qanastek/EMEA-V3 huggingface dataset:
In order to be able to
Dawn jistgħu jinkludu għaraq kiesaħ, ġilda
ed take action immediately, patients should carry glucose with them at all times.
t za pallida u kiesħa, għeja kbira, nervożiżmu jew rogħda, ansjetà, għeja jew dgħjufija mhux tas- soltu, konfużjoni, diffikultà fil- konċentrazzjoni, ħedla, ġuħ eċċessiv, tibdil fil- viżta, uġigħ ta ’ ras, dardir u
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
L- ipogliċemija serja tista ’ twassal għal telf mis- sensi u/ jew aċċessjonijiet u tista ’ tirriżulta f’ indeboliment temporanju jew permanenti tal- funzjoni tal- moħħ jew anke mewt.
ris Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised
Il- pazjenti għandhom iġorru l- glukosju magħhom il- ħin kollu, sabiex ikunu jistgħu jieħdu azzjoni immedjata.
ho accordingly.
aw Jekk tinqabeż ikla jew jekk isir eżerċizzju fiżiku qawwi mhux ippjanat, dan jista ’ jwassal għal ipogliċemija.
Usual warning symptoms may disappear in patients with longstanding diabetes.
x Pazjenti li l- kontroll tal- glukosju f’ demmhom huwa mtejjeb bil- bosta eż. b’ terapija bl- insulina
ut ra A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin to human insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
du intensifikata, jistgħu jesperjenzaw bidla fis- sintomi ta ’ twissija tagħhom tas- soltu u għandhom għalhekk jiġu avżati.
Before travelling between different time zones, the patient should be advised to consult the doctor, since this may mean that the patient has to take insulin and meals at different times. lo Inadequate dosage or discontinuation of treatment especially in insulin-dependant diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal. o tn
Is- sintomi ta ’ twissija tas- soltu jistgħu jisparixxu f’ pazjenti li ilhom ibatu bid- dijabete. ’ g Ftit mill- pazjenti li esperjenzaw reazzjonijiet ipogliċemiċi wara trasferiment minn insulina li ġejja mill- annimali għal insulina umana rrapportaw li s- sintomi ta ’ twissija bikrija ta ’ l- ipogliċemija kienu im
When used with other antidiabetic agents, the dose of each agent should be carefully adjusted to determine the optimal dose required to achieve the desired pharmacological effect. uc
Qabel jivvjaġġaw bejn żoni ta ’ ħinijiet differenti, il- pazjenti għandhom jiġu avżati biex jikkonsultaw lit- tabib, minħabba li dan jista ’ jfisser li l- pazjent ikollu jieħu l- insulina u l- ikliet f’ ħinijiet differenti. al
Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or stress. od
Dożaġġ mhux adegwat jew twaqqif ta ’ trattament speċjalment f’ persuni li għandhom id- dijabete in
Pulmonary Safety pr
dipendenti fuq l- insulina, jista ’ jwassal għal ipergliċemija u ketoaċidożi dijabetika; kondizzjonijiet li iċ
Underlying respiratory disorders al
jistgħu jkunu letali. ed
EXUBERA should not be used in patients with lung disease such as asthma and COPD, as there are insufficient data to support the safe use in these patients. in ic
Meta wżata ma ’ mediċini ta ’ kontra d- dijabete, id- doża ta ’ kull mediċina għandha tiġi aġġustata bir - reqqa biex tiġi stabbilita l- aqwa doża biex jinkseb l- effett farmakoloġiku mixtieq. m
The concomitant use of bronchodilators such as salbutamol may increase the absorption of EXUBERA and may therefore increase the risk of hypoglycaemia when used to relieve acute ed
Il- ħtiġijiet għall- insulina jistgħu jinbidlu waqt kondizzjonijiet interkurrenti bħal mard, disturbi emozjonali jew stress. t ot
M
Sigurtà Pulmonari od
Respiratory
Disturbi respiratorji diġà eżistenti Pr
Any patients experiencing such a reaction should discontinue EXUBERA and seek medical evaluation immediately.
EXUBERA m’ għandhiex tintuża f’ pazjenti b’ mard pulmonari bħalma huma l- ażżma u s- COPD, minħabba li m’ hemmx biżżejjed tagħrif biex isostni użu mingħajr periklu f’ dawn il- pazjenti.
Re-administration of EXUBERA requires a careful risk evaluation, and may only be done under close medical monitoring with appropriate clinical facilities.
L- użu fl- istess ħin ta ’ dilaturi tal- bronki bħalma huwa salbutamol jistgħu jżidu l- assorbiment ta ’ EXUBERA u jistgħu jżidu r- riskju ta ’ ipogliċemija meta wżati biex itaffu sintomi respiratorji akuti (ara sezzjoni 4. 5).
21 Decline in pulmonary function
21 F’ każijiet rari jista ’ jseħħ bronkospażmu.
In clinical trials small but consistent treatment group differences in decline of pulmonary function (particularly Forced Expiratory Volume in one second (FEV1)) favouring comparator treated subjects have been observed.
Fi provi kliniċi ġew osservati differenzi żgħar imma konsistenti fit- tnaqqis tal- funzjoni pulmonari fil - grupp tat- trattament (b’ mod partikolari Volum Espiratorju Sfurzat f’ sekonda (FEV1)) li jiffavorixxu suġġetti ttrattati b’ komparatur.
ed baseline FEV1 < 70% predicted have not been established and the use of inhaled human insulin in this population is not recommended A follow-up lung function measurement is recommended after the first 6 months of therapy.
to umana inalata f’ pazjenti bil- linja bażi mistennija FEV1 < 70% ma ġietx stabbilita, u l- użu ta ’ l- insulina umana inalata f’ din il- popolazzjoni mhux rakkomandata.
A number of substances affect glucose metabolism and may require dose adjustment of insulin.
22 Għadd ta ’ sustanzi jaffettwaw il- metaboliżmu tal- glukosju u jistgħu jeħtieġu aġġustament tad- doża ta ’ l- insulina.
22 Administration of fluticasone prior to EXUBERA does not appear to affect insulin absorption (see section 5.2).
t za L- għoti ta ’ fluticasone qabel EXUBERA ma jidhirx li jaffettwa l- assorbiment ta ’ l- insulina (ara sezzjoni 5. 2).
23 The table below contains adverse reactions seen in controlled clinical studies including more than 1970 patients exposed to EXUBERA.
23 It- tabella hawn taħt fiha r- reazzjonijiet avversi li dehru fi provi kliniċi b’ kontrolli li jinkludu aktar minn 1970 pazjent esposti għal EXUBERA.
