qanastek/EMEA-V3 huggingface dataset:
Of the 213 patients in whom the outcome was known the survival was 58%.
Mill- 213- il pazjent li fihom ir- riżultat kien magħruf, is- sopravivenza kienet ta ’ 58%.
Of the 89 patients who died, 63 were initially found in cardiac arrest, suggesting that many of these patients had almost certainly suffered irreparable brain injury prior to administration of hydroxocobalamin.
Mid- 89 pazjent li mietu, 63 inizjalment instab li kellhom waqfien kardijaku, u dan jissuġġerixxi li ħafna minn dawn il- pazjenti kważi ċertament sofrew ħsara irreparabbli fil- moħħ qabel l- għoti ta ’ hydroxocobalamin.
Among 144 patients not in initial cardiac arrest whose outcomes were known, 118 (82%) survived.
Fost 144 pazjent li ma kellhomx waqfien inizjali kardijaku li r- riżultati tagħhom kienu magħrufa, 118 (82%) baqgħu ħajjin.
Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥ 100 µmol/ l), 21 (62%) survived following treatment with hydroxocobalamin.
Kif ukoll, fi 34 pazjent b’ konċentrazzjonijiet magħrufa ta ’ cyanide iktar mill- limitu letali (≥ 100 µmol/ l), 21 (62%) baqgħu ħajjin wara t- trattament b’ hydroxocobalamin.
Administration of hydroxocobalamin was generally associated with a normalisation of blood pressure (systolic blood pressure > 90 mmHg) in 17 of 21 patients (81%) who had low blood pressure (systolic blood pressure > 0 and ≤ 90 mmHg) after exposure to cyanide.
L- għoti ta ’ hydroxocobalamin kien ġeneralment assoċjat ma ’ normalizazzjoni tal- pressjoni tad- demm (pressjoni sistolika tad- demm ta ’ > 90 mmHg) fi 17 minn 21 pazjent (81%) li kellhom pressjoni tad - demm baxxa (pressjoni sistolika tad- demm ta ’ > 0 u ≤ 90 mmHg) wara espożizzjoni għal cyanide.
Where neurological assessment over time was possible, (96 patients of the 171 patients who presented with neurological symptoms prior to hydroxocobalamin administration), 51 (53%) patients receiving hydroxocobalamin showed improvement or a complete restoration.
Fejn l- evalwazzjoni newroloġika fuq perjodu ta ’ żmien kienet possibbli, (96 pazjent mill- 171 pazjent li kellhom sintomi newroloġiċi qabel l- għoti ta ’ hydroxocobalamin), 51 (53%) tal- pazjenti li kienu qed jirċievu hydroxocobalamin urew titjib jew fejqan sħiħ.
• Elderly
• Anzjani
Approximately 50 known or suspected cyanide victims aged 65 or older received hydroxocobalamin in clinical studies.
Madwar 50 vittma ta ’ cyanide magħrufa jew suspettati li kellhom 65 sena jew aktar, irċivew hydroxocobalamin fi studji kliniċi.
In general, the effectiveness of hydroxocobalamin in these patients was similar to that of younger patients.
B’ mod ġenerali, l- effikaċja ta ’ hydroxocobalamin f’ dawn il - pazjenti kienet simili għal dik ta ’ pazjenti żgħar.
• Paediatric patients
8 • Pazjenti pedjatriċi
Documentation on efficacy is availablefor 54 paediatric patients.
Id- dokumentazzjoni fuq effikaċja hi disponibbli għal 54 pazjent pedjatriku.
The mean age of the paediatric patients was about six years and the mean dose of hydroxocobalamin was about 120 mg/ kg body weight.
Il- medja ta ’ l- età tal - pazjenti pedjatriċi kienet ta ’ madwar sitt snin u d- doża medja ta ’ hydroxocobalamin kienet ta ’ madwar 120 mg/ kg ta ’ piż tal- ġisem.
The survival rate of 41% depended very much on the clinical situation.
Ir- rata ta ’ sopravivenza ta ’ 41% kienet tiddependi ħafna fuq is - sitwazzjoni klinika.
Out of the 20 paediatric patients without initial cardiac arrest, 18 (90%) survived, of whom 4 with sequelae.
Fost l- 20 pazjenti pedjatriċi li ma kellhomx waqfien kardijaku inizjali, 18 (90%) baqgħu ħajjin, li minnhom 4 kellhom sequelae.
In general, the effectiveness of hydroxocobalamin in paediatric patients was similar to that of adults.
B’ mod ġenerali, l- effettività ta ’ hydroxocobalamin fil - pazjenti pedjatriċi kienet simili għal dik ta ’ pazjenti adulti.
5.2 Pharmacokinetic properties
5. 2 Proprjetajiet farmakokinetiki
The low molecular weight cobalamins-(III) formed including
Wara l- għoti ġol- vini ta ’ Cyanokit, iseħħ tgħaqqid sinjifikanti mal- proteini tal- plażma u piż molekulari baxx ta ’ komposti fiżjoloġiċi, biex jifforma kumplessi varji ta ’ cobalamin - (III) bis- sostituzzjoni tal - ligand hydroxo.
8 hydroxocobalamin are termed free cobalamins-(III); the sum of free and protein-bound cobalamins is termed total cobalamins-(III).
Ic- cobalamins - (III) b’ piż molekulari baxx li ffurmaw, li jinkludu hydroxocobalamin, huma msejħa cobalamins - (III) ħielsa; it- total ta ’ cobalamins ħielsa u ta ’ dawk imwaħħlin mal- proteini jissejjaħ cobalamins - (III) totali.
In order to reflect the exposure to the sum of all derivatives, pharmacokinetics of cobalamins-(III) were investigated instead of hydroxocobalamin, requiring the concentration unit µg eq/ ml (i. e. cobalamin-(III) entity without specific ligand).
Sabiex tirrifletti l - espożizzjoni għat- total tad- derivattivi kollha, il - farmakokinetika ta ’ cobalamins - (III) kienet investigata minflok dik ta ’ hydroxocobalamin, li kienet teħtieġ l- unità tal- konċentrazzjoni µg eq/ ml (i. e. l- entità cobalamin - (III) mingħajr ligand speċifiku).
Dose-proportional pharmacokinetics were observed following single dose intravenous administration of 2.5 to 10 g of Cyanokit in healthy volunteers.
Il- farmakokinetika proporzjonali għad- doża kienet osservata wara l- għoti ta ’ doża waħda ġol- vini ta ’ 2. 5 sa 10 g ta ’ Cyanokit f’ voluntiera b’ saħħithom.
Mean free and total cobalamins-(III) Cmax values of 113 and 579 µg eq/ ml, respectively, were determined following a dose of 5 g Cyanokit (the recommended initial dose).
Il- medja tal- valuri tas- Cmax ta ’ cobalamins - (III) ħielsa u dawk totali, ta ’ 113 u 579 µg eq/ ml rispettivament, kienet stabbilita wara doża ta ’ 5 g ta ’ Cyanokit (id- doża inizjali rakkomandata).
Similarly, mean free and total cobalamins-(III) Cmax values of 197 and 995 µg eq/ ml, respectively, were determined following the dose of 10 g Cyanokit.
Bl- istess mod, il- medja tal- valuri ħielsa u totali tas- Cmax ta ’ cobalamins - (III), ta ’ 197 u 995 µg eq/ ml rispettivament, kienet stabbilita wara doża ta ’ 10 g ta ’ Cyanokit.
The predominant mean half-life of free and total cobalamins-(III) was approximately 26 to 31 hours at the 5 and 10 g dose level.
Il- medja predominanti ħielsa u totali tal- half- life ta ’ cobalamins - (III) kienet ta ’ madwar 26 sa 31 siegħa fil- livell tad- doża ta ’ 5 u 10 g.
The mean total amount of cobalamins-(III) excreted in urine during the collection period of 72 hours was approximately 60% of a 5 g dose and approximately 50% of a 10 g dose of Cyanokit.
Il- medja ta ’ l- ammont totali ta ’ cobalamins - (III) li tneħħew fl- awrina matul il- perjodu ta ’ ġbir ta ’ 72 siegħa kienet ta ’ madwar 60% ta ’ doża ta ’ 5 g u madwar 50% ta ’ doża ta ’ 10 g ta ’ Cyanokit.
Overall, the total urinary excretion was calculated to be at least 60 to 70% of the administered dose.
Globalment, it- tneħħija totali permezz ta ’ l- awrina kienet ikkalkulata li hi mill- inqas 60 sa 70% tad - doża li tkun ingħatat.
The majority of the urinary excretion occurred during the first 24 hours, but red coloured urine was observed for up to 35 days following the intravenous infusion.
Il- maġġoranza tat- tneħħija fl- awrina seħħet matul l- ewwel 24 siegħa, iżda awrina ta ’ kulur aħmar kienet osservata sa 35 jum wara l- infużjoni ġol- vini.
When normalized for body weight, male and female subjects revealed no major differences in plasma and urinary pharmacokinetic parameters of free and total cobalamins-(III) following the administration of 5 g or 10 g Cyanokit.
Meta normalizzati għal piż tal- ġisem, pazjenti rġiel u nisa ma żvelaw l- ebda differenzi maġġuri fil - plażma u fil- parametri farmakokinetiċi ta ’ l- awrina ta ’ cobalamins - (III) ħielsa u totali, wara l- għoti ta ’ 5 g jew 10 g ta ’ Cyanokit.
In cyanide-poisoned patients, hydroxocobalamin is expected to bind cyanide to form cyanocobalamin, which is excreted in the urine.
F’ pazjenti li jkunu avvelenati b’ cyanide, hydroxocobalamin hu mistenni li jingħaqad ma ’ cyanide biex jifforma cyanocobalamin, li jitneħħa fl- awrina.
The pharmacokinetics of total cobalamins-(III) in this population may be affected by the body's cyanide load, since cyanocobalamin was reported to exhibit a 2-3 times lower half-life than total cobalamins-(III) in healthy volunteers.
Il- farmakokinetika ta ’ cobalamins - (III) totali f’ din il - popolazzjoni tista ’ tkun affettwata mill- ammont ta ’ cyanide fil- ġisem, għax cyanocobalamin kien irrappurtat li juri half- life li hi 2- 3 darbiet iktar baxxa mil- cobalamins - (III) totali f’ voluntiera b’ saħħithom.
In anaesthetised rabbits, hydroxocobalamin exerted haemodynamic effects (increased mean arterial blood pressure and total peripheral resistance, decreased cardiac output) related to its nitric oxide- scavenging property.
Fi fniek li kienu taħt l- effett tal- loppju, hydroxocobalamin ħoloq effetti emodinamiċi (żieda fil- medja arterjali tal- pressjoni tad- demm u fir- reżistenza periferali totali, tnaqqis fir- risultat kardijaku) relatati man- natura tiegħu ta ’ nitric oxide- scavenging.
No special hazard for humans was identified based on conventional studies of single and repeated dose toxicity and genotoxicity.
L- ebda periklu speċjali għal bniedem ma kien identifikat, ibbażat fuq studji konvenzjonali ta ’ l- effett tossiku minn dożi waħidhom u ripetuti, u ta ’ l- effett tossiku fuq il- ġeni.
The liver and kidney were found to be the major target organs.
Instab li l- fwied u l- kliewi kienu l- organi li l- aktar li kienu fil- mira.
However findings were only seen at exposure levels considered being higher than the maximum human exposure, indicating limited relevance to clinical use.
Madankollu, is- sejbiet kienu osservati biss f’ livelli ta ’ espożizzjoni li kienu kkunsidrati li huma ogħla mill - espożizzjoni massima fil- bniedem, li tindika rilevanza limitata għall- użu kliniku.
In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/ kg.
Ma tantx hemm rilevanza ta ’ din
The relevance of this finding to humans is unlikely since it was not reported in short-term studies conducted with hydroxocobalamin.
9 is- sejba għall- bniedem, għax ma kinitx irrappurtata fi studji li saru fuq medda qasira ta ’ żmien b’ hydroxocobalamin.
Developmental toxicity, including teratogenicity, was observed in rats and rabbits at dose levels of 150 mg/ kg and higher administered daily throughout organogenesis.
It- tossiċità waqt l- iżvilupp, li tinkludi t- teratoġeniċità kienet osservata fil- firien u fil- fniek f’ livelli ta ’ doża ta ’ 150 mg/ kg u ogħla mogħtija kuljum matul l- organoġenesi.
The dose of 150 mg/ kg approximately corresponds to the maximum recommended human dose.
Id- doża ta ’ 150 mg/ kg tikkorrispondi bejn wieħed u ieħor għad- doża umana massima rakkomandata.
No data are available on male and female fertility as well as on peri- and postnatal development.
M’ hemm l- ebda informazzjoni disponibbli dwar il- fertilità ta ’ l- irġiel u tan- nisa, kif ukoll dwar l - iżvilupp ta ’ qabel u wara t- twelid.
Hydroxocobalamin has not been evaluated for carcinogenic potential.
Hydroxocobalamin ma kienx evalwat għall- potenzjal karċinoġeniku.
Hydrochloric acid
Hydrochloric acid.
9 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Physical incompatibility (particle formation) was observed with the mixture of hydroxocobalamin in solution and the following medicinal products: diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, pentobarbital, phenytoin sodium, propofol and thiopental.
L- inkompatibilità fiżika (formazzjoni ta ’ partiċelli) kienet osservata mat- taħlita ta ’ hydroxocobalamin fis- soluzzjoni u l- prodotti mediċina li ġejjin: diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, pentobarbital, phenytoin sodium, propofol u thiopental.
Chemical incompatibility was observed with sodium thiosulfate, sodium nitrite, and has been reported with ascorbic acid.
L- inkompatibilità kimika kienet osservata ma ’ sodium thiosulfate, sodium nitrite, u kienet irrappurtata ma ’ ascorbic acid.
Consequently, these medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
Konsegwentement, dawn il - prodotti mediċinali m’ għandhomx jingħataw kontemporaneament minn ġo l- istess linja tal- vini bħal hydroxocobalamin.
Simultaneous administration of hydroxocobalamin and blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) through the same intravenous line is not recommended (see section 6.6).
L- għoti fl- istess ħin ta ’ hydroxocobalamin u ta ’ prodotti tad- demm (demm sħiħ, ċelluli ħomor ippakkjati, konċentrat tal- plejtlits u plażma friska ffriżata) minn ġo l- istess linja tal- vini mhuwiex rakkomandat (ara sezzjoni 6. 6).
6.3 Shelf life
6. 3 Skadenza tal- prodott
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 6 hours at a temperature between 2°C and 40°C.
L- istabbiltà kimika u fiżika waqt l- użu tas- soluzzjoni rikostitwita ntweriet għal 6 sigħat f’ temperatura ta ’ bejn 2°C sa 40°C.
From a microbiological point of view, the product should be used immediately.
Mill- aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8ºC.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r - responsabbiltà ta ’ l- utent u normalment ma jkunx itwal minn 6 sigħat f’ temperatura ta ’ 2°C sa 8°C.
For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5°C to 40°C), transport in the desert (4 days submitted to temperatures ranging from 5°C to 60°C) and freezing/ defrosting cycles (15 days submitted to temperatures ranging from -20°C to 40°C).
Għal skopijiet ta ’ użu ambulatorju, Cyanokit jista ’ jkun espost waqt perjodi qosra għal varjazzjonijiet tat- temperatura waqt it- trasport normali (15- il jum espost għal temperaturi li jvarjaw minn 5°C sa 40°C), trasport fid- deżert (4 ijiem espost għal temperaturi li jvarjaw minn 5°C sa 60°C) u ċikli ta ’ ffriżar/ iddefrostjar (15- il jum espost għal temperaturi li jvarjaw minn - 20°C sa 40°C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
6.5 Nature and contents of container
10 6. 5 In- natura u kontenut tal- kontenitur
Type II colourless 250 ml glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.
Kunjett wieħed ta ’ 250 ml magħmul minn ħġieġ ta ’ Tip II bla kulur, magħluq b’ tapp tal- lastku tal - bromobutyl u b’ għatu ta ’ l- aluminju b’ għatu tal- plastik.
Each vial contains 2.5 g powder for solution for infusion.
Kull kunjett fih 2. 5 g ta ’ trab għal soluzzjoni għall- infużjoni.
Each carton contains two glass vials (each glass vial packed in one cardboard box), two sterile transfer devices, one sterile intravenous infusion set and one sterile short catheter for administration to children.
Kull kaxxa tal- kartun fiha żewġ kunjetti tal- ħġieġ (kull kunjett tal- ħġieġ hu ppakkjat f’ kaxxa waħda tal- kartun), żewġ strumenti sterili għat- trasferiment, sett wieħed sterili ta ’ infużjoni ġol- vini u kateter sterili qasir wieħed għall- għoti lit- tfal.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali għar- imi u immaniġġar ieħor
Each vial is to be reconstituted with 100 ml of diluent using the supplied sterile transfer device.
Kull kunjett li għandu jkun rikostitwit b’ 100 ml ta ’ dilwent bl - użu ta ’ strumenti sterili għat - trasferiment li hu provdut.
Sodium chloride 9 mg/ ml (0.9%) solution for injection is the recommended diluent.
Soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml ta ’ sodium chloride (0. 9%) hi d - dilwent rakkomandat.
Only when sodium chloride 9 mg/ ml (0.9%) solution for injection is not available, Lactated Ringer solution or 5% glucose can also be used.
Huwa biss meta soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml ta ’ sodium chloride (0. 9%) ma tkunx disponibbli, li tista ’ tintuża wkoll soluzzjoni ta ’ Lactated Ringer jew 5% glukosju.
The Cyanokit vial is to be rocked or inverted for at least 30 seconds to mix the solution.
Il- kunjett ta ’ Cyanokit għandu jixxengel jew jinqaleb għal mill- inqas 30 sekonda biex tħallat is - soluzzjoni.
