FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum solubility of the product in water of at least 10 °C is approximately 6 g/l within 10 minutes.
Maltese: Solubilità massimu tal-prodott fl-ilma ta' mill-inqas 10 °C huwa ta' madwar 6 g/l fi żmien 10 minuti.
English: The beta-lactamase could be encoded in chromosomal or plasmidic genes.
Maltese: Il-beta-lactamase jista' jiġi kodifikat kromosomali jew ġeni plasmidic.
English: The composition of Solamocta differs to that of the reference product (Amoxinsol 100% w/w Powder for Oral Solution) in that it contains only 80% w/w amoxicillin trihydrate and in addition three excipients (sodium carbonate monohydrate, sodium citrate and colloidal anhydrous silica) that are not present in the reference product.
Maltese: Il-kompożizzjoni ta' Solamocta hija differenti minn dik tal-prodott ta' referenza (Amoxinsol 100% w/w Trab għal Soluzzjoni Orali) peress li fiha 80% w/w amoxicillin trihydrate biss u barra minn hekk tliet eċċipjenti (sodium carbonate monohydrate, sodium citrate u colloidal anhydrous silica) li mhumiex preżenti fil-prodott ta' referenza.
English: 2 CVMP guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water EMEA/CVMP/540/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004462.pdf
Maltese: CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105372.pdf 2 CVMP guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water EMEA/CVMP/540/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004462.pdf
English: There are three main mechanisms of resistance to beta-lactams: beta-lactamase production, altered expression and/or modification of penicillin binding proteins (PBP), and decreased penetration of the outer membrane.
Maltese: Hemm tliet mekkaniżmi ewlenin ta' reżistenza għal beta-lactams: produzzjoni beta-lactamase, espressjoni mibdula u/jew modifikazzjoni ta' peniċillina jorbot proteini (PBP), u naqas penetrazzjoni talmembrana ta' barra.
English: Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (thereafter called ‘Solamocta') contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Maltese: Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani (minn hawn 'il quddiem imsejjaħ 'Solamocta') fih 800 mg amoxicillin trihydrate (ekwivalenti għal 697 mg amoxicillin) bħala prodott b'sustanza attiva għal kull gramma.
English: Belgium Eurovet Animal Health BV Handelsweg 25
Maltese: Id-Danimarka Eurovet Animal Health BV Handelsweg 25
English: The use of extended spectrum beta-lactam drugs (e.g. aminopenicillins) might lead to the selection of multi-resistant bacterial phenotypes (e.g. those producing extended spectrum beta-lactamases (ESBLs)).
Maltese: L-użu ta' spettru estiż ta' drogi beta-lactam (eż aminopenicillins) jista' iwassal għall-għażla ta' fenotipi batterji multi-reżistenti (eż dawk li jipproduċu beta-lactamases ispettru estiża (ESBLs)).
English: Amoxicillin is a bactericidal antibiotic belonging to the semisynthetic penicillin group.
Maltese: Amoxicillin huwa antibijotiku batteriċida tal-grupp tal-peniċillina semisintetika.
English: Solubility
Maltese: Solubbiltà
English: The applicant Eurovet Animal Health B.V. submitted a marketing authorisation application, via the decentralised procedure, for Solamocta according to Article 13(3) of Directive 2001/82/EC, referring to the reference product Amoxinsol 100% w/w Powder for Oral Solution authorised in the United Kingdom.
Maltese: L-applikant Eurovet Animal Health B.V. issottometta applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq, permezz ta' proċedura deċentralizzata għal Solamocta skont l-Artikolu 13(3) tadDirettiva 2001/82/KE, li tagħmel referenza għall-prodott ta' referenza Amoxinsol 100% w/w Trab għal Soluzzjoni Orali awtorizzat fir-Renju Unit.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi ta' annimali, rotta ta' amministrazzjoni, applikant fl-Istati Membri
English: At lower temperatures (4 °C), the maximum solubility is approximately 5 g/l within 10 minutes.
Maltese: °C), il-solubilità massimu huwa ta' madwar 5 g/l fi żmien 10 minuti.
English: The warnings are in line with CVMP guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3.
