FrancophonIA/ELRC3.0 huggingface dataset:
English: Richter-Helm BioLogics GmbH & Co. KG Dengelsberg
Maltese: Richter-Helm BioLogics GmbH & Co.
English: Terrosa is indicated in adults.
Maltese: Terrosa huwa indikat fl-adulti.
English: The pivotal study included 1,637 postmenopausal women (mean age 69.5 years).
Maltese: L-istudju prinċipali inkluda 1,637 mara wara l-menopawża (eta' medja 69.5 sena).
English: *Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone.
Maltese: *Teriparatide, rhPTH(1-34), magħmul f'E. coli, permezz tat-teknoloġija rikombinanti tad-DNA, huwa identiku għas-sekwenza ta' 34 N-terminal amino acid ta' l-ormon uman paratirodje endoġenu.
English: Multiple vertebral fractures (≥2) a
Maltese: (≥2) a
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għall-umani mhuwiex magħruf.
English: Teriparatide increases serum uric acid concentrations.
Maltese: Teriparatide jżid il-konċentrazzjonijiet ta' uric acid fis-serum.
English: Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.
Maltese: L-ormon endoġenu 84-amino-acid tal-paratirojde (PTH) huwa r-regulatur prinċipali tal-metaboliżmu ta' calcium u phosphate fl-għadam u fil-kliewi.
English: Chemical in-use stability has been demonstrated for 28 days at 2 - 8 °C.
Maltese: Stabilita' kimika waqt l-użu ntweriet għal 28 jum f'temperatura ta' bejn 2 u 8°C.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (≥1/10,000 to
Maltese: Bħala klassifikazzjoni tar- reazzjonijiet avversi ġiet użata s-sistema li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), u rari(≥ 1/10,000 sa < 1/1,000).
English: Colourless, clear solution for injection with a pH of 3.8 - 4.5.
Maltese: Soluzzjoni ċara u bla kulur għall-injezzjoni b'pH ta' 3.8-4.5.
English: Terrosa is a biosimilar medicinal product.
Maltese: Terrosa huwa prodott mediċinali bijoloġiku simili.
English: Terrosa Pen parts push button; display window; threaded rod; flange; Terrosa cartridge; peel foil; pen needle; inner needle cap; outer needle cap; pen cap; cartridge holder, dosage knob, housing
Maltese: Partijiet tat-Terrosa Pen buttuna fejn tagħfas; tieqa tad-displej; stud; flanġ; Terrosa skartoċċ; fojl li jitqaxxar; labra tal-pinna; għatu ta' ġewwa tal-labra; għatu ta' barra tal-labra; għatu tal-pinna; kontenitur tal-iskartoċċ, pum taddożaġġ, korp
English: The volume of distribution is approximately 1.7 L/kg.
Maltese: Il-volum tad-distribuzzjoni huwa madwar 1.7 L/kg.
English: 1,013 (74.5%) patients completed the 24-month follow-up.
Maltese: 1,013-il pazjenta (74.5%) temmew l-24 xahar ta' segwitu.
English: Terrosa cartridge and pen pack: 1 carton of Terrosa cartridge (containing 1 cartridge) and 1 carton of Terrosa Pen (containing 1 pen).
Maltese: Kartuna 1 ta' Terrosa skartoċċ (li fiha skartoċċ 1) u kartuna 1 ta' Terrosa Pen (li fiha pinna 1).
English: Hypercalcaemia greater than 3.25 mmol/L
Maltese: 3.25 mmol/L
English: Overdose experience based on post-marketing spontaneous reports
Maltese: Esperjenza ta' doża eċċessiva bbażata fuq rapporti spontanji wara t-tqegħid fis-suq
English: Hypercalcaemia greater than 2.76 mmol/L, hyperuricaemia
Maltese: 2.76 mmol/L,
English: The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), p=0.0009.
