FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/339/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/339/003
English: All women were given calcium (400-500 mg) and vitamin D (400 IU) supplements.
Maltese: In-nisa kollha ngħataw supplimenti ta' kalċju (400-500 mg) u vitamina
English: • Store in a refrigerator (2-8°C).
Maltese: • Aħżen fi friġġ (2-8°C).
English: Parathyroid hormone is a natural peptide that is not metabolised by, and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g. cytochrome P450 isoenzymes).
Maltese: L-ormon tal-paratirojde huwa peptide naturali li ma jiġix metabolizzat minn, u ma jinibixxix enzimi mikrosomali epatiċi li jimmetabolizzaw il-mediċina (p.e. isoenzimi ta' cytochrome P450).
English: Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid, dilwit (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: • flu,
Maltese: • influwenza,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24.04.2006
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24.04.2006
English: Inclusion criteria were; women between 55 and 85 years of age with BMD T-scores below -2.5 or below -2 and at least one additional risk factor for fracture.
Maltese: Il-kriterji tal-inklużjoni kienu; nisa ta' bejn 55 u 85 sena b'T-scores tal-BMD taħt -2.5 jew taħt -2 u mill-anqas fattur ta' riskju wieħed addizzjonali għal ksur.
English: Citric acid monohydrate Sodium chloride
Maltese: Citric acid monohydrate
English: There was no significant difference between the treatment groups in the incidence of any non-vertebral clinical fracture: 5.52% for Preotact vs. 5.86% for placebo.
Maltese: Ma kienx hemm differenza sinifikanti bejn il-gruppi ta' kura fl-inċidenza ta' xi ksur kliniku mhux vertebrali: 5.52% għal Preotact vs. 5.86% għall-plaċebo.
English: Under normal physiologic conditions, full-length parathyroid hormone (1-84) constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.
Maltese: F'kondizzjonijiet fiżjoloġiċi normali, ormon tal-paratirojde ta' tul sħiħ (1-84) jikkostitwixxi biss 5-30% tal-forom fiċ-ċirkolazzjoni tal molekula, filwaqt li 70-95% huwa preżenti bħala frammenti carboxy-terminali.
English: • pain in arms and legs (extremities),
Maltese: • uġigħ fid-dirgħajn u r-riġlejn (estremitajiet),
English: Stopper (center and end): Bromobutyl rubber, grey.
Maltese: Tapp (tan-nofs u tat-tarf): Lastku tal-bromobutyl, griż.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jista' jaffettwa sa persuna 1 f'100):
English: Hypercalcemia was reported in 25.3% of patients and hypercalciuria in 39.3% of patients treated with Preotact.
Maltese: L-iperkalċimja kienet irrapportata f'25.3% tal-pazjenti u l-iperkalċurja f'39.3% tal-pazjenti kkurati bi Preotact.
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskolu-skeltriċi u tat-tessut konnettiv Komuni
English: Interindividual variability in systemic clearance is about 15%.
Maltese: Il varjabilità fit-tneħħija sistemika bejn individwu u ieħor hija madwar 15%.
English: Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1,0.7 and -0.6% for placebo (p<0.001).
Maltese: Żidiet sinifikanti fil-BMD tal-ġenb (totali, għonq femorali, trokanter) kienu osservati fl-endpoint ta' l-istudju: 1.0, 1.8 u 1.0% rispettivament, għal Preotact kontra -1.1, -0.7 u -0.
English: At baseline a total of 165 women (69%) had a T-score below -2.5, and 112 (47%) reported at least one fracture after menopause.
Maltese: Fil-linja bażi, total ta' 165 mara (69%) kellhom T-score taħt -2.5, u 112 (47%) irrapportaw mill-anqas ksur wieħed wara l-menopawsa.
English: Crimp cap (containing a rubber seal): Aluminium .The rubber seal is made of bromobutyl rubber.
Maltese: Crimp cap (li fih siġill tal-lastku): Aluminju.
English: Keep the product protected from light.
Maltese: Qaxxar il-karta protettiva mill-għatu tal-labra.
English: No osteosarcomas have been observed in clinical trials.
Maltese: Ma kinux osservati osteosarkomi fil-provi kliniċi.
English: Preotact contains recombinant human parathyroid hormone which is identical to the full-length native 84-amino acid polypeptide.
Maltese: Preotact fih ormon tal-paratirojde uman rikombinanti li huwa identiku għall-polipeptide nattiv ta' tul sħiħ ta' 84 aċidu amminiku.
