FrancophonIA/ELRC3.0 huggingface dataset:
English: Dosage recommendations have been defined from the effects of andexanet alfa in healthy volunteers administered a direct FXa inhibitor and from the ability to reverse the levels of anti-FXa activity.
Maltese: Ir-rakkomandazzjonijiet tad-dożaġġ ġew definiti mill-effetti ta' andexanet alfa f'voluntiera b'saħħithom li ngħataw inibitur dirett tal-FXa u mill-abilità li jreġġa' lura l-livelli tal-attività anti-FXa.
English: Using a 20 mL (or larger) syringe and a 20 gauge (or larger) needle, withdraw 20 mL of water for injections.
Maltese: 3. Uża siringa ta' 20 mL (jew akbar) u labra b'gauge ta' 20 (jew akbar), iġbed lura 20 mL ilma għall-injezzjoni.
English: Urticaria common
Maltese: Iperidrożi komuni
English: Acute myocardial infarction uncommon
Maltese: Disturbi fis-sistema immuni Urtikarja komuni
English: Data from bleeding patients are limited.
Maltese: Id-data minn pazjenti bi ħruġ ta' demm hija limitata.
English: Preliminary data suggest higher risk of thrombosis for patients receiving the higher dose of andexanet, previous lower dose of the anti-FXa inhibitor, and patients on rivaroxaban.
Maltese: Data preliminari tissuġġerixxi riskju ogħla ta' trombożi għal pazjenti li qed jirċievu doża ogħla ta' andexanet, doża aktar baxxa ta' inibitur anti-FXa preċedenti, u pazjenti li qed jieħdu rivaroxaban.
English: Breast-feeding should be discontinued during treatment with andexanet alfa.
Maltese: It-treddigħ għandu jitwaqqaf waqt it-trattament b'andexanet alfa.
English: No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in patients with hepatic impairment.
Maltese: Ma twettqux provi biex tiġi investigata l-farmakokinetika ta' andexanet alfa f'pazjenti b'indeboliment epatiku.
English: Pro-coagulant factor treatments (e.g., 3- or 4-factor prothrombin complex concentrate (PCC)/activated PCC, recombinant factor VIIa, fresh frozen plasma) and whole blood should be avoided unless absolutely required, due to lack of data in combination with these treatments.
Maltese: Trattamenti b'fatturi favur il-koagulazzjoni (eż., fattur-3 jew-4 konċentrat kumpless tal-protrombin (PCC, prothrombin complex concentrate)/PCC attivat, fattur VIIa rikombinanti, plażma ffriżata friska) u demm sħiħ għandhom jiġu evitati ħlief jekk ikunu assolutament meħtieġa, minħabba nuqqas ta' data flimkien ma' dawn it-trattamenti.
English: • chest discomfort
Maltese: • Awtorizzazzjoni għat-tqegħid fis-suq kondizzjonali
English: Powder for solution for infusion White to off-white lyophilized powder
Maltese: Fertilità M'hemm l-ebda data dwar l-effetti ta' andexanet alfa fuq il-fertilità tal-bniedem.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla komuni
English: When andexanet alfa was administered as a bolus followed by a continuous infusion, the maximum decrease in unbound FXa inhibitors was rapid (within two minutes of the end of the bolus) and was sustained over the course of the infusion then gradually increased over time, reaching a maximum at approximately two hours following the end of infusion.
Maltese: Meta andexanet alfa ngħata bħala bolus segwit minn infużjoni kontinwa, it-tnaqqis massimu f'inibituri ta' FXa mhux marbuta kien rapidu (fi żmien żewġ minuti wara l-bolus) u kien sostnut matul linfużjoni mbagħad żdied b'mod gradwali maż-żmien, u laħaq massimu f'madwar sagħtejn wara li ntemmet l-infużjoni.
English: Andexanet alfa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min over 15 (low dose) or 30 minutes (high dose), immediately followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Maltese: Andexanet alfa jingħata bħala bolus ġol-vini (IV) b'rata fil-mira ta' madwar 30 mg/min għal 15-il (doża baxxa) jew 30 minuta (doża għolja), u jiġi immedjatament segwit mill-għoti ta' infużjoni kontinwa ta' 4 mg (doża baxxa) jew 8 mg (doża għolja) kull minuta għal 120 minuta (ara tabella 1).
