FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of Kinzalmono may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Maltese: L-effetti ta' Kinzalmono jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra linfjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister (28 x 1 tablets pack)
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI Folja b'doża waħda (Pakkett ta' 28 x 1 pilloli)
English: NAME OF THE MEDICINAL PRODUCT Kinzalmono 80 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Kinzalmono 80 mg pilloli Telmisartan
English: NAME OF THE MEDICINAL PRODUCT Kinzalmono 20 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Kinzalmono 20 mg pilloli Telmisartan
English: Renovascular hypertension
Maltese: Pressjoni għolja renovaskulari
English: NAME OF THE MEDICINAL PRODUCT Kinzalmono 40 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Kinzalmono 40 mg pilloli Telmisartan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kinzalmono 20 mg tablets
Maltese: U KWANTITATTIVA Kinzalmono 20 mg pilloli
English: Children and adolescents The use of Kinzalmono in children and adolescents up to the age of 18 years is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Kinzalmono fit-tfal u fl-adolexxenti sal-età ta' 18-il sena mhuwiex rakkomandat.
English: Kinzalmono 40 mg and 80 mg tablets Pack sizes: Blister with 14, 28, 56 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Maltese: Folja b'14, 28, 56 jew 98 pillola jew folji perforati b'doża waħda bi 28 x 1 pillola.
English: Kinzalmono may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Kinzalmono.
Maltese: Kinzalmino jista' jintuża flimkien ma' dijuretiċi (‘pilloli tal-awrina') bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il-pressjoni tad-demm b'Kinzalmono.
English: Dyspnoea, cough Interstitial lung disease
Maltese: Il-bidla kienet tiddependi mid-doża.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: Espożizzjoni għall-kura b'antagonisti tar-riċetturi ta' angiotensin II matul it-tieni u t-tielet trimestri hu magħruf li jinduċi fetotossiċità (tnaqqis fil-funzjoni renali, oligoidramnios, ittardjar fl-ossifikazzjoni tal-kranju) u tossiċità fit-trabi tat-twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija).
English: The full EPAR for Mavenclad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance cladribine.
Maltese: Fih is-sustanza attiva kladribina.
English: This is a summary of the European public assessment report (EPAR) for Mavenclad.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mavenclad.
English: Mavenclad has been shown to be effective in one main study involving 1,326 patients with relapsingremitting multiple sclerosis.
Maltese: Mavenclad wera li huwa effettiv fi studju ewlieni wieħed li kien jinvolvi 1,326 pazjent bi sklerożi multipla rikaduta-remittenti.
English: The active substance in Mavenclad, cladribine, has a similar chemical structure to purine, one of the substances needed to make up the DNA.
Maltese: Is-sustanza attiva f'Mavenclad, il-kladribina, għandha struttura kimika simili għal purin, waħda missustanzi meħtieġa biex tiġi ffurmata d-DNA.
English: Other information about Mavenclad
Maltese: Informazzjoni oħra dwar Mavenclad
English: Relapsing means that the patient has repeated flare-ups of the symptoms.
Maltese: Rikaduti tfisser li l-pazjent ikollu taħrix f'daqqa ripetut tas-sintomi.
English: Patients treated with Mavenclad had a relapse rate of 0.14 per year on average, compared with 0.33 for patients given placebo; at the end of 96 weeks, around 8 out 10 patients given standard doses of Mavenclad and 6 out of 10 given placebo had not had a relapse.
Maltese: Il-pazjenti kkurati b'Mavenclad kellhom rata ta' rikaduta ta' 0.14 kull sena bħala medja, meta mqabbla ma' 0.33 għal pazjenti mogħtija l-plaċebo; fittmiem tas-96 ġimgħa, madwar 8 minn kull 10 pazjenti li ngħataw dożi standard ta' Mavenclad u 6 minn kull 10 mogħtija l-plaċebo ma kellhomx rikaduta.
English: Why is Mavenclad approved?
Maltese: Għaliex ġie approvat Mavenclad?
English: In addition, patients given Mavenclad were nearly 50% less likely to have disease progression (indicated as an increase in disability that lasted for at least 6 months).
