FrancophonIA/ELRC3.0 huggingface dataset:
English: The content, objectives and implementation of the RMP should be discussed between the relevant MAH and the NCA and it should be agreed and implemented.
Slovenian: O vsebini, ciljih in izvajanju načrta za obvladovanje tveganja mora zadevni imetnik dovoljenja za promet z zdravilom razpravljati s pristojnim nacionalnim organom ter z njim soglašati in ga izvajati.
English: Manic episodes in bipolar disorder
Slovenian: Manične epizode pri bipolarni motnji
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALPROATERATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA VALPROATERATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
English: The initial recommended daily dose is 750 mg.
Slovenian: Priporočeni začetni dnevni odmerek je 750 mg.
English: You should not take this medicine if you are pregnant or a women of child-bearing age unless explicitly advised by your doctor.
Slovenian: Če ste noseči ali v rodni dobi, ne smete jemati tega zdravila, razen če vam je to izrecno predpisal zdravnik.
English: Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterion (time to recurrence of any mood episode), patients treated with valproate had better outcomes on several secondary outcome measures than those treated with lithium or placebo.
Slovenian: Medtem ko Bowdenova študija, ki je bila nadzorovana z litijem in placebom, ni uspela dokazati statistično pomembne razlike z vidika merila primarnega izida (čas do ponovitve katere koli razpoloženjske epizode), so bili pri bolnikih, zdravljenih z valproatom, pri več merilih sekundarnega izida opaženi boljši izidi kot pri bolnikih, zdravljenih z litijem ali placebom.
English: Whereas, in the original analysis time to recurrence of any mood episode or depressive episode, respectively was not significantly different in the three treatment groups, post-hoc analyses showed that valproate treated patients dropped out significantly less frequent than placebo treated patients because of a mood episode and due to a depressive episode, respectively, whereas the respective difference was not statistically significant compared to lithium treated patients.
Slovenian: Medtem ko se v prvotni analizi čas do ponovitve katere koli razpoloženjske oziroma depresivne epizode v treh zdravljenih skupinah ni bistveno razlikoval, so naknadne analize pokazale, da so bolniki, zdravljeni z valproatom, mnogo redkeje prekinili sodelovanje zaradi razpoloženjske oziroma depresivne epizode kot bolniki, zdravljeni s placebom, pri čemer zadevna razlika ni bila statistično pomembna v primerjavi z bolniki, zdravljenimi z litijem.
English: - The Committee considered the referral made under article of Article 6 of Commission Regulation (EC) No 1084/2003, for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) initiated by The Netherlands.
Slovenian: - Odbor je proučil napotitev, ki jo je sprožila Nizozemska v skladu s členom 6 Uredbe Komisije (ES) št. 1084/2003, za zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezana imena).
English: To support the bipolar indication the MAHs submitted several published studies.
Slovenian: V podporo indikacije pri bipolarni motnji je imetnik dovoljenja za promet z zdravilom predložil več objavljenih študij.
English: The MAHs should update the Product Information to include the relevant sections as proposed by the CHMP regarding the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo informacije o zdravilu posodobiti tako, da bodo vključevale ustrezna poglavja, kot jih je predlagal CHMP v zvezi s predlagano dopolnjeno indikacijo za zdravljenje manije pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
English: Furthermore, according to clinical practice and the dose recommendations, the daily dose should be adapted individually to the clinical response between a specific dose range and the lowest effective dose should be used in the prevention of recurrence in bipolar disorder.
Slovenian: Poleg tega je treba glede na klinično prakso in priporočila glede odmerjanja dnevni odmerek prilagoditi posamično glede na klinični odziv v okviru določenega razpona odmerka, pri čemer se pri preprečevanju ponovitev bipolarne motnje uporabi najmanjši učinkoviti odmerek.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III and in accordance to the conditions set out in Annex IV.
