FrancophonIA/ELRC3.0 huggingface dataset:
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli followed by conjugation with polyethylene glycol (PEG) It belongs to a group of proteins called cytokines.
Maltese: Coli segwit b'konjugazzjoni bi polyethylene glycol (PEG). Jappartjeni għal grupp ta' proteini msejħa ċitokini.
English: FIGURE 11
Maltese: FIGURA 11
English: For more information, see section 5.1 Excipient with known effect
Maltese: Għal aktar informazzjoni, are sezzjoni 5.1 Eċċipjent b'effett magħruf
English: FIGURE 6
Maltese: FIGURA 6
English: FIGURE 3
Maltese: FIGURA 3
English: FIGURE 10
Maltese: FIGURA 10
English: FIGURE 4
Maltese: FIGURA 4
English: • have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)
Maltese: • jekk inti reċentement kellek infezzjoni serja tal-pulmun (pnewmonja), fluwidu fil-pulmuni (edima pulmonari) , infjammazzjoni tal-pulmun (marda tal-interstizju tal-pulmun ), jew x-ray mhux normali tas-sider (infiltrazzjoni fil-pulmun)
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Maltese: Profil tal-konċentrazzjoni medjana ta' pegfilgrastim fis-serum u l-għadd assolut ta' newtrofili (ANC - Absolute Neutrophil Count) f'pazjenti ttrattati b'kimoterapija wara injezzjoni waħda ta' 6 mg
English: - The other ingredients are acetic acid and sodium acetate (for pH adjustment), sorbitol (E420),
Maltese: - Is-sustanzi l-oħra huma acetic acid u sodium acetate, (għal aġġustament pH), sorbitol (E420),
English: Sodium acetate trihydrate (for pH adjustment) Acetic acid (for pH adjustment) Sorbitol (E420)
Maltese: Sodium acetate trihydrate (għal aġġustament pH)
English: Solution for injection in pre-filled syringe (0.6 ml).
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (0.6 ml).
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Maltese: Pazjenti li jiżviluppaw sintomi ta' sindrome ta' tnixxija tal-kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu trattament sintomatiku standard, li jista' jinkludi ħtieġa ta' kura intensiva (ara sezzjoni 4.8).
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa pazjent wieħed minn kull 1,000 persuna)
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Maltese: Żidiet mhux komuni fit-testijiet tal-funzjoni tal-fwied (LFTs - liver function tests) għal ALT (alanine aminotransferase jew AST f'aspartate aminotransferase ), ġew osservati f'pazjenti wara li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
English: (acute febrile dermatosis)1,2;
Maltese: Sindrome ta' Sweet (dermatożi akuta biddeni)1,2;
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Maltese: Dan jista' jkun sinjal ta' Sindrome ta' Distress Respiratorju Akut (ARDS - Acute Respiratory Distress Syndrome)
English: Human G-CSF is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il- G-CSF uman huwa glikoproteina li tirregola il-produzzjoni u r-reħa ta' newtrofili mill-mudullun.
English: • bone pain.
Maltese: • ftuq tal-.
English: • Thighs
Maltese: • Koxox
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: G-CSF jista' jippromwovi it-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jiġu osservati fuq xi ċelluli mhux majelojdi in vitro.
English: • have sickle cell anaemia.
Maltese: • jekk inti għandek anemija taċ-ċellula sickle.
English: This will ensure you have received the full dose (see Figure 15).
Maltese: Dan jiżgura li tkun ħadt id-doża kollha (ara Figura 15).
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-met-Hu-G-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Maltese: Pegfilgrastim huwa magħmul minn G-CSF rikombinanti uman (r-met-Hu-G-CSF) marbut b'rabta kovalenti ma' molekola waħda ta' polyethylene glycol (PEG) ta' 20 kd. Pegfilgrastim huwa forma ta' filgrastim li jdum aktar fil-ġisem minħabba li t-tneħħija mill-kliewi hija mnaqqsa.
English: In a second study (n = 310), which used a weight-adjusted dose (100 μg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
Maltese: Fi studju ieħor (n = 310), fejn intużat doża maħduma skont il-piż (100 μg//kg), iddewmien medju tan-newtropenija ta' grad 4 għall-grupp b'pegfilgrastim kienet ta' 1.7 ijiem, imqabbel ma' 1.8 ijiem fil-grupp ta' filgrastim (differenza ta' 0.03 ijiem, CI ta' 95% -0.36, 0.30).