Maltese: Barra minn hekk, il-pazjenti li ngħataw Mavenclad kellhom kważi 50 % inqas ċans li jkollhom progressjoni tal-marda (indikata bħala żieda fiddiżabilità li damet għal mill-inqas 6 xhur).
English: What are the risks associated with Mavenclad?
Maltese: X'inhuma r-riskji assoċjati ma' Mavenclad?
English: The most common side effects with Mavenclad are lymphopenia (reduction in lymphocytes, which may affect more than 1 in 10 people) and infections with herpes zoster virus, in up to 1 patient in 10.
Maltese: L-effetti sekondarji l-aktar komuni b'Mavenclad huma l-limfopenija (tnaqqis fil-limfoċiti, li jista' jaffettwa aktar minn 1 minn kull 10 persuni) u infezzjonijiet bil-virus herpes zoster, f'sa pazjent 1 minn kull 10 pazjenti.
English: The first year, patients take one to two tablets a day for 4 or 5 days; after one month, they again take one to two tablets a day for 4 or 5 days, adding up to a total dose of 1.75 mg per kg body weight over the two periods.
Maltese: Fl-ewwel sena, il-pazjenti jieħdu minn pillola waħda sa tnejn kuljum għal 4 jew 5 ijiem; wara xahar, dawn jerġgħu jieħdu minn pillola waħda sa tnejn kuljum għal 4 jew 5 ijiem, fejn dan jammonta għal doża totali ta' 1.75 mg għal kull kg ta' piż tal-ġisem matul iż-żewġ perjodi.
English: Cladribine is already approved in the EU for the treatment of certain leukaemias (cancers affecting lymphocytes).
Maltese: Il-kladribina huwa diġà approvat fl-UE għall-kura ta' ċerti lewkimji (kanċers li jaffettwaw il-limfoċiti).
English: In multiple sclerosis, the body's immune (defence) system attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Maltese: L-isklerożi multipla, is-sistema (ta' difiża) immunitarja tal-ġisem tattakka u tagħmel ħsara lir-rita protettiva madwar iċ-ċelloli tan-nervaturi fis-sistema nervuża ċentrali (il-moħħ u l-korda spinali).
English: This appeared to be most marked in patients with highly active disease, in whom the clinical benefits were considered to outweigh the risks of a severe long-term lowering in lymphocyte numbers, which increases the risk of infection and possibly of cancer.
Maltese: Dan deher li kien l-aktar evidenti f'pazjenti b'marda attiva ħafna, fejn fihom il-benefiċċji kliniċi kienu meqjusa li kienu akbar mir-riskji ta' tnaqqis sever fit-tul fl-għadd tal-limfoċiti, fejn dan iżid ir-riskju ta' infezzjoni u possibbilment kanċer.
English: The company that markets Mavenclad will provide information on the medicine for healthcare professionals and patients, including advice on the side effects and safety concerns, the need for monitoring before and during treatment, and on pregnancy prevention and effective contraception in both female and male patients.
Maltese: Il-kumpanija li tqiegħed Mavenclad fis-suq se tipprovdi informazzjoni dwar il-mediċina għallprofessjonisti fil-qasam tal-kura tas-saħħa u għall-pazjenti, inkluż parir dwar l-effetti sekondarji u ttħassib dwar is-sigurtà, il-ħtieġa għall-monitoraġġ qabel u matul il-kura, u dwar il-prevenzjoni tat-tqala u l-kontraċezzjoni effettiva kemm f'pazjenti femminili kif ukoll dawk maskili.
English: Mavenclad is a medicine used to treat adults with the relapsing forms of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Maltese: Mavenclad huwa mediċina użata biex tikkura adulti b'forom rikaduti ta' sklerożi multipla, marda li fiha l-infjammazzjoni tagħmel ħsara lill-għata protettiva madwar iċ-ċelluli tan-nervituri fil-moħħ u fis-sinsla tad-dahar.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku kladribina
English: Mavenclad cladribine
Maltese: Kif jintuża Mavenclad?
English: Mavenclad has been shown to reduce relapse rates and delay disease progression in patients with relapsing multiple sclerosis.
Maltese: Mavenclad intwera li jnaqqas ir-rati ta' rikaduta u jdewwem il-progressjoni tal-marda f'pazjenti bi sklerożi multipla rikaduta.
English: This brings about the death of the lymphocytes, slowing down the progression of multiple sclerosis.
Maltese: Dan iwassal għall-mewt tal-limfoċiti, fejn jitnaqqas irritmu tal-progressjoni tal-isklerożi multipla.
English: It must not be given to patients with active cancers.
Maltese: Dan m'għandux jingħata lil pazjenti b'kanċers attivi.
English: For the full list of all side effects reported with Mavenclad, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Mavenclad, ara l-fuljett ta' tagħrif.
English: Effects on lymphocytes reduce the body's immune defence against infections and cancer: Mavenclad must not be given to patients with active long-term infections such as tuberculosis or hepatitis, nor to patients with HIV infection or whose immune defences are weakened for other reasons such as treatment with medicines that suppress the immune system.
Maltese: Mavenclad m'għandux jingħata lil pazjenti b'infezzjonijiet attivi fuq perjodu twil bħat-tuberkulożi jew lepatite, u lanqas lil pazjenti b'infezzjoni tal-HIV jew li d-difiżi immunitarji tagħhom huma mdgħajfa għal raġunijiet bħall-kura b'mediċini li jissoppressaw is-sistema immunitarja.
English: Mavenclad is used in patients whose disease is highly active.
Maltese: Mavenclad jintuża f'pazjenti li l-marda tagħhom hija attiva ħafna.
English: It is not intended to provide practical advice on how to use Mavenclad.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Mavenclad.
English: Whereas
Maltese: IU).
English: • Safety
Maltese: • Sigurtà
English: Statistical issues (meta-analysis)
Maltese: Kwistjonijiet statistiċi (meta-analiżi)
English: Pharmacovigilance
Maltese: Farmakoviġilanza
English: More recently a new oral formulation for calcitonin has been developed which consists of the peptide hormone and 5-CNAC (8-(N-2-hydroxy-5-chloro-benzoyl)-amino-carpylic acid), a newly developed enhancer of gastrointestinal peptide absorption.
Maltese: Aktar reċenti ġiet żviluppata formulazzjoni orali ġdida għal calcitonin li tikkonsisti mill-ormon peptide u 5-CNAC (8-(N-2-hydroxy-5-chloro-benzoyl)-amino-carpylic acid), enhancer żviluppat ġdid tal-assorbiment gastrointestinali tal-peptide.
English: One IU corresponds to approximately 0.2μg of synthetic salmon calcitonin.
Maltese: UI waħda tikkorrispondi għal madwar 0.2μg ta' calcitonin sintetiku mis-salamun.
English: Concerns on the efficacy of certain indications were previously raised, which resulted in a referral under Article 12 of Directive 75/319/EC (corresponding to Article 31 of Directive 2001/83/EC) in 2000.
Maltese: Preċedentement kien tqajjem tħassib dwar l-effikaċja ta' ċerti indikazzjonijiet, li wassal għal riferiment skont l-Artikolu 12 tad-Direttiva 75/319/KE (li jikkorrispondi għall-Artikolu 31 tadDirettiva 2001/83/KE) fl-2000.
English: • The Committee considered the referral made under Article 31 of Directive 2001/83/EC for calcitonin-containing medicines;
Maltese: • Il-Kumitat ikkunsidra r-riferiment magħmul skont l-Artikolu 31 tad-Direttiva 2001/83/KE għallmediċini li fihom calcitonin;
English: These data are also supported by the meta-analysis of the 3 studies (C2301, C2302 and A2303) performed with the oral formulations.
Maltese: Din id-dejta hija wkoll appoġġjata mill-meta-analiżi tat-3 studji (C2301, C2302 and A2303) mwettqa bil-formolazzjonijiet orali.
English: Injectable calcitonin is available as a solution for injection or infusion at 50, 100 or 200 International Units (IU)/ml.
Maltese: Calcitonin injettabbli huwa disponibbli bħala soluzzjoni għall-injezzjoni jew għall-infużjoni f'50, 100 jew 200 Unità Internazzjonali (UI)/ml.
English: The increased risk of cancer with calcitonin in the other two trials with the new oral formulation, was not statistically significant incidence rate ratio of 1.61 (0.81-3.16) and 1.10 (0.821.48) for studies C2302 and A2303 respectively.
Maltese: Iż-żieda fir-riskju ta' kanċer b'calcitonin fiż-żewġ provi l-oħra bil-formulazzjoni orali l-ġdida, ma kinitx proporzjon ta' rata ta' inċidenza statistikament sinifikanti ta' 1.61 (0.81-3.16) u 1.10 (0.82-1.48) għall-istudji C2302 u A2303 rispettivament.
English: The indication of fracture prevention in osteoporosis, is supported by results from a reasonably sized, placebo controlled double blind study known as the PROOF (Prevent Recurrence of Osteoporotic Fractures) study.
Maltese: L-indikazzjoni ta' prevenzjoni tal-ksur fl-osteoporożi, hija appoġġjata mir-riżultati ta' studju double blind ta' daqs raġonevoli, ikkontrollat minn plaċebo, magħruf bħala l-istudju PROOF (Prevent Recurrence of Osteoporotic Fractures).
English: Calcitonin is a hypocalcaemic compound secreted from the thyroid.
Maltese: Calcitonin huwa kompost ipokalċimiku merħi mit-tirojde.
English: • Efficacy
Maltese: • Effikaċja
English: Data from the Sanofi-Aventis pharmacovigilance database and the Novartis Global Safety Database were also analysed to identify all cases mapping to the Neoplasms benign, malignant and unspecified system organ class (SOC).
Maltese: Ġiet analizzata wkoll id-dejta mid-database tal-farmakoviġilanza ta' Sanofi-Aventis u d-Database Globali dwar is-Sigurtà ta' Novartis sabiex jiġu identifikati l-każijiet kollha li jimmappjaw għanNeoplażmi beninni, malinni u sistema tal-klassifika tal-organi (SOC) mhux speċifikata.
English: Since 1987 calcitonin has also been available as an intranasal formulation.
Maltese: Mill-1987, calcitonin kien disponibbli wkoll bħala formulazzjoni intranażali.
English: In exceptional circumstances eg.
Maltese: IV tal-Opinjoni.
English: The intranasal formulation is available at 100 or 200 International Units (IU)/ml.
Maltese: Unità Internazzjonali (UI)/ml.
English: The CHMP also endorsed a communication i.e. Dear Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Maltese: Is-CHMP approva wkoll komunikazzjoni, jiġifieri Dear Healthcare Professional Communication (DHPC), sabiex jikkomunika l-eżitu tal-valutazzjoni preżenti.
English: The CHMP considered that BMD, is still regarded to be an important surrogate marker, which was shown to have a modest but statistically significant increase in comparison with placebo.
Maltese: Is-CHMP qies li l-BMD, għadu meqjus bħala markatur surrogat importanti, li intwera li għandu żieda modesta iżda statistikament sinifikanti meta mqabbel mal-plaċebo.
English: The MAH also discusses the lack of causality based on the Bradford-Hill criteria, which have been taken into account and assessed.
Maltese: L-MAH jiddiskuti wkoll in-nuqqas ta' kawżalità bbażata fuq il-kriterji Bradford-Hill, li ġew ikkunsidrati u vvalutati.
English: In this setting, the statistical significance is superseded by clinical relevance.
Maltese: F'dan l-ambjent, is-sinifikat statistiku huwa megħlub mir-rilevanza klinika.
English: In November 2010, preliminary safety findings relating to prostate cancer were observed during two clinical trials for the new oral formulation of calcitonin.
Maltese: F'Novembru 2010, kienu osservati sejbiet preliminari dwar is-sigurtà relatati mal-kanċer filprostata waqt żewġ provi kliniċi għall-formulazzjoni orali l-ġdida ta' calcitonin.
English: Two of these were osteoarthritis studies (C2301 and C2302), where patients received 0.8mg twice daily.
Maltese: Tnejn minn dawn kienu studji dwar l-osteoartrite (C2301 u C2302), fejn il-pazjenti rċevew 0.8mg darbtejn kuljum.
English: In the first of these trials (study C2301), a statistical significant increased risk of cancer was reported in patients treated with calcitonin compared with placebo (incidence rate ratio 4.13 (1.67-10.19)).
Maltese: Fl-ewwel minn dawn it-tliet provi (studju C2301), kienet irrapportata żieda statistikament sinifikanti fir-riskju ta' kanċer fil-pazjenti kkurati b'calcitonin meta mqabbel mal-plaċebo (proporzjon tar-rata ta' inċidenza 4.13 (1.67-10.19)).
English: The results of the biggest of the trials conducted with intra-nasal calcitonin , study CT320 (also known as the PROOF study), provides some evidence of an increased risk of cancer in the calcitonin arm compared with placebo even though the reported results fail to reach statistical significance (relative risk, 95%CI: 1.47 (0.91-2.36)).
Maltese: Ir-riżultati tal-akbar waħda mill-provi mwettqa b'calcitonin intranażali, l-istudju CT320 (magħruf ukoll bħala l-istudju PROOF), jipprovdu xi evidenza ta' riskju akbar ta' kanċer fil-grupp li ħa calcitonin meta mqabbel mal-plaċebo, għalkemm ir-riżultati rrapportati jonqsu milli jilħqu sinifikat statistiku (riskju relattiv, 95%CI: 1.47 (0.91-2.36)).
English: The Odds Ratio (OR) for the incidence of cancer in these trials in patients treated with calcitonin was 1.61 (1.11-2.34).
Maltese: L-Odds Ratio (OR) għall-inċidenza ta' kanċer f'dawn il-provi fil-pazjenti kkurati b'calcitonin kien 1.61 (1.11-2.34).
English: In addition, the metaanalysis of the trials with the new formulation showed a statistical significant increase in the incidence rate ratio for patients treated with calcitonin, 1.33 (1.035-1.72), similar to the increase observed during the intranasal trials.
Maltese: Barra minn hekk, il-meta-analiżi tal-provi bil-formulazzjoni l-ġdida wriet żieda statistikament sinifikanti fil-proporzjon tar-rata ta' inċidenza għall-pazjenti kkurati b'calcitonin, 1.33 (1.035-1.72), simili għaż-żieda osservata fil-provi intranażali.
English: Grounds for re-examination were received on 22 September 2012.
Maltese: Ir-raġunijiet għal eżaminazzjoni mill-ġdid waslu fit-22 ta' Settembru 2012.
English: The Committee concluded that the benefit-risk balance of calcitonin-containing injectable formulations indicated in the treatment of Paget's disease, hypercalcaemia of malignancy and for the prevention of acute bone loss due to sudden immobilisation, remains positive under normal conditions of use, subject to the restrictions in indication (for Paget's disease), limitation of treatment duration and warnings to be introduced in the product information.
Maltese: Il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju tal-formulazzjonijiet injettabbli li fihom calcitonin, indikati fil-kura tal-marda ta' Paget, iperkalċemija minn tumuri malinni u għallprevenzjoni ta' telf akut ta' għadam minħabba immobilizzazzjoni f'daqqa, jibqa' pożittiv f'kundizzjonijiet ta' użu normali, soġġett għar-restrizzjonijiet fl-indikazzjoni (għall-marda ta' Paget), il-limitazzjoni tat-tul tal-kura u t-twissijiet li għandhom jiġu introdotti fl-informazzjoni dwar il-prodott.
English: The CHMP reviewed the currently available short and long-term evidence of efficacy of calcitonin in the authorised indications (as per Commission Decision of 12 June 2003), and the information about the risk of cancer with calcitonin from pre-clinical studies, clinical trials, post-marketing spontaneous reports, pharmacoepidemiological studies and published literature.
Maltese: Is-CHMP irreveda l-evidenza attwalment disponibbli tal-effikaċja għal perjodu qasir u fit-tul ta' calcitonin fl-indikazzjonijiet awtorizzati (skont id-Deċiżjoni tal-Kummissjoni tat-12 ta' Ġunju 2003), u l-informazzjoni dwar ir-riskju ta' kanċer b'calcitonin minn studji ta' qabel l-użu kliniku, provi kliniċi, rapporti spontanji ta' wara t-tqegħid fis-suq, studji farmakoepidemjoloġiċi u r-riċensjoni ppubblikata.
English: The CHMP also consulted a group of experts on 6 November 2012 to gain their view on a number issues.
Maltese: Is-CHMP ikkonsulta wkoll lil grupp ta' esperti fis-6 ta' Novembru 2012 sabiex jikseb il-fehma tagħhom dwar għadd ta' kwistjonijiet.
English: Further evidence of a possible association between calcitonin and the risk of cancer is provided by a meta-analysis of 17 randomised, controlled, double blind studies with intranasal calcitonin performed by one of the MAHs.
Maltese: Aktar evidenza ta' relazzjoni possibbli bejn calcitonin u r-riskju ta' kanċer hija pprovduta minn meta-analiżi ta' 17-il studju każwali, double blind u kkontrollat b'calcitonin intranażali mwettqa minn wieħed mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs).
English: The MAH argued that the improvement in bone mineral density (BMD) underestimates fracture efficacy.
Maltese: L-MAH argumenta li t-titjib tad-densità tal-minerali tal-għadam (BMD) jissottovaluta l-effikaċja talksur.
English: The CHMP accepted that some evidence of efficacy in this indication has been provided, mainly by the study by Tsakalakos et al.
Maltese: Is-CHMP aċċetta li ġiet ipprovduta xi evidenza tal-effikaċja f'din l-indikazzjoni, prinċipalment mill-istudju ta' Tsakalakos et al.
English: Even when overlooking these limitations, the overall clinical benefit of calcitonin in osteoporosis appears to be very modest, with an absolute reduction of approximately 6% and 1.7% in the patients with ≥1 and ≥2 new vertebral fracture respectively compared to patients treated with placebo.
Maltese: Anki meta jiġu injorati dawn il-limitazzjonijiet, il-benefiċċju kliniku globali ta' calcitonin fl-osteoporożi jidher li huwa modest ħafna, bi tnaqqis assolut ta' madwar 6% u 1.7% fil-pazjenti li kellhom ≥1 u ≥2 ksur vertebrali ġdid, rispettivament, meta mqabbel mal-pazjenti li ngħataw plaċebo.
English: The MAH argues that the studies included in the meta-analysis lacked a defined PICO (population, intervention, comparison and outcome) statement.
Maltese: L-MAH jargumenta li l-istudji inklużi filmeta-analiżi ma kellhomx dikjarazzjoni ta' PICO (popolazzjoni, intervent, tqabbil u riżultat) definita.
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations of the injectable formulations of calcitonin and suspension of the marketing authorisations of the intranasal formulations of calcitonin
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għall-varjazzjoni fit-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq tal-formulazzjonijiet injettabbli ta' calcitonin u s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq talformulazzjonijiet intranażali ta' calcitonin
English: Importantly, cancer mortality was again considerably higher in calcitonin treated patients in these trials compared to placebo; 7 cases (37.5%) compared to 2 (10.5%).
Maltese: Fuq kollox, il-mortalità bilkanċer reġgħet kienet konsiderevolment ogħla fil-pazjenti kkurati b'calcitonin f'dawn il-provi meta mqabbel mal-plaċebo; 7 każijiet (37.5%) meta mqabbel ma' 2 (10.
English: Overall there appears to be sufficient and consistent evidence from the intranasal and oral calcitonin trials, that calcitonin is associated with an increased risk of cancer.
Maltese: B'mod ġenerali, jidher li hemm evidenza suffiċjenti u konsistenti mill-provi intranażali u orali ta' calcitonin, li calcitonin huwa assoċjat ma' żieda fir-riskju ta' kanċer.
English: • Treatment of hypercalcaemia of malignancy (injectable formulation)
Maltese: • Kura tal-osteoporożi sabiex jitnaqqas ir-riskju ta' ksur vertebrali (formulazzjoni intranażali)