FrancophonIA/ELRC3.0 huggingface dataset:
English: The scientific points of disagreement presented in the MAHs detailed grounds included efficacy aspects, safety aspects in relation to the risk of cancer (non-clinical, pharmacovigilance, and statistical issues) and overall benefit-risk assessment.
Maltese: Il-punti xjentifiċi ta' nuqqas ta' qbil ippreżentanti fir-raġunijiet dettaljati tal-MAHs inkludew aspetti tal-effikaċja, aspetti tas-sigurtà fir-rigward tar-riskju ta' kanċer (kwistjonijiet mhux kliniċi, farmakoviġilanza u statistiċi) u valutazzjoni ġenerali tal-benefiċċju-riskju.
English: Following the adoption of the CHMP opinion and recommendations during the July 2012 CHMP meeting, a re-examination request was received on 8 August 2012 from one of the MAHs Therapicon, who was involved in the referral procedure.
Maltese: Wara l-adozzjoni tal-opinjoni u tar-rakkomandazzjonijiet tas-CHMP matul il-laqgħa tas-CHMP ta' Lulju 2012, fit-8 ta' Awwissu waslet talba għal eżaminazzjoni mill-ġdid mingħand wieħed mill-MAHs Therapicon, li kien involut fil-proċedura ta' riferiment.
English: • In view of the new safety concerns in relation to the risk of cancer in long-term use and the limited efficacy of calcitonin in the treatment of osteoporosis, the Committee is of the opinion that pursuant to Article 116 of Directive 2001/83/EC the benefit-risk balance of the intranasal formulations of calcitonin-containing medicinal products is not positive under normal conditions of use.
Maltese: • Minħabba t-tħassib ġdid dwar is-sigurtà b'rabta mar-riskju ta' kanċer fl-użu għal perjodu fit-tul u l-effikaċja limitata ta' calcitonin fil-kura tal-osteoporożi, il-Kumitat huwa tal-opinjoni li skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-bilanċ bejn il-benefiċċju u r-riskju talformulazzjonijiet intranażali ta' prodotti mediċinali li fihom calcitonin mhuwiex pożittiv taħt kundizzjonijiet ta' użu normali.
English: The consistency of the evidence across clinical trial data, provide strong evidence of a causal association.
Maltese: Il-konsistenza tal-evidenza tul id-dejta mill-provi kliniċi, tipprovdi evidenza qawwija ta' relazzjoni kawżali.
English: Paget's disease hypercalcaemia of malignancy
Maltese: Aspetti mhux kliniċi
English: Risk Minimisation Measures
Maltese: Miżuri ta' Minimizzazzjoni tar-Riskju
English: Overall conclusion of the re-examination procedure The scope of the re-examination was the benefit/risk of intranasal formulation of calcitonin-containing medicinal products in the indication of “treatment of osteoporosis in order to reduce the risk of vertebral fractures”.
Maltese: Konklużjoni ġenerali tal-proċedura ta' eżaminazzjoni mill-ġdid L-ambitu tal-eżaminazzjoni mill-ġdid kien il-benefiċċju/riskju ta' formolazzjoni intranasali ta' prodotti mediċinali li fihom calcitonin fl-indikazzjoni ta' “kura tal-osteoporożi sabiex jitnaqqas irriskju ta' ksur vertebrali”.
English: The re-examination of the CHMP opinion was related to the benefit-risk balance of the intranasal formulation of calcitonin in the indication “treatment of osteoporosis in order to reduce the risk of vertebral fractures”.
Maltese: L-eżaminazzjoni mill-ġdid tal-opinjoni tas-CHMP kienet relatata mal-bilanċ tal-benefiċċju-riskju tal-formulazzjoni intranasali ta' calcitonin fl-indikazzjoni “kura talosteoporożi sabiex jitnaqqas ir-riskju ta' ksur vertebrali”.
English: This pivotal study showed that only one of the investigated doses - 200IU calcitonin/day was associated with a statistical significant effect, although for this dose, statistical significance was not achieved when analysing patients with at least 2 new vertebral fractures.
Maltese: Dan l-istudju pivotali wera li doża waħda biss mid-dożi investigati - 200UI calcitonin/jum kienet assoċjata ma' effett statistikament sinifikanti, għalkemm għal din id-doża, ma nkisibx sinifikat statistiku meta kienu analizzati pazjenti li kellhom mill-anqas 2 ksur ġodda tal-vertebri.
