FrancophonIA/ELRC3.0 huggingface dataset:
English: The Composite foil containing the following layers from outside to inside: coated Kraft paper, low density polyethylene foil, aluminium foil, Surlyn (thermoplastic ethylene-methacrylic acid copolymer).
Maltese: Il-fojl Composite huwa magħmul minn dawn is-saffi, minn barra għal ġewwa: karta Kraft miksija, fojl ta' polyethylene b'densita' baxxa, fojl ta' l-aluminju, Surlyn (thermoplastic ethylene-methacrylic acid copolymer).
English: Prolonged use of Fentanyl-ratiopharm can cause physical dependence.
Maltese: L-użu fit-tul ta' Fentanyl-ratiopharm jista' jirriżulta f'dipendenza fiżika.
English: Uncommon: exanthema, erythema.
Maltese: Mhux komuni: exantema, eritema
English: General disorders and administration site conditions Rare:
Maltese: Disturbi ġenerali u kundizzjonijiet fil-post tal-amministrazzjoni Rari:
English: Generalised acute allergic reactions with a fall in the blood pressure and/or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).
Maltese: Rejazzjonijiet allerġiċi ġenerali b'inżul fil-pressjoni tad-demm u/jew problemi fin-nifs (rejazzjonijiet anafilattiċi), ħsibijiet mhux normali, eċċitament eċċessiv, debbolezza, dipressjoni, ansjeta', confużjoni, funzjoni sesswali anormali, sintomi assoċjati malwaqfien tal-kura, problemi fil-koordinazzjoni, aċċessjonijiet (kemm tat-tip kloniku kif ukoll grand mal), vista mnaqqsa, indeboliment tas-sistema respiratorja (dipressjoni respiratorja), waqfien tas-sistema respiratorja (apneja), nefħa fl-istonku bl-uġigħ, blukkaġġ tas-sistema diġestiva, uġigħ fil-bużżieqa tal-awrina, produzzjoni mnaqqsa ta' awrina (eskrezzjoni mnaqqsa tal-awrina).
English: Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Maltese: Itraconazole (inibitur qawwi ta' CYP3A4) mogħti f'doża orali ta' 200 mg/ġurnata għal erbat ijiem ma' kellu ebda effett sinjifikanti fuq il-farmakokinetika ta' fentanyl mogħti minn ġol-vina.
English: Combination with barbituric acid derivatives, buprenorphine, nalbuphine and pentazocine should in general be avoided (see section 4.5).
Maltese: Bħala regola, l-użu kkombinat ma derivattivi ta' barbituric acid, buprenorphine, nalbuphine u pentazocine għandu jiġi evitat (ara sezzjoni 4.5)
English: Equianalgesic doses (mg)
Maltese: Doża li tipprovdi effett analġesiku ekwivalenti (mg)
English: WARNING:
Maltese: Manifattur:
English: ataxia, seizures (including clonic and grand mal seizures).
Maltese: ataxia, aċċessjonijiet, (kemm tat-tip kloniku kif ukoll grand mal).
English: Patients with myasthenia gravis
Maltese: Pazjenti b'majestenja gravis
English: Fentanyl-ratio 100µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 µg/uur United Kingdom Ribofen 100 microgram/hr Transdermal patch
Maltese: Fentanyl-ratio 100µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 µg/uur Ir-Renju Unit Ribofen 100 microgram/hr Transdermal patch
English: Fentanyl-ratiopharm should be administered with caution to patients with bradyarrhythmias.
Maltese: Fentanyl-ratiopharm irid jiġi amministrat bi prudenza f'pazjenti li jbatu minn bradiarritmija.
English: The obtained sum should be converted to correspond the oral morphine dosage using Table 1.
Maltese: It-total miksub għandu jiġi mibdul fid-doża ekwivalenti ta' morfina orali permezz ta' Tabella 1.
English: Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Maltese: Kull garża ta' 22.5 cm2 fiha 12.375 mg fentanyl.
English: Table 1: Equianalgesic potency conversion
Maltese: Tabella 1: Konverżjoni tad-doża li tipprovdi effett analġesiku ekwivalenti:
English: The major metabolite, norfentanyl, is inactive.
Maltese: Il-metabolit prinċipali, norfentanyl, m'huwiex attiv.
English: Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Maltese: Kull garża ta' 7.5 cm2 fiha 4.125 mg fentanyl.
English: Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Maltese: Għalhekk, it-treddiegħ irid jitwaqqaf waqt il-kura u sa mill-inqas 72 siegħa wara li titneħħa il-Fentanyl-ratiopharm (ara sezzjoni 4.4)
English: Each patch of 15 cm2 contains 8.25 mg fentanyl.
Maltese: Kull garża ta' 15 cm2 fiha 8.25 mg fentanyl.
English: Transdermal fentanyl release (micrograms/h)
Maltese: Irħir ta' fentanyl transdermali (mikrogramma/siegħa)
English: Each patch of 30 cm2 contains 16.5 mg fentanyl.
Maltese: Kull garża ta' 30 cm2 fiha 16.5 mg fentanyl.
English: Its principal therapeutic effects are analgesia and sedation.
Maltese: L-effetti prinċipali huma analġesija u sedazzjoni.
English: Fentanyl-ratio 75 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 µg/uur United Kingdom Ribofen 75 microgram/hr Transdermal patch
Maltese: Fentanyl-ratio 75 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 µg/uur Ir-Renju Unit Ribofen 75 microgram/hr Transdermal patch
English: Polyethylene terephthalate foil (siliconised)
Maltese: Fojl magħmul minn Polyethylene terephthalate (bis-silicone)
English: These medicines may increase the effects and side effects of Fentanyl-ratiopharm.
Maltese: Dawn il-mediċini jistgħu iżidu l-effetti kif ukoll l-effetti sekondarji ta'Fentanyl-ratiopharm.
English: An exception can be made if the doctor has expressly prescribed Fentanyl-ratiopharm.
Maltese: Tista' ssir eċċezzjoni meta t-tabib ikun ippreskriva espressivament Fentanyl-ratiopharm.
English: This applies, for example, to: - ritonavir (used to treat AIDS) - ketoconazole, itraconazole (used to treat fungal diseases) - diltiazem (used to treat heart disease) - cimetidine (used to treat gastrointestinal diseases) - macrolide antibiotics (used to treat infections)
Maltese: Dan japplika għal, per eżempju: - ritonavir (użat fil-kura tal-marda t'AIDS) - ketoconazole, itraconazole (użati għall-kura ta' infezzjonijiet tal-fungu) - diltiazem (użat għall-kura ta' mard fil-qalb) - cimetidine (użat għall-kura ta' mard gastro-intestinali)
English: Less than 10 % of fentanyl is excreted unchanged by the kidneys, and unlike morphine, there are no known active metabolites eliminated by the kidneys.
Maltese: Inqas minn 10 % ta' fentanyl jiġi eliminat bħala prodott mhux mibdul mill-kliewi u, kuntrarjament għal morfina, m'hemm l-ebda metaboliti attivi magħrufa li jiġu eliminati mill-kliewi.
English: Eye disorders Very rare:
Maltese: Mhux komuni: dijarea Rari:
English: There is also no clinical data available which demonstrates withdrawal symptoms in patients treated with transdermal fentanyl after injection of buprenorphine.
Maltese: Ma hemm l-ebda dejta disponibbli li turi sintomi ta' irtirar f'pazjenti ittrattati b'fentanyl transdermali wara injezzjoni ta' buprenorphine.
English: As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Maltese: Peress illi fentanyl jiġi eliminat fil-ħalib tal-omm, it-treddiegħ għandu jitwaqqaf waqt kura bil-Fentany-ratiopharm (ara sezzjoni 4.6)
English: [20 transdermal patches:] Date
Maltese: [20 garża transdermali:] Data
English: Following administration of Fentanyl-ratiopharm, fentanyl is continuously absorbed through the skin over a period of 72 hours.
Maltese: Wara l-amministrazzjoni ta' Fentanyl-ratiopharm, fentanyl jiġi assorbit kontinwament minn ġol-ġilda għal perijodu ta' 72 siegħa.
English: [5 transdermal patches:] Date
Maltese: [5 garża transdermali:] Data
English: In patients who experience a marked decrease in the period 48-72 hours after application, replacement of fentanyl after 48 hours may be necessary.
Maltese: F'pazjenti li jħossu tnaqqis sostanzjali tal-effett fil-perijodu bejn 48-72 siegħa wara l-applikazzjoni, tista' tinbidel il-garża ta' fentanyl wara 48 siegħa.
English: When treatment with Fentanyl-ratiopharm is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50 % in 13-22 hours in adults or 22-25 hours in children, respectively.
Maltese: Meta titwaqqaf il-kura bil-Fentanyl-ratiopharm il-konċentrazzjoni ta' fentanyl fis-serum taqa' gradwalment, u titbaxxa b'madwar 50 % fit-13 sa 22 siegħa fl-adulti jew fit-22 sa 25 siegħa fit-tfal, rispettivament.
English: delusional ideas, states of excitement, asthenia, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms.
Maltese: ħsibijiet delużjonali, eċċitament eċċessiv, astenja, dipressjoni, ansjeta', konfużjoni, anormalita' fil-funzjoni sesswali, sintomi assoċjati mal-waqfien mill-kura.
English: The points of disagreement leading to this referral procedure under Article 29(4) of Directive 2001/83/EC pertained to: 1- The therapeutic indication to be extended to non-cancer patients suffering of severe chronic pain 2- The choice of conversion tables(s) to be included in the SPC 3- Whether breast-feeding and co-administration with partial agonist opioids should be contraindicated 4- The bioequivalence studies needed to demonstrate the equivalence with the reference product
Maltese: Il-punti tan-nuqqas ta' qbil li wasslu għal din il-proċedura ta' referenza taħt l-Artikolu 29(4) tadDirettiva 2001/83/KE kellhom x'jaqsmu ma': 1- L-indikazzjoni terapewtika li kellha tiġi estiża għal pazjenti li m'għandhomx kanċer li jsofru minn uġigħ kroniku qawwi 2- L-għażla ta' tabella(i) ta' konverżjoni li għandhom jiġu inklużi fis-Sommarju tal-Karatteristiċi tal-Prodotti (SPC) 3- Jekk it-treddigħ u l-ko-amministrazzjoni ma' agonisti parzjali ta' l-opijojdi għandhomx ikunu kontra-indikati 4- L-istudji tal-bijoekwivalenza meħtieġa biex juru l-ekwivalenza mal-prodott ta' referenza
English: Uncommon: euphoria, amnesia, insomnia, hallucinations, agitation.
Maltese: Mhux komuni: ewforija, amnesija, nuqqas ta' rqad, alluċinazzjonijiet, aġitazzjoni.
English: What Fentanyl-ratiopharm contains - The active substance is fentanyl.
Maltese: - Is-sustanza attiva hi fentanyl.
English: Around 75 % of fentanyl is excreted into the urine, mostly as metabolites, with less than 10 % as unchanged active substance.
Maltese: Madwar 75 % ta' fentanyl jiġi eliminat fl-awrina, l-biċċa l-kbira bħala metaboliti, b'inqas minn 10 % mneħħi bħala prodott mhux mibul.
English: fentanyl
Maltese: Anzjani
English: Patients with fever/external heat
Maltese: Pazjenti b'deni/sħana esterna
English: After exhibiting a serious adverse reaction a patient should be monitored for 24 hours following removal of a transdermal patch due to the half life of fentanyl (see section 5.2).
Maltese: Wara reazzjoni avversa u serja, il-pazjent irid jibqa' taħt osservazzjoni għal 24 siegħa wara li titneħħa il-garża minħabba il-half life ta' fentanyl (ara sezzjoni 5.2).
English: 25 µg/h transdermal patch transdermal use 4.125 mg/7.5 cm² which release 25 µg fentanyl per hour
Maltese: 4.125 mg/7.5 cm² li terħi 25 µg fentanyl fis-siegħa
English: Immune system disorders Very rare:
Maltese: Disturbi fis-sistema immunitarja Rari ħafna:
English: Common less than 1 in 10, but more than 1 in 100 patients Uncommon less than 1 in 100, but more than 1 in 1000 patients Rare less than 1 in 1000, but more than 1 in 10,000 patients Very rare less than 1 in 10,000 patients, including isolated reports
Maltese: Rari iseħħu f'inqas minn 1 kull 1000, iżda f'iktar minn 1 minn kull 10000 pazjenti
English: For the same reason you should avoid exposing the patch on the skin to direct heat such as electric blankets, hot-water bottles, sauna, solarium or hot baths.
Maltese: Għall-istess raġuni, għandek tevita li tesponi l-garza mwaħħla fuq il-ġilda għal sorsi ta' sħana esterna bħal kutri tal-elettriku, hot water bottles, sawna, solarium jew banju sħun.
English: France ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Maltese: Franza ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, IlĠermanja
English: If patients with renal impairment receive transdermal fentanyl they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Maltese: Pazjenti li jbatu minn indeboliment tal-fwied għandhom jiġu osservati b'attenzjoni u id-doża għandha tiġi mnaqqsa fejn ikun hemm bżonn.
English: Fentanyl-ratio 50 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 µg/uur United Kingdom Ribofen 50 microgram/hr Transdermal patch
Maltese: Fentanyl-ratio 50 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 µg/uur Ir-Renju Unit Ribofen 50 microgram/hr Transdermal patch
English: Tolerance and physical and psychological dependence may develop upon repeated administration of opioids, but is rare in treatment of cancer related pain.
Maltese: Tolleranza u dipendenza fisika u psikoloġika tista' tiżviluppa bl-amministrazzjoni ripetuta tal-opjojdi, iżda huma rari fil-kura ta' l-uġigħ relatat mal-kanċer .
English: [3 transdermal patches:] Date
Maltese: [3 garża transdermali:] Data
English: Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Maltese: Fentanyl, sustanza li għandha rata ta' tneħħija għolja, tiġi metabolizzata malajr u b'mod estensiv, l-aktar minn CYP3A4.
English: Due to the polymer matrix and the diffusion of fentanyl through the skin layers, the release rate remains relatively constant.
Maltese: Kawża tal- polymer matrix u d-diffużjoni ta' fentanyl mis-saffi tal-ġilda, ir-rata ta' rħir tibqa' relattivament kostanti.
English: Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Maltese: Sinjali ta' tossiċita' huma sedazzjoni qawwija, ataxia, miosis, konvulżjonijiet u dipressjoni respiratorja, b'dan ta' l-aħħar ikun is-sintomu ewlieni.
English: [10 transdermal patches:] Date
Maltese: [10 garża transdermali:] Data
English: The CHMP considered also that bioequivalence between test and reference medicinal product has been sufficiently characterised in 2 studies (single and multiple dose) performed with a reduced patch size (7.5 cm²).
Maltese: Il-CHMP ikkunsidra wkoll illi l-bijoekwivalenza bejn test u prodotti mediċinali ta' referenza ġiet ikkaratterizzata suffiċjentement f'2 studji (doża waħda u multipla) magħmula b'roqgħa ta' daqs imnaqqas (7.5 ċm²).
English: 75 µg/h transdermal patch transdermal use 12.375 mg/22.5 cm² which release 75 µg fentanyl per hour
Maltese: 12.375 mg/22.5 cm² li terħi 75 µg fentanyl fis-siegħa
English: Lactation
Maltese: IPPREŻENTATI
English: The conservative conversion scheme (150:1) as specified in the present SPC of Fentanyl ratiopharm for patient who have a need for opioid rotation and the conversion scheme 100:1 (Donner's table) for patients under stable and well -tolerated opioid therapy.
Maltese: L-iskema ta' konverżjoni konservattiva (150:1) kif speċifikata fis-Sommarju talKaratteristiċi tal-Prodotti (SPC) preżenti ta' Fentanyl ratiopharm hija għal pazjenti li għandhom bżonn rotazzjoni ta' l-opijojdi u l-iskema ta' konverżjoni 100:
English: Route of administration
Maltese: Tul ta' l-amministrazzjoni
English: hiccup.
Maltese: anafilassi.
English: Fentanyl-ratio 25 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 µg/uur United Kingdom Ribofen 25 microgram/hr Transdermal patch
Maltese: Fentanyl-ratio 25 µg/h, dispositif transdermique L-Olanda Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 µg/uur Ir-Renju Unit Ribofen 25 microgram/hr Transdermal patch Dan il-fuljett kien approvat l-aħħar f' {XX/SSSS}
English: 100 µg/h transdermal patch transdermal use 16.5 mg/30 cm² which release 100 µg fentanyl per hour
Maltese: 16.5 mg/30 cm² li terħi 100 µg fentanyl fis-siegħa
English: As fentanyl is excreted into breast milk, lactation should be discontinued under the treatment with fentanyl (see also section 4.6)
Maltese: Minħabba li fentanyl huwa eskretat fil-ħalib tas-sider, it-treddigħ għandu jitwaqqaf waqt it-trattament b'fentanyl (ara ukoll sezzjoni 4.6)
English: The serum concentrations of fentanyl that cause a minimal analgesic effect in opioid-naive patients fluctuate between 0.3-1.5 ng/ml; an increased incidence of adverse reactions is observed if serum levels exceed 2 ng/ml.
Maltese: Il-konċentrazzjoni ta' fentanyl fis-serum, li tikkawża effett minimu ta' analġesija f'pazjenti li qed jirċievu opjojdi għall-ewwel darba, tvarja bejn 0.3-1.5ng/ml; isseħħ żieda fl-inċidenza ta' reazzjonijiet avversi meta l-livelli fis-serum jiskorru 2ng/ml.
English: Regarding the co-administration with other opioids, it is acknowledged that the risk of combining fentanyl with a mixed agonist/antagonist, like buprenorphine, nalbuphine and pentazocine, consists first in impaired analgesia, due to competitive antagonistic effects, and secondly in the onset of a withdrawal syndrome, which also represents a serious health concern.
Maltese: Fir-rigward ta' l-amministrazzjoni fl-istess ħin ma' opijojdi oħra, huwa rikonoxxut li r-riskju ta' likkumbinar ta' fentanyl ma' agonist/antagonist imħallat bħal buprenorphine, nalbuphine u pentazocine, jikkonsisti l-ewwel f'analġiżja imxekkla, minħabba effetti antagonisti kompettitivi, u ttieni fil-bidu ta' sindromu ta' irtirar, li ukoll jirrappreżenta tħassib serju għas-saħħa.
English: The CHMP considers that the criteria of the guideline on transdermal dosage formsCPMP/EWP/280/96- (i.e. exact proportionality of the formulation and acceptable in vitro release test) were met with the fentanyl ratiopharm transdermal patch as well as with the reference medicinal product.
Maltese: Il-CHMP jikkunsidra li l-kriterji tal-linja gwida fuq forom ta' dożaġġ transdermaliCPMP/EWP/280/96- (jiġifieri proporzjonalità eżatta tal-formulazzjoni u test ta' rilaxx aċċettabbli in vitro) intlaqgħu bir-roqgħa ta' fentanyl ratiopharm transdermali kif ukoll bil-prodott mediċinali ta' referenza.
English: Non-epileptic (myo)clonic reactions can occur.
Maltese: Jista' jkun hemm rejazzjonijiet mhux epilettiċi (mijo)kloniċi.
English: Reversing the narcotic effect can give rise to acute pain and release of catecholamines.
Maltese: L-inverzjoni tal-effett narkotiku tista' tirriżulta f'uġigħ akut u l-liberazzjoni ta' catecholamines.
English: The Netherlands ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Maltese: L-Olanda ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, IlĠermanja
English: The corresponding fentanyl dosage should be determined as follows: a) using Table 2 for patients who have a need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to150:1) b) using Table 3 for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1)
Maltese: 1) b) permezz ta' Tabella 3 għal dawk il-pażjenti li qegħdin fuq kura stabbli u tollerata tajjeb blopjojdi (ir-ratio tal-konverżjoni minn morfina għal fentanyl transdermali huwa ta' 100:1)
English: Impaired liver function
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI
English: The CHMP recommended also adding the following statement in section 4.4 of the SPC: “In chronic non-cancer pain, it might be preferable to initiate the treatment with immediate-release strong opoids (e.g. morphine) and to prescribe fentanyl transdermal patch after determination of the efficacy and the optimal dosage of the strong opioid.”
Maltese: Il-CHMP irrakkomanda wkoll iż-żieda ta' l-istqarrija segwenti f'sezzjoni 4.4 tas-Sommarju talKaratteristiċi tal-Prodotti (SPC): “F'uġigħ kroniku mhux relatat mal-kanċer, jista' jkun preferibbli li tibda t-trattament b'opijojdi qawwija li jirrilaxxaw ruħhom minnufih (eż. morfina) u li tagħti b'riċetta roqgħa b'fentanyl transdermali wara d-determinazzjoni ta' l-effikaċja u d-dożaġġ ottimu ta' l-opijojd qawwi.