Dyspnoea
Qtugħ ta ’ Nifs
Thoracic and Mediastinal
respiratorji,
Productive Cough Throat Irritation
Sogħla Produttiva
Bronchospasm Wheezing
Bronkospażmu
Disorders
toraċiċi u
Dry Throat
Irritazzjoni tal- Gerżuma
Dysphonia
Tħarħir
Pharyngolaryngeal Pain
medjastinali
ho Tonsillar Disorder
Gerżuma Xotta
Gastrointestinal
Disfownja
Dry Mouth
aw Uġigħ Farinġolarinġeali Disturbi Tonsillari
ut Disorders
x
ra Disorders and Administration Site Conditions
du intestinali
n
Disturbi ġenerali u kondizzjonijiet
In the overall clinical program, including uncontrolled extension studies, there were two reports of pleural effusion in which a treatment-related effect could not be excluded. lo Hypoglycaemia o
Fil- program kliniku totali, inkluż studji t’ estensjoni mingħajr kontrolli, kien hemm żewġ im
As with other insulins, hypoglycaemia was the most frequently observed undesirable effect in patients tn
rapporti ta ’ tnixxija plewrali fejn effett relatat mat- trattament ma setax jiġi eskluż.
treated with EXUBERA. uc
Ipogliċemija il
Cough
Sogħla iċ
The cough tended to occur within seconds to minutes after insulin inhalation and was predominantly od
Is- sogħla kellha t- tendenza li tibda fi żmien sekondi sa minuti wara l- inalazzjoni ta ’ l- insulina u din ed
mild in severity.
kienet prinċipalment ħafifa fis- serjetà.
One percent of patients discontinued EXUBERA treatment due to cough. pr
Wieħed fil- mija tal- pazjenti waqqfu t- trattament b’ EXUBERA minħabba s- sogħla. m
Dyspnoea al
Qtugħ ta ’ Nifs t ot
In EXUBERA treated subjects in
Il- maġġoranza (> 95%) tal- qtugħ ta ’ nifs kien irrapportat bħala ħafif għal moderat.
0.4% discontinued treatment due to dyspnoea. ic
F’ pazjenti ttrattati b’ EXUBERA, 0. 4% waqqfu t- trattament minħabba l- qtugħ ta ’ nifs. od
A range of different chest symptoms were reported as treatment-related adverse reactions and were referred to as non-specific chest pain..
Ġiet irrapportata firxa sħiħa ta ’ sintomi tas- sider differenti bħala reazzjonijiet avversi relatati mat - trattament u saret referenza għalihom bħala uġigħ fis- sider mhux speċifiku.
The majority (> 95%) of these events was reported as mild to M
Il- maġġoranza (> 95%) ta ’ dawn ir- reazzjonijiet kienu rrapportati bħala ħfief għal moderati.
24 Other reactions
24 Tnaqqis fl- FEV1
A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated type 1 subjects
t Kien hemm tnaqqis mil- linja bażi ta ’ referenza ta ’ FEV1 ta ’ > 15% f’ 1. 3% ta ’ pazjenti ta ’ tip 1 ittrattati
ed and in 5.0% of EXUBERA-treated type 2 subjects.
za b’ EXUBERA u f’ 5. 0% ta ’ pazjenti ta ’ tip 2 ittrattati b’ EXUBERA.
Insulin antibodies
riz Antikorpi ta ’ l- Insulina
ris Insulin antibodies may develop during treatment with all insulins including EXUBERA.
Antikorpi ta ’ l- insulina jistgħu jiżviluppaw waqt trattament bl- insulini kollha inkluż EXUBERA.
In clinical
Fi
ho trials, insulin antibodies developed more frequently and mean levels of insulin antibodies were higher in patients who switched their subcutaneous human insulin to EXUBERA compared to subjects who remained on subcutaneous human insulin.
to provi kliniċi, antikorpi ta ’ l- insulina żviluppaw b’ mod aktar frekwenti u l- livelli ta ’ antikorpi ta ’ l -
Insulin antibody levels were higher in patients with type 1
aw insulina kienu ogħla f’ pazjenti li qalbu l- insulina umana tagħhom li tittieħed taħt il- ġilda għal EXUBERA meta mqabbla ma ’ suġġetti li baqgħu fuq l- insulina umana li ttittieħed taħt il- ġilda.
ut diabetes compared to type 2 diabetes and plateaued within 6-12 months of exposure in both groups.
Ma ġie
ra No clinical significance of these antibodies has been identified.
x identifikat l- ebda sinifikat kliniku ta ’ dawn l- antikorpi.
Hypersensitivity reactions
du Reazzjonijiet ta ’ Sensittività Eċċessiva
As with other insulins, generalised allergic reactions may occur very rarely.
Bħal b’ insulini oħra, reazzjonijiet allerġiċi ġenerali jistgħu jseħħu b’ mod rari ħafna.
Such reactions to insulin or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock and may be life-threatening (see section 4.4 Respiratory). lo
Reazzjonijiet bħal dawn għall- insulina jew is- sustanzi mhux attivi jistgħu, per eżempju, jkunu assoċjati ma ’ reazzjonijiet ’ g ġenerali tal- ġilda, anġjo- edema, bronkospażmi, pressjoni baxxa u xokk u jistgħu jkunu ta ’ theddida għall- ħajja (ara sezzjoni 4. 4 Respiratorji). im
Refraction abnormalities of the eye may occur upon initiation of insulin therapy.
Anormalitajiet fir- refrazzjoni ta ’ l - al
These effects are usually transitory. uc
għajn jistgħu jseħħu hekk kif tinbeda t- terapija bl- insulina.
4.9 Overdose od
4. 9 Doża eċċessiva ed
Hypoglycaemia may occur as a result of an excess of insulin relative to food intake, energy expenditure or both. pr
L- ipogliċemija tista ’ sseħħ bħala riżultat ta ’ eċċess ta ’ insulina meta mqabbel mat- teħid ta ’ l- ikel, ħela ta ’ enerġija jew it- tnejn. m
Mild episodes of hypoglycaemia usually can be treated with oral carbohydrates.
Episodji ħfif ta ’ ipogliċemija jistgħu ġeneralment jiġu ttrattati b’ karboidrati orali.
Adjustments in drug dosage, meal patterns, or exercise may be needed. al
Jistgħu jkunu meħtieġa aġġustamenti fid- doża tal- mediċina, fil- mod kif jittieħed l- ikel jew fl- eżerċizzju. t ot
More severe episodes, with coma, seizure, or neurological impairment may be treated with in
Episodji aktar serji, b’ koma, aċċessjoni, jew indeboliment newroloġiku jistgħu jiġu ttrattati bi od
Glucose ic
glukagon intramuskolari/ taħt il- ġilda (0. 5 sa 1 mg) jew glukosju ikkonċentrat mogħti ġol- vini.