English: Possible explanations for these discrepant results include the lower dose in the osteoporosis trial, and the premature discontinuation of male patients and an intensive prostate cancer screening programme in the second osteoarthritis trial, which identified additional cases and may have masked possible imbalances of cancer cases across the different treatment arms in these trials.
Maltese: L-ispjegazzjonijiet possibbli għal dawn ir-riżultati diskrepanti jinkludu d-doża aktar baxxa fil-prova dwar l-osteoporożi, u l-waqfien qabel iż-żmien tal-pazjenti rġiel u programm intensiv ta' skrinjar għall-kanċer tal-prostata fit-tieni prova dwar l-osteoartrite, li identifikat każijiet addizzjonali u li setgħet ħbiet żbilanċi possibbli ta' każijiet ta' kanċer tul il-gruppi differenti ta' kura f'dawn il-provi.
English: Grounds for the suspension of the marketing authorisation for the intranasal calcitonincontaining medicinal products Whereas
Maltese: Raġunijiet għas-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali intranażali li fihom calcitonin Billi
English: With regards to prostate cancer, information provided on prostate specific antigen (PSA) levels from all male patients in the first two osteoarthritis studies C2301 and C2302 showed that calcitonin does not have an effect on PSA levels.
Maltese: Fir-rigward tal-kanċer tal-prostata, l-informazzjoni pprovduta dwar il-livelli tal-antiġeni speċifiċi talprostata (PSA) mill-pazjenti rġiel kollha fl-ewwel żewġ studji dwar l-osteoartrite, C2301 u C2302, uriet li calcitonin m'għandux effett fuq il-livelli tal-PSA.
English: From the meta-analysis of the intranasal calcitonin studies, the data point towards an increase in the risk of cancer in patients treated with intranasal calcitonin compared to placebo.
Maltese: Mill-meta-analiżi tal-istudji ta' calcitonin intranasali, id-dejta tindika żieda fir-riskju ta' kanċer f'pazjenti kkurati b'calcitonin intranasali meta mqabbel ma' plaċebo.
English: The MAH addressed a number of non-clinical, pharmacovigilance, and statistical issues in relation to the CHMP assessment of the risk of cancer with the use of calcitonin-containing medicinal products.
Maltese: L-MAH indirizza għadd ta' kwistjonijiet mhux kliniċi, ta' farmakoviġilanza u statistiċi fir-rigward talvalutazzjoni min-naħa tas-CHMP tar-riskju ta' kanċer bl-użu ta' prodotti mediċinali li fihom calcitonin.
English: The CHMP is of the view that it is not possible to reach a conclusion about the association between calcitonin and cancer progression from the results of the published non-clinical in vitro studies.
Maltese: Is-CHMP huwa tal-fehma li mhuwiex possibbli li tintlaħaq konklużjoni dwar l-assoċjazzjoni bejn calcitonin u l-progressjoni għal kanċer mir-riżultati tal-istudji in vitro mhux kliniċi ppubblikati.
English: Based on the totality of the data available on the safety and the efficacy of intranasal calcitonincontaining medicinal products and having noted the opinion of the Ad-Hoc Expert meeting, the CHMP confirmed its initial conclusion that the limited efficacy in this indication needs to be balanced against evidence from clinical trials for an increased risk of cancer with long-term use of calcitonin.
Maltese: Fuq il-bażi tat-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' prodotti mediċinali intranasali li fihom calcitonin, u wara li ġiet ikkunsidrata l-opinjoni tal-laqgħa tal-Esperti Ad-Hoc, is-CHMP ikkonferma l-konklużjoni inizjali tiegħu li l-effikaċja limitata f'din l-indikazzjoni teħtieġ li tiġi bbilanċjata kontra l-evidenza minn provi kliniċi għal riskju miżjud ta' kanċer b'użu fit-tul ta' calcitonin.
English: • Overall benefit-risk assessment
Maltese: • Valutazzjoni ġenerali tal-benefiċċju-riskju
English: When including trials in which no cases of malignancy had been reported the estimated OR is 2.12.
