FrancophonIA/ELRC3.0 huggingface dataset:
English: As Glubrava contains metformin hydrochloride, it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Maltese: Peress li Competact fih metgormin hydrochloride, dan għandu jitwaqqaf fi żmien il-kirurġija taħt anestesija ġenerali, spinali jew epidurali.
English: Many of these patients reported concurrent peripheral oedema.
Maltese: Ħafna minn dawn ilpazjenti rrappurtaw edima periferali fl-istess ħin.
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Maltese: 500 mg metformin hija ta' madwar 50-60% f'persuni b'saħħithom.
English: Frequency of adverse reactions Pioglitazone Metformin Glubrava
Maltese: Frekwenza ta' reazzjoniijiet avversi Pioglitazone
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting treatment with a NSAID.
Maltese: Għandha tittieħed kawtela speċjali f'sitwazzjonijiet fejn il-funzjoni renali tista' tkun imnaqqsa, per eżempju meta tinbeda terapija anti-ipertensiva jew terapija dijuretika u meta tinbeda kura b'NSAID.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Maltese: Fil-bnedmin, indipendentement mill-azzjoni tiegħu fuq il-gliċemija, metformin għandu effetti favorevoli fuq il-metaboliżmu tal-lipidi.
English: Angiotensin-converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Maltese: Inibituri tal-enzima li tikkonverti angiotensin (ACE, angiotensin-converting enzyme) jistgħu jnaqqsu l livelli ta' glukożju fid-demm.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD05.
Maltese: Mediċini li jittieħdu fid-dijabete, taħlitiet ta' mediċini orali li jbaxxu ż-żokkor fid-demm; Kodiċi ATC:
English: Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Maltese: Għoti intravaskulari ta' sustanzi ta' kuntrast jodinati jista' jwassal għal nefropatija kkawżata mill-kuntrast, li twassal għal akkumulazzjoni ta' metformin u riskju akbar ta' aċidożi lattika.
English: Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Maltese: Pioglitazone għandu jintuża b'attenzjoni waqt l-għoti fl-istess ħin ta' inibituri (e.ż. gemfibrozil) jew indutturi (e.ż. rifampicin) taċ-ċitokromju P450 2C8.
English: When clinically appropriate, direct change from metformin monotherapy to Glubrava may be considered.
Maltese: Fejn klinikament xieraq, jista' jiġi kkunsidrat tibdil dirett minn monoterapija b'metformin għal
English: 1 bottle + 2 syringes
Maltese: 1 flixkun + 2 siringi
English: Oral suspension bottle (PET)
Maltese: Flixkun (PET)
English: EU/1/06/378/017 Inovelon 40 mg/ml
Maltese: 40 mg/ml
English: Strength Pharmaceutical Form
Maltese: Isem inventat Qawwa Għamla farmaċewtika
English: Packaging Content Package size
Maltese: Kontenut Daqs talpakkett
English: Invented Name
Maltese: Kaxxa ta' fjala
English: Withdrawal period
Maltese: Ippakkjar
English: EU Number
Maltese: Numru tal-UE Isem ivvintat
English: EMA/482355/2014 EMEA/H/C/001090
Maltese: EMEA/H/C/001090
English: It is available as tablets (25, 50 and 100 mg).
Maltese: Jiġi f'għamla ta' pilloli (25, 50 u 100 mg).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom severe kidney problems should start treatment with the 25 mg dose.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom għal 25 mg skont l-effikaċja u l-effetti sekondarji.
English: The full EPAR for Sildenafil Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active ingredient in Sildenafil Actavis, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva f'Sildenafil Actavis, is-sildenafil, tifforma parti minn grupp ta' mediċini magħruf bħala inibituri tal-fosfodjesterażi tat-tip 5 (PDE5) (phosphodiesterase type 5 [PDE5] inhibitors).
English: Sildenafil Actavis is a ‘generic medicine'.
Maltese: Sildenafil Actavis huwa ‘mediċina ġenerika'.
English: This summary was last updated in 08-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2014.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Maltese: Taħdem billi timblokka l-enzima fosfodjesterażi, li normalment tkisser sustanza magħrufa bħala monofosfat gwanożina ċikliku (cGMP).