English: The most frequently observed adverse reactions were mild or moderate infusion-related reactions (see table 4) comprising symptoms such as flushing, feeling hot, cough, dysgeusia, and dyspnoea occurring within a few minutes to a few hours of the infusion.
Maltese: Irreazzjonijiet avversi osservati bl-aktar mod frekwenti kienu reazzjonijiet ħfief jew moderati marbuta mal-infużjoni (ara tabella 4) li kienu jinkludu sintomi bħal fwawar, sħana, sogħla, disturbi fit-togħma, u dispnea li jseħħu fi żmien ftit minuti għal ftit sigħat wara l-infużjoni.
English: Nausea common
Maltese: Deni komuni
English: Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thrombotic events.
Maltese: Il-pazjenti ttrattati b'terapija tal-inibitur FXa għandhom stati tal-mard sottostanti li jippredisponuhom għal avvenimenti trombotiċi.
English: Paediatric population The pharmacokinetics of andexanet alfa has not been studied in paediatric patients.
Maltese: Il-farmakokinetika ta' andexanet alfa ma ġietx studjata f'pazjenti pedjatriċi.
English: • dizziness
Maltese: FIS-SUQ
English: Pyrexia common
Maltese: Ħalq xott komuni
English: For subjects on rivaroxaban, high-dose andexanet alfa (bolus plus infusion) resulted in increased thrombin generation above two standard deviations.
Maltese: Għal individwi fuq rivaroxaban, doża għolja ta' andexanet alfa (bolus flimkien ma' infużjoni) irriżultat f'żieda fil-ġenerazzjoni tat-thrombin ogħla minn żewġ devjazzjonijiet standard.
English: To date, the occurrence of positive, non-neutralizing antibodies to andexanet alfa following treatment in patients in the ANNEXA-4 study (8.5% or 20/236 patients) has been similar to that observed in healthy subjects.
Maltese: S'issa, l-okkorrenza ta 'antikorpi pożittivi li ma jinnewtralizzawx għal andexanet alfa wara t-trattament f'pazjenti fl-istudju ANNEXA-4 (8.5% jew 20/236 tal-pazjenti) kienet simili għal dik osservata f'individwi b'saħħithom.
English: Renal impairment: The effect of renal impairment on andexanet alfa exposure levels has not been evaluated.
Maltese: L-effett ta' indeboliment renali fuq il-livelli tal-esponiment għal andexanet alfa ma ġiex evalwat.
English: According to region, death rates were 22.1% (31/140) in patients recruited in the European Union and 10.9% (23/211) in patients recruited in North America.
Maltese: Skont ir-reġjun, ir-rati ta' mewt kienu ta' 22.1% (31/140) f'pazjenti li ġew mill-Unjoni Ewropea u 10.9% (23/211) f'pazjenti li ġew mill-Amerka ta' Fuq.
English: • hives
Maltese: Imwiet
English: Deaths
Maltese: Tqala
English: Headache common
Maltese: Dardir komuni
English: Read all of this leaflet carefully, because it contains important information for you.
Maltese: Iddata ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Read the package leaflet before use.
Maltese: Daqs tal-pakkett ta' erba' kunjetti.
English: In clinical trials of patients with life-threatening bleeding, fever and stroke may affect up to 1 in 10 people; transient ischaemic attack (TIA), heart attack, and blood clots in the legs or lungs may affect up to 1 in 100 people (uncommon side effects).
Maltese: Fi provi kliniċi ta' pazjenti bi ħruġ ta' demm ta' periklu għall-ħajja, deni u puplesija jistgħu jaffettwaw sa persuna 1 minn 10; attakk iskemiku temporanju (TIA, transient ischaemic attack), attakk tal-qalb, u emboli tad-demm fis-saqajn jew filpulmun jistgħu jaffettwaw sa 1 minn 100 persuna (effetti sekondarji mhux komuni).