Maltese: Meta ġew inklużi l-provi li fihom ma kinux irrapportati każi ta' tumuri malinni, l-OR stmat kien 2.12.
English: Overall summary of the scientific evaluation of calcitonin-containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom calcitonin (ara Anness I)
English: After review of the available data, the CHMP (previously CPMP) adopted an opinion on 21 November 2002, on a favourable benefit/risk balance of injectable calcitonin in the following indications:
Maltese: Wara valutazzjoni tad-dejta disponibbli, is-CHMP (li qabel kien isCPMP) adotta opinjoni fil-21 ta' Novembru 2002, dwar bilanċ favorevoli għall-benefiċċju/riskju ta' calcitonin injettabbli fl-indikazzjonijiet li ġejjin: il-prevenzjoni ta' telf akut ta' għadam minħabba immobilizzazzjoni f'daqqa bħal f'pazjenti bi ksur osteoporotiku reċenti il-marda ta' Paget iperkalċemija minn tumuri malinni
English: • Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures (injectable formulation)
Maltese: • Prevenzjoni ta' telf akut ta' għadam minħabba immobilizzazzjoni f'daqqa bħal f'pazjenti bi ksur osteoporotiku reċenti (formulazzjoni injettabbli)
English: While this argument might be valid for observational studies, the CHMP is of the view that potential bias in randomised clinical trials that could favour one of the treatment arms is unlikely, as the randomisation procedure provides sufficiently well balanced groups.
Maltese: Filwaqt li dan l-argument jista' jkun wieħed validu għal studji osservazzjonali, is-CHMP huwa talfehma li bias potenzjali fi provi kliniċi każwali li jista' jiffavorixxi waħda mill-fergħat ta' kura mhuwiex probabbli, minħabba li l-proċedura ta' għażla b'mod każwali tipprovdi b'mod suffiċjenti gruppi bbilanċjati sew.
English: In addition to the lack of a dose response, the results of this study are further limited by important methodological limitations (lack of adjustment for multiple testing and very high percentage of patients discontinuing the study).
Maltese: Minbarra n-nuqqas ta' rispons għad-doża, ir-riżultati ta' dan l-istudju huma limitati ulterjorment minn limitazzjonijiet metodoloġiċi importanti (nuqqas ta' aġġustament għal ittestjar multiplu u perċentwali għoli ħafna ta' pazjenti li ma komplewx l-istudju).
English: While it is recognised by the CHMP that the inclusion or exclusion of single trials will adjust the overall odds ratio (OR) in different directions, it is acknowledged that it is reasonable to conduct a list of sensitivity analyses to assess the robustness of the results.
Maltese: Filwaqt li huwa rikonoxxut mis-CHMP li l-inklużjoni jew l-esklużjoni ta' provi singoli sejrin jaġġustaw l-odds ratio (OR) ġenerali f'direzzjonijiet differenti, huwa rikonoxxut li huwa raġonevoli li titwettaq lista ta' analiżi tas-sensittività sabiex tiġi vvalutata rrobustezza tar-riżultati.
English: Further evidence of a positive association between calcitonin and cancer was provided from the analysis of recently conducted trials with the new oral calcitonin formulation.
Maltese: Aktar evidenza ta' relazzjoni pożittiva bejn calcitonin u l-kanċer kienet ipprovduta mill-analiżi ta' provi li twettqu dan l-aħħar bil-formulazzjoni orali l-ġdida ta' calcitonin.
English: Moreover, beyond any discussion of whether the statistical significance is achieved in some cases or not, there is an evident, consistent and clear trend of an increased risk of cancer.
Maltese: Barra minn hekk, lil hinn minn kull diskussjoni dwar jekk is-sinifikat statistiku jintlaħaqx jew le f'xi każijiet, hemm tendenza evidenti, konsistenti u ċara ta' riskju miżjud ta' kanċer.
English: The CHMP noted that the low reporting is not unexpected in this particular situation where the event under scrutiny (i.e malignancies), is not uncommon in the target population that otherwise receive a number of concomitant medications, where the risk increases with time making it very unlikely for physicians to establish a possible relation.