Slovenian: CHMP je zato priporočil ohranitev dovoljenj za promet z zdravili iz Dodatka I, katerih dopolnila zadevnih poglavij povzetkov glavnih značilnosti zdravila in navodila za uporabo so navedena v Dodatku III in so v skladu s pogoji iz Dodatka IV.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Nausea, sedation, extrapyramidal disorders.
Slovenian: Slabost, sedacija, ekstrapiramidne motnje
English: Manic episodes in bipolar disorder:
Slovenian: Manične epizode pri bipolarni motnji:
English: Safety
Slovenian: 2 Varnost
English: According to the CHMP recommendation for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names the indication should be adapted in the following due to the limitations and shortcomings of the data from clinical trials:
Slovenian: V skladu s priporočilom CHMP je treba indikacijo za zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten in z njim povezana imena zaradi omejitev in pomanjkljivosti podatkov iz kliničnih preskušanj prilagoditi na naslednji način:
English: Evidence of efficacy of valproate in the prevention of mood episodes is thus not completely convincing based on the performed clinical studies alone.
Slovenian: Dokazi učinkovitosti valproata pri preprečevanju razpoloženjskih epizod, ki izhajajo iz izvedenih kliničnih študij, zato niso najbolj prepričljivi.
English: 4.2 Posology and method of administration
Slovenian: 4.2 ODMERJANJE IN NAČIN UPORABE
English: Continuation of treatment of manic episodes in bipolar disorder should be adapted individually using the lowest effective dose.
Slovenian: Nadaljevanje zdravljenja maničnih epizod pri bipolarni motnji je treba prilagoditi posamezniku, tako da se uporabi najmanjši učinkoviti odmerek.
English: A small number of people being treated with anti-epileptics such as <active substance> have had thoughts of harming or killing themselves.
Slovenian: Bodite posebno pozorni pri uporabi zdravila {LASTNIŠKO IME} Majhno število ljudi, ki se zdravijo z antiepileptiki, kot je <zdravilna učinkovina>, so razmišljali o tem, da bi se poškodovali ali ubili.
English: Preventive treatment of mania will be adapted individually using the lowest effective dose.
Slovenian: Preprečevalno zdravljenje manije se prilagodi individualno na najmanjši učinkoviti odmerek.
English: The daily dosage should be established and controlled individually by your doctor.
Slovenian: Vaš dnevni odmerek mora določiti in nadzorovati zdravnik.
English: 89070 Ulm Germany
Slovenian: 89079 Ulm
English: ANNEX III AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND THE PACKAGE LEAFLET
Slovenian: DODATEK III SPREMEMBE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: Concerns were raised by the Netherlands regarding the efficacious and safe use of Valproateratiopharm chrono 300/500 mg Retardtabletten (and associated names) in the acute treatment of manic episodes and the prevention of recurrence of mood episodes in patients with bipolar disorder.
Slovenian: Nizozemska je izrazila pomisleke glede učinkovite in varne uporabe zdravila Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezanih imen), pri akutnem zdravljenju maničnih epizod in pri preprečevanju ponovitve razpoloženjskih epizod pri bolnikih z bipolarno motnjo.
English: Women of child-bearing potential have to use effective contraception during treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
English: The MAHs for valproate authorised products who apply for the new indication should contact the national competent authorities (NCAs) of the respective member states in order to submit a Risk Management Plan.
Slovenian: Imetniki dovoljenja za promet z odobrenimi zdravili, ki vsebujejo valproat in ki jim bo dodana nova indikacija, morajo pristojnemu nacionalnemu organu zadevne države članice predložiti načrt za obvladovanje tveganja.
English: <Valproinsäure-ratiopharm chrono 300 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (3 ½ and 6 ½ tablets).
Slovenian: <[BLAGOVNA ZNAMKA] 300 TABLETE S PODALJŠANIM SPROŠČANJEM> Razpon priporočenih dnevnih odmerkov je navadno od 1000 do 2000 mg (od 3 ½ do 6 ½ tablete).
English: The daily dose should be adapted to the clinical response to establish the lowest effective dose for the individual patient.