Maltese: It-twissijiet huma konformi mal-linja gwida tasCVMP dwar l-SPC għal prodotti antimikrobiċi (EMEA/CVMP/SAGAM/383441/2005
English: Advice for prudent use
Maltese: Parir għal użu prudenti
English: Solamocta contains sodium carbonate monohydrate as a solubility improvement agent, sodium citrate as a complexing agent and silica colloidal anhydrous as a flow conditioning agent.
Maltese: Solamocta fih is-sodium carbonate monohydrate bħala aġent li jtejjeb is-solubbiltà, is-sodium citrate bħala aġent kumplessanti u s-silica colloidal anhydrous bħala aġent tal-kondizzjonament tal-fluss.
English: It is also active against a limited range of Gram negative bacteria on which the outer layer of the bacterial cell wall is composed of lipopolysaccharide and proteins.
Maltese: Hija wkoll attiva kontra firxa limitata ta' batterji Gram negattivi fuq li s-saffi ta' barra tal-ħajt taċ-ċellula batterjali huwa magħmul minn lipopolysaccharide u proteini.
English: Since the issues raised by Denmark remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation for the product Solamocta and consequently the matter was referred to the CVMP on 28 May 2015 under Article 33(4) of Directive 2001/82/EC.
Maltese: Peress li l-kwistjonijiet imqajmin mid-Danimarka baqgħu ma ssolvewx, l-Istati Membri kkonċernati naqsu milli jilħqu qbil fir-rigward tal-awtorizzazzjoni għattqedgħid fis-suq għall-prodott Solamocta u konsegwentement il-kwistjoni ġiet riferuta lis-CVMP fit28 ta' Mejju 2015 skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: The SPC section 4.5 Special precautions for use in animals, now includes the standard wording regarding use based on susceptibility testing where possible and advising to follow the instructions given in the product information, and the SPC section 5.1 Pharmacodynamic properties, now includes up-to-date information regarding the mode of action of amoxicillin and the three main mechanisms of resistance to beta-lactams.
Maltese: Is-sezzjoni 4.5 tal-SPC, Prekawzjonijiet speċjali għall-użu fl-annimali, issa tinkludi l-formulazzjoni standard rigward l-użu bbażat fuq testijiet tas-suxxettibbiltà fejn ikun possibbli u tagħti parir li jiġu segwiti l-istruzzjonijiet mogħtija fl-informazzjoni tal-prodott, u s-sezzjoni 5.1 tal-SPC Proprjetajiet farmakodinamiċi, issa tinkludi informazzjoni aġġornata rigward il-mod ta' azzjoni ta' amoxicillin u t-tliet mekkaniżmi prinċipali ta' reżistenza għal beta-lactams.
English: The formulation of Solamocta does not alter the pH of the medicated drinking water beyond the naturally occurring range of drinking water.
Maltese: Il-formulazzjoni ta' Solamocta ma tbiddilx il-pH tal-ilma tax-xorb medikat lil hinn mill-medda li sseħħ b'mod naturali fl-ilma tax-xorb.
English: They have demonstrated that the highest therapeutic concentration is fully soluble within 10 minutes in hard/high pH water and soft/low pH water and have determined the maximum solubility (within 10 minutes) in water of different qualities and different temperatures, including very cold (4 °C) water.
Maltese: Huma wrew li l-ogħla konċentrazzjoni terapewtika tinħall kompletament fi żmien 10 minuti f'ilma bilġebla/b'pH għoli u ilma artab/b'pH baxx u ddeterminaw is-solubbiltà massima (fi żmien 10 minuti) flilma ta' kwalitajiet differenti u temperaturi differenti, inkluż ilma kiesaħ ħafna (4°C).
English: Cross-resistance is observed between amoxicillin and other penicillins, particularly with aminopenicillins.
Maltese: Kross reżistenza hija osservata bejn amoxicillin u peniċillini oħra, b'mod partikolari fir-aminopenicillins.
English: The applicant has claimed exemption from the requirement for bioequivalence studies in accordance with section 7.1.c) of the aforementioned CVMP guideline (EMA/CVMP/016/00-Rev.2).
Maltese: L-applikant talab eżenzjoni mir-rekwiżit għal studji ta' bijoekwivalenza skont is-sezzjoni 7.1.c) tal-linja gwida tas-CVMP msemmija qabel (EMA/CVMP/016/00-Rev.2).
