FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose of Budesonide nasal spray is a total of 4 [Nationally completed name] 64 micrograms/dose nasal spray, suspension] sprays (256 micrograms) each day.
Maltese: Id-doża rakkomandata tal-bidu ta' Budesonide sprej għall-imnieħer hi total ta' 4 Budesonide Sprej għall-Imnieħer 64 mikrogramma/doża ta' sprej għall-imnieħer, suspensjoni sprejs (256 mikrogramma) kuljum.
English: It may cause irritation of the skin or mucous membranes (e.g. contact dermatitis).
Maltese: Jista' jikkawża irritazzjoni talġilda jew tal-membrani mukużi (eż. dermatite tal-kuntatt).
English: Budesonide has a high systemic clearance (appr. 1.2 L/min) and the half-life in plasma following an intravenous dose is on average appr. 4 hours.
Maltese: Budesonide għandu tneħħija sistemika għolja (madwar 1.2 L/min) u l-half-life fil-plażma wara doża ġol-vina hi, fil-medja, ta' madwar 4 sigħat.
English: Budesonide Sandoz and the originator product have the same pharmaceutical form, contain the same amount of active substance and have identical delivery devices.
Maltese: Budesonide Sandoz u l-prodott oriġinatur għandhom l-istess forma farmaċewtika, fihom l-istess ammont ta' sustanza attiva u għandhom l-istess apparat ta' forniment.
English: In this leaflet:
Maltese: Importanti:
English: Common: local symptoms like nasal mucosa irritation, slight haemorrhagic secretion, epistaxis (immediately after application)
Maltese: ANNESS I LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET)
English: The metabolites are eliminated in the urine in unchanged or conjugated form.
Maltese: Il-metaboliti jiġu eliminati fl-awrina f'sura mhux mibdula jew konjugata.
English: Budesonide Sandoz and associated names (see Annex I) 32 µg nasal spray suspension Budesonide Sandoz and associated names (see Annex I) 64 µg nasal spray suspension [See Annex I - To be completed nationally] Budesonide
Maltese: Budesonide Sandoz u ismijiet assoċjati miegħu (ara Anness I) 32 µg suspensjoni ta' sprej għallimnieħer Budesonide Sandoz u ismijiet assoċjati miegħu (ara Anness I) 64 µg suspensjoni ta' sprej għallimnieħer [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Treatment and prevention of signs and symptoms of seasonal and perennial allergic rhinitis Treatment of signs and symptoms of nasal polyps
Maltese: Kura u prevenzjoni ta' sinjali u sintomi staġjonali u rinite allerġika perenni
English: Excipient(s):
Maltese: Kodiċi ATC:
English: Comparable systemic exposure of the test and reference product has not unequivocally been shown in the adult population.
Maltese: Espożizzjoni sistemika komparabbli tal-prodott ittestjat u dak ta' referenza ma ntwerietx b'mod ċar fil-popolazzjoni adulta.
English: Rare: glaucoma, cataract (with long-term treatment)
Maltese: Rari: glawkoma, katarretti (b'kura fit-tul)
English: • the treatment and prevention of the symptoms of year-round nasal allergy caused for example by house dust (chronic rhinitis)
Maltese: • kura u l-prevenzjoni tas-sintomi ta' allerġija tal-imnieħer matul is-sena kollha kkawżata, per eżempju, minn trab fid-dar (rinite kronika)
English: Consideration of potential systemic effects may be needed in severe impairment of hepatic function.
Maltese: Jista' jkun hemm bżonn li wieħed jikkunsidra l-effetti sistemiċi potenzjali f'każ ta' indeboliment sever tal-funzjoni epatika.
English: The Applicant discussed the available knowledge regarding the systemic exposure of intranasally applied budesonide including its high topical potency and low systemic bioactivity, primarily due to absorption through the nasal mucosa and the metabolism steps involved.
Maltese: L-Applikant iddiskuta l-għarfien disponibbli rigward l-espożizzjoni sistematika ta' budesonide applikat minn ġol-imnieħer inkluż il-qawwa topikali għolja u l-bijoattività sistematika baxxa tiegħu, l-aktar minħabba l-assorbiment minn ġol-mukoża tal-imnieħer u l-passi tal-metaboliżmu involuti.