Slovenian: Dnevni odmerek je treba prilagoditi glede na klinični odziv, da se določi najmanjši učinkoviti odmerek za posameznega bolnika.
English: Furthermore, when the proposed indication is granted the MAHs should submit a Risk Management Plan to the NCAs for assessment.
Slovenian: Ko bo predlagana indikacija odobrena, bodo morali imetniki dovoljenja za promet z zdravilom pristojnemu organu države članice v oceno predložiti načrt za obvladovanje tveganja.
English: The daily dose should be adapted individually to the clinical response to establish the lowest effective dose for of the individual patient.
Slovenian: Dnevni odmerek je treba prilagoditi individualno glede na klinični odziv, da se določi najmanjši učinkoviti odmerek za posameznega bolnika.
English: Women of child-bearing potential have to use effective contraception.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko zaščito.
English: - The Committee considered all the available data submitted on efficacy and the safety for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names), in relation to the treatment of mania in bipolar disorder as well in the prevention of recurrence of mood episodes.
Slovenian: - Odbor je upošteval vse razpoložljive predložene podatke o učinkovitosti in varnosti zdravila Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezanih imen) v zvezi z zdravljenjem manije pri bipolarni motnji in za preprečevanje ponovitev razpoloženjskih epizod.
English: Children and adolescents under 18 years of age: […] should not be used in children and adolescents under 18 years of age for the treatment of mania.
Slovenian: Zdravilo [...] se pri otrocih in mladostnikih, mlajših od 18 let, ne sme uporabljati za zdravljenje manije.
English: Ratiopharm GmbH Graf Arco Strasse 3
Slovenian: Združeno kraljestvo ratiopharm GmbH Graf-Arco-Strasse 3
English: “Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Slovenian: „Zdravljenje maničnih epizod pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
English: Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Slovenian: Zdravljenje manične epizode pri bipolarni motnji, kadar je litij kontraindiciran ali ga bolnik ne prenaša.
English: - The Committee concluded that the Product Information of all Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) should include information to the amended indication on the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristic and Package Leaflet accordingly.
Slovenian: - Odbor je zaključil, da je treba v informacije o zdravilu Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezana imena) vključiti podatke o dopolnjeni indikaciji zdravljenja manije pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša, in je zato priporočil temu ustrezna dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo.
English: - The Committee concluded that Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) have a positive benefit-risk ratio in the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Slovenian: - Odbor je zaključil, da ima zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezana imena) pozitivno razmerje med koristmi in tveganji pri predlagani dopolnjeni indikaciji „zdravljenje maničnih epizod pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
English: <Valproinsäure-ratiopharm chrono 500 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (2 and 4 tablets).
Slovenian: <[BLAGOVNA ZNAMKA] 500 TABLETE S PODALJŠANIM SPROŠČANJEM> Razpon priporočenih dnevnih odmerkov je navadno od 1000 do 2000 mg (od 2 do 4 tablete).
English: The continuation of treatment after manic episode could be considered in patients who have responded to <valproate> for acute mania.
Slovenian: O nadaljevanju zdravljenja po manični epizodi se lahko razmisli pri bolnikih, ki so se pri akutni maniji odzvali na <valproat>.
English: Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Slovenian: Srednji dnevni odmerek Razpon priporočenih dnevnih odmerkov je navadno od 1000 do 2000 mg.
English: Valprotek CR 500 mg (prolonged release) tablets 500 mg
Slovenian: Valprotek CR 500 mg (prolonged release) tablets
English: 199,8 mg + 87 mg Prolonged-release tablet Oral use
Slovenian: 199,8 mg + 87 mg
English: Moreover, no specific safety issues have been identified in studies in which antidepressant co-medication has been used in patients with bipolar disease.
Slovenian: Poleg tega iz študij, v katerih so za zdravljenje bolnikov z bipolarno motnjo uporabljali tudi antidepresive, niso razvidni posebni zadržki glede varnosti.
