FrancophonIA/ELRC3.0 huggingface dataset:
English: • discomfort or itching in the vulva and vagina
Maltese: • skumdità jew ħakk fil-vulva u l-vaġina
English: Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic medicinal products class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).
Maltese: Ma twettqux studji ta' interazzjoni speċifiċi mal-prodotti mediċinali lidocaine/prilocaine u kontra larritmija tal-klassi III (eż. amiodarone), iżda hija rrakkomandata kawtela (ara wkoll sezzjoni 4.4).
English: Fortacin may reduce the possibility of pregnancy, but is not a reliable contraceptive.
Maltese: Fortacin jista' jnaqqas il-possibbiltà li tinqabad tqila, iżda mhuwiex kontraċettiv affidabbli.
English: No 2,6-xylidine or o-toluidine was detectable at any time-point in vaginal fluids following local application of the medicinal product in female volunteers.
Maltese: Ma ġie identifikat l-ebda 2,6-xylidine jew o-toluidine fi kwalunkwe punt ta' ħin fil-fluwidi vaġinali wara l-applikazzjoni lokali tal-prodott mediċinali fil-voluntiera nisa.
English: Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Maltese: Fortacin 150 mg/mL + 50 mg/mL sprej għall-ġilda, soluzzjoni lidocaine/prilocaine
English: The terminal elimination half-life of lidocaine from the plasma following intravenous administration is approximately 65 - 150 minutes and the systemic clearance is 10 - 20 mL/min/kg.
Maltese: 65 - 150 minuta u t-tneħħija sistemika hija ta' 10 - 20 mL/min/kg.
English: Following intravenous administration, the steady state volume of distribution of prilocaine is 0.7 to 4.4 L/kg.
Maltese: Wara l-għoti ġol-vina, il-volum fi stat stabbli ta' distribuzzjoni ta' prilocaine huwa ta' 0.7-4.4
English: First pass metabolism is rapid and extensive and bioavailability is about 35% after oral doses.
Maltese: Il-metaboliżmu first pass huwa rapidu u estensiv filwaqt li l bijodisponibbiltà hija madwar 35% wara d-dożi orali.
English: Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution
Maltese: Fortacin 150 mg/mL + 50 mg/mL sprejgħall-ġilda, soluzzjoni
English: • Nitrofurantoin - an antibiotic used to treat urinary and kidney infections
Maltese: • Nitrofurantoin - antibijotiku li jintuża biex jittratta infezzjonijiet urinarji u fil-kliewi
English: Uncommon Abnormal orgasm
Maltese: Orgażmu anormali
English: • Para-aminosalicylic acid (PAS) - used to treat tuberculosis
Maltese: • Aċidu para-Aminosalicylic (PAS) - li jintuża biex jittrattaw t-tuberkulożi
English: There is limited data on the efficacy and safety of Fortacin in patients 65 years and over.
Maltese: Hemm data limitata dwar l-effikaċja u s-sigurtà ta' Fortacin f'pazjenti li għandhom 65 sena jew aktar.
English: The metabolism of lidocaine and prilocaine results in the formation of 2,6-xylidine and o-toluidine, respectively, amongst other metabolites.
Maltese: Il-metaboliżmu ta' lidocaine u prilocaine jwassal għall-formazzjoni ta' 2,6-xylidine u o-toluidine,
English: The plasma levels of lidocaine and prilocaine in male and female subjects were below the level associated with toxicity (5,000 ng/ml).
Maltese: Il-livelli ta' plażma ta' lidocaine u prilocaine fis-suġġetti rġiel u nisa kienu taħt il-livell assoċjat ma' tossiċità (5000 ng/mL).
English: Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine.
Maltese: Kull mL ta' soluzzjoni fih 150 mg lidocaine u 50 mg prilocaine.
English: 85.2% of subjects in the Fortacin group achieved a mean IELT of > 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute.
Maltese: 85.2% tas-suġġetti fil-grupp ta' Fortacin laħqu medja ta' IELT ta' > minuta matul il-kors ta' 3 xhur ta' trattament bih, filwaqt li 46.4% tas-suġġetti tal-plaċebo kellhom medja ta' IELT ta' > minuta. 66.2% ta' Fortacin tas-suġġetti ttrattati u 18.8% tas-suġġetti ttrattati bil-plaċebo laħqu medja ta' IELT > 2 minuti.
English: (methaemoglobinaemia).
Maltese: anemija jew methaemoglobinaemia);
English: Hypersensitivities
Maltese: Ipersensittivitajiet
English: Other medicines and Fortacin
Maltese: Mediċini oħra u Fortacin
English: Fortacin is indicated for the treatment of primary premature ejaculation in adult men.
Maltese: Fortacin huwa indikat għat-trattament ta' eġakulazzjoni prematura primarja fl-irġiel adulti.
English: The active substances lidocaine and prilocaine block the transmission of nerve impulses in the glans penis, reducing the sensitivity of the glans penis.
Maltese: Is-sustanzi attiva lidocaine u prilocaine jimblukkaw it-trażmissjoni tal-impulsi tan-nervituri fil-pene glans, u jnaqqsu s-sensittività tal-pene glans.
English: • Sulphonamides (also called sulpha medicines) e.g. sulfamethoxazole - an antibiotic used to treat urinary infections, and sulfasalazine - used to treat Crohn's disease, ulcerative colitis and rheumatoid arthritis
Maltese: • Sulphonamides (imsejħa wkoll mediċini sulpha) eż. sulfamethoxazole - antibjotiku li jintuża biex jiġu ttrattati infezzjonijiet fis-sistema urinarja, u sulfasalazine - li jintuża biex jittratta lmarda ta' Crohn, il-kolite ulċerattiva u l-artrite idjopatika
English: • difficulty or pain passing urine
Maltese: • sensazzjoni mnaqqsa fil-vaġina u madwarha
English: • Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrate and nitrite medicines - used to treat angina (chest pain caused by the heart)
Maltese: • Metoclopramide - li jintuża biex jittratta sintomi ta' mard (dardir) u rimettar, inkluż f'pazjenti bl-emigranja • Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate,
English: Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
Maltese: Kull attwazzjoni tagħti 50 mikrolitru li fih 7.5 mg lidocaine u 2.5 mg prilocaine.
English: The steady-state volume of distribution is 1.1 to 2.1 L/kg after intravenous administration.
Maltese: Il-volum fi stat fiss ta' distribuzzjoni wara l-għoti ta' mikrodoża ġol-vina huwa ta' 1.1 sa 2.1 L/kg.
English: Note, this dose did result in tumours.
Maltese: rispettivament, fost metaboliti oħra.
English: - The other ingredient is norflurane
Maltese: - Is-sustanza l-oħra hija norflurane
English: Male volunteers had maximum plasma concentrations of lidocaine which were less than 4% of toxic levels, and prilocaine which were less than 0.4% of toxic levels, after repeat dosing.
Maltese: Il-voluntiera rġiel kellhom konċentrazzjonijiet massimi fil-plażma ta' lidocaine li kienu anqas minn 4% tal-livelli tossiċi, u ta' prilocaine li kienu anqas minn 4% tal-livelli tossiċi, wara dożaġġ ripetut.
English: The risk of additional systemic toxicity should be considered when large doses of Fortacin are applied to patients already using other local anaesthetics or structurally related medicinal products, e.g. class I anti-arrhythmics such as mexiletine.
Maltese: Ir-riskju ta' tossiċità sistemika addizzjonali għandu jiġi kkunsidrat meta dożi kbar ta' Fortacin jiġu applikati lill-pazjenti li jkunu diġà qed jużaw anestetiċi lokali jew prodotti mediċinali oħra relatati strutturalment, eż. anti-arritmiċi tal-klassi I bħal mexiletine.
English: In vitro interaction studies with topical antifungal (clotrimazole, econazole, imidazole, nystatin, miconazole, ketoconazole), antibacterial (clindamycin, metronidazole) and antiviral medicinal products (acyclovir), showed no effect on antimicrobial activity.
Maltese: miconazole, ketoconazole), il-prodotti mediċinali antibatteriċi (clindamycin, metronidazole) u antivirali
English: Tel: + 34 91 659 15 50
Maltese: Casen Recordati, S.L. Tel: + 34 91 659 15 50
English: The most frequent adverse reactions reported with the use of this medicinal product in female partners were vulvovaginal burning sensation (3.9%), and genital hypoaesthesia (1.0%).
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti rrapportati bl-użu ta' dan il-prodott mediċinali f'pazjenti nisa kienu sensazzjoni ta' ħruq vulvovaġinali (3.9%) u ipoesteżija ġenitali (4.4%).
English: • Sodium nitroprusside, isosorbide dinitrate - used to treat high blood pressure and heart failure
Maltese: • Sodium nitroprusside, isosorbide dinitrate - li jintużaw biex tiġi ttrattata pressjoni tad-demm għolja u insuffiċjenza tal-qalb
English: Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain, vulvovaginal pruritus
Maltese: Sensazzjoni ta' ħruq vulvovaġinali, ipoesteżija
English: Each dose consists of a total of 22.5 mg lidocaine and 7.5 mg prilocaine per application (1 dose is equal to 3 actuations).
Maltese: Kull doża tikkonsisti minn total ta' 22.5 mg lidocaine u 7.5 mg prilocaine għal kull applikazzjoni (doża waħda hija ugwali għal 3 attwazzjonijiet).
English: Genotoxicity and carcinogenicity
Maltese: Ġenotossiċità u karċinoġeniċità
English: • Inability to develop or maintain an erection
Maltese: • Inkapaċità li tiġi żviluppata jew tinżamm erezzjoni
English: Human exposure is 1000 fold less than than the minimum dose studied.
Maltese: L-esponiment tal-bniedem huwa 1000 darba anqas mid-doża minima studjata.
English: In carcinogenicity studies of o-toluidine in rats, mice and hamsters, tumours were observed in several organs.
Maltese: Fi studji tal-karċinoġenità ta' o-toluidine fil-firien, il-ġrieden u l-ħamsters, kienu osservati tumuri f'diversi organi.
English: Each container of 6.5 ml delivers a minimum of 20 doses.
Maltese: Kull kontenitur ta' 6.5 mL jagħti minimu ta' 20 doża.
English: Fortacin is only indicated for application to the glans penis.
Maltese: Fortacin huwa indikat biss għall-applikazzjoni fuq il-pene glans.
English: Uncommon Pyrexia
Maltese: taħt il-ġilda
English: Patients on anti-arrhythmic medicinal products class III (e.g. amiodarone) should be treated with caution.
Maltese: Pazjenti li jieħdu prodotti mediċinali kontra l-arritmija tal-klassi III (eż. amiodarone) għandhom jiġu ttrattati b'kawtela.
English: • vaginal thrush (Candida) infection
Maltese: • infezzjoni (Candida) tat-traxx tal-vaġina
English: Medicinal products that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given intravenously in repeated high doses over a long time period (30 hours).
Maltese: Il-prodotti mediċinali li jnaqqsu t-tneħħija ta' lidocaine (eż. cimetidine jew l-imblukkaturi beta) jistgħu jikkawżaw konċentrazzjonijiet potenzjalment tossiċi fil-plażma meta lidocaine jingħata ġol-vina f'dożi ripetuti għolja għal tul ta' ħin twil (30 siegħa).
English: Clinical trials have shown Fortacin to increase the intra-vaginal ejaculatory latency time (IELT), increase control over ejaculation and reduce the feelings of distress in patients with premature ejaculation as measured by the Index of Premature Ejaculation (IPE).
Maltese: Provi kliniċi wrew li Fortacin jżid l-ħin ta' latenza tal-eġakulazzjoni intra-vaġinali (IELT), iżid ilkontroll fuq l-eġakulazzjoni u jnaqqas is-sensazzjoni ta' skumdità f'pazjenti b'eġakulazzjoni prematura kif imkejjel mill-Indiċi tal-Eġakulazzjoni Prematura (IPE).
English: - Each spray container of 6.5 ml delivers a minimum of 20 doses.
Maltese: - Kull kontenitur tal-isprej ta' 6.5 mL jagħti minimu ta' 20 doża.
English: Uncommon Genital erythema, ejaculation failure, paraesthesia of male genital, penile pain, penis disorder, pruritus genital
Maltese: Eritema ġenitali, nuqqas ta' eġakulazzjoni, parasteżija tal ġenitali tal-irġiel, uġigħ fil-pene, disturb fil-pene, ħakk fil-ġenitali
English: The efficacy of Fortacin was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Maltese: L-effikaċja ta' Fortacin ntweriet f'żewġ studji kkontrollati tal-plaċebo, double-blind, każwali, multinazzjonal, multiċentrali, li t-tnejn kienu segwiti minn fażi b'tikketta miftuħa.
English: Each container of 5 ml delivers a minimum of 12 doses.
Maltese: Kull kontenitur ta' 5 mL jagħti minimu ta' 12-il doża.
English: Prilocaine crosses the blood-brain barrier and also crosses the placenta.
Maltese: Prilocaine jaqsam il-barriera tad-demm-moħħ u jaqsam ukoll il-plaċenta.
English: Contents of the pack and other information What Fortacin contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Fortacin
English: Caution is advised in case of severe hepatic impairment (see section 4.4).
Maltese: Hija rakkomandata kawtela fil-każ ta' indeboliment epatiku sever (ara sezzjoni 4.4).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In a carcinogenicity study of rats exposed to 2,6-xylidine in utero, postnatally and throughout their lifetime, tumours in the nasal cavity, subcutaneous tumours and liver tumours were observed.
Maltese: Fi studju tal-karċinoġenità tal-firien esposti għal 2,6-xylidine in utero, wara t-twelid u matul il-ħajja tagħhom, kienu osservati tumuri fil-kavità nasali, tumuri taħt il-ġilda u tumuri tal-fwied.
English: This hypoaesthesia may mask normal pain sensations and, therefore, increase the dangers of localised injury.
Maltese: Din l-ipoesteżija tista' taħbi sensazzjonijiet ta' wġigħ normali u, għalhekk, iżżid ir-riskju ta' korrimenti lokalizzati.
English: • local irritation of the throat (if inhaled)
Maltese: • irritazzjoni lokali tal-griżmejn (jekk jinxtamm)
English: Systemic exposure to lidocaine and prilocaine and their metabolites (respectively 2,6-xylidine and o-toluidine), is low following application to the glans penis in male patients and application to the cervix/vagina fornices in female subjects, at doses higher than recommended.
Maltese: L-esponiment sistemiku għal lidocaine u prilocaine u l-metaboliti tagħhom (rispettivament 2,6-xylidine u o-toluidine), huwa baxx wara l-applikazzjoni fuq il-pene glans fil-pazjenti rġiel u l-applikazzjoni fuq il-forniċi taċ-ċerviċi/vaġina fis-suġġetti nisa, b'dożi ogħla minn dawk irrakkomandati.
English: Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation
Maltese: Ipoesteżija tal-ġenitali tal-irġiel, disfunzjoni erettili, sensazzjoni ta' ħruq fil-ġenitali
English: Uncommon Throat irritation
Maltese: Irritazzjoni tal-ġilda
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Uncommon Headache
Maltese: Mhux Komuni
English: If you use Fortacin with condoms, you may be more likely to be unable to develop or maintain an erection.
Maltese: Jekk tuża Fortacin mal-kondoms, huwa aktar probabbli li ma tkunx tista' tiżviluppa jew iżżomm erezzjoni.
English: Each pack contains one spray container with 6.5 ml or 5 ml solution.
Maltese: Kull pakkett fih kontenitur tal-isprej wieħed b'6.5 mL jew 5 mL ta' soluzzjoni.
English: The following side effects have been reported with Fortacin in male patients:
Maltese: Dan huwa partikolarment importanti jekk tkun qed tieħu l-mediċini li ġejjin li jistgħu jinteraġġixxu ma' Fortacin:
English: - Each spray container of 5 ml delivers a minimum of 12 doses.
Maltese: - Kull kontenitur tal-isprej ta' 5 mL jagħti minimu ta' 12-il doża.
English: There is no relevant use of Fortacin in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Maltese: M'hemm l-ebda użu rilevanti ta' Fortacin fil-popolazzjoni pedjatrika għall-indikazzjoni tat-trattament tal-eġakulazzjoni prematura primarja fl-irġiel adulti.
English: Recordati Ireland Ltd. Tlf: + 353 21 4379400
Maltese: Tlf: + 353 21 4379400
English: Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Maltese: depressjoni kardjovaskulari u tas-sistema nervuża ċentrali.
English: For all of the three monthly assessments completed by the subjects, there was a significant difference between Fortacin and placebo (p < 0.0001).
Maltese: Għall kull waħda minn dawn it-tliet valutazzjonijiet ta' kull xahar imwettqa mis-suġġetti, kien hemm differenza sinifikanti bejn Fortacin u l-plaċebo (p < 0.0001).
English: Patients or their partner with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicinal product-induced methaemoglobinaemia (see section 4.5).
Maltese: Kondizzjonijiet relatati mal-anemija Il-pazjenti jew is-sieħeb/sieħba tagħhom b'defiċjenza ta' glucose-6-phosphate dehydrogenase jew methaemoglobinaemia konġenitali jew idjopatika huma aktar suxxettibbli għall-methaemoglobinaemia indotta mill-prodotti mediċinali (ara sezzjoni 4.5).
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: As Fortacin is applied topically to the glans penis the risk of overdose is low.
Maltese: Peress li Fortacin jiġi applikat topikament fuq il-pene glans, ir-riskju ta' doża eċċessiva huwa baxx.
English: Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products.
Maltese: Is-sintomi newroloġiċi severi (aċċessjonijiet, depressjoni CNS) għandhom jiġu ttrattati b'mod sintomatiku minn appoġġ respiratorju u l-għoti ta' prodotti mediċinali kontra l-aċċessjonijiet.
English: Deterioriation was observed when Fortacin was used with polyurethane-based female and male condoms (see section 4.4).
Maltese: Kienet osservata deterjorazzjoni meta Fortacin ntuża ma' kondoms tal-irġiel u n-nisa magħmulin mill polyurethane (ara sezzjoni 4.4).
English: If some medicine accidentally gets into your eyes or your partner's eyes, rinse them immediately with cold water or saline solution and cover them gently until any effects, such as numbness, wear off. Be aware that normal protective mechanisms, such as blinking, or sensation of a foreign body in the eye, may not occur until the numbness has worn off.
Maltese: Ma twettqux studji kliniċi f'pazjenti b'funzjoni renali indebolita, madankollu minħabba l-metodu ta' kif għandu jingħata u l-assorbiment sistemiku baxx ħafna tiegħu, ma huwa meħtieġ l-ebda aġġustament fid-dożaġġ.
English: Uncommon Skin irritation
Maltese: Irritazzjoni fil-griżmejn
English: The clinically significant increases in IELT were paralleled by significant differences in the IPE scores (p <0.0001).
Maltese: Kien hemm ukoll differenza sinifikanti mill-plaċebo fl oqsma kollha għar-risponsi mis-sieħba (p < 0.0001).
English: Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine Each spray container of 6.5 ml delivers a minimum of 20 doses Each spray container of 5 ml delivers a minimum of 12 doses
Maltese: Kull kontenitur tal-isprej ta' 6.5 mL jagħti minimu ta' 20 doża Kull kontenitur tal-isprej ta' 5 mL jagħti minimu ta' 12-il doża.
English: In a study of pregnant rats receiving a combination of lidocaine and prilocaine during organogenesis, no effects on embryonic/foetal development were observed.
Maltese: Fi studju tal-firien tqal li jirċievu kombinazzjoni ta' lidocaine u prilocaine matul l-organoġenesi, ma ġie osservat l-ebda effett fuq l-iżvilupp embrijoniku/fetali.
English: Female volunteers receiving repeated doses directly to the cervix and vagina of up to five times the recommended dose for the male partner, had maximum plasma levels of lidocaine which were less than 8% of toxic levels, and prilocaine which were less than 1% of toxic levels.