English: There is no clinical experience with overdose of andexanet alfa.
Maltese: M'hemm l-ebda esperjenza klinika b'doża eċċessiva ta' andexanet alfa.
English: How Ondexxya is stored
Maltese: X'inhu Ondexxya u għalxiex jintuża
English: What Ondexxya is and what it is used for 2.
Maltese: X'inhu Ondexxya u għalxiex jintuża 2.
English: 345 andexanet alfa-treated healthy subjects were tested for antibodies cross reacting with andexanet alfa and antibodies to factor X and FXa.
Maltese: Ma ġew identifikati l-ebda antikorpi newtralizzanti jew antikorpi għall-fattur X jew FXa.
English: The interaction between andexanet alfa and TFPI has not been fully characterized.
Maltese: L-interazzjoni bejn andexanet alfa u TFPI ma ġietx ikkaratterizzata għal kollox.
English: Deep vein thrombosis uncommon
Maltese: Disturbi vaskulari Trombożi tal-vini profondi mhux komuni
English: not less than 3.99 log10 PFU**
Maltese: mhux inqas minn 3.99 PFU log10 PFU**
English: (3) Produced in human diploid (MRC-5) cells.
Maltese: (3) Prodott f'ċelloli diplojdi umani (MRC-5).
English: (2) Produced in human diploid lung (WI-38) fibroblasts.
Maltese: (2) Prodott f'fibroblasti diplojdi tal-pulmun uman (WI-38).
English: *50% cell culture infectious dose **plaque-forming units
Maltese: * 50% doża infettuża tal-kultura taċ-ċelloli ** unitajiet li jiffurmaw plakek (1) Prodott f'ċelloli ta' l-embrijoni tal-flieles.
English: § Measles virus1 Enders' Edmonston strain (live, attenuated)
Maltese: Virus tal-ħosba1 razza Enders' Edmonston, (ħaj, attenwat)
English: Varicella virus3 Oka/Merck strain (live, attenuated)
Maltese: Virus tal-ġidri r-riħ3, razza Oka/Merck, (ħaj, attenwat)
English: Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated)
Maltese: Virus tal-gattone1 razza Jeryl Lynn™ (Livell B) (ħaj, attenwat)
English: 1 vial + 1 pre-filled syringe + 2 needles
Maltese: 1 kunjett + siringa mimlija għal-lest + 2 labriet
English: 10 vials + 10 pre-filled syringes with attached needle
Maltese: 10 kunjetti + 10 siringi mimlijin għal-lest + 10 labriet
English: 1 vial + 1 pre-filled syringe + 1 needle
Maltese: 1 kunjett + 1 siringa mimlija għal-lest mingħajr labra mwaħħla
English: Ediburgh: Churchill Livingstone, 1991; T20-1
Maltese: Ediburgh: Churchill Livingstone, 1991;
English: Testosterone Deficiency in Men: Systematic Review and Standard Operating Procedures for Diagnosis and Treatment.
Maltese: Testosterone Deficiency in Men: Systematic Review and Standard Operating Procedures for
English: Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), pg 238, abstract # 1353; available at: https://www.aace.com/files/late-breaking-abstracts-2014.pdf 9 Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress
Maltese: Annual Meeting of the American Association of Clinical Endocrinologists (AACE), pg 238, abstract # 1353; available at: https://www.aace.com/files/late-breaking-abstracts-2014.pdf 9 Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress
English: 4 Vigen et al. “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” JAMA.
Maltese: Vigen et al. “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.”
English: Exp Opin Drug Safety 2014 (Posted online on August 19, 2014.
Maltese: Exp Opin Drug Safety 2014
English: Buvat J, Maggi M, Guay A, Torres LO.
Maltese: T20-1 2 Buvat J, Maggi M, Guay A, Torres LO.
English: Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: The low T
Maltese: Testosterone therapy is not associated with higher risk of myocardial infarction or stroke:
English: • The PRAC considered the procedure under Article 31 of directive 2001/83/EC for testosteronecontaining medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom it-testosteron.
English: Ann Pharmacother 2014; 48(9):1138-1144.