English: UDENYCA contains sorbitol (E420) and sodium acetate UDENYCA contains sorbitol (a type of sugar).
Maltese: UDENYCA fih sorbitol (E420) u sodium acetate.
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Maltese: Reazzjonijiet avversi relatati mal-pulmun (pulmonite tal-interstizju, edima fil-pulmun, infiltrati fil-pulmun u fibrosi filpulmun) Haemoptysis
English: With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Maltese: ta' riskju għoli li kienu qed jirċievu 100 μg /kg pegfilgrastim wara li temmew doxorubicin/docetaxel (ara sezzjonijiet 4.8 u 5.1).
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Maltese: F'żewġ studji randomised, double-blind, ewlenin, f'pazjenti b'kanċer tas-sider ta' riskju għoli ta' stadju II-IV li kienu qed jingħataw kimoterapija majelosoppressiva li tikkonsisti minn doxorubicin u docetaxel, l-użu ta' pegfilgrastim, bħala doża waħda f'kull ċiklu, naqqset id-dewmien tannewtropenija u l-inċidenza ta' newtropenija bid-deni b'mod simili għal dak osservat bl-għoti ta' kuljum ta' filgrastim (medjan ta' 11-il għoti kuljum).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċinihttp://www.ema.europa.eu.
English: Thrombocytopenia1 Leukocytosis1
Maltese: Uġigħ fis-sit talinjezzjoni1
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in
Maltese: U MNEJN GĦANDU JINGĦATA UDENYCA 6 mg pegfilgrastim
English: Pegfilgrastim is injected subcutaneously.
Maltese: Pegfilgrastim huwa injettat taħt il-ġilda.
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1).
Maltese: Data klinika limitata tissuġġerixxi li l-effett fuq il-ħin biex tirkupra minn newtropenija severa f'pazjenti li reġgħet qabdithom lewkimja majelojde akuta (acute myeloid leukaemia) mill-ġdid, huwa komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5.1).
English: • damage to the tiny filters inside your kidneys (glomerulonephritis)
Maltese: • ħsara lill-filtri ċkejkna ġewwa l-kliewi tiegħek (glomerulonefrite)
English: 2 Allow medicine to reach room temperature and gather supplies.
Maltese: 2 Ħalli l-mediċina tilħaq temperatura ambjentali u iġbor il-provvisti.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Maltese: B'mod mhux komuni, każijiet irriżultaw f'insuffiċjenza respiratorja jew Sindrome ta' Diffikultà Respiratorja Akuta (ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: 8 Position fingers.
Maltese: 8 Pożizzjoni tas-swaba'.
English: What UDENYCA looks like and contents of the pack UDENYCA is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Maltese: Kif jidher UDENYCA u l-kontenut tal-pakkett UDENYCA huwa soluzzjoni ċara u bla kulur, għall-injezzjoni ġo siringa mimlija għal-lest (6 mg/0.6 ml).
English: Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Maltese: Uġigħ muskoluskeletriku (majalġja, artralġja, uġigħ flestremitajiet, uġigħ fid-dahar, uġigħ muskoluskeletriku, uġigħ flgħonq)
English: There is insufficient information on the excretion of pegfilgrastim/ metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Maltese: M'hemmx informazzjoni suffiċjenti dwar l-eliminazzjoni ta' pegfilgrastim/metaboliti fil-ħalib tassider tal-bniedem, u riskju għat-trabi ta' twelid/trabi ma jistax jiġi eskluż.
English: Clean the injection site with an alcohol swab (see Figure 9).
Maltese: Naddaf is-sit tal-injezzjoni bi swab bl-alkoħol (ara Figura 9).
English: The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%,-1.1%).
Maltese: Ir-rata totali ta' newtropenija bid-deni kienet ta' 9% tal-pazjenti ttrattati b'pegfilgrastim u 18% tal-pazjenti ttrattati b'filgrastim (differenza ta' 9%, CI ta' 95% ta' -16.
English: 11 Dispose of syringe and treat injection site.
Maltese: 11 Armi s-siringa u kkura s-sit tal-injezzjoni.
English: UDENYCA 6 mg solution for injection in pre-filled syringe pegfilgrastim
Maltese: UDENYCA 6 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Pegfilgrastim
English: Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon in cancer patients undergoing chemotherapy following administration of G-CSFs; see section 4.4 and section “Description of selected adverse reactions” below.
Maltese: Sindrome ta' Tnixxija tal-Kapillari, li tista' tkun ta' periklu għall-ħajja jekk it-trattament ikun ittardjat, ġie irrappurtat bħala mhux komuni f'pazjenti bil-kanċer waqt il-kimoterapija wara l-għoti ta' G-CSFs; ara sezzjoni 4.4 u s-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt.
English: NAME OF THE MEDICINAL PRODUCT UDENYCA 6 mg solution for injection in pre-filled syringe pegfilgrastim
Maltese: TAL-PRODOTT MEDIĊINALI UDENYCA 6 mg soluzzjoni għall-injezzjoni mimlija għal-lest pegfilgrastim
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon).
Maltese: Reazzjonijiet tat-tip ta' sensittività eċċessiva, inkluż raxx tal-ġilda, urtikarja, anġjoedima, qtugħ ta' nifs, eritema, fwawar u pressjoni baxxa seħħew mal-ewwel trattament jew ma' trattament sussegwenti b'pegfilgrastim (mhux komuni).
English: In an open label, single dose study (n = 31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Maltese: (n = 31), diversi stadji ta' indeboliment tal-kliewi, inkluż marda tal-kliewi tal-aħħar stadju, ma kellhom l-ebda impatt fuq il-farmakokinetika ta' pegfilgrastim.
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 yrs (75%) compared to older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see sections 4.8 and 5.2).
Maltese: Barra dan kienet osservata inċidenza ogħla ta' newtropenija bid-deni fi tfal iżgħar b'età ta' 0-5 snin (75%) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (70% u 33%, rispettivament) u ma' adulti (ara sezzjonijiet 4.8 u 5.2).
English: These measures will help to protect the environment.
Maltese: UDENYCA ma ġiex ittestjat f'nisa tqal.
English: FIGURE 1 B: Open the carton and remove the sealed syringe tray (see Figure 2).
Maltese: FIGURA 1 B: Iftaħ il-pakkett u neħħi l-pjanċa ssiġillata tas-siringa (ara Figura 2).
English: • breathing problems.
Maltese: Respiratory Distress Syndrome).
English: Hypersensitivity to the active substance or to any of the excipients.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim * in 0.6 ml solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim* f'0.6 mL ta' soluzzjoni għall-injezzjoni.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Maltese: Fiprovi kliniċi, pegfilgrastim ingħata b'mod sikur 14-il jum qabel il-kimoterapija.
English: Prepare the injection
Maltese: Preparazzjoni għall-injezzjoni
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Bidu ta' sinjali pulmonari bħal sogħla, deni u qtugħ ta' nifs flimkien ma' sinjali radjuloġiċi ta' infiltrati fil-pulmun, u deterjorazzjoni tal-funzjoni tal-pulmun flimkien ma' żieda fl-għadd ta' newtrofili jistgħu jkunu sinjali tal-bidu tas-Sindrome ta' Tbatija Respiratorja Akuta (ARDS - Acute
English: B: Gather the following supplies (see Figure 4).
Maltese: B: Iġbor il-provvisti li ġejjin (ara Figura 4).
English: Storage information Store the pre-filled syringes in the refrigerator between 2° to 8° C in its original carton.
Maltese: Informazzjoni dwar il-ħżin Aħżen is-siringi mimlijin għal-lest fil-friġġ bejn 2° sa 8° C fil-pakkett oriġinali tagħhom.
English: • experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin
Maltese: • jekk inti jkollok reazzjoni allerġika inkluż indeboliment, tbaxxija tal-pressjoni tad-demm, diffikultà biex tieħu n-nifs, nefħa fil-wiċċ (anafilassi) , ħmura u fwawar, raxx tal-ġilda ħakk filġilda.
English: UDENYCA may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Maltese: UDENYCA jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) għal perjodu wieħed ta' massimu ta' 72 siegħa.
English: FIGURE 17 DO NOT throw away loose needles and syringes in your household waste.
Maltese: FIGURA 17 TARMIX labar u siringi separati fiż-żibel tad-dar tiegħek.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fi studji fuq lannimali, l-għoti ta' pegfilgrastim flimkien ma' 5-fluorouracil (5- FU) jew anti-metaboliti oħra intwera li jżid il-majelosoppressjoni.
English: If you experience a loss of response or decrease in response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Maltese: Jekk ikollok telf ta' rispons jew tnaqqis fir-rispons bi trattament ta' pegfilgrastim, it-tabib tiegħek se jinvestiga r-raġunijiet għaliex, inkluż jekk żviluppajtx antikorpi li jinnewtralizzaw l-attività ta' pegfilgrastim.
English: Pull the needle cap straight off (see Figure 10).
Maltese: Neħħi t-tapp tal-labra mill-ewwel (ara Figura 10).
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Maltese: Wara doża waħda ta' pegfilgrastim taħt il-ġilda, l-ogħla konċentrazzjoni ta' pegfilgrastim fis-serum tintlaħaq minn 16 sa 120 siegħa wara d-dożaġġ u l-konċentrazzjonijiet fis-serum ta' pegfilgrastim jinżammu tul il-perjodu ta' newtropenija wara kimoterapija majelosoppressiva.
English: Single doses of 300 µg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Maltese: Dożi singoli ta' 300 µg /kg ġew mogħtija taħt il-ġilda lil numru limitat ta' voluntiera f'saħħithom u pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun mingħajr reazzjonijiet avversi serji.
English: musculo-skeletal pain, neck pain)
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: • increased spleen size
Maltese: GĦAMLA KWALITATTIVA
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Maltese: • Infjammazzjoni tal-aorta (l-arterja l-kbira li ġġorr id-demm mill-qalb għall-ġisem) rari ġiet irraportata f'pazjenti bil-kanċer u donaturi b'saħħithom.
English: 14 tablets 60 tablets 120 tablets
Maltese: 14-il pillola 60 pillola 120 pillola
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 26 August 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 30 Novembru, 2009 Data tal-aħħar tiġdid: Awissu 26, 2014
English: EU/1/09/598/001 EU/1/09/598/002 EU/1/09/598/003 EU/1/09/598/004 EU/1/09/598/005 EU/1/09/598/006
Maltese: EU/1/09/598/001 EU/1/09/598/002 EU/1/09/598/003 EU/1/09/598/004
English: Metabolite 14-OH clarithromycin
Maltese: 14-OH clarithromycin
English: Sodium starch glycolate (Type A) Colloidal silicon dioxide Magnesium stearate
Maltese: Sodium starch glycolate (Tip A), Colloidal silicon dioxide Magnesium stearate.
English: In the multinational 2NN study, a population pharmacokinetic substudy of 1,077 patients was performed that included 391 females.
Maltese: Fl-istudju multinazzjonali 2NN, sar sottostudju farmakokinetiku ta' popolazzjoni ta'1,077 pazjent li kien jinkludi 391 mara.
English: Microcrystalline cellulose Lactose (as monohydrate) Povidone K25
Maltese: Microcrystalline cellulose, Lactose monohydrate, Povidone K25,
English: No clinical data available.
Maltese: L-ebda dejta klinika mhi disponibbli.
English: White opaque PVC/PE/PVdC - Aluminium blisters or OPA/Alu/PVC - Aluminium blisters.
Maltese: Strixxi opaki tal-PVC/PE/PVdC - aluminju jew folji ta' OPA/Alu/PVC - aluminju.
English: ANTIVIRALS FOR CHRONIC HEPATITIS B AND C
Maltese: ANTIVIRALI GĦAL EPATITE B U Ċ KRONIKA
English: Depotmedroxyprogesterone acetate (DMPA) 150 mg every 3 months
Maltese: Depotmedroxyprogesterone acetate (DMPA) 150 mg kull 3 xhur
English: Frequency is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Il-frekwenza hija mfissra permezz tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000) rari ħafna (<1/10,000).