Maltese: Il-voluntiera nisa li rċevew dożi ripetuti direttament fiċ-ċerviċi u l-vaġina sa ħames darbiet aktar mid-doża rakkomandata għas-sieħeb raġel, kellhom livelli massimi fil-plażma ta' lidocaine li kienu anqas minn 8% tal-livelli tossiċi, u prilocaine li kienu anqas minn 1% tal-livelli tossiċi.
English: Medicinal products subject to medical prescription.
Maltese: U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Fortacin is indicated for the treatment of lifelong premature ejaculation in adult men.
Maltese: Fortacin huwa indikat għat-trattament ta' eġakulazzjoni prematura tul il-ħajja fl-irġiel adulti.
English: Fortacin sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear.
Maltese: Is-sintomi ta' meta Fortacin jintuża żżejjed huma elenkati hawn taħt.
English: - Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine - Each spray delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
Maltese: - Kull sprej jagħti 50 mikrolitru li fih 7.5 mg lidocaine u 2.5 mg prilocaine.
English: The recommended dose is 3 actuations applied to cover the glans penis.
Maltese: Id-doża rrakkomandata hija ta' 3 attwazzjonijiet applikati biex ikopru l-pene glans.
English: Any barrier contraceptives (e.g. male or female condom), which are made from polyurethane-based material cannot be guaranteed to protect against disease or pregnancy when you are also using Fortacin.
Maltese: Kwalunkwe kontraċettiv barriera (eż. kondom tal-irġiel jew tan-nisa) li huwa magħmul minn materjal ibbażat fuq il-polyurethane ma jistax jiggarantixxi li jipproteġi kontra mard jew tqala meta tkun qed tuża Fortacin wkoll.
English: Due to the risk of partner transfer, patients hoping to achieve conception should either avoid using Fortacin, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible 5 minutes after applying the spray but prior to intercourse (see section 4.6).
Maltese: Minħabba r-riskju ta' trasferiment għas-sieħba, il-pazjenti li jkunu qed jittamaw li jikkonċepixxu għandhom jevitaw li jużaw Fortacin, jew, jekk ikun essenzjali li jkun hemm penetrazzjoni, għandhom jaħslu l-pene glans kemm jista' jkun bir-reqqa 5 minuti wara l-applikazzjoni tal-isprej iżda qabel l-att sesswali (ara sezzjoni 4.6).
English: Patients should be advised to use alternative methods of contraception.
Maltese: Il-pazjenti għandhom jingħataw parir biex jużaw metodi alternattivi ta' kontraċezzjoni.
English: Adjusted mean change scores (Fortacin vs. placebo) at Month 3 were 8.2 vs. 2.2 for the ejaculatory control score, 7.2 vs. 1.9 for the sexual satisfaction score, and 3.7 vs. 1.1 for the distress score.
Maltese: 2.2 għall-punteġġ ta' kontroll tal-eġakulazzjoni, 7.2 vs.
English: • failure to ejaculate during sexual intercourse
Maltese: • nuqqas ta' eġakulazzjoni matul l-att sesswali • orgażmu anormali
English: Lidocaine can cross the blood brain barrier and the placenta and is distributed in breast milk.
Maltese: Lidocaine jista' jaqsam il-barriera tad-demm-moħħ u l-plaċenta u jiġi distribwit fil-ħalib tas-sider.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Fortacin should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.
Maltese: Il-pazjenti allerġiċi għad-derivattivi tal-aċidu paraaminobenzoic (procaine, tetracaine, benzocaine, eċċ) ma wrewx sensittività trasversali għal lidocaine u/jew prilocaine, madankollu, Fortacin għandu jintuża b'kawtela f'pazjenti bi storja (jew sieħeb/sieħba bi storja) ta' sensittivitajiet għal prodotti mediċinali, speċjalment jekk il-prodott mediċinali etijoloġiku mhuwiex ċert.
English: Recordati Ireland Ltd. Τηλ: + 353 21 4379400
Maltese: Τηλ: + 353 21 4379400
English: • pain in the vagina
Maltese: • uġigħ fil-vaġina
English: Do not use this medicine after the expiry date which is stated on the spray container label and the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq it-tikketta tal-kontenitur tal-isprej u lkartuna wara “JIS”.