English: Systemic clearance of parathyroid hormone (45.3 l/hour) following an intravenous dose is close to normal liver plasma flow and is consistent with extensive hepatic metabolism of the active substance.
Maltese: It-tneħħija sistemika ta' l-ormon tal-paratirojde (45.3 l/siegħa) wara doża ġol-vini hija qrib tal-fluss normali tal-plażma fil-fwied u konsistenti ma' metaboliżmu epatiku estensiv tas-sustanza attiva.
English: • with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism
Maltese: • b'iperkalċimja diġà eżistenti u disturbi oħra fil-metaboliżmu tal-kalċju u l-fosfru
English: Data support continuous treatment with Preotact for up to 24 months (see section 4.4).
Maltese: L-informazzjoni ssostni trattament kontinwu bi Preotact sa perjodu ta' 24 xahar (ara sezzjoni 4.4).
English: Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
Maltese: Il-BMD volumetrika trabekulari fil-parti lombari tas-sinsla żdiedet bi 38% fuq il-linja bażi wara 18-il xahar.
English: The effects of Preotact on bone architecture were evaluated using quantitative computed tomography (QCT) and peripheral QCT.
Maltese: L-effetti ta' Preotact fuq l-arkitettura ta' l-għadam ġew evalwati bl-użu ta' tomografija kwantitattiva komputata (QCT) u QCT periferali.
English: Urine calcium/creatinine ratio increased Urine calcium increased
Maltese: kalċju/kreatinina fl-awrina Żieda ta' kalċju fl-awrina
English: Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Maltese: Bl-istess mod, il-BMD volumetrika trabekulari fil-ġenb sħiħ żdiedet b'9, 6 u 2%, rispettivament, fit-3 gruppi.
English: The recommended dose of Preotact is 100 micrograms per day.
Maltese: Id-doża rakkomandata ta' Preotact hija 100 mikrogramma kuljum.
English: A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
Maltese: Total ta' 238 mara ta' wara l-menopawsa ġew assenjati b'mod każwali għal wieħed mill-gruppi ta' kura segwenti; Preotact (100 mikrogramma ta' ormon tal-paratirojde), alendronate (10 mg), jew taħlita tat-tnejn, u kienu segwiti għal 12-il xahar.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Preotact in combination with hormone replacement therapy (HRT) in 180 postmenopausal women has been shown to significantly increase lumbar spine BMD at 12 months compared with HRT alone (7.1 % vs. 1.1%, p<0.001).
Maltese: Preotact flimkien ma' terapija ta' sostituzzjoni ta' l-ormoni (HRT) f'180 mara ta' wara l-menopawsa ġie muri li jżid b'mod sinifikanti l-BMD fil-parti lombari tas-sinsla wara 12-il xahar meta pparagunat ma' HRT waħedha (7.1% vs. 1.1%, p<0.001).
English: • constipation, diarrhoea,
Maltese: • stitikezza, dijarea
English: Volumetric trabecular BMD at the lumbar spine increased by 26, 13, and 11% (Preotact, Preotact and alendronate and alendronate, respectively) over baseline at 12 months.
Maltese: Il-BMD volumetrika trabekulari fil-parti lombari tas-sinsla żdiedet b'26, 13 u 11% (Preotact, Preotact u alendronate u alendronate,
English: For all subjects who received parathyroid hormone 100 micrograms blood uric acid increase was reported for 8 subjects (0.6%) and hyperuricemia was reported for 5 subjects (0.4%).
Maltese: Għall-pazjenti kollha li rċevew ormon tal-paratirojde 100 mikrogramma, żieda ta' l-aċidu uriku fid-demm ġiet irrapportata għal 8 pazjenti (0.6%) u iperuriċemja kienet irrapportata għal 5 pazjenti (0.4%).
English: Parosmia
Maltese: Astenja
English: The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Maltese: Il-farmakokinetika ta' l-ormon tal-paratirojde f'pazjenti b'indeboliment akut renali (tneħħija tal-kreatinina ta' anqas minn 30 ml/min) ma ġietx investigata.
English: A total of 2532 patients (1286 Preotact and 1246 placebo), aged 45-94 years (8.1% 45-54 years and 11.4% > 75 years), were randomised to receive 100 micrograms/day or placebo with daily calcium (700 mg) and vitamin D (400 IU) supplementation.
Maltese: Total ta' 2532 pazjent (1286 Preotact u 1246 pla ċebo), ta' 45-94 sena (8.1% ta' 45-54 sena u 11.4% >
English: Pharmacotherapeutic group: Calcium homeostatis, parathyroid hormones and analogues, ATC code: H05AA03.