Maltese: Is-CHMP innota li rapportar baxx mhuwiex mistenni f'din is-sitwazzjoni partikolari fejn l-episodju taħt skrutinju (jiġifieri tumuri malinni), mhuwiex mhux komuni fil-popolazzjoni fil-mira li inkella kienet tirċievi għadd ta' medikazzjonijiet konkomittanti, fejn ir-riskju jiżdied maż-żmien u jagħmilha ferm improbabbli għat-tobba li jistabbilixxu relazzjoni possibbli.
English: • The Committee in light of the previous review and in the absence of new efficacy data, considered that the intranasal calcitonin-containing medicines can be effective in the treatment of established postmenopausal osteoporosis in order to reduce the risk of vertebral fractures.
Maltese: • Fid-dawl tal-valutazzjoni preċedenti u fin-nuqqas ta' dejta ġdida dwar l-effikaċja, il-Kumitat ikkunsidra li l-mediċini intranażali li fihom calcitonin jistgħu jkunu effettivi fil-kura ta' osteoporożi stabbilita ta' wara l-menopawsa sabiex jitnaqqas ir-riskju ta' ksur vertebrali.
English: However the evidence of efficacy of intranasal calcitonin-containing medicines in this indication remains limited.
Maltese: Madankollu, l-evidenza tal-effikaċja ta' mediċini intranasali li fihom calcitonin f'din lindikazzjoni tibqa' limitata.
English: The CHMP noted that any meta-analysis driven by a safety signal will always be, per definition, conducted post-hoc, the objective of such an analysis being to quantitatively rule out a potential harm to patients.
Maltese: Is-CHMP innota li xi meta-analiżi xprunati minn sinjal tas-sigurtà sejrin dejjem ikunu, skont id-definizzjoni, imwettqa post-hoc, l-objettiv ta' tali analiżi jkun li kwantitivament tiġi eliminata ħsara potenzjali għall-pazjenti.
English: • The Committee is of the opinion that data from clinical studies provide evidence for an increased risk of cancer with long-term use of calcitonin.
Maltese: • Il-Kumitat huwa tal-opinjoni li d-dejta mill-istudji kliniċi tipprovdi evidenza għal żieda fir-riskju ta' kanċer b'użu fit-tul ta' calcitonin.
English: On the basis of this new safety information the UK requested the opinion of the Committee for Medicinal Products for Human Use (CHMP), under Article 31 of Directive 2001/83/EC whether the marketing authorisations for medicinal products containing calcitonin should be maintained, varied, suspended or withdrawn.
Maltese: Fuq il-bażi ta' din linformazzjoni ġdida dwar is-sigurtà, ir-Renju Unit talab l-opinjoni tal-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), skont l-Artikolu 31 tad-Direttiva 2001/83/KE, dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali li fihom calcitonin għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati.
English: The differences are not considered to be sufficiently convincing to alter the previous CHMP conclusion regarding an increased risk of cancer with calcitonin-containing medicinal products.
Maltese: Id-differenzi mhumiex meqjusin li huma konvinċenti biżżejjed sabiex jibdlu l-konklużjoni preċedenti tas-CHMP fir-rigward ta' riskju miżjud ta' kanċer bi prodotti mediċinali li fihom calcitonin.
English: EMA/244342/2019 EMEA/H/C/004837
Maltese: EMA/244342/2019 EMA/H/C/004837
English: Further information on Xromi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xromi .
Maltese: ema.europa.eu/medicines/human/EPAR/xromi.
English: Xromi is a ‘hybrid medicine'.
Maltese: Xromi huwa ‘mediċina ibrida'.
English: This included information from 4 main studies in sickle cell disease, including 3 studies involving 384 adults and children in whom hydroxycarbamide was shown to substantially reduce the risk of severe, painful blockages of blood supply (called vaso-occlusive crises) compared with a dummy treatment, and a fourth study involving 121 children that showed hydroxycarbamide to be at least as effective as standard treatment using blood transfusions in reducing blood vessel damage in the brain and the risk of stroke.
Maltese: Din inkludiet informazzjoni minn 4 studji ewlenin filmarda tas-sickle cell, inklużi 3 studji li involvew 384 adult u tifel u tifla li fihom intwera li lidrossikarbammid naqqset b'mod sostanzjali r-riskju ta' imblokki severi u li jikkawżaw uġigħ filprovvista tad-demm (imsejħa kriżijiet vażo-okklussivi) meta mqabbla ma' kura finta, u r-raba' studju li involva 121 tifel u tifla li wera li l-idrossikarbammid kienet tal-inqas effettiva daqs kura standard li tuża t-trasfużjonijiet ta-demm fit-tnaqqas tal-ħsara tal-vażijiet fil-moħħ u r-riskju ta' puplesija.
