FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with rheumatoid arthritis, the immune system (the body's defences) attacks healthy tissue, causing inflammation in the joints.
Maltese: F'pazjenti bl-artrite rewmatojde, is-sistema immuni (id-difiżi tal-ġisem) tattakka tessut b'saħħtu, u tikkawża infjammazzjoni fil-ġogi.
English: It found that after 24 weeks, 48% of patients were in remission (clear of symptoms) after treatment with Rinvoq compared with 19% of patients receiving methotrexate.
Maltese: Dan sab li wara 24 ġimgħa, 48 % tal-pazjenti kienu f'remissjoni (fiequ s-sintomi) wara l-kura b'Rinvoq meta mqabbla ma' 19 % tal-pazjenti li rċevew methotrexate.
English: Rinvoq was effective at controlling moderate to severe rheumatoid arthritis in patients whose disease had not improved enough with other disease-modifying anti-rheumatic medicines.
Maltese: Rinvoq kien effettiv fil-kontroll ta' artrite rewmatojde moderata sa severa f'pazjenti li l-marda tagħhom ma tjibitx biżżejjed b'mediċini oħra antirewmatiċi li jimmodifikaw il-marda.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: Ħarsa ġenerali lejn Rinvoq u għalfejn huwa awtorizzat fl-UE
English: As for all medicines, data on the use of Rinvoq are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Rinvoq hija ssorveljata kontinwament.
English: The company that markets Rinvoq will provide information to healthcare professionals about the risks of infection, harm to the unborn baby if Rinvoq is taken during pregnancy, and problems affecting the heart and circulation.
Maltese: Il-kumpanija li tqiegħed Rinvoq fis-suq se tipprovdi informazzjoni lill-professjonisti tal-kura tas-saħħa dwar ir-riskji ta' infezzjoni, il-ħsara lit-tarbija fil-ġuf jekk Rinvoq jittieħed waqt it-tqala, u l-problemi li jaffettwaw il-qalb u ċ-ċirkolazzjoni.
English: It found that 45% of the patients treated with Rinvoq on its own had low disease activity after 14 weeks compared with 19% of patients continuing their methotrexate treatment.
Maltese: Dan sab li 45 % tal-pazjenti kkurati b'Rinvoq waħdu kellhom attività tal-marda baxxa wara 14-il ġimgħa meta mqabbla ma' 19 % tal-pazjenti li komplew il-kura b'methotrexate.
English: It can be used on its own or with methotrexate, another medicine for rheumatoid arthritis.
Maltese: Jista' jintuża waħdu jew ma' methotrexate, mediċina oħra għall-artrite rewmatojde.
English: Rinvoq is a medicine for treating adults with rheumatoid arthritis, a disease that causes inflammation of the joints.
Maltese: Rinvoq huwa mediċina għall-kura ta' adulti b'artrite rewmatojde, marda li tikkawża infjammazzjoni talġogi.
English: For the full list of side effects of Rinvoq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Rinvoq, ara l-fuljett ta' tagħrif.
English: The company will also supply a patient alert card describing warning signs of Rinvoq's serious side effects and how to get help, and a reminder not to use it during pregnancy.
Maltese: Il-kumpanija se tipprovdi wkoll kard ta' twissija tal-pazjent li tiddeskrivi sinjali ta' twissija tal-effetti sekondarji serji ta' Rinvoq u kif tinkiseb l-għajnuna, u tfakkira biex ma jintużax waqt it-tqala.
English: This means that it reduces the activity of the immune system.
Maltese: Dan ifisser li dan inaqqas lattività tas-sistema immuni.
English: The second study was in patients whose disease was not well controlled with disease-modifying antirheumatic medicines.
Maltese: It-tieni studju kien f'pazjenti li l-marda tagħhom ma kinitx ikkontrollata tajjeb b'mediċini antirewmatiċi li jimmodifikaw il-marda.