English: After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Maltese: Wara t-tmiem tal-perjodu ta' medikazzjoni s-sistema tal-provvista tal-ilma għandha tiġi mnaddfa approprjat biex tiġi evitata inġestjoni ta' ammonti sub-terapewtiku tas-sustanza attiva.
English: These enzymes are capable of cleaving the beta-lactam ring of penicillins, making them inactive.
Maltese: Dawn l-enzimi huma kapaċi li jaqsmu ċ-ċirku beta-lactam tal-peniċillini, li jagħmluhom inattivi.
English: Overall summary of the scientific evaluation of Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani (ara l-Anness I)
English: Sodium citrate binds calcium and magnesium ions (present in hard water) and prevents the formation of insoluble carbonate salts.
Maltese: Sodium citrate jorbot il-joni tal-kalċju u l-manjeżju (preżenti f'ilma li fih il-ġebla) u jipprevjeni l-formazzjoni ta' mluħa karbonati insolubbli.
English: Recommended dosage is 17.4 mg amoxicillin (equivalent to 25 mg veterinary medicinal product) per kg body weight for 3 consecutive days.
Maltese: Dożaġġ rakkomandata hija 17.4 mg amoxicillin (ekwivalenti għal 25 mg prodott mediċinali veterinarju) għal kull kg piż tal-ġisem għal 3 ijiem konsekuttivi.
English: One of the most important is the inactivation of penicillin by beta-lactamase enzymes produced by certain bacteria.
Maltese: Wieħed mill-aktar importanti huwa l-inattivazzjoni tal-peniċillina minn enzimi beta-lactamase prodotti minn ċerti batterji.
English: A satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Maltese: Ġiet ipprovduta ġustifikazzjoni sodisfaċenti li l-prodott, Solamocta, huwa eliġibbli għal rinunzja mirrekwiżit biex tintwera bijoekwivalenza in vivo mal-prodott ta' referenza skont is-sezzjoni 7.1.c) tal-linja gwida tas-CVMP dwar it-tmexxija ta' studji ta' bijoekwivalenza għal prodotti mediċinali veterinarji (EMA/CVMP/016/00-Rev.2) u li l-eċċipjenti mhux se jkollhom impatt fuq il-bijodisponibbiltà jew issigurtà ta' dan il-prodott meta mqabbel mal-prodott ta' referenza.
English: Turkeys
Maltese: Papri
English: For turkeys the recommended dosage is 13.1-17.4 mg amoxicillin (equivalent to 18.8 to 25 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Maltese: Dożaġġ rakkomandat huwa 13.1-17.4 mg amoxicillin (ekwivalenti għal 18.8-25 mg prodott mediċinali veterinarju) għal kull kg ta' piż tal-ġisem għal 3 ijiem jew f'każijiet serji għal 5 ijiem.
English: The applicant has provided all solubility data as required by the CVMP guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMEA/CVMP/540/03Rev.1)2.
Maltese: L-applikant ipprovda d-data tas-solubbiltà kollha kif meħtieġ mil-linja gwida tas-CVMP dwar l-aspetti tal-kwalità tal-mediċini veterinarji farmaċewtiċi għall-għoti permezz tal-ilma tax-xorb (EMEA/CVMP/540/03-Rev.1)2.
English: For ducks the recommended dosage is 17.4 mg amoxicillin (equivalent to 25 mg veterinary medicinal product) per kg body weight for 3 consecutive days.
Maltese: Dożaġġ rakkomandat huwa 17.4 mg amoxicillin (ekwivalenti għal 25 mg prodott mediċinali veterinarju) għal kull kg piż tal-ġisem għal 3 ijiem konsekuttivi.
English: No reference can be found to any evidence that they can affect the gastrointestinal transit, absorption or in vivo stability of amoxicillin.
Maltese: Ma tista' tinstab ebda referenza għal kwalunkwe evidenza li tista' taffettwa t-tranżitu gastrointestinali, l-assorbiment jew l-istabbiltà in vivo ta' amoxicillin.