English: Other information about Xromi
Maltese: Informazzjoni oħra dwar Xromi
English: The active substance in Xromi is hydroxycarbamide.
Maltese: Is-sustanza attiva fi Xromi hija idrossikarbammid.
English: The most common side effects with Xromi (which may affect more than 1 in 10 people) are bone marrow suppression (reduced ability to produce blood cells) and reduced fertility in men due to oligospermia (low sperm counts) or azoospermia (absence of sperm).
Maltese: L-effetti sekondarji l-aktar komuni b'Xromi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) huma soppressjoni tal-mudullun (abbiltà mnaqqsa fil-produzzjoni ta' ċelloli tad-demm) u fertilità mnaqqsa fl-irġiel minħabba oligospermja (għadd baxx ta' sperma) jew ażoospermja (nuqqas ta' sperma).
English: Xromi (hydroxycarbamide)
Maltese: Xromi (idrossikarbammid)
English: What are the risks associated with Xromi?
Maltese: X'inhuma r-riskji assoċjati ma' Xromi?
English: Xromi is available as a liquid to be swallowed containing hydroxycarbamide 100 mg/mL, and doses are based on the patient's body weight.
Maltese: Xromi jiġi bħala likwidu biex jinbela' li fih l-idrossikarbammid 100 mg/mL, u d-dożi huma bbażati fuq ilpiż tal-ġisem tal-pazjent.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but is given as a liquid to be swallowed rather than as capsules and is authorised for different uses.
Maltese: Dan ifisser li hu simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda jingħata bħala likwidu biex jinbela' minflok bħala kapsuli u huwa awtorizzat għal użijiet differenti.
English: The reference medicine for Xromi is Hydrea.
Maltese: Il-mediċina ta' referenza għal Xromi hija Hydrea.
English: The company provided updated information showing the benefits of hydroxcarbamide in preventing complications of sickle cell disease in patients over 2 years of age.
Maltese: Il-kumpanija tipprovdi informazzjoni aġġornata li turi l-benefiċċji ta' idrossikarbammid fil-prevenzjoni ta' komplikazzjonijiet tal-marda tas-sickle cell f'pazjenti 'l fuq minn sentejn.
English: For the full list of side effects of Xromi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Xromi, ara l-fuljett ta' tagħrif.
English: Patients are usually started at a daily dose of 15 mg for each kg of body weight, and increased if necessary every 8 weeks to a maximum of 35 mg per kg.
Maltese: Normalment il-pazjenti jinbdew fuq doża ta' kuljum ta' 15 mg għal kull kg tal-piż tal-ġisem, u jekk ikun meħtieġ tiżdied kull 8 ġimgħat sa massimu ta' 35 mg għal kull kg.
English: Because hydroxycarbamide is a well-established substance that has been used for many years in the EU the company provided information from the published literature on the benefits and risks of hydroxycarbamide in its approved uses.
Maltese: Minħabba li l-idrossikarbammid hija sustanza stabbilita sew li ilha tintuża għal ħafna snin fl-UE, ilkumpanija pprovdiet informazzjoni mid-dokumentazzjoni ppubblikata dwar il-benefiċċji u r-riskji talidrossikarbammid fl-użijiet approvati tagħha.
English: Xromi is a medicine used in adults, adolescents and children over two years of age who have sickle cell disease, a genetic disease where the red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle).
Maltese: Xromi huwa mediċina li tintuża fl-adulti, fl-adolexxenti u fit-tfal 'il fuq minn sentejn li għandhom ilmarda tas-sickle cell, marda ġenetika fejn iċ-ċelloli ħomor tad-demm isiru riġidi u jwaħħlu, u jinbidlu minn forma ta' diska għal forma ta' nofs qamar (bħal minġel).
English: The company that markets Xromi will put in place an educational programme for doctors and patients about the correct use of the medicine and preventing harm, including guidance on use of the appropriate syringe for dosing and the need for regular blood testing.