25 Mode of Action
Mod ta ’ kif jaħdem
ris SC Lispro (18 U)
x du SC Lispro (18 U) Exubera (6mg) ħa GIR medja (% tal -
ho Mean GIR (% of Maximum)
Insulina Umana li Massimu
Exubera (6mg))
Tahdem Malajr ’ g
ra (18 U)
(18 U) im il al
Time (min) (o
Hin (min) in iċ
Mean Glucose Infusion Rate (GIR) Normalised to GIRmax for Each Subject Treatment tn
Rata ta ’ Infużjoni ta ’ Glukosju Medja (GIR) Normalizzata għal GIRmax għal Kull ed
Versus Time in Healthy Volunteers.
Trattament tas- Suġġett Kontra Ħin f’ Voluntiera b’ Saħħithom.
When human insulin is inhaled, the onset of glucose lowering activity is within 10-20 minutes, the uc
Meta l- insulina umana hija inalata, il- bidu ta ’ l- attività li tbaxxi l- glukosju jseħħ fi żmien 10- 20 m
The duration of action lasts approximately 6 hours. od
L- azzjoni ddum għaddejja bejn wieħed u ieħor 6 sigħat. t ot
In subjects with type 1 or type 2 diabetes, inhaled human insulin has a faster onset of glucose pr
F’ suġġetti b’ dijabete ta ’ tip 1 jew 2, l- azzjoni b’ effett li jbaxxi l- glukosju ta ’ l- insulina inalata tibda aktar malajr fis- sigħat bikrin wara d- dożaġġ meta mqabbla ma ’ l- insulina umana li taħdem malajr od
lowering effect in the early hours after dosing when compared with subcutaneously administered fast- acting human insulin. al
Pr
The intra-subject variability of glucose lowering activity of inhaled human insulin was generally comparable to that of subcutaneously administered fast-acting human insulin in subjects with type 1 in
Il- varjiabilità ta ’ l- attività li tbaxxi l- glukosju ta ’ insulina umana inalata bejn is- suġġetti nfushom kienet ġeneralment komparabbli ma ’ dik ta ’ l- insulina umana li taħdem malajr mogħtija taħt il- ġilda f’ suġġetti b’ dijabete mellitus tip 1 u 2.
Use of inhaled human insulin is associated with an increase in frequency, and levels of insulin ed
L- użu ta ’ insulina inalata huwa assoċjat ma ’ żieda fil- frekwenza, u livelli ta ’ antikorpi ta ’ l- insulina.
Controlled clinical trials in type 1 or type 2 diabetes have shown that EXUBERA achieves and maintains effective glycaemic control comparable to subcutaneously administered fast-acting human insulin.
Fi studju esploratorju prospettiv ta ’ 6 xhur f’ suġġetti b’ dijabete tip 1, ma ġewx osservati alterazzjonijiet fil- farmakodinamiċi b’ insulina inalata.
26 Type 1 Diabetes
26 Tagħrif fuq il- Provi Kliniċi
Fasting plasma glucose levels were significantly lower in patients treated with regimens including EXUBERA compared with those treated with subcutaneously administered fast-acting human insulin only regimens.
t za komparabbli bejn il- gruppi ta ’ trattament.
ed Type 2 Diabetes
Livelli sajmin ta ’ glukosju fil- plażżma kienu ferm aktar baxxi f’ pazjenti ttrattati b’ reġimens li jinkludu
ris Patients in a clinical trial for type 2 diabetes, who used a regimen of EXUBERA in combination with long- or intermediate-acting insulin, had similar changes in HbA1c compared with patients treated
riz EXUBERA meta mqabbla ma ’ dawk ittrattati b’ reġimens b’ insulina umana li taħdem malajr mogħtija taħt il- ġilda biss.
ho with subcutaneous insulin alone.
to Dijabete ta ’ Tip 2
Fasting plasma glucose levels were significantly lower in patients treated with EXUBERA regimens
aw Pazjenti fi prova klinika għad- dijabete ta ’ Tip 2, li użaw reġimen ta ’ EXUBERA f’ kombinazzjoni ma ’ insulina li taħdem b’ mod intermedju jew fit- tul kellhom tnaqqis simili fil- HbA1c meta mqabbla ma ’
ut compared with those treated with subcutaneous insulin.
x pazjenti li kienu qed jieħdu insulina taħt il- ġilda biss.
ra In clinical trials involving patients with type 2 diabetes not sufficiently controlled with oral agents alone, patients using a regimen of EXUBERA alone or in combination with oral agents, had greater
Fil- parti l- kbira ta ’ dawn l - im
ge improvements in HbA1c compared with patients treated with oral agents alone.
istudji, il- perċentwali ta ’ pazjenti li laħqu HbA1c < 7. 0% kienu ogħla għal pazjenti fuq reġimen li kien jinkludi EXUBERA meta mqabbla ma ’ pazjenti fuq mediċini orali biss.
In most of these studies the percentages of patients achieving HbA1c < 7.0% were higher for patients using a regimen n including EXUBERA compared to patients on oral agents alone.
Livelli sajmin ta ’ glukosju kienu simili għal jew aktar baxxi f’ pazjenti li ħadu reġimen li kien jinkludi EXUBERA meta mqabbla il
Fasting plasma glucose was similar to or lower in patients using a regimen including EXUBERA compared to patients treated with oral lo agents alone.
ma ’ pazjenti ttrattati b’ mediċini orali waħidhom.
In patients with type 2 diabetes sufficiently controlled with oral agents the glycaemic control was not further improved by inhaled insulin. o tn
F’ pazjenti b’ dijabete tip 2 ikkontrollata biżżejjed al
FEV1 decline
Tnaqqis fil- FEV1 in
Randomised, open label parallel group studies were conducted to examine FEV1 changes following uc
Saru provi magħmula b’ mod każwali, fi gruppi paralleli, b’ tiketta murija biex jeżaminaw tibdil fil - iċ
initiation of EXUBERA therapy in type 1 and 2 subjects.
FEV1 wara l- bidu ta ’ terapija b’ EXUBERA f’ suġġetti ta ’ tip 1 u tip 2.
Small od
b’ EXUBERA kif ukoll dawk ittrattati b’ mediċina ta ’ tqabbil, maż- żmien esperjenzaw tnaqqis fil - funzjoni tal- pulmun waqt dawn il- provi (Figuri 2 u 3).