English: Patients treated with Rinvoq may have side effects that include infection, neutropenia (low count of a type of white blood cell), and blood tests that suggest liver or muscle damage and raised blood lipids.
Maltese: Il-pazjenti kkurati b'Rinvoq jista' jkollhom effetti sekondarji li jinkludu infezzjoni, newtropenija (għadd baxx ta' tip ta' ċellola bajda taddemm), u testijiet tad-demm li jissuġġerixxu ħsara fil-fwied jew fil-muskoli u żieda fil-lipidi tad-demm.
English: Upadacitinib works by blocking the action of enzymes called Janus kinases.
Maltese: Aktar informazzjoni dwar Rinvoq tinstab fis-sit web tal-Aġenzija:
English: Rinvoq must not be used in patients with tuberculosis or serious infections.
Maltese: Rinvoq m'għandux jintuża f'pazjenti b'tuberkulożi jew b'infezzjonijiet serji.
English: These enzymes are involved in setting up processes that lead to inflammation, and blocking their effect brings inflammation in the joints under control.
Maltese: Dawn l-enzimi huma involuti fl-istabbiliment ta' proċessi li jwasslu għal infjammazzjoni, u l-imblukkar tal-effett tagħhom ipoġġi l-infjammazzjoni fil-ġogi taħt kontroll.
English: How is Rinvoq used?
Maltese: Kif jintuża Rinvoq?
English: Gel, 60 g
Maltese: Ġell, 60 g
English: 2 = Moderate
Maltese: 2 = Moderata
English: Study 2 (BD)
Maltese: Studju 2 (BD)
English: Grade 0, 1 or 2
Maltese: Grad 0, 1 jew 2
English: Partial Response (PR) % 34.3
Maltese: Rispons Parzjali (PR) % 34.3
English: 3 = Severe
Maltese: 3 = Severa
English: The frequency of adverse events are classified as very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Maltese: Il-frekwenza tal-avvenimenti avversi hi kklassifikata bħala komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); u mhux komuni (≥1/1,000 sa <1/100).
English: Adverse events include verbatim terms in parentheses.
Maltese: L-avvenimenti avversi jinkludu t-termini verbatim fil-parentesi.
English: Date of first authorization: 11 October 2000 Date of latest renewal: 27 September 2010
Maltese: Data tal-aħħar tiġdid: 27 ta' Settembru 2010
English: Clinical Complete Response (CCR) %
Maltese: Rispons Kliniku Sħiħ (CCR) %
English: Carcinogenesis, mutagenesis, impairment of fertility
Maltese: Karċinoġenesi, mutaġenesi, indeboliment tal-fertilità
English: Unopened: 3 years.
Maltese: Mhux miftuħ: 3 snin
English: DEFINING CLINICAL SIGNS
Maltese: DEFINIZZJONI TAS-SINJALI KLINIĊI
English: • Pregnancy and breast-feeding (see section 4.6).
Maltese: • Fit-tqala u waqt it-treddigħ (ara sezzjoni 4.6).
English: Alitretinoin (9-cis-retinoic acid), a naturally-occurring endogenous hormone related to vitamin A, binds to and activates all known intracellular retinoid receptor subtypes (RAR, RAR, RAR, RXR, RXR, RXR).
Maltese: Alitretinoin (9-cis-retinoic acid), ormon endoġeniku naturali assoċjat mal-vitamina A, jeħel u jattiva s-sottotipi magħrufa kollha tar-riċetturi retinojdi intraċellulari (RARα, RAR, RAR, RXRα, RXRβ, RXRγ).
English: In Study 2a (N = 99), the overall response rate increased to 56.1%.
Maltese: Fi Studju 2a (N = 99), ir-rata tar-rispons globali żdiedet għal 56.1%.
English: In the open label phase of Study 1 (N = 184), the overall response rate increased to 66.7%.
Maltese: Fil-fażi open label ta' Studju 1 (N = 184), ir-rata tar-rispons totali żdiedet għal 66.7%.
English: Progressive Disease %
Maltese: Marda Progressiva %
English: Overall Response %
Maltese: Rispons Globali %
English: Table 1 Grading of local dermal irritation GRADE
Maltese: Tabella 1 Klassifikazzjoni tal-irritazzjoni lokali tal-ġilda GRAD
English: The incidence of mild/moderate rash (all events regardless of causality) was less in patients treated for less than 16 weeks than in those treated for 16 weeks or more (mild, 33% v 63%; moderate, 29% v 43%).
Maltese: L-inċidenza ta' raxx ħafif/moderat (l-avvenimenti kollha mingħajr ma jingħata kas tal-kawżalità) kienet inqas f'pazjenti li kienu kkurati għal inqas minn 16-il ġimgħa milli f'dawk li kienu kkurati għal 16-il ġimgħa jew aktar (ħafif, 33% v 63%; moderat, 29% v 43%).
English: Table 4 Best response according to ACTG criteria for vehicle controlled phase Study 1 (TID, QID)
Maltese: Tabella 4 L-aħjar rispons skont il-kriterji ACTG għall-fażi kontrollata bil-vehicle Studju 1 (TID, QID)
English: Phlebitis, Vascular disorder
Maltese: Flebite, Disturbi vaskulari
English: Three doses of alitretinoin (0.01%, 0.05%, or 0.5%) in a topical gel formulation were given to rats in a 28-day dermal toxicology study.
Maltese: Tliet dożi ta' alitretinoin (0.01%, 0.05%, jew 0.5%) f'formulazzjoni ta' ġell topiku, ingħataw lil firien fi studju dwar it-tossikoloġija tal-ġilda li dam 28 jum.
English: Also contains ethanol, macrogol 400, hydroxypropylcellulose, butylhydroxytoluene.
Maltese: Fih ukoll ethanol, macrogol 400, hydroxypropylcellulose, butylhydroxytoluene.
English: - Panretin contains alcohol.
Maltese: - Panretin fih l-alkoħol.
English: There was no clinical evidence in the vehicle-controlled studies of interactions with systemic antiretroviral agents, including protease inhibitors; macrolide antibiotics and azole antifungals.
Maltese: Ma kien hemm l-ebda evidenza klinika fl-istudji kkontrollati bil-vehicle ta' interazzjonijiet ma' sustanzi antiretrovirali, li jinkludu inibituri tal-protease; antibijotiċi macrolide u antifungali azole.
English: 1 g of gel contains 1 mg alitretinoin (0.1%).
Maltese: 1 g ta' ġell fih 1 mg ta' alitretinoin (0.1%).
English: Skin disorder (cracking, scab, crusting, excoriation, drainage, oozing), Rash (erythema, redness, scaling, irritation, dermatitis), Pruritus (itching, pruritus)
Maltese: Disturb tal-ġilda (qsim, skorċa, qoxra, brix, ħruġ ta' likwidu, tnixxija), Raxx (eritema, ħmura, qxur li jitfarfar, irritazzjoni, dermatite), Pruritus (ħakk, pruritus)
English: Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi's sarcoma (KS) when:
Maltese: Il-ġell Panretin huwa indikat għall-kura topika ta' leżjonijiet tal-ġilda f'pazjenti b'sarkoma ta' Kaposi (Kaposi's sarcoma - KS) marbuta mal-AIDS meta:
English: Haemorrhage (bleeding at or around lesions), Oedema (oedema, swelling, inflammation), Peripheral oedema
Maltese: Emorraġija (fsada mil-leżjonijiet jew madwarhom), Edema (edema, nefħa, infjammazzjoni), Edema periferali
English: The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS-related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Maltese: Is-sigurtà tal-ġell Panretin kienet evalwata fi studji kliniċi fuq aktar minn 469 pazjent b'KS marbuta mal-AIDS, li 439 minnhom kienu kkurati b'konċentrazzjoni ta' alitretinoin ta' 0.1%.
English: Panretin gel 0.1%
Maltese: Ġell ta' Panretin 0.1%
English: Panretin 0.1% gel Alitretinoin
Maltese: Panretin 0.1% ġell Alitretinoin
English: Panretin 0.1 % gel alitretinoin
Maltese: Panretin 0.1% ġell alitretinoin
English: Cellulitis, Vesiculobullous rash, Maculopapular rash, Allergic reaction
Maltese: Ċellulite, Raxx bl-infafet, Raxx makulari bil-ponot, Reazzjoni allerġika
English: Study 2 was followed by an open label study (Study 2a), which included only patients electing to continue from Study 2.
Maltese: Studju 2 kien segwit minn studju open label (Studju 2a), li inkluda biss pazjenti li għażlu li jkomplu jipparteċipaw minn Studju 2.
English: Study 1, 6 index lesions; Study 2, up to 8 index lesions Each index lesion assessed individually for response.
Maltese: Studju 1, 6 leżjonijiet indiċi; Studju 2, sa 8 leżjonijiet indiċi Kull leżjoni indiċi kienet evalwata individwalment għar-rispons.
English: The following side effects have been noted on the skin where Panretin has been applied:
Maltese: L-effetti sekondarji li ġejjin kienu osservati fuq il-ġilda fejn kien applikat Panretin:
English: What Panretin contains - The active substance is alitretinoin.
Maltese: X'fih Panretin - Is-sustanza attiva hi alitretinoin.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: LO1XX22
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi oħrajn, Kodiċi ATC:
English: - A mild soap is recommended when bathing or showering.
Maltese: - Sapuna ħafifa hi rakkomandata meta tkun qed tieħu banju jew doċċa.
English: When applying Panretin gel, 69.1% of patients experienced adverse drug reactions at the application site.
Maltese: Meta applikaw il-ġell Panretin, 69.1% tal-pazjenti kellhom reazzjonijiet avversi għall-mediċina fis-sit tal-applikazzjoni.
English: Paraesthesia (stinging, tingling)
Maltese: Parestesija (tingiż, tnemnim)
English: A subset of these patients were followed during treatment of up to 64 lesions (range 4-64, median 11.5 lesions) for up to 44 weeks (range 2-44, median 15 weeks).
Maltese: Sottosett ta' dawn il-pazjenti kienu segwiti matul il-kura fuq mhux aktar minn 64 leżjoni (medda 4-64, medjan 11.5 leżjonijiet) għal mhux aktar minn 44 ġimgħa (medda 2-44, medjan 15-il ġimgħa).
English: In study 1, of 110 responding patients, 36 (33%) relapsed, while all but four still being on active treatment.
Maltese: Fi Studju 1, minn 110 pazjenti li rrispondew għall-kura, 36 (33%) irkadew, waqt li kollha kemm huma ħlief erbgħa kienu għadhom qed jieħdu l-kura.
English: - The other ingredients are ethanol, macrogol 400, hydroxypropylcellulose, and butylhydroxytoluene.
Maltese: - Is-sustanzi mhux attivi l-oħra huma ethanol, macrogol 400, hydroxypropylcellulose, u butylhydroxytoluene.
English: Table 2 Adjustment guidelines for treatment-limiting toxicity LOCAL DERMAL IRRITATION
Maltese: Tabella 2 Linji gwida dwar l-aġġustament meħtieġ biex tkun illimitata t-tossiċità tal-kura IRRITAZZJONI LOKALI
English: 1 g of gel contains 1 mg of alitretinoin.
Maltese: 1 g ta' ġel fih 1 mg ta' alitretinoin.
English: Local dermal irritation may be graded according to the five-point scale shown in Table 1.
Maltese: Irritazzjoni lokali tal-ġilda tista' tkun ikklassifikata skont l-iskala ta' ħames punti murija f'Tabella 1.
English: Therefore, there is a low potential for interactions with systemic medicinal products.
Maltese: Għalhekk, hemm potenzjal baxx għal interazzjonijiet ma' prodotti mediċinali sistemiċi.
English: Stinging, tingling
Maltese: Tingiż, tnemnim
English: Stable Disease %
Maltese: Marda Stabbli %
English: Clinical pathology evaluations revealed significant increases in absolute polymorphonuclear leukocyte counts, monocyte counts, percentage of monocytes and decreases in percentage of lymphocyte differential white blood cell counts on day 29 of rats treated with alitretinoin 0.5% gel.
Maltese: Evalwazzjonijiet patoloġiċi kliniċi żvelaw żidiet sinifikanti fl-għadd assolut tal-lewkoċiti polimorfonukleari, fl-għadd tal-monoċiti, fil-perċentwali tal-monoċiti, u tnaqqis fil-perċentwali tad-differenzjal tal-limfoċiti fl-għadd taċ-ċelluli bojod tad-demm fid-29 jum, ta' firien li kienu kkurati bil-ġell alitretinoin 0.5%. Evalwazzjonijiet kimiċi kliniċi żvelaw żidiet sinifikanti bijoloġikament rilevanti fil-medja tal-BUN u fil-valuri ta' alkaline phosphatase fin-nisa wara l-kura li damet 28 jum.
English: • Hypersensitivity to retinoids in general, to the active substance alitretinoin or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għar-retinojdi b'mod ġenerali, għas-sustanza attiva alitretinoin jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Alitretinoin was studied for genotoxic potential using the Ames test, the in vivo mouse micronucleus assay, the chromosomal aberration test in human lymphocytes, and the CHO cell mutation test.
Maltese: Alitretinoin kien studjat għall-potenzjal ġenotossiku billi ntuża t-test ta' Ames, l-assaġġ tal-mikronukleu tal-ġurdien in vivo, it-test tal-aberrazzjoni tal-kromosomi fil-limfoċiti umani, u t-test CHO tal-mutazzjoni taċ-ċelluli.
English: Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.
Maltese: It-tossiċità sistemika wara doża eċċessiva akuta bl-applikazzjoni topika tal-ġell Panretin mhijiex mistennija.
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: Table 5 Index/indicator lesion 1 responses within patients during the first 12 weeks on study in initial blinded phase Patients with given number of index/indicator lesion responses (CCR or PR) Study 1
Maltese: 1 indiċi/indikaturi fost il-pazjenti matul l-ewwel 12-il ġimgħa tal-istudju waqt il-fażi blinded inizjali Pazjenti b'numru fiss ta' risponsi ta' leżjonijiet indiċi/indikaturi (CCR jew PR) Studju 1
English: Do not use Panretin: - if you are allergic to alitretinoin or to similar medicines containing retinoids - if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant - if you are planning a pregnancy - if you are breast-feeding - on KS lesions close to any other skin complaint
Maltese: Tużax Panretin: - jekk inti allerġiku/a għal alitretinoin jew għal mediċini simili li fihom retinojdi - jekk inti allerġiku/għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6) - jekk inti tqila - jekk qed tippjana tqala - jekk qed tredda' - fuq leżjonijiet ta' KS li jkunu qrib ta' xi mard ieħor fil-ġilda
English: Panretin 0.1 % gel
Maltese: Panretin 0.1% ġell
English: However, the mutagenic potential has been evaluated, and alitretinoin has tested negative in the Ames test, the in vivo mouse micronucleus assay, the chromosomal aberration test in human lymphocytes, and the CHO cell mutation test.
Maltese: Madankollu, il-potenzjal mutaġeniku kien evalwat, u alitretinoin kellu riżultat negattiv fit-test ta' Ames, fl-assaġġ tal-mikronukleu tal-ġurdien in vivo, fit-test tal-aberrazzjoni tal-kromosomi fil-limfoċiti umani, u fit-test CHO tal-mutazzjoni taċ-ċelluli.
English: It is not recommended for patients to apply Panretin gel concurrently with products that contain N,N-diethyl-m-toluamide (DEET ), a common component of insect repellent products.
Maltese: Mhuwiex rakkomandat li l-pazjenti japplikaw il-ġell Panretin flimkien ma' prodotti li fihom N,N-diethyl-m-toluamide (DEET), komponent komuni fil-prodotti li jbiegħdu l-insetti minn fuq il-ġisem.
English: The results suggest that alitretinoin absorbs light in the UV range and is subject to photodegradation to other isomers (predominantly all-trans-retinoic acid).
Maltese: Ir-riżultati jissuġġerixxu li alitretinoin jassorbi d-dawl fil-medda UV u hu suġġett għal fotodegradazzjoni f'isomeri oħrajn (il-biċċa l-kbira all-trans-retinoic acid).
English: Panretin gel is supplied in a multi-use 60 g epoxy-lined aluminium tube.
Maltese: Panretin hu fornut fi stoċċ tal-aluminju ta' 60 g għal użu multiplu, miksi bl-epoxy.
English: - Avoid scratching the treated areas.
Maltese: - Evita li tħokk il-partijiet kkurati tal-ġilda.
English: Pharmacokinetic studies indicate that the range and frequency of detection of quantifiable 9-cis-retinoic acid plasma concentrations in patients with KS after application of the medicinal product were comparable to the range and frequency of detection of quantifiable plasma concentrations of circulating, naturally-occurring 9-cis-retinoic acid in untreated individuals (see section 5.2).
Maltese: Studji farmakokinetiċi jindikaw li l-medda u l-frekwenza tal-osservazzjoni ta' konċentrazzjonijiet li jistgħu jiġu kkwantifikati ta' 9-cis-retinoic acid fil-plażma f'pazjenti b'KS wara li wżaw il-prodott mediċinali, kienu kumparabbli mal-medda u l-frekwenza tal-osservazzjoni ta' konċentrazzjonijiet li jistgħu jiġu kkwantifikati ta' 9-cis-retinoic acid li jiċċirkola u li jseħħ b'mod naturali fil-plażma ta' individwi li ma kinux ikkurati (ara sezzjoni 5.2).
English: Clear yellow gel.
Maltese: Ġell isfar trasparenti.
English: Following treatment with alitretinoin 0.5% gel, mean plasma concentrations in the female rats were generally below the lower limit of quantitation (5 nMol) and mean plasma concentrations in the male rats were about 200 nMol.
Maltese: Wara l-kura bil-ġell alitretinoin 0.5%, il-konċentrazzjonijiet medji fil-plażma tal-firien nisa ġeneralment kienu taħt il-limitu l-baxx tal-kejl tal-kwantità (5 nMol), u l-konċentrazzjonijiet medji fil-plażma tal-firien irġiel kienu ta' madwar 200 nMol.
English: Plasma concentrations of 9-cis-retinoic acid were evaluated during clinical studies in patients with cutaneous lesions of AIDS-related KS after repeated multiple-daily dose application of Panretin gel for up to 60 weeks.
Maltese: Il-konċentrazzjonijiet ta' 9-cis-retinoic acid fil-plażma kienu evalwati matul l-istudji kliniċi f'pazjenti li kellhom leżjonijiet fil-ġilda ta' KS marbuta mal-AIDS, wara l-applikazzjoni ripetuta ta' dożi multipli kuljum tal-ġell Panretin sa mhux aktar minn 60 ġimgħa.
English: Patients with renal or hepatic impairment
Maltese: Pażjenti b'indeboliment renali u epatiku
English: Other medicines and Panretin
Maltese: Mediċini oħra u Panterin
English: Table 3 Adverse reactions reported in patients in clinical trials
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati fil-pazjenti waqt il-provi kliniċi Sistema tal-Klassifika tal-Organi (Terminoloġija
English: There were no biologically relevant haematology differences or serum chemistry differences after the 14-day period.
Maltese: Ma kienx hemm differenzi ematoloġiċi bijoloġikament rilevanti jew differenzi fil-kimika tas-serum wara l-perjodu ta' 14-il jum.
English: In contrast to these findings in rats, plasma concentrations of 9-cis-retinoic acid in patients with KS applying Panretin gel never exceeded 0.638 ng/ml (2.13 nMol).
Maltese: B'kuntrast ma' dawn is-sejbiet fil-firien, il-konċentrazzjonijiet ta' 9-cis-retinoic acid fil-plażma ta' pazjenti b'KS li applikaw il-ġell Panretin qatt ma qabżu l-0.638 ng/ml (2.13 nMol).
English: lips, vagina, tip of the penis, rectum, or anus.
Maltese: il-ħalq, ix-xufftejn, il-vaġina, il-ponta tal-pene, ir-rektum, jew l-anus.
English: In cell-based in vitro assays, alitretinoin showed weak phototoxic potential.
Maltese: F'assaġġi bbażati fuq ċelluli in vitro, alitretinoin wera potenzjal fototossiku dgħajjef.
English: Skin ulcer, Serous drainage, Exfoliative dermatitis (flaking, peeling, desquamation, exfoliation), Skin discoloration (brown discoloration, surrounding hyperpigmentation, paler), Dry skin
Maltese: Ulċera fil-ġilda, Ħruġ ta' likwidu qisu serum, Dermatite bil-qxur (qxur irqiq li jitfarfar, tqaxxir, jitqaxxru qxur qxur, jaqgħu qxur qxur), Tibdil fil-kulur tal-ġilda (tibdil f'kulur kannella, iperpigmentazzjoni tal-ġilda tal-madwar, ġilda pallida), Ġilda xotta
English: Swollen lymph glands
Maltese: OĦRA, JEKK MEĦTIEĠA
English: 1 = Mild
Maltese: 1 = Ħafifa
English: Panretin is used in patients with AIDS-related Kaposi's sarcoma (KS) and is for the treatment of the KS lesions: - that are on the skin only - which have not responded to your HIV treatment - where the skin or lesion is not broken - where the surrounding skin is not swollen - if your doctor thinks that other treatments are not suitable for you.
Maltese: Panretin jintuża f'pazjenti li għandhom sarkoma ta' Kaposi (Kaposi's sarcoma - KS) marbuta mal-AIDS u hu għall-kura ta' leżjonijiet ta' KS: - li jkunu fuq il-ġilda biss - li ma rrispondewx għall-kura tiegħek kontra l-HIV - fejn il-ġilda jew il-leżjoni ma tkunx maqsuma - fejn il-ġilda tal-madwar ma tkunx minfuħa - jekk it-tabib tiegħek jaħseb li kuri oħrajn mhumiex adattati għalik.
English: Genotoxicity
Maltese: Teratoġeniċità
English: It is recommended that HIV-infected mothers do not breast-feed their children to exclude the risk of transmission of the virus.
Maltese: Hu rakkomandat li ommijiet infettati bl-HIV ma jreddgħux lil uliedhom biex jeskludu r-riskju li jgħaddulhom il-virus.
English: The side effects are most likely to appear at the site where Panretin was applied and typically begins as redness.
Maltese: L-effetti sekondarji huma l-aktar probabbli li jidhru fis-sit fejn Panretin ikun ġie applikat, u normalment jibdew bħala ħmura.
English: Infection, including bacterial infection
Maltese: Infezzjoni, li tinkludi infezzjoni batterjali
English: The dermal toxicity typically begins as erythema; with continued application of Panretin gel erythema may increase and oedema may develop.
Maltese: It-tossiċità fil-ġilda normalment tibda bħala eritema; jekk il-ġell Panretin ikompli jintuża, l-eritema tista' tiżdied u l-edima tista' tiżviluppa.
English: Safety and effectiveness in women have not been established because of the paucity of clinical data.
Maltese: Is-sigurtà u l-effettività fin-nisa għadhom ma ġewx determinati s'issa minħabba n-nuqqas ta' tagħrif kliniku.