Maltese: Il-kumpanija li tqiegħed Xromi fis-suq se tistabbilixxi programm edukattiv għat-tobba u l-pazjenti dwar l-użu korrett tal-mediċina u l-prevenzjoni ta' ħsara, inkluża gwida dwar l-użu tas-siringa adegwata għad-dożaġġ u l-ħtieġa ta' ttestjar regolari tad-demm.
English: Xromi can only be obtained with a prescription and treatment must be supervised by a healthcare professional experienced in the management of sickle cell disease.
Maltese: Xromi jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tiġi ssorveljata minn professjonist tal-kura tas-saħħa b'esperjenza fil-ġestjoni tal-marda tas-sickle cell.
English: The medicine is supplied with two oral syringes for measuring the dose, a smaller red one for measuring doses up to a total of 300 mg (3 mL of liquid), and a larger white one for use if doses are bigger than this.
Maltese: Ilmediċina hija fornuta b'żewġ siringi orali għall-kejl tad-doża, waħda ħamra iżgħar għall-kejl tad-dożi sa total ta' 300 mg (3 mL ta' likwidu), u waħda bajda akbar għall-użu jekk id-dożi jkunu akbar minn dan.
English: How does Xromi work?
Maltese: Kif jintuża Xromi?
English: It also carried out a study that showed Xromi is bioequivalent to the reference medicine, Hydrea.
Maltese: Hi wettqet ukoll studju li wera li Xromi huwa bijoekwivalenti għall-mediċina ta referenza, Hydrea.
English: The safety issues with hydroxycarbamide are well understood, and Xromi has been shown to be bioequivalent to an authorised hydroxycarbamide medicine.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Hydroxycarbamide, which used to be known as hydroxyurea, has been used for many years to treat sickle cell disease, and has been authorised in EU countries for several decades as Hydrea for use in some types of cancer.
Maltese: L-idrossikarbammid, li kienet magħrufa bħala idrossiurea, ilha tintuża għal ħafna snin biex tikkura lmarda tas-sickle cell, u ilha awtorizzata fil-pajjiżi tal-UE għal diversi deċennji bħala Hydrea għall-użu f'ċerti tipi ta' kanċer.
English: The active substance in Xromi, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells.
Maltese: Is-sustanza attiva f'Xromi, l-idrossikarbammid, timblokka t-tkabbir u r-riproduzzjoni ta' ċerti ċelloli, bħaċ-ċelloli tad-demm.
English: telephone number: XXXXXXXXXXX e-mail: XXXXXXXXXXX
Maltese: XXXXXXXXXXX email: XXXXXXXXXXX
English: Relative risk (95% CI) vs. placebo
Maltese: Riskju relativ (95% CI) vs. plaċebo
English: Legal manufacturer:
Maltese: Manifattur legali:
English: Brunnmattstrasse 6
Maltese: Ypsomed AG Brunnmattstrasse 6
English: Organ System Class
Maltese: Klassi tas-sistema tal-organi
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 January 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04 ta' Jannar 2017
English: Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
Maltese: Teriparatide (rhPTH(1-34)) hija l-parti attiva (1-34) ta' l-ormon endoġenu uman tal-paratirojde.
English: - Severe renal impairment.
Maltese: - Indeboliment renali serju.
English: QR code to be included www.terrosapatient.com
Maltese: Kodiċi QR li għandu jiġi nkluż www.terrosapatient.com
English: - Unexplained elevations of alkaline phosphatase.
Maltese: - Livelli għoljin mhux spjegati ta' alkaline phosphatase.
English: • Ypsomed mylifeClickfine 29 to 31 gauge (diameter 0.25 - 0.33 mm) and 12, 10, 8 or 6 mm length
Maltese: • Ypsomed mylife Clickfine 29 sa 31 gejġ (dijametru 0.25 - 0.33 mm) u tul ta' 12, 10, 8 jew 6 mm
English: 3401 Burgdorf, Switzerland
Maltese: 3401 Burgdorf, L-Iżvizzera
English: radius, humerus, ribs and pelvis)
Maltese: radjus, omeru, kustilji u pelvis)
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jolqtu sa persuna 1 minn kull 1,000 persuni):
English: Teriparatide has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
Maltese: Teriparatide ġie evalwat fi studji ta' interazzjoni farmakodinamika ma' hydrochlorothiazide.