English: Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
Maltese: L-anzjani u pazjenti debboli jistgħu ikollhom rata ta' eliminazzjoni ta' fentanyl baxxa li twassal għal half life terminali mtawwal.
English: Time
Maltese: TIKKETTA
English: cystalgia, oliguria.
Maltese: uġigħ fil-bużżieqa ta' l-awrina, oligurja.
English: 50 µg/h transdermal patch transdermal use 8.25 mg/15 cm² which release 50 µg fentanyl per hour
Maltese: 8.25 mg/15 cm² li terħi 50 µg fentanyl fis-siegħa
English: Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
Maltese: Sinjali u sintomi oħrajn ta' doża eċċessiva huma ħedla, temperatura baxxa, rata baxxa tat-taħbit tal-qalb, tnaqqis fit-ton tal-muskoli, sedazjoni profonda, telf ta' koordinazzjoni fil-muskoli, djuq fil-pupilla tal-għajnejn u konvulżjonijiet.
English: Fentanyl-ratiopharm is available in packs of 3, 5, 10 or 20 transdermal patches.
Maltese: Fentanyl-ratiopharm huwa disponibbli f'paketti ta' 3, 5, 10 jew 20 il-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda.
English: United Kingdom ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Maltese: Ir-Renju Unit ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, IlĠermanja
English: Regarding breast-feeding, section 4.6 of the proposed SPC reads: “Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant.
Maltese: Fir-rigward tat-treddigħ, is-sezzjoni 4.6 tas-Sommarju tal-Karatteristiċi tal-Prodotti (SPC) ipproponut tgħid: “Fentanyl jiġi eskretat għal ġol-ħalib tas-sider u jista' jikkaġuna sedazzjoni u dipressjoni respiratorja fit-tarbija li tkun qedgħa tiġi imreddgħa.
English: As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
Maltese: Peress li l-garża transdermali hija protetta b'film estern fuq in-naħa ta' wara li jiflaħ għall-ilma, tista' tintlibes wkoll waqt id-doċċa.
English: The biostatistical evaluation of the existing single dose study with replicate design (but showing nonbioequivalence) could be considered suitable to evaluate intra-individual variability and to determine the influence of the biopharmaceutical performance, in relation to the different release mechanisms (reservoir versus matrix).
Maltese: L-evalwazzjoni bijostatistika ta' l-istudju b'doża waħda eżistenti b'disinn replika (iżda ma turix bijoekwivalenza) tista' tkun ikkunsidrata tajba biex tevalwa l-varjabbilità ġo l-individwu u biex tiddetermina l-influwenza ta' l-eżekuzzjoni bijofarmaċewtika, fir-rigward tal-mekkaniżmi ta' rilaxx differenti (riserva kontra matriċi).
English: Table 2: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Maltese: Tabella 2: Doża inizjali rakkomandata ta'fentanyl transdermali bbażata fuq doża ta' ġurnata ta' morfina orali (għal dawk il-pażjenti li jkollhom bżonn ta' tibdil regolari fil-kura bl-opjojdi )
English: If intravenous administration is impossible, naloxone hydrochloride can also be given intramuscularly or subcutaneously.
Maltese: Jekk l-amministrazzjoni minn ġol-vina ma tkunx possibli, naloxone hydrochloride jista' jingħata wkoll fil-muskolu jew taħt ilġilda.
English: Adhesive layer: Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)
Maltese: Fojl magħmul minn Polypropylene, Linka għall-istampar kaħlanija Release liner:
English: Dose titration and maintenance therapy
Maltese: Titrazzjoni tad-doża u d-dożaġġ ta' manteniment
English: Combined use of ritonavir or other potent CYP3A4-inhibitors with transdermal fentanyl is not recommended, unless the patient is carefully observed.
Maltese: Sintomi assoċjati mal-waqfien tal-kura ġew irrapportati meta kura fit-tul b'morfina nbidlet f'wahda transdermali b'fentanyl, minkejja kura analġesika effikaċi u adeguata.