English: These data have been used to specify appropriate product administration instructions in the Summary of Product Characteristics (SPC) section 4.9 Amounts to be administered and administration route, which will ensure that Solamocta will be fully in solution at the time of administration at the appropriate therapeutic concentration.
Maltese: Din id-data intużat biex tispeċifika struzzjonijiet xierqa dwar l-għoti tal-prodott fis-Sommarju talKaratteristiċi tal-Prodott (SPC) sezzjoni 4.9 Ammonti li għandhom jingħataw u l-mod ta' kif jingħataw, li se tiżgura li Solamocta se jkun kompletament f'soluzzjoni fil-ħin ta' meta jingħata fil-konċentrazzjoni terapewtika xierqa.
English: It is therefore considered that the applicant has demonstrated compliance with the requirements of section 7.1.c) of the abovementioned CVMP guideline (EMA/CVMP/016/00-Rev.2), allowing bridging to the safety and efficacy data associated with the reference product.
Maltese: Għalhekk jitqies li l-applikant wera konformità mar-rekwiżiti tas-sezzjoni 7.1.c) tal-linja gwida tasCVMP msemmija hawn fuq (EMA/CVMP/016/00-Rev.2), li tippermetti li tgħaqqad id-data ta' sigurtà u leffikaċja assoċjati mal-prodott ta' referenza.
English: Given the legal basis of this application (under Article 13(3) of Directive 2001/82/EC - a hybrid or mixed application) and the satisfactory justification for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the abovementioned CVMP guideline (EMA/CVMP/016/00-Rev.2), it is considered that the safety and efficacy of amoxicillin can be extrapolated from that of the reference product.
Maltese: Minħabba l-bażi legali ta' din l-applikazzjoni (skont l-Artikolu 13(3) tad-Direttiva 2001/82/KEapplikazzjoni ibrida jew imħallta ) u l-ġustifikazzjoni sodisfaċenti għal rinunzja mir-rekwiżit biex tintwera bijoekwivalenza in vivo mal-prodott ta' referenza skont sezzjoni 7.1.c) tal-linja gwida tas
English: The recommended dosage for chickens is 13.1 mg amoxicillin (equivalent to 18.8 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Maltese: Id-doża rakkomandata hija 13.1 mg amoxicillin (ekwivalenti għal 18.8 mg prodott mediċinali veterinarju) għal kull kg ta' piż tal-ġisem għal 3 ijiem jew f'każijiet serji għal 5 ijiem.
English: In this procedure, the CVMP was asked to consider whether the available data related to Solamocta is sufficient to support exemption from the requirement for bioequivalence studies in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)1.
Maltese: F'din il-proċedura, is-CVMP ġie mistoqsi jqis jekk id-data disponibbli relatata ma' Solamocta hijiex biżżejjed biex tappoġġja eżenzjoni mir-rekwiżit għall-istudji ta' bijoekwivalenza skont is-sezzjoni 7.1c) tal-linja gwida tas-CVMP dwar it-twettiq ta' studji ta' bijoekwivalenza għal prodotti mediċinali veterinarji (EMA/CVMP/016/00-Rev.
English: In particular, Denmark considered that Solamocta is essentially different from the reference product Amoxinsol and that these differences could be sufficient to require a formal bioequivalence study.
Maltese: B'mod partikolari, id-Danimarka kkunsidrat li Solamocta huwa essenzjalment differenti mill-prodott ta' referenza Amoxinsol u li dawn id-differenzi jistgħu jkunu biżżejjed biex ikun hemm bżonn ta' studju formali ta' bijoekwivalenza.
English: Amoxicillin is a time-dependent bactericidal antibiotic which acts by inhibiting the synthesis of bacterial cell walls during bacterial replication.
Maltese: Amoxicillin huwa dipendenti fuq żmien antibijotiku batteriċida li jaġixxi billi jinibixxi s-sintesi ta' ħitan taċ-ċelluli batterjali matul replikazzjoni batterjali.
English: Advice on prudent use has been proposed to address responsible use in relation to development of antimicrobial resistance.
Maltese: Ġie propost parir dwar l-użu prudenti sabiex jindirizza l-użu responsabbli fir-rigward tal-iżvilupp ta' reżistenza antimikrobika.