Maltese: Omeostasi tal-kalċju, ormoni u analogi tal-paratirojde, Kodiċi ATC:
English: Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
Maltese: Relattivament ftit pazjenti li qabżu l-menopawsa b'anqas minn 5 snin u ta' 45-54 sena kienu rreġistrati fl-istudju ta' fażi III (2-3%).
English: Marketing Authorisation Holder NPS Pharma Holdings Limited Grand Canal House 1 Grand Canal Street Upper Dublin 4
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq NPS Pharma Holdings Limited Grand Canal House
English: Name and address of the manufacturer responsible for batch release Nycomed Danmark ApS
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Nycomed Danmark ApS
English: One year of therapy, showed the following results: the increases in lumbar spine BMD above baseline were similar in the Preotact and combination-therapy groups (6.3 and 6.1%, respectively), but were somewhat smaller in the alendronate group (4.6%).
Maltese: Iż-żidiet fil-BMD tal-parti lombari tas-sinsla fuq illinja bażi kienu simili fil-gruppi ta' Preotact u tat-terapija kombinata (6.3 u 6.1%, rispettivament), iżda kienu kemxejn anqas fil-grupp ta' alendronate (4.6%).
English: 2 pre-filled pens per pack.
Maltese: 2 pinen mimlijin għal-lest għal kull pakkett.
English: Elderly Dose adjustment based upon age is not required (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża bbażat fuq l-età (ara sezzjoni 5.2).
English: During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
Maltese: Matul il-perjodu ta' 28 ġurnata, is-soluzzjoni rikostitwita tista' tinħażen sa 7 ijiem f'temperaturi taħt 25°C.
English: • Release residual air (prime the pen)
Maltese: • Neħħi l-arja residwali (ipprajmja l-pinna)
English: Similarly, volumetric trabecular BMD at the total hip increased by 4.7%.
Maltese: Bl-istess mod, il-BMD volumetrika trabekulari fil-ġenb sħiħ żdiedet b'4.7%.
English: Treatment of osteoporosis with combination and sequential therapy The PaTH study was a National Institute of Health (NIH) sponsored randomised, placebo-controlled, 2 year, multicenter, double-blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis.
Maltese: L-istudju PaTH kien studju tal-Istitut Nazzjonali tas-Saħħa (NIH) li kien multiċentrali, randomised, tat-tip double-blind ikkontrollat bil-plaċebo, fuq perjodu ta' sentejn, dwar Preotact u alendronate bħala monoterapija u flimkien għat-trattament tal-osteoporożi ta' wara l-menopawsa.
English: • You can store the mixed pre-filled pen for up to 7 days at room temperature, between 2-25°C.
Maltese: • Inti tista' żżomm il-pinna mimlija bil-lest mħallta sa 7 ijiem f'temperatura ambjentali, ta' bejn 2-25°C.
English: • Check that the medicine is clear.
Maltese: • Iċċekkja li l-mediċina tkun ċara.
English: Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Maltese: Il-frammenti carboxy-terminali jiġu ffiltrati mill kliewi, iżda suċċessivament jiġu mkissra fi frammenti saħansitra iżgħar matul ir-riassorbiment tubulari.
English: Physiological actions of parathyroid hormone include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular reabsorption of calcium and excretion of phosphate by the kidney.
Maltese: L-effetti fiżjoloġiċi ta' l-ormon tal-paratirojde jinkludu stimulazzjoni tal-formazzjoni ta' l-għadam b'effetti diretti fuq iċ-ċelloli li jiffurmaw l-għadam (osteoblasts) li indirettament iżidu l-assorbiment intestinali tal-kalċju u jżidu r-riassorbiment tubulari tal-kalċju u l-eskrezzjoni tal-fosfat mill-kliewi.
English: Management of elevated serum calcium
Maltese: Ġestjoni ta' kalċju elevat fis-serum
English: Approximately 71.4% of the patients on parathyroid hormone reported at least one ADR.
Maltese: Madwar 71.4% tal-pazjenti fuq l-ormon tal-paratirojde rrapportaw mill-anqas ADR wieħed.
English: In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
Maltese: Fl-istudju ta' 24 xahar dwar it-terapija kombinata b'alendronate (PaTH), l-effetti ta' Preotact fuq l-arkitettura ta' l-għadam ġew evalwati wkoll bl-użu ta' QCT.
English: In the Preotact clinical program, accidental overdose has been reported.
Maltese: Fil-programm kliniku bi Preotact, doża eċċessiva aċċidentali ġiet irrapportata.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
Maltese: INDIVIDWALI 1.61 mg ormon tal-paratirojde u 1.13 mg ta' solvent (14-il doża)
English: Reconstituted solution: Store in a refrigerator (2-8°C).
