qanastek/EMEA-V3 huggingface dataset:
ho OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
aw UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
ut ra 11.
x du 11.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Pfizer Limited Ramsgate Road Sandwich Kent
MARKETING AUTHORISATION NUMBER(S) uc
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ al
EU/ 1/ 05/ 327/006 EU/1/05/327/007 od
EU/ 1/ 05/ 327/ 006 in
EU/1/05/327/008 pr
EU/ 1/ 05/ 327/ 007 EU/ 1/ 05/ 327/ 008 iċ ed
{number} in ic
{numru} t ot
GENERAL CLASSIFICATION FOR SUPPLY ed
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA od
EXUBERA 3 mg inhalation powder pre-dispens ed Insulin human
EXUBERA 3 mg trab għall- inalazzjoni magħmul għal- lest Insulina umana
ris Each unit dose blister contains 3 mg insulin human.
riz Kull bużżieqa ta ’ doża waħda fiha 3 mg ta ’ insulina umana.
90 x 1 perforated unit dose blisters tn
Trab għall- inalazzjoni magħmul għal- lest ’ g 30 x 1 bużżieqa ta ’ doża waħda perforata 60 x 1 bużżieqa ta ’ doża waħda perforata im
180 x 1 perforated unit dose blisters 270 x 1 perforated unit dose blisters uc
90 x 1 bużżieqa ta ’ doża waħda perforata 180 x 1 bużżieqa ta ’ doża waħda perforata 270 x 1 bużżieqa ta ’ doża waħda perforata il al
METHOD AND ROUTE(S) OF ADMINISTRATION od
MOD TA ’ KIF U MNEJN JINGĦATA in iċ
Inhalation use. pr
Jintuża għal inalazzjoni.
For use only with the insulin inhaler.
Biex jintuża biss ma ’ l- inalatur ta ’ l- insulina. ed
Read package leaflet and instructions for use of the inhaler before use. al
Aqra l- fuljett ta ’ tagħrif u l- istruzzjonijiet għall- użu ta ’ l- inalatur qabel l- użu.
If 3 mg blisters are unavailable, use only in
Jekk il- bżieżaq ta ’ 3 mg ma jkunux m
two 1 mg blisters as replacement. ic ed
disponibbli, uża biss żewġ bżieżaq ta ’ 1 mg bħala sostitut għal waħda ta ’ 3 mg. t ot
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 od
Keep out of the reach and sight of children.
Pr
Do not refrigerate or freeze.
riz Tagħmlux fil- friġġ jew friża.
10.
to aw 10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
ris 11.
x du 11.
ra Kent CT13 9NJ
Kent CT13 9NJ Ir- Renju Unit il al
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ in
EU/1/05/327/009
EU/ 1/ 05/ 327/ 009 iċ
EU/ 1/ 05/ 327/010 tn
EU/ 1/ 05/ 327/ 010 ed
EU/1/05/327/011 EU/1/05/327/012 EU/1/05/327/013 uc od
EU/ 1/ 05/ 327/ 011 EU/ 1/ 05/ 327/ 012 EU/ 1/ 05/ 327/ 013 m t
BATCH NUMBER pr
NUMRU TAL- LOTT ot od
{number} al
{numru} Pr
GENERAL CLASSIFICATION FOR SUPPLY in
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Medicinal product subject to medical prescription. ic ed
Prodott mediċinali jingħata bir- riċetta tat- tabib.
INSTRUCTIONS ON USE M
STRUZZJONIJIET DWAR L- UŻU
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
EXUBERA 3 mg inhalation powder pre-dispens ed Insulin human
EXUBERA 3 mg trab għall- inalazzjoni magħmul għal- lest
48 MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
EXUBERA 3 mg inhalation powder pre-dispensed
EXUBERA 3 mg trab għall- inalazzjoni magħmul għal- lest
Insulin human
t Insulina umana
METHOD AND ROUTE(S) OF ADM INISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
Pfizer Limited pr al
Pfizer Limited iċ ed
BATCH NUMBER in
NUMRU TAL- LOTT m
Lot{number} ic ed
Lott {numru} t ot
OTHER M
OĦRAJN od Pr
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton/Unit dose blisters (60, 90, 180, 270)
Kartuna/ Bżieżaq ta ’ doża waħda (60, 90, 180, 270)
ho Each unit dose blister contains 3 mg insulin human.
to Kull bużżieqa ta ’ doża waħda fiha 3 mg ta ’ insulina umana.
60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin o
60 x 1 Bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (2 pawċijiet) u 2 Units ta ’ im
Release Units (IRU) tn
Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ
90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin uc
90 x 1 Bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (3 pawċijiet) u 2 Units ta ’ il
Release Units (IRU)
Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ al
180 x 1 PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin od
180 x 1 Bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (6 pawċijiet) u 2 Units ta ’ in
Release Units (IRU) pr
Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ iċ
270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU) al
270 x 1 Bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (9 pawċijiet) u 6 Units ta ’ ed
90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 in
90 x 1 Bużżieqa ta ’ doża waħda perforata tal- PVC/ Aluminju (3 pawċijiet), 1 inalatur ta ’ m
spare chamber and 6 spare Insulin Release Units (IRU) ic
l- insulina, 1 ċejmber addizzjonali u 6 Units ta ’ Rilaxx ta ’ l- Insulina (IRU) fuq ir- riħ t ot
METHOD AND ROUTE(S) OF ADMINISTRATION ed
MOD TA ’ KIF U MNEJN JINGĦATA od
Inhalation use.
Jintuża għal inalazzjoni.
Read package leaflet and instructions for use of the inhaler before use.
Aqra l- fuljett ta ’ tagħrif u l- istruzzjonijiet għall- użu ta ’ l- inalatur qabel l- użu.
If 3 mg blisters are unavailable, use only two 1 mg blisters as replacement.
Jekk il- bżieżaq ta ’ 3 mg ma jkunux disponibbli, uża biss żewġ bżieżaq ta ’ 1 mg bħala sostitut għal waħda ta ’ 3 mg.
ed 8.
t 8.
ris EXP:
za JIS:
ho 9.
riz to 9.
ut Store below 30˚C.
aw Aħżen f’ temperatura taħt 30˚C.
ra After opening the foil overwrap:
Wara li tiftaħ ir- rita ta ’ barra tal- fojl:
Use within 3 months of opening.
Użah fi żmien 3 xhur minn meta
Do
x tiftħu.
not refri gerate or freeze. n
du Tagħmlux fil- friġġ jew friża.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS lo OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE o tn
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX ’ g UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN im
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER uc
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID il
Pfizer Limited od
Pfizer Limited in
Ramsgate Road Sandwich Kent pr
Ramsgate Road iċ
CT13 9NJ United Kingdom al in
CT13 9NJ Ir- Renju Unit m
MARKETING AUTHORISATION NUMBER(S) ic
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ t ot
EU/ 1/ 05/ 327/014 ed
EU/ 1/ 05/ 327/ 014 od
EU/ 1/ 05/ 327/015 EU/1/05/327/016 EU/1/05/327/017 M
EU/ 1/ 05/ 327/ 015 EU/ 1/ 05/ 327/ 016 EU/ 1/ 05/ 327/ 017 Pr
ed EXUBERA 3 mg
t za EXUBERA 3 mg
ris ho ut ra n ge lo o tn 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
53 tn o lo B.
53 Pr od ot
PACKAGE LEAFLET n ge ra ut ho ris ed PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF ħa du x aw to riz za t FULJETT TA ’ TAGĦRIF:
EXUBERA 1 mg inhalation powder pre-dispensed EXUBERA 3 mg inhalation powder pre-dispensed Insulin human
EXUBERA 1 mg trab għal inalazzjoni imqassam għal- lest EXUBERA 3 mg trab għal inalazzjoni imqassam għal- lest Insulina umana
- If you have further questions, please ask your doctor, diabetes nurse or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- infermiera tad- dijabete jew lill- ispiżjar
ed if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
please tell your doctor or pharmacist.
riz imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
ris In this leaflet:
to F’ dan il- fuljett:
ho 1.
aw 1.
What EXUBERA is and what it is used for 2.
X’ inhi EXUBERA u għalxiex tintuża 2.
Before you take EXUBERA 3.
Qabel ma tieħu EXUBERA 3.
How to take EXUBERA
Kif għandek tieħu EXUBERA
ut 4.
x 4.
Possible side effects
Effetti sekondarji li jista ’ jkollha
ra 5 How to store EXUBERA 6.
Kif taħżen EXUBERA 6.
ge Taking three separate 1 mg unit dose blisters delivers more insulin to your lungs than a single 3 mg unit dose blister does.
It- teħid ta ’ tliet bżieżaq ta ’ doża waħda ta ’ 1 mg jirrilaxxa aktar insulina fil- pulmun tiegħek milli bużżieqa ta ’ doża waħda ta ’ 3 mg.
Three 1 mg unit dose blisters should not be substituted for one 3mg blister (see n section 2, “Take special care with EXUBER A”, section 3, “How to take EXUBERA” and section 6 “Further information”). lo
Tliet bżieżaq ta ’ doża waħda ta ’ 1 mg m’ għandhomx jiġu ’ g ssostitwiti b’ bużżieqa waħda ta ’ 3 mg (ara sezzjoni 2, “ Oqgħod attent ħafna b’ EXUBERA ”, sezzjoni 3, “ Kif tieħu EXUBERA ” u sezzjoni 6 “ Aktar tagħrif ”). im
A unit dose blister is the individual container in which the insulin powder is packaged and will be o
Bużżieqa ta ’ doża waħda hija l- kontenitur individwali fejn it- trab ta ’ l- insulina jiġi ppakkjat u fil - kumplament ta ’ dan il- fuljett tissejjaħ bużżieqa. il al
WHAT EXUBERA IS AND WHAT IT IS USED FOR
X’ INHU EXUBERA U GĦALXIEX JINTUŻA in
EXUBERA is an inhalation powder contained in blisters.
EXUBERA huwa trab għall- inalazzjoni li jiġi fi bżieżaq.
The contents of the blisters should be od
Il- kontenut tal- bżieżaq għandu jittieħed man - iċ
breathed in through your mouth into your lungs using the insulin inhaler. pr
nifs minn ġo ħalqek għal ġol- pulmun permezz ta ’ l- inalatur ta ’ l- insulina. ed
EXUBERA is an anti-diabetic agent that lowers your blood sugar.
EXUBERA hija mediċina kontra d- dijabete li tbaxxilek iz- zokkor fid- demm. m
EXUBERA is a fast-acting insulin.
EXUBERA hija insulina li taħdem malajr.
minutes after you take it, with a maximum effect at 2 hours and the effect will last for around 6 hours. in
Dan ifisser li hija tibda tbaxxilek iz- zokkor f’ demmek 10 - 20 minuta wara li teħodha, b’ effett massimu wara sagħtejn u l- effett idum 6 sigħat. t ot
EXUBERA is often given in combination with other diabetes treatments. ic
EXUBERA tintuża ta ’ spiss f’ kumbinazzjoni ma ’ trattamenti tad- dijabete oħra. od
EXUBERA is used to reduce high blood sugar in adult patients with type 2 diabetes mellitus who ed
EXUBERA tintuża biex tnaqqas livell għoli ta ’ zokkor fid- demm f’ pazjenti adulti b’ dijabete mellitus tip 2 li għandhom bżonn l- insulina.
EXUBERA can also be used to treat type 1 diabetes in adults whose level of blood sugar is not well- controlled by insulin injections.
EXUBERA tista ’ ukoll tintuża biex tittratta dijabete tip 1 f’ adulti li l- livell ta ’ zokkor f’ demmhom mhuwiex ikkontrollat sewwa bl- injezzjonijiet ta ’ l- insulina.
Diabetes is a disease in which your body does not produce enough insulin to control the level of blood sugar.
Id- dijabete hija marda fejn ġismek ma jipproduċix biżżejjed insulina biex tikkontrolla l- livell taz - zokkor fid- demm.
Do not take EXUBERA
QABEL MA TIEĦU EXUBERA 55 Tieħux EXUBERA
• If you feel hypoglycaemia (low blood sugar) coming on.
• Jekk tħoss li tkun ġejja ipogliċemija (livell baxx ta ’ zokkor fid- demm).
See the information at the end of section 4 “Possible side effects” of this leaflet for further advice. • If you are allergic to insulin, the active ingredient contained in EXUBERA or any of the other ingredients of EXUBERA.
Ara t- tagħrif fl - aħħar ta ’ sezzjoni 4 “ Effetti sekondarji possibbli ” ta ’ dan il- fuljett għal aktar tagħrif. • Jekk inti allerġiku/ a għall- insulina, l- ingredjent attiv li fiha EXUBERA jew xi ingredjenti oħra ta ’ EXUBERA.
If you suspect an allergy to EXUBERA, speak to your doctor imm ediately. • If you smoke, or if you have smoked in the last six months you must not take EXUBERA as
Jekk tissuspetta li qed tbati minn allerġija għal EXUBERA, kellem lit- tabib tiegħek minnufih. • Jekk tpejjep jew kont tpejjep f’ dawn l- aħħar sitt xhur m’ għandekx tieħu EXUBERA
ed you may have extra risk of hypoglycaemia (very low blood sugar).
Jekk
Please speak to your doctor immediately if you take EXUBERA and resume smoking or have smoked in the last 6 months before starting to take EXUBERA.
za jogħġbok kellem lit- tabib tiegħek minnufih jekk tkun qed tieħu EXUBERA u terġa ’ tibda tpejjep jew jekk tkun pejjipt fl- aħħar 6 xhur qabel tibda tieħu EXUBERA.
ris • If you have poorly controlled, unstable, or severe asthma. • If you have severe (GOLD stage III or IV), Chronic Obstructive Pulmonary Disease (COPD).
riz • Jekk għandek ażżma ikkontrollata ħażin, instabbli, jew ażżma qawwija. • Jekk għandek Mard Pulmonari ta ’ Imblukkar Kroniku (COPD) qawwi (fażijiet III jew IV GOLD).
ho Take special care with EXUBERA
to aw Oqgħod attent ħafna b’ EXUBERA
ut Please follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical
Jekk jogħġbok imxi kemm jista ’ jkun ma ’ l- istruzzjonijiet għad- dożaġġ, il- monitoraġġ (testijiet tad - demm u ta ’ l- awrina), id- dieta u l- attività fiżika (xogħol u eżerċizzju fiżiku) kif diskuss mat- tabib jew
ra activity (physical work and exercise) as discussed with your doctor or nurse.
x infermiera tiegħek.
Before you start taking EXUBERA your doctor or nurse will tell you how to use the inhaler properly.
du Qabel ma tibda tieħu EXUBERA, it- tabib jew l- infermiera tiegħek jispjegawlek kif tuża l- inalatur.
ge Please also read the “Instructions for Use” of the inhaler at the end of the package leaflet carefully before taking EXUBERA.
Jekk jogħġbok aqra sewwa wkoll l - “ Istruzzjonijiet għall- Użu ” ta ’ l- inalatur fl- aħħar tal- Fuljett ta ’ ħa Tagħrif qabel ma tieħu EXUBERA.
Make sure that you can use the inhaler properly as this could affect the amount of insulin you brea the in. n lo You should avoid taking EXUBERA in moist conditions e.g. a bathroom following a steamy shower as this will usually give you a lower insulin dose than you need (see “Instructions for Use” at the end o
Kun żgur li tista ’ tuża l- inalatur kif suppost għax dan jista ’ jaffettwa l- ammont ta ’ insulina li tiġbed man- nifs. ’ g
of the package leaflet for advice). tn
għax dan huwa soltu li jagħtik doża ta ’ insulina aktar baxxa milli jkollok bżonn (ara “ Struzzjonijiet għall- Użu ” fl- aħħar tal- Fuljett ta ’ Tagħrif għal parir). il
If you accidentally expose your inhaler to moist conditions during use, this will usually decrease the uc
Jekk bi żball tesponi l- inalatur tiegħek għal kondizzjonijiet umidi waqt l- użu, dan huwa soltu li jwassal al
dose of insulin you take.
għal tnaqqis fid- doża ta ’ l- insulina li tieħu.
In this case you must change the Insulin Release Unit (IRU) prior to your next inhalation. od
F’ dan il- każ trid tibdel il- Unit ta ’ Rilaxx ta ’ l- Insulina (IRU) qabel l- inalazzjoni li jmissek. in
Dosing pr
Dożaġġ iċ ed
Your doctor will prescribe your starting pre-meal dose of EXUBERA based on your body weight.
It- tabib tiegħek jiktiblek id- doża ta ’ EXUBERA ta ’ qabel l- ikel li għandek tibda biha fuq il- bażi tal- piż ta ’ ġismek.
This may include a mix of 1 mg (green coloured) and 3 mg (blue coloured) blisters.
Din tista ’ tinkludi taħlita ta ’ bżieżaq ta ’ 1 mg (kulur aħdar) u ta ’ 3 mg (kulur blu).
It is important to follow your doctor’s instructions exactly. al in
Huwa importanti li ssegwi eżattament l- istruzzjonijiet tat- tabib tiegħek. m
A 1 mg unit dose blister is approximately equal to 3 IU of fast-acting subcutaneous insulin and a 3 mg unit dose blister is approximately equal to 8 IU of fast-acting subcutaneous insulin. ic
Bużżieqa ta ’ doża waħda ta ’ 1 mg hija ekeivalenti għal madwar 3 IU ta ’ insulina li taħdem malajr t
Dose adjustments may be required based on meal size and nutrient composition, time of day (higher ed
mogħtija taħt il- ġilda u bużżieqa ta ’ doża waħda ta ’ 3 mg hija ekwivalenti għal madwar 8 IU ta ’ ot
M
Jistgħu jkunu meħtieġa aġġustamenti fid- doża fuq il- bażi tad- daqs ta ’ l- ikla u kompożizzjoni nutrittiva, il- ħin tal- ġurnata (ħtiġiet ta ’ l- insulina ogħla filgħodu), il- konċentrazzjoni ta ’ glukosju fid - Pr
Do not use three separate 1 mg blisters in place of one 3 mg blister, as this will give you a much higher insulin dose (see “How to take EXUBERA” for further advice).
Tiħux tlett bżieżaq separati ta ’ 1 mg minflok waħda ta ’ 3 mg, għax dan jagħtik doża ħafna aktar għolja (ara “ Kif tieħu EXUBERA ” għal aktar taghrif).
If you have low body weight check with your doctor if you can use EXUBERA.
Jekk il- piż ta ’ ġismek huwa ħafif ara mat- tabib tiegħek jekk tistax tuża EXUBERA.
If you need dose titrations of less than 1 mg it is recommended you do not use EXUBERA (see section 3 “How to take EXUBERA” for further advice and section 6 “Further information”).
Jekk għandek bżonn titrazzjonijiet tad- doża ta ’ inqas minn 1 mg, huwa rrikmandat li ma tużax EXUBERA (ara sezzjoni 3 “ Kif tieħu EXUBERA u sezzjoni 6 “ Aktar tagħrif ”).
55 Special patient groups
56 Gruppi ta ’ pazjenti speċjali
If your liver or kidneys do not function well speak to your doctor, who may advise that you use lower insulin doses.
Jekk il- fwied jew il- kliewi tiegħek ma jaħdmux sew kellem lit- tabib tiegħek, li jista ’ jagħtik parir biex tuża dożi ta ’ insulina aktar baxxi.
If you are under 18 years of age, please speak to your doctor, as use of EXUBERA is not recommended for patients under 18 years of age.
Jekk għandek taħt it- 18- il sena, jekk jogħġbok kellem lit- tabib tiegħek, peress li l- użu ta ’ EXUBERA mhuwiex irrikomandat għal pazjenti taħt it- 18- il sena.
There is little experience with EXUBERA in patients older than 75 years.
Ftit hemm esperjenza b’ EXUBERA f’ pazjenti akbar minn 75 sena.
There is very little experience with EXUBERA in patients with congestive heart failure.
Ftit hemm esperjenza b’ EXUBERA f’ pazjenti b’ falliment konġestiv tal- qalb.
EXUBERA
EXUBERA mhix
ed is not recommended if you have breathing difficulties with congestive heart failure.
t za irrikmandata jekk għandek diffikultajiet biex tieħu n- nifs jew falliment konġestiv tal- qalb.
Lung diseases
Mard tal- Pulmun
ris Talk to your doctor if you have any lung disease such as asthma, emphysema or chronic bronchitis.
riz Kellem lit- tabib tiegħek jekk għandek xi mard tal- pulmun bħal ażżma, emfisima jew bronkite kronika.
ho EXUBERA is not recommended for patients with lung disease.
to EXUBERA mhix irrikmandata għal pazjenti b’ mard tal- pulmun.
Also, if you experience breathing difficulties that you have not previously discussed with your doctor, you should discuss them before starting EXUBERA treatment.
Barra minn hekk, jekk tesperjenza diffikultajiet fit- teħid tan- nifs li ma tkunx iddiskutejt mat- tabib tiegħek qabel, dawn għandek
ut ra Before starting treatment your doctor will carry out a simple test on your lung function to decide whether EXUBERA is the right treatment for you.
Qabel tibda t- trattament it- tabib tiegħek ser jagħmilek test sempliċi fuq il- funzjoni tal- pulmun biex
O nce you start treatment, your doctor will check your lung function again after 6 months and at other times to see how well you are tolerating EXUBERA.
Ladarba tibda t- trattament, it -
n
du tabib tiegħek jiċċekkjalek il- funzjoni tal- pulmun tiegħek wara 6 xhur u fi żminijiet oħra biex jara kemm qed tittollera EXUBERA tajjeb.
If you notice an immediate and severe worsening of your breathing soon after taking a dose of EXUBERA, you should stop taking EXUBERA and tell your doctor immediately or go to the casualty lo department at your nearest hospital. o
Jekk tinnota deterjorament immedjat jew serju fit- teħid ta ’ nifsek ftit wara li tieħu doża ta ’ EXUBERA, għandek tieqaf tieħu EXUBERA u tgħid lit- tabib tiegħek minnufih jew tmur fid - ’ g dipartiment ta ’ l- emerġenza fl- eqreb sptar. im
You should also tell your doctor if you develop any other increasing breathing difficulties while tn
Għandek tgħid ukoll lit- tabib tiegħek jekk tiżviluppa diffikultajiet fit- teħid tan- nifs oħra li jiżdiedu waqt li tkun qed tieħu EXUBERA il
Illness and injuries uc
Mard u korrimenti al
If you are ill or have a major injury, then your blood sugar may increase (hyperglycaemia) or if you od
Jekk tkun ma tiflaħx jew jekk ikollok xi korriment serju, il- livell taz- zokkor f’ demmek jista ’ jiżdied in
are not eating enough your blood sugar may become too low (hypoglycaemia).
(ipergliċemija) jew jekk ma tkunx qed tiekol biżżejjed, dan jista ’ jinżel baxx ħafna (ipogliċemija).
In such situations, the management of your diabetes may require a lot of care and you may need to seek advice from your pr
F’ sitwazzjonijiet bħal dawn, il- ġestjoni tad- dijabete tiegħek tista ’ tkun teħtieġ ħafna kura u jista ’ iċ
doctor or nurse.
jkollok tieħu parir mingħand l- infermiera jew it- tabib tiegħek. ed
If you have infection in your airways (such as bronchitis or upper respiratory tract infection) while al
Jekk ikollok infezzjoni fil- passaġġi ta ’ l- arja tiegħek (bħal bronkite jew infezzjoni repiratorja tal - passaġġi ta ’ fuq) waqt li tkun qed tieħu EXUBERA għandek tagħti kas ta ’ spiss tal- livell ta ’ glukosju m
taking EXUBERA you should monitor your blood glucose frequently and you may need to adjust your EXUBERA dose.
fid- demm u jista ’ jkollok bżonn taġġusta d- doża ta ’ EXUBERA.
Please talk to your doctor if you have problems administering EXUBERA or in
Ma t
There is no experience with EXUBERA in patients with infection of ic
hemm l- ebda esperjenza f’ pazjenti b’ infezzjoni tal- pulmun fil- fond (pnewmonja). ot
the deep lung (pneumonia). ed
Jekk jogħġbok ara tmiem sezzjoni 4 għal tagħrif importanti dwar l- ipogliċemija u l- ipergliċemija u t - od
Please see the end of section 4 for important information about hypoglycaemia and hyperglycaemia and its treatment.
trattament tagħħa.
Travel
Vjaġġar
Before travelling, consult your doctor or nurse to talk about timings of meals and insulin administration while travelling, the possible effects of changing to different time zones on blood sugar levels and control and the availability of EXUBERA in the countries you are visiting.
Qabel tivjaġġa, ikkonsulta mat- tabib jew l- infermiera tiegħek dwar il- ħinijiet ta ’ l- ikel u l- għoti ta ’ l - insulina waqt l- ivjaġġar, l- effetti possibbli tal- bdil għal żoni differenti ta ’ ħin fuq il- livelli taz- zokkor fid- demm u l- kontroll u d- disponibbilità ta ’ EXUBERA fil- pajjiżi li tkun qed iżżur.
56 Taking other medicines
Teħid ta ’ mediċini oħra
Some medicines cause the blood sugar level to fall, some cause it to rise, others may have both effects, depending on the situation.
57 Xi mediċini jikkaġunaw waqa ’ fil- livell taz- zokkor fid- demm, oħrajn iġiegħlu l- livell jitla ’, oħrajn jista ’ jkollhom iż- żewġ effetti, jiddependi fuq is- sitwazzjoni.
In each case, it may be necessary to adjust your insulin dosage to avoid too low or too high blood sugar levels.
F’ kull każ, jista ’ jkun meħtieġ li taġġusta d- doża ta ’ l- insulina tiegħek biex tevita livelli ta ’ zokkor fid- demm baxxi jew għoljin iżżejjed.
Be careful not only when you start another medicine, but also when you stop it.
Oqgħod attent mhux biss meta tibda mediċina oħra, iżda ukoll meta twaqqafha.
Tell your doctor about all medicines that you are taking, including those you have bought without a prescription (such as from a Pharmacy or other shop).
Għid lit- tabib tiegħek dwar il- mediċini kollha li qed tieħu, inklużi dawk li xtrajt mingħajr riċetta (bħalma dawk minn spiżerija jew minn xi ħanut ieħor).
Before taking a m edicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Qabel tieħu mediċina staqsi lit- tabib tiegħek jekk tistax taffettwalek il- livell taz- zokkor f’ demmek, u x’ azzjoni, jekk hemm bżonn, għandek tieħu.
ed Medicines that may cause your blood sugar to fall include diabetes tablets, angiotensin converting enzyme (ACE) inhibitors (used for the treatment of certain heart conditions, high blood pressure or
t Mediċini li jistgħu jikkaġunaw waqa ’ fil- livell taz- zokkor f’ demmek jinkludu pilloli tad- dijabete,
ris elevated protein/albumin in the urine), monoamine oxidase (MAO) inhibitors (used for the treatment of depression), certain beta-blockers (used for the treatment of certain heart
za impedituri ta ’ angiotensin converting enzyme (ACE) (użati għat- trattament ta ’ ċerti kondizzjonijiet tal - qalb, pressjoni għolja jew proteina/ albumina għolja fl- awrina), impedituri monoamine oxidase (MAO)
ho conditions and high blood pressure), salicylates (e.g. aspirin, used to relieve pain and lower fever) and sulphonamide antibiotics.
riz (użati fit- trattament ta ’ depressjoni), ċertu beta- blockers (użati għat- trattament ta ’ ċerti kondizzjonijiet tal- qalb u pressjoni għolja), salicylates (eż. aspirina, użata biex ittaffi l- uġigħ u tniżżel id- deni) u antibijotiċi sulphonamide.
ra co nditions, except topical administration), danazol (used for the treatment of some female hormonal disorders), oral contraceptives (used for birth control), thyroid hormones (used for the treatment of malfunction of the thyroid gland), growth hormones (used in endocrine conditions), sympathomimetic
to aw Mediċini li jistgħu jgħollu z- zokkor f’ demmek jinkludu kortikosterojdi (użati fit- trattament ta ’ kondizzjonijiet infjammatorji, ħlief għal amministrazzjoni topika), danazol (użat għat- trattament ta ’ xi disturbi ormonali tan- nisa), kontraċettivi orali (użati għall- kontroll tat- twelid), ormoni tat- tirojde (użati għat- trattament ta ’ funzjoni ħażina tat- tirojde), ormoni ta ’ l- iżvilupp (użati f’ kondizzjonijiet
agents (used for the treatment of asthma) and thiazides (used in special endocrine conditions).
x endokrinoloġiċi), mediċini simpatomimetiċi (użati fit- trattament ta ’ l- ażżma) u thiazides (użati
The use of a bronchodilator (reliever inhaler) for asthma or other airway conditions may cause a more pronounced fall in blood sugar in response to inhaled insulin (see section 2 “Do not take EXUBERA” lo and section 2 “Take special care with EXUBERA”). o
du f’ kondizzjonijiet endokrinoloġiċi speċjali). ħa L- użu ta ’ bronkodilatur (inalatur reliever) għal ażżma jew xi kondizzjonijiet oħra tal- passaġġi ta ’ l- arja jista ’ jikkaġuna waqa ’ akbar fiz- zokkor fid- demm b’ reazzjoni għal insulina inalata (ara sezzjoni 2 “ Tiħux EXUBERA ” u sezzjoni 2 “ Oqgħod attent ħafna b’ EXUBERA ”) ’ g im
Beta- tn
Il- livell taz- zokkor f’ demmek jista ’ jinżel jew jitla ’ jekk tieħu beta blockers jew tixrob l- alkoħol.
blockers may weaken the warning symptoms of a hypoglycaemic reaction or suppress them entirely.
Beta - blockers jistgħu jdgħajjfu s- sintomi ta ’ twissija ta ’ reazzjoni ipogliċemika jew irażżnuhom għal kollox.
Alcohol may increase the action of insulin and cause low blood sugar levels.
L- alkoħol jista ’ jżid l- azzjoni ta ’ l- insulina u jikkaġuna livelli baxxi ta ’ zokkor fid- demm. il
Octreotide/lanreotide (used in special endocrine conditions) may change the need for insulin. uc
Octreotide/ lanreotide (użat f’ kondizzjonijiet endokrinoloġiċi speċjali) jistgħu jnaqqsu l- ħtieġa għall - insulina. al
If you smoke, the amount of insulin your body absorbs will be increased and you will have a greater od
Jekk tpejjep, l- ammont ta ’ insulina li jassorbi ġismek jiżdied u jkollok riskju akbar ta ’ ipogliċemija. in
If you are taking EXUBERA, do not smoke (see section 2, “Do not take EXUBERA”). pr
Jekk tkun qed tieħu EXUBERA, tpejjipx (ara sezzjoni 2, “ Tiħux EXUBERA ”). iċ
In contrast, exposure to other people’s cigarette smoke may decrease the amount of insulin your body absorbs. al
B’ kuntrast, l- espożizzjoni għad- duħħan tas- sigaretti ta ’ nies oħra jista ’ jnaqqas l- ammont ta ’ insulina li ed
Pregnancy and breast-feeding in ic
jassorbi ġismek. m
There is no experience on the use of EXUBERA in pregnant women.
Ma hemm l- ebda esperjenza fuq l- użu ta ’ EXUBERA f’ nisa tqal.
Inform your doctor or nurse if you are planning to become pregnant or if you are ed
EXUBERA m’ għandhiex tittieħed t ot
already pregnant.
fit- tqala.
Your doctor may replace EXUBERA with an injectable insulin for your diabetes.
Għarraf lit- tabib jew lill- infermiera tiegħek jekk qed tippjana li toħroġ tqila jew jekk inti diġà tqila.
Careful control M
Għad- dijabete tiegħek, it- tabib jista ’ jissostitwixxi EXUBERA ma ’ insulina li tiġi injettata. od
of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Pr
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Jekk qed tredda ’ ikkonsulta mat- tabib tiegħek peress li jista ’ jkollok bżonn xi aġġustamenti fid- dożi ta ’ l- insulina u d- dieta tiegħek.
57 Driving and using machines
Sewqan u tħaddim ta ’ magni
Your ability to concentrate or react may be reduced if you have too low blood sugar (hypoglycaemia).
L- abbiltà tiegħek li tikkonċentra jew tirreaġġixxi tista ’ titnaqqas jekk ikollok zokkor fid- demm baxx wisq (ipogliċemija).
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery).
Jekk jogħġbok żomm din il- problema f’ moħħok fis- sitwazzjonijiet kollha fejn tista ’ tpoġġi lilek innifsek jew lill- oħrajn fir- riskju (eż. sewqan ta ’ karozza jew tħaddim ta ’
You should contact your doctor about the advisability of driving if you have:
Għandek tikkuntattja lit- tabib tiegħek dwar rakkomandazzjonijiet fuq is- sewqan jekk ikollok:
- frequent episodes of hypoglycaemia,
- Episodji frekwenti ta ’ ipogliċemija,
- r educed or absent warning signs of hypoglycaemia.
- Sinjali ta ’ twissija ta ’ ipogliċemija mnaqqsa jew ma jinħassux.
HOW TO TAKE EXUBERA
3 KIF GĦANDEK TIEĦU EXUBERA
EXUBERA should be taken within 10 minutes before the start of a meal.
EXUBERA għandha tittieħed fi żmien 10 minuti qabel ma tibda l- ikla.
ris Your doctor will decide how much EXUBERA you will initially need based on your weight and
t za It- tabib tiegħek jiddeċiedi kemm għandha tkun id- doża ta ’ EXUBERA fil- bidu fuq il- bażi tal- piż tiegħek u l- ammont ta ’ eżerċizzju.
A 1 mg blister of EXUBERA gives you abo ut the same insulin dose as 3 IU of subcutaneously
riz Bużżieqa ta ’ 1 mg ta ’ EXUBERA tagħtik madwar l- istess doża ta ’ insulina daqs 3 IU ta ’ insulina umana li taħdem malajr injettata taħt il- ġilda.
ut injected fast-acting insulin human.
Bużżieqa ta ’ 3 mg ta ’ EXUBERA tagħtik madwar l -
ra dose as 8 IU of subcutaneously injected fast-acting insulin human.
to istess doża ta ’ insulina daqs 3 8U ta ’ insulina umana li taħdem malajr injettata taħt il- ġilda.
If you have low body weight check with your doctor if you can use EXUBERA.
Jekk il- piż ta ’ ġismek huwa ħafif iċċekkja mat- tabib tiegħek tistax tieħu EXUBERA.
If you need dose titrations of less than 1 mg it is recommended you do not use EXUBERA.
Jekk għandek bżonn
n
aw titrazzjonijiet fid- doża ta ’ inqas minn 1 mg huwa rrakkomandat li ma tużax EXUBERA.
Always make sure you have the correct strength and number of EXUBERA blisters available before taking your dose.
Dejjem agħmel ċert li għandek in- numru ta ’ bżieżaq ta ’ EXUBERA u l- qawwa korretta qabel tieħu d -
It is important that you take the number of 1 mg and 3 mg blisters that your doctor recommends in the combination that he or she recommends. lo
Huwa importanti li tieħu n- numru ta ’ bżieżaq ta ’ 1 mg u 3 mg li t- tabib tiegħek
Do not use three 1 mg blisters in place of one 3 mg blister, as this will give you a much higher o
du jirrikmandalek fil- kombinazzjoni li huwa jew hija tirrikmanda.
If you temporarily run out of 3 mg blisters, two 1 mg blisters should be used and tn
Tużax tliet bżieżaq ta ’ 1 mg minflok bużżieqa waħda ta ’ 3 mg, għax dan jagħtik doża ħafna ħa ogħla ta ’ insulina.
you should monitor your blood glucose levels closely.
Jekk temporanjament jispiċċawlek il- bżieżaq ta ’ 3 mg, għandhom jintużaw żewġ bżieżaq ta ’ 1 mg u għandek tiċċekkja l- livelli tal- glukosju f’ demmek bir- reqqa.
You should contact your doctor or pharmacist as soon as possible to get more 3 mg blisters.
Għandek ’ g tikkuntattja lit- tabib jew lill- ispiżjar tiegħek kemm jista ’ jkun malajr biex iġġib aktar bżieżaq ta ’ 3 mg.
If you are unsure contact your doctor, nurse or pharmacist. uc
Jekk m’ intix ċert ikkuntattja lit- tabib, infermier/ a jew spiżjar tiegħek. im
Preparing to take EXUBERA od
Preparazzjoni biex tieħu EXUBERA il
To use an EXUBERA blister, first separate the blister from the spine by tearing along the tear line pr
Biex tuża bużżieqa ta ’ EXUBERA, l- ewwel ifred il- bużżieqa minn ma ’ l- ispina billi ċċarrat matul is - al
(perforation).
sinjal tat- tiċrit (perforazzjoni) in
Do not open the blister containing EXUBERA.
Tiftaħx il- bużżieqa li fiha EXUBERA.
The blister will be punctured inside the inhaler when al
Il- bużżieqa tinfaqa ’ ġewwa l- inalatur meta tużah.
Do not swallow the contents of the blister. in
Tiblax il - kontenut tal- bużżieqa. iċ
EXUBERA should only be breathed in through your mouth and should only be taken with your ic
EXUBERA għandha ttieħed man- nifs minn ġol- ħalq u għandha ttittieħed biss mill- inalatur ta ’ l - ed
insulin inhaler. ed
insulina tiegħek. m
Always follow your doctor’s instructions about when and how to take EXUBERA.
Dejjem imxi skond l- istruzzjonijiet tat- tabib tiegħek dwar meta u kif għandek tieħu EXUBERA.
Please see the “Instructions for Use” at the end of the package leaflet for advice on how to use your insulin inhaler, M
Jekk jogħġbok ara “ Tagħrif Dwar l- Użu ” fl- aħħar tal- Fuljett ta ’ Tagħrif għal tagħrif fuq kif għandek tuża l - t
and how to care for it.
inalatur ta ’ l- insulina, u kif għandek tieħu ħsiebu.
Check with your doctor, nurse or pharmacist if you have any questions regarding EXUBERA or the insulin inhaler.
Iċċekkja mat- tabib, infermiera jew spiżjar tiegħek ot
Mistakes in dosage
Żbalji fid- dożaġġ Pr
Please discuss with your doctor what you should do if you were to take too much or too little EXUBERA, or if you miss a dose, so that you know what to do.
Jekk jogħġbok iddiskuti mat- tabib tiegħek x’ għandek tagħmel jekk tieħu ftit jew wisq EXUBERA, jew jekk tinsa tieħu doża, sabiex tkun taf x’ għandek tagħmel.
–If you have taken too much insulin, you may develop hypoglycaemia.
– Jekk inti tkun ħadt wisq insulina, tista tiżviluppa ipogliċemija.
Check your blood sugar frequently.
Iċċekkja z- zokkor f’ demmek ta ’ spiss.
In general, to prevent hypoglycaemia you must eat more food and monitor your blood
B’ mod ġenerali, biex tilqa ’ kontra l- ipogliċemija għandek tiekol aktar ikel u tissorvelja z- zokkor f’ demmek.
For information on the treatment of hypoglycaemia, see the end of section 4 “Possible side effects”.
Għal tagħrif dwar it- trattament ta ’ l- ipogliċemija, ara l- aħħar ta ’ sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu ”.
–If you have missed a dose of insulin or if you have taken too low a dose, your blood sugar level may become too high.
59 – Jekk inti tkun qbiżt doża ta ’ insulina jew jekk tkun ħadt doża baxxa wisq, il- livell ta ’ zokkor f’ demmek jista ’ jsir għoli wisq.
For further information on hyperglycaemia, see the end of section 4 “Possible side effects”.
Għal tagħrif dwar it- trattament ta ’ l- ipergliċemija, ara t- tmiem ta ’ sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu ”.
ed Like all medicines, EXUBERA can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, EXUBERA jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects reported very commonly
t za Effetti sekondarji rrapportati b’ mod komuni ħafna (Intwerew f’ aktar minn 1 sa 10 pazjenti)
ris (Seen in more than 1 in 10 patients)
Jekk jogħġbok ara t- tmiem ta ’ din is- sezzjoni għal aktar
Please see the end of this section for important further information abo ut hypoglycaemia and its treatment.
to tagħrif importanti dwar l- ipogliċemija u t- trattament tagħha.
ut ra Cough - A cough may occur within seconds to minutes after inhaling EXUBERA.
aw Sogħla – Tista ’ tiżviluppa sogħla wara ftit sekondi sa minuti wara l- inalazzjoni ta ’ EXUBERA.
The cough is usually mild and often gets better over time.
Is - sogħla hija ġeneralment ħafifa u ta ’ spiss titjieb biż- żmien.
Side effects reported commo nly (Seen in less than 1 in 10 but more than 1 in 100 patients)
x Effetti sekondarji rrapportati b’ mod komuni
n
du (Intwerew f’ anqas minn 1 f’ 10 persuni imma aktar minn 1 f’ 100 pazjent)
Commonly reported side effects are mild to moderate shortness of breath (dyspnoea), productive lo cough, throat irritation and dry throat. o
Effetti sekondarji rrapportati b’ mod komuni huma qtugħ ta ’ nifs (dispneja) ħafifa għal moderata, ħa sogħla produttiva, irritazzjoni fil- ġriżmejn jew ġerżuma xotta. ’ g Effetti sekondarji rrapportati b’ mod mhux komuni (Intwerew f’ anqas minn 1 f’ 100 persuna imma aktar minn 1 f’ 1000 pazjent). im
(Seen in less than 1 in 100 but more than 1 in 1000 patients).
Effetti sekondarji mhux komuni huma infjammazzjoni tal- ġriżmejn (farinġite), emorraġija mill - imnieħer (epistassi), egħluq tal- passaġġi ta ’ l- arja b’ diffikultajiet fit- teħid tan- nifs (bronkospażmu), il
Uncommon side effects are inflammation of the throat (pharyngitis), nose bleed (epistaxis), airway uc
tħarħir, bidla fil- vuċi (disfonja), uġigħ fil- ġriżmejn (uġigħ faringolarinġejali), disturb fit- tunsilli, ħalq al
constriction with difficulties breathing (bronchospasm), wheezing, voice alteration (dysphonia), throat pain (pharyngolaryngeal pain), tonsillar disorder, dry mouth and chest pain. od
xott u uġigħ fis- sider. in
Other side effects pr
Effetti sekondarji oħra iċ
Some patients have experienced fluid in the lung lining (pleural effusion). al
Xi pazjenti esperjenzaw fluwidu fir- rita tal- pulmun (effużjoni plewrali). ed
Insulin treatment can cause the body to produce antibodies to insulin (substances that bind to insulin).
Trattament bl- insulina jista ’ jġiegħel lill- ġisem jipproduċi antikorpi għall- insulina (sustanzi li jorbtu ma ’ l- insulina).
Development of such antibodies is seen more commonly in patients treated with EXUBERA in
Żvilupp ta ’ antikorpi bħal dawn jidher b’ mod aktar komuni f’ pazjenti ttrattati m
compared to subcutaneous insulin.
b’ EXUBERA meta mqabbla ma ’ insulina mogħtija taħt il- ġilda.
Although these antibodies may be produced, they do not have any ic
Għalkemm dawn l- antikorpi jistgħu jiġu prodotti, m’ għandhom l- ebda effett fuq il- kontroll tal- glukosju f’ demmek. t ot
effect on your blood glucose control. ed
Tnaqqis żgħir fil- funzjoni tal- pulmun tiegħek jista ’ jseħħ waqt trattament b’ EXUBERA, għalkemm od
A small decrease in your lung function may occur during EXUBERA treatment, although you should not notice any symptoms.
Jekk twaqqaf terapija b’ EXUBERA, il- funzjoni tal- pulmun tiegħek ġeneralment tirritorna għal- livell normali tiegħek.
This change occurs within the first months of treatment and usually doesn’t M
Jekk tinnota xi bidla Pr
If you notice a change in your breathing while taking EXUBERA inform your doctor.
fit- teħid tan- nifs tiegħek waqt li qed tieħu EXUBERA informa t- tabib tiegħek
Severe allergic reactions to insulin are very rare.
Reazzjonijiet allerġiċi serji għall- insulina huma rari ħafna.
Such reactions to insulin or to the other ingredients can cause skin reactions, severe swelling of skin or mucous membranes (angio-oedema), shortness of breath, a fall in blood pressure and may become life threatening.
Reazzjonijiet bħal dawn għall- insulina jew għas- sustanzi l- oħra jistgħu jikkaġunaw reazzjonijiet fil- ġilda, nefħa serja tal- ġilda jew tar- riti mukużi (anġjo- edema), qtugħ ta ’ nifs, waqa ’ fil- pressjoni u jistgħu jsiru ta ’ theddida għall- ħajja.
Changes to your sight may occur upon starting insulin therapy.
Tista ’ sseħħ bidla fil- viżta tiegħek hekk kif tibda terapija bl- insulina.
These changes are usually mild and go away with time.
Bidla bħal din tkun ġeneralment ħafifa u tgħaddi maż- żmien.
59 Insulin treatment may also cause temporary build-up of water in the body with swelling in the calves and ankles.
60 Trattament bl- insulina jista ’ jikkaġuna akkumulazzjoni temporanja ta ’ ilma fil- ġisem b’ nefħa fil - pxiexen u l- għekiesi.
If any of these side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
If your blood sugar is too low (hypoglycaemia) Your blood sugar levels may fall too much, if for example: – you take too much insulin, – you miss meals or delay them,
Jekk iz- zokkor tiegħek huwa baxx wisq (ipogliċemija) Il- livelli ta ’ zokkor f’ demmek jistgħu jitbaxxew ħafna, jekk per eżempju: – tieħu wisq insulina
ed – you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), – you lose or are unable to consume carbohydrates due to vomiting or diarrhoea,
za – ma tikolx biżżejjed, jew tiekol ikel li fih inqas karboidrati mis- soltu (zokkor u sustanzi simili għaz - zokkor huma msejjħin karboidrati: madankollu, sweeteners artifiċjali MHUMIEX karboidrati),
ris – you drink alco hol, particularly if you are not eating much, – you take more physical exercise than usual or a different type of physical activity,
riz – titlef jew ma tkunx tista ’ tikkonsma karboidrati minħabba rimettar jew dijarea, – tixrob l- alkoħol, partikolarment jekk ma tkunx qed tiekol ħafna, – tagħmel aktar eżerċizzju fiżiku mis- soltu jew tagħmel tip differenti ta ’ attività fiżika,
ho – you are recovering from an injury or operation or other stress, – you are recovering from a feverish illness or from another illness,
to – tkun qed tirkupra minn korriment jew operazzjoni jew stress ieħor,
ut – you are taking or have stopped taking certain other medicines (see section 2, “Taking other medicines”).
aw – tkun qed tirkupra minn mard bid- deni jew xi mard ieħor, – qed tieħu jew waqaft tieħu ċerti mediċini oħra (ara sezzjoni 2 “ Meta tieħu mediċini oħra ”).
ra Hypoglycaemia (low blood sugar levels) are also more likely to occur if: – you have just begun insulin treatment or changed to another insulin preparation, – your blood sugar levels are almost normal or are unstable, ge – you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism. n lo Symptoms that tell you that your blood sugar level is falling too much or too fast may be, for example: sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat, chest pain (angina pectoris).
L- ipogliċemija (livelli baxxi taz- zokkor fid- demm) x’ aktarx tista ’ sseħħ ukoll jekk:
These symptoms often develop before the symptoms o
x – tkun għadek kif bdejt trattament bl- insulina jew bdilt għal fuq preparazzjoni oħra ta ’ l- insulina,
of a low sugar level in the brain. tn
Sintomi li jgħidulek li l- livell taz- zokkor f’ demmek niżel baxx wisq jew malajr wisq, huma per ’ g eżempju: ħruġ ta ’ għaraq, ġilda għallieka, ansjetà, taħbit tal- qalb mgħaġġel, pressjoni għolja, im
The following symptoms indicate a low sugar level in the brain: headaches, intense hunger, nausea, uc
Dawn is- sintomi ta ’ spiss jiżviluppaw qabel is- sintomi ta ’ livell baxx taz- zokkor fil- moħħ. il
vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and od
Is- sintomi li ġejjin jindikaw livell baxx taz- zokkor fid- demm fil- moħħ: uġigħ ta ’ ras, ġuħ qawwi, dardir, rimettar, għeja, ngħas, disturbi fl- irqad, irrekwitezza, imġiba aġġressiva, nuqqas ta ’ al
tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness. pr
konċentrazzjoni, reazzjonijiet imxekkla, depressjoni, konfużjoni, disturbi fil- kliem (xi kultant telf għal kollox tal- kliem), disturbi fil- vista, tregħid, paraliżi, sensazzjonijiet ta ’ tnemnim (parastiżja), tirżiħ u in
The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker or may be missing altogether if: al
sensazzjonijiet ta ’ tnemnim fil- parti tal- ħalq, sturdament, telf ta ’ kontroll tiegħek innifsek, inabilità li iċ
– you are elderly, in
tieħu ħsieb tiegħek innifsek, aċċessjonijiet, telf mis- sensi. ed
– you have had diabetes for a long time – due to diabetes, you suffer from a certain type of nervous disease (autonomic neuropathy), ic
– inti anzjan – kellek id- dijabete għal żmien twil – minħabba d- dijabete tbati minn ċertu tip ta ’ mard nervuż (neropatija awtonomika), t ot
– you have recently suffered hypoglycaemia (e.g. the day before) or if it develops slowly, – you have almost normal or, at least, greatly improved blood sugar levels, ed
– batejt minn ipogliċemija riċentament (eż. il- jum ta ’ qabel) jew jekk din tiżviluppa bil- mod, – għandek livelli taz- zokkor kważi normali jew, ta ’ l- anqas livelli ta ’ zokkor fid- demm imtejbin ħafna, od
– you are taking or have taken certain other medicines (see section 2, “Taking other medicines”).
– qed tieħu jew ħadt ċerti mediċini oħra (ara sezzjoni 2, “ Meta tieħu mediċini oħra ”).
In such a case, you may develop severe hypoglycaemia (and even lose consciousness) before you are aware of the problem.
F’ dan il- każ, tista ’ tiżviluppa ipogliċemija serja (u anke tintilef mis- sensi) qabel ma tinduna bil - problema.
Try always to keep familiar with your warning symptoms.
Dejjem ipprova żomm ruħek familjari mas- sintomi ta ’ twissija.
If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that might otherwise be overlooked.
Jekk ikun hemm bżonn, testijiet taz- zokkor fid- demm aktar frekwenti jistgħu jgħinu biex jidentifikaw episodji ħfief li kieku inkella jiġu injorati.
While you are not confident about recognising your warning symptoms, avoid situations (e.g. driving a car) in which you or others would be put at risk by hypoglycaemia.
Meta ma tkunx kunfidenti dwar kif tagħraf is- sintomi ta ’ twissija tiegħek, evita sitwazzjonijiet (eż sewqan ta ’ karozza) fejn inti jew oħrajn tistgħu titpoġġew f’ riskju minħabba ipogliċemija.
Do not take more insulin.
61 X’ għandek tagħmel f’ każ ta ’ ipogliċemija 1.
Immediately take about 10 to 20 gram sugar, e.g. as glucose, sugar cubes or a sugar-sweetened drink.
Tiħux aktar insulina Ħu madwar 10 sa 20 gm zokkor minnufih eż. bħal glukosju, dadi taz- zokkor jew xarba ħelwa biz- zokkor.
(Measure once as spoonfuls or lumps of sugar or glucose tablets to see how much this means).
(Kejjel darba b’ kuċċarini jew ammonti ta ’ zokkor jew pilloli tal- glukosju biex tara għal kemm jammonta dan).
Caution: please remember that artificial sweeteners and foods with artificial sweeteners (e.g. diet drinks) are of no help in hypoglycaemia.
Attenzjoni: jekk jogħġbok ftakar li sweeteners artifiċjali u ikel bi sweeteners artifiċjali (eż. xarbiet tad- dieta) ma huma ta ’ ebda għajnuna f’ ipogliċemija.
Then eat something that has a long-acting effect in raising your blood sugar (e.g. bread).
Imbagħad kul xi ħaġa li għandha effett li tgħolli fuq tul ta ’ żmien iz- zokkor f’ demmek (eż. ħobż).
Your doctor or nurse will have discussed this with you.
It- tabib jew l- infermiera tiegħek ikunu ddiskutew dan miegħek.
If the hypoglycaemia comes back again take another 10 to 20 gram sugar.
Jekk l- ipogliċemija terġa ’ sseħħ, ħu 10 sa 20 gramma zokkor oħra.
Speak to a doctor imm ediately if you are not able to control the hypoglycaemia or if it recurs.
Kellem tabib minnufih jekk ma tkunx tista ’ tikkontrolla l- ipogliċemija jew jekk din terġa ’ sseħħ.
ed Always carry some sugar (at least 20 grams) with you.
za Dejjem ġorr xi zokkor miegħek (għallinqas 20 gramma).
ris glucagon (a medicine which increases blood sugar).
riz Jekk ma tkunx tista ’ tibla ’ jew jekk tkun mitluf minn sensik, tkun teħtieġ injezzjoni ta ’ glukosju jew ta ’ glukagon (mediċina li żżid iz- zokkor).
These injections may be justified even if it is not certain that you have hypoglycaemia.
Dawn l- injezzjonijiet jistgħu jkunu ġġustifikati anke jekk ma jkunx stabbilit jekk inti għandekx ipogliċemija.
ho It is advisable to test your blood sugar immediately after taking glucose to check that you really have
to aw Huwa ta ’ min tittestja z- zokkor f’ demmek minnufih wara li tieħu l- glukosju biex tiċċekkja li veru għandek ipogliċemija.
ut hypoglycaemia.
Jekk iz- zokkor f’ demmek huwa għoli wisq (ipergliċemija)