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil Actavis has been shown to have comparable quality and to be bioequivalent to Viagra.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Sildenafil Actavis għandu kwalità komparabbli u li huwa bijoekwivalenti għal Viagra.
English: This is a summary of the European public assessment report (EPAR) for Sildenafil Actavis.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sildenafil Actavis.
English: Because Sildenafil Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Maltese: Billi Sildenafil Actavis huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Viagra.
English: Sildenafil Actavis is a medicine that contains the active substance sildenafil.
Maltese: Sildenafil Actavis huwa mediċina li fiha s-sustanza attiva sildenafil.
English: This means that Sildenafil Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Maltese: Dan ifisser li Sildenafil Actavis huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Viagra.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Maltese: Din tikkawża r-rilassament tal-muskolu fit-tessut li qisu sponża tal-pene (il-corpora cavernosa).
English: Sildenafil Actavis is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Maltese: Sildenafil Actavis jintuża fit-trattament ta' rġiel adulti bi problemi waqt erezzjoni (xi drabi tissejjaħ impotenza), meta ma jkunx jista' jkollhom jew ma jkunux jistgħu jżommu l-pene iebes (erezzjoni) biżżejjed għal attività sesswali sodisfaċenti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Actavis on 10 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sildenafil Actavis fl-1-10 ta' Diċembru 2009.
English: What is Sildenafil Actavis?
Maltese: X'inhu Sildenafil Actavis?
English: Because Sildenafil Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Sildenafil Actavis huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: For Sildenafil Actavis to be effective, sexual stimulation is required.
Maltese: Biex Sildenafil Actavis ikun effettiv irid ikun hemm stimulazzjoni sesswali.
English: By blocking the breakdown of cGMP, Sildenafil Actavis restores erectile function.
Maltese: Billi jiġi mblukkat it-tkissir tascGMP, Sildenafil Actavis ireġġa' l-funzjoni erettili għan-normal.
English: Netherlands
Maltese: In-Netherlands
English: United Kingdom B.Braun Melsungen Ag
Maltese: Ir-Repubblika Ċeka B.Braun Melsungen Ag
English: B.Braun Adria D.O.O.
Maltese: B.Braun Adria D.O.O. Tetraspan
English: 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Maltese: 3.27g/1000ml, L-Aċidu Maliku 0.67g/1000ml
English: Equihes Ecobag Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride
Maltese: Equihes Ecobag Klorur tal-Manjeżju Eżaidrat 0.2g/1000ml, Klorur talPotassju 0.
English: Hydroxyethyl) Starch 100g/1000ml
Maltese: Hydroxyethyl) Lamtu 100g/1000ml
English: Hydroxyethyl) Starch 60g/1000ml
Maltese: Hydroxyethyl) Lamtu 60g/1000ml
English: Haes-Steril Hes Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5
Maltese: Haes-Steril Hes Klorur tas-Sodju 9 g/1 000 ml, Lamtu tal-Idrossietil 200/0.5
English: Hes Hipertónico Sodium Chloride 72g/1000ml, Hydroxyethyl Starch 200/0.5
Maltese: Hes Hipertónico Klorur tas-Sodju 72g/1000ml, Lamtu tal-Idrossietil 200/0.5
English: Fresenius Kabi D.O.O.
Maltese: Fresenius Kabi D.O.O. Volulyte
English: Hydroxyethyl) Starch 60g/1000ml, L-Malic Acid 0.67g/1000ml
Maltese: Idrossietil) Lamtu 60g/1000ml, L-Aċidu Maliku 0.67g/1000ml
English: Sodium Chloride 4.5g/500ml, Hydroxyethyl Starch 130/0.4 30g/500ml
Maltese: Klorur tas-Sodju 4.5g/500ml, Lamtu tal-Idrossietil 130/0.4 30g/500ml
English: Sodium Chloride 9g/1000ml, Hetastarch 60g/1000ml
Maltese: Klorur tas-Sodju 9 g/1 000 ml, Hetalamtu 60 g/1 000 ml
English: Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 200/0.5 100g/1000ml
Maltese: Klorur tas-Sodju 9g/1000ml, Lamtu tal-Idrossietil 200/0.5 100g/1000ml
English: Sodium Chloride 9g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Maltese: Klorur tas-Sodju 9g/1000ml, Poli (0 2 Idrossietil) Lamtu 60g/1000ml
English: Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 100gl
Maltese: Klorur tas-Sodju 9 gl, Poli (0 2 Idrossietil) Lamtu 100gl
English: Magnesium Chloride Hexahydrate 0.3gl, Potassium Chloride 0.3gl, Sodium Chloride 6.02gl, Sodium Acetate Trihydrate 4.63gl, Hydroxyethyl Starch 130/0.4 60gl
Maltese: Klorur tal-Manjeżju Eżaidrat 0.3 gl, Klorur tal-Potassju 0.3 gl, Klorur tas-Sodju 6.02 gl, Aċetat tas-Sodju Triidrat 4.63 gl, Lamtu tal-Idrossietil 130/0.4 60 gl
English: Sodium Chloride 9gl, Poly (0 2 Hydroxyethyl) Starch 60gl
Maltese: Klorur tas-Sodju 9 gl, Poli (0 2 Idrossietil) Lamtu 60gl
English: Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0.4 100g/1000ml
Maltese: Klorur tas-Sodju 9g/1000ml, Lamtu tal-Idrossietil 130/0.4 100g/1000ml
English: Sodium Chloride 9g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Maltese: Klorur tas-Sodju 9 g/1 000 ml, Lamtu tal-Idrossietil 130/0.4 60g/1000ml
English: Sodium Chloride 9g/1000ml, Poly (O-2-Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Maltese: Klorur tas-Sodju 9g/1000ml, Poli (O-2-Idrossietil) Lamtu 130/0.4 (Ph.Eur.) 100g/1000ml
English: Magnesium Chloride Hexahydrate 0.203g/1000ml, Potassium Chloride 0.298g/1000ml, Sodium Chloride 6.252g/1000ml, Calcium Chloride Dihydrate 0.367g/1000ml, Malic Acid 0.671g/1000ml, Sodium Acetate Trihydrate 3.266g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Maltese: Klorur tal-Manjeżju Eżaidrat 0.203g/1000ml, Klorur talPotassju 0.298g/1000ml, Klorur tas-Sodju 6.252g/1000ml, Klorur tal-Kalċju Diidrat 0.367g/1000ml, Aċidu Maliku 0.671g/1000ml, Aċetat tasSodju Triidrat 3.266g/1000ml, Lamtu tal-Idrossietil 130/0.4 60g/1000ml
English: Magnesium Chloride Hexahydrate 0.203g/1000ml, Potassium Chloride 0.298g/1000ml, Sodium Chloride 6.252g/1000ml, Calcium Chloride Dihydrate 0.367g/1000ml, Sodium Acetate Trihydrate 3.266g/1000ml, LMalic Acid 0.671g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Maltese: Klorur tal-Manjeżju Eżaidrat 0.203g/1000ml, Klorur talPotassju 0.298g/1000ml, Klorur tas-Sodju 6.252g/1000ml, Klorur tal-Kalċju Diidrat 0.367g/1000ml, Aċetat tasSodju Triidrat 3.266g/1000ml, L-Aċidu Maliku 0.671g/1000ml, Lamtu tal-Idrossietil 130/0.4 60g/1000ml
English: 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate
Maltese: 3g/1000ml, Klorur tas-Sodju 6.25g/1000ml, Klorur tal-Kalċju Diidrat 0.37g/1000ml, Hetalamtu 60g/1000ml, Aċetat tas-Sodju Triidrat
English: 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Maltese: 3g/1000ml, Klorur tas-Sodju 6.25g/1000ml, Klorur tal-Kalċju Diidrat 0.37g/1000ml, Hetalamtu 100g/1000ml, Aċetat tas-Sodju Triidrat 3.27g/1000ml, L-Aċidu Maliku 0.67g/1000ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.4g/1000ml, Sodium Chloride 6g/1000ml, Calcium Chloride Dihydrate 0.134g/1000ml, Hetastarch 60g/1000ml, Sodium Acetate Trihydrate 3.7g/1000ml
Maltese: 4g/1000ml, Klorur tas-Sodju 6g/1000ml, Klorur tal-Kalċju Diidrat 0.134g/1000ml, Hetalamtu 60g/1000ml, Aċetat tas-Sodju Triidrat 3.7g/1000ml
English: Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Hydroxyethyl Starch 130/0.4 60g/1000ml
Maltese: Klorur tal-Manjeżju Eżaidrat 0.3 g/1 000 ml, Klorur talPotassju 0.3 g/1 000 ml, Klorur tas-Sodju 6.02 g/1 000 ml, Aċetat tas-Sodju Triidrat 4.63 g/1 000 ml, Lamtu talIdrossietil 130/0.4 60g/1000ml
English: Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3gl, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (O-2Hydroxyethyl) Starch 130/0.4 (Ph.Eur.)