treatment group differences (favouring comparator) in change from baseline of 0.034L in type 1 and 0.039L in type 2 occurred after 2 years of therapy. pr
Differenzi żgħar fil- grupp ta ’ trattament (li jiffavorixxu l- mediċina ta ’ tqabbil) fil- bidla mil- linja ta ’ referenza bażi ta ’ 0. 034L f’ tip 1 u 0. 039L m
A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated and 1.0% of comparator-treated type 1 subjects and in 5.0% of EXUBERA-treated and 3.4% of comparator-treated al
Seħħ tnaqqis fil- FEV1 mil- linja bażi ta ’ > 15% f’ 1. 3% ta ’ suġġetti ta ’ tip 1 ittrattati b’ EXUBERA u ot
type 2 subjects. in ic ed M
f’ 1. 0% ta ’ dawk ittrattati b’ mediċina ta ’ tqabbil u f’ 5. 0% ta ’ suġġetti ta ’ tip 2 ittrattati b’ EXUBERA u fi 3. 4% ta ’ dawk ittrattati b’ mediċina ta ’ tqabbil. od Pr
27 0 .3 IN H 0 .2 5 C o m p ar a to r 0 .2 0 .1 5 Change from Baseline in FEV1 (L)
27
o
INH Comparator Komparatur INH Washout INH Washout 0. 3 il Bidla minn Linja Bażi ta ’ Referenza f’ FEV1 (L)
0.3
0. 2 al
0.25 Change from Baseline in FEV1 (L)
0. 15 0. 1 0. 05 (Mean + / - SD)
uc
in
od
- 0. 05 - 0. 1 iċ
0 -0.05 -0.1 -0.15 pr
- 0. 15 - 0. 2 ed
-0.2 -0.25 -0.3 -0.35 al
- 0. 25 - 0. 3 - 0. 35 - 0. 4 m
-0.4 -0.45
- 0. 45 - 0. 5
+12
Linja ta ’ bażi t ot
Visit (weeks) N=Number of Subjects at Baseline, week 52, week 104, week +6, week +12. ed
Visit (weeks) Żjara (ġimgħat) N=Number of Subjects at Baseline, week 52, week 104, week +6, week +12.
6 of these discontinued subjects underwent follow-up pulmonary function testing.
Dawn is- suġġetti esperjenzaw tnaqqis medju fl- FEV1 ta ’ 21% (fuq medda ta ’ 16% - 33%) mil- linja ta ’ referenza bażi u kienu ttrattati b’ EXUBERA għal medja ta ’ 23 xahar.
No further information is available for the remaining 3 subjects who discontinued.
Sitta minn dawn is -
28 FEV1 reversibility
28 suġġetti li twaqqfu sarulhom testijiet ta ’ follow- up tal- funzjoni pulmonari.
In type 2 subjects, resolution of small treatment group differences (0.039L favouring comparator) occurred within 6 weeks of EXUBERA cessation following 2 years of therapy (Figure 3).
F’ pazjenti ta ’ tip 2, seħħet riżoluzzjoni ta ’ differenzi żgħar fil- grupp ta ’ trattament (0. 039L
In a smaller group (n=36) of mixed type 1 and 2 subjects treated with EXUBERA for > 36 months, cessation of therapy resulted in a mean FEV1 increase of 0.036L over the subsequent 6 months.
Fi grupp iżgħar (n=36) ta ’ suġġetti tip 1 u 2 imħallta, ittrattati b’ EXUBERA għal > 36- il xahar, it- twaqqif tat- terapija irriżulta f’ żieda medja fl- FEV1 ta ’ 0. 036L fuq is- 6 xhur ta ’ wara.
ed Absorption
to Assorbiment
ris Inhaled human insulin is delivered by the pulmonary route.
aw L- insulina inalata hija imwassla permezz tar- rotta pulmonari.
ho human insulin in healthy subjects and in subjects with type 1 or type 2 diabetes (see Figure 4).
L- insulina umana inalata hija assorbita malajr daqs analogi ta ’ l- insulina li jaħdmu malajr u aktar malajr minn insulina umana li taħdem malajr mogħtija taħt il- ġilda f’ suġġetti b’ saħħithom u f’ suġġetti bid- dijabete ta ’ tip 1 jew ta ’ tip 2 (ara Figura
Figure 4:
x 4).
ge 80
du ħa 80 Bidla minn Linja Bażi ta ’ Insulina Mingħajr Serum
70 Change From Baseline Serum Free Insulin
’ g 70 Change From Baseline Serum Free Insulin
n EXUBERA (4mg) lo 60
60 Konċentrazzjoni (uU/ ml)
Inha le d Ins ulin Concentration (uU/ ml)
Insulina Ins ulin Inha le d Inalata Concentration (uU/ ml)
o
Insulina mogħtija taħt il- ġilda
tn
il
40 uc
40 al
30
Insulina Umana li taħdem malajr (12 30 in
20 od
IU) 20 iċ
10 pr
10 ed
T im
T im e (m in) Ħin (min)
The time to peak insulin concentration (Tmax) is generally half of that for subcutaneously administered in
ta ’ 4 mg ta ’ insulina umana jew injezzjoni taħt il- ġilda ta ’ 12 IU insulina umana li taħdem malajr f’ suġġetti ħoxnin ħafna b’ dijabete tip 2. od
fast-acting human insulin.
Il- konċentrazzjoni massima ta ’ l- insulina Pr
Peak insulin concentration is reached generally by 45 minutes for inhaled ic
ġeneralment tintlaħaq f’ 45 minuta għal insulina umana inalata.
Intrasubject variability of time to peak insulin concentrations was less for inhaled human insulin than for subcutaneous fast-acting human insulin in subjects with type 1 or 2 diabetes. ed
Il- varjabilità fis- suġġetti tal- ħin biex tintlaħaq il- konċentrazzjoni massima ta ’ l- insulina kienet inqas għal insulina umana inalata milli għal insulina umana li taħdem malajr mogħtija taħt il- ġilda f’ pazjenti b’ dijabete ta ’ tip 1 jew 2.
For Cmax, the intrasubject variability of inhaled insulin is greater than that of subcutaneously administered fast- acting human insulin.
Għas- Cmax il- varjiabilità ta ’ insulina inalata fis- suġġetti hija akbar minn dik ta ’ l- insulina umana li taħdem malajr mogħtija taħt il - ġilda.
The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
29 Il- bijodisponibilità relattiva ta ’ EXUBERA meta mqabbla ma ’ insulina umana li taħdem malajr mogħtija taħt il- ġilda hija madwar 10%.
In a study in healthy subjects, systemic exposure (AUC and Cmax) of inhaled human insulin
Fi studju f’ pazjenti b’ saħħithom, l- espożizzjoni sistemika (AUC u Cmax) ta ’ insulina umana inalata żdiedet b’ mod bejn wieħed u ieħor proporzjonali għad- doża minn 1 mg għal 6 mg meta ngħataw massimu ta ’ żewġ bżieżaq ta ’ qawwa waħda jew l- oħra jew il- kombinazzjoni tagħhom.
29 increased in an approximately dose proportional fashion from 1 mg to 6 mg when a maximum of two blisters from either strength or their combination was administered.
t Cmax u l- AUC ta ’ l- inalazzjoni ta ’ bużżieqa waħda ta ’ 3 mg kienu madwar 30% u 40% akbar,
In a study where the dosage form of three 1 mg blisters was compared with one 3 mg blister, Cmax and AUC of inhaling three 1 mg blisters were approximately 30% and 40% greater, respectively, than that of inhaling from one 3 mg blister, indicating that three 1 mg blisters are not interchangeable with one 3 mg blister (see sections 2, 4.2 and 4.4).
za rispettivament, milli dawk ta ’ inalazzjoni ta ’ bużżieqa waħda ta ’ 3 mg, li tindika li 3 bżieżaq ta ’ 1 mg mhumiex skambjabbli ma ’ bużżieqa ta ’ 3 mg (ara sezzjoni 2, 4. 2 u 4. 4).
