qanastek/EMEA-V3 huggingface dataset:
What PREZISTA contains
X’ fih PREZISTA
- The active substance is darunavir.
- Is- sustanza attiva hija darunavir.
Each tablet contains 3 00 mg of darunavir as ethanolate.
Kull pillola fiha 300 mg ta ’ darunavir bħala ethanolate.
- The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone,
- Is- sustanzi l- oħra huma microcrystalline cellulose, colloidal anhydrous silica, crospovidone,
magnesium stearate.
magnesium stearate.
The film-coating contains poly(vinyl alcohol) - partially hydrolyzed, macrogol 3350, titanium dioxide (E171), talc, sunset yellow FCF (E110).
Il- kisja tar- rita fiha poly( vinyl alkoħol) – parzjalment idrolizzat, macrogol 3350, titanium dioxide (E171), terra, sunset yellow FCF (E110).
What PREZISTA looks like and contents of the pack Film-coated, orange, oval shaped tablet, mentioning TMC114 on one side, 300MG on the other side.
Id- Dehra ta ’ PREZISTA u l- kontenuti tal- pakkett Pillola oranġjo, b’ forma ovali, miksija b’ rita, li fiha TMC114 fuq naħa waħda u 300 mg fuq in- naħa l - oħra.
120 tablets in a plastic bottle.
120 pillola fi flixkun tal- plastik.
Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Janssen- Cilag International NV, Turnhoutseweg 30, 2340 Beerse, il- Belġju
Janssen, 04010 Borgo San Michele, Latina, Italy
Janssen, 04010 Borgo San Michele, Latina, l- Italja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rapprezentant lokali tad - tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Česká republika TIBOTEC, divize JANSSEN-CILAG s.r.o.
88 Česká republika TIBOTEC, divize JANSSEN- CILAG s. r. o.
Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000 Tel: +356 2397 6000
Mangion Building, Triq il- Ġdida fi Triq Valletta MT- Ħal- Luqa LQA 6000 Tel: +356 2397 6000
Slovenská republika TIBOTEC, divízia Johnson & Johnson s.r.o.
89 Slovenská republika Ísland TIBOTEC, divízia Johnson & Johnson s. r. o.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
PREZISTA 400 mg film -coated tablets darunavir
PREZISTA 400 mg pilloli miksijin b’ rita darunavir
PREZISTA 400 mg is used to treat adults who are infected by HIV and who have not used antiretroviral medicines before.
PREZISTA 400 mg jintuża għat- trattament ta ’ adulti li huma infettati bl- HIV u li qatt ma kienu użaw mediċini antiretrovirali qabel.
PREZISTA 400 mg is not for use in children and adolescents, as it has not been studied in patients under 18 years.
PREZISTA 400 mg mhuwiex qiegħed għall- użu fit- tfal u l- adoloxxenti, minħabba li ma ġiex studjat f’ pazjenti li għandhom anqas minn 18- il sena.
advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
pazjenti b’ infezzjoni avvanzata ta ’ l- HIV u storja ta ’ infezzjonjiet opportunistiċi, sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet ta ’ qabel tista ’ sseħħ ftit wara li jinbeda trattament kontra l- HIV.
- Tell your doctor if you have haemophilia.
Għid lit- tabib tiegħek jekkk għandek l- emofilja.
There are some medicines that you must not combine with PREZISTA.
92 Hemm xi mediċini li m’ għandekx tieħu ma ’ PREZISTA.
In most cases, PREZISTA can be combined with anti -HIV medicines belonging to another class (e.g.
F’ ħafna mill- każi PREZISTA jista ’ jittiehed flimkien ma ’ mediċini li jagħmlu parti minn klassi oħra (e. ż.
PREZISTA with ritonavir has not been
NRTI’ s (impedituri tan- nucleoside reverse transcriptase), NNRTI’ s (mhumiex impedituri tan - nucleoside reverse transcriptase), antagonisti ta ’ CCR5 u FIs (impedituri ta ’ fużjoni)).
86 tested with all PIs (protease inhibitors) and should not be used with some PIs.
PREZISTA ma ’ ritonavir ma ’ ġiex ittestjat mal- PI’ s (Impedituri ta ’ Protease) kollha u ma jistax jintuża ma xi wħud mill- PIs.
The effects of PREZISTA might be reduced if you take any of the following products.
L- effetti ta ’ PREZISTA jistgħu jitnaqqsu jekk tieħu xi wieħed minn dawn il- prodotti.
Pregnancy and breast-feeding Tell your doctor immediately if you are pregnant or if you are breast-feeding.
93 Għid lit- tabib tiegħek immedjatament jekk inti tqila jew qed tredda ’.
It is recommended that HIV infected women should not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.
Huwa rrakkomandat li nisa infettati bl- HIV m’ għandhomx ireddgħu t- trabi tagħhom kemm minħabba l- possibiltà li t- tarbija tiegħek tiġi nfettata bl- HIV li jgħaddi mill- ħalib tiegħek kif ukoll minħabba l- effetti mhux maghrufa tal- mediċina fuq it- tarbija tiegħek.
Always use PREZISTA exactly as your doctor has told you.
Dejjem għandek tieħu PREZISTA skond il- parir eżatt tat- tabib.
Adults who have not taken antiretroviral medicines before (your doctor will determine this) The usual dose of PREZISTA is 800 mg (2 tablets containing 400 mg of PREZISTA) once daily.
Adulti li qatt ma ħadu kura b’ mediċini antiretrovirali qabel (it- tabib tiegħek jiddetermina dan) Id- doża tas- soltu ta ’ PREZISTA hija ta ’ 800 mg (2 pilloli li fihom 400 mg ta ’ PREZISTA) darba kuljum.
You must take PREZISTA every day and always in combination with 100 mg of ritonavir and with food.
Inti għandek tieħu PREZISTA kuljum u dejjem tieħdu flimkien ma ’ 100 mg ritonavir u mal- ikel.
PREZISTA cannot work properly without ritonavir and food.
PREZISTA ma ’ jistax jaħdem sewwa mingħajr ritonavir u l- ikel.
You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and ritonavir.
Inti għandek tiekol ikla jew xi ħaġa ħafifa 30 minuta qabel ma tieħu PREZISTA u ritonavir.
The type of food is not important.
It- tip ta ’ ikel mhuwiex importanti.
- Take two 400 mg tablets at the same time, once a day, every day.
Struzzjonijiet Ħu żewġ pilloli ta ’ 400 mg PREZISTA dejjem fl- istess ħin, darba kuljum.
- Take PREZISTA always together with 100 mg of ritonavir.
Dejjem ħu PREZISTA flimkien ma ’ 100 mg ta ’ ritonavir.
- Take PREZISTA with food.
Ħu PREZISTA mal- ikel.
- Take your other HIV medicines used in combination with PREZISTA and ritonavir as
Ħu l- mediċini l- oħra tal- HIV li jintużaw flimkien ma ’ PREZISTA u ritonavir kif irrakkomandat
recommended by your doctor.
mit- tabib tiegħek.
Adults who have taken antiretroviral medicines before (your doctor will determine this) You will require a different dosing schedule and dose of PREZISTA, which cannot be carried out with these 400 mg tablets.
Adulti li diġà ħadu kura b’ mediċini antiretrovirali qabel (it- tabib tiegħek jiddetermina dan) Inti se jkollok bżonn skeda u doża ta ’ PREZISTA differenti, li ma tistax issir b’ dawn il- pilloli ta ’ 400 mg.
Other strengths of this product are available.
Qawwiet oħra ta ’ dan il- prodott huma disponibbli.
Removing the child resist ant cap
Kif tneħħi l- għatu li ma jinfetaħx mit- tfal
If you forget to take PREZISTA If you notice within 12 hours, you must take the tablets immediately.
Jekk tinsa tieħu PREZISTA Jekk tinduna fi żmien 12- il siegħa, inti għandek tieħu l- pilloli immedjatament.
If you notice after 12 hours, then skip the intake and take the next doses as usual.
Jekk tinduna wara 12- il sieġħa, aqbeż id- doża li tkun suppost ħadt u ħu d- dożi li jkun imiss bħas- soltu.
Do not take a double dose to make up for a forgotten dose.
Tieqafx tieħu PREZISTA mingħajr ma ’ l- ewwel tkellem lit- tabib tiegħek
Do not stop using PREZISTA without talking to your doctor first HIV therapy may increase your sense of well -being.
94 Terapija ta ’ l- HIV tista ’ ġġgħalek tħossok aktar tajjeb.
When treating HIV infection, it is not always easy to identify what side effects are caused by PREZISTA, which are caused by other medicines you are taking, or which are caused by the HIV infection itself.
Fit- trattament ta ’ infezzjoni ta ’ l- HIV, m’ huwiex dejjem faċli li tiddentifika liema effetti sekondarji huma kkawżati minn PREZISTA, liema huma kkawżati minn mediċini oħra li qed tieħu, jew liema huma kkawżati mill- infezzjoni ta ’ l- HIV innifisha.
88 The frequency of possible side effects listed below is defined using the following convention:
Il- frekwenza tal- effetti sekondarji li jista ’ jkun hemm imniżżlin hawn taħt hija ddefinita bl- użu tal - konvenzjoni li ġejja: komuni ħafna: jaffettwaw iktar minn persuna 1 minn kull 10 li jużawh
- common: affects 1 to 10 users in 100
- komuni: jaffettwaw minn persuna 1 sa 10 persuni minn kull 100 li jużawh
- uncommon: affects 1 to 10 users in 1,000
- mhux komuni: jaffettwaw minn persuna 1 sa 10 persuni minn kull 1, 000 li jużawh
- rare: affects 1 to 10 users in 10,000
- rari: jaffettwaw minn persuna 1 sa 10 persuni minn kull 10, 000 li jużawh
- very rare: affects less than 1 user in 10,000
rari ħafna: jaffettwaw inqas minn persuna 1 minn kull 10, 000 jużawh
- not known: the frequency cannot be estimated from the available data.
- mhux magħruf: ma tistax tittieħed stima mid- data disponibbli.
- headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of
- uġigħ ta ’ ras, għejja, sturdament, ngħas, titrix, tnemnim jew uġigħ fl- idejn jew fis- saqajn, telf ta ’
- visual disturbance, red or dry eyes
95 disturb fil- vista, għajnejn ħomor jew xotti
and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and
ta’ xaħam mir- riġlejn, mid- dirgħajn u mill- wiċċ, żieda fix- xaħam ta ’ l- addome (taż- żaqq) u organi interni oħra, tkabbir tas- sider u ċapep ta ’ xaħam fuq wara ta ’ l- għonq (ħotba tal- buflu).
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża ta ’ dawn il- kundizzjonijiet u l- effetti tagħhom fit- tul fuq is- saħħa m’ humiex magħrufa f’ dan iż- żmien.
Each tablet contains 4 00 mg of darunavir as ethanolate.
Kull pillola fiha 400 mg ta ’ darunavir bħala ethanolate.
What PREZISTA looks like and contents of the pack Film-coated, light orange, oval shaped tablet, mentioning TMC on one side, 400MG on the other side.
Id- Dehra ta ’ PREZISTA u l- kontenuti tal- pakkett Pillola oranġjo ċara, b’ forma ovali, miksija b’ rita, li fiha TMC fuq naħa waħda u 400MG fuq in- naħa l- oħra.
60 tablets in a plastic bottle.
60 pillola fi flixkun tal- plastik.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
96 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rapprezentant lokali tad - tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
España JANSSEN-CILAG, S.A. división TIBOTEC Paseo de las Doce Estrellas, 5-7 Campo de las Naciones E-28042 Madrid Tel: +34 91 722 81 00
97 España JANSSEN- CILAG, S. A. división TIBOTEC Paseo de las Doce Estrellas, 5- 7 Campo de las Naciones E- 28042 Madrid Tel: +34 91 722 81 00
This leaflet was last approved in {MM/YYYY}.
98 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
92 PACKAGE LEAFLET:
99 FULJETT TA ’ TAGĦRIF:
PREZISTA 600 mg film -coated tablets darunavir
PREZISTA 600 mg pilloli miksijin b’ rita darunavir
PREZISTA is not for use in children and adolescents, as it has not been studied in patients under 18 years.
PREZISTA mhuwiex qiegħed għall- użu fit- tfal u l- adoloxxenti, minħabba li ma ġiex studjat f’ pazjenti li għandhom anqas minn 18- il sena.
There are some medicines that you must not combine with PREZISTA.
101 Hemm xi mediċini li m’ għandekx tieħu ma ’ PREZISTA.
94 tested with all PIs (protease inhibitors) and should not be used with some PIs.
PREZISTA ma ’ ritonavir ma ’ ġiex ittestjat mal- PI’ s (Impedituri ta ’ Protease) kollha u ma jistax jintuża ma xi wħud mill- PIs.
Pregnancy and breast-feeding Tell your doctor immediately if you are pregnant or if you are breast-feeding.
102 Għid lit- tabib tiegħek immedjatament jekk inti tqila jew qed tredda ’.
Instructions
Struzzjonijiet
- The usual dose of PREZISTA is one 600 milligram tablet twice daily.
- Id- doża ta ’ PREZISTA li s- soltu tingħata hija ta ’ ta ’ pillola waħda ta ’ 600 milligramma darbtejn
- In the morning, take one 600 milligram PREZISTA tablet together with 100 milligram ritonavir.
Filgħodu, ħu pillola waħda ta ’ 600 milligramma PREZISTA flimkien ma ’ 100 milligramma
- In the evening, take one 600 milligram PREZISTA tablet together with 100 milligram ritonavir.
Filgħaxija, ħu pillola waħda ta ’ 600 milligramma PREZISTA flimkien ma ’ 100 milligramma
The pl astic bottle comes with a child resistant cap and should be opened as follows:
Il- flixkun tal- plastik jiġi b’ għatu li ma jinfetaħx mit- tfal u għandu jinfetaħ kif ġej:
If you forget to take PREZISTA If you notice within 6 hours, you must take your missed dose immediately.
Jekk tinsa tieħu PREZISTA Jekk tinduna fi żmien 6 sigħat, inti għandek tieħu d- doża li nsejt tieħu immedjatament.
Do not stop using PREZISTA without talking to your doctor first HIV therapy may increase your sense of well-being.
Tieqafx tieħu PREZISTA mingħajr ma ’ l- ewwel tkellem lit- tabib tiegħek Terapija ta ’ l- HIV tista ’ ġġgħalek tħossok aktar tajjeb.
Like all medicines, PREZISTA can cause side effects, although not everybody gets them.
103 Bħal kull mediċina oħra, PREZISTA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention:
Il- frekwenza tal- effetti sekondarji li jista ’ jkun hemm imniżżlin hawn taħt hija ddefinita bl- użu tal - konvenzjoni li ġejja: komuni ħafna: jaffettwaw iktar minn persuna 1 minn kull 10 li jużawh
97 Do not use PREZISTA after the expiry date which is stated on the box and on the bottle after the letters EXP.
Tużax PREZISTA wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- flixkun wara l- ittri JIS.
Each tablet contains 6 00 mg of darunavir as ethanolate.
Kull pillola fiha 600 mg ta ’ darunavir bħala ethanolate.
What PREZISTA looks like and contents of the pack Film-coated, orange, oval shaped tablet, mentioning TMC on one side, 600MG on the other side.
Id- Dehra ta ’ PREZISTA u l- kontenuti tal- pakkett Pillola oranġjo, b’ forma ovali, miksija b’ rita, li fiha TMC fuq naħa waħda u 600MG fuq in- naħa l - oħra.
België/Belgique/Belgien TIBOTEC, een divisie van, une division de, eine Division der JANSSEN-CILAG NV/SA Roderveldlaan 1 B-2600 Berchem Tél/Tel: +32 3 280 54 11
105 België/ Belgique/ Belgien TIBOTEC, een divisie van, une division de, eine Division der JANSSEN- CILAG NV/ SA Roderveldlaan 1 B- 2600 Berchem Tél/ Tel: +32 3 280 54 11
România TIBOTEC, subsidiară a Janssen-Cilag, Johnson & Johnson d.o.o.
106 România France TIBOTEC, subsidiară a Janssen- Cilag, Johnson & TIBOTEC, une division de JANSSEN- CILAG Johnson d. o. o.
Prialt 100 micrograms/ ml solution for infusion.
Prialt 100 mikrogramma/ ml soluzzjoni għall- infużjoni.
One ml solution contains 100 μ g ziconotide (as ziconotide acetate).
1 ml soluzzjoni fih 100 μg ta ’ ziconotide (bħala ziconotide acetate).
1 ml vial:
Kunjett ta ’ 1 ml:
Each vial contains 100 μ g ziconotide (as ziconotide acetate).
Kull kunjett fih 100 μg ta ’ ziconotide (bħala ziconotide acetate).
2 ml vial:
Kunjett ta ’ 2 ml:
Each vial contains 200 μ g ziconotide (as ziconotide acetate).
Kull kunjett fih 200 μg ta ’ ziconotide (bħala ziconotide acetate).
Each vial contains 500 μ g ziconotide (as ziconotide acetate).
Kull kunjett fih 500 μg ta ’ ziconotide (bħala ziconotide acetate).
Clear, colourless solution, free of visible particles.
Soluzzjoni ċara, bla kulur, mingħajr partikuli viżibbli.
Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.
Ziconotide hu indikat għall- kura ta ’ uġigħ sever kroniku f’ pazjenti li jeħtieġu analġeżja għal ġot- teka (intrathecal - IT).
Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products.
Il- kura b’ ziconotide għandha ssir biss minn tobba b’ esperjenza fl- għoti għal ġot- teka (IT) ta ’ prodotti mediċinali.
Prialt is for intrathecal use only.
Prialt hu għall- użu għal ġot- teka biss.
For instructions for use and handling, see section 6.6.
Għal struzzjonijiet dwar l- użu u l- immaniġġjar, ara sezzjoni 6. 6.
Adults (including the elderly ≥ 65 years of age)
Adulti (li jinkludi l- anzjani ≥ 65 sena)
Dosing of ziconotide should be initiated at 2.4 μ g/ day and titrated on an individual patient basis according to the patient’ s analgesic response and adverse reactions.
Id- dożaġġ ta ’ ziconotide għandu jinbeda b’ doża ta ’ 2. 4 μg/ kuljum u jkun ittitrat fuq bażi individwali għal kull pazjent skond ir- rispons analġesiku tal- pazjent u r- reazzjonijiet avversi.
Patients should be titrated in dose increments of ≤ 2.4 μ g/ day, up to a maximum dose of 21.6 μ g/ day.
Il- pazjenti għandhom ikunu ttitrati f’ inkrementi tad- doża ta ’ ≤ 2. 4 μg/ kuljum, sa doża massima ta ’ 21. 6 μg/ kuljum.
The minimal interval between dose increases is 24 hours; the recommended interval, for safety reasons, is 48 hours or more.
L- inqas intervall bejn iż- żidiet fid- doża hu ta ’ 24 siegħa; l- interval rakkomandat, għal raġunijiet ta ’ sigurtà, hu ta ’ 48 siegħa jew iktar.
If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse reactions.
Jekk ikun meħtieġ, id- doża tista ’ titnaqqas bi kwalunkwe ammont (li jinkludi t - twaqqif ta ’ l- infużjoni) għall- immaniġġjar ta ’ reazzjonijiet avversi.
Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤ 9.6 μ g/ day.
Madwar 75% tal- pazjenti li jirrispondu b’ mod sodisfaċenti għall- kura jeħtieġu doża ta ’ ≤ 9. 6 μg/ kuljum.
Ziconotide must be administered as a continuous infusion via an intrathecal catheter, using an external or internally implanted mechanical infusion pump capable of delivering an accurate infusion volume.
Ziconotide irid jingħata bħala infużjoni kontinwa permezz ta ’ kateter ġot- teka, bl- użu ta ’ pompa ta ’ l - infużjoni mekkanika esterna jew impjantata internament li tkun kapaċi tforni volum preċiż ta ’ l - infużjoni.
As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods.
Minħabba li r- riskju ta ’ meninġite sekondarja għal kateterizzazzjoni fit- tul ta ’ l- ispazju ġot - teka hu akbar b’ sistema ta ’ infużjoni b’ kateter estern, is- sistemi interni huma rakkomandati biex ziconotide jingħata għal perjodi twal.
An external catheter system should only be used when an internal system cannot be implanted.
Sistema b’ kateter estern għandha tintuża biss meta sistema interna ma tkunx tista ’ tiġi impjantata.
When low doses of ziconotide are required, for example when initiating titration, ziconotide must be diluted before use with preservative-free sodium chloride 9 mg/ ml (0.9%) solution for injection.
Meta dożi baxxi ta ’ ziconotide ikunu meħtieġa, per eżempju meta tibda t- titrazzjoni, ziconotide irid ikun dilwit qabel l- użu permezz ta ’ preservative- free sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
(see section 6.6).
(ara sezzjoni 6. 6.)
2 Use in paediatric patients (< 18 years of age)
2 L- użu f’ pazjenti pedjatriċi (< 18- il sena)
Prialt is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Prialt mhux rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba muqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
Use in patients with impaired hepatic function
L- użu f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied
Studies have not been conducted in patients with impaired hepatic function.
Ma sarux studji f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied.
Caution should be exercised when ziconotide is administered to patients with impaired hepatic function.
Għandha tingħata attenzjoni meta ziconotide jingħata lill- pazjenti b’ indeboliment fil- funzjoni tal- fwied.
Use in patients with impaired renal function
L- użu f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi
Studies have not been conducted in patients with impaired renal function.
Ma sarux studji f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi.
Caution should be exercised when ziconotide is administered to patients with impaired renal function.
Għandha tingħata attenzjoni meta ziconotide jingħata lill- pazjenti b’ indeboliment fil- funzjoni tal- kliewi.
Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.5).
Ziconotide hu kontra- indikat għall- użu flimkien ma ’ kimoterapija IT (ara sezzjoni 4. 5).
Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted (see section 5.1).
Għalkemm ziconotide kien studjat fi provi kliniċi li saru fuq tul ta ’ żmien, dwar is- sigurtà, tat- tip open label, ma sarux studji kkontrollati ta ’ iktar minn 3 ġimgħat (ara sezzjoni 5. 1).
Possible long-term local toxic effects on the spinal cord have not been excluded and preclinical data in this respect are limited (see section 5.3).
L- effetti tossiċi lokali fit- tul possibbli fuq is- sinsla ma kienux esklużi u informazzjoni ta ’ qabel l- użu kliniku f’ dan ir- rigward hi limitata (ara sezzjoni 5. 3).
Therefore, caution is needed during long-term treatment.
Għalhekk, l- attenzjoni hi meħtieġa matul kura fit- tul.
The administration of medicinal products by the intrathecal (IT) route carries the risk of potentially serious infections, such as meningitis, which may be life threatening.
L- għoti ta ’ prodotti mediċinali permezz tar- rotta għal ġot- teka (IT) iġġib magħha r- riskju ta ’ infezzjonijiet potenzjalment serji, bħal meninġite, li jistgħu jkunu ta ’ periklu għall- ħajja.
Meningitis due to the entrance of organisms along the catheter track or inadvertent contamination of the infusion system is a known complication of intrathecal medicinal product administration, especially with external systems.
Il- meninġite minħabba d- dħul ta ’ organiżmi matul il- medda tal- kateter jew kontaminazzjoni involontarja tas - sistema ta ’ l- infużjoni hi kumplikazzjoni magħrufa ta ’ l- għoti tal- prodott mediċinali għal ġot- teka, speċjalment b’ sistemi esterni.
Patients and physicians must be vigilant for typical symptoms and signs of meningitis.
Il- pazjenti u t- tobba jridu jkunu viġilanti għal sintomi tipiċi u sinjali ta ’ meninġite.
The optimal intrathecal placement of the catheter tip has not been established.
L- aħjar tqegħid tat- tarf tal- kateter ġot- teka ma kienx stabbilit.
Lower catheter tip placement, e. g. at the lumbar level, may reduce the incidence of ziconotide-related neurological adverse reactions.
It- tqegħid tat- tarf tal- kateter iktar fil - baxx, eż. fil- livell tas- sinsla, jista ’ jnaqqas l- inċidenza ta ’ reazzjonijiet avversi newroloġiċi relatati ma ’ ziconotide.
Therefore, catheter tip placement should be carefully considered to allow adequate access to spinal nociceptive segments whilst minimising medicinal product concentrations at cerebral levels.
Għalhekk, it- tqegħid tat- tarf tal- kateter għandu jkun ikkunsidrat bl- attenzjoni biex jippermetti aċċess adegwat għal segmenti nociceptive tal- kolonna vertebrali, filwaqt li jimminimizza l - konċentrazzjonijiet tal- prodott mediċinali fil- livelli ċerebrali.
Only a small number of patients have received systemic chemotherapy and IT ziconotide.
Numru żgħir biss ta ’ pazjenti rċievew kimoterapija sistemika u ziconotide IT.
Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.5).
Għandha tingħata attenzjoni meta ziconotide jingħata lil pazjenti li jkunu qedgħin jirċievu kimoterapija sistemika (ara sezzjoni 4. 5).
Elevations in creatine kinase, which are usually asymptomatic, are common amongst patients on intrathecal ziconotide.
Elevazzjonijiet fil- creatine kinase, li huma normalment asintomatiċi, huma komuni fost il- pazjenti li jingħataw ziconotide għal ġot- teka.
Progressive elevation of the creatine kinase is uncommon.
Elevazzjoni progressiva tal- creatine kinase mhix komuni.
However monitoring of creatine kinase is recommended.
Madankollu il- monitoraġġ tal- creatine kinase hu rakkomandat.
In the event of progressive elevation, or clinically significant elevation in association with clinical features of myopathy or rhabdomyolysis, discontinuation of ziconotide should be considered.
F’ każ ta ’ elevazzjoni progressiva, jew elevazzjoni klinikament sinifikanti b’ rabta mal- karatteristiċi kliniċi ta ’ mijopatija jew rabdomijolosi, it- twaqqif ta ’ ziconotide għandu jkun ikkunsidrat.
Hypersensitivity reactions including anaphylaxis have not been observed during clinical trials and the immunogenicity of ziconotide administered by the IT route appears to be low.
Reazzjonijiet ta ’ sensittività eċċessiva li jinkludu l- anafilassi ma kienux osservati matul il- provi kliniċi, u l- immunoġeniċità ta ’ ziconotide mogħti mir- rotta IT tidher li hi baxxa.
However, the potential for severe allergic reactions cannot be excluded.
Madankollu, il - potenzjal għal reazzjonijiet allerġiċi severi ma jistax jiġi eskluż.
3 Cognitive and neuropsychiatric adverse reactions, particularly confusion, are common in patients treated with ziconotide.
3 Reazzjonijiet avversi konjittivi u newropsikjatriċi, partikularment il- konfużjoni, huma komuni f’ pazjenti kkurati b’ ziconotide.
Cognitive impairment typically appears after several weeks of treatment.
Indeboliment konjittiv tipikament jidher wara diversi ġimgħat ta ’ kura.
Episodes of acute psychiatric disturbances, such as hallucinations, paranoid reactions, hostility, delirium, psychosis and manic reactions have been reported in patients treated with ziconotide.
Episodji ta ’ disturbi psikjatriċi akuti, bħal alluċinazzjonijiet, reazzjonijiet paranojde, ostilità, delirju, psikosi u reazzjonijiet manijaċi kienu rrappurtati f’ pazjenti kkurati b’ ziconotide.
The ziconotide dose should be reduced or discontinued if signs or symptoms of cognitive impairment or neuropsychiatric adverse reactions develop, but other contributing causes should also be considered.
Id- doża ta ’ ziconotide għandha titnaqqas jew titwaqqaf jekk jiżviluppaw sinjali jew sintomi ta ’ indeboliment konjittiv jew reazzjonijiet newropsikjatriċi avversi, iżda kawżi oħrajn li jikkontribwixxu għal dan għandhom ukoll jiġu kkunsidrati.
The cognitive effects of ziconotide are typically reversible within 1 - 4 weeks after discontinuation of the medicinal product, but may persist in some cases.
L- effetti konjittivi ta ’ ziconotide huma tipikament riversibbli fi żmien 1 - 4 ġimgħat wara t- twaqqif tal- prodott mediċinali, iżda jistgħu jippersistu f’ xi każijiet.
Patients have experienced depressed levels of consciousness while receiving ziconotide.
Il- pazjenti ġarrbu livelli mnaqqsa ta ’ koxjenza waqt li kienu qed jirċievu ziconotide.
The patient usually remains conscious and breathing is not depressed.
Normalment il - pazjent jibqa ’ f’ sensih u r- respirazzjoni ma tkunx dipressa.
The event may be self limited, but ziconotide should be discontinued until the event resolves.
L- avveniment jista ’ jkun limitat minnu nnifsu, iżda ziconotide għandu jitwaqqaf sakemm l- avveniment jgħaddi.
The re-introduction of ziconotide is not recommended in these patients.
L- introduzzjoni mill- ġdid ta ’ ziconotide mhix rakkomandata f’ dawn il- pazjenti.
Withdrawal of concomitant CNS depressant medicinal products should also be considered as they may contribute to the reduced level of arousal.
It- twaqqif ta ’ prodotti mediċinali sedattivi CNS fl - istess ħin għandu wkoll ikun ikkunsidrat, għax dawn jistgħu jikkontribwixxu għal- livell imnaqqas ta ’ eċċitament.
In patients with severe chronic pain there is a higher incidence of suicide and suicide attempts than in the general population.
F’ pazjenti b’ uġigħ sever kroniku, hemm inċidenza ogħla ta ’ suwiċidji u attentati ta ’ suwiċidju milli fil - popolazzjoni ġenerali.
Ziconotide may cause or worsen depression with the risk of suicide in susceptible patients.
Ziconotide jista ’ jikkawża jew iħarrax id- depressjoni bir- riskju ta ’ suwiċidju f’ pazjenti suxxettibbli.
Specific clinical medicinal product interaction studies have not been conducted with ziconotide.
Ma saru l- ebda studji dwar l- interazzjoni speċifika klinika tal- prodott mediċinali b’ ziconotide.
However, low plasma ziconotide concentrations, metabolism by ubiquitous peptidases and relatively low plasma protein binding (see section 5.2) make metabolic-based interactions or plasma protein displacement type interactions between ziconotide and other medicinal products unlikely.
Madankollu, konċentrazzjonijiet baxxi ta ’ ziconotide fil- plażma, metaboliżmu minn peptidases li huma preżenti kullimkien u twaħħil relattivament baxx tal- proteina fil- plażma (ara sezzjoni 5. 2) jagħmlu l- interazzjonijiet ibbażati fuq il- metaboliżmu jew interazzjonijiet tat- tip ta ’ l- ispostament tal - proteina fil- plażma bejn ziconotide u prodotti mediċinali oħrajn, mhux mistennija.
No clinical data are available on the interaction between IT chemotherapy and IT ziconotide.
L- ebda informazzjoni klinika mhi disponibbli dwar l- interazzjoni bejn kimoterapija IT u ziconotide IT.
Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.3).
Ziconotide hu kontra- indikat għall- użu flimkien ma ’ kimoterapija IT (ara sezzjoni 4. 3).
Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.4).
Għandha tingħata attenzjoni meta ziconotide jingħata lil pazjenti li jkunu qedgħin jirċievu kimoterapija sistemika (ara sezzjoni 4. 4).
Medicinal products that affect specific peptidases/ proteases would not be expected to impact upon ziconotide plasma exposure.
Prodotti mediċinali li jaffettwaw peptidases/ proteases speċifiċi mhumiex mistennija li jkollhom impatt fuq l- espożizzjoni tal- plażma ta ’ ziconotide.
Based on very limited clinical investigations, both angiotensin converting enzyme inhibitors (e. g., benazepril, lisinopril and moexipril) and HIV protease inhibitors (e. g., ritonavir, saquinavir, indinavir), have no readily apparent effect on plasma ziconotide exposure.
Fuq bażi ta ’ investigazzjonijiet limitati ħafna, kemm l - inibituri ta ’ l- enzimi li jibdlu angiotensin (eż., benazepril, lisinopril u moexipril) u inibituri ta ’ l- HIV protease (eż., ritonavir, saquinavir, indinavir), m’ għandhom l- ebda effett apparenti fil- pront fuq l - espożizzjoni ta ’ ziconotide fuq il- plażma.
Ziconotide does not interact with opiate receptors.
Ziconotide ma jagħmilx interazzjoni ma ’ riċetturi ta ’ l- opiate.
If discontinuing opiates when initiating ziconotide therapy, opiate withdrawal should be gradual.
Jekk jitwaqqfu l- opiates meta tibda t - terapija b’ ziconotide, it- twaqqif ta ’ l- opiate għandu jkun gradwali.
For patients being withdrawn from IT opiates, the IT opiate infusion dose should be gradually tapered over a few weeks and replaced with a pharmacologically equivalent dose of oral opiates.
Għal pazjenti li qed titwaqqfilhom il- kura bl- IT opiates, id- doża ta ’ l- infużjoni ta ’ l- IT opiate għandha titwaqqaf gradwalment fuq perijodu ta ’ ftit ġimgħat u tinbidel ma ’ doża farmakoloġikament ekwivalenti ta ’ opiates orali.
Adding IT ziconotide to stable doses of IT morphine (see section 5.1), is possible but requires special attention, as a high rate of neuropsychiatric adverse events (confusion/ thinking abnormal, paranoid reactions and hallucinations, and abnormal gait), some of them serious, was observed in Study 202 despite a low dose of ziconotide.
Li żżid ziconotide IT ma ’ dożi stabbli ta ’ morphine IT (ara sezzjoni 5. 1), hu possibbli, iżda dan jeħtieġ attenzjoni speċjali, għax rata għolja ta ’ avvenimenti newropsikjatriċi avversi (konfużjoni/ ħsibijiet anormali, reazzjonijiet paranojde u alluċinazzjonijiet, u mixi b’ mod anormali), li xi wħud minnhom kienu serji, kienu osservati fi Studju 202 minkejja doża baxxa ta ’ ziconotide.
Vomiting and anorexia, and peripheral edema were also observed when IT ziconotide was added to IT morphine.
Ir- rimettar u l- anoreksja, u l- edema periferali kienu osservati wkoll meta ziconotide IT żdied mal- morphine IT.
The addition of IT morphine to stable doses of IT ziconotide is better tolerated (pruritis has been reported).
Iż- żieda ta ’ morphine IT ma ’ dożi stabbli ta ’ ziconotide IT hi ttollerata aħjar (kien irrappurtat ħakk).
(See section 5.1).
(Ara sezzjoni 5. 1).
An increased incidence of somnolence has been observed when ziconotide is administered concomitantly with systemic baclofen, clonidine, bupivacaine or propofol.
Żieda fl- inċidenza ta ’ ngħas kienet osservata meta ziconotide jingħata fl- istess ħin ma ’ baclofen, clonidine, bupivacaine jew propofol sistemiċi.
4 4.6 Pregnancy and lactation
4 M’ hemm l- ebda informazzjoni disponibbli dwar l- użu fl- istess ħin ta ’ użu ta ’ agonisti opjojdi parzjali (eż. buprenorphine) ma’ ziconotide.
There are no adequate data from the use of ziconotide in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ ziconotide f’ nisa tqal.
Ziconotide should not be used during pregnancy unless clearly necessary.
Ziconotide m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
It is not known whether ziconotide is excreted in breast milk, therefore it should not be administered to breast-feeding women unless clearly necessary.
Mhux magħruf jekk ziconotide jitneħħiex fil- ħalib tas- sider, u għalhekk m’ għandux jingħata lil nisa li jkunu qed ireddgħu jekk ma jkunx hemm bżonn ċar.
Ziconotide may cause confusion, somnolence and other neurological adverse reactions, therefore patients must be advised not to drive or operate machines if affected.
Ziconotide jista ’ jikkawża konfużjoni, ngħas u reazzjonijiet newroloġiċi avversi oħrajn, u għalhekk il - pazjenti għandhom jingħataw parir biex ma jsuqux jew iħaddmu l- magni jekk ikun affettwati.
The safety of ziconotide administered as a continuous intrathecal infusion has been evaluated in more than 1,400 patients participating in acute and chronic pain clinical trials.
Is- sigurtà ta ’ ziconotide mogħti bħala infużjoni kontinwa għal ġot- teka, kienet evalwata f’ iktar minn 1, 400 pazjent li kienu qed jipparteċipaw fi provi kliniċi dwar uġigħ akut u kroniku.
The duration of treatment has ranged from one-hour bolus infusion to continuous use for more than 6 years.
It- tul ta ’ żmien tal - kura varja minn infużjoni bolus ta ’ siegħa sa użu kontinwu għal iktar minn 6 snin.
The median exposure time was 43 days.
Il- medjan taż- żmien ta ’ l- espożizzjoni kien ta ’ 43 jum.
The infusion dose rate ranged from 0.03 - 912 μ g/ day, with a median final dose rate of 7.2 μ g/ day.
Ir- rata ta ’ l- infużjoni varjat minn 0. 03 - 912 μg/ kuljum, b’ medjan tar- rata tad- doża finali ta ’ 7. 2 μg/ kuljum.
In clinical trials, 88% of patients experienced adverse drug reactions (ADRs).
Fi provi kliniċi, 88% tal- pazjenti kellhom reazzjonijiet avversi tal- mediċina (adverse drug reactions - ADRs).
The most commonly reported ADRs reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%), headache (12%), asthenia (13%), vomiting (11%), and somnolence (10%).
L- iktar ADRs li kienu rrappurtati b’ mod komuni fi studji kliniċi fit- tul kienu sturdament (42%), tqallih (30%), nystagmus (23%), stat ta ’ konfużjoni (25%), mixi anormali (16%), indeboliment tal- memorja (13%), vista mċajpra (14%), uġigħ ta ’ ras (12%), astenja (13%), rimettar (11%), u ngħas (10%).
Most ADRs were mild to moderate in severity and resolved over time.
Il- biċċa l- kbira ta ’ l- ADRs kienu minn ħfief sa moderati fis- severità u fiequ maż- żmien.
All ADRs reported in the intrathecal clinical trials with ziconotide (short- and long-term exposure) are listed below in order of frequency.
L- ADRs kollha rrappurtati fil- provi kliniċi ta ’ ġot- teka b’ ziconotide (espożizzjoni qasira u fit- tul) huma elenkati hawn taħt skond il- frekwenza.
Very Common (> 1/ 10), Common (> 1/ 100 ,< 1/10), Uncommon (> 1/ 1,000, < 1/ 100)
Komuni Ħafna (> 1/ 10), Komuni (> 1/ 100, < 1/ 10), Mhux Komuni (> 1/ 1, 000, < 1/ 100)
Uncommon: sepsis, meningitis
Mhux komuni: sepsis, meninġite
Common: appetite decreased, anorexia
Komuni: nuqqas t’ aptit, anoreksja
Very common: confusional state
Komuni ħafna: stat ta ’ konfużjoni
Common: anxiety, auditory hallucination, insomnia, agitation, disorientation, hallucination, visual hallucination, depression, paranoia, irritability, depression aggravated, nervousness, affect lability, mental status changes, anxiety aggravated, confusion aggravated
Komuni: ansjetà, alluċinazzjoni tas- smigħ, nuqqas ta ’ rqad, aġitazzjoni, diżorjentament, alluċinazzjoni, alluċinazzjoni viżwali, depressjoni, paranojja, irritabilità, depressjoni aggravata, nervożità, daħk/ tbissim/ biki patoloġiku, tibdil fl- istat mentali, ansjetà aggravata, konfużjoni aggravata
Uncommon: delirium, psychotic disorder, suicidal ideation, suicide attempt, thought blocking, abnormal dreams
Mhux komuni: delirju, mard psikotiku, formazzjoni ta ’ ħsieb biex jitwettaq suwiċidju, attentat ta ’ suwiċidju, imblukkar tal- ħsibijiet, ħolm anormali
5 Nervous system disorders
5 Disturbi fis- sistema nervuża:
Very Common: dizziness, nystagmus, memory impairment, headache, somnolence
Komuni Ħafna: sturdament, nystagmus, indeboliment tal- memorja, uġigħ ta ’ ras, ngħas
Common: dysarthria, amnesia, dysgeusia, tremor, balance impaired, ataxia, aphasia, burning sensation, sedation, paraesthesia, hypoaesthesia, disturbance in attention, speech disorder, areflexia, coordination abnormal, dizziness postural, cognitive disorder, hyperaesthesia, hyporeflexia, ageusia, depressed level of consciousness, dysaesthesia, parosmia, mental impairment
Komuni: disartrija, amnesija, disgewżja, rogħda, indeboliment fil- bilanċ, atassja, afasja, sensazzjoni ta ’ ħruq, sedazzjoni, parestesija, ipoestesija, disturb fl- attenzjoni, taħwid fid- diskors, assenza ta ’ riflessi, koordinazzjoni anormali, sturdament li jiddependi mill- qagħda, mard konjittiv, iperestesija, hyporeflexia, telf tas- sens tat- togħma, livell baxx ta ’ koxjenza, disestesija, parosmija, indeboliment mentali
Uncommon: incoherence, loss of consciousness, coma, stupor, convulsions, cerebrovascular accident, encephalopathy
Mhux komuni: inkoerenza, tintilef minn sensik, koma, sturdament, konvulżjonijiet, inċident ċerebrovaskulari, enċefalopatija
Very Common: vision blurred
Komuni Ħafna: vista mċajpra
Common: diplopia, visual disturbance, photophobia
Komuni: diplopja, disturb tal- vista, fotofobija
Common: vertigo, tinnitus
Komuni: sturdament, żanżin fil- widnejn
Uncommon: atrial fibrillation
Mhux komuni: fibrillazzjoni atrijali
Common: orthostatic hypotension, hypotension
Komuni: pressjoni tad- demm baxxa ħafna meta wieħed ikun bilwieqfa, pressjoni tad- demm baxxa ħafna
Common: dyspnoea
Komuni: dispnea
Uncommon: respiratory distress
Mhux komuni: problemi respiratorji
Very Common: nausea, vomiting
Komuni Ħafna: tqallih, rimettar
Common: diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain
Komuni: dijarea, ħalq xott, stitikezza, tqallih aggravat, uġigħ addominali fin- naħa ta ’ fuq
Uncommon: dyspepsia
Mhux komuni: dispepsja
Common: pruritus, sweating increased
Komuni: ħakk, żieda fl- għaraq
Uncommon: rash
Mhux komuni: raxx
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeltrali, u tal- connective tissue
Common: pain in limb, myalgia, muscle spasms, muscle cramp, muscle weakness, arthralgia, peripheral swelling
Komuni: uġigħ fir- riġlejn jew fid- dirgħajn, mijalġja, spażmi tal- muskoli, bugħawwieġ fil- muskoli, dgħjufija fil- muskoli, artralġja, nefħa periferali
6 Renal and urinary disorders
6 Mhux komuni: rabdomijolosi, mijosite, uġigħ fid- dahar, kontrazzjonijiet tal- muskoli, uġigħ fl- għonq
Common: urinary retention, urinary hesitation, dysuria, urinary incontinence
Komuni: żamma ta ’ l- awrina, eżitazzjoni urinarja, uġigħ u diffikultà biex tagħmel l- awrina, inkontinenza fl- awrina
Uncommon: acute renal failure
Mhux komuni: insuffiċjenza akuta renali
Very Common: gait abnormal, asthenia
Komuni Ħafna: mixi anormali, astenja
Common: fatigue, pyrexia, lethargy, oedema peripheral, rigors, fall, chest pain, feeling cold, pain, feeling jittery, pain exacerbated
Komuni: għeja kbira, deni, letarġija, edema periferali, tertir, waqgħat, uġigħ fid- sider, tħoss il- bard, uġigħ, tħossok nervuż/ a, uġigħ jiħrax
Uncommon: difficulty in walking
Mhux komuni: diffikultà biex timxi
Common: blood creatine phosphokinase increased, weight decreased
Komuni: żieda fil- creatine phosphokinase fid- demm, tnaqqis fil- piż
Uncommon: electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased
Mhux komuni: elettrokardjogramm anormali, żieda fl- aspartate aminotransferase, żieda fil- creatine phosphokinase MM fid- demm, żieda fit- temperatura tal- ġisem
Specific comments and particular caution regarding meningitis, elevations of creatine kinase, and CNS adverse events can be found in Section 4.4.
Kummenti speċifiċi u attenzjoni partikulari dwar il- meninġite, elevazzjonijiet tal- creatine kinase, u avvenimenti avversi CNS jinsabu f’ Sezzjoni 4. 4.
In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to 70,000 μ g/ day or 3,200 times the maximum recommended daily intrathecal infusion dose.
Fi studji dwar l- infużjoni fil- vina, voluntiera rġiel b’ saħħithom irċievew ziconotide f’ dożi sa 70, 000 μg/ kuljum jew 3, 200 darba tal- massimu rakkomandat tad- doża ta ’ infużjoni ta ’ kuljum għal ġot- teka.
Postural hypotension was observed in almost all subjects who received high intravenous doses of ziconotide.
Pressjoni tad- demm baxxa ħafna li tiddependi mill- qagħda kienet osservata fi kważi l - pazjenti kollha li rċievew dożi qawwija ta ’ ziconotide fil- vina.
The maximum recommended intrathecal dose is 21.6 μ g/ day.
Id- doża massima rakkomandata għal ġot- teka hi ta ’ 21. 6 μg/ kuljum.
The maximum intended intrathecal dose of ziconotide in clinical trials was 912 μ g/ day following upward titration over 7 days.
Id- doża massima intenzjonata ta ’ ziconotide għal ġot- teka fi provi kliniċi kienet ta ’ 912 μg/ kuljum wara żieda fit- titrazzjoni fuq perijodu ta ’ 7 ijiem.
In one clinical study a male cancer patient received an accidental IT ziconotide overdose of 744 μ g over a 24-hour period (31 μ g/ hour) and resumed treatment at the intended dose after experiencing a reduction in Visual Analog Scale of Pain Intensity (VASPI) from 82 to 2.5 mm.
Fi studju kliniku, pazjent raġel bil- kanċer, irċieva doża eċċessiva ta ’ 744 μg ta ’ ziconotide IT b’ mod aċċidentali fuq perijodu ta ’ 24 siegħa (31 μg/ siegħa) u kompla l- kura bid- doża intenzjonata wara li ġarrab tnaqqis fil- Visual Analog Scale of Pain Intensity (VASPI) minn 82 għal 2. 5 mm.
In some patients who received intrathecal doses greater than the maximum recommended dose, exaggerated pharmacological effects, e. g., ataxia, nystagmus, dizziness, stupor, depressed level of consciousness, muscle spasms, confusional state, sedation, hypotension, aphasia, speech disorder, nausea and vomiting were observed.
F’ xi pazjenti li rċievew dożi għal ġot- teka akbar mid- doża massima rakkomandata, effetti farmakoloġiċi esaġerati, eż., atassja, nystagmus, sturdament, mejt, livell baxx ta ’ koxjenza, spażmi tal- muskoli, stat ta ’ konfużjoni, sedazzjoni, pressjoni tad- demm baxxa ħafna, afasja, taħwid fid- diskors, tqallih u rimettar kienu osservati.
There was no indication of respiratory depression.
Ma kien hemm l- ebda indikazzjoni ta ’ depressjoni respiratorja.
Most patients under observation recovered within 24 hours of withdrawal of the medicinal product.
Il- biċċa l- kbira tal- pazjenti taħt osservazzjoni, irkupraw fi żmien 24 siegħa minn meta twaqqaf il- prodott mediċinali.
General medical supportive measures should be administered to patients who receive an overdose until the exaggerated pharmacological effects of the medicinal product have resolved.
Miżuri ta ’ appoġġ mediku ġenerali għandhom jingħataw lil pazjenti li jirċievu doża eċċessiva, sakemm l- effetti farmakoloġiċi esaġerati tal- prodott mediċinali jfiequ.
Analgesics ATC code:
Analġesiċi Kodiċi ATC:
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari, ma kienx possibli li tinkiseb informazzjoni kompleta dwar dan il - prodott mediċinali.
The European Medicines Agency (EMEA) will review any new information, which may become available every year and this SPC will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi l- informazzjoni l - ġdida kull sena u ser taġġorna dan is- Sommarju tal- Karatteristiċi tal- Prodott, skond il- bżonn.
7 Ziconotide is a synthetic analogue of a ω -conopeptide, MVIIA, found in the venom of the Conus magus marine snail.
Ziconotide hu analogu sintetiku ta ’ ω- conopeptide, MVIIA, li jinsab fil- velenu ta ’ Conus magus, bebbuxu tal- baħar.
It is an N-type calcium channel blocker (NCCB).
Hu N- type calcium channel blocker (NCCB).
NCCs regulate neurotransmitter release in specific neuronal populations responsible for the spinal processing of pain.
L- NCCs jirregolaw in - neurotransmitter release f’ popolazzjonijiet newronali speċifiċi li huma responsabbli għall- ipproċessar ta ’ l- uġigħ fil- kolonna vertebrali.
In binding to these neuronal NCCs ziconotide inhibits the voltage sensitive calcium current into primary nociceptive afferents terminating in the superficial layers of the dorsal horn of the spinal cord.
Billi jeħel ma ’ dawn l- NCCs newronali, ziconotide jinibixxi l - kurrent tal- calcium sensittiv għall- vultaġġ ġon- nociceptive afferents primarji li jispiċċaw fis- saffi superfiċjali tad- dorsal horn tas- sinsla.
In turn, this inhibits their release of neurotransmitters (including Substance P) and therefore, the spinal signalling of pain.
Imbagħad, dan jinibixxi n- neurotransmitter release tagħhom (li tinkludi Sustanza P) u għalhekk, is- senjalazzjoni ta ’ l- uġigħ tal- kolonna vertebrali.
Though statistically significant relationships and reasonable correlation between cerebrospinal fluid (CSF) exposure (AUC, Cmax) and clinical response measures have been observed following 1 hour IT administration, no well-defined dose-concentration-response relationships have yet been identified.
Għalkemm kienu osservati relazzjonijiet statistikament sinifikanti u korrelazzjoni raġonevoli bejn l - espożizzjoni tal- fluwidu ċerebrospinali (cerebrospinal fluid - CSF) (AUC, Cmax) u l- miżuri tar- rispons kliniku, wara l- għoti IT ta ’ siegħa, l- ebda relazzjonijiet doża- konċentrazzjoni definiti tajjeb ma kienu identifikati s’ issa.
Many responsive patients obtain near-maximal analgesia within a few hours of delivery of an appropriate dose.
Ħafna pazjenti li rrispondew jiksbu kważi analġeżja massima fi żmien ftit sigħat mill- forniment ta ’ doża adattata.
However, maximal effects may be delayed for approximately 24 hours in some patients.
Madankollu, l- effetti massimi jistgħu jittardjaw għal madwar 24 siegħa f’ xi pazjenti.
Given the occurrence of analgesia and adverse drug reactions at similar doses, the recommended interval between dose increases is 48 hours or more.
Minħabba l- fatt li l- okkorrenza ta ’ l- analġeżja u r- reazzjonijiet avversi tal - mediċina f’ dożi simili, l- intervall rakkomandat bejn iż- żidiet fid- doża hu ta ’ 48 siegħa jew iktar.
If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse drug reactions.
Jekk ikun meħtieġ, id- doża tista ’ titnaqqas bi kwalunkwe ammont (li jinkludi t- twaqqif ta ’ l- infużjoni) għall- immaniġġjar ta ’ reazzjonijiet avversi tal- mediċina.