FrancophonIA/ELRC3.0 huggingface dataset:
English: In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Solymbic responded, compared with 72% of those given Humira.
Maltese: Fl-istudju tal-artrite rewmatojde, ir-rispons tkejjel bħala 20 % ta' titjib jew aktar fil-punteġġ tassintomu wara 24 ġimgħa ta' kura: 75 % ta' dawk li ngħataw Solymbic irrispondew, imqabbla ma' 72 % ta' dawk li ngħataw Humira.
English: The reference medicine for Solymbic is Humira.
Maltese: Il-mediċina ta' referenza għal Solymbic hija Humira.
English: Other information about Solymbic
Maltese: Informazzjoni oħra dwar Solymbic
English: Solymbic contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Solymbic fih is-sustanza attiva adalimumab u huwa "mediċina bijosimili".
English: Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Maltese: Effetti sekondarji serji u rari oħra (li dehru f'bejn wieħed minn kull 10,000 pazjenti sa wieħed minn kull 1,000 pazjent) jinkludu nuqqas tal-mudullun milli jipproduċi ċelloli tad-demm, disturb tan-nervituri, lupus u kundizzjonijiet simili għal-lupus (meta s-sistema immunitarja tattakka t-tessuti tal-pazjent innifsu, u b'hekk tikkawża infjammazzjoni u ħsara fl-organi), u s-sindrome ta' Stevens-Johnson (kundizzjoni serja tal-ġilda).
English: The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis that had not responded adequately to methotrexate, and in another study in 350 patients with moderate to severe psoriasis.
Maltese: Il-mediċina wriet li kellha effetti simili għal Humira fi studju ewlieni wieħed li involva 526 pazjent b'artrite rewmatojde moderata għal gravi li ma kinux irrispondew b'mod adegwat għal metotreksat, u fi studju ieħor bi 350 pazjent bi psorijażi moderata għal gravi.
English: This is a summary of the European public assessment report (EPAR) for Solymbic.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Solymbic.
English: Why is Solymbic approved?
Maltese: Għaliex ġie approvat Solymbic?
English: In the psoriasis study, which looked at the degree of improvement after 16 weeks, there was an 81% improvement in symptom score with Solymbic compared with an 83% improvement with Humira.
Maltese: Fl-istudju tal-psorijażi, li ħares lejn il-grad ta' titjib wara 16-il ġimgħa, kien hemm titjib ta' 81 % fil-punteġġ tas-sintomu b'Solymbic imqabbel ma' titjib ta' 83 % b'Humira.
English: Extensive laboratory studies comparing Solymbic with Humira have shown that adalimumab in Solymbic is highly similar to adalimumab in Humira in terms of chemical structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li qabblu Solymbic ma' Humira wrew li l-adalimumab f'Solymbic hija simili ħafna għall-adalimumab f'Humira f'termini ta' struttura kimika, purità u attività bijoloġika.
English: • axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation
Maltese: • spondiloartrite aksjali (infjammazzjoni tas-sinsla li tikkawża wġigħ fid-dahar), inkluż spondilite ankilosanti u fejn ma jkun hemm l-ebda ħsara fuq ir-raġġi X iżda sinjali ċari ta' infjammazzjoni
English: • active enthesitis-related arthritis (a rare disease causing inflammation in the joints)
Maltese: • artrite assoċjata ma' entesite attiva (marda rari li tikkawża infjammazzjoni tal-ġogi).
English: The active substance in Solymbic, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Solymbic, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' messaġġier kimiku fil-ġisem imsejjaħ fattur ta' nekrożi tumorali (TNF).
English: This means that Solymbic is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Solymbic huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-"mediċina ta' referenza") li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: What are the risks associated with Solymbic?
Maltese: X'inhuma r-riskji assoċjati ma' Solymbic?
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Maltese: L-effetti sekondarji l-aktar komuni b'adalimumab (li dehru f'aktar minn pazjenti wieħed minn kull 10) huma infezzjonijiet fl-imnieħer u fil-griżmejn, fis-sinus u fin-naħa ta' fuq tal-passaġġ respiratorju, reazzjonijiet fis-sit tal-injezzjoni (ħmura, ħakk, dmija, uġigħ jew nefħa), uġigħ ta' ras u wġigħ filmuskoli u fl-għadam.
English: The company that markets Solymbic must provide educational packs for doctors who will prescribe the medicine.
Maltese: Il-kumpanija li tqiegħed Solymbic fis-suq għandha tipprovdi pakketti edukattivi lit-tobba li ser jippreskrivu l-mediċina.