English: The recommended dosage is 13.1 mg amoxicillin (equivalent to 18.8 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Maltese: Dożaġġ rakkomandat huwa 13.1 mg amoxicillin (ekwivalenti għal 18.8 mg prodott mediċinali veterinarju) għal kull kg ta' piż tal-ġisem għal 3 ijiem jew f'każijiet serji għal 5 ijiem.
English: J Am Med Assoc 2004b;291(16):1999-2006.
Maltese: Falls. J Am Med Assoc 2004b;291(16):
English: Rheumatol Int 2013;33(3):637-43; Epub 2012 Apr 8.
Maltese: Rheumatol Int 2013;33(3):637-43; Epub 2012 Apr 8. 11 Kaya U et al.
English: 10 Ringe JD, Farahmand P, Schacht E. Alfacalcidol in men with osteoporosis: a prospective, observational, 2-year trial on
Maltese: Alfacalcidol in men with osteoporosis: a prospective, observational, 2-year trial on
English: Alfacalcidol alone was slightly superior to alendronate + plain Vitamin D + calcium after two years (MW = 0.5422; CI-LB = 0.4838; p = 0.0785).
Maltese: Alfakalċidol waħdu kien kemxejn superjuri għal alendronat + Vitamina D plain + kalċju wara sentejn (MW = 0.5422; CI-LB = 0.4838; p = 0.0785).
English: Richy F, Dukas L, Schacht E. Differential effects of D-hormone analogs and native Vitamin D on the risk of falls: A comparative meta-analysis.
Maltese: Differential effects of D-hormone analogs and native Vitamin D on the risk of falls: A comparative meta-analysis.
English: • The Committee considered the notification of the referral triggered by Germany under Article 29(4) of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdi mill-Ġermanja taħt l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: 6 Bischoff-Ferrari HA, Dawson-Hughes B, Willett WC, Staehelin HB, Bazemore MG, Zee RY, Wong JB.
Maltese: HA, Dawson-Hughes B, Willett WC, Staehelin HB, Bazemore MG, Zee RY, Wong JB. Effect of Vitamin D on
English: Falls.
Maltese: Billi
English: 5 Ringe JD, Farahmand P, Schacht E, Rozehnal A. Superiority of a combined treatment of Alendronate and Alfacalcidol compared to the combination of Alendronate and plain vitamin D or Alfacalcidol alone in established postmenopausal or male osteoporosis (AAC-Trial).
Maltese: Superiority of a combined treatment of Alendronate and Alfacalcidol compared to the combination of Alendronate and plain vitamin D or Alfacalcidol alone in established postmenopausal or male osteoporosis (AAC-Trial).
English: Significant fall reduction in alfacalcidol-treated subject with a total calcium intake of more than 512 mg/d (median Ca intake in the study) (OR 0.45; 95% CI 0.21-0.97, p=0.042) was observed but not in those with less Ca intake than 512 mg/d (OR 1.00, 95% CI 0.47-2.11, p=0.998).
Maltese: Tnaqqis sinifikanti fil-waqgħat f'individwi li rċevew kura b'alfakalċidol b'teħid totali ta' kalċju ta' aktar minn 512 mg/d (teħid medjan ta' Ca fl-istudju) (OR 0.45; 95% CI 0.21-0.97, p=0.042) kien osservat iżda mhux f'dawk b'teħid ta' Ca anqas minn 512 mg/d (OR 1.00, 95% CI 0.
English: Treatment with calcitriol 0.25 μg twice daily significantly reduced the number of fallers (OR 0.54 (95% CI 0.31-0.94, p<0.03) and decreased the incidence of falls compared to placebo (0.27 versus 0.43, p=0.0015) in this 3 years trial.
Maltese: Kura b'calcitriol 0.25 μg darbtejn kuljum naqqset b'mod sinifikanti l-għadd ta' persuni li waqgħu (OR 0.54 (95% CI 0.31-0.94, p<0.03) u naqqset l-inċidenza ta' waqgħat meta mqabbla ma' plaċebo (0.27 kontra 0.43, p=0.0015) f'din il-prova ta' 3 snin.