English: No detectable effects on hypothalamic-pituitary-adrenal (HPA) axis function have been observed at the recommended dose, which is in agreement with the rapid hepatic metabolism of the substance and the elimination half-life, suggesting that neither Budesonide Sandoz nor Rhinocort influence cortisol excretion.
Maltese: L-ebda effett li jista' jiġi osservat fuq ilfunzjoni tal-assi ipotalamiku-pitwitarju-adrenali (IPA) ma ġie osservat fid-doża rakkomandata, u dan jaqbel mal-metaboliżmu tal-fwied mgħaġġel tas-sustanza u l-half-life ta' eliminazzjoni.
English: - the therapeutic equivalence of Budesonide Sandoz to the originator in adults has been established and
Maltese: - l-ekwivalenza terapewtika ta' Budesonide Sandoz għall-oriġinatur fl-adulti ġiet stabbilita u
English: • increased pressure in the eyes
Maltese: • toqba fil-kartilaġni li taqsam l-imnifsejn tiegħek
English: How can comparable safety in the paediatric population be concluded based on the facts that: a.) Comparable systemic exposure of the test and reference product has not unequivocally been shown in the adult population.
Maltese: Kif tista' tiġi konkluża sigurtà komparabbli fil-popolazzjoni pedjatrika bbażata fuq il-fatti li: a.) Espożizzjoni sistematika komparabbli tal-prodott ittestjat u dak ta' referenza ma ntwerietx b'mod ċar fil-popolazzjoni adulta.
English: The Applicant also stated that nasally applied budesonide did not significantly alter hypothalamic-pituitary-adrenal (HPA) axis function in the originator's clinical studies.
Maltese: L-Applikant iddikjara wkoll li budesonide applikat minn ġol-imnieħer ma biddilx b'mod sinifikanti l-funzjoni tal-assi ipotalamiku-pitwitarju-adrenali (IPA) fl-istudji kliniċi tal-oriġinatur.
English: • for the treatment of symptoms of nasal polyps (small growths on the lining of the nose).
Maltese: • kura ta' sintomi ta' polipi tal-imnieħer (nefħiet żgħar fuq il-kisja tal-imnieħer).
English: The Applicant stated that available studies show that budesonide has no effect on growth as measured by knemometry in doses below 400 µg/d and that it can be virtually excluded that locally applied corticosteroids cause relevant permanent growth retardation, clinically relevant growth suppression or reduced adult height.
Maltese: L-Applikant iddikjara li studji disponibbli juru li budesonide m'għandux effett fuq liżvilupp kif imkejjel permezz tal-knemometrija f'dożi taħt l-400 µg/kuljum u jista' jkun virtwalment eskluż li kortikosterojds applikati lokalment jikkawżaw dewmien fl-iżvilupp permanenti u rilevanti, trażżin kliniku tal-iżvilupp rilevanti jew tnaqqis fit-tul tal-adult.
English: A clinical study conducted by the Applicant, demonstrated therapeutic equivalence to the originator, indicated similar local availability of budesonide and identified no safety concerns that could be attributed to an increased systemic availability.
Maltese: Studju kliniku li tmexxa mill-applikant, wera ekwivalenza terapewtika għall-oriġinatur, wera disponibbiltà lokali simili ta' budesonide u ma identifika l-ebda tħassib dwar sigurtà li jista' jiġi attribwit għal żieda fid-disponibbiltà sistematika.
English: • if you are hypersensitive (allergic) to budesonide, or any of the other ingredients of Budesonide Nasal Spray suspension (see section 6.
Maltese: • jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal budesonide, jew sustanzi oħra ta' Budesonide Sprej għall-Imnieħer (ara sezzjoni 6.
English: This may cause symptoms such as anorexia, abdominal pain, weight loss, nausea, headache, vomiting, decreased level of consciousness, low blood sugar,levels and seizures.
Maltese: Dan jista' jikkawża sintomi bħal anoreksja, uġigħ ta' żaqq, telf ta' piż, nawseja, uġigħ ta' ras, rimettar, tnaqqis fil-livell ta' koxjenza, livelli baxxi ta' zokkor fiddemm u aċċessjonijiet.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Maltese: DATA TA' META ĠIET RIVEDUTA
English: The CHMP noted the clinical equivalence study and agreed that therapeutic equivalence has been demonstrated in adults, although no formal bioequivalence studies on systemic exposure were performed, neither in adults nor in children.
Maltese: Il-CHMP innota l-istudju ta' ekwivalenza klinika u qabel li fl-adulti, l-ekwivalenza terapewtika intweriet, għalkemm ma sar l-ebda studju formali ta' bijoekwivalenza dwar l-espożizzjoni sistematika, la fl-adulti u lanqas fit-tfal.
English: Nasal polyps Adults, adolescents (12 years of age and older) and children older than 6 years of age: The recommended starting dose of Budesonide nasal spray is a total of 8 [Nationally completed name] 32 micrograms/dose nasal spray, suspension] sprays (256 micrograms) each day.
Maltese: Id-doża rakkomandata tal-bidu ta' Budesonide sprej għall-imnieħer hi total ta' 8 Budesonide Sprej għall-Imnieħer 32 mikrogramma/doża ta' sprej għall-imnieħer, suspensjoni] sprejs (256 mikrogramma) kuljum.
English: Each 0.05 ml dose (one spray) of this nasal spray, suspension, contains 32 micrograms of budesonide Each 0.05 ml dose (one spray) of this nasal spray, suspension, contains 64 micrograms of budesonide
Maltese: Kull doża ta' 0.05 ml (sprej wieħed) ta' dan l-isprej għall-imnieħer, suspensjoni fiha 32 mikrogramma ta' budesonide.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Maltese: Id-doża għandha tiġi ttritata għallinqas doża li fiha jinżamm kontroll effettiv tas-sintomi.
English: The impact of ascorbic acid on the unidirectional mucosal permeability of budesonide was assessed and the results show that addition of ascorbic acid at a concentration of 600µM did not facilitate mucosal permeability.
Maltese: Trid tuża din il-mediċina regolarment, inkella mhix ser taħdem kif suppost.
English: Undesirable effects frequencies were defined as follows:
Maltese: Il-frekwenzi tal-effetti mhux mixtieqa huma definiti kif ġej:
English: HOW TO STORE Budesonide Nasal Spray
Maltese: KIF TUŻA Budesonide Sprej għall-Imnieħer
English: When patients are transferred from systemic corticosteroid (oral or parenteral) to Budesonide nasal spray suspension, adverse reactions outside the nasal area which were previously under control by systemic therapy e.g. allergic conjunctivitis or dermatitis, may become unmasked.
Maltese: Meta l-pazjenti tinbidlilhom il-kura minn kortikosterojdi sistemiċi (orali jew parenterali) għal Budesonide suspensjoni ta' sprej għall-imnieħer, reazzjonijiet avversi 'il barra miż-żona tal-imnieħer li qabel kienu kkontrollati mit-terapija sistemika eż. konġuntivite allerġika jew dermatite, jistgħu jinkixfu.
English: Paediatric Adverse Events like growth retardation have not been addressed.
Maltese: Ma ġewx indirizzati Avvenimenti Avversi
English: Endocrine disorders
Maltese: TAL-PRODOTT MEDIĊINALI
English: Special care is needed in patients with tuberculosis.
Maltese: Attenzjoni speċjali hi meħtieġa f'pazjenti bit-tuberkulosi.
English: Raiffeisenstraße 11
Maltese: Kif jingħata 1.
English: Furthermore, the safety profile of Budesonide Sandoz in the therapeutic equivalence trial was similar to that of both the originator product and the placebo and it is therefore reasonable and justified to assume comparable safety in all target populations, including children ≥ 6 years of age and adolescents.
Maltese: Barra minn hekk, il-profil ta' sigurtà ta' Budesonide Sandoz fil-prova ta' ekwivalenza terapewtika kien jixbaħ kemm lil dak tal-oriġinatur kif ukoll il-plaċebo u għaldaqstant huwa raġonevoli u ġġustifikat li wieħed jassumi sigurtà komparabbli fil-popolazzjonijiet kollha filmira, inkluż tfal ≥ 6 snin u adolexxenti.
English: Based on the review of the data on quality, safety and efficacy, the CHMP considers that the overall benefit/risk ratio of Budesonide Sandoz in children is positive and that the application for Budesonide Sandoz, in the treatment of seasonal and perennial allergic rhino-conjunctivitis (SAR, PAR) as well as nasal polyps, is approvable.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta dwar il-kwalità, is-sigurtà u l-effikaċja, il-CHMP iqis li l-bilanċ totali bejn il-benefiċċju u r-riskju ta' Budesonide Sandoz fit-tfal huwa wieħed pożittiv u li lapplikazzjoni għal Budesonide Sandoz, fil-kura ta' rino konġuntivite allerġika staġjonali u perenni (SAR, PAR) kif ukoll ta' qarnit fl-imnieħer, tista' tiġi approvata.
English: Uncommon side effects (fewer than 1 patient in every 100 and more than 1 patient in every 1.000 patients treated):
Maltese: Effetti sekondarji mhux komuni (li jaffettwaw inqas minn pazjent 1 minn kull 100 pazjent, u iktar minn pazjent 1 minn kull 1,000 pazjent li jkunu kkurati):
English: • Remove the plastic nozzle with a clean tissue and wash in warm - not hot - water.
Maltese: • Aqla' ż-żennuna tal-plastik b'tissue nadifa u aħsilha f'ilma sħun - mhux jaħraq.
English: - the safety profile for children of Budesonide Sandoz is not expected to differ from that of the originator,
Maltese: - il-profil tas-sigurtà ta' Budesonide Sandoz għat-tfal mhuwiex mistenni li jkun differenti minn dak tal-oriġinatur,
English: Finally, the CHMP agreed that no local safety related issues are expected for Budesonide Sandoz nasal spray and that there is no evidence that the safety of Budesonide Sandoz in children is different from that of the originator.
Maltese: Fl-aħħar nett, il-CHMP qabel li ma hija mistennija ebda kwistjoni relatata mas-sigurtà lokali għall-isprej tal-imnieħer Budesonide Sandoz u li mhemmx prova li s-sigurtà ta' Budesonide Sandoz fit-tfal hija differenti minn dik tal-oriġinatur.
English: Children should be treated under guidance of an adult.
Maltese: It-tfal għandhom jiġu kkurati taħt il-gwida ta' persuna adulta.
English: Wipe the nozzle with a clean tissue and replace the protective cap. 6.
Maltese: Imsaħ iż-żennuna b'tissue nadifa u poġġi l-għatu protettiv f'postu.
English: Take special care with Budesonide Nasal Spray
Maltese: QABEL MA TUŻA Budesonide Sprej għall-Imnieħer
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BUDESONIDE SANDOZ AND ASSOCIATED NAMES (SEE ANNEX I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' BUDESONIDE SANDOZ U ISMIJIET ASSOĊJATI (ARA ANNESS I)
English: Very rare side effects (fewer than 1 patient in every 10.000 patients treated), or where the frequency is not known (cannot be estimated from the available data):
Maltese: Effetti sekondarji rari ħafna (li jaffettwaw inqas minn pazjent 1 minn kull 10,000 pazjent), jew fejn il-frekwenza ma tkunx magħrufa (ma tistax tkun stmata mid-data disponibbli):
English: Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Maltese: Il-kura b'dożi ogħla mid-dożi rakkomandati ta' kortikosterojdi tal-imnieħer tista' tirriżulta fi trażżin adrenali klinikament sinifikanti.
English: Rare: growth suppression in children (see section 4.4), Very rare: adrenal supression
Maltese: Rari ħafna: trażżin adrenali
English: Budesonide in not metabolised locally in the nasal mucosa.
Maltese: Budesonide ma jiġix immetabolizzat lokalment fil-mukuża tal-imnieħer.
English: 0.9 ml intravenous use syringe (glass) with needle safety guard with needle safety guard
Maltese: (10000 IU/ml) mimlijin għallest siringa mimlija għal-lest (ħġieġ) bi protezzjoni tassigurtà tal labra siringa mimlija għal-lest (ħġieġ) bi protezzjoni tassigurtà tallabra
English: 3 Chlormadinone, estradiol; chlormadinone acetate, ethinylestradiol ; conjugated estrogens, medrogestone ; conjugated estrogens, medroxyprogesterone acetate; conjugated estrogens, norgestrel; cyproterone, ethinylestradiol; cyproterone acetate, estradiol valerate; desogestrel; desogestrel ,ethinylestradiol; dienogest, estradiol; dienogest, ethinylestradiol; drospirenone, estradiol; drospirenone, ethinylestradiol; estradiol, estriol, levonorgestrel; estradiol, gestodene; estradiol, levonorgestrel; estradiol, medroxyprogesterone acetate; estradiol, nomegestrol acetate; estradiol, norethisterone; estradiol, norgestimate; estradiol (17-beta), progesterone; estradiol (17-beta), trimegestone; estradiol valerate, norgestrel; ethinylestradiol, etonogestrel; ethinylestradiol, etynodiol; ethinylestradiol, gestodene; ethinylestradiol, gestodene; ethinylestradiol, levonorgestrel; ethinylestradiol, lynestrenol; ethinylestradiol, norethisterone; ethinylestradiol, norgestimate; ethinylestradiol, norgestrel; levonorgestrel, ethinylestradiol; ethinylestradiol; levonorgestrel; medroxyprogesterone; mestranol, norethisterone; nomegestrol; nomegestrol acetate, estradiol; norelgestromin, ethinyl estradiol; norethisterone
Maltese: Chlormadinone, estradiol; chlormadinone acetate, ethinylestradiol ; conjugated estrogens, medrogestone ; conjugated estrogens, medroxyprogesterone acetate; conjugated estrogens, norgestrel; cyproterone, ethinylestradiol; cyproterone acetate, estradiol valerate; desogestrel; desogestrel ,ethinylestradiol; dienogest, estradiol; dienogest, ethinylestradiol; drospirenone, estradiol; drospirenone, ethinylestradiol; estradiol, estriol, levonorgestrel; estradiol, gestodene; estradiol, levonorgestrel; estradiol, medroxyprogesterone acetate; estradiol, nomegestrol acetate; estradiol, norethisterone; estradiol, norgestimate; estradiol (17-beta), progesterone; estradiol (17-beta), trimegestone; estradiol valerate, norgestrel; ethinylestradiol, etonogestrel; ethinylestradiol, etynodiol; ethinylestradiol, gestodene; ethinylestradiol, gestodene; ethinylestradiol, levonorgestrel; ethinylestradiol, lynestrenol; ethinylestradiol, norethisterone; ethinylestradiol, norgestimate; ethinylestradiol, norgestrel; levonorgestrel, ethinylestradiol; ethinylestradiol; levonorgestrel; medroxyprogesterone; mestranol, norethisterone; nomegestrol; nomegestrol acetate, estradiol; norelgestromin, ethinyl estradiol; norethisterone tesperjenza bidliet fil-burdata u sintomi dipressivi, ikkuntattja lit-tabib tiegħek minnufih biex tirċievi parir mediku.
English: Psychiatric disorders:
Maltese: Disturbi psikjatriċi:
English: Fertility, pregnancy and lactation
Maltese: Fertilità, tqala u treddigħ
English: Summary of product characteristics 4.8.
Maltese: Sommarju tal-karatteristiċi tal-prodott 4.8.
English: Pregnancy
Maltese: Dislipidemija
English: Teriflunomide - Dyslipidaemia (EPITT no 19227)
Maltese: Teriflunomide - Dislipidemija (EPITT nru 19227)
English: More than 1000 outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Maltese: Aktar minn 1 000 eżitu minn esponiment fit-tieni u t-tielet trimestru f'nisa tqal jindikaw li ma hemmx evidenza ta' riskju akbar ta' effetti negattivi malformattivi u fetali/neonatali.
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%).
Maltese: L-inċidenza tad-difetti fit-tubu newrali fil-popolazzjoni ġenerali tvarja minn 0.5-1 każ f'kull 1 000 twelid ħaj (0.05-0.1 %).
English: Package leaflet 2.
Maltese: Fuljett ta' tagħrif 2.
English: Adopted at the 1-4 October 2018 PRAC
Maltese: Adottata fil-PRAC ta' bejn il-1-4 ta' Ottubru 2018
English: Direct acting antivirals (DAAV) indicated for the treatment of hepatitis C2 - Dysglycaemia (EPITT no 19234)
Maltese: Mediċini antivirali li jaġixxu direttament (DAAV, Direct acting antivirals) indikati għall-kura tal-epatite Ċ2Disgliċemija (EPITT nru 19234)
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Maltese: Data preliminari minn studju ta' sorveljanza tissuġġerixxi inċidenza akbar ta' difetti fit-tubu newrali (0.9 %) f'ommijiet esposti għal dolutegravir fi żmien il-konċezzjoni, meta mqabbel ma' ommijiet esposti għal reġimi li ma jinkludux dolutegravir (0.1 %).
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli)
English: Dolutegravir - Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women (EPITT no
Maltese: Dolutegravir - Evalwazzjoni tad-data preliminari minn studju ta' osservazzjoni dwar l-eżiti tat-twelid f'nisa infettati bil-virus tal-immunodefiċjenza umana (HIV) (EPITT nru 19244)
English: Hormonal contraceptives3 - Suicidality with hormonal contraceptives following a recent publication (EPITT no
Maltese: 3. Kontraċettivi ormonali3 - Suwiċidalità bil-kontraċettivi ormonali wara pubblikazzjoni reċenti (EPITT nru 19144)
English: Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8).
Maltese: Burdati dipressivi u dipressjoni huma effetti mhux mixtieqa iżda magħrufa sew tal-użu tal-kontraċettivi ormonali (ara s-Sezzjoni 4.8).
English: If you could get pregnant while receiving {product name}, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Maltese: Jekk tista' tinqabad tqila waqt li tkun qed tirċievi {isem il-prodott}, jeħtieġ li tuża metodu affidabbli ta' kontraċezzjoni tat-tip barriera (pereżempju kondom), flimkien ma' metodi oħrajn ta' kontraċezzjoni li jinkludu dik orali (il-pillola) jew kontraċettivi ormonali oħra (pereżempju impjanti, injezzjoni) biex tevita t-tqala.
English: In animal reproductive toxicology studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Maltese: Fi studji tossikoloġiċi fuq ir-riproduzzjoni tal-annimali, ma ġewx identifikati eżiti avversi fl-iżvilupp, inklużi difetti fit-tubu newrali (ara s-Sezzjoni 5.3). Intwera li dolutegravir taqsam il-plaċenta flannimali.
English: Undesirable effects Tabulated list of adverse reactions Metabolism and nutrition disorders Frequency ‘Not known'': Dyslipidaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Frekwenza “Mhux magħrufa”:
English: • abnormal levels of fats (lipids) in the blood
Maltese: livelli anormali ta' xaħam (lipidi) fid-demm
English: Some women using hormonal contraceptives including {product name} have reported depression or depressed mood.
Maltese: Xi nisa li jużaw kontraċettivi ormonali, inkluż {isem il-prodott} irrappurtaw dipressjoni jew burdata dipressiva.
English: Due to the potential risk of neural tube defects, dolutegravir should not be used during the first trimester unless there is no alternative.
Maltese: Minħabba r-riskju potenzjali ta' difetti fit-tubu newrali, dolutegravir ma għandux jintuża matul l-ewwel trimestru, dment li ma jkunx hemm alternattiva oħra.
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir.
Maltese: Nisa li jista' jkollhom it-tfal (WOCBP, Women of childbearing potential) għandhom ikunu soġġetti għal ittestjar tat-tqala qabel jibdew jieħdu dolutegravir.
English: Your doctor will review your treatment.
Maltese: It-test attwali li għandu jitħassar huwa maqtugħ.
English: Glucose levels of diabetic patients initiating {direct acting antiviral / DAA} therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Maltese: Il-livelli tal-glukożju ta' pazjenti bid-dijabete li jibdew terapija {b'mediċina antivirali li taġixxi direttament / DAA} għandhom jiġu mmonitorjati mill-qrib, b'mod partikolari fl-ewwel tliet xhur, u lmedikazzjoni dijabetika tagħhom għandha tiġi modifikata meta jkun meħtieġ.
English: Dolutegravir should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Maltese: Dolutegravir għandha tintuża biss matul it-tieni u t-tielet trimestru tat-tqala, meta l-benefiċċju mistenni jiġġustifika r-riskju potenzjali għall-fetu.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV {direct acting antiviral / DAA} treatment.
Maltese: Pazjenti bid-dijabete jistgħu jesperjenzaw kontroll aħjar tal-glukożju, li potenzjalment jirriżulta f'ipogliċemija sintomatika, wara li tinbeda l-kura għall-HCV {b'mediċina antivirali li taġixxi direttament / DAA}