Maltese: 3g/1000ml, Klorur talPotassju 0.3gl, Klorur tas-Sodju 6.02g/1000ml, Aċetat tas-Sodju Triidrat 4.63g/1000ml, Poli (O2-Idrossietil) Lamtu 130/0.4 (Ph.Eur.) 60g/1000ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, Poly (0 2
Maltese: 3g/1000ml, Klorur tas-Sodju 6.25g/1000ml, Klorur tal-Kalċju Diidrat 0.37g/1000ml, Aċetat tas-Sodju Triidrat 3.27g/1000ml, Poly (0 2
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.4g/1000ml, Sodium Chloride 6g/1000ml, Calcium Chloride Dihydrate 0.134g/1000ml, Sodium Acetate Trihydrate 3.7g/1000ml, Poly (0 2
Maltese: 4g/1000ml, Klorur tas-Sodju 6g/1000ml, Klorur tal-Kalċju Diidrat 0.134g/1000ml, Aċetat tasSodju Triidrat 3.7g/1000ml, Poly (0 2 Hydroxyethyl) Lamtu 100g/1000ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Malic Acid 0.67g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, Poly (0 2
Maltese: 3g/1000ml, Klorur tas-Sodju 6.25g/1000ml, Klorur tal-Kalċju Diidrat 0.37g/1000ml, Aċidu Maliku 0.67g/1000ml, Aċetat tas-Sodju Triidrat 3.27g/1000ml, Poli (0 2
English: Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Maltese: 4g/1000ml, Klorur tas-Sodju 6g/1000ml, Klorur tal-Kalċju Diidrat 0.134g/1000ml, Aċetat tasSodju Triidrat 3.7g/1000ml, Poly (0 2 Hydroxyethyl) Lamtu 60g/1000ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 60g/1000ml, Malic Acid 0.67g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml
Maltese: 3g/1000ml, Klorur tas-Sodju 6.25g/1000ml, Klorur tal-Kalċju Diidrat 0.37g/1000ml, Hetalamtu 60g/1000ml, Aċidu Maliku 0.67g/1000ml, Aċetat tas-Sodju Triidrat 3.27g/1000ml
English: A-1121 Vienna
Maltese: A-1121 Wien
English: Study 1 - REPLACE
Maltese: Studju 1 - REPLACE
English: Study 2 - RACE
Maltese: Studju 2 - RACE
English: Very common (1/10) Common (1/100 to
Maltese: Komuni ħafna (1/10) Komuni (1/100 sa
English: Active vitamin D
Maltese: Vitamina D attiva
English: 30 June 2023
Maltese: 30 ta' Ġunju 2023
English: Date of latest renewal: 29 April 2019
Maltese: Data tal-aħħar tiġdid: 29 ta' April 2019
English: This medicine has been given ‘conditional approval'.
Maltese: Din il-mediċina ngħatat ‘approvazzjoni kondizzjonali'.
English: Above the upper limit of normal (ULN) (2.55 mmol/L)*
Maltese: Ogħla mil-limitu ta' fuq tan-normal (ULN) (2.55 mmol/L)*
English: Read “Section 7.
Maltese: Aqra “Sezzjoni 7.
English: Lower than 2 mmol/L
Maltese: Inqas minn 2 mmol/L
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 April 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' April 2017
English: The apparent terminal half-life (t1/2) was 3.02 and 2.83 hours for the 50 and 100 micrograms dose, respectively.