Maltese: kienet 4.8% fil-pazjenti ttrattati b'teriparatide u 9.8% fil-pazjenti ttrattati b'risedronate, proporzjon ta' periklu (95% CI) = 0.48 (0.32-0.74), p=0.0009.
English: Teriparatide has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
Maltese: Teriparatide ngħata f'dożi waħedhom sa 100 mikrogramma u f'dożi ripetuti sa 60 mikrogramma/jum għal 6 ġimgħat.
English: At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study.
Maltese: Fil-linja bażi, n-nisa kellhom età medja ta' 72.1 sena u medjan ta' 2 ksur prevalenti tal-vertebrae; 57.9% tal-pazjenti kienu rċivew terapija preċedenti b'bisphosphonate u 18.8% ħadu glukokortikojdi fl-istess waqt matul l-istudju.
English: One cartridge of 2.4 mL of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
Maltese: Skartoċċ wieħed ta' 2.4 mL ta' soluzzjoni li fiha 600 mikrogramma ta' teriparatide (li tikkorrispondi għal 250 mikrogramma f'kull mL).
English: Male osteoporosis
Maltese: l-osteoporożi.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jolqtu sa persuna 1 minn kull 10 persuni):
English: Terrosa contains sodium
Maltese: Terrosa fih is-sodium
English: The skeletal effects of teriparatide depend upon the pattern of systemic exposure.
Maltese: L-effetti skeletriċi ta' teriparatide jiddependu fuq il-mod ta' espożizzjoni sistemika.
English: INFORMATION IN BRAILLE Terrosa cartridge
Maltese: INFORMAZZJONI BIL-BRAILLE Terrosa skartoċċ
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.290.68), p<0.0001.
Maltese: Għall-dawk l-individwi li kellhom radjugrafs tas-sinsla tal-linja bażi u tas-segwitu, linċidenza ta' ksur vertebrali ġdid kienet 28/516 (5.4%) fil-pazjenti ttrattati b'teriparatide u 64/533 (12.0%) fil-pazjenti ttrattati b'risedronate, riskju relattiv (95% CI) = 0.44 (0.29-0.68), p<0.
English: During a median of 18 months following discontinuation of teriparatide, there was a 41% reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
Maltese: Matul medja ta' 18-il xahar wara l-waqfien tal-kura b'teriparatide, kien hemm 41% tnaqqis (p=0.004) meta mqabbel mal-plaċebo fin-numru ta' pazjenti b'minimu ta' ksur waħdani vertebrali ġdid.
English: Teriparatide increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p<0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p<0.05).
Maltese: Teriparatide żied il-BMD tal-ġenbejn kollu (3.6 %) meta mqabbel ma' alendronate (2.2 %) (p<0.01) kif ukoll fl-għonq ta' l-għadma tal-koxxa (3.7 %) meta mqabbel ma' alendronate (2.1 %) (p<0.05).
English: Emphysema
Maltese: Emfisema
English: Pregnancy Terrosa is contraindicated for use during pregnancy (see section 4.3).
Maltese: Tqala Waqt it-tqala l-użu ta' Terrosa huwa kontra-indikat (ara sezzjoni 4.3).
English: Do not use Terrosa:
Maltese: Tużax Terrosa:
English: Answer
Maltese: LISTA
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jolqtu sa persuna 1 minn kull 100 persuni):
English: All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Maltese: Il-pazjenti kollha ġew mogħtija 1,000 mg calcium kuljum u mhux inqas minn 400 IU vitamina D kuljum.
English: Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA02
Maltese: Omeostasi tal-kalċju, ormoni tal-paratirojde u analogi, Kodiċi ATC:
English: One cartridge of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
Maltese: Skartoċċ wieħed ta' 2.4 mL fih 600 mikrogramma ta' teriparatide (li jikkorrispondu għal 250 mikrogramma għal kull mL).
English: QR code to be included
Maltese: Kodiċi QR għandu jiġi inkluż
English: Other medicines and Terrosa
Maltese: Mediċini oħra u Terrosa
English: There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on Bone Mineral Density (BMD) response.