An approximately 40% higher bioavailability of three 1 mg unit dose blisters compared to one 3 mg unit dose blister was observed in healthy subjects.
riz Bijodisponibilità madwar 40% ogħla ta ’ tlett bżieżaq ta ’ doża waħda ta ’ 1 mg meta imqabbla ma ’ doża waħda ta ’ 3 mg kienet osservata f’ suġġetti b’ saħħithom.
An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters
L- ispjegazzjoni għad- differenzi fil -
ed since with less powder in the blister the inhaler is more efficient in breaking up or de-agglomerating the powder leading to a larger proportion of smaller aerodynamic particle sizes for the 1 mg blister (see sections 2 and 4.4).
to bijodisponibilità jidher li hija l- proporzjon differenti ta ’ l- enerġija kontra l- massa bejn bużżieqa waħda ta ’ 1 mg u bużżieqa ta ’ 3 mg minħabba li b’ inqas trab fil- bużżieqa, l- inalatur huwa aktar effiċjenti fit -
ho Following oral inhalation of a single dose of human insulin approximately 30% of the total blister content remains in the blister or device, 20% is deposited in the oropharynx, 10% in the conducting
aw tkissir jew deagglomerazzjoni tat- trab li jwassal għal proporzjon akbar ta ’ partikuli erodinamiċi iżgħar għall- bużżieqa ta ’ 1 mg (ara sezzjonijiet 2 u 4. 4).
ut airways and 40% reaches the deep lung.
x Distribuzzjoni
ra Animal studies did not show that inhaled human insulin accumulates in the lung.
du Wara inalazzjoni orali ta ’ doża waħda ta ’ insulina umana madwar 30% tal- kontenut totali tal- bużżieqa jibqa ’ fil- bużżieqa jew fl- inalatur, 20% huwa depożitat fl- orofarinġi, 10% fil- passaġġi li jwasslu l- arja ħa u 40% jilħaq fil- fond tal- pulmun. ’ g Studji fl- annimali ma wrewx li insulina inalata takkumula fil- pulmun. im
Special Populations
Populazzjoniet Speċjali
Smoking
Tipjip il al
Smoking greatly increases the rate and extent of absorption of inhaled human insulin (Cmax about 3 to 5 times and AUC about 2 to 3 times higher) and therefore could increase the risk of hypoglycaemia o
It- tipjip iżid bil- bosta r- rata u l- firxa ta ’ assorbiment ta ’ l- insulina umana inalata (is- Cmax huwa madwar 3 sa 5 drabi u l- AUC huwa madwar 2 jew 3 drabi ogħla) u għalhekk jista ’ jżid ir- riskju ta ’ in
(see sections 4.3 and 4.5). tn
ipogliċemija (ara sezzjonijiet 4. 3 u 4. 5). iċ
When EXUBERA was administered to healthy volunteers following 2-hours of passive exposure to cigarette smoke in a controlled experimental setting, insulin AUC and Cmax were reduced by uc
Meta EXUBERA ngħatat lil voluntiera b’ saħħithom wara sagħtejn ta ’ espożizzjoni passiva għad - ed
approximately 17 and 30%, respectively (see section 4.5). od
duħħan tas- sigaretti f’ sitwazzjoni esperimentali, l- AUC u s- Cmax ta ’ l- insulina tnaqqsu b’ madwar 17% u 30%, rispettivament (ara sezzjonijiet 4. 5). m
Respiratory Diseases (Underlying Lung Disease) pr
Mard Respiratorju (Mard tal- Pulmun Diġà Eżistenti) t
In non-diabetic subjects with mild to moderate asthma, AUC and Cmax for inhaled human insulin in the absence of treatment with a bronchodilator was slightly less than in subjects without asthma. al
F’ suġġetti mhux dijabetiċi b’ ażżma ħafifa għal moderata, l- AUC u s- Cmax għal insulina inalata fin - ot
In non-diabetic subjects with COPD, the absorption of inhaled human insulin appeared greater compared with that in subjects without COPD (see section 4.4). in ic
nuqqas ta ’ trattament kienu daqsxejn anqas minn dawk f’ suġġetti mingħajr ażżma. od
when EXUBERA was administered alone (see sections 4.2 and 4.5).
F’ suġġetti mhux dijabetiċi b’ COPD, l- assorbiment ta ’ insulina inalata deher ogħla meta mqabbel ma ’ dak f’ suġġetti mingħajr COPD (ara sezzjoni 4. 4).
Administration of fluticasone 30 minutes prior to EXUBERA did not affect the pharmacokinetics of EXUBERA in non-diabetic subjects with mild-moderate asthma (see section 4.5).
Għoti ta ’ fluticasone 30 minuta qabel EXUBERA ma effettwax il- farmakokinetiċi ta ’ EXUBERA f’ suġġetti mhux dijabetiċi b’ ażżma ħafifa- moderata (ara sezzjoni 4. 5).
30 Renal impairment
Indeboliment tal- kliewi
The effect of renal impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
30 L- effett ta ’ indeboliment tal- kliewi fuq l- assorbiment ta ’ insulina umana inalata ma ġiex studjat (ara sezzjoni 4. 2).
Hepatic impairment
Indeboliment tal- fwied
ed Gender
Sess
ris inhaled human insulin were observed between men and women.
t za F’ pazjenti bid- dijabete u f’ pazjenti mingħajr dijabete, ma ġiet osservata l- ebda differenza evidenti fl - assorbiment ta ’ insulina inalata bejn l- irġiel u n- nisa.
ho Children and adolescents
riz Tfal u adolexxenti
In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, inhaled human insulin
to Fi tfal (6- 11- il sena) u adolexxenti (12- 17- il sena) b’ dijabete tip 1, l- insulina umana inalata kienet
ut was absorbed more rapidly than fast-acting human insulin.
aw assorbita aktar malajr milli insulina li taħdem malajr.
ra relative to subcutaneously administered fast-acting human insulin was comparable to that of adult subjects with type 1 diabetes (see section 4.2).
Il- bijodisponibilità ta ’ insulina umana inalata meta mqabbla ma ’ insulina umana li taħdem malajr mogħtija taħt il- ġilda kienet komparabbli ma ’ dik f’ pazjenti adulti b’ dijabete ta ’ tip 1 (ara sezzjoni 4. 2).
Elderly
x du Anzjani
In older subjects with type 2 diabetes, inhaled human insulin was absorbed more rapidly than subcutaneously administered fast-acting human insulin.
F’ pazjenti akbar b’ dijabete ta ’ tip 2, l- insulina inalata kienet assorbita aktar malajr milli insulina ħa umana li taħdem malajr mogħtija taħt il- ġilda.
Bioavailability of inhaled human insulin lo relative to subcutaneously administered fast-acting human insulin was comparable to those in younger adult subjects with type 2 diabetes. o tn
Il- bijodisponibilità ta ’ insulina umana inalata meta mqabbla ma ’ insulina umana li taħdem malajr mogħtija taħt il- ġilda kienet komparabbli ma ’ dik ’ g f’ suġġetti adulti iżgħar b’ dijabete tip 2. im
Inhalation toxicity studies in rats and monkeys for up to 6 months gave no evidence for a special risk uc
Studji ta ’ tossiċità ta ’ l- inalazzjoni fil- firien u fix- xadini għal mhux aktar minn 6 xhur ma taw l- ebda il
to the respiratory tract due to insulin inhalation powder. od
evidenza għal riskju speċjali għall- passaġġi respiratorji minnħabba l- inalazzjoni ta ’ trab ta ’ l- insulina. al in
PHARMACEUTICAL PARTICULARS pr
TAGĦRIF FARMAĊEWTIKU iċ
6.1 List of excipients al
6. 1 Lista ta ’ sustanzi mhux attivi ed
Mannitol Glycine in
Mannitol Glycine m
Sodium Citrate (as dihydrate) ic
Sodium Citrate (bħala dihydrate) Sodium Hydroxide t ot
6.2 Incompatibilities M
6. 2 Inkompatibilitajiet od
Not applicable.
Pr
31 6.4 Special precautions for storage
31 6. 4 Prekawzjonijiet speċjali għall- ħażna
The inhaler and its components should be stored and used in a dry place.
L- inalatur u l- komponeneti tiegħu għandhom jinħażnu u jintużaw f’ post xott.
ed Do not refrigerate or freeze the insulin inhaler.
t za Tpoġġix l- inalatur ta ’ l- insulina fil- friġġ jew fil- friża.
ris One blister card contains 6 perforated unit dose blisters (PVC/ Aluminium).
Bużżieqa waħda fiha 6 bżieżaq ipperforati (PVC/ Aluminju) ta ’ doża waħda.
Five blister cards are in a
Ħames bżieżaq bil -
ho clear plastic (PET) thermoformed tray with a desiccant and covered with a clear plastic (PET) lid.
to bżieżaq jiġu fi trej tal- plastik ċar (PET) iffurmat bis- sħana flimkien ma ’ dessikant u miksi b’ għatu tal - plastik trasparenti (PET).
ut Packaging sizes supplied:
aw Daqsijiet ta ’ pakketti fornuti:
ra • Cardboard box containing 30 x 1 PVC/ Aluminium perforated unit dose blisters (1 pouch)
x • Kaxxa tal- kartun fiha 30 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (pawċ 1)
• n ge Cardboard box containing 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches)
du • Kaxxa tal- kartun fiha 60 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (2 pawċijiet) ħa • Kaxxa tal- kartun fiha 90 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (3 pawċijiet) ’ g • Kaxxa tal- kartun fiha 180 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (6 pawċijiet) im
Cardboard box containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches) lo • Cardboard box containing 180 x 1 PVC/Aluminium perforated unit dose blisters (6 pouches) o
• Kaxxa tal- kartun fiha 270 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (9 pawċijiet)
• Cardboard box containing 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) tn
Kaxxa tal- kartun fiha 60 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (2 pawċijiet) u 2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ al
• Cardboard box containing 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and uc
• Kaxxa tal- kartun fiha 90 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (3 pawċijiet) u in
2 spare Insulin Release Units (IRU)
2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ iċ
• Cardboard box containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches) and od
• Kaxxa tal- kartun fiha 180 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (6 pawċijiet) ed
2 spare Insulin Release Units (IRU) pr
u 2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ
• Cardboard box containing 180 x 1 PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Release Units (IRU) al
• m
• Cardboard box containing 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) in
Kaxxa tal- kartun fiha 270 x 1 bżieżaq ipperforati tal- PVC/ Aluminju ta ’ doża waħda (9 pawċijiet) u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ t
and 6 spare Insulin Release Units (IRU) ic
• ot
• A kit containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) ed
Kitt fih 90 x 1 bżieżaq ipperforati tal- PVC/ Aluminju b’ doża waħda (3 pawċijiet), inalatur ta ’ l - insulina, ċejmber fuq ir- riħ u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ od
Additional insulin inhaler, insulin release units and chamber packages are available.
Jiġu wkoll inalatur ta ’ l- insulina, Units ta ’ Rilaxx ta ’ l- insulina u pakketti taċ- ċejmbers addizjonali.
EXUBERA unit dose blisters must only be used with the insulin inhaler.
Il- bżieżaq ta ’ doża waħda ta ’ EXUBERA għandhom jintużaw biss ma ’ inalatur ta ’ l- insulina.
The insulin inhaler should be replaced annually.
L- inalatur ta ’ l- insulina għandu jinbidel kull sena.
32 The Insulin Release Unit (IRU) should be replaced once every 2 weeks.
Il- Unit ta ’ Rilaxx ta ’ l- Insulina (IRU) għandu jinbidel darba kull ġimagħtejn.
If the insulin inhaler is inadvertently exposed to extremely moist conditions during use this usually leads to a subsequent decreased the insulin dose delivered from the inhaler.
32 Jekk l- inalatur ta ’ l- insulina jkun espost bi żvista għal kondizzjonijiet estremament umidi waqt l- użu, dan issoltu jirriżulta fi tnaqqis tad- doża ta ’ l- insulina mogħtija.
In this case, the Insulin Release Unit (IRU) must be changed prior to the next inhalation (see section 4.4).
F’ dan il- każ, il- Unit ta ’ Rilaxx ta ’ l - Insulina (IRU) irid jiġi mibdul qabel l- inalazzjoni li jkun imiss (ara sezzjoni 4. 4).
Pfizer Limit ed
Pfizer Limited Ramsgate Road, Sandwich,
ed Ramsgate Road, Sandwich, Kent, CT13, 9NJ United Kingdom
t za Kent, CT13, 9NJ Ir- Renju Unit
ris ho 8.
riz 8.
EU/1/05/327/009
to EU/ 1/ 05/ 327/ 009
ut EU/1/05/327/010
x EU/ 1/ 05/ 327/ 013
ra EU/1/05/327/011 EU/1/05/327/012 EU/1/05/327/013 EU/1/05/327/014 EU/1/05/327/015 EU/1/05/327/016 EU/1/05/327/017 EU/1/05/327/018
du EU/ 1/ 05/ 327/ 014 EU/ 1/ 05/ 327/ 015 EU/ 1/ 05/ 327/ 016 ħa EU/ 1/ 05/ 327/ 017 EU/ 1/ 05/ 327/ 018 ’ g im
24/01/2006 uc od
24/ 01/ 2006 il al
DATE OF REVISION OF THE TEXT pr al in ic ed M
DATA TA ’ META ĠIET RIVEDUTA L- KITBA in iċ ed m t ot od Pr
33 ed ris ho ut ra ANNEX II
33 t za riz to aw x du ANNESS II ħa
SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR o
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ’ g ATTIVA( I) U > DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ im
BATCH RELEASE tn
TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION uc od pr
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - il
ic ed M
TQEGĦID FIS- SUQ al in iċ ed m t ot od Pr
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U > DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - HRUĠ TAL- LOTT
KG Industry Park Hoechst 65926 Frankfurt am Main Germany
KG Industry Park Hoechst 65926 Frankfurt am Main Il- Ġermanja
ed Name and address of the manufacturer responsible for batch release
t za Isem u indirizz tal- manifattur responsabbli għall- hruġ tal- lott
ris Heinrich Mack Nachf.
riz Heinrich Mack Nachf.
ho 89257 Illertissen Germany
to 89257 Illertissen Il- Ġermanja
ut ra B.
aw
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
B.
Medicinal product subject to medical prescription.
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
lo
x du • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ħa Prodott mediċinali jingħata bir- riċetta tat- tabib. ’ g • KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI im
n
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jimplimenta pjan edukattiv nazzjonali, qabel it- tqegħid fis- suq, u kif miftiehem ma ’ l- awtoritajiet kompetenti fl- Istati il
ge
Membri. al
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT o tn
Bħala parti minn dan il- pjan, id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq jipprovdi lill - in
The Marketing Authorisation Holder must implement nationally an educational plan, prior to marketing, and as agreed with the competent authorities in the Member States. uc
professjonisti tal- kura tas- saħħa b’ materjali edukattivi għall- professjonisti tal- kura tas- saħħa u pazjenti li għandhom l- għan li jnaqqsu r- riskju kemm jista ’ jkun u li jappoġġjaw l- użu sigur u effettiv tal - iċ
As part of this plan, the Marketing Authorisation Holder will provide health care professionals with educational materials for healthcare professionals and patients that are aimed at risk minimisation and od
prodott mill- pazjent. ed
will support safe and effective use for the product by the patient. pr
Il- materjal edukattiv għandu jikkonsisti minn tagħrif immirat biex jimminimizza r- reazzjonijiet avversi u jappoġġja l- użu effettiv permezz ta ’ edukazzjoni adegwata dwar: a) Il- ħtieġa ta ’ teknika ta ’ inalazzjoni konsistenti u standard li tassigura għotja kemm ottima kif m
Educational material shall consist of information aiming to minimise adverse events and support effective use through adequate education about: a) The need for consistent and standard inhalation technique to ensure both optimal and consistent al
ukoll konsistenti tal- prodott. b) Prekawzjoni speċjali bl- inalatur ta ’ l- insulina t
product delivery in
c) Ipogliċemija ot
b) Special precaution with the insulin inhaler c) Hypoglycemia ic
d) In- nuqqas ta ’ ekwivalenza bejn doża ta ’ 1 mg u doża ta ’ 3 mg e) Id- daqs tal- passi tat- titrazzjoni u l- prekawzjonijiet li jridu jittieħdu od
f) T he change in pulmonary function and the need for pulmonary function monitoring g) Smoking in relation to induced alteration in pharmacokinetics M
f) Il- bidla fil- funzjoni pulmonari u l- ħtieġa għal sorveljanza tal- funzjoni pulmonari g) It- tipjip fir- rigward tal - kambjament indott fil- farmakokinetiċi Pr
h) Rare pulmonary events i) Increased insulin antibody levels j) Recommendation for special populations; underlying lung diseases such as asthma and COPD, congestive heart failure, pregnancy, children and adolescent
h) Reazzjonijiet pulmonari rari i) Żjieda fil- livelli ta ’ antikorpi ta ’ l- insulina j) Rakkomandazzjoijiet għall- popolazzjonijiet speċjali; mard diġà eżistenti bħal ażżma jew COPD, falliment konġestiv tal- qalb, tqala, tfal u adolexxenti.
35 • OTHER CONDITIONS
35 • KUNDIZZJONIJIET OĦRA Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jassigura li jkun hemm sistema ta ’ farmakoviġilanza fis- seħħ u li din tkun qed taħdem qabel mal- prodott jitqiegħed fis- suq.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jobbliga ruħu li jagħmel studji u attivitajiet addizjonali ta ’ farmakoviġilanza mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Flimkien mal- PSURs għandu jiġi ppreżentat Pjan ta ’ Maniġment ta ’ Riskju Aġġornat, bħal fil- Linja
An updat ed Risk Management Plan, as per the CHMP Guideline on Risk Management Systems for
t ta ’ Gwida fuq Sistemi ta ’ Maniġment tar- Riskju għal prodotti mediċinali għal użu mill- bniedem, fi
ed medicinal products for human use, should be submitted at the same time as the PSURs, within 60 days of an important (Pharmacovigilance or Risk minimisation) milestone being reached or when the results of a study becoming available or at the request of the Competent authority.
za żmien 60 jum minn meta jseħħ episodju importanti (Farmakoviġilanza jew Minimizzazzjoni tar - Riskju) jew meta jingħataw ir- riżultati ta ’ studju jew fuq talba ta ’ awtorità kompetenti..
uc od pr al in ic ed M
riz to aw x du ħa ’ g im il al in iċ ed m t ot od Pr
36 ed ris ho ut ra ANNEX III
36 t za riz to aw x du ANNESS III ħa TIKKETTA U FULJETT TA ’ TAGĦRIF ’ g im il al in iċ ed m t ot od Pr
37 M ed ic in al pr od uc
37 Pr od ot
38 tn o A.
38 im A.
LABELLING lo n ge ra ut ho ris ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA ’ g ħa du x aw to riz za t TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton/Unit dose blisters (30, 60, 90, 180 and 270)
Pakkett ta ’ barra/ Bżieżaq ta ’ doża waħda (30, 60, 90, 180 u 270)
EXUBERA 1 mg inhalation powder pre-dispens ed Insulin human
EXUBERA 1 mg trab għall- inalazzjoni magħmul għal- lest
ed ris 2.
za riz 2.
ho Each unit dose blister contains 1 mg insulin human.
to Kull bużżieqa ta ’ doża waħda fiha 1 mg ta ’ insulina umana.
ra Also contains:
x Fih ukoll:
Mannitol, glycine, sodium citrate (as dihydrate), sodium hydroxide
Mannitol, glycine, sodium citrate (bħala dihydrate), sodium hydroxide
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder pre-dispensed
GĦAMLA FARMAĊEWTIKA U KONTENUT ħa Trab għall- inalazzjoni magħmul għal- lest ’ g
60 x 1 perforated unit dose blisters tn
30 x 1 bużżieqa ta ’ doża waħda perforata im
90 x 1 perforated unit dose blisters 180 x 1 perforated unit dose blisters uc
60 x 1 bużżieqa ta ’ doża waħda perforata 90 x 1 bużżieqa ta ’ doża waħda perforata 180 x 1 bużżieqa ta ’ doża waħda perforata il
270 x 1 perforated unit dose blisters od
270 x 1 bużżieqa ta ’ doża waħda perforata al in
METHOD AND ROUTE(S) OF ADMINISTRATION pr
MOD TA ’ KIF U MNEJN JINGĦATA iċ
Inhalation use.