English: Solymbic must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Maltese: Solymbic ma għandux jintuża f'pazjenti b'tuberkolożi attiva jew infezzjonijiet gravi oħra, jew f'pazjenti b'insuffiċjenza kardijaka moderata sa gravi (il-qalb ma tkunx kapaċi tippompja biżżejjed demm madwar il-ġisem).
English: • rheumatoid arthritis (a disease causing inflammation of the joints)
Maltese: • artrite rewmatojde (marda li tikkawża infjammazzjoni tal-ġogi).
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF, l-adalimumab timblokka l-attività tiegħu, għaldaqstant tnaqqas l-infjammazzjoni u sintomi oħra tal-mard.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor, bil-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Solymbic has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Solymbic għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit bl-istess mod fil-ġisem.
English: Patients may be given other medicines during treatment with Solymbic, such as methotrexate or corticosteroids (other anti‑inflammatory medicines).
Maltese: Il-pazjenti jistgħu jingħataw mediċini oħra matul il-kura b'Solymbic, bħall-metotreksat jew kortikosterojdi (mediċini antinfjammatorji oħra).
English: Doctors treating uveitis should also take advice from doctors who have experience of using Solymbic.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Solymbic.
English: How is Solymbic used?
Maltese: Kif jintuża Solymbic?
English: Solymbic and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Maltese: Solymbic u mediċini oħra tal-klassi tiegħu jista' wkoll jaffettwaw l-abbiltà tas-sistema immunitarja li tiġġieled l-infezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u kanċers tad-demm f'pazjenti li użaw l-adalimumab.
English: What measures are being taken to ensure the safe and effective use of Solymbic?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Solymbic?
English: • plaque psoriasis (a disease causing red, scaly patches on the skin)
Maltese: • psorijażi bil-qoxra (marda li tikkawża rqajja' ħomor, bil-qoxra fuq il-ġilda)
English: EU/1/17/1223/001 Vosevi
Maltese: EU/1/17/1223/001
English: Strength
Maltese: Vosevi
English: 400 mg / 100 mg / 100 mg Film-coated tablet Oral use bottle (HDPE)
Maltese: 400 mg / 100 mg / 100 mg
English: 28 tablets
Maltese: Użu orali flixkun (HDPE) 28 pillola
English: Content
Maltese: Kontenut konċentrazzjoni
English: What Karvea contains  The active substance is irbesartan.
Maltese: X'fih Karvea - Is-sustanza attiva hi irbesartan.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Karvea, amlodipine and placebo.
Maltese: IDNT kienet prova double blind, ikkontrollata, ta' morbożità u mortalità li qabblet Karvea, amlodipine u plaċebo.
English: Linearity/ non-linearity
Maltese: Linearità/nuqqas ta' linearità
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Karvea, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Maltese: Il-pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta' manteniment ta' 300 mg ta' Karvea, minn 2.5 mg għal 10 mg ta' amlodipine, jew plaċebo skont kemm felħu.
English: Karvea contains lactose.
Maltese: Karvea fih lactose.
English: Lithium: the combination of lithium and Karvea is not recommended (see section 4.5).
Maltese: Lithium: it-taħlit ta' litju u Karvea mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Karvea 300 mg group (34%) than in the placebo group (21%).
Maltese: Rigressjoni għal albuminuria normali (< 30 mg/jum) kienet iktar frekwenti fil-grupp ta' Karvea 300 mg (34%) milli fil-grupp tal-plaċebo (21%).
English: Other medicines and Karvea
Maltese: Mediċini oħra u Karvea
English:  The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000,
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċiupjenti, ara sezzjoni 6.1.
English: The concomitant use of Karvea with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' Karvea ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (rata ta filtrazzjoni mill-glomeruli (GFR) < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: Irbesartan AUC and Cmax values were also somewhat greater in oldersubjects (≥ 65 years) than those of young subjects (18-40 years).
Maltese: Il-valuri ta' irbesartan AUC u Cmax kienu xi ftit ogħla f'individwi akbar fl-età (≥ 65 sena) milli f'individwi żgħar (18-40 sena).
English: Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Maltese: Effetti mhux mixtieqa, fejn il-frekwenza mhijiex magħrufa huma: tħoss rasek iddur bik, uġigħ ta' ras, disturbi fit-togħma, żarżir fil-widnejn, bugħawwieġ, uġigħ fil-ġogi u fil-muskoli, tnaqqis fin-numru tal-plejtlits, funzjoni talfwied anormali, livelli għoljin ta' potassium fid-demm, funzjoni tal-kliewi indebolita, infjammazzjoni tal-vini ż-żgħar li taffettwa l-ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis) u reazzjonijiet allerġiċi severi (xokk anafilattiku).
English:  The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, u poloxamer 188.
English: Karvea 300 mg tablets irbesartan
Maltese: Karvea 300 mg pilloli irbesartan ISEM
English: While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Karvea, effetti simili għandhom ikunu antiċipati b'antagonisti tar-riċetturi angiotensin-II.
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Karvea on the progression of renal disease and all-cause mortality were examined.
Maltese: F'1,715-il pazjent bi pressjoni għolja u b'dijabete tip 2, proteinuria ≥ 900 mg/jum u krejatinina fisserum li tvarja minn 1.0-3.0 mg/dl, ġew eżaminati l-effetti fit-tul (medja ta' 2.6 sena) ta' Karvea fuq lavvanz ta' mard renali u l-kawżi kollha ta' mortalità.
English: Please see section 2 “Karvea contains lactose”.
Maltese: Jekk jogħġbok ara sezzjoni 2 “ Karvea fih lactose”.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).
Maltese: - Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Karvea” u “Twissijiet u prekawzjonijiet”).
English: See also information under the heading “Do not take Karvea”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Karvea”.
English: Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, bid-defiċjenza totali ta' lactase jew bi problemi ta' assorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: F'pazjenti li mhumiex ikkontrollati biżżejjed b'150 mg darba kuljum, id-doża ta' Karvea tista' tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta' kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: The safety and efficacy of Karvea in children aged 0 to 18 has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Karvea fit-tfal ta' bejn 0 sa 18-il sena ma ġewx determinati s'issa.
English: Karvea 75 mg film-coated tablets irbesartan
Maltese: Karvea 75 mg pilloli irbesartan ISEM
English: hyperkalaemia
Maltese: iperkalemija
English: Karvea 150 mg film-coated tablets irbesartan
Maltese: Karvea 150 mg pilloli irbesartan ISEM
English: EU/1/97/049/026-030 EU/1/97/049/033 EU/1/97/049/036 EU/1/97/049/039
Maltese: EU/1/97/049/033 EU/1/97/049/036 EU/1/97/049/039
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets.
Maltese: Karvea 75 mg pilloli.
English: Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Karvea 75 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Karvea has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Maltese: Dijuretiċi u mediċini oħra kontra l-pressjoni għolja: mediċini oħra kontra l-pressjoni għolja jistgħu jżidu l-effetti ta' tnaqqis fil-pressjoni ta' irbesartan; madankollu Karvea ingħata mingħajr periklu ma' mediċini oħra ta' kontra l-pressjoni għolja, bħal beta-blockers, imblokkaturi tal-kanali ta' calcium li jaħdmu fit-tul, u dijuretiċi thiazides.
English: EU/1/97/049/001-003 EU/1/97/049/010 EU/1/97/049/013
Maltese: EU/1/97/049/001-003 EU/1/97/049/010
English: Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Karvea 150 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Karvea 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Karvea 300 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Maltese: Karvea 150 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Karvea 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Maltese: Karvea 75 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Maltese: Karvea 300 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: The study examined the long-term effects (2 years) of Karvea on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Maltese: L-istudju eżamina l-effetti fit-tul (sentejn) ta' Karvea fuq il-progressjoni għal proteinuria klinikali (li tidher) (ir-rata ta' tneħħija t'albumina 'mal-urina (UAER)
English: Package leaflet: Information for the user Karvea 75 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Karvea 75 mg pilloli irbesartan
English: EU/1/97/049/011 - 14 tablets EU/1/97/049/004 - 28 tablets EU/1/97/049/005 - 56 tablets EU/1/97/049/014 - 56 x 1 tablets EU/1/97/049/006 - 98 tablets
Maltese: EU/1/97/049/011 - 14-il pillola EU/1/97/049/004 - 28 pillola EU/1/97/049/005 - 56 pillola EU/1/97/049/014 - 56 x 1 pillola EU/1/97/049/006 - 98 pillola
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Karvea, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Maltese: Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is-sistema ta' renin-angiotensinaldosterone, iperkalimja tista' sseħħ waqt il-kura b'Karvea, speċjalment fil-preżenza t'indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad-dijabete, u/jew insuffiċjenza tal-qalb.
English: Each tablet of Karvea 300 mg contains 300 mg irbesartan.
Maltese: Kull pillola miksija b'rita fiha 300 mg irbesartan.
English: Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Maltese: Karvea b'doża ta' 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l24 siegħa għall-pressjoni tad-demm minn 75 mg.
English: What Karvea looks like and contents of the pack Karvea 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Maltese: Il-pilloli Karvea 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2872 imnaqqax fuq in-naħa l-oħra.
English: EU/1/97/049/021 - 14 tablets EU/1/97/049/022 - 28 tablets EU/1/97/049/035 - 30 tablets EU/1/97/049/023 - 56 tablets EU/1/97/049/024 - 56 x 1 tablets EU/1/97/049/032 - 84 tablets EU/1/97/049/038 - 90 tablets EU/1/97/049/025 - 98 tablets
Maltese: EU/1/97/049/021 - 14-il pillola EU/1/97/049/022 - 28 pillola EU/1/97/049/035 - 30 pillola EU/1/97/049/023 - 56 pillola EU/1/97/049/024 - 56 x 1 pillola EU/1/97/049/032 - 84 pillola EU/1/97/049/038 - 90 pillola EU/1/97/049/025 - 98 pillola
English: EU/1/97/049/016 - 14 tablets EU/1/97/049/017 - 28 tablets EU/1/97/049/034 - 30 tablets EU/1/97/049/018 - 56 tablets EU/1/97/049/019 - 56 x 1 tablets EU/1/97/049/031 - 84 tablets EU/1/97/049/037 - 90 tablets EU/1/97/049/020 - 98 tablets
Maltese: EU/1/97/049/016 - 14-il pillola EU/1/97/049/017 - 28 pillola EU/1/97/049/034 - 30 pillola EU/1/97/049/018 - 56 pillola EU/1/97/049/019 - 56 x 1 pillola EU/1/97/049/031 - 84 pillola EU/1/97/049/037 - 90 pillola EU/1/97/049/020 - 98 pillola
English: Each tablet of Karvea 75 mg contains 75 mg irbesartan.
Maltese: Kull pillola miksija b'rita fiha 75 mg irbesartan.
English: EU/1/97/049/021-025 EU/1/97/049/032 EU/1/97/049/035 EU/1/97/049/038
Maltese: EU/1/97/049/032 EU/1/97/049/035
English: o aliskiren
Maltese: OĦRAJN
English: Hepatic impairment:
Maltese: Indeboliment epatiku
English: EU/1/97/049/012 - 14 tablets EU/1/97/049/007 - 28 tablets EU/1/97/049/008 - 56 tablets EU/1/97/049/015 - 56 x 1 tablets EU/1/97/049/009 - 98 tablets
Maltese: EU/1/97/049/012 - 14-il pillola EU/1/97/049/007 - 28 pillola EU/1/97/049/008 - 56 pillola EU/1/97/049/015 - 56 x 1 pillola EU/1/97/049/009 - 98 pillola
English: EU/1/97/049/026 - 14 tablets EU/1/97/049/027 - 28 tablets EU/1/97/049/036 - 30 tablets EU/1/97/049/028 - 56 tablets EU/1/97/049/029 - 56 x 1 tablets EU/1/97/049/033 - 84 tablets EU/1/97/049/039 - 90 tablets EU/1/97/049/030 - 98 tablets
Maltese: EU/1/97/049/026 - 14-il pillola EU/1/97/049/027 - 28 pillola EU/1/97/049/036 - 30 pillola EU/1/97/049/028 - 56 pillola EU/1/97/049/029 - 56 x 1 pillola EU/1/97/049/033 - 84 pillola EU/1/97/049/039 - 90 pillola EU/1/97/049/030 - 98 pillola
English: What Karvea looks like and contents of the pack Karvea 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Maltese: Il-pilloli Karvea 300 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2873 imnaqqax fuq in-naħa l-oħra.
English: EU/1/97/049/010 - 14 tablets EU/1/97/049/001 - 28 tablets EU/1/97/049/002 - 56 tablets EU/1/97/049/013 - 56 x 1 tablets EU/1/97/049/003 - 98 tablets
Maltese: EU/1/97/049/010 - 14-il pillola EU/1/97/049/001 - 28 pillola EU/1/97/049/002 - 56 pillola EU/1/97/049/013 - 56 x 1 pillola EU/1/97/049/003 - 98 pillola
English: What Karvea looks like and contents of the pack Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Maltese: Il-pilloli Karvea 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2771 imnaqqax fuq in-naħa l-oħra.
English: What Karvea looks like and contents of the pack Karvea 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Maltese: Il-pilloli Karvea 300 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2773 imnaqqax fuq in-naħa l-oħra.
English: Package leaflet: Information for the user Karvea 150 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Karvea 150 mg pilloli irbesartan