FrancophonIA/ELRC3.0 huggingface dataset:
English: Most of the hypocalcaemic events occurring in the clinical trials were mild to moderate in severity.
Maltese: Ħafna mill-avvenimenti ipokalċemiċi, li seħħew fil-provi kliniċi kienu ta' severità ħafifa sa moderata.
English: • allergic reactions (hypersensitivity), such as: swelling of the face, lips, mouth, or tongue;
Maltese: • reazzjonijiet allerġiċi (sensittività eċċessiva), bħal: nefħa fil-wiċċ, fix-xofftejn, fil-ħalq jew fl ilsien; qtugħ ta' nifs; ħakk; raxx; ħorriqija
English: It is normal to see small air bubbles in the liquid.
Maltese: Huwa normali li tara bżieżaq żgħar tal-arja fil-likwidu.
English: Natpar is not protein bound and has a low volume of distribution.
Maltese: Natpar ma jeħilx mal-proteini u għandu volum baxx ta' distribuzzjoni.
English: Figure C Medicine Tracker
Maltese: Traċċatur tal-Mediċina
English: Natpar is produced in E. coli using recombinant DNA technology, and is identical to the 84 amino acid sequence of endogenous human parathyroid hormone.
Maltese: Natpar jiġi prodott f'E. coli permezz tat-teknoloġija tad-DNA rikombinanti, u huwa identiku għassekwenza tal-amminoaċidu 84 ta' ormon endoġenu tal-paratirojde tal-bniedem.
English: Natpar 25 micrograms/dose powder and solvent for solution for injection in pre-filled pen Natpar 50 micrograms/dose powder and solvent for solution for injection in pre-filled pen Natpar 75 micrograms/dose powder and solvent for solution for injection in pre-filled pen Natpar 100 micrograms/dose powder and solvent for solution for injection in pre-filled pen
Maltese: Natpar 25 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Natpar 50 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Natpar 75 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Natpar 100 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għallest
English: Natpar 25 microgram/dose powder and solvent for solution for injection in pre-filled pen Natpar 50 microgram/dose powder and solvent for solution for injection in pre-filled pen Natpar 75 microgram/dose powder and solvent for solution for injection in pre-filled pen Natpar 100 microgram/dose powder and solvent for solution for injection in pre-filled pen Parathyroid hormone (rDNA)
Maltese: Natpar 25 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Natpar 50 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Natpar 75 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Natpar 100 mikrogramma/doża trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għallest Ormon tal-paratirojde
English: Purple pen label.
Maltese: • Kompli pponta l-labra dritt 'l isfel.
English: PTH has a variety of critical physiological functions that include its central role in modulating serum calcium and phosphate levels within tightly regulated levels, regulating renal calcium and phosphate excretion, activating vitamin D, and maintaining normal bone turnover.
Maltese: Il-PTH għandu varjetà ta' funzjonijiet fiżjoloġiċi kritiċi li jinkludu r-rwol ċentrali tiegħu filmodulazzjoni tal-livelli ta' kalċju u ta' fosfati fis-serum f'livelli regolati ħafna, li jirregolaw leliminazzjoni tal-kalċju u tal-fosfati mill-kliewi, li jattivaw il-vitamina D, u jżommu t-tibdil normali fl-għadam.
English: In these studies, Natpar was self-administered, with daily doses ranging from 25 to 100 micrograms per subcutaneous injection.
Maltese: Persuni jista' jkollhom bżonn bejn 25 u 100 mikrogramma ta' Natpar kuljum.
English: The most frequent adverse reactions among patients treated with Natpar were hypercalcaemia, hypocalcaemia, and their associated clinical manifestations including headache, diarrhoea, vomiting, paraesthesia, hypoaesthesia and hypercalciuria.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti fost pazjenti li ngħataw kura b'Natpar kienu iperkalċimija, ipokalċimija, u l-manifestazzjonijiet kliniċi assoċjati tagħhom fosthom uġigħ ta' ras, dijarea, rimettar, parastesija, ipoestesija u iperkalċurja.