Maltese: Aħżen fi friġġ (2-8°C).
English: To prevent one or more new vertebral fractures, 48 women had to be treated for a median of 18 months for the total population.
Maltese: Biex ikun evitat ksur vertebrali ġdid, 48 mara kellhom jiġu kkurati medja ta' 18-il xahar għall popolazzjoni kollha.
English: Antibodies to parathyroid hormone
Maltese: Antikorpi għall-ormon tal-paratirojde
English: Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar ir-rikostituzzjoni tal-prodott mediċinali qabel tingħata, ara sezzjoni 6.6.
English: uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (<1/10,000), including isolated reports.
Maltese: Il-kategoriji li ġejjin huma użati biex jikklassifikaw ir-reazzjonijiet avversi skont il-frekwenza tal-okkorrenza: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); u rari ħafna (<1/10,000), fosthom rapporti iżolati.
English: Hypercalcemia
Maltese: Iperkalċimja
English: No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Maltese: Ma kienu rilevati l-ebda differenzi fil-farmakokinetiċi ta' Preotact fir-rigward ta' l-età (medda 44-88
English: Preotact contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Pretact fih anqas minn 1 mmol ta' sodju (23 mg) għal kull doża.
English: The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55%.
Maltese: Il-bijodisponibiltà assoluta ta' 100 mikrogramma ta' ormon tal-paratirojde wara għoti taħt il-ġilda fl-addome hija 55%.
English: • Ensure that you have a needle on the pre-filled pen (see pictures 3 and 4).
Maltese: • Iżgura li inti għandek labra fil-pinna mimlija għal-lest (ara l-istampi 3 u 4).
English: Metabolism and nutrition disorders Very common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna
English: Treatment with Preotact reduced volumetric cortical bone BMD (measured at the distal radius and mid-shaft tibia), while periosteal circumference or indices of cortical bone strength were maintained.
Maltese: It-trattament bi Preotact naqqas il-BMD volumetriku ta' l-għadma kortikali (imkejla fid-distal radjus u l-mid-xaft tibia), filwaqt li ċ-ċirkonferenza perjosteali jew l-indiċi tas-saħħa tal-għadma kortikali kienu miżmuma.
English: Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.
Maltese: Mhuwiex rakkomandat monitoraġġ lil hinn minn 6 xhur għal pazjenti li l-kalċju totali fis-serum tagħhom ikun fil-limiti normali wara 6 xhur.
English: • decreased muscle strength, muscle cramps, dizziness,
Maltese: • saħħa anqas fil-muskoli, bugħawwieġ fil-muskoli, sturdament,
English: - Keep this leaflet.
Maltese: Ġestjoni ta' doża eċċessiva
English: The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney.
Maltese: Il-frammenti derivati mill-amino-terminus ikomplu jiġu degradati fiċ-ċellola filwaqt li l-frammenti derivati mill-carboxy-terminius jerġgħu jiġu rilaxxati fid-demm u jitneħħew mill-kliewi.
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone produced in Escherichia coli by recombinant DNA technology For a full list of excipients, see section 6.1.
Maltese: Wara r-rikostituzzjoni, kull doża ta' 71.4 mikrolitru fiha 100 mikrogramm ta' ormon tal-paratirojde li jiġi prodott minn Escherichia coli b'tekonoloġija rikombinanti tad-DNA.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jista' jaffettwa sa persuna 1 f'kull 10):
English: • Mix the medicine
Maltese: • Ħallat il-mediċina
English: It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3, 4.4, and 5.1).
Maltese: Matul il-programm kliniku hija kienet ġestita bil-monitoraġġ tal-valuri tal-laboratorju u l-użu ta' proċeduri ta' ġestjoni stabbiliti minn qabel (ara sezzjoni 4.3, 4.4, u 5.1).
English: Patients with urolithiasis
Maltese: Pazjenti b'urolitijasi
English: 30 months
Maltese: D (400
English: Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
Maltese: Wara doża taħt il-ġilda ta' Preotact, il-frammenti C-terminali jikkostitwixxu madwar 60-90% tal-forom fiċ-ċirkolazzjoni talmolekula.
English: Patients in the Preotact treatment group had a 61% relative risk reduction of a new vertebral fracture at month 18 compared to the patients in the placebo group.
Maltese: Ilpazjenti fil-grupp ta' kura bi Preotact kellhom tnaqqis relattiv ta' 61% fir-riskju ta' ksur vertebrali ġdid wara 18-il xahar meta mqabbel mal-pazjenti fil-grupp tal-plaċebo.
English: INSTRUCTIONS FOR USE
Maltese: Informazzjoni Prattika
English: Similar increases occurred at the femoral neck, trochanter, and intertrochanter.
Maltese: Żidiet simili seħħew fl-għonq femorali, it-trokanter, u l-intertrokanter.
English: Continued treatment for up to 24 months in an open-label extension of this study resulted in a continued increase in BMD.
Maltese: It-trattament kontinwu sa 24 xahar f'estensjoni open-label ta' dan l-istudju rriżultat f'żieda kontinwa fil-BMD.
English: Parathyroid hormone is the principal regulator of serum calcium homeostasis.
Maltese: L-ormon tal-paratirojde huwa r-regolatur prinċipali ta' l-omeostasi tal-kalċju fis-serum.
English: No potential for drug interactions was identified in the clinical program.
Maltese: Ma ġie identifikat l-ebda potenzjal għal interazzjonijiet bejn il-mediċini fil-programm kliniku.
English: Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Maltese: Ladarba l-iskartoċċ jiġi rikostitwit, huwa jista' jinħażen f'temperatura taħt 25°C sa 7 ijiem matul il-perjodu ta' użu ta' 28 ġurnata.
English: Hypercalciuria
Maltese: L-Awstrija
English: After mixing
Maltese: Mhux komuni
English: Based on two placebo-controlled studies involving 2642 postmenopausal osteoporotic women, hypercalcemia was reported in 25.3% of patients treated with Preotact compared to 4.3% of placebotreated patients.
Maltese: wara l-menopawsa, l-iperkalċimja ġiet irrapportata f'25.3% tal-pazjenti kkurati bi Preotact meta mqabbel ma' 4.3% tal-pazjenti kkurati bi plaċebo.
English: • nausea.
Maltese: sena).
English: There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
Maltese: għall-ormon tal-paratirojde fi studju li twettaq fuq 6 ir ġiel u 6 nisa b'indeboliment epatiku moderat meta mqabbel ma' grupp korrispondenti ta' 12-il pazjent b'funzjoni epatiku normali.
English: • headache,
Maltese: • uġigħ ta' ras,
English: Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen Parathyroid hormone
Maltese: Preotact 100 mikrogramm trab u solvent għal soluzzjoni għall-injezzjoni Ormon tal-paratirojde
English: In these women with a positive titre, there was no evidence of hypersensitivity reactions, allergic reactions, effects on bone mineral density response, or effects on serum calcium.
Maltese: ma kien hemm ebda evidenza ta' reazzjonijiet ta' sensittività e ċċessiva, reazzjonijiet allerġiċi, effetti fuq ir-rispons tad-densità minerali fl-għadam, jew effetti fuq il-kalċju fis-serum.
English: • irritation of the skin at the injection site,
Maltese: • irritazzjoni tal-ġilda fil-post tal-injezzjoni,
English: The dose counter
Maltese: Il-kontatur tad-dożi
English: Caution should be exercised in patients receiving cardiac glucosides due to the risk of digitalis toxicity if hypercalcemia develops (see section 4.5).
Maltese: Trid tingħata attenzjoni għal dawk il-pazjenti li jkunu qegħdin jirċievu glukosidi kardijaċi minħabba r-riskju ta' tossiċità minn digitalis kemm-il darba tiżviluppa iperkalċemija (ara sezzjoni 4.5).
English: • tiredness.
Maltese: TA' EĊĊIPJENTI
English: Discuss with your doctor if you consider stopping the treatment with Preotact before you finish the prescribed period.
Maltese: Iddiskuti mat-tabib tiegħek jekk qed tikkonsidra li twaqqaf it-trattament bi Preotact qabel ma ttemm ilperjodu preskritt.
English: • if you have high levels of alkaline phosphatase (an enzyme produced by the organism; may signal certain medical conditions, related to bones and liver);
Maltese: • jekk għandek livelli għoljin ta' alkaline phosphatase (enzima li tiġi prodotta mill-organiżmu:
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u l-attivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deciż fl-verżjoni 03 tas-Sistema ta' l-Immaniġġar tar-Riskju inkluz f' Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti tas-Sistema ta'
English: Preotact increases serum uric acid concentrations.
Maltese: Preotact iżid il-konċentrazzjonijiet ta' aċidu uriku fis-serum.
English: The pen can be used with standard injection pen needles.
Maltese: Il-pinna tista' tintuża ma' labar standard ta' pinen tal-injezzjoni.