English: 7 Bischoff-Ferrari HA, Willett WC, Wong JB, Stuck AE, Staehelin HB, Orav EJ, Thoma A, Kiel DP, Henschkowski J. Prevention of Nonvertebral Fractures with Oral Vitamin D and Dose Dependency.
Maltese: HA, Willett WC, Wong JB, Stuck AE, Staehelin HB, Orav EJ, Thoma A, Kiel DP, Henschkowski J.
English: The results over 36 weeks showed that alfacalcidol treatment was associated with fewer non-significantly fallers than placebo (OR (Odds ratio) 0.69, 95% CI (confidence interval): 0.41-1.16).
Maltese: Ir-riżultati fuq 36 ġimgħa wrew li kura b'alfakalċidol kienet assoċjata b'mod mhux sinifikanti ma' anqas persuni li waqgħu minn plaċebo (OR (Proporzjon ta' probabbiltà) 0.69, 95% CI (intervall ta' fiduċja): 0.41-1.16).
English: Ringe et al (2007) presented a randomised trial, where three treatments were compared ‘alfacalcidol alone', ‘alfacalcidol + alendronate' and ‘alendronate + vitamin D + calcium'.
Maltese: Ringe et al (2007) ippreżenta prova każwali, fejn tqabblu tliet trattamenti: ‘alfakalċidol waħdu, ‘alfakalċidol + alendronat' u ‘alendronat + Vitamina D + kalċju'.
English: O'Donnell S, Moher D, Thomas K, Hanley D A, Cranney A. Systematic review of the benefits and harms of calcitriol and alfacalcidol for fractures and falls.
Maltese: O'Donnell S, Moher D, Thomas K, Hanley D A, Cranney A.
English: Population pharmacokinetic modelling and simulation at steady state
Maltese: Immudellar tal-farmakokinetika tal-popolazzjoni u simulazzjoni fl-istat stabbli
English: These results are supported by two other studies published by Ringe and Schacht (2012, 2013).
Maltese: Dawn irriżultati huma appoġġati minn żewġ studji oħra ppubblikati minn Ringe u Schacht (2012, 2013).
English: Gallagher et al (2004) examined the effects of calcitriol on falls in a randomised, double-blind, placebocontrolled study in 489 postmenopausal, Vitamin D replete/sufficient women with osteopenia.
Maltese: Gallagher et al (2004) eżamina l-effetti ta' calcitriol fuq il-waqgħat fi studju każwali, bi blindaġġ doppju, ikkontrollat bi plaċebo f'489 mara wara l-menopawża, b'biżżejjed/suffiċjenza ta' Vitamina D b'osteopenija.
English: Valebo is a combination package consisting of tablets containing 70 mg of alendronate sodium (alendronic acid) and soft capsules containing 1µg of alfacalcidol.
Maltese: Valebo huwa pakkett ta' kombinazzjoni li jikkonsisti minn pilloli li fihom 70 mg ta' alendronat tas-sodju (aċidu alendroniku) u kapsuli rotob li fihom 1µg ta' alfakalċidol.
English: It is converted rapidly in the liver to 1,25 dihydroxyvitamin D, so called calcitriol.
Maltese: Fil-fwied jiġi konvertit malajr f'1,25 dihydroxyvitamin D, magħruf bħala calcitriol.
English: The combination ‘alendronate + alfacalcidol' showed a significant superiority in reduction of falls compared to ‘alendronate + plain Vitamin D + calcium' after two years (MannWhitney (MW) = 0.5506; Confidence interval Lower bound (CI-LB) = 0.4937; p=0.0407) but not superiority to ‘alfacalcidol alone'.
Maltese: Il-kombinazzjoni ‘alendronat + alfakalċidol' uriet superjorità sinifikanti fit-tnaqqis ta' waqgħat meta mqabbla ma' ‘alendronat + Vitamina D plain + kalċju' wara sentejn (Mann-Whitney (MW) = 0.5506;
English: However, the CHMP agreed to provide the respective information in the section 5.1 of the SmPC “In some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly”.
Maltese: Madankollu, is-CHMP qabel li jipprovdi l-informazzjoni rispettiva fis-sezzjoni 5.1 tal-SmPC “F'xi studji kliniċi, alfakalċidol intwera li jnaqqas ir-riskju ta' waqgħat fl-anzjani”.