English: Citric acid monohydrate Sodium hydroxide (for pH adjustment)
Maltese: Aċidu ċitriku monoidrat Idrossidu tas-sodju (għall-aġġustament tal-pH)
English: Call Shire at +44 (0)800 055 6614 for help.
Maltese: Ċempel lil Shire fuq +44 (0)800 055 6614 għall-għajnuna.
English: Urolithiasis
Maltese: Takifilassi
English: Each pre-filled pen contains 1400 micrograms parathyroid hormone (rDNA).
Maltese: Kull pinna mimlija għal-lest fiha 1400 mikrogramma tal-ormon tal-paratirojde (rDNA).
English: You may have forgotten to prime the pen as instructed in “New Pen Setup & Mixing” (Section B).
Maltese: Jista' jkun li nsejt tipprajmja l-pinna skont l-istruzzjonijiet fi “Preparazzjoni u Taħlit ta' Pinna Ġdida” (Sezzjoni B).
English: Following a single 100 micrograms subcutaneous dose, the mean Cmax and baseline-corrected Cmax values were 18% to 20% greater in the moderately impaired subjects than in those with normal function.
Maltese: Wara doża unika ta' 100 mikrogramma taħt il-ġilda, il-valuri medji tas-Cmax u tas-Cmax ikkoreġuti fil-linja bażi kienu ta' 18 % sa 20 % akbar fl-individwi b'indeboliment moderat milli f'dawk b'funzjoni normali.
English: The final clinical study report should be submitted by:
Maltese: Ir-rapport finali ta' studju kliniku għandu jiġi ppreżentat:
English: • Write today's date in the space next to “Date Mixed”.
Maltese: • Ikteb id-data tal-lum fl-ispazju ħdejn “Data Meta Tħalltet”.
English: Rats treated with daily injections of Natpar for 2 years had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to a non-genotoxic mechanism.
Maltese: Firien li ngħataw kura b'injezzjonijiet ta' kuljum ta' Natpar għal sentejn kellhom formazzjoni esaġerata tal-għadam dipendenti fuq id-doża u żieda fl-inċidenza ta' tumuri fl-għadam, inkluż osteosarkoma, probabbilment minħabba mekkaniżmu mhux ġenotossiku.
English: Grey pen label.
Maltese: Ipprova ssikka l-labra mill-ġdid.
English: If pre-dose serum calcium is >2.25 mmol/L, a starting dose of 25 micrograms can be considered.
Maltese: Jekk qabel tingħata d-doża l-kalċju fis-serum ikun ta' >2.25 mmol/L, tista' tiġi kkunsidrata doża tal-bidu ta' 25 mikrogramma.
English: The clinical study report should be submitted by:
Maltese: Ir-rapport ta' studju kliniku għandu jiġi ppreżentat sa:
English: Less than or equal to 2.25 mmol/L and above 2 mmol/L
Maltese: Inqas minn jew ta' 2.25 mmol/L u ogħla minn 2 mmol/L
English: • Otherwise, go to “Daily Injection” (Section C).
Maltese: • Inkella, mur għal “Injezzjoni ta' Kuljum” (Sezzjoni C).
English: • Check that the yellow dose counter lines up with the black dot (See Figure E).
Maltese: • Iċċekkja li l-indikatur isfar tad-doża ikun qiegħed bi dritt it-tikka s-sewda (Ara Figura E).
English: In monkeys receiving daily subcutaneous doses for 6 months, there was an increased occurrence of renal tubular mineralisation at exposure levels 2.7 times the clinical exposure levels at the highest dose.
Maltese: F'xadini li kienu qed jirċievu dożi ta' kuljum taħt il-ġilda għal 6 xhur, kien hemm okkorrenza akbar ta' mineralizzazzjoni tubulari renali f'livelli ta' esponiment ta' 2.7 darbiet il-livelli ta' esponiment kliniku fl-ogħla doża.
English: 6 • Remove the paper tab back from the needle cap (See Figure N).
Maltese: 6 • Neħħi s-siġill tal-karta mill-għatu tal-labra (Ara Figura N).
English: Natpar 75 micrograms/dose
Maltese: Natpar 75 mikrogramma/doża Tikketta tal-pinna griża.
English: Get to know the Natpar Pre-filled Pen Natpar Pre-filled Pen
Maltese: • TUŻAX pinna li kienet fil-friża.
English: Natpar is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - who are receiving or who have previously received radiation therapy to the skeleton - with skeletal malignancies or bone metastases - who are at increased baseline risk for osteosarcoma such as patients with Paget's disease of bone or hereditary disorders - with unexplained elevations of bone-specific alkaline phosphatase - with pseudohypoparathyroidism.
Maltese: Natpar huwa kontraindikat f'pazjenti: - b'sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 - li jkunu qegħdin jirċievu jew li qabel ikunu irċevew terapija ta' radjazzjoni fl-iskeletru - b'tumuri skeletriċi jew metastasi fl-għadam - li qegħdin f'riskju bażi akbar għal osteosarkoma bħal pazjenti bil-marda tal-għadam ta' Paget jew b'mard ereditarju - b'żidiet mhux spjegati ta' fosfatażi alkalina speċifiċi għall-għadam - bi psewdoipoparatirojdiżmu.
English: Powder and solvent for solution for injection.
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni.
English: Hypercalcaemia of any cause may predispose to digitalis toxicity.
Maltese: Iperkalċimija ta' kwalunkwe kawża tista tippredisponi għal tossiċità diġitalis.
English: Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves.
Maltese: Livell baxx ta' kalċju jista' jikkawża sintomi f'ħafna partijiet tal-ġisem tiegħek, inkluż flgħadam, fil-qalb, fil-ġilda, fil-muskoli, fil-kliewi, fil-moħħ u fin-nervituri.
English: B. New Pen Setup & Mixing
Maltese: .8 Effetti mhux mixtieqa
English: Missed dose
Maltese: Aġġusta t-tieni
English: Initiating Natpar
Maltese: Ikkunsidra tnaqqis
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva/i
English: Each pre-filled pen contains 1050 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Maltese: Kull pinna mimlija għal-lest fiha 1050 mikrogramma tal-ormon tal-paratirojde (rDNA) bħala trab flewwel kompartiment u 1000 mikrolitru ta' solvent fit-tieni kompartiment (li jikkorrispondi għal 14-il doża).
English: Pack size: Carton containing 2 pre-filled pens.
Maltese: • Inkella, kompli bil-Pass 2 hawn taħt.
English: There were no apparent differences in the serum total calcium concentration-time profiles between the 2 hepatic function groups.
Maltese: Ma kien hemm ebda differenza evidenti fil-profili tal-konċentrazzjoni mal-ħin tal-kalċju totali fis-serum bejn iż-żewġ gruppi talfunzjoni epatika.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul talRMP.
English: • Refer to the following Frequently Asked Questions.
Maltese: • Irreferi għall-Mistoqsijiet Frekwenti li ġejjin.
English: Each pre-filled pen contains 350 micrograms parathyroid hormone (rDNA).
Maltese: Kull pinna mimlija għal-lest fiha 350 mikrogramma tal-ormon tal-paratirojde (rDNA).
English: • muscle spasms
Maltese: • uġigħ fis-sider
English: Respiratory, thoracic and mediastinal cough disorders Gastrointestinal disorders diarrhoea*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali sogħla
English: Each pre-filled pen contains 700 micrograms parathyroid hormone (rDNA).
Maltese: Kull pinna mimlija għal-lest fiha 700 mikrogramma tal-ormon tal-paratirojde (rDNA).
English: Adjust third
Maltese: Ara sezzjoni 5
English: • fatigue and lack of energy*
Maltese: • għeja u nuqqas ta' enerġija*
English: Each pre-filled pen contains 350 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Maltese: Kull pinna mimlija għal-lest fiha 350 mikrogramma tal-ormon tal-paratirojde (rDNA) bħala trab flewwel kompartiment u 1000 mikrolitru ta' solvent fit-tieni kompartiment (li jikkorrispondi għal 14-il doża).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku fuq ilġeni, effett tossiku fuq il-fertilità u s-sistema riproduttiva ġenerali, u t-tolleranza lokali ma juri l-ebda periklu speċjali għall-bnedmin.
English: Each pre-filled pen contains 700 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Maltese: Kull pinna mimlija għal-lest fiha 700 mikrogramma tal-ormon tal-paratirojde (rDNA) bħala trab flewwel kompartiment u 1000 mikrolitru ta' solvent fit-tieni kompartiment (li jikkorrispondi għal 14-il doża).
English: The safety and clinical efficacy of Natpar in adults with hypoparathyroidism is derived from 1 randomised, placebo-controlled study and an open-label extension study.
Maltese: Is-sigurtà u l-effikaċja klinika ta' Natpar f'adulti b'ipoparatirojdiżmu huma derivati minn studju randomizzat ikkontrollat bi plaċebo u studju ta' estensjoni b'tikketta miftuħa.
English: Patients should be monitored until signs and symptoms resolve (see sections 4.3 and 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati sakemm jgħaddu s-sinjali u s-sintomi (ara sezzjonijiet 4.3 u 4.8).
English: Urinary calcium excretion
Maltese: Eliminazzjoni tal-kalċju fl-awrina
English: Each pre-filled pen contains 1400 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Maltese: Kull pinna mimlija għal-lest fiha 1400 mikrogramma tal-ormon tal-paratirojde (rDNA) bħala trab flewwel kompartiment u 1000 mikrolitru ta' solvent fit-tieni kompartiment (li jikkorrispondi għal 14-il doża).
English: Tachyphylaxis
Maltese: FARMAĊEWTIKU
English: Figure L The setup of your pen is complete.
Maltese: B. Preparazzjoni u Taħlit ta' Pinna Ġdida
English: Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 100 mikrogramma ta' ormon tal-paratirojde (rDNA) f'soluzzjoni ta' 71.4 mikrolitri wara r-rikostituzzjoni.
English: There are no data available in patients with severe hepatic impairment (see section 4.4).
Maltese: M'hemm l-ebda data disponibbli f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.4).
English: abdominal pain upper*
Maltese: • pressjoni għolja tad-demm*
English: If you do not wait 10 seconds after pressing the blue button, you may not receive your full dose.
Maltese: Jekk ma tistenniex 10 sekondi wara li tagħfas il-buttuna l-blu, tista' ma tirċevix id-doża sħiħa tiegħek.
English: Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 75 mikrogramma ta' ormon tal-paratirojde (rDNA) f'soluzzjoni ta' 71.4 mikrolitri wara r-rikostituzzjoni.
English: In the kidney, parathyroid hormone and C-terminal fragments are cleared by glomerular filtration.
Maltese: Fil-kliewi, l-ormon tal-paratirojde u l-frammenti ta' terminali C jitneħħew permezz ta' filtrazzjoni glomerulari.
English: shortness of breath; itching; rash; hives
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: • If the dose counter shows “0” (no doses remaining) or the “Discard On” date has passed (see Medicine Tracker), discard the used pen in the sharps container (See Figure Z) as instructed in Step 17: “Discard your used needles and pens.”
Maltese: Nhar” għaddiet (ara t-Traċċatur tal-Mediċina), armi l-pinna użata fil-kontenitur għar-rimi ta' oġġetti li jaqtgħu u bil-ponta (Ara Figura Z) skont l-istruzzjonijiet filPass 17: “Armi l-labar u l-pinen użati tiegħek.
English: 17 Discard your used needles:
Maltese: 17 Armi l-labar użati tiegħek:
English: If Natpar is to be discontinued, monitoring for hypocalcaemia is necessary (see section 4.2).
Maltese: Jekk Natpar għandu jitwaqqaf, huwa meħtieġ monitoraġġ għal ipokalċimija (ara sezzjoni 4.2).
English: Temporary or permanent discontinuation of Natpar treatment must be accompanied by monitoring of serum calcium levels and adjustment, as necessary, of exogenous calcium and/or active vitamin D (see section 4.4).
Maltese: It-twaqqif temporanju jew permanenti tal-kura b'Natpar għandu jkun akkumpanjat minn monitoraġġ tal-livelli tal-kalċju fis-serum u aġġustamenti, skont kif ikun meħtieġ, tal-kalċju u/jew tal-vitamina D attiva esoġeni (ara sezzjoni 4.4).
English: Cases of hypocalcaemia resulting in seizures have been reported post-marketing (see section 4.4).
Maltese: Każijiet ta' ipokalċimija li jwasslu għal aċċessjonijiet ġew irrappurtati wara t-tqegħid fis-suq (ara sezzjoni 4.4).
English: Suggested adjustments to Natpar, active vitamin D and calcium supplements based on serum calcium levels are provided below:
Maltese: L-aġġustamenti ssuġġeriti għal Natpar, għall-vitamina D attiva u għassuppliment tal-kalċju abbażi tal-livelli ta' kalċju fis-serum huma pprovduti hawn taħt:
English: Adjust dose of active vitamin D or calcium supplement or both based on serum calcium value and clinical assessment (i.e., signs and symptoms of hypocalcaemia or hypercalcaemia).
Maltese: Aġġusta d-doża tal-vitamina D attiva jew tas-suppliment tal-kalċju jew it-tnejn abbażi tal-valur tal-kalċju fis-serum u valutazzjoni klinika (jiġifieri sinjali u sintomi ta' ipokalċimija jew iperkalċimija).
English: 16 • Squeeze the needle cap and unscrew the needle (See Figure W).
Maltese: 16 • Agħfas l-għatu tal-labra u neħħi l-labra billi ddawwarha (Ara Figura W).
English: Decrease
Maltese: Deskrizzjoni
English: Severe hypercalcaemia may be a life-threatening condition requiring urgent medical care and careful monitoring (see section 4.4).
Maltese: Iperkalċimija severa tista' tkun kundizzjoni ta' theddida għall-ħajja li teħtieġ kura medika urġenti u monitoraġġ bir-reqqa (ara sezzjoni 4.4).
English: Downward titration to a minimum of 25 micrograms can occur at any time.
Maltese: Titrazzjoni 'l isfel sa minimu ta' 25 mikrogramma tista' sseħħ fi kwalunkwe ħin.
English: In the clinical studies, these reactions were generally mild to moderate in severity and transient, and were managed with adjustments of Natpar, calcium and/or active vitamin D doses (see sections 4.4 and 5.1).
Maltese: Fl-istudji kliniċi, dawn ir-reazzjonijiet kienu ġeneralment ħfief għal moderati fis-severità u temporanji, u kienu ġestiti b'aġġustamenti fid-doża ta' Natpar, tal-kalċju u/jew tal-vitamina D attiva (ara sezzjonijiet 4.4 u 5.1).
English: Adverse reactions for Natpar-treated patients in the placebo-controlled study and in post-marketing experience are listed below by MedDRA system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi għall-pazjenti li ngħataw kura b'Natpar fl-istudju kkontrollat bi plaċebo u f'esperjenza ta' wara t-tqegħid fis-suq huma elenkati hawn taħt skont is-sistema tal-klassifika talorgani MedDRA u skont il-frekwenza.
English: Treatment with Natpar increases serum calcium concentration in hypoparathyroidism patients, and this increase occurs in a dose-related manner.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Repeat steps 4 and 5 until target pre-dose serum calcium concentration is within the range of 2.0-2.25 mmol/L, active vitamin D has been discontinued and calcium supplementation is sufficient to meet daily requirements.
Maltese: Irrepeti l-passi 4 u 5 sakemm il-konċentrazzjoni tal-kalċju fil-mira qabel tingħata d-doża tkun fil-medda ta' 2.0-2.25 mmol/L, il-vitamina D tkun twaqqfet u s-supplimentazzjoni tal-kalċju tkun biżżejjed biex tissodisfa l-ħtiġijiet ta' kuljum.
English: 8 • Use an alcohol wipe to clean the injection site area of the thigh (See Figure O).
Maltese: 8 • Uża mselħa tal-alkoħol biex tnaddaf iż-żona tas-sit tal-injezzjoni tal-koxxa (Ara Figura O).
English: • neck pain
Maltese: Doża maqbuża
English: This means that there is more evidence to come about this medicine.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar din il-mediċina.
English: Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 50 mikrogramma tal-ormon tal-paratirojde (rDNA) f'soluzzjoni ta' 71.4 mikrolitri wara r-rikostituzzjoni.
English: Each dose contains 75 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 75 mikrogramma ta' ormon tal-paratirojde f'soluzzjoni ta' 71.4 mikrolitri wara rrikostituzzjoni.
English: Pregnancy
Maltese: Urolitjażi
English: Each dose contains 25 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 25 mikrogramma tal-ormon tal-paratirojde (rDNA) f'soluzzjoni ta' 71.4 mikrolitri wara r-rikostituzzjoni.
English: The glass dual-chamber cartridge inside the pen is made from type I glass with 2 bromobutyl rubber stoppers and a crimp cap (aluminium) with a bromobutyl rubber seal.
Maltese: L-iskartoċċ tal-ħġieġ b'żewġ kompartimenti ġewwa l-pinna huwa magħmul minn ħġieġ tat-tip I b'2 tappijiet tal-lasktu bromobutyl u tapp tennej (tal-aluminju) b'siġill tal-gomma tal-bromobutyl.
English: Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 25 mikrogramma ta' ormon tal-paratirojde (rDNA)* f'soluzzjoni ta' 71.4 mikrolitri wara r-rikostituzzjoni.
English: After reconstitution, chemical and physical in-use stability of the solution has been demonstrated for up to 14 days when stored in a refrigerator (2°C - 8°C) and for up to 3 days when stored outside the refrigerator not above 25°C during the 14-day use period.
Maltese: Wara r-rikostituzzjoni, l-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni intweriet sa 14-il jum meta maħżuna fi friġġ (2°C - 8°C) u sa 3 jiem meta maħżuna barra mill-friġġ f'temperatura ta' mhux aktar minn 25°C matul il-perjodu ta' użu ta' 14-il jum.
English: It is available in 4 different strengths of pen (each pre-filled pen contains 14 doses): Natpar 25 micrograms
Maltese: Huwa disponibbli f'4 pinen b'qawwiet differenti (kull pinna mimlija għal-lest fiha 14-il doża):
English: If leaking occurs, call Shire at +44 (0)800 055 6614 for help.
Maltese: Jekk mhuwiex, ċempel lil Shire fuq +44 (0)800 055 6614 għallgħajnuna.
English: General disorders and administration site conditions asthenia*, chest pain fatigue, injection site reactions, thirst*
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata astenja*, uġigħ fissider
English: Temporary or permanent discontinuation of Natpar must be accompanied by monitoring of serum calcium levels and increase of exogenous calcium and/or active vitamin D sources as necessary.
Maltese: It-twaqqif temporanju jew permanenti ta' Natpar għandu jkun akkumpanjat minn monitoraġġ tal-livelli tal-kalċju fis-serum u ż-żieda ta' sorsi eżoġeni ta' kalċju u/jew ta' vitamina D attiva skont il-bżonn.
English: Based on these results, no dose adjustment is necessary in patients with mild-to-moderate renal impairment (CLcr 30 to 80 mL/min).
Maltese: Abbażi ta' dawn ir-riżultati, ma hemm bżonn ta' ebda aġġustament fid-doża f'pazjenti b'indeboliment renali minn ħafif sa moderat (CLcr 30 sa 80 mL/min).
English: This means that it is essentially “sodium-free”.
Maltese: Dan ifisser li huwa essenzjalment “ħieles mis-sodju”.
English: PTH exerts its action via cell-surface parathyroid hormone receptors, present in bone, kidney and nerve tissue.
Maltese: Il-PTH jeżerċita l-azzjoni tiegħu permezz ta' riċetturi tal-ormon tal-paratirojde fuq ilwiċċ taċ-ċelloli, li huma preżenti fit-tessuti tal-għadam, tal-kliewi u tan-nervituri.