Maltese: Risk of myocardial infarction in older men receiving testosterone therapy. Ann Pharmacother 2014; 48(9):1138-1144.
English: There are no treatment alternatives to testosterone for male hypogonadism (Buvat et al. 20132)
Maltese: Ma hemm ebda alternattiva ta' kura għat-testosteron għal ipogonadiżmu maskili (Buvat et al., 20132)
English: The next PSUR, will have the common DLP to all testosterone-containing medicinal products of 31 December 2015.
Maltese: Il-PSUR li jmiss sejjer ikollu DLP komuni għall-prodotti mediċinali kollha li fihom it-testosteron sal-31 ta' Diċembru 2015.
English: Xu L, Freeman G, Cowling BJ,Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
Maltese: JAMA. 2013 Nov 6;310(17):1829-36. 5 Xu L, Freeman G, Cowling BJ,Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
English: 2001/83/EC was therefore initiated, to review the benefit-risk balance of testosterone containing medicinal products.
Maltese: Direttiva 2001/83/KE, biex jiġi rivedut il-bilanċ benefiċċju-riskju ta' prodotti mediċinali li fihom ittestosteron.
English: Baillargeon J, Urban RJ, Kuo Y-F, Ottenbacher KJ, Raji MA, Du F, Lin Y-l, Goodwin JS. Risk of myocardial infarction in older men receiving testosterone therapy.
Maltese: 6 Baillargeon J, Urban RJ, Kuo Y-F, Ottenbacher KJ, Raji MA, Du F, Lin Y-l, Goodwin JS.
English: The major goal of testosterone therapy (TT) is to achieve normal physiological levels of testosterone levels to relieve symptoms of hypogonadism like decreased sexual function, infertility, decreased energy, depressed mood, mild anaemia, reduced muscle bulk and strength, increased body fat and body mass index (BMI) and psychological impairment.
Maltese: L-għan ewlieni tat-terapija bit-testosteron (TT - Testosterone Therapy) huwa li jinkisbu livelli fiżjoloġiċi normali ta' livelli tat-testosteron biex iserrħu minn sintomi ta' ipogonadiżmu bħal funzjoni sesswali mnaqqsa, infertilità, enerġija mnaqqsa, burdata depressa, anemija ħafifa, massa u saħħa tal-muskoli mnaqqsin, xaħam tal-ġisem u indiċi tal-massa tal-ġisem (BMI - Body Mass Index) miżjudin u indeboliment fiżjoloġiku.
English: Testosterone is an androgenic hormone secreted by the Leydig cells in the testis.
Maltese: It-testosteron huwa ormon androġeniku prodott miċ-ċelloli Leydig fit-testikoli.
English: As an example, recently published studies (Baillargeon et al., 20146; Corona et al., 20147; Tan et al., 20148; Hildreth et al., 20139), with the objective to examine the risk of cardiovascular events with TT, did not report an increase in this risk.
Maltese: Tan et al., 20148; Hildreth et al., 20139), bl-iskop li jeżaminaw ir-riskji ta' avvenimenti kardjovaskolari b'TT, ma rrappurtawx żieda f'dan ir-riskju.
English: The PRAC also recognised that testosterone may have both direct and indirect effect on the cardiovascular systems: low testosterone increases the risk of the metabolic syndrome, which could potentially increase the risk of adverse cardiovascular events.
Maltese: Il-PRAC irrikonoxxa wkoll li t-testosteron jista' jkollu effett kemm dirett kif ukoll indirett fuq issistemi kardjovaskolari: testosteron baxx iżid ir-riskju tas-sindromu metaboliku, li potenzjalment iżid irriskju ta' avvenimenti kardjovaskolari avversi.
English: • The PRAC noted that some of the studies have methodological limitations.
Maltese: • Il-PRAC innota li xi studji għandhom limitazzjonijiet metodoloġiċi.
English: J Clin Endocrinol Metab 2013; 98(5): 1891-1900.
Maltese: Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels. J Clin Endocrinol Metab 2013; 98(5): 1891-1900.