Maltese: Ma kienx hemm evidenza ta' reazzjonijiet ta' sensittivita' e ċċessiva, reazzjonijiet allerġiċi, effetti fuq calcium fis-serum, jew effetti fuq id-Densità Minerali tal-Għadam (BMD).
English: • BD Micro-Fine Ultraneedles 29 to 31 gauge (diameter 0.25 - 0.33 mm) and 12.7, 8 or 5 mm length Pen needles from other manufacturers can be used according to their stated compatibility details.
Maltese: Ultra labar 29 sa 31 gejġ (dijametru 0.25 - 0.33 mm) u tul ta' 12.7, 8 jew 5 mm Labar tal-pinna minn manifatturi oħrajn jistgħu jintużaw skont id-dettalji tal-kompatibbiltà ddikjarati tagħhom.
English: d p≤0.025 compared with placebo.
Maltese: 025 meta mqabbel mal-plaċebo
English: In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 micrograms) of a teriparatide pen have been administered as a single dose.
Maltese: F'rapporti spontanji wara t-tqegħid fis-suq, kien hemm każijiet ta' żbalji fil-medikazzjoni fejn ilkontenut kollu (sa 800 mikrogramma) ta' pinna ta' teriparatide ngħata f'doża waħda.
English: The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm.
Maltese: Il-medja (medjan) tad-doża kumulattiva talglukokortikojd kienet 474.3 (66.2) mg fil-fergħa ta' teriparatide u 898.0 (100.0) mg fil-fergħa ta' risedronate.
English: At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5%, 2.6 % and 3.9% respectively.
Maltese: Fl-24 xahar, iż-żieda medja fil-BMD tas-sinsla lumbari, tat-total tal-ġenbejn u tal-għonq femorali mil-linja bażi kien rispettivament 10.5 %, 2.6 % u 3.9 %.
English: No data are available in patients with impaired hepatic function (see section 5.3).
Maltese: Indeboliment epatiku M' hemmx informazzjoni dwar pazienti b'indeboliment fil-funzjoni tal-fwied (ara sezzjoni 5.3.).
English: In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving teriparatide.
Maltese: F' prova klinika kbira, l-antikorpi li ġew cross-reacted ma' teriparatide instabu f'2.8% tan-nisa li ngħataw teriparatide.
English: Sodium acetate trihydrate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sodium acetate trihydrate Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide(għall-aġġustament tal-pH) Ilma għall-injezzjoni
English: Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Maltese: Bħala linja bażi, il-medja tat-T-scores tad-densità minerali ta' lgħadam tas-sinsla u ta' l-għonq tal-femorali kienu ta' -2.2 u ta' -2.1 rispettivament.
English: INFORMATION IN BRAILLE Terrosa cartridge and pen
Maltese: INFORMAZZJONI BIL-BRAILLE Terrosa skartoċċ u pinna
English: • irregular heartbeats
Maltese: • taħbit irregolari tal-qalb
English: New vertebral fracture (≥1) a
Maltese: (≥1) a
English: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Maltese: Glacial acetic acid, sodium acetate, trihydrate, mannitol, metacresol, ilma għall-injezzjonijiet, hydrochloric acid (għall-aġġustament tal-pH) u sodium hydroxide (għall-aġġustament tal-pH).
English: 1103 Budapest, Hungary
Maltese: 1103 Budapest, L-Ungerija
English: This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart disease) may interact with teriparatide.
Maltese: Dan huwa importanti, għax xi mediċini (eż, digoxin/digitalis, mediċina għall-kura tal-mard fil-qalb) jistgħu jinteraġixxu ma' teriparatide.
English: What Terrosa contains - The active substance is teriparatide.
Maltese: Is-sustanza attiva hi teriparatide.
English: 1103 Budapest HUNGARY
Maltese: 1103 Budapest L-UNGERIJA
English: It is limited to replacement of the pen.
Maltese: Din hija limitata għas-sostituzzjoni tal-pinna.
English: OTHER
Maltese: It
English: Each Terrosa cartridge contains 28 doses of fixed 80 microlitres Terrosa.
Maltese: Kull Terrosa skartoċċ fih 28 doża ta' 80 mikrolitru fiss ta' Terrosa.
English: No differences in teriparatide pharmacokinetics were detected with regard to age (range 31 to 85 years).
Maltese: L-ebda differenza ma dehret fil-farmakokinetiċita' ta' teriparatide rigward l-eta' (medda 31 sa 85 sena).
English: Urolithiasis
Maltese: Urolitjażi (Urolithiasis)
English: Terrosa cartridge and pen pack: 1 Terrosa cartridge packed in a plastic tray sealed with lid foil and packed in a carton and 1 Terrosa Pen packed into a separate carton.
Maltese: Terrosa skartoċċ 1 ippakkjat fi trej tal-plastik issiġillat b'għatu tal-fojl u ppakkjat f'kartuna u Terrosa Pen 1 ippakkjata f'kartuna separata.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • the pen being used with a medical device, accessories or consumables other than those recommended by Gedeon Richter Plc.
Maltese: • meta l-pinna tintuża ma' apparat mediku, aċċessorji jew oġġetti intiżi għall-użu minbarra dawk rakkomandati minn Gedeon Richter Plc.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/001 [1 cartridge] EU/1/16/1159/002 [3 cartridges] EU/1/16/1159/003 [cartridge and pen pack]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1159/003 [pakkett ta' skartoċċ u pinna]
English: In clinical trials the following reactions were reported at a ≥1% difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
Maltese: Fi studji kliniċi, ġew irrapportati dawn ir-reazzjonijiet li ġejjin b'differenza ta' frekwenza mill-plaċebo ta' ≥ 1 %: vertigo, tqalligħ, uġigħ fid-dirgħajn u fir-riġlejn, dipressjoni, qtugħ ta' nifs.
English: In clinical trials, 2.8% of teriparatide patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients.
Maltese: Fil-provi kliniċi, 2.8% tal-pazjenti li ħadu teriparatide kellhom konċentrazzjonijiet ta' uric acid fis-serum ogħla mill-limitu ta' fuq tannormal meta mqabbel ma' 0.7% ta' pazjenti li ġew ikkurati bil-plaċebo.
English: • Handle your pen with care.
Maltese: • Immaniġġja l-pinna tiegħek b'attenzjoni.
English: At the 18 month endpoint, teriparatide significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p<0.001).
Maltese: Fit-tmiem tat-18-il xahar, teriparatide żied b'mod sinifikanti l-BMD fil-parti lumbari ta' l-ispina (7.2 %) meta mqabbel ma' alendronate (3.4 %) (p<0.001).
English: Detailed and updated information on this product is available by scanning the QR code included below or the outer carton with a smartphone.The same information is also available on the following URL: www.terrosapatient.com
Maltese: Informazzjoni dettaljata u aġġornata dwar dan il-prodott hija disponibbli billi tiskennja l-kodiċi QR inkluż hawn taħt jew il-kartuna ta' barra bi smartphone, L-istess informazzjoni hija disponibbli wkoll fuq l-URL li ġej: www.terrosapatient.com
English: Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the principal cleavage system (Kupffer cells) and consequently clearance of PTH(1-84).
Maltese: L-istudji fl-annimali wrew li ċ-ċirkolazzjoni mnaqqsa ħafna tad-demm fil-fwied inaqqas lespożizzjoni ta' PTH għas-sistema prinċipali ta' cleavage (ċelluli ta' Kupffer) u konsegwentement ittneħħija ta' PTH(1-84).
English: BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34% had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9% had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD
Maltese: Fil-linja bażi, in-nisa wara l-menopawża kellhom età medja ta' 61 sena, medja ta' BMD fil- parti lumbari ta' l-ispina b'valur T ta' -2.7, doża medja ekwivalenti għal 7.5 mg/jum ta' prednisone u 34 %, skond ir-radjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra; in-nisa qabel il-menopawża kellhom età medja ta' 37 sena, medja ta' BMD fil-parti lumbari ta' l-ispina b'valur T ta' -2.5, doża medja ekwivalenti għal 10 mg/jum ta' prednisone u 9 %, skond irradjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra; u l-irġiel kellhom età medja ta' 57 sena, medja ta' BMD fil-parti lumbari ta' l-ispina b'valur T ta' -2.2, doża medja ekwivalenti għal 10 mg/jum ta' prednisone u 24 %, skond ir-radjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra.
English: Haemorrhoids
Maltese: Ipprajmjar
English: 1 Terrosa cartridge
Maltese: Tużax Terrosa
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Terrosa 20 mcg/80 mcL injection teriparatide
Maltese: U MNEJN GĦANDU JINGĦATA Terrosa 20 mcg/80 mcL injezzjoni teriparatide
English: Lumbar spine BMD significantly increased by 3 months.
Maltese: BMD tas-sinsla lumbari żdied b'mod sinjifikanti wara 3 xhur.
English: b p≤0.001 compared with placebo.
Maltese: b p ≤0.
English: Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event.
Maltese: F' pazjenti fil-provi b'teriparatide, 82.8% tal-pazjenti li ħadu teriparatide u 84.
English: ........................{the grey-shaded text refers to the 3x pack size}
Maltese: {Jidhru fil-każ ta' 1x u 3x skrataċ biss.
English: • a compatible pen needle
Maltese: • ġebel fil-kliewi
English: Make sure that the two indicator stripes are aligned.
Maltese: Kun ċert li ż-żewġ strixxi tal-indikatur ikunu allinjati.
English: Each cartridge contains 28 doses of 20 micrograms (per 80 microliters).
Maltese: Kull skartoċċ fih 28 doża ta' 20 mikrogramma (għal kull 80 mikrolitru).
English: While attaching the needle some drops may escape, this is normal.
Maltese: Meta tkun qed twaħħal il-labra, jistgħu jaqgħu xi qatriet, dan huwa normali.
English: If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Terrosa.
Maltese: Jekk inti mara li tista' to ħroġ tqila, għandek tuża metodi effettivi ta' kontraċezzjoni waqt l-użu ta' Terrosa.
English: Teriparatide is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Maltese: Teriparatide jiġi eliminat permezz ta' tneħħija mill-fwied u barra mill-fwied (madwar 62 L/hr fin-nisa u 94
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/003 [cartridge and pen pack]
Maltese: EU/1/16/1159/003 [pakkett ta' skartoċċ u pinna]
English: - The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Maltese: Is-sustanzi mhux attivi l-oħra huma: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (għall-aġġustament tal-pH), sodium hydroxide (għallaġġustament tal-pH), u ilma għall-injezzjoni.
English: Read the patient information leaflet for Terrosa cartridge provided separately.
Maltese: Aqra l-fuljett ta' tagħrif għal Terrosa skartoċċ ipprovdut separatament.
English: Compatible pen needles
Maltese: Labar tal-pinna kompatibbli
English: After 12 months, BMD had increased in the lumbar spine and total hip by 5% and 1%, respectively, compared with placebo.
Maltese: Wara 12-il xahar, BMD kien żdied fil-għadma tal-ġenbejn b'5% u 1% rispettivament meta mqabbel ma' plaċebo.
English: Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral)
Maltese: Il-possibiltà ta' avvenimenti allerġiċi ftit wara l injezzjoni: qtugħ ta' nifs akut, edima orali/tal-wiċċ, urtikarja ġeneralizzata,
English: The Terrosa Pen has a service life of two years.
Maltese: It-Terrosa Pen għandha ħajja operattiva ta' sentejn.
English: INSTRUCTIONS ON USE
Maltese: KONDIZZJONIJIET U REKWIŻITI
English: 3 mL cartridge (siliconised Type I glass), with a plunger stopper (bromobutyl) and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and packed in a carton.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Skartoċċ ta' 3 mL (ħġieġ silikoniżżat tat-Tip I) b' tapp planġer (bromobutyl) u siġill fil- forma ta' diska (aluminium u siġilli b'kisja tal-lasktu), ippakkjati fi trej tal-plasik issiġillat b'għatu tal-fojl u ppakkjati f'kartuna.
English: Results from up to 24 months (median: 19 months) treatment with teriparatide demonstrate statistically significant fracture reduction (Table 1).
Maltese: Ir-riżultati sa 24-il xahar (medja: 19-il xahar) kura b'teriparatide wrew tnaqqis ta' ksur statistikament sinjifikanti (Tabella 1).
English: • feeling faint
Maltese: • qtuġħ ta' nifs
English: Make sure the display shows an arrow sign and the two indicator stripes are aligned.
Maltese: Kun ċert li d-displej turi sinjal ta' vleġġa u li ż-żewġ strixxi tal-indikatur ikunu allinjati.
English: Once-daily administration of teriparatide increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Maltese: L-għotja ta' teriparatide darba kuljum iżżid il-formazzjoni ta' għadam ġdid fis-superfiċje ta' l-għadam trabekulari u kortikali, permezz ta' stimolu preferenzjali ta' attivita' osteoblastika fuq attivita' osteoklastika.
English: The 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: RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Each cartridge contains 2.4 mL of solution corresponding to 28 doses of 20 micrograms (per 80 microliters).
Maltese: Kull skartoċċ fih 2.4 mL ta' soluzzjoni li tikkorrispondi għal 28 doża ta' 20 mikrogramma (għal kull
English: After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9% and 4% compared with placebo (p<0.001).
Maltese: Wara 19-il xahar (medja) ta' kura, id-densità minerali ta' l-għadam (BMD) kienet żdiedet fis-sinsla lumbari u fl-għadma tal-ġenbejn, b'9 % u 4 % rispettivament meta mqabbla mal-plaċebo (p<0.
English: Terrosa 20 micrograms/80 microliters solution for injection:
Maltese: Terrosa 20 mikrogramma/80 mikrolitru soluzzjoni għall-injezzjoni:
English: • Transport and store the Terrosa Pen with inserted cartridge at temperatures specified in the Terrosa package leaflet, provided separately.
Maltese: • Ittrasporta u aħżen it-Terrosa Pen bl-iskartoċċ imdaħħal f'temperaturi speċifikati fil-fuljett ta' tagħrif ta' Terrosa, ipprovdut separatament.
English: Do not use this medicine after the expiry date which is stated on the carton and the cartridge after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-pinna wara JIS/EXP.
English: EU/1/16/1159/002 [3 cartridges] {Displayed in case of 1x and 3x cartridges only.
Maltese: EU/1/16/1159/002 [3 skrataċ]
English: Instructions for use Terrosa Pen
Maltese: Istruzzjonijiet għall-użu Terrosa Pen
English: Teriparatide was not genotoxic in a standard battery of tests.
Maltese: Teriparatide ma kienx ġenotossiku f'sensiela ta' testijiet standardizzati.
English: The mean increase in BMD from 18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, respectively.
Maltese: Iż-żieda medja mit-18 sa 24 xahar fil-BMD tal-parti lumbari tas-sinsla, tat-total tal-ġenbejn u tal-għonq femorali kien rispettivament 1.4 %, 1.2 % u 1.6 %
English: Terrosa cartridges are designed to be used only with the Terrosa Pen reusable, multidose delivery system and compatible pen needles.
Maltese: Terrosa Pen, li terġa' tintuża u ma' labar tal-pinna kompatibbli.
English: Each dose of 80 microliters contains 20 micrograms of teriparatide.
Maltese: Kull doza ta' 80 mikrolitru fih 20 mikrogramma ta' teriparatide.
English: Ypsomed AG
Maltese: L-ewwel użu: