasni terapiji z ustreznimi antibiotiki za zdravljenje razjed, povezanih s H. pylori, • zdravljenje benignih razjed želodca in dvanajstnika, povezanih z NSAID, pri bolnikih, ki potrebujejo nadaljnje zdravljenje z NSAID, • profilaksa razjed želodca in dvanajstnika, povezanih z NSAID, pri bolnikih s povečanim tveganjem (glejte poglavje 4. 2), ki potrebujejo nadaljnje zdravljenje, • simptomatska gastroezofagealna refluksna bolezen, • Zollinger- Ellisonov sindrom.
The divergences identified at the start of the referral were resolved.
Razhajanja, opredeljena na začetku napotitvenega postopka, so bila odpravljena.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The CHMP gave a positive opinion on 21 September 2006 recommending the harmonisation of the SPC, labelling and package leaflet for Agopton and associated names.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged CHMP je dne 21. septembra 2006 izdal pozitivno mnenje, s katerim je priporočil uskladitev SPC, označevanja in Navodil za uporabo za zdravilo Agopton in z njim povezana imena.
The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Znanstveni zaključki so na voljo v Dodatku II skupaj z dopolnjenim SPC, označevanjem in Navodili za uporabo v Dodatku III.
A Decision was issued by the European Commission on 13 December 2006.
Evropska komisija je odločbo izdala dne 13. decembra 2006.
London, 1 October 2007 EMEA/ CHMP/ 432352/ 2007
London, 1. oktobra 2007 EMEA/ CHMP/ 432352/ 2007
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I)
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31 ZA Agreal in z njim povezana imena (glejte Dodatek I)
BACKGROUND INFORMATION*
OSNOVNE INFORMACIJE *
Veralipride was authorised in 6 European Member States:
Veralipride je bil odobren v šestih evropskih državah:
Belgium, France, Italy, Luxembourg and Portugal.
Belgiji, Franciji, Italiji, Luksemburgu in na Portugalskem.
On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC.
Po umiku zdravila veralipride s španskega trga zaradi poročil o resnih neželenih stranskih učinkih, ki vplivajo na živčni sistem, je Evropska komisija dne 7. septembra 2006 napotila zadevo na agencijo EMEA v skladu s členom 31 Direktive 2001/ 83/ ES.
Eric Abadie and Barbara van Zwieten-Boot, respectively.
Poročevalec in soporočevalka sta bila Eric Abadie in Barbara van Zwieten- Boot.
Oral explanations were given on 20 June 2007.
Ustna pojasnila so bila podana dne 20. junija 2007.
On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Dne 19. julija 2007 je CHMP na podlagi trenutno razpoložljivih podatkov in poročevalčevih poročil o oceni menil, da je razmerje med koristmi in tveganji zdravil, ki vsebujejo veralipride negativno, in je zato izdal mnenje, s katerim priporoča umik dovoljenja za promet z vsemi zdravili, ki vsebujejo veralipride.
* Note:
* Opomba:
The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
Informacije, podane v tem dokumentu in v Dodatkih odražajo mnenje CHMP z dne 19. julija 2007.
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, POT UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Sanofi-Aventis France 1-13 Boulevard Anatole France France
Sanofi- Aventis France 1- 13 Boulevard Anatole France Francija
Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c, Luxembourg
Sanofi- Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c Luksemburg
PRT Empreendimento Lagoas Park - Edifício 7 -
Empreendimento Lagoas Park – Edificio 7 – 2° e 3° Portugalska
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
CHMP/ 309507/ 2007 SCIENTIFIC CONCLUSIONS
©EMEA 2007 CHMP/ 309507/ 2007 ZNANSTVENI ZAKLJUČKI
Spain therefore withdrew veralipride’ s marketing authorisation on 27 June 2005.
Španija je iz tega razloga dne 27. junija 2005 umaknila dovoljenje za promet za veraliprid.
Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride’ s product information was restricted with the aim to reduce the risk of patients developing side effects.
Zakonski ukrepi so bili sprejeti tudi v nekaterih drugih državah članicah EU, v katerih je izdelek odobren, tako da bile z namenom, da bi zmanjšali tveganje za pojav neželenih učinkov pri bolnikih, informacije o izdelku zaostrene.
Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/ risk assessment of veralipride.
Zaradi tega je Evropska komisija 7. septembra 2006 sprožila napotitveni postopek in zaprosila CHMP za mnenje, ali naj se dovoljenje za promet z izdelki, ki vsebujejo veraliprid, ohrani, spremeni, zacasno preklice ali umakne po vsej Evropski uniji v skladu z oceno z njimi povezanih tveganj in oceno razmerja med koristmi in tveganji zdravila veraliprid.
Efficacy In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
Učinkovitost V tem pregledu je CHMP ovrednotil vse razpoložljive informacije o varnosti in učinkovitosti veraliprida.
Safety The 27-year post-marketing period offers a long period of safety profile surveillance.
Varnost 27- letno postmarketinško obdobje predstavlja dolgo obdobje spremljanja varnostnega profila.
However, cases of tardive
Omeniti je treba, da pri vrednotenju vzročnosti veraliprida v psihiatričnih dogodkih vloga veraliprida ni vedno jasna.
dyskinesia have also been reported within the first 3 months of treatment.
Da bi preprečil psihiatrične neželene učinke, ekstrapiramidalne simptome in tardivno diskinezijo, je imetnik dovoljenja za promet predlagal najdaljše dopustno trajanje zdravljenja z veralipridom 3 mesece.
The proposal of close monitoring including neurological examination after each 20 day treatment cycle might reduce these risks, but is a measure of considerable burden to both patient and doctor.
Skrbno spremljanje, vključno z nevrološkim pregledom po vsakem 20- dnevnem ciklu zdravljenja, bi utegnilo zmanjšati ta tveganja, vendar pa predstavlja tak ukrep znatno obremenitev tako za bolnika kot zdravnika.
Veralipride treatment is contra-indicated in patients with prolactin- dependent tumours such as pituitary gland prolactinoma and breast cancer.
Zdravljenje z veralipridom je kontraindicirano pri bolnikih s tumorji, odvisnimi od prolaktina, kot so prolaktinom hipofize ali rak dojke.
Benefit/ risk In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Koristi/ tveganja Z ozirom na razpoložljive klinične podatke je CHMP zaključil, da tveganja, povezana z uporabo veraliprida za zdravljenje navalov vročice, ki so povezani z menopavzo, zlasti nevrološke reakcije (diskinezija, ekstrapiramidalni zaplet, Parkinsonov sindrom) in psihiatrične reakcije (depresija, anksioznost, sindrom odtegnitve) presegajo omejene koristi.
Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QT- prolongation are considered a concern.
V povezavi z zdravljenjem z veralipridom so poročali o primerih nenapovedljive in potencialno nepovratne tardivne diskinezije, kakor tudi o zgodnjih ekstrapiramidalnih simptomih, depresiji, anksioznosti in sindromu odtegnitve; ta tveganja skupaj s tveganjem za hiperprolaktinemijo ter za podaljšanje QT, ki je značilno za celoten razred teh zdravil, so ocenjena kot zadržek.
The CHMP took note of the MAH’ s proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
Ti predlogi so:
-Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
- Omejitev trajanja zdravljenja na 3 mesece v kombinaciji z mesečnimi pregledi, da bi tako omejili psihiatrične in nevrološke neželene učinke.
-Introduction of the contraindications in patients with Parkinson’ s disease, or in combination with other neuroleptics and dopaminergic agonists.
- Vključitev kontraindikacij za bolnike s Parkinsonovo boleznijo ali v kombinaciji z drugimi nevroleptiki in dopaminergičnimi agonisti.
-Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
- Vključitev opozorila glede učinkov, značilnih za cel razred nevroleptikov (nevroleptični maligni sindrom, podaljšanje QT, tardivna diskinezija), in simptomov odtegnitve, kot so anksioznost in depresivni sindrom.
-Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10- day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
- Priporočilo za zdravniške preglede dojk in intermitentno shemo (20 dni zdravljenja, ki mu sledi 10 dnevno obdobje nezdravljenja), da bi tako zmanjšali tveganje za hiperprolaktinemijo, vse z namenom izboljšanja varnosti za zdravje dojk (vendar pa ni znano, ali ima ta ukrep kakšen vpliv na opažen vzorec neželenih učinkov v zvezi z hiperprolaktinemijo kot so povečanje dojk, galaktoreja in tveganje za paciente s tumorji, odvisnimi od prolaktina, kot so prolaktinom hipofize ali rak dojke.
©EMEA 2007
Nadalje lahko nekateri izmed teh učinkov nastopijo ne le med zdravljenjem, temveč tudi ko je le- to prekinjeno, poleg tega pa je nemogoče napovedati, katere ženske so ogrožene.
The CHMP therefore concluded on 19 July 2007 that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
CHMP je zato 19. julija 2007 zaključil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo veraliprid, pri normalnih pogojih uporabe ni pozitivno.
GROUNDS FOR THE WITHDRAWAL OF THE MA
PODLAGA ZA UMIK DOVOLJENJA ZA PROMET
• The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended, for medicinal products containing veralipride • The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause; • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/ 83/ ES, z vsemi spremembami, za zdravila, ki vsebujejo veraliprid; • Odbor je bil mnenja, da zdravila, ki vsebujejo veraliprid, izkazujejo le omejeno učinkovitost pri zdravljenju navalov vročice, povezanih z menopavzo; • Odbor je ugotovil, da so pri uporabi veraliprida poročali o nevroloških reakcijah (diskineziji, ekstrapiramidalnem zapletu, Parkinsonovem sindromu) in psihiatričnih reakcijah (depresiji, anksioznosti, sindromu odtegnitve), vključno s tardivno diskinezijo, ki je potencialno lahko nepovratna.
In addition, hyperprolactinemia and the risk of QT prolongation are also concerns; • The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
Nadalje predstavljata pomislek tudi hiperprolaktinemija in tveganje za podaljšanje QT; • Z ozirom na razpoložljive klinične podatke je Odbor zaključil, da tveganja, povezana z uporabo veraliprida pri zdravljenju navalov vročice, ki so povezani z menopavzo, presegajo omejene koristi.
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk; • The Committee, as a consequence, concluded that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Nadalje je Odbor menil, da predlagane aktivnosti za minimaliziranje tveganja ne morejo zmanjšati tveganja na sprejemljivo raven ali napovedati, katere ženske utegnejo biti ogrožene; • Odbor je posledično zaključil, da razmerje med tveganji in koristmi zdravil, vsebujočih veraliprid, pri normalnih pogojih uporabe ni pozitivno.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Invented name
Predlagatelj
Pharmaceutical
Izmišljeno ime Ime
HEXAL A/ S Kanalholmen 8-12, 2650 Hvidovre, Denmark
HEXAL A/ S Kanalholmen 8- 12, 2650 Hvidovre, Danska
10 mg per tablet
10 mg na tableto
HEXAL A/ S Kanalholmen 8-12, 2650 Hvidovre, Denmark
HEXAL A/ S Kanalholmen 8 - 12, 2650 Hvidovre, Danska
2 ANNEX II
2 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
3 SCIENTIFIC CONCLUSIONS
3 ZNANSTVENI ZAKLJUČKI
Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations below the mean value of a normal young population or as a previous fragility fracture, irrespective of bone mineral density.
Osteoporoza je opredeljena kot mineralna gostota kosti (MGK) hrbtenice ali kolkov za 2, 5 standardne deviacije pod povprečno vrednostjo, ki velja za normalno mlado populacijo, ali kot predhoden primer zloma zaradi krhkosti, do katerega pride ne glede na mineralno gostoto kosti.
The applicant was asked to further justify the broad indication “ treatment of osteoporosis in men” for Alendronate HEXAL.
Vlagatelj je bil zaprošen, da podrobneje utemelji široko zastavljeno indikacijo "zdravljenje osteoporoze pri moških" z zdravilom Alendronate HEXAL.
An effect on non- vertebral fractures has nonetheless not been demonstrated in this population.
Učinek zdravila na nevertebralne zlome pa v tej populaciji kljub vsemu ni bil dokazan.
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
PODLAGA ZA DOPOLNILO POVZETKA( OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
- the literature provided by the applicant provide evidence that 10 mg daily could increase bone
- literatura, ki jo je predložil vlagatelj, je pokazala, da lahko 10 mg alendronata dnevno poveča
mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis,
mineralno gostoto kosti v vetrebralnem kot tudi v nevertebralnem okostju moških s primarno osteoporozo,
- an effect on non-vertebral fractures has nonetheless not been demonstrated in this population.
- učinek na nevertebralne zlome kosti v tej populaciji kljub vsemu ni bil dokazan,
The CHMP has recommended the following indication, which is in accordance with the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CHMP/ EWP/ 552/ 95 Rev.2)
je CHMP priporočil naslednjo indikacijo, ki je usklajena s smernico o ocenjevanju zdravil za zdravljenje primarne osteoporoze (CHMP/ EWP/ 552/ 95 Rev. 2)
“ Treatment of osteoporosis in men at increased risk of fracture.
"Zdravljenje osteoporoze pri moških s povečanim tveganjem za zlom.
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated .”
Dokazano je bilo zmanjšanje pojavnosti vertebralnih zlomov, ne pa tudi nevertebralnih zlomov. "
4 ANNEX III
4 DODATEK III
5 SUMMARY OF PRODUCT CHARACTERISTICS
5 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Alendronate HEXAL and associated names (see Annex I) 10 mg tablets
Alendronat HEXAL in pripadajoča imena (glejte Dodatek I) 10 mg tablete
Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate).
Vsaka tableta vsebuje 10 mg alendronske kisline (v obliki natrijevega alendronata trihidrata).
103.95 mg lactose monohydrate per tablet
103, 95 mg laktoze monohidrata na tableto Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Tablet White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Tableta Tableta v obliki kapsule, bele ali skoraj bele barve, ki ima na eni strani vtisnjeno oznako "AN 10", na drugi strani pa "Arrow logo".
(see section 5.1).
(Glejte poglavje 5. 1)
Osteoporosis in men:
Osteoporoza pri moških:
To obtain satisfactory absorption of alendronate Alendronate HEXAL tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day.
Da bi omogočili zadostno absorpcijo Alendronata HEXAL Alendronat HEXAL tablete je treba vzeti na prazen želodec takoj po jutranjem vstajanju izključno z navadno vodo in najmanj 30 minut pred zaužitjem prve hrane, pijače ali drugih zdravil v tem dnevu.
Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5).
Druge pijače (vključno z mineralno vodo), hrana in nekatera zdravila lahko zmanjšajo absorpcijo Alendronata HEXAL (glejte poglavje 4. 5).
7 To assist delivery to the stomach and thus reduce the risk of irritation/ side effects locally and in the oesophagus (see section 4.4) • Alendronate HEXAL tablets should only be swallowed on rising for the day with a whole glass of water (not less than 200 ml or 7 fl. oz). • Alendronate HEXAL tablets should be swallowed whole.
7 Za hiter prehod v želodec in zmanjšanje tveganja za draženje/ neželene učinke lokalno in v požiralniku (glejte poglavje 4. 4) • Alendronat HEXAL tablete mora bolnik pogoltniti po jutranjem vstajanju s polnim kozarcem vode (ne manj kot 200 ml). • Alendronat HEXAL tablete je treba pogoltniti cele.
The tablets should not be chewed, sucked or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration. • Patients should not lie down until after the first meal of the day, which must be at least 30 minutes after taking the tablet. • Patients should not lie down within 30 minutes of taking Alendronate HEXAL tablets. • Alendronate HEXAL tablets should not be taken at bedtime or before arising for the day.
Bolnik tablet ne sme žvečiti, sesati ali jih raztopiti v ustih, ker obstaja tveganje za razjedo v ustih in žrelu. • Bolnik ne sme leči, dokler ne zaužije prvega dnevnega obroka, kar pa ne sme biti prej kot 30 minut po zaužitju tablete. • Bolnik ne sme leči prej kot 30 minut po zaužitju Alendronat HEXAL tablet. • Bolnik Alendronat HEXAL tablet ne sme vzeti pred spanjem ali preden zjutraj vstane.
Patients should be given a calcium and vitamin D supplement if the diet is inadequate (see section 4.4).
V primeru neustrezne prehrane morajo bolniki prejemati dodatek kalcija in vitamina D (glejte poglavje 4. 4).
In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
Uporaba pri starejših V kliničnih preskušanjih ni bilo nobene od starosti odvisne razlike v učinkovitosti ali varnosti Alendronata HEXAL.
Use in impaired renal function No dose adjustment is necessary in patients with a glomerular filtration rate (GFR) greater than 35 ml/ min.
Uporaba pri bolnikih z motnjami v delovanju ledvic Pri bolnikih, pri katerih je hitrost glomerulne filtracije (GFR) večja od 35 ml/ min, prilagajanje odmerka ni potrebno.