English: • The Committee agreed, that it is justified to reflect in the product information of all testosterone-containing medicinal products the current knowledge on cardiovascular risks associated with testosterone therapy and recommended changes in section 4.1 (therapeutic indications), section 4.4 (warnings and precautions for use) and section 4.8 (undesirable effects) of the Summary of Product Characteristics.
Maltese: • Il-Kumitat qabel, li huwa ġġustifikat li fl-informazzjoni tal-prodott tal-prodotti mediċinali kollha li fihom it-testosteron jiġi rifless l-għarfien attwali fuq riskji kardjovaskolari assoċjati ma' terapija bit-testosteron u rrakkomanda bidliet f'sezzjoni 4.1 (indikazzjonijiet terapewtiċi), f'sezzjoni 4.4
English: The clinical symptoms depend on the age of onset androgen deficiency.
Maltese: Is-sintomi kliniċi jiddependu fuq l-età tal-bidu tad-defiċenzja tal-androġenu.
English: • The PRAC also concluded that there was the need for all MAHs to closely monitor cardiovascular risk and discuss the findings including venous thromboembolic events and possible mechanism(s) and usage pattern and adverse events in patients older than 65 years in the next PSUR.
Maltese: • Il-PRAC ikkonkluda wkoll li kien hemm il-bżonn li d-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) kollha jimmonitorjaw b'attenzjoni riskju kardjovaskolari u jiddiskutu s-sejbiet inklużi avvenimenti tromboemboliċi venużi u mekkaniżmu/i possibbli u xejriet ta' użu u avvenimenti avversi f'pazjenti akbar minn 65 sena fil-PSUR li jmiss.
English: It is an essential hormone for the development of male reproductive tissues as the testis and the prostate and in promoting secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair (Dollery et al., 19911).
Maltese: Huwa ormon essenzjali għall-iżvilupp tat-tessut riproduttiv maskili bħat-testikoli u l-prostata u biex jippromwovi l-karatteristiċi sesswali sekondarji bħala muskoli mkabbra, massa tal-għadam, u t-tkabbir tax-xagħar tal-ġisem (Dollery et al., 19911).
English: Concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease (Finkle et al, 20143; Vigen et al, 20134 and Xu et al, 20135).
Maltese: Tqajjem tħassib fir-rigward ta' riskju potenzjali ta' avvenimenti kardjovaskolari, l-iktar infart mijokardjaku, f'irġiel li jiġu kkurati bit-testosteron u li diġà għandhom xi mard tal-qalb (Finkle et al, 20143;
English: Hypogonadism is classified into primary testicular failure due to a problem in the testicles and secondary testicular failure, due to a problem in the hypothalamus or the pituitary gland.
Maltese: Ipogonadiżmu huwa kklassifikat bħala falliment testikolari primarju minħabba problema fit-testikoli, u falliment testikolari sekondarju, minħabba problema fl-ipotalamu jew fil-glandola pitwitarja.
English: Hypogonadism in men is a congenital or acquired syndrome, in which the testis fails to produce physiological levels of testosterone and spermatozoa, as there is a disruption in the hypothalamicpituitary-testicular axis (HPT).
Maltese: Ipogonadiżmu fl-irġiel huwa sindromu konġenitali jew akkwistat, li fih it-testikoli ma jipproduċux livelli fiżjoloġiċi ta' testosteron u spermatożoa, minħabba li jkun hemm tfixkil fl-assi ipotalamika-pitwitarjatestikolari (HPT - Hypothalamic-Pituitary-Testicular axis).
English: In such case, treatment must be stopped immediately.
Maltese: Diagnosis and Treatment.
English: All testosterone-containing medicinal products approved in the European Union were included in this review performed by the PRAC.
Maltese: Il-prodotti mediċinali kollha li fihom it-testosteron approvati fl-Unjoni Ewropea ġew inklużi f'din irreviżjoni mwettqa mill-PRAC.
English: All were authorised nationally and are available in different pharmaceutical forms: solution for intramuscular injection, oral capsules, cutaneous gel, cutaneous solution and transdermal patch.