It must not be shaken as shaking the vial may cause foam and therefore may make checking reconstitution less easy.
M’ għandux jitħawwad, għax it- taħwid tal- kunjett jista ’ jikkawża r- ragħwa, u għaldaqstant jagħmel l- iċċekkjar tar- rikostituzzjoni inqas faċli.
Because the reconstituted solution is a dark red solution, some insoluble particles may not be seen.
Minħabba li s- soluzzjoni rikostitwita hi soluzzjoni ta ’ kulur aħmar skur, xi partikuli li ma jinħallux jistgħu ma jkunux jidhru.
The intravenous infusion set provided in the kit must then be used as it includes an appropriate filter 10 and is to be primed with the reconstituted solution.
Imbagħad, is- sett ta ’ l - infużjoni ġol- vini ipprovdut fil- kitt irid jintuża għax jinkludi filtru adattat u għandu jkunu ipprajmat bis- soluzzjoni rikostitwita.
Repeat this procedure if necessary with the second vial.
Jekk ikun hemm bżonn irrepeti din il- proċedura bit- tieni kunjett.
If blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) and hydroxocobalamin are administered simultaneously, use of separate intravenous lines (preferably on contralateral extremities) is recommended (see section 6.2).
Jekk il- prodotti tad- demm (demm sħiħ, ċelluli ħomor ippakkjati, konċentrat tal- plejtlits u plażma friska iffriżata) u hydroxocobalamin jingħataw fl- istess ħin, l- użu ta ’ linji separati tal- vini (preferibbilment fuq estremitajiet kontralaterali) hu rakkomandat (ara sezzjoni 6. 2).
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS- SUQ
37, rue Saint-Romain 69379 Lyon Cedex 08 France
37, rue Saint- Romain 69379 Lyon Cedex 08 Franza
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZAZZJONI/ TIĠDID TA ’ L- AWTORIZAZZJONI
11 ANNEX II
11 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZAZZJONI GĦAT - TQEGĦID FIS- SUQ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Centre de production de Semoy 2, rue du Pressoir Vert FR-45400 Semoy France
Centre de production de Semoy 2, rue du Pressoir Vert FR- 45400 Semoy Franza
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizazzjoni għat- tqegħid fis- suq jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 3. 0, ippreżentata fil- modulu 1. 8. 1. tal- Applikazzjoni ta ’ l- Awtorizazzjoni għat - tqegħid fis- suq, tkun implimentata u taħdem qabel u waqt li l- prodott ikun fuq s- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 6.0 dated 21 October 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju Id- detentur ta ’ l- awtorizazzjoni għat- tqegħid fis- suq iwiegħed li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza kif miftehma f’ verżjoni 6. 0 (21 t’ Ottubru 2008) tal- Pjan dwar l- Immaniġġjar tar- Riskju (PIR) ippreżentat fil- modulu 1. 8. 2 tal - Applikazzjoni ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u kwalunkwe aġġornamenti sussegwenti tal - PIR mifthema mill- CHMP (Committee for Medicinal Products for Human Use).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHMP dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, il- PIR aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR, Periodic Safety Update Report) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jkun sottomess PIR aġġornat: • meta wieħed jircievi informazzjoni ġdida li tista ’ teffetwa l- ispeċifikazzjoni tas- Sigurta` kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskji • fi żmien 60 jum minn meta jintlaħaq punt (ta ’ Farmakoviġilanza jew tnaqqis ta ’ riskji) importanti • fuq talba ta ’ l- EMEA
13 ANNEX III
13 ANNESS III
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Cyanokit 2.5 g powder for solution for infusion Hydroxocobalamin
Cyanokit 2. 5 g trab għal soluzzjoni għall- infużjoni Hydroxocobalamin
Hydrochloric acid.
Hydrochloric acid.
Two vials, each containing 2.5 g of powder for solution for infusion.
Żewġ kunjetti fihom 2. 5 g kull wieħed ta ’ trab għal soluzzjoni għall- infużjoni.
Two transfer devices.
Żewġ strumenti għat- trasferiment.
One intravenous infusion set.
Sett wieħed ta ’ l- infużjoni għal ġol- vini.
One short catheter for administration to children.
Kateter qasir wieħed għall- għoti lit- tfal.
This kit does not contain diluent.
Dan il- kitt ma fihx dilwent.
Read the leaflet for storage conditions in ambulatory use.
Aqra l- fuljett għall- kundizzjonijiet tal- ħażna waqt l- użu ambulatorju.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata fuq riċetta tat- tabib.
Justification for not including Braille accepted
Il- ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARDBOARD BOX
KAXXA TAL- KARTUN
One vial containing 2.5 g of powder for solution for infusion.
Kunjett wieħed fih 2. 5 g ta ’ trab għal soluzzjoni għall- infużjoni.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 18 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
19 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Powder for solution for infusion containing 2.5 g of hydroxocobalamin.
Trab għal soluzzjoni għall- infużjoni li fih 2. 5 g ta ’ hydroxocobalamin.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 20 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
21 MEDICAL OR HEALTHCARE PROFESSIONALS EDUCATIONAL STICKER
21 STICKER EDUKATTIV MEDIKU JEW TAL- PROFESSJONISTI FIL- QASAM TAS- SAĦĦA
“ To be attached to the patient ’ s medical record:
“ Biex jitwaħħal mar- rekord mediku tal- pazjent:
Cyanokit has been administered to this patient.
Cyanokit ingħata lil dan il- pazjent.
Cyanokit may interfere with burn assessment (red coloration of the skin) and laboratory tests (see SPC) .”
Cyanokit jista ’ jinterferixxi ma ’ l- evalwazzjoni tal- ħruq (ħmura tal- ġilda) u testijiet tal- laboratorju (ara Sommarju tal- Karatteristiċi tal- Prodott). ”
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
Cyanokit 2.5 g powder for solution for infusion hydroxocobalamin
Cyanokit 2. 5 g trab għal soluzzjoni għall- infużjoni hydroxocobalamin
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, igħid lit- tabib jew lill- ispiżjar tiegħek.
What Cyanokit is and what it is used for 2.
