FrancophonIA/ELRC3.0 huggingface dataset:
English: Phase I studies evaluating the effect of capecitabine on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5'-DFUR.
Maltese: It-tossiċità kkawżata meta jittieħed capecitabine tista' tiġi ttrattatabi trattament sintomatiku u/jew tibdil fid-doża (interruzzjoni tat-trattament jew tnaqqis fid-doża).
English: Patients taking phenytoin concomitantly with capecitabine should be regularly monitored for increased phenytoin plasma concentrations.
Maltese: Pazjenti li qed jieħdu phenytoin flimkien ma' capecitabine għandhom jiġu osservati regolarment għal żidiet fil-konċentrazzjonijiet ta'phenytoin fil-plażma.
English: Careful monitoring of patients ≥ 60 years of age is advisable.
Maltese: Sorveljanza bir-reqqa ta' pazjenti li għandhom ≥ 60 sena huwa rakkomandat.
English: (130 mg/m² on day 1).
Maltese: (625 mg/m² darbtejn kuljum b'mod kontinwu).
English: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Maltese: Capecitabine medac 150 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 150 mg capecitabine.
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m² leucovorin intravenous followed by 425 mg/m² intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Maltese: F'dawn il-provi, 603 pazjenti kienu magħżula b'mod każwali għat-trattament b'capecitabine (1,250 mg/m² darbtejn kuljum għal ġimagħtejn segwiti minn perjodu ta' ġimgħa ta' waqfien tat-trattament u mogħtija bħala ċikli ta' 3 ġimgħat). 604 pazjenti ġew randomised għat-trattament b'5-FU u leucovorin (kors ta' Mayo: 20 mg/m² leucovorin fil-vini segwit minn 425 mg/m² 5-FU bolus fil-vini, mill-ewwel sal-ħames jum, kull 28 jum).
English: Gastroesophageal reflux disease, Oral pain,
Maltese: Tromboflebite Trombożi fil-vini lkbar, Ipertensjoni,
English: Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Maltese: Capecitabine jista' jikkawża reazzjonijiet severi fil-ġilda bħas-sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide. Capecitabine għandu jitwaqqaf b'mod permanenti f'pazjenti li jkollhom reazzjoni severa tal-ġilda waqt it-trattament.
English: Neutropenia, Anaemia
Maltese: Parasteżija, Disasteżija,
English: Date of latest renewal: 19 November 2019
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2019
English: Half-life is approximately 30 minutes.
Maltese: Il-half-life hija madwar 30 minuta.
English: Implant.
Maltese: Impjant.
English: Other medicines and SCENESSE
Maltese: Mediċini oħra u SCENESSE
English: Gastrointestinal infection Gastroenteritis Folliculitis
Maltese: Infezzjoni gastro-intestinali Gastroenterite Follikulite
English: SCENESSE contains the active substance afamelanotide.
Maltese: SCENESSE fih is-sustanza attiva afamelanotide.
English: It has been demonstrated that EPP patients receiving afamelanotide had more exposure to direct sunlight (10:00 to 18:00 hours) during a 180 day trial period compared to placebo recipients (p=0.044; afamelanotide arithmetic mean: 115.6 h, median 69.4h; placebo mean 60.6h, median 40.8h).
Maltese: Intwera li l-pazjenti EPP li jirċievu afamelanotide kellhom espożizzjoni akbar għad-dawl tax-xemx dirett (10:00-18:00) matul perjodu ta' prova ta' 180 jum meta mqabbla ma' riċevituri ta' plaċebo (p=0.044; medja aritmetika ta' afamelanotide: 115.6 h, medjan ta' 69.4h; medja tal-plaċebo ta' 60.6h, medjan ta' 40.8h).
English: - The other ingredient is poly (D,L-lactide-co-glycolide).
Maltese: - Is-sustanza l-oħra hija poly (D,L-lactide-co-glycolide).
English: Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH).
Maltese: Afamelanotide hija forma sintetika ta' ormon talġisem imsejjaħ alpha-melanocyte stimulating hormone (α-MSH) .
English: Store in a refrigerator (2oC - 8oC).
Maltese: Aħżen fi friġġ (2oC - 8oC).
English: SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Maltese: SCENESSE huwa indikat għall-prevenzjoni ta' fototossiċità f'pazjenti adulti bi protoporfirja eritropojetika (EPP).
English: SCENESSE 16 mg implant afamelanotide
Maltese: SCENESSE 16 mg impjant afamelanotide
English: - Select a 14 gauge (1.6 mm inner diameter) catheter with needle.
Maltese: - Agħżel kateter 14 gejġ (dijametru intern ta' 1.6 mm) b'labra.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Presence of severe hepatic disease - Hepatic impairment (see section 5.2) - Renal impairment (see section 5.2)
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 - Preżenza ta' mard epatiku sever - Indeboliment epatiku (ara sezzjoni 5.2) - Indeboliment renali (ara sezzjoni 5.2)
English: Frequencies are defined as: 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) and not known (cannot be estimated from the available data)
Maltese: Il-frekwenzi huma ddefiniti bħala: 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) u mhux magħruf
English: Clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's disease, Addison's disease, Peutz-Jeghers syndrome), neurological (including seizures) and haematological (especially anaemia) systems have not been evaluated.
Maltese: Disturbi klinikament sinifikanti tas-sistema gastrointestinali, kardjovaskulari, respiratorja, endokrinali (inkluż id-dijabete, il-marda ta' Cushing, il-marda ta' Addison, is-sindrome ta' Peutz-Jeghers),
English: The adverse reactions reported during clinical trials conducted with afamelanotide are listed in the table below by MedDRA system organ class and frequency convention.
Maltese: Ir-reazzjonijiet avversi rrapportati matul il-provi kliniċi mwettqa b'afamelanotide huma elenkati fittabella ta' hawn taħt permezz tas-sistema tal-klassifika tal-organi u l-konvenzjoni tal-frekwenza MedDRA.
English: - Mark 1.5 to 2 cm on the catheter shaft using surgical ink.
Maltese: - Immarka 1.5 sa 2cm fuq ix-xaft tal-kateter permezz ta' linka kirurġika.
English: There are no clinical data on the effects of afamelanotide on fertility.
Maltese: M'hemmx data klinika dwar l-effetti ta' afamelanotide fuq il-fertilità.
English: Following subcutaneous administration of the implant, most of the active substance is released within the first 48 hours with over 90% released by day 5.
Maltese: Wara t-tqegħid taħt il-ġilda tal-impjant, ħafna mis-sustanza attiva tiġi lliberata fl-ewwel 48 siegħa b'aktar minn 90% tkun liberata sa jum 5.
English: For patients with renal or hepatic impairment see sections 4.3 and 5.2.
Maltese: Għal pazjenti b'indeboliment renali u epatiku, ara sezzjonijiet 4.3 u 5
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Diċembru 2014
English: or suspected or confirmed susceptibility to cutaneous melanoma (CMM1, MIM #155600,
Maltese: jew suxxettibbiltà suspettata jew ikkonfermata għal melanoma fil-ġilda (CMM1, MIM #155600,
English: In repeated dose toxicity studies, the only finding of relevance was an increase in melanin pigmentation in the dog, which is consistent with the active substance's pharmacological activity.
Maltese: Fi studji ta' tossiċita ta' doża ripetuta, l-uniku sejba ta' rilevanza kienet iż-żieda fil-pigmentazzjoni tal-melanina fil-klieb, li hija konsistenti mal-attivita farmakoloġika tas-sustanza attiva.
English: Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter.
Maltese: Virga solida bajda għal offwajt twila madwar 1.7 cm u b'dijametru ta' madwar 1.5 mm.
English: Store in a refrigerator (2˚C - 8˚C)
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2˚C - 8˚C)
English: Depression Depressed mood Insomnia
Maltese: Dipressjoni Burdata depressa Insomnja
English: The most commonly reported adverse reactions are nausea, experienced by approximately 19% of subjects who received treatment with this medicinal product, headache (20%), and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema).
Maltese: Ir-reazzjonijiet avversi rrapportati b'mod l-aktar komuni huma dardir, esperjenzati minn madwar 19 % tal-individwi li ngħataw kura b'dan il-prodott mediċinali, uġigħ ta' ras (20%), u reazzjonijiet fis-sit tal impjant (21 %, prinċipalment telf tal-kulur, uġigħ, ematoma, eritema).
English: Special caution is warranted in patients with an - individual or family history of melanoma (inclusive of in-situ melanoma, e.g. lentigo maligna)
Maltese: Hija rakkomandata attenzjoni speċjali f'pazjenti - bi storja individwali jew fil-familja ta' melanoma (inkluż melanoma in-situ, eż. lentigo maligna)
English: The overall duration of treatment is at the specialist physician's discretion (see section 4.4).
Maltese: It tul totali tal-kura huwa fid-diskrezzjoni tat-tabib speċjalista (ara sezzjoni 4.4).
English: synonyms: familial atypical mole-malignant melanoma syndrome, FAMMM; dysplastic naevus syndrome, DNS; B-K mole syndrome; CMM2 MIM #155601) and/or an - individual history of basal cell carcinoma, squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or premalignant skin lesions.
Maltese: sinonimi: sindromu ta' melanoma familjali atipiku ta' tbajja' malinni (familial atypical molemalignant melanoma syndrome), FAMMM; sindromu ta' naevus displastiku (dysplastic naevus syndrome), DNS; sindromu tat-tbajja' B-K (B-K mole syndrome); CMM2 MIM #155601)
English: Sensation of heaviness
Maltese: Sensazzjoni ta' sħana
English: Afamelanotide is thought to mimic the endogenous compound's pharmacological activity by activating the synthesis of eumelanin mediated by the MC1R receptor.
Maltese: Huwa maħsub li afamelanotide jimita l-attività farmakoloġika tal-kompost endoġenu billi jattiva s sintesi ta' eumelanin medjata mir-riċettur MC1R.
English: Long-term safety data for afamelanotide are limited.
Maltese: Data dwar is-sigurtà fit-tul ta' afamelanotide hija limitata.
English: - Disinfect the skin above the supra-iliac crest.
Maltese: - Iddiżinfetta l-ġilda 'l fuq mis-“supra-iliac crest”.
English: The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' afamelanotide fit-tfal u adolexxenti minn età ta' 0 sa 17-il sena għadhom ma ġewx determinati s'issa.
English: - The active substance is afamelanotide.
Maltese: X'fih SCENESSE - Is-sustanza attiva hi afamelanotide.
English: • Risk management plan (RMP) The marketing authorisation holder (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: • Pjan tal-ġestjoni tar-riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Lichen planus Rash vesicular Pruritus generalised Rash
Maltese: Lichen planus Raxx vesikulari
English: - if you have kidney problems.
Maltese: - jekk għandek problemi bil-kliewi.
English: The implant is absorbed by the body within 50 to 60 days after administration.
Maltese: L-impjant jiġi assorbit mill-ġisem fi żmien 50 sa 60 jum wara t-tqegħid.
English: Eumelanin contributes to photoprotection through different mechanisms including: - strong broadband absorption of UV and visible light, where eumelanin acts as a filter - antioxidant activity through scavenging of free radicals; and - inactivation of the superoxide anion and increased availability of superoxide dismutase to reduce oxidative stress.
Maltese: Eumelanin jikkontribwixxi għall-fotoprotezzjoni permezz ta' mekkaniżmi differenti fosthom: - assorbiment qawwi ta' medda wiesgħa ta' UV u dawl viżibbli, fejn eumelanin jaġixxi bħala filtru - attività anti-ossidanti permezz tat-tfittix għal radikali ħielsa; u - inattivazzjoni tal- enajin superoxide u żieda fid-disponibbiltà ta' superoxide dismutase biex jitnaqqas l-istress ossidattiv.
English: As an oligopeptide with a short half-life, afamelanotide is expected to be rapidly hydrolysed into shorter peptide fragments and into its individual amino acids.
Maltese: Bħala oligopeptide b'half-life qasira, afamelanotide huwa mistenni li jiġi idrolizzat malajr fi frammenti ta' peptide iqsar u fl-amino aċidi individwali tiegħu.
English: Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the body.
Maltese: Afamelanotide jaħdem b'mod simili għall-ormon naturali, billi jġiegħel liċ-ċelluli tal-ġilda jipproduċu eumelanin li hija tip kannella-iswed tal-pigment tal-melanin fil-ġisem.
English: Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1R).
Maltese: Afamelanotide huwa tridecapeptide sintetiku u analogu strutturali ta' ormon li jistimula α-melanocyte (α-MSH). Afamelanotide huwa agonist tar-riċettur melanocortin u jeħel b'mod predominanti marriċettur melanocortin-1 (MC1R).
English: One implant contains 16 mg of afamelanotide.
Maltese: Kull impjant fih 16 mg afamelanotide.
English: A referral to a dermatology specialist might be necessary.
Maltese: Jista' jkun hemm bżonn ta' referenza għal speċjalista tad-dermatoloġija.
English: Pruritus
Maltese: Presbjopja
English: OTHER
Maltese: importanti
English: Abdominal distension Gingival pain
Maltese: Ematoma Pressjoni dijastolika għolja
English: The implant is a solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter in an amber glass vial sealed with a PTFE coated rubber stopper.
Maltese: L-impjant huwa virga solida bajda għal offwajt twila madwar 1.7 cm u b'dijametru ta' 1.5 mm f'kunjett tal-ħġieġ kulur l-ambra ssiġillat b'tapp tal-gomma miksi bil-PTFE.
English: Cystitis
Maltese: KUNJETT
English: Haemangioma
Maltese: Emanġjoma
English: • Face to face training material,
Maltese: • Vidjow edukattiv, • Folja ta' informazzjoni tar-reġistru.
English: NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant
Maltese: SCENESSE 16 mg impjant
English: Patients taking substances which reduce coagulation, such as vitamin K antagonists (e.g. warfarin), acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Maltese: warfarin), acetylsalicylic acid u mediċina anti-infjammatorja mhux sterojdali (non-steroidal anti inflammatory drug - NSAIDs) jistgħu jesperjenzaw żieda fit-tbenġil jew fsada fis-sit tal impjantazzjoni.
English: Abdominal symptom Bowel movement irregularity Flatulence
Maltese: Sindrome ta' sieq irrikwieta Iperestesija
English: Intermediate reports: annual submission.
Maltese: Kummissjoni Ewropea Rapporti intermedji: sottomissjoni annwali.
English: Wound complication Open wound Fall
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4).
Maltese: Minħabba data limitata dwar trattament ta' pazjenti anzjani, l-użu ta' afamelanotide mhux rakkomandat (ara sezzjoni 4.4).
English: The pharmacokinetics of afamelanotide have not been fully characterised yet, i.e. distribution, metabolism or excretion are not clear.
Maltese: Il-farmakokinetika ta' afamelanotide għadha ma ġietx kompletament ikkaratterizzata, jiġifieri ddistribuzzjoni, il-metaboliżmu jew l-eliminazzjoni mhumiex ċari.
English: - Irregularity of skin, rash with small blisters, itch, rash, red rash, red swelling on skin, rash with small bumps, itchy rash, skin irritation, lighter skin patches, acne, eczema, secretions on skin, skin peeling, skin with loss of colour, hair colour changes, excessive sweating
Maltese: - Irregolarità tal-ġilda, raxx b'infafet żgħar, ħakk, raxx, raxx ħamrani, nefħa ħamranija fuq ilġilda, raxx b'ħotob żgħar, raxx b'ħakk, irritazzjoni tal-ġilda, rqajja' tal-ġilda aktar ċari, akne, ekżema, tnixxijiet fuq il-ġilda, tqaxxir tal-ġilda, ġilda b'telf fil-kulur, tibdil fil-kulur tax-xagħar, għaraq eċċessiv
English: - Cushing's disease (a hormone disorder where the body produces too much of the hormone cortisol); - Addison's disease (a disorder of the adrenal glands causing a lack of some hormones); - Peutz-Jeghers syndrome (a disorder that causes blockage of the bowel and where your hands, soles of your feet and surface of your lips may have brown freckles); - epilepsy (or have been told that you are at risk of having fits); - anaemia (low counts of red blood cells in your blood); - melanoma (an aggressive type of skin cancer), including in-situ melanoma, e.g. lentigo maligna; or if you have certain inherited conditions that increase the risk of developing a melanoma; - skin cancer of the types, basal cell carcinoma or squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma or other malignant or premalignant skin problems.
Maltese: - dijabete; - il-marda ta' Cushing (disturb fl-ormoni fejn il-ġisem jipproduċi wisq mill-ormon kortisol); - il-marda ta' Addison (disturb tal-glandoli adrenali li jikkawża nuqqas ta' xi ormoni); - is-sindrome ta' Peutz-Jeghers (disturb li jikkawża mblukkar tal-imsaren u li bih, idejk, il-qiegħ tas-saqajn u l-wiċċ tax-xofftejn jista' jitlagħlhom nemex kannella);
English: Rash erythematous Rash papular Rash pruritic Skin irritation Vitiligo
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI
English: No pharmacokinetic information is available on any of its metabolites (active or inactive).
Maltese: M'hija disponibbli l-ebda informazzjoni farmakokinetika dwar xi wieħed mill-metaboliti tiegħu (attivi jew inattivi).
English: Presbyopia
Maltese: Presinkope
English: Pain in extremity Muscle spasm Musculoskeletal pain Musculoskeletal stiffness Joint stiffness Groin pain
Maltese: Spażmi tal-muskoli Uġigħ muskoluskeletriċi
English: Lip oedema
Maltese: mnejn jingħata
English: Oedema peripheral Oedema mucosal Pain
Maltese: Edema fil-kappell tal għajnejn
English: • Methods to prevent or minimise application errors and application site reactions Registry information sheet shall contain the following key messages:
Maltese: • Metodi għall-prevenzjoni u l-minimizzazzjoni ta' żbalji tal-applikazzjoni u ta' reazzjonijiet fissit tal-applikazzjoni
English: - Increased hunger, nausea following implant insertion, indigestion, infection in stomach and intestines, inflamed stomach and intestines, heartburn, inflamed stomach, irregular bowel movements, wind, bloated tummy, tummy pain
Maltese: - Żieda fil-ġuħ, dardir wara l-inserzjoni ta' impjant, indiġestjoni, infezzjoni fl-istonku u flintestini, stonku u intestini infjammati, ħruq ta' stonku, stonku infjammat, movimenti irregolari tal-imsaren, gass, żaqq minfuħa, uġigħ ta' żaqq
English: 6.6 Special precautions for disposal and other handling For instructions on correct administration and preparation see section 4.2.
Maltese: Għal istruzzjonijiet dwar l-għoti korrett u l-preparazzjoni korretta ara sezzjoni 4.2.
English: Migraine Dizziness Lethargy Somnolence
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: - Remove the needle from within the catheter using a sterile technique.
Maltese: - Neħħi l-labra minn ġewwa l-kateter permezz ta' teknika sterili.
English: Inflammation was observed in the Harderian gland in the rat.
Maltese: Ġiet osservata infjammazzjoni fil-glandola ta' Harderian fil-firien.
English: Liver function test abnormal Transaminases increased Transferrin saturation decreased
Maltese: Żieda fl-alanine aminotrasferase Żieda fl-aspartate aminotransferase Test anormali tal-funzjoni tal-fwied
English: - Using a suitable device (such as a stylet) gently push the implant down the full length of the catheter lumen.
Maltese: - Permezz ta' apparat xieraq (bħal pereżempju stylet) imbotta l-impjant bil-mod sa ġewwa nett tal-lumen tal-kateter.
English: This medicine should not be given to children and adolescents under 18 years of age because it has not been tested in this age group.
Maltese: Din il-mediċina ma għandhiex tingħata lil tfal u adolexxenti li għandhom inqas minn 18-il sena minħabba li ma ġietx ittestjata f'dan il-grupp ta' età.
English: Pharmacotherapeutic group: Emollients and protectives, protectives against UV-radiation for systemic use, ATC code: D02BB02
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Cheilitis
Maltese: Pożoloġija
English: In a fertility study no effects on the reproductive function of male or female Sprague-Dawley rats were observed after subcutaneous application of afamelanotide.
Maltese: Fi studju tal-fertilità, ma ġie osservat l-ebda effett fuq il-funzjoni riproduttiva tal-firien SpragueDawley irġiel jew nisa wara applikazzjoni taħt il-ġilda ta' afamelanotide.
English: - With the bevel of the needle facing upwards, insert the catheter laterally 1.5 to 2 cm into the subcutaneous layer at a 30 to 45 degree angle to the skin surface in one continuous flowing movement.
Maltese: - Bix-xifer imżerżaq tal-labra jħares 'il fuq, daħħal il-kateter lateralment 1.5-2 cm fis-saff taħt il ġilda f'angolu ta' 30 sa 45 grad mal-wiċċ tal-ġilda b'moviment wieħed kontinwu u mexxej.
English: - Joint pain, muscle pain, pain in arms and legs, sudden muscle contraction, pain in muscles and bones, stiffness of muscles and bones, joint stiffness, groin pain, feeling of heaviness, swelling in lower limbs
Maltese: - Uġigħ fil-ġogi, uġigħ fil-muskoli, uġigħ fid-dirgħajn u fir-riġlejn, kontrazzjoni f'daqqa talmuskoli, uġigħ fil-muskoli u fl-għadam, ebusija tal-muskoli u tal-għadam, ebusija tal-ġogi, uġigħ fl-irqiq ta' bejn il-koxxa u ż-żaqq, sensazzjoni ta' toqol, nefħa fil-parti t'isfel tar-riġlejn
English: If such patients are treated they must be monitored after each implant administration, including vital signs, routine haematology, and biochemistry.
Maltese: Jekk tali pazjenti jiġu kkurati, dawn għandhom jiġu ssorveljati wara t-tqegħid ta' kull impjant, inkluż għal sinjali vitali, l-ematoloġija ta' rutina u l bijokimika.
English: - Observe the patient for 30 minutes to ensure that you will notice if the patient develops an allergic or hypersensitivity reaction (immediate type).
Maltese: - Osserva l-pazjent għal 30 minuta biex tiżgura li tinnota jekk il-pazjent jiżviluppa reazzjoni allerġika jew ta' sensittività eċċessiva (ta' tip immedjat).
English: - Heavy and prolonged period, abnormal period, breast tenderness, irregular periods, discharge from vagina, decreased sex drive
Maltese: - Menstrwazzjoni qawwija u mtawla, menstrwazzjoni mhux normali, sensittività fis-sider, menstrwazzjoni irregolari, nixxigħat mill-vaġina, tnaqqis fl-aptit sesswali
English: • The importance of maintaining aseptic conditions.
Maltese: • L-importanza li jinżammu kundizzjonijiet asettiċi.
English: - Infected hair follicle, fungal infection, urinary tract infection
Maltese: - Follikuli tax-xagħar infettati, infezzjoni fungali, infezzjoni fil-passaġġ tal-awrina
English: Menorrhagia Dysmenorrhoea Breast tenderness Menstruation irregular Vaginal discharge Libido decreased
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall
English: Flushing Hot flush
Maltese: Żieda fl-aptit