FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oxyglobin exceed the risks for the provision of oxygen-carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition, and recommended that Oxyglobin be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċju ta' Oxyglobin huma ikbar mir-riskju tiegħu għall-għoti ta' appoġġ ta' ġarr ta' ossiġenu lil klieb, billi tejjeb is-sinjali kliniċi ta' anemija għal mill-inqas 24 siegħa, indipendentament mill-kundizzjoni bażi, u rrakkomanda li Oxyglobin jingħata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: Oxyglobin is a haemoglobin-based oxygen-carrying solution.
Maltese: Oxyglobin huwa soluzzjoni li ġġorr l-ossiġenu bbażata fuq l-haemoglobin.
English: What is Oxyglobin?
Maltese: X'inhu Oxyglobin?
English: Why has Oxyglobin been approved?
Maltese: Għaliex ġie aprovat Oxyglobin?
English: It took longer until additional treatment was needed in dogs treated with Oxyglobin.
Maltese: Kien hemm bżonn ta' perjodu itwal sakemm kien meħtieġ trattament addizzjonali fi klieb trattati b'Oxyglobin.
English: This increases the amount of oxygen carried in the blood in the arteries, helping to reduce the symptoms of anaemia.
Maltese: Dan iżid l-ammont ta' ossiġenu miġrur fid-demm fl-arterji, u jgħin inaqqas is-sintomi ta' anemija.
English: For a full list of all side effects reported with Oxyglobin, see the Package Leaflet.
Maltese: Għal lista sħiħ ta' l-effetti sekondarji kollha rrapportati b'Oxyglobin, ara l-Fuljett ta' Tagħrif.
English: What is the risk associated with Oxyglobin?
Maltese: X'inhu r-riskju assoċjat ma' Oxyglobin?
English: It contains haemoglobin glutamer-200, which is made from haemoglobin (the protein in red blood cells that carries oxygen around the body) extracted from cows' blood and diluted in a standard solution (Ringer's lactate) used to replace blood volume.
Maltese: Fih haemoglobin glutamer-200, li huwa magħmul minn haemoglobin (il-proteina fiċ-ċelloli tad-demm ħomor li ġġorr l-ossiġenu madwar il-ġisem) meħud mid-demm tal-baqar u dilwit f'soluzzjoni standard (lactate ta' Ringer) użat biex jissostitwixxi l-volum ta' demm. Meta Oxyglobin jingħata lill-klieb, iżid l-ammont ta' haemoglobin fid-demm kif ukoll iżid il-volum ta' demm fil-ġisem.
English: Other information about Oxyglobin:
Maltese: Tagħrif ieħor dwar Oxyglobin:
English: How does Oxyglobin work?
Maltese: Għalxiex jintuża Oxyglobin?
English: Other common side effects are vomiting, loss of appetite and fever.
Maltese: Effetti sekondarji komuni oħrajn huma rimettar, telf ta' aptit u deni.
English: The study compared the effects of Oxyglobin with no treatment.
Maltese: L-istudju qabbel l-effetti ta' Oxyglobin mingħajr trattament.
English: How has Oxyglobin been studied?
Maltese: Kif ġie studjat Oxyglobin?
English: Oxyglobin should be used for at least 24 hours.
Maltese: Oxyglobin għandu jintuża għal mill-inqas 24 siegħa.
English: Additional studies supported these results, showing that Oxyglobin can take up, transport and release oxygen in animals other than cows.
Maltese: Studji addizzjonali appoġġjaw dawn ir-riżultati, u urew li Oxyglobin jista' jieħu, jittrasporta u jirrilaxxa ossiġenu f'annimali oħra minbarra baqar.
English: Invented name
Maltese: Numru ta' l-EU sem inventat I
English: Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika nejn jingħata
English: 1 vial l t o r
Maltese: 10 kunjetti għall-infużjoni t x
English: EU number
Maltese: M
English: Cetrotide (cetrorelix)
Maltese: Cetrotide (setroreliks)
English: Further information on Cetrotide can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cetrotide.
Maltese: ema.europa.eu/medicines/human/EPAR/cetrotide.
English: Other information about Cetrotide
Maltese: Informazzjoni oħra dwar Cetrotide
English: Results showed that between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for buserelin and 97% for triptorelin.
Maltese: Ir-riżultati wrew li bejn 95 u 97 % tal-pazjenti li kienu qegħdin jirċievu Cetrotide ma kellhom l-ebda żieda f'daqqa ta' LH, meta mqabbla ma' 98 % għal buserelin u 97 % għal triptorelin.
English: Cetrotide received a marketing authorisation valid throughout the EU on 13 April 1999.
Maltese: Cetrotide ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-13 ta' April 1999.
English: Cetrotide contains the active substance cetrorelix.
Maltese: Cetrotide fih is-sustanza attiva setroreliks.
English: The studies involved 814 women and compared Cetrotide with buserelin nasal spray and triptorelin depot injection.
Maltese: L-istudji involvew 814-il mara u qabbel Cetrotide mal-isprej għall-imnieħer buserelin u mal-injezzjoni depot triptorelin.
English: The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening.
Maltese: Id-doża rakkomandata hija ta' 0.25 mg mogħtija kull 24 siegħa, jew filgħodu jew filgħaxija.
English: The most common side effects with Cetrotide (which may affect between 1 and 10 patients in 100) are mild to moderate overstimulation of the ovaries (which can occur as a side effect of the ovarian stimulation procedure itself) and reactions at the injection site, such as redness, swelling and itching.
Maltese: L-effetti sekondarji l-iktar komuni b'Cetrotide (li dehru f'bejn pazjent 1 u 10 pazjenti f'100) huma stimulazzjoni żejda tal-ovarji minn ħafifa għal moderata (li tista' sseħħ bħala effett sekondarju talproċedura ta' stimulazzjoni tal-ovarji nnifisha) u reazzjonijiet fis-sit tal-injezzjoni, bħal ħmura, nefħa u ħakk.
English: The active substance in Cetrotide, cetrorelix, blocks the effects of luteinising-hormone-releasing hormone (LHRH) in the body.
Maltese: Is-sustanza attiva f'Cetrotide, is-setroreliks, timblokka l-effetti tal-ormon ta' rilaxx tal-ormon lutejinazzazzjoni (LHRH) fil-ġisem.
English: Cetrotide is an effective alternative to existing treatments for the prevention of premature ovulation and its side effects are manageable.
Maltese: Cetrotide huwa alternattiva effettiva għall-kuri eżistenti għall-prevenzjoni ta' ovulazzjoni prematura u l-effetti sekondarji tiegħu huma maniġġabbli.
English: Once the assisted-reproduction procedure was completed, 23% of patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.
Maltese: Ladarba lproċedura ta' riproduzzjoni assistita kienet intemmet, 23 % tal-pazjenti li rċevew Cetrotide inqabdu tqal, meta mqabbla ma' 32 % fil-gruppi komparaturi.
English: Sudden, severe allergic reactions have been reported with Cetrotide and may affect between 1 and 10 patients in 1,000.
Maltese: Ġew irrapportati reazzjonijiet allerġiċi severi f'salt b'Cetrotide u dawn jistgħu jaffettwaw bejn pazjent 1 u 10 pazjenti f'1,000.
English: By blocking the effect of LHRH, Cetrotide stops the production of LH, and therefore prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF).
Maltese: Meta jimblokka l-effett tal-LHRH, Cetrotide jwaqqaf il-produzzjoni tal-LH, u għalhekk jipprevjeni l-ovulazzjoni prematura, li tista' tirriżulta fir-rilaxx ta' bajd li jkun immatur u mhux adattat għall-użu f'tekniki bħall-fertilizzazzjoni invitro (IVF).
English: As for all medicines, data on the use of Cetrotide are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Cetrotide hija ssorveljata kontinwament.
English: Treatment starts usually on day 5 or 6 of ovarian stimulation, continued throughout the ovarian stimulation period, until the evening before or the morning of the day when the induction of ovulation (the release of eggs) is planned.
Maltese: Il-kura normalment tibda fil-5 jew fis-6 jum ta' stimulazzjoni tal-ovarji, u titkompla matul il-perijodu ta' stimulazzjoni talovarji, sa lejlet jew dakinhar filgħodu tal-jum li fih tkun ippjanata li ssir l-induzzjoni tal-ovulazzjoni (irrilaxx tal-bajd).
English: What are the risks associated with Cetrotide?
Maltese: X'inhuma r-riskji assoċjati ma' Cetrotide?
English: Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor, and the patient closely watched for 30 minutes.
Maltese: Minħabba r-riskju ta' reazzjonijiet allerġiċi serji, l-ewwel injezzjoni għandha tkun issorveljata minn tabib, u l-pazjenta għandha tkun immonitorjata mill-qrib għal 30 minuta.
English: How does Cetrotide work?
Maltese: Kif jintuża Cetrotide?
English: Cetrotide must not be used in people who are hypersensitive (allergic) to any hormones that are chemically similar to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone medicines similar to Cetrotide).
Maltese: Cetrotide m'għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għal kwalunkwe ormon li huwa kimikament simili għall-ormon li jirrilaxxa l-gonadotropina, jew għal ormoni peptidi estrinsiċi (mediċini bbażati fuq l-ormoni simili għal Cetrotide). Cetrotide m'għandux jintuża f'nisa li jkunu tqal jew li jkunu qegħdin ireddgħu, jew f'pazjenti li għandhom mard serju tal-kliewi.
English: Cetrotide is a medicine used to prevent premature ovulation (early release of eggs from the ovary).
Maltese: Cetrotide huwa mediċina li tintuża biex tipprevjeni l-ovulazzjoni prematura (ir-rilaxx bikri ta' bajd millovarju).
English: For the full list of side effects and restrictions with Cetrotide, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Cetrotide, ara l-fuljett ta' tagħrif.
English: It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs).
Maltese: Jingħata lil nisa li jkollhom stimulazzjoni tal-ovarji (kura tal-fertilità fejn l-ovarji jiġu stimulati biex jipproduċu aktar bajd).
English: In three main studies, Cetrotide was as effective as the comparator treatments in preventing a surge in the production of LH.
Maltese: Fi tliet studji ewlenin, Cetrotide kien effettiv daqs il-kuri komparaturi fil-prevenzjoni ta' żieda f'daqqa fil-produzzjoni tal-LH.
English: LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation.
Maltese: L-LHRH jikkontrolla l-produzzjoni u r-rilaxx ta' ormon ieħor imsejjaħ ormon ta' lutejinazzazzjoni (LH), li jikkawża l-ovulazzjoni.
English: What measures are being taken to ensure the safe and effective use of Cetrotide?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cetrotide?
English: 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 28 x 1 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 28 x 1 pillola
English: Possible side effects of PritorPlus:
Maltese: Effetti sekondarji possibbli ta' PritorPlus:
English: Date of latest renewal: 14 May 2007
Maltese: Data tal-aħħar tiġdid: 14 ta' Mejju, 2007
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2002
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' April, 2002
English: PritorPlus 80 mg/12.5 mg tablets EU/1/02/215/006-010, 012, 014
Maltese: PritorPlus 80 mg/12.5 mg pilloli EU/1/02/215/006-010, 012, 014
English: The effect of PritorPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Maltese: L-effetti ta' PritorPlus jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti-inflammatory drugs, eż. aspirina jew ibuprofen).
English: MARKETING AUTHORISATION NUMBER(S) PritorPlus 40 mg/12.5 mg tablets EU/1/02/215/001-005, 011, 013
Maltese: PritorPlus 40 mg/12.5 mg pilloli EU/1/02/215/001-005, 011, 013
English: PritorPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: PritorPlus hu taħlita ta' antagonist tar-riċetturi ta' angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Maltese: haloperidol, droperidol) - oħrajn: (eż. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
English: INFORMATION IN BRAILLE PritorPlus 40 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PritorPlus 40 mg/12.5 mg
English: See also information under the heading “Do not take PritorPlus”.
Maltese: Ara wkoll l-informazzjoni taħt t-titlu “Tiħux PritorPlus”.
English: Do not take PritorPlus
Maltese: Tiħux PritorPlus
English: The terminal elimination half-life of hydrochlorothiazide is 10 - 15 hours.
Maltese: Il-half-life ta' l-eliminazzjoni terminali ta' hydrochlorothiazide hi ta' 1015-il siegħa.
English: België / Belgique / Belgien Bayer SA-NV
Maltese: België / Belgique / Belgien
English: Pack sizes: - Blister with 14, 28, 30, 56, 90, or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets.
Maltese: - Folja b'14, 28, 30, 56, 90, jew 98 pillola jew - Folji perforati bid-doża ta' l-unità bi 28 x 1 pillola.
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Maltese: Ċikatriċi progressivi ta' tessut tal-pulmun (mard interstizjali tal-pulmun)**
English: PritorPlus contains milk sugar (lactose) and sorbitol.
Maltese: PritorPlus fih zokkor tal-ħalib (lactose) u sorbitol.
English: PritorPlus is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets
Maltese: PritorPlus hu disponibbli f'pakketti tal-folji li fihom 14, 28, 30, 56, 90 jew 98 pillola, jew pakketti talfolji bid-doża ta' l-unità li fihom 28 x 1 pillola.
English: PritorPlus must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Maltese: PritorPlus ma jistax jintuża f'pazjenti b'indeboliment renali sever (rata ta' tneħħija tal-krejatinina ta' < 30 ml/min) (ara sezzjoni 4.3).
English: The overall incidence of adverse reactions reported with PritorPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Maltese: L-inċidenza totali ta' reazzjonijiet avversi rrappurtati bi PritorPlus kienet komparabbli ma' dawk irrappurtati b'telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma' hydrochlorothiazide (835) jew telmisartan biss (636).
English: How to store PritorPlus
Maltese: X'fih PritorPlus
English: PritorPlus with food and alcohol
Maltese: PritorPlus ma' ikel u alkoħol
English: PritorPlus 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: PritorPlus 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: PritorPlus 80 mg/12.5 mg tablets
Maltese: PritorPlus 40 mg/12.5 mg pilloli
English: PritorPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: It-taħlita fissa tad-doża ta' PritorPlus (40 mg telmisartan/12.5 mg ta' hydrochlorothiazide u 80 mg telmisartan/12.5 mg ta' hydrochlorothiazide) hi indikata għal adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew b'telmisartan waħdu.
English: INFORMATION IN BRAILLE PritorPlus 80 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PritorPlus 80 mg/25 mg pilloli
English: PritorPlus 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: PritorPlus 40 mg/12.5 mg pilloli Kull pillola fiha 40 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: PritorPlus 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: PritorPlus 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: PritorPlus 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: PritorPlus 80 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: PritorPlus fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on PritorPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Maltese: PritorPlus taħlita fissa tad-doża (80 mg telmisartan/25 mg hydrochlorothiazide) hi indikata f'adulti li pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat bi PritorPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) jew f'adulti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.
Maltese: It-tħarrix jew l-attivazzjoni ta' lupus erythematosus sistemiku kien irrappurtat bl-użu ta' djuretiċi ta' thiazide, li jinkludu hydrochlorothiazide.
English: INFORMATION IN BRAILLE PritorPlus 80 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PritorPlus 80 mg/12.5 mg pilloli
English: Telmisartan: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 20 - 160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses.
Maltese: Il-farmakokinetika ta' telmisartan mogħti mill-ħalq mhux lineari tul dożi minn 20 - 160 mg b'żidiet aktar milli proporzjonali tal-konċentrazzjonijiet fil-plażma (Cmax u AUC) b'żidiet fid-dożi.
English: Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Maltese: L-għoti flimkien ta' lithium u PritorPlus mhuwiex rakkomandat (ara sezzjoni 4.4).
English: The concomitant use of PritorPlus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' PritorPlus flimkien ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u
English: PritorPlus 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: PritorPlus 80 mg/12.5 mg pilloli Kull pillola fiha 80 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: EU/1/02/215/015 14 tablets EU/1/02/215/016 28 tablets EU/1/02/215/017 28 x 1 tablets EU/1/02/215/018 30 tablets EU/1/02/215/019 56 tablets EU/1/02/215/020 90 tablets EU/1/02/215/021 98 tablets
Maltese: EU/1/02/215/018 30 pillola EU/1/02/215/019 56 pillola EU/1/02/215/020 90 pillola EU/1/02/215/021 98 pillola
English: EU/1/02/215/001 14 tablets EU/1/02/215/002 28 tablets EU/1/02/215/003 28 x 1 tablets EU/1/02/215/013 30 tablets EU/1/02/215/004 56 tablets EU/1/02/215/011 90 tablets EU/1/02/215/005 98 tablets
Maltese: EU/1/02/215/013 30 pillola EU/1/02/215/004 56 pillola EU/1/02/215/011 90 pillola EU/1/02/215/005 98 pillola
English: NAME OF THE MEDICINAL PRODUCT PritorPlus 80 mg/25 mg tablets
Maltese: PritorPlus 80 mg/25 mg pilloli
English: PritorPlus 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Maltese: PritorPlus 80 mg/12.5 mg pilloli Pillola ħamra u bajda ta' 6.2 mm b'żewġ saffi, b'forma ovali, imnaqqxa bin-numru tal-kodiċi 'H8'.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (See section 5.3).
Maltese: Espożizzjoni għall-kura b'antagonisti tar-riċetturi ta' angiotensin II matul it-tieni u t-tielet trimestri hu magħruf li tikkaġuna fetotossiċità (tnaqqis fil-funzjoni renali, oligoidramnios, ittardjar flossifikazzjoni tal-kranju) u tossiċità fit-trabi tat-twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija) (Ara sezzjoni 5.3).
English: The use of PritorPlus in children and adolescents up to the age of 18 years is not recommended.
Maltese: L-użu ta' PritorPlus fit-tfal u fl-adolexxenti sa l-età ta' 18-il sena mhuwiex rakkomandat.
English: 2: For further description, please see sub-section “Description of selected adverse reactions” Additional information on individual components
Maltese: 3: Għal deskrizzjoni addizzjonali, jekk jogħġbok ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
Maltese: Rilassanti tal-muskoli skeletriċi li mhumiex depolarizzanti (eż. tubocurarine)
English: EU/1/02/215/006 14 tablets EU/1/02/215/007 28 tablets EU/1/02/215/008 28 x 1 tablets EU/1/02/215/014 30 tablets EU/1/02/215/009 56 tablets EU/1/02/215/012 90 tablets EU/1/02/215/010 98 tablets
Maltese: EU/1/02/215/014 30 pillola EU/1/02/215/009 56 pillola EU/1/02/215/012 90 pillola EU/1/02/215/010 98 pillola
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Maltese: Sepsis* (ta' spiss imsejħa “avvelenament tad-demm”, hi infezzjoni severa b'rispons infjammatorju talġisem kollu), nefħa mgħaġġla tal-ġilda u l-mukuża (anġjoedema), jitilgħu l-infafet u s-saff ta' fuq talġilda jitqaxxar (nekrolisi epidermali tossika); dawn l-effetti sekondarji huma rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) jew ta' frekwenza mhux magħrufa (nekrolisi epidermali tossika) iżda huma estremament serji u l-pazjenti għandhom jieqfu jieħdu l-mediċina u jaraw lit-tabib tagħhom immedjatament.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take PritorPlus” and “Warnings and precautions”).
Maltese: - Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux PritorPlus” u “Twissijiet u prekawzjonijiet”).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/215/015-021
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/215/015-021
English: PritorPlus 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Maltese: Il-pilloli PritorPlus 80 mg/25 mg huma sofor u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bilkodiċi 'H9'.
English: Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting, gastritis
Maltese: Dijarea, ħalq xott, gass, Uġigħ addominali, stitikezza, dispepsja, rimettar, gastrite
English: Hydrochlorothiazide crosses the placenta.
Maltese: hydrochlorothiazide żdiedet.
English: Exacerbation or activation of systemic lupus erythematosus
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: Rare cases have also been reported with angiotensin II receptor antagonists (including PritorPlus).
Maltese: Każijiet rari kienu irrappurtati wkoll b'antagonisti ta' riċetturi ta' angiotensin II (li jinkludu PritorPlus).