X’ inhu Cyanokit u għalxiex jintuża 2.
Before you use Cyanokit 3.
Qabel ma tuża Cyanokit 3.
How to use Cyanokit 4.
Kif għandek tuża Cyanokit 4.
Possible side effects 5.
Effetti sekondarji possibbli 5.
How to store Cyanokit 6.
Kif taħżen Cyanokit 6.
WHAT CYANOKIT IS AND WHAT IT IS USED FOR
X’ INHU CYANOKIT U GĦALXIEX JINTUŻA
Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning.
Cyanokit hu antidotu għat- trattament ta ’ avvelenament magħruf jew suspettat b’ cyanide.
Cyanide is a highly poisonous chemical.
Cyanide hu kimika velenuża ħafna.
Cyanide poisoning may be caused by exposure to smoke from household and industrial fires, breathing or swallowing cyanide, or contact with cyanide on skin.
L- avvelenament b’ cyanide jista ’ jkun ikkawżat mill - espożizzjoni għal duħħan minn nirien fid- dar jew industrijali, ġbid jew bligħ bin- nifs ta ’ cyanide, jew b’ kuntatt ma ’ cyanide fuq il- ġilda.
BEFORE YOU USE CYANOKIT
QABEL MA TUŻA CYANOKIT
Take special care with Cyanokit
Oqgħod attent ħafna b’ Cyanokit
Tell your doctor or other health personnel • if you are allergic to hydroxocobalamin or vitamin B12.
Igħid lit- tabib tiegħek jew lil staff ieħor tat- trattament tas- saħħa • jekk inti allerġiku/ a għal hydroxocobalamin jew vitamina B12.
They will have to take it into account before treating you with Cyanokit. • that you have been treated with Cyanokit if you need to have any blood or urine tests.
Dan irid ikun ikkunsidrat qabel ma inti tkun trattat/ a b’ Cyanokit. • jekk ikollok bżonn ta ’ xi testijiet tad- demm jew ta ’ l- awrina, li inti kont trattat/ a b’ Cyanokit.
Cyanokit may modify the results of these tests.
Cyanokit jista ’ jibdel ir- riżultati ta ’ dawn it- testijiet.
Using other medicines
Użu ta ’ mediċini oħra
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok igħid lit- tabib tiegħek jekk qiegħed tieħu jew dan l- aħħar ħadt xi mediċini oħra, anki dawk mingħajr riċetta.
Detailed information for your doctor or other health personnel regarding simultaneous administration of Cyanokit with other medicines can be found at the end of this package leaflet (see'Handling instructions').
Informazzjoni dettaljata għat- tabib tiegħek jew għal staff ieħor tal- kura tas- saħħa dwar l- għoti fl- istess ħin ta ’ Cyanokit ma ’ mediċini oħrajn jinsab fl- aħħar ta ’ dan il- fuljett ta ’ tagħrif (ara ‘ Struzzjonijiet dwar l- Immaniġġjar ’).
This medicine is an emergency treatment.
Din il- mediċina hi trattament ta ’ emerġenza.
It can be administered during pregnancy and breast-feeding.
Tista ’ tingħata matul it- tqala u waqt it- treddigħ.
Tell your doctor as soon as possible if you were pregnant or think you may have been pregnant during treatment with Cyanokit.
Għandek tgħid lit- tabib tiegħek immedjatament jekk kont tqila jew jekk taħseb li kont tqila matul it - trattament b’ Cyanokit.
24 Driving and using machines
24 Sewqan u tħaddim ta ’ magni
It is not known whether Cyanokit affects the ability to drive or use machines.
Mhuwiex magħruf jekk Cyanokit jaffettwax il- ħila li ssuq jew tuża l- magni.
HOW TO USE CYANOKIT
KIF GĦANDEK TUŻA CYANOKIT
You will have Cyanokit by infusion into a vein.
Inti ser tingħata Cyanokit permezz ta ’ infużjoni ġo vina.
You may have one or two infusions.
Tista ’ tingħata infużjoni waħda jew żewġ infużjonijiet.
You will have the first infusion of Cyanokit over 15 minutes.
Ser tingħata l- ewwel infużjoni ta ’ Cyanokit fuq perjodu ta ’ 15- il minuta.
If you need a second infusion, you will have it over 15 minutes to 2 hours.
Jekk tkun teħtieġ it- tieni infużjoni, din ser tingħatalek fuq perjodu ta ’ 15- il minuta sa sagħtejn.
It depends on how serious the poisoning is.
Dan jiddependi minn kemm hu serju l- avvelenament.
Detailed instructions for your doctor or other health personnel on how to prepare the Cyanokit infusion and how to determine the dose can be found at the end of this package leaflet (see'Handling instructions').
Struzzjonijiet dettaljati għat- tabib tiegħek jew għal staff ieħor tal- kura tas- saħħa dwar kif ikun ippreparat Cyanokit għall- infużjoni u kif tiddetermina d- doża jinsabu fl- aħħar ta ’ dan il- fuljett ta ’ tagħrif (ara ‘ Struzzjonijiet dwar l- immaniġġjar ’).
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI POSSIBBLI
Like all medicines, Cyanokit can cause side effects, although not everybody gets them.
Bħal kull mediċina, Cyanokit tista ’ tikkawża effetti sekondarji, għalkemm mhux kulħadd jista ’ jkun effettwat.
The following side effects may be expected:
L- effetti sekondarji li ġejjin jistgħu jkunu mistennija:
Most patients will experience a reversible red colouration of the skin and membranes lining body cavities (mucous membranes) that may last up to 15 days after administration of Cyanokit.
Il- biċċa l- kbira tal- pazjenti ser ikollhom ħmura riversibbli fil- ġilda u fil- membrani li jiksu l- kavitajiet tal- ġisem (membrani mukużi), li tista ’ ddum sa 15- il jum wara l- għoti ta ’ Cyanokit.
Allergy (hypersensitivity)
Allerġija (sensittività eċċessiva)
Tell your doctor immediately if you have the following symptoms during or after this treatment: • swelling around the eyes, lips, tongue, throat or hands • breathing difficulties, hoarseness, difficulty in speaking • skin redness, nettle rash (urticaria) or itching.