Jintuża għal inalazzjoni. ed
For use only with the insulin inhaler. al
Biex jintuża biss ma ’ l- inalatur ta ’ l- insulina.
Read package leaflet and instructions for use of the inhaler before use. in
Aqra l- fuljett ta ’ tagħrif u l- istruzzjonijiet għall- użu ta ’ l- inalatur qabel l- użu. m
Do not substitute three 1 mg blisters for one 3 mg blister.
Tissostitwixxix tliet bżieżaq ta ’ 1 mg b’ waħda ta ’ 3 mg.
If 3 mg blisters are unavailable, use only two 1 mg blisters as replacement. ic ed
Jekk il- bżieżaq ta ’ 3 mg ma jkunux disponibbli, uża biss żewġ bżieżaq ta ’ 1 mg bħala sostitut għal waħda ta ’ 3 mg. t ot od
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN M
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL Pr
Store below 30˚C.
Aħżen f’ temperatura taħt 30˚C.
ed After opening the foil overwrap:
t za Wara li tiftaħ ir- rita ta ’ barra tal- fojl:
Store below 25˚C.
Aħżen f’ temperatura taħt 25˚C.
Use within 3 months of opening.
Użah fi żmien 3 xhur minn meta tiftħu.
ris Do not refrigerate or freeze.
riz Tagħmlux fil- friġġ jew friża.
ho 10.
to aw 10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
ra 11.
x du 11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ħa Pfizer Limited ’ g Ramsgate Road Sandwich im
Pfizer Limited Ramsgate R oad Sandwich Kent CT13 9NJ
Kent CT13 9NJ Ir- Renju Unit il al
MARKETING AUTHORISATION NUMBER(S) uc od
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ in iċ
EU/1/05/327/003 EU/1/05/327/004 EU/1/05/327/005 al in
EU/ 1/ 05/ 327/ 002 EU/ 1/ 05/ 327/ 003 EU/ 1/ 05/ 327/ 004 m
BATCH NUMBER ic ed
NUMRU TAL- LOTT od
{number} M
{numru} Pr
ris ho ut ra n ge lo o tn uc od pr al in ic ed M
t za riz to aw x du ħa ’ g im il al in iċ ed m t ot od Pr
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
{NATURE/TYPE}
{NATURA/ TIP}
ho ut 3.
to aw 3.
ra EXP{MMYYYY}
{XX/ SSSS}
4.
x du 4.
Lot{number} n ge lo o
NUMRU TAL- LOTT ħa Lott {numru} ’ g im
OTHER tn uc od pr al in ic ed M
OĦRAJN il al in iċ ed m t ot od Pr
42 MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
FOIL OVERWRAP
RITA TA ’ BARRA TAL- FOJL
ho Inhalation powder pre-dispensed
to Trab għall- inalazzjoni magħmul għal- lest
30x 1 perforated unit dose blisters
aw 30x 1 bużżieqa ta ’ doża waħda perforata
ut ra 3.
x 3.
METHOD AND ROUTE(S) OF ADM INSTRATION
METODU TA ’ KIF GĦANDU JINGĦATA
nhalation use n
du Jintuża għal inalazzjoni
If 3 mg blisters are unavailable, use only two 1 mg blisters as replacement. lo o
Jekk il- bżieżaq ta ’ 3 mg ma jkunux disponibbli, uża biss żewġ bżieżaq ta ’ 1 mg bħala sostitut għal waħda ta ’ 3 mg. ’ g im
EXPIRY DATE tn
DATA TA ’ META JISKADI
{MM/YYYY} uc
{XX/ SSSS} il al
NAME OF MARKETING AUTHORISATION HOLDER od
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ in
Pfizer Limited pr
Pfizer Limited iċ ed
BATCH NUMBER al
NUMRU TAL- LOTT m
Lot{number} in ic
Lott {numru} t ot
OTHER ed M
OĦRAJN od Pr
Carton/Unit dose blisters (60, 90, 270)
Kartuna/ Bżieżaq ta ’ doża waħda (60, 90, 270)
EXUBERA 1 mg inhalation powder pre-dispens ed Insulin human
EXUBERA 1 mg trab għall- inalazzjoni magħmul għal- lest Insulina umana
ris Each unit dose blister contains 1 mg insulin human.
riz Kull bużżieqa ta ’ doża waħda fiha 1 mg ta ’ insulina umana.
ho 3.
to aw 3.
ut Also contains:
Fih ukoll:
Mannitol, glycine, sodium cit rate (as dihydrate), sodium hydroxide
Mannitol, glycine, sodium citrate (bħala dihydrate), sodium hydroxide
ra 4.
x du 4.
Inhalation powder pre-dispensed
GĦAMLA FARMAĊEWTIKA U KONTENUT
Box containing:
Trab għall- inalazzjoni magħmul għal- lest ’ g Kaxxa li fiha:
60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU) o tn
60 x 1 bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (2 pawċijiet) u 2 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ im
Box containing:
Kaxxa li fiha:
270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU) uc
270 x 1 bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (9 pawċijiet) u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ il al
90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) od pr
90 x 1 bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (3 pawċijiet), 1 inalatur ta ’ l- insulina, 1 ċejmber addizzjonali u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ in iċ
METHOD AND ROUTE(S) OF ADMINISTRATION al
MOD TA ’ KIF U MNEJN JINGĦATA ed
Inhalation use.
Jintuża għal inalazzjoni. m
For use only with the insulin inhaler. in
Biex jintuża biss ma ’ l- inalatur ta ’ l- insulina.
Read package leaflet and instructions for use of the inhaler before use. ic
Aqra l- fuljett ta ’ tagħrif u l- istruzzjonijiet għall- użu ta ’ l- inalatur qabel l- użu. t
If 3 mg blisters are unavailable, use only ed
Jekk il- bżieżaq ta ’ 3 mg ma jkunux ot
M
disponibbli, uża biss żewġ bżieżaq ta ’ 1 mg bħala sostitut għal waħda ta ’ 3 mg. od
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA Pr
After opening the foil overwrap:
t za Wara li tiftaħ ir- rita ta ’ barra tal- fojl:
ed Do not refrigerate or freeze.
riz Tagħmlux fil- friġġ jew friża.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX