FrancophonIA/ELRC3.0 huggingface dataset:
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: • 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: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz .
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' Pelgraz.
English: • have sickle cell anaemia.
Maltese: • għandek anemija taċ-ċellula sickle.
English: Other medicines and Pelgraz
Maltese: Mediċini oħra u Pelgraz
English: • coughing up blood (haemoptysis)
Maltese: • tisgħol id-demm (emoptiżi)
English: The incidence of hospitalisations and intravenous antiinfective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001).
Maltese: dħul l-isptar u l-użu ta' sustanzi ġol-vini kontra l-infezzjonijiet assoċjati ma' dijanjosi klinika ta' newtropenija bid-deni kienet aktar baxxa fil-grupp ta' pegfilgrastim meta mqabbla mal-grupp talplaċebo (1% versus 14%, p < 0.001; u 2% versus 10%, p < 0.001).
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p < 0.001).
Maltese: inċidenza tan-newtropenija bid-deni kienet aktar baxxa f'pazjenti randomised biex jirċievu pegfilgrastim meta mqabbla ma' dawk li rċevew plaċebo (1% versus 17%, p < 0.001).
English: Pre-filled syringe with needle safety guard b.
Maltese: Siringa mimlija għal-lest bil-protezzjoni tas-sigurtà tal-labra b.
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1).
Maltese: 22.5 mcg·siegħa/ml) minn tfal akbar b'età ta' 6-11-il sena u 12-21 sena (22.0 ± 13.1 mcg·hr/mL u 29.3 ± 23.2 mcg·siegħa/mL, rispettivament) (ara sezzjoni 5.1).
English: G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: G-CSF jista' jippromovi t-tkabbir in vitro ta' ċelluli majelojdi, inklużi ċelluli malinni,
English: Pelgraz contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodiumfree'.
Maltese: Pelgraz fih anqas minn 1 mmol (23 mg) sodium f'kull doża ta' 6 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: (acute febrile dermatosis)1,2
Maltese: Sindrome ta' Sweet (dermatożi akuta bid-deni)1,2;
English: Mobilisation of PBPC
Maltese: Ara wkoll sezzjoni 4.8 Mobilizzazzjni ta' PBPC
English: • Place the injector straight onto your skin (about 90 degrees).
Maltese: • Poġġi l-injettatur dritt ġol-ġilda tiegħek (madwar 90 grad).
English: Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Maltese: Din iż-żieda tal-WBCs hija temporanja, tipikament osservata 24 sa 48 siegħa wara l-għoti u hija konsistenti mal-effetti farmakodinamiċi ta' dan il-prodott mediċinali.
English: This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 6 mg dose.
Maltese: Dan il-prodott mediċinali fih 50 mg sorbitol f'kull volum ta' unità, li huwa ekwivalenti għal 30 mg f'kull doża ta' 6 mg.
English: Subcutaneous use.
Maltese: vaskulite fil-ġilda.
English: Solution for injection 1 pre-filled injector + 1 alcohol swab
Maltese: Soluzzjoni għall-injezzjoni Injettatur mimli għal-lest 1 + swab tal-alkoħol 1
English: Rates of generation of antibodies against pegfilgrastim is generally low.
Maltese: antikorpi kontra pegfilgrastim huma ġeneralment baxxi.
English: Anaphylaxis
Maltese: Emoptiżi
English: Three reported cases show a causal relationship between the adverse drug reaction (ADR) StevensJohnson syndrome and pegfilgrastim.
Maltese: Tliet każijiet irrappurtati juru relazzjoni każwali bejn ir-reazzjoni avversa għall-mediċina (ADR) is sindrome ta' Stevens-Johnson u pegfilgrastim.
English: Adult Respiratory Distress
Maltese: Disturbi respiratorji,
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħal fil-każ ta' fatturi ta' tkabbir ematopoetiku oħra, G-CSF wera kwalitajiet stimulanti in vitro fuq ċelluli talendotelju uman.
English: Syndrome2;
Maltese: Respiratorju flAdulti2;
English: Pelgraz is for use in adults aged 18 and over.
Maltese: Pelgraz huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count).
Maltese: Is-sintomi li ġew esperjenzati kienu deni, uġigħ addominali, telqa, uġigħ fiddahar u żieda fil-markaturi infjammatorji (eż. proteina reattiva C u għadd ta' WBC).
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'
Maltese: Din il-mediċina fiha anqas minn 1 mmol (23 mg) sodium f'kull doża ta' 6 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Pull straight as shown in pictures 1 and 2.
Maltese: Iġbdu dritt kif jidher fi stampi 1 u 2.
English: Sweet's syndrome
Maltese: Sindrome ta' Distress
English: Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Maltese: Kull injettatur mimli għal-lest fih 6 mg ta' pegfilgrastim f'0.6 mL (10 mg/mL) ta' soluzzjoni għallinjezzjoni).
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: Irrata totali ta' newtropenija bid-deni kienet ta' 9% tal-pazjenti ttrattati b'pegfilgrastim u 18% talpazjenti ttrattati b'filgrastim (differenza ta' 9%, CI ta' 95% ta' -16.
English: In a second study (n = 310), which used a weightadjusted dose (100 mcg/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: id-dewmien 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: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Maltese: (majalġja, artralġja, uġigħ fl estremitajiet,
English: Leukocytosis1
Maltese: Tromboċitopenija1 Lewkoċitosi1
English: Capillary leak syndrome
Maltese: Uġigħ muskolu skeletriku
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Maltese: Konsistenti mal-effetti kliniċi u l-potenzjal għal lewkoċitosi, għadd ta' WBC
English: Solution for injection 1 pre-filled syringe + 1 alcohol swab
Maltese: Siringa mimlija għal-lest 1 + swab tal-alkoħol 1
English: The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 7).
Maltese: L-għata protettiva awtomatikament ser tgħatti llabra u ser jinstema' ħoss ta' “klikk” biex tikkonferma l-attivazzjoni tal-protezzjoni (ara stampa 7).
English: It is quite normal to have a number of courses of treatment with Pelgraz.
Maltese: Huwa pjuttost normali li tirċievi numru ta' korsijiet ta' kura b'Pelgraz.
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 Adult Respiratory Distress Syndrome (ARDS).
Maltese: 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 fl-Adulti (ARDS - Acute Respiratory Distress Syndrome).
English: Cutaneous vasculitis1,2
Maltese: Uġigħ fis-sit talinjezzjoni1
English: Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Pelgraz.
Maltese: Esponiment aċċidentali għal temperaturi ffriżati sa 24 siegħa ma jaffettwax l istabbiltà ta' Pelgraz.
English: • Clean injection site: use an alcohol swab to wipe site clean.
Maltese: • Naddaf is-sit tal-injezzjoni: uża swab tal-alkoħol biex timsaħ is-sit.
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa pazjent 1 minn kull 1,000 persuna):
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon
Maltese: ikollok reazzjoni allerġika inkluż indeboliment, tbaxxija tal-pressjoni tad-demm, diffikultà biex tieħu n-nifs, nefħa fil-wiċċ (anafilassi) , ħmura u fwawar, raxx tal-ġilda u partijiet tal-ġilda bil-ħakk.
English: In view of the possible risk of microbial contamination, Pelgraz syringes are for single use only.
Maltese: Fid-dawl tar-riskju possibbli ta' kontaminazzjoni mikrobika, is-siringi ta' Pelgraz huma għal użu ta' darba biss.
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m2 every 3 weeks for
Maltese: Fi studju double-blind, ikkontrollat bil-plaċebo, f'pazjenti b'kanċer tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenija bid-deni wara l-għoti ta' kors ta' kimoterapija assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20% (docetaxel 100 mg/m2 kull 3 ġimgħat għal 4 ċikli).
English: Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim
Maltese: Pelgraz 6 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest pegfilgrastim
English: Do not recap.
Maltese: OĦRA TAL
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Maltese: Fi provi kliniċi, pegfilgrastim ingħata b'mod sikur 14-il jum qabel il-kimoterapija.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo AML compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Maltese: II, randomised u double-blind f'pazjenti li kienu qed jirċievu kimoterapija għal AML de novo, pegfilgrastim (doża waħda ta' 6 mg) kien imqabbel ma' filgrastim, mogħtija waqt kimoterapija ta' induzzjoni.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim f'0.6 mL (10 mg/mL) ta' soluzzjoni għallinjezzjoni).
English: Thrombocytopenia and anaemia
Maltese: toraċiċi u medjastinali
English: Acute myeloid leukaemia (AML)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA (INJETATTUR MIMLI GĦAL-LEST)
English: Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim.
Maltese: trattament sussegwenti ġew irrappurtati f'pazjenti ttrattati b'pegfilgrastim.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Maltese: Dawn ġeneralment seħħew f'pazjenti b'mard malinn avanzat, sepsis, li jieħdu prodotti mediċinali multipli tal-kimoterapija jew għaddejjin minn aferesi (ara sezzjoni 4.4).
English: Aortitis has been reported after filgrastim or pegfilgrastim administration in healthy subjects and in cancer patients.
Maltese: Aortite ġiet irrappurtata wara l-għoti ta' filgrastim jew pegfilgrastim f'individwi b'saħħithom u f'pazjenti bil-kanċer.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija tat-tfassil tad-DNA segwita minn konjugazzjoni ma' polyethylene glycol (PEG). **Il-konċentrazzjoni hija ta' 20 mg/mL jekk jiġi inkluż il-porzjoni PEG.
English: Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim
Maltese: Pelgraz 6 mg soluzzjoni għall-injezzjoni f'injettatur mimli għal-lest pegfilgrastim
English: Pelgraz 6 mg solution for injection in pre-filled syringe 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: Haemoptysis
Maltese: Anafilassi
English: The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy.
Maltese: Is-sigurtà u l-effikaċja ta' pegfilgrastim ma ġewx investigati f'pazjenti b'sindrome majelodisplastika,
English: • a pre-filled syringe of Pelgraz;
Maltese: • inti tqila;
English: Excipients with known effect
Maltese: Madankollu, l-effetti fit-tul ta'
English: How do I give my injection?
Maltese: Fejn għandi nagħti l-injezzjoni tiegħi?
English: The safety and efficacy of Pelgraz have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Maltese: Is-sigurtà u l-effikaċja ta' Pelgraz ma ġewx evalwati f'pazjenti li kienu qed jirċievu kimoterapija assoċjata ma' majelosoppressjoni ittardjata eż. nitrosoureas.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Maltese: soluzzjonijiet ta' sodium chloride.
English: • Check expiration date on package.
Maltese: • Iċċekkja d-data ta' meta jiskadi fuq il-pakkett.
English: Common cases of thrombocytopenia have been reported.
Maltese: Tmissx il-labra jew timbotta l-planġer.
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo AML (see section 5.1).
Maltese: Lewkimja majelojde akuta (AML) Data klinika limitata tissuġġerixxi li l-effett fuq il-ħin biex tirkupra minn newtropenija severa f'pazjenti li reġgħet qabdithom AML mill-ġdid, huwa komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5.1).
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Maltese: granuloċiti u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edima u emokonċentrazzjoni.
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Maltese: fertilità, ċikl oestrous, ġranet bejn it-tqabbil u l-kopulazzjoni, u s-sopravivenza fil-ġuf ma ġewx affettwati minn Pegfilgrastim mogħti taħt il-ġilda.
English: How to use Pelgraz
Maltese: X'fih Pelgraz
English: Pelgraz 6 mg solution for injection in pre-filled syringe Pelgraz 6 mg solution for injection in pre-filled injector
Maltese: Informazzjoni għall-utent Pelgraz 6 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest pegfilgrastim
English: Check the expiry date on the pre-filled syringe label (EXP).
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq it-tikketta tas-siringa (wara EXP).
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 l-annimali, l-għoti ta' pegfilgrastim flimkien ma' 5-fluorouracil (5- FU) jew anti-metaboliti oħra intwera li jżid il-majelosoppressjoni.
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Maltese: Is-sigurtà u l-effikaċja tal-għoti ta' pegfilgrastim ma' ċitoġenetiċi t(15;17) f'pazjenti taħt il-55 sena li qabdithom AML mill-ġdid, għadhom ma ġewx determinati s'issa.
English: Pelgraz 6 mg solution for injection in pre-filled injector Each pre-filled injector contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Maltese: Kull injettatur mimli għal-lest fih 6 mg ta' pegfilgrastim* f'0.6 mL ta' soluzzjoni għall-injezzjoni.
English: Headache1
Maltese: Treddigħ
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Maltese: pegfilgrastim mhux lineari mad-doża; u t-tneħħija mis-serum ta' pegfilgrastim tonqos hekk kif tiżdied id-doża.
English: Effectiveness of naloxone
Maltese: Effettività ta' naloxone
English: - The active substance is naloxone.
Maltese: - Is-sustanza attiva hi naloxone.
English: 3832 RC Leusden Netherlands
Maltese: 3832 RC Leusden L-Olanda
English: Call for an ambulance.
Maltese: Ċempel għal ambulanza.
English: After 2-3 mins, use 2nd spray.
Maltese: Wara 2-3 minuti, użu t-2ni sprej.
English: Date of first authorisation: 10 November 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 10 Novembru 2017
English: Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as very common: (≥ 1/10); common: (≥ 1/100, < 1/10); uncommon: (≥ 1/1,000, < 1/100); rare: (≥ 1/10,000, < 1/1,000) very rare: (< 1/10,000); not known
Maltese: Il-kategoriji ta' frekwenza jiġu assenjati biss għal dawk ir- reazzjonijiet avversi li huma kkunsidrati li jkunu talinqas possibbilment kawżalment relatati ma' naloxone u li huma definiti bħala komuni ħafna: (≥ 1/10); komuni: (≥ 1/100, < 1/10); mhux komuni: 1/1,000, < 1/100); rari: (≥ 1/10,000, < 1/1,000) rari ħafna: (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The principal metabolites are naloxone-3-glucuronide, 6-beta-naloxol and its glucuronide.
Maltese: Il-metaboliti ewlenin huma naloxone-3glucuronide, 6-beta-naloxol u l-glucuronide tiegħu.
English: Cardiac fibrillation, Cardiac arrest
Maltese: Fibrillazzjoni kardijaka, Waqfien kardijaku
English: CAMBRIDGE, CB4 0GW,
Maltese: Milton Road Cambridge CB4 0GW
English: Name and address of the manufacturer(s) responsible for batch release BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD,
Maltese: BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON
English: SIA Inovatīvo biomedicīnas tehnoloģiju institūts Tel: + 37167800810
Maltese: SIA Inovatīvo biomedicīnas tehnoloģiju institūts Tel: + 37167800810 anita@ibti.lv
English: Napp Pharmaceuticals Limited
Maltese: Bard Pharmaceuticals Limited
English: България ТП„Мундифарма медикъл ООД“
Maltese: ТП„Мундифарма медикъл ООД“ Тел.:
English: A study demonstrated mean absolute bioavailability of 47% and mean half-lives of 1.4 h from intranasal doses of 2 mg.
Maltese: Studju wera bijodisponibilità assoluta medja ta' 47% half-lives medji ta' 1.4 sigħat minn dożi intranażali f'dożi ta' 2 mg.
English: 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu lidentifikatur uniku inkluż.
English: Nyxoid is not a substitute for emergency medical care.
Maltese: Nyxoid mhuwiex sostitut għal kura medika ta' emerġenza.
English: This medicine contains the active substance naloxone.
Maltese: Din il-mediċina fiha s-sustanza attiva naloxone.
English: Naloxone, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors.
Maltese: Naloxone, derivattiv ta' morfina semisintetika (N-allyl-nor-oxymorphone), hu antagonist opjojdi speċifiku li jaġixxi b'mod kompetittiv fir-riċetturi tal-opjojdi.
English: Nyxoid is indicated in adults and adolescents aged 14 years and over.
Maltese: Nyxoid huwa indikat f'adulti u adolexxenti li għandhom 14-il sena u aktar.
English: Mundipharma Ges.m.b.H.-o.z.
Maltese: Slovenská republika Mundipharma Ges.m.b.H.-o.z.
English: Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described, more typically when naloxone is used post-operatively (see sections 4.4 and 4.8).
Maltese: Pressjoni għolja, arritmiji kardijaċi, edema pulmonari u waqfien kardijaku ġew deskritti, aktar tipikament meta naloxone jintuża wara operazzjoni (ara sezzjonijiet 4.4 u 4.8).
English: Call an ambulance
Maltese: Ċempel għal ambulanza
English: Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia.
Maltese: Sinjali u sintomi ta' sindrome ta' meta wieħed jieqaf jieħu l-mediċina jinkludu irrekwitezza, irritabilità, iperestesija, dardir, rimettar, uġigħ gastrointestinali, spażmi fil-muskoli, disforija, insomnja, ansjetà, iperidrożi, piloerezzjoni, takikardija, żieda fil-pressjoni tad-demm, titwib, deni.
English: The Video should include:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: After a period of 72 hours, 65% of the injected dose was recovered in urine in the healthy volunteers compared with 68% of the dose in opiate-dependent patients.
Maltese: Wara perjodu ta' 72 siegħa, 65% tad-doża injettata ġiet irkuprata fl-awrina fil-voluntiera b'saħħithom meta mqabbla ma' 68% tad-doża f'pazjenti dipendenti fuq l-opiates.
English: Excipients: Trisodium citrate dihydrate, sodium chloride, hydrochloric acid sodium hydroxide, purified water.
Maltese: Trisodium citrate dihydrate, sodium chloride, hydrochloric acid sodium hydroxide, ilma ppurifikat.
English: Tel: + (48 22) 866 87 12 biuro@mundipharma.pl
Maltese: Mundipharma Polska Sp. z o.o. Tel: + (48 22) 866 87 12 biuro@mundipharma.pl
English: Austria - organizační složka Tel: + 420 222 318 221
Maltese: Tel: + 420 222 318 221
English: Naloxone temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine and morphine.
Maltese: Naloxone jikkawża it-treġġigħ lura temporanju taleffetti tal-opjojdi bħal eroina, methadone, fentanyl, oxycodone, buprenorphine u morfina.
English: • If you use buprenorphine.
Maltese: Nyxoid • Jekk tuża buprenorphine.
English: Gebührenfreie Info-Line: +49 69 506029-000 info@mundipharma.de
Maltese: +49 69 506029-000 info@mundipharma.de
English: Uncommon Arrhythmia, Bradycardia Very rare
Maltese: Arritmija, Bradikardija
English: The half value duration (HVD) values for intranasal administration were longer than for IM administration (intranasal, 2 mg, 1.27h, IM, 0.4 mg 1.09h) from which we can infer a longer duration of action of naloxone given by the intranasal rather than the IM route.
Maltese: Il-valuri tat-tul tan-nofs il-valur (HVD, half value duration) għall-għoti intranażali kienu itwal milli għall-għoti IM (intranażali, 2 mg, 1.27h, IM, 0.4 mg 1.09h), u minn dan nistgħu niddeduċu tul ta' żmien itwal ta' azzjoni ta' naloxone mogħti mir-rotta intranażali milli mir-rotta IM.
English: In the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.
Maltese: Fl-assenza ta' opjojdi jew effetti agonistiċi ta' antagonisti oħrajn tal opjojdi, ma juri essenzjalment l-ebda attività farmakoloġika.
English: 1 mg, 30 (8, 60) minutes for 2 mg and 15 (10, 60) minutes for 4 mg intranasal doses.
Maltese: Studju li investiga naloxone intranażali f'dożi ta' 1, 2, 4 mg (MR903-1501) juri li t-tmax medjan (medda) assoċjat mal-għoti intranażali ta' naloxone kien ta' 15 (10, 60)-il minuta għal dożi intranażali ta' 1 mg, 30 (8, 60) minuta għal 2 mg, u 15 (10, 60)-il minuta għal 4 mg.