Għid lit- tabib tiegħek immedjatament jekk ikollok dawn is- sintomi li ġejjin matul jew wara dan it - trattament: • nefħa madwar l- għajnejn, xufftejn, ilsien, gerżuma jew idejn • diffikultajiet biex tieħu n- nifs, ħanqa, diffikultà biex titkellem • ħmura fil- ġilda, raxx bħal dak ikkawżat mill- ħurrieq (urtikarja) jew ħakk.
Such side effects may be serious and need immediate attention.
Effetti sekondarji bħal dawn jistgħu jkunu serji u jeħtieġu attenzjoni immedjata.
Heart and blood pressure problems
Problemi tal- qalb u tal- pressjoni tad- demm
• symptoms such as headache or dizziness, as they may be due to a rise in blood pressure.
• sintomi bħal uġigħ ta ’ ras jew sturdament, għax dawn jistgħu jkunu minħabba żieda fil- pressjoni tad- demm.
This rise in blood pressure especially occurs at the end of having this treatment and usually settles down within several hours • irregular heart beat • redness of the face (flush).
Din iż- żieda fil- pressjoni tad- demm isseħħ b’ mod speċjali fit- tmiem ta ’ dan it - trattament, u normalment tgħaddi fi żmien diversi sigħat • taħbit tal- qalb irregolari • ħmura tal- wiċċ (fwawar).
A decrease in blood pressure and a faster heart beat have also been observed in patients who have cyanide poisoning.
Tnaqqis fil- pressjoni tad- demm u taħbit iktar mgħaġġel tal- qalb kienu osservat ukoll f’ pazjenti li jkollhom avvelenament b’ cyanide.
Breathing and chest problems
Problemi biex tieħu n- nifs u tas- sider
• fluid in the chest (pleural effusion) • breathing difficulties • a feeling of tightness in the throat • dry throat • chest discomfort.
• fluwidu fis- sider (ħruġ ta ’ likwidu mill- plewra) • diffikultajiet biex tieħu n- nifs • sensazzjoni ta ’ tagħfis fil- gerżuma
Gastrointestinal (digestive) problems
Problemi gastrointestinali (diġestivi)
25 • discomfort in your stomach • indigestion • diarrhoea • feeling sick (nausea) • being sick (vomiting) • difficulty in swallowing.
• skomdu fl- istonku tiegħek • indiġestjoni • dijarea • tħossok imdardar (nawsja) • ħass ħażin • diffikultà biex tibla ’.
Eye problems
Problemi ta ’ l- għajnejn
• swelling, irritation, redness.
• nefħa, irritazzjoni, ħmura.
Skin reactions
Reazzjonijiet tal- ġilda
• blister-like lesions on the skin (pustular rashes).
• leżjonijiet qishom bżieżaq fuq il- ġilda (raxx bil- ponot).
These may last for several weeks, and affect mainly the face and the neck. • inflammation in the part of the body where the medicine was infused.
Dawn jistgħu jdumu għal diversi ġimgħat, u jaffettwaw primarjament il- wiċċ u l- għonq. • infjammazzjoni fil- parti tal- ġisem fejn il- mediċina ngħatat bħala infużjoni.
Other side effects
Effetti sekondarji oħrajn
• restlessness • problems with memory • dizziness • headache • swelling of ankles • changes in the results of blood tests for certain white blood cells (lymphocytes) • coloured plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters.
• nuqqas ta ’ kwiet • problemi fil- memorja • sturdament • uġigħ ta ’ ras • nefħa ta ’ l- għekiesi • tibdil fir- riżultati ta ’ testijiet tad- demm għal ċerti ċelluli bojod tad- demm (limfoċiti) • plażma kkulurita, li tista ’ tikkawża żieda jew tnaqqis artifiċjali fil- livelli ta ’ ċerti parametri tal - laboratorju.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, igħid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CYANOKIT
KIF TAĦŻEN CYANOKIT
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jarawhx it- tfal.
Do not use Cyanokit after the expiry date which is stated on the vial, the cardboard box and the carton after EXP.
Tużax Cyanokit wara d- data ta ’ skadenza li tidher fuq il- kunjett, il- kaxxa tal- kartun u l- kartuna wara JIS.
For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of • usual transport (15 days submitted to temperatures ranging from 5 to 40°C) • transport in the desert (4 days submitted to temperatures ranging from 5 to 60°C) and • freezing/ defrosting cycles (15 days submitted to temperatures ranging from -20 to 40°C).
Għal skopijiet ta ’ użu ambulatorju, Cyanokit jista ’ jkun espost waqt perjodi qosra għal varjazzjonijiet tat- temperatura • waqt it- trasport normali (15- il jum espost għal temperaturi li jvarjaw minn 5°C sa 40°C) • trasport fid- deżert (4 ijiem espost għal temperaturi li jvarjaw minn 5°C sa 60°C) u • ċikli ta ’ ffriżar/ iddefrostjar (15- il jum espost għal temperaturi li jvarjaw minn - 20°C sa 40°C).
For storage conditions of the reconstituted medicine, see'Handling instructions' at the end of this package leaflet.
Għal kundizzjonijiet ta ’ ħażna ta ’ mediċinali rikonstitwiti, ara ‘ Struzzjonijiet dwar l- immaniġġjar ’ fl - aħħar ta ’ dan il- fuljett ta ’ tagħrif.
Medicines should not be disposed of via wastewater or household waste.
26 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ humiex aktar ta ’ bżonn.
FURTHER INFORMATION
X’ fih Cyanokit
What Cyanokit contains
Kull kunjett fih 2. 5 g ta ’ trab għal soluzzjoni għall - infużjoni.
After reconstitution with 100 ml of diluent, each ml of the reconstituted solution contains 25 mg of hydroxocobalamin. • The other ingredient is hydrochloric acid.
Wara r- rikostituzzjoni b’ 100 ml ta ’ dilwent, kull millilitru tas- soluzzjoni rikostitwita jkun fih 25 mg ta ’ hydroxocobalamin. • Is- sustanza l- oħra hi hydrochloric acid.
What Cyanokit looks like and contents of the pack
Id- Dehra ta ’ Cyanokit u l- kontenuti tal- pakkett
Cyanokit powder for solution for infusion is a dark red crystalline powder supplied in a glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.
Cyanokit trab għal soluzzjoni għall- infużjoni hu trab kristallin aħmar skur fornut f’ kunjett tal- ħġieġ magħluq b’ tapp tal- lastku tal- bromobutyl u għatu ta ’ l- aluminju b’ għatu tal- plastik.
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizazzjoni għat- tqegħid fis- suq
Merck Santé s. a. s. / SEMOY 2, rue du Pressoir Vert 45400 Semoy France
Merck Santé s. a. s. / SEMOY 2, rue du Pressoir Vert 45400 Semoy Franza
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. --------------------------------------------------------------------------------------------------------------------------- --
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /. ---------------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
27 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku jew tal- kura tas- saħħa:
Handling Instructions
Struzzjonijiet dwar l- Immaniġġjar
Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures.
It- trattament ta ’ avvelenament b’ cyanide jrid jinkludi attenzjoni immedjata għall- ftuħ tal - passaġġ tan- nifs, ossiġinazzjoni u idratazzjoni adegwati, sapport kardjovaskulari u l - immaniġġjar tal- puplesiji.
Consideration must be given to decontamination measures based on the route of exposure.
Trid tingħata konsiderazzjoni għal miżuri ta ’ dekontaminazzjoni bbażati fuq ir- rotta ta ’ l - espożizzjoni.
However, if a cyanide blood level determination is planned, it is recommended to draw the blood sample before initiation of treatment with Cyanokit.
Madankollu, jekk tkun ippjanata determinazzjoni tal- livell ta ’ cyanide fid- demm, hu rakkomandat li l- kampjun tad- demm jittieħed qabel il- bidu tal- kura b’ Cyanokit.
27 and/ or signs and symptoms of cyanide intoxication.
Id- deċiżjonijiet dwar it- trattament jridu jsiru abbażi ta ’ l- istorja klinika u/ jew sinjali u sintomi ta ’ intossikazzjoni ta ’ cyanide.
If there is clinical suspicion of cyanide poisoning, it is strongly recommended that Cyanokit be administered without delay.
Jekk ikun hemm suspett kliniku ta ’ avvelenament b’ cyanide, hu rakkomandat bis- saħħa li Cyanokit jingħata mingħajr dewmien.
Preparation of Cyanokit
It- tħejjija ta ’ Cyanokit
Each vial is to be reconstituted with 100 ml of diluent using the supplied sterile transfer device.
Kull kunjett għandu jkun rikostitwit b’ 100 ml ta ’ dilwent bl - użu ta ’ strumenti sterili għat - trasferiment li hu provdut.
The intravenous infusion set provided in the kit must then be used as it includes an appropriate filter and is to be primed with the reconstituted solution.
Imbagħad, is- sett ta ’ l - infużjoni ġol- vini ipprovdut fil- kitt irid jintuża għax jinkludi filtru adattat u għandu jkunu ipprajmat bis- soluzzjoni rikostitwita.
Depending upon the severity of the poisoning and the clinical response, a second dose may be administered by intravenous infusion.
Skond is- serjetà ta ’ l- avvelenament u r- rispons kliniku, tista ’ tingħata t- tieni doża permezz ta ’ infużjoni ġol- vini.
Paediatric patients:
28 Pazjenti pedjatriċi:
Maximum dose
Doża massima
The maximum recommended dose is 10 g.
Id- doża massima rakkomandata hi 10 g.
In infants to adolescents, the maximum recommended dose is 140 mg/ kg not exceeding 10 g.
Fi tfal żgħar sa adolexxenti, id- doża massima rakkomandata hi ta ’ 140 mg/ kg, u ma taqbiżx l- 10 g.
Renal and hepatic impairments No dosage adjustment is required in these patients.
Indebolimenti renali u epatiku L- ebda aġġustament fid- dożaġġ mhu meħtieġ f’ dawn il- pazjenti.
28 Simultaneous administration of Cyanokit and other products
L- għoti fl- istess ħin ta ’ Cyanokit u prodotti oħrajn
Cyanokit must not be mixed with other medicinal products except sodium chloride 9 mg/ ml (0.9%) solution for injection or Lactated Ringer solution or 5% glucose.
Cyanokit m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief 9 mg/ ml ta ’ sodium chloride (0. 9%) soluzzjoni għall- injezzjoni jew soluzzjoni Lactated Ringer jew 5% glukosju.
If blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) and hydroxocobalamin are administered simultaneously, use of separate intravenous lines (preferably on contralateral extremities) is recommended.
Jekk il- prodotti tad- demm (demm sħiħ, ċelluli ħomor ippakkjati, konċentrat tal- plejtlits u plażma friska iffriżata) u hydroxocobalamin jingħataw fl- istess ħin, l- użu ta ’ linji separati tal- vini (preferibbilment fuq estremitajiet kontralaterali) hu rakkomandat (ara sezzjoni 6. 2).
Combination with another cyanide antidote:
Kumbinazzjoni b’ antidotu ieħor ta ’ cyanide:
Chemical incompatibility was observed with sodium thiosulfate and sodium nitrite.
L- inkompatibilità kimika kienet osservata ma ’ sodium thiosulfate u sodium nitrite.
If the decision is made to administer another cyanide antidote with Cyanokit, these medicinal products must not be administered concurrently in the same intravenous line.
Jekk issir id- deċiżjoni li jingħata antidotu ieħor ta ’ cyanide ma ’ Cyanokit, dawn il- prodotti mediċinali ma jridux jingħataw fl- istess ħin ġo l- istess linja tal- vini.
In-use stability of the reconstituted solution
Stabbiltà tas- soluzzjoni rikostitwita waqt l- użu
Chemical and physical in-use stability has been demonstrated for 6 hours at a temperature between 2°C to 40°C.
L- istabbiltà kimika u fiżika waqt l- użu ntweriet għal 6 sigħat f’ temperatura ta ’ bejn 2°C sa 40°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8°C.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r - responsabbiltà ta ’ l- utent, u normalment ma jkunux itwal minn 6 sigħat f’ temperatura ta ’ 2 sa 8°C.
Package size
Daqs tal - pakkett
Gastro-resistant capsule, hard
Kapsula gastro - reżistenti, iebsa
blister (PVC/ PE/ PCTFE/ alu)
folja (PVC/ PE/ PCTFE/ alu)
7 capsules
7 kapsuli
CYMBALTA 30 mg hard gastro-resistant capsules
CYMBALTA 30 mg kapsuli gastro- reżistenti ibsin
Each capsule contains 30 mg of duloxetine (as hydrochloride)
Kull kapsula fiha 30 mg ta ’ duloxetine (bħala hydrochloride)
Excipients: sucrose 8.6 mg.
Sustanzi mhux attivi: sucrose 8. 6 mg.
For a full list of excipients, see section 6.1.
Għal lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Hard gastro-resistant capsule.
Kapsula gastro- reżistenti iebsa.
The CYMBALTA 30 mg capsule has an opaque white body, imprinted with ‘ 30 mg’ and an opaque blue cap, imprinted with ‘ 9543’.
Il- kapsula ta ’ CYMBALTA 30 mg għandha l- parti prinċipali tagħha abjad opak, stampat b ’ ‘ 30 mg ’ u għatu blu opak, stampat b ’ ‘ 9543 ’.
Clinical particulars
TAGĦRIF KLINIKU
Treatment of major depressive episodes.
Kura ta ’ episodji depressivi maġġuri.
Treatment of diabetic peripheral neuropathic pain in adults.
Kura ta ’ uġigħ newropatiku periferiku tad- dijabete fl- adulti.
Treatment of generalised anxiety disorder.
Kura ta ’ disturb ta ’ ansjetà ġeneralizzata
Adults Major Depressive Episodes:
Adulti Episodji Depressivi Maġġuri:
The starting and recommended maintenance dose is 60 mg once daily with or without food.
Id- doża tal- bidu u dik irrakkomandata ta ’ manteniment hija ta ’ 60 mg darba kuljum ma ’ l- ikel jew fuq stonku vojt.
Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Dożi ta ’ aktar minn 60 mg darba kuljum, sa doża massima ta ’ 120 mg kuljum mogħtija f’ dożi mqassma ndaqs, ġew valutati mill- aspett tas- sigurtà f’ provi kliniċi.
However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations.
Madankollu, m’ hemm l - ebda evidenza klinika li tissuġerixxi li pazjenti li ma rrispondewx għad- doża inizjali rrakkomandata jistgħu jibbenefikaw minn aktar żidiet fid- doża.
Therapeutic response is usually seen after 2-4 weeks of treatment.
Ir- rispons għat- terapija ġeneralment jidher wara 2- 4 ġimgħat ta ’ kura.
After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse.
Wara t- tisħiħ tar- rispons anti- depressiv, huwa rrakkomandat li l- kura titkompla għal ħafna xhur, sabiex jiġi evitat li l- pazjent jirkadi.
Generalised Anxiety Disorder:
Disturb ta ’ Ansjetà Ġeneralizzata:
The recommended starting dose in patients with Generalised Anxiety Disorder is 30 mg once daily with or without food.
Huwa rakkomandat li f’ pazjenti b’ Disturb ta ’ Ansjetà Ġeneralizzata d- doża inizjali għandha tkun ta ’ 30 mg darba kuljum ma ’ l- ikel jew fuq stonku vojt.
In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients.
F’ pazjenti fejn ir- rispons ma jkunx suffiċjenti d - doża għandha tiżdied għal 60 mg li hija d- doża ta ’ manteniment li s- soltu tintuża fil- parti l- kbira tal - pazjenti.
In patients with co-morbid Major Depressive Episodes, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above).
F’ pazjenti li fl- istess ħin qed ibatu wkoll minn Episodji Depressivi Maġġuri, id- doża inizjali u ta ’ manteniment hi ta ’ 60 mg darba kuljum (jekk jogħġbok ara wkoll ir- rakkomandazzjoni tad- dożaġġ fuq).
Doses up to 120 mg per day have been shown to be efficacious and have been evaluated from a safety perspective in clinical trials.
Ġie muri li dożi sa 120 mg kuljum kienu effikaċji u f’ studji kliniċi dawn ġew evalwati mil- lat ta ’ sigurtà.
In patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
F’ pazjenti li m’ għandhomx rispons suffiċjenti għal 60 mg, għandhom jiġu kkunsidrati żidiet sa 90 mg jew 120 mg.
Dose escalation should be based upon clinical response and tolerability.
Iż- żieda fid- doża għandha tkun ibbażata fuq ir- rispons kliniku u t- tollerabbilità.
2 After consolidation of the response, it is recommended to continue treatment for several months, in order to avoid relapse.
2 Wara li jintlaħaq rispons suffiċjenti, huwa rakkomandat li l- kura tkompli għal ħafna xhur sabiex jiġi evitat li jkun hemm rikadenza.
Diabetic Peripheral Neuropathic Pain:
Uġigħ Newropatiku Periferiku Tad- dijabete:
The starting and recommended maintenance dose is 60 mg daily with or without food.
Id- doża tal- bidu u dik irrakkomandata ta ’ manteniment hija ta ’ 60 mg darba kuljum ma ’ l- ikel jew fuq stonku vojt.
The plasma concentration of duloxetine displays large inter-individual variability (see 5.2).
Il- konċentrazzjoni fil - plażma ta ’ duloxetine turi varjabbilità kbira bejn individwu u ieħor (ara 5. 2).
Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
Għalhekk, xi pazjenti li ma jirrispondux b’ mod suffiċjenti għal 60 mg jistgħu jibbenefikaw minn doża ogħla.
The medicinal product response should be evaluated after 2 months’ of treatment.
Wara xahrejn ta ’ kura għandu jiġi valutat ir- rispons għall- prodott mediċinali.