Maltese: Il-half-life (t1/2) terminali evidenti kienet ta' 3.02 u 2.83 siegħa għad-doża ta' 50 u 100 mikrogramma, rispettivament.
English: Tests and checks
Maltese: Testijiet u kontrolli
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Ireland.
Maltese: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, L-Irlanda.
English: The active substance is parathyroid hormone (rDNA).
Maltese: Is-sustanza attiva hija l-ormon tal-paratirojde (rDNA).
English: • diarrhoea*
Maltese: • dijarea*
English: • Email Shire at medinfoEMEA@shire.com.
Maltese: • Ibgħat email lil Shire fuq medinfoEMEA@shire.com.
English: The mean age was 47.3 years (range 19 to 74 years); 79% were females.
Maltese: 3 snin (medda 19 sa 74 sena), 79 % kienu nisa.
English: • Store in a refrigerator (2°C to 8°C).
Maltese: • Aħżen fi friġġ (2°C sa 8°C).
English: What is Natpar?
Maltese: X'inhu Natpar?
English: Absorption Natpar administered subcutaneously had an absolute bioavailability of 53%.
Maltese: Assorbiment Natpar mogħti taħt il-ġilda kellu bijodisponibilità assoluta ta' 53%.
English: PTH (1-84) is the principal regulator of plasma calcium homeostasis.
Maltese: PTH (1-84) huwa r-regolatur prinċipali tal-omeostasi tal-kalċju fil-plasma.
English: • Confirm 25-OH vitamin D stores are sufficient.
Maltese: • Ikkonferma li l-ħażniet tal-vitamina D 25-OH huma suffiċjenti.
English: Can I use different needles?
Maltese: Nista' nuża labar differenti?
English: This leaflet was last revised in 07/2019.
Maltese: Dan il-fuljett kien rivedut l-aħħar f'07/2019.
English: even if their signs of illness are the same as yours.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.
English: Figure X
Maltese: Figura X
English: Natpar pen 25 Natpar pen 50 Natpar pen 75 Natpar pen 100
Maltese: Pinna ta' Natpar 75 Pinna ta' Natpar 100
English: Figure A
Maltese: Figura A
English: Boehringer Ingelheim RCV GmbH & Co KG Dr.-Boehringer-Gasse 5-11
Maltese: KG Dr.-Boehringer-Gasse 5-11
English: Greater than 2.25 mmol/L and below the upper limit of normal (2.55 mmol/L)*
Maltese: Aktar minn 2.25 mmol/L u taħt il-limitu ta' fuq tan-normal (2.55 mmol/L)*
English: , nausea*,
Maltese: , dardir*,
English: Use pen needles (31Gx5 mm, 31Gx8 mm, or 32Gx4 mm).
Maltese: Uża labar tal-pinna (31Gx5 mm, 31Gx8 mm, jew 32Gx4 mm).
English: 25 micrograms - Purple 50 micrograms - Red 75 micrograms - Grey 100 micrograms - Blue
Maltese: 25 mikrogramma - Vjola 50 mikrogramma - Aħmar 75 mikrogramma - Griż 100 mikrogramma - Kaħlani
English: • antibodies (produced by your immune system) to Natpar
Maltese: • antikorpi (prodotti mis-sistema immunitarja tiegħek) għal Natpar
English: • In the Medicine Tracker below (See Figure C):
Maltese: • Fit-Traċċatur tal-Mediċina hawn taħt (Ara Figura C):
English: Adjust second
Maltese: ANNESS II
English: Psychiatric disorders anxiety †, insomnia*
Maltese: Disturbi psikjatriċi ansjetà †, insomnja*
English: Natpar 100 micrograms
Maltese: Natpar 100 mikrogramma
English: Phosphate
Maltese: Fosfat
English: The results demonstrate durability of the physiological effects of Natpar over 60 months including maintenance of mean albumin-corrected serum calcium levels (n=49, 2.11 ±0.19 mmol/L), a decrease from baseline in urinary calcium excretion (n=47, -2.23 ±5.9 mmol/24 h), a decrease in serum phosphate (n=49, -0.29 ±0.28 mmol/L) and the maintenance of normal calcium phosphate product (n=49, <4.4mmol
Maltese: 19 mmol/L), tnaqqis mil-linja bażi fleskrezzjoni tal-kalċju fl-awrina (n=47, -2,23 ±5,9 mmol/24 h), tnaqqis ta' fosfat fis-serum (n=49, -0.29±0.28 mmol/L) u ż-żamma ta' prodott normali ta' fosfati tal-kalċju (n=49, <4.4 mmol²/L²).
English: Patients received doses of 25 micrograms, 50 micrograms, 75 micrograms or 100 micrograms/day for up to approximately 60 months (mean 1161 days, range 41 to 1820 days).
Maltese: Il-pazjenti rċevew dożi ta' 25 mikrogramma, 50 mikrogramma, 75 mikrogramma jew 100 mikrogramma/kuljum għal madwar 60 xahar (medja ta' 1161 jum, medda minn 41 sa 1820 jum).
English: Mixing” (Section B).
Maltese: Taħlit ta' Pinna Ġdida” (Sezzjoni B).
English: Use with pen needles (31Gx5 mm, 31Gx8 mm, or 32Gx4 mm)
Maltese: Uża b'labar tal-pinna (31Gx5 mm, 31Gx8 mm, jew 32Gx4 mm)
English: Immune system dysorders
Maltese: Disturbi fis-sistema immuni
English: Sodium chloride, mannitol, citric acid monohydrate, metacresol, sodium hydroxide (for pH adjustment), water for injections.
Maltese: Klorur tas-sodju, mannitol, aċidu ċitriku monoidrat, metacresol, idrossidu tas-sodju (għallaġġustament tal-pH), ilma għall-injezzjonijiet.
English: For a list of symptoms of low calcium, see section 4.
Maltese: Għal lista ta' sintomi ta' kalċju baxx, ara sezzjoni 4.
English: Hypersensitivity reactions, (dyspnoea, angioedema, urticaria, rash)
Maltese: Reazzjonijiet ta' sensittività eċċessiva, (qtugħ ta' nifs, anġjoedima, urtikarja, raxx).
English: Figure H
Maltese: Figura H
English: Metabolism and nutrition disorders hypercalcaemia, hypocalcaemia hypomagnesaemia tetany
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni iperkalċimija, ipokalċimija ipomagneżimja †, tetnu
English: In the solvent:
Maltese: Fis-solvent:
English: Contents of the pack and other information 7 Instructions for use
Maltese: Kontenut tal-pakkett u informazzjoni oħra 7 Struzzjonijiet għall-użu
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Figure B
Maltese: Figura B
English: In the placebo-controlled study in adults with hypoparathyroidism, the incidence of anti-parathyroid hormone (PTH) antibodies was 8.8% (3/34) and 5.9% (1/17) in patients who received subcutaneous administration of 50 to 100 micrograms Natpar or placebo once daily for 24 weeks, respectively.
Maltese: Fl-istudju kkontrollat bi plaċebo f'adulti b'ipoparatirojdiżmu, l-inċidenza ta' antikorpi kontra l-ormon tal-paratirojde (PTH) kienet ta' 8.8 % (3/34) u ta' 5.9 % (1/17) fil-pazjenti li ngħataw 50 sa 100 mikrogramma ta' Natpar jew plaċebo taħt il-ġilda darba kuljum għal 24 ġimgħa, rispettivament.
English: Cardiac disorders palpitations*
Maltese: Disturbi fil-qalb palpitazzjonijiet*
English: Figure Q
Maltese: Figura Q
English: Natpar 75 micrograms
Maltese: Natpar 75 mikrogramma
English: Vascular disorders hypertension*
Maltese: Disturbi gastrointestinali dijarea*
English: In patients using active vitamin D, decrease the dose of active vitamin D by 50%, if pre-dose serum calcium is above 1.87 mmol/L.
Maltese: F'pazjenti li jkunu qed jużaw vitamina D attiva, naqqas id-doża tal-vitamina D attiva b'50 %, jekk qabel tingħata d-doża l-kalċju fis-serum ikun ta' aktar minn 1.87 mmol/L.
English: Figure M
Maltese: Figura M
English: Figure J
Maltese: Figura J
English: Figure O
Maltese: Figura O