English: The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Maltese: L-analiżi konsolidata ta' protokolli 245, 356, 366, 377, u 403 tal-Paediatric AIDS Clinical Trials
English: Stavudine: 30/40 mg BID
Maltese: 30/40 mg BID
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate, povidone K25, sodium starch glycolate (Type A), colloidal silicon dioxide and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, lactose monohydrate, povidone K25, sodium starch glycolate (Tip A), colloidal silicon dioxide u magnesium stearate.
English: Nevirapine metabolites: Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/sulfamethoxazole.
Maltese: metaboliti hydroxylated ta' nevirapine ma kinux affettwati bil-preżenza ta' dapsone, rifabutin, rifampicin, u trimethoprim/sulfamethoxazole.
English: Nevirapine Teva tablets are supplied in blisters, with 14 (Calendar Pack), 60 or 120 tablets per carton.
Maltese: Il-pilloli Nevirapine Teva jiġu f'folji, b'14 (Pakkett bil-kalendarju), 60 jew 120 pillola f'kull kartuna.
English: Nevirapine: there was no significant difference in nevirapine pharmacokinetic parameters.
Maltese: Nevirapine: ma kienx hemm differenza sinifikanti fil-parametri farmakokinetiċi ta' Nevirapine.
English: One side is debossed with "N", a scoreline and "200".
Maltese: Fuq naħa minnhom hemm intaljat “N”, sinjal imnaqqax u “200”.
English: - St John's Wort (Hypericum perforatum, medicine to treat depression) - rifampicin (medicine to treat tuberculosis) - rifabutin (medicine to treat tuberculosis) - macrolides e.g. clarithromycin (medicine to treat bacterial infections) - fluconazole (medicine to treat fungal infections) - ketoconazole (medicine to treat fungal infections) - itraconazole (medicine to treat fungal infections) - methadone (medicine used for treatment of opiate addicts) - warfarin (medicine to reduce blood clotting) - hormonal contraceptives (e.g. the “pill”) - atazanavir (another medicine to treat HIV-infection) - lopinavir/ritonavir (another medicine to treat HIV-infection) - fosamprenavir (another medicine to treat HIV-infection) - efavirenz (another medicine to treat HIV-infection) - etravirine (another medicine to treat HIV-infection) - rilpivirine (another medicine to treat HIV-infection) - delavirdine (another medicine to treat HIV-infection) - zidovudine (another medicine to treat HIV-infection) - boceprevir (medicine to treat hepatitis C) - telaprevir (medicine to treat hepatitis C) - elvitegravir/cobicistat (another medicine to treat HIV-infection)
Maltese: - itraconazole (mediċina li tikkura l-infezzjonijiet fungali) - methadone (mediċina użata biex tikkura 'l persuni viżjati bil-loppji) - warfarin (mediċina li tnaqqas li jsiru emboli tad-demm) - kontraċettivi ormonali (eż. il-“pill”) - atazanavir (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - lopinavir/ritonavir (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - fosamprenavir (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - efavirenz (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - etravirine (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - rilpivirine (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - delavirdine (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - zidovudine (mediċina oħra għall-kura ta' infezzjoni bl-HIV) - boceprevir (mediċina li tikkura l-epatite Ċ) - telaprevir (mediċina li tikkura l-epatite Ċ) - elvitegravir/cobicistat (mediċina oħra li tikkura infezzjoni bl-HIV)
English: ANTI-INFECTIVES Antiretrovirals
Maltese: Antiretrovirali
English: In an open-label clinical study (ACTG 180) granulocytopenia assessed as medicinal product-related occurred in 5/37 (13.5 %) of patients.
Maltese: Fi studju kliniku b'tikketta tidher (ACTG 180) granuloċitopenija assessjata bħala relatata mal-prodott mediċinali seħħet f'5/37 (13.5%) pazjent.
English: If a patient is already taking St. John‘s Wort check nevirapine and if possible viral levels and stop St John‘s Wort.
Maltese: John's Wort, iċċekkja l livell ta' nevirapine u jekk possibbli llivelli virali u waqqaf St John's Wort.
English: Nevirapine is about 60 % bound to plasma proteins in the plasma concentration range of 1-10 μg/ml.
Maltese: Madwar 60% tan-nevirapine jeħel malproteini tal-plażma b'konċentrazzjoni fil-plażma minn 1 - 10 µg/ml.