Maltese: Kollha ġew awtorizzati fuq livell nazzjonali u huma disponibbli f'forom farmaċewtiċi differenti: soluzzjoni għal injezzjoni intramuskolari, kapsuli orali, ġel għall-ġilda, soluzzjoni għall-ġilda u roqgħa transdermali.
English: • The Committee considered the studies that heightened concerns about the increased risk of cardiovascular events associated with testosterone therapy and available data submitted from clinical trials, observational studies, meta-analyses, post-marketing data and further published data.
Maltese: • Il-Kumitat ikkunsidra l-istudji li żiedu t-tħassib dwar ir-riskju miżjud ta' avvenimenti kardjovaskolari assoċjati ma' terapija bit-testosteron u dejta disponibbli sottomessa minn provi kliniċi, studji ta' osservazzjoni, meta-analiżijiet, dejta ta' wara t-tqegħid fis-suq u aktar dejta ppubblikata.
English: The PRAC noted that the findings from several other observational studies, clinical trials and meta-analysis of randomised clinical trials do not provide evidence of an association between testosterone and cardiovascular events.
Maltese: Il-PRAC innota li s-sejbiet minn diversi studji ta' osservazzjoni, provi kliniċi u meta-analiżi ta' provi kliniċi randomizzati oħrajn ma jipprovdux evidenza ta' assoċjazzjoni bejn tesotsteron u avvenimenti kardjovaskolari.
English: Also, that there is limited data regarding elderly patients above the age of 65 and this will also be reflected in the warning section of the product information of all testosterone-containing medicinal products.
Maltese: Barra minn hekk, hemm dejta limitata dwar pazjenti anzjani ta' aktar minn 65 sena u dan sejjer jiġi rifless ukoll fis-sezzjoni tat-twissijiet talinformazzjoni tal-prodott tal-prodotti mediċinali kollha li fihom it-testosteron.
English: Given the
Maltese: Bl
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Maltese: 2 - Spjegazzjoni dettaljata tar-raġunijiet xjentifiċi għal differenzi mir rakkomandazzjoni tal-PRAC
English: 7 Corona G, Maseroli E, Rastrelli G, Isidori A, Mannucci E, Maggi M. Cardiovascular risk associated with testosterone boosting medications: a systematic review and metaanalysis.
Maltese: Cardiovascular risk associated with testosterone boosting medications: a systematic review and metaanalysis.
English: Overall summary of the scientific evaluation by PRAC
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tal-PRAC
English: The symptoms are less specific if the hypogonadism develops after puberty and are characterized by e.g. decreased sexual function, infertility, decreased energy, depressed mood, mild anaemia, reduced muscle bulk and strength, increase body fat and BMI (guideline of Endocrine Society).
Maltese: Is-sintomi huma inqas speċifiċi jekk l-ipogonadiżmu jiżviluppa wara l-pubertà u huma kkaratterizzati minn eż. funzjoni sesswali mnaqqsa, infertilità, enerġija mnaqqsa, burdata depressa, anemija ħafifa, massa u saħħa tal-muskoli mnaqqsa, żieda fixxaħam tal-ġisem u l-BMI (linja gwida tas-Soċjetà Emdokrina).
English: The PRAC reviewed all data available from clinical trials, observational studies, meta-analyses, postmarketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Maltese: Il-PRAC irreveda kull dejta disponibbli minn provi kliniċi, studji ta' osservazzjoni, dejta ta' wara ttqegħid fis-suq u aktar dejta ppubblikata fuq ir-riskji kardjovaskolari assoċjati ma' terapija bittestosteron.
English: The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation of the marketing authorisations of testosterone containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata 9 ta' Ottubru 2014 skont Artikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq ftehim fuq il-varjazzjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom it-testosteron li għalihom sezzjonijiet relevanti tassommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif huma stabbiliti f'Anness
English: The Committee recognised the limited available information on testosterone therapy for age-related hypogonadism and also the lack of reference.
Maltese: Il-Kumitat irrikonoxxa l-informazzjoni limitata disponibbli dwar terapija bit-testosteron għal ipogonadiżmu relatat mal-età kif ukoll in-nuqqas ta' referenza.