English: The daily dosage should be established and controlled individually by the treating physician.
Slovenian: Dnevni odmerek mora lečeči zdravnik določiti in nadzorovati glede na posameznika.
English: POSSIBLE SIDE EFFECTS Nausea, sedation, extrapyramidal disorders.
Slovenian: 4.8 NEŽELENI UČINKI Navzea, sedacija, ekstrapiramidne motnje
English: Valprotek CR 300 mg (prolonged release) tablets 300 mg
Slovenian: Valprotek CR 300 mg (prolonged release) tablets
English: Acido valproico E sodio Valproato Ratiopharm 300 mg
Slovenian: Acido valproico E sodio Valproato Ratiopharm
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Slovenian: Pri bolnikih, ki so se zaradi več indikacij zdravili z antiepileptiki, so poročali o samomorilnih mislih in vedenju.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES
Slovenian: SPREMEMBE, KI JIH JE TREBA VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA BLAGOVNA ZNAMKA 300/500 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
English: The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.”
Slovenian: Nadaljevanje zdravljenja po manični epizodi bi bilo smiselno pri bolnikih, ki so se odzvali na valproat pri akutni maniji.“
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF PACKAGE LEAFLET FOR VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES
Slovenian: SPREMEMBE, KI JIH JE TREBA VKLJUČITI V USTREZNA POGLAVJA NAVODIL ZA UPORABO ZDRAVILA BLAGOVNA ZNAMKA 300/500 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
English: As a consequence,the CHMP has recommended the granting of the variation for which the Summary of Product Characteristics and Package Leaflet is set out in Annex III for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names (see Annex I).
Slovenian: CHMP je posledično priporočil odobritev spremembe za zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten in z njim povezana imena (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila in navodilo za uporabo sta navedena v Dodatku III.
English: Children and adolescents under 18 years of age: {Invented name} should not be used in children and adolescents under 18 years of age for the treatment of mania.
Slovenian: Zdravilo {lastniško ime} se pri otrocih in mladostnikih, mlajših od 18 let, ne sme uporabljati za zdravljenje manije.
English: Summary of Product Characteristics and Package Leaflet.
Slovenian: Povzetek glavnih značilnosti zdravila in navodilo za uporabo
English: Product Name
Slovenian: Ime
English: Seizures:
Slovenian: Ob upoštevanju naslednjega:
English: The continuation of treatment after manic episode could be considered in patients who have responded to the medicinal product for acute mania.
Slovenian: Nadaljevanje zdravljenja po manični epizodi bi bilo smiselno pri bolnikih, ki so se odzvali na zdravilo, uporabljeno pri zdravljenju akutne manije.
English: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovenian: Nemčija ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: BEFORE YOU TAKE {INVENTED NAME}
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO {LASTNIŠKO IME}
English: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm
Slovenian: Slovaška ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Natriumvalproaat ratiopharm chrono 300 mg 300 mg
Slovenian: Natriumvalproaat ratiopharm chrono 300 mg
English: Natriumvalproaat ratiopharm chrono 500 mg 500 mg
Slovenian: Natriumvalproaat ratiopharm chrono 500 mg
English: Marketing Authorisation Holder
Slovenian: NAVODILO ZA UPORABO
English: 333 mg + 145 mg Prolonged-release tablet Oral use
Slovenian: 333 mg + 145 mg
English: Italy
Slovenian: Portugalska
English: * International units per ml of rabbit serum determined by haemolysis inhibition assay
Slovenian: * mednarodne enote na ml kunčjega seruma, določeno s preizkusom zaviranja hemolize
English: 500ml 6 bottles
Slovenian: 6 plastenk nič dni
English: 500ml 1 bottle
Slovenian: 1 plastenka nič dni
English: Date of first authorisation: 15 April 2005 Date of latest renewal: 19 January 2015
Slovenian: Datum prve odobritve: 15. april 2005 Datum zadnjega podaljšanja: 19. januar 2015
English: Unopened bottle: 3 years
Slovenian: Neodprta steklenica: 3 leta
English: Currently available data for children aged 5 to 17 years are described in section 5.1.
Slovenian: Trenutno razpoložljivi podatki o uporabi pri otrocih, ki so stari od 5 do 17 let, so opisani v poglavju 5.1.
English: Low levels of phosphate in the blood.
Slovenian: Nizke koncentracije fosfatov v krvi.
English: The following information is intended for healthcare professionals only (see section 3):
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju (glejte poglavje 3):
English: Not to be sold separately.
Slovenian: Ni namenjeno ločeni prodaji.
English: Aclasta with food and drink
Slovenian: Zdravilo Aclasta skupaj s hrano in pijačo
English: • Key signs and symptoms of serious adverse reactions
Slovenian: • ključne znake in simptome resnih neželenih učinkov,
English: All clinical fractures were verified based on the radiographic and/or clinical evidence.
Slovenian: Vsi klinični zlomi so bili dokazani radiografsko in/ali na podlagi kliničnih znakov.
English: It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Slovenian: Pomembno je, da se skrbno ravnate po tem nasvetu, da se vam koncentracije kalcija v krvi v času po infuziji ne znižajo preveč.
English: What Aclasta is and what it is used for
Slovenian: Kaj je zdravilo Aclasta in za kaj ga uporabljamo
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Slovenian: Neželeni učinki, kot je na primer omotičnost, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Slovenian: Celotni sistemski očistek je 5,04  2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa ali telesna masa.
English: No dose adjustment is required (see section 5.2).
Slovenian: Prilagajanje odmerjanja ni potrebno (glejte poglavje 5.2).
English: Your doctor will advise you and decide how long you should be treated with Aclasta.
Slovenian: Zdravnik vam bo svetoval in presodil, kako dolgo bi se morali zdraviti z zdravilom Aclasta.
English: Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months
Slovenian: Preglednica 2 Pregled učinkovitosti glede zlomov vretenc po 12, 24 in 36 mesecih
English: No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Slovenian: Prilagajanje odmerjanja ni potrebno, ker so vrednosti biološke uporabnosti, porazdelitve in izločanja iz telesa pri starejših bolnikih in mlajših preiskovancih podobne.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden vam bodo dali to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: There are no data available for children under 5 years of age.
Slovenian: O uporabi pri otrocih, ki so stari manj kot 5 let, ni na voljo nobenih podatkov.
English: Your doctor, pharmacist or nurse knows how to store Aclasta properly.
Slovenian: Vaš zdravnik, farmacevt in medicinska sestra vedo, kako je treba zdravilo Aclasta pravilno shranjevati.
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Slovenian: To je zlasti pomembno pri bolnikih, ki prejemajo diuretike (tablete za odvajanje vode), in pri starejših bolnikih (starih 65 let ali več).
English: Long-term safety data in this population cannot be established from this study.
Slovenian: Iz navedene študije ni bilo mogoče pridobiti podatkov o dolgoročni varnosti pri tej skupini bolnikov.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Aclasta on an individual patient basis, particularly after 5 or more years of use.
Slovenian: Potrebo po nadaljevanju zdravljenja z zdravilom Aclasta je treba periodično ponovno oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
English: It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.
Slovenian: Zaenkrat ni jasno, ali to nepravilno bitje srca povzroča zdravilo Aclasta, kljub temu pa morate zdravniku sporočiti, če pri vas pride do takih simptomov po prejemu zdravila Aclasta.
English: EXP After opening: 24 hours at 2°C - 8°C.
Slovenian: EXP Po odpiranju: 24 ur pri 2°C - 8°C.
English: Other medicines and Aclasta
Slovenian: Druga zdravila in zdravilo Aclasta
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Slovenian: V prvih 24 urah se v seč izloči 39  16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
English: Aclasta may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Slovenian: Zdravilo Aclasta lahko povzroča tudi druge neželene učinke Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) vročina