qanastek/EMEA-V3 huggingface dataset:
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
36 Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xaħam taħt il- ġilda, it- tip tad- dijabete).
34 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma ġiet osservata ebda rabta qawwija mal- proteini tal- plażma, ħlief ma ’ l- antikorpi ta ’ l- insulina (jekk kienu preżenti) li jkunu qegħdin jiċċirkolaw.
6.3 Shelf life
37 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
35 During use: do not refrigerate.
Waqt l- użu: tagħmilhomx fil- friġġ.
Actrapid InnoLet is for single person use only.
Actrapid InnoLet hi maħsuba biex tintuża minn persuna waħda biss.
Actrapid FlexPen 100 IU/ ml solution for injection in a pre-filled pen
Actrapid FlexPen 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
1 pre-filled pen contains 3 ml equivalent to 300 IU.
Millilitru fih 100 UI ta ’ insulina umana Pinna mimlija għal- lest fiha 3 ml ekwivalenti għal 300 UI.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
40 L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta ’ insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
37 Administration For subcutaneous use.
Kif jingħata Għall- użu taħt il- ġilda.
This procedure should only be carried out by health care professionals.
Din il- proċedura għandha ssir biss minn professjonisti fil- kura tas- saħħa.
Actrapid FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Actrapid FlexPen hi maħsuba biex tintuża ma ’ labar NovoFine bl- għatu qasir ta ’ 8 mm jew iqsar.
FlexPen delivers 1-60 units in increments of 1 unit.
FlexPen tipprovdi 1- 60 unità f’ inkrementi ta ’ unità waħda.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
41 metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l - annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
38 reduce or prevent these reactions.
Bħal kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Sustanzi ipogliċemiċi li jittieħdu mill- ħalq (OHA), inibituri ta ’ monoamine oxidase (MAOI), sustanzi li jimblukkaw ir- riċetturi beta mhux selettivi, inibituri ta ’ l- enzima li tikkonverti l- angjotensin (ACE), salicylates, alkoħol, sterojdi anaboliċi u sulphonamides.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
42 Wara l- ħlas, il- ħtiġijiet ta ’ l- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
43 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
40 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Madankollu, l- ipogliċemija tista ’ tiżviluppa fi stadji sekwenzjali: • Episodji ipoglicemiċi ħfief jistgħu jkunu kkurati bl- għoti mill- ħalq ta ’ glukosju jew ta ’ prodotti li fihom iz- zokkor.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
44 Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xaħam taħt il- ġilda, it- tip tad- dijabete).
41 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma ġiet osservata ebda rabta qawwija mal- proteini tal- plażma, ħlief ma ’ l- antikorpi ta ’ l- insulina (jekk kienu preżenti) li jkunu qegħdin jiċċirkolaw.
6.3 Shelf life
45 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
30 months when stored between 2°C - 8°C..
30 xahar meta jinħażen f’ temperatura ta ’ bejn 2°C - 8°C.
42 During use: do not refrigerate.
Waqt l- użu: tagħmilhomx fil- friġġ.
Actrapid FlexPen is for single person use only.
Actrapid FlexPen hi maħsuba biex tintuża minn persuna waħda biss.
October 2002
07 Ottubru 2002
43 ANNEX II
47 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZAI BIJOLOĠIKAĊI ATTIVAI U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg Id- Danimarka
Actrapid Penfill and FlexPen:
Actrapid Penfill u FlexPen:
45 ANNEX III
49 ANNESS III
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actrapid 40 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid 40 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana (rDNA)
1 ml solution contains 40 IU (1.4 mg) of insulin human (rDNA).
1 ml soluzzjoni fih 40 UI (1. 4 mg) ta ’ insulina umana (rDNA).
zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.
zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid u ilma għall- injezzjonijiet
Solution for injection 1 x 10 ml 5 x 10 ml
Soluzzjoni għall- injezzjoni 1 x 10 ml 5 x 10 ml
Subcutaneous or intravenous use Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP/ During use: use within 4 weeks
JIS / Waqt l- użu: użah fi żmien 4 ġimgħat
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Tagħmlux fil- friġġ jew taħżnu f’ temperatura ’ l fuq minn 25°C
Actrapid vial 40 IU/ ml
Actrapid kunjett 40 UI/ ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actrapid 40 IU/ mlsolution for injection Insulin human (rDNA) SC, IV use
Actrapid 40 UI/ ml soluzzjoni għall- injezzjoni Insulina umana (rDNA) Użu għal taħt il- ġilda jew għal ġol- vini
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actrapid 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid 100 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana (rDNA)
1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
1 ml soluzzjoni fih 100 UI (3. 5 mg) ta ’ insulina umana (rDNA).
EXP/ During use: use within 6 weeks
JIS / Waqt l- użu: użah fi żmien 6 ġimgħat
1 vial of 10 ml contains 1000 IU
Kunjett wieħed ta ’ 10 ml fih 1000UI
Actrapid vial 100 IU/ ml
Actrapid kunjett 100 UI/ ml
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actrapid 100 IU/ ml solution for injection Insulin human (rDNA) SC, IV use
Actrapid 100 UI/ ml soluzzjoni għall- injezzjoni Insulina umana (rDNA) Użu għal taħt il- ġilda jew għal ġol- vini
10 ml 1 vial of 10 ml contains 1000 IU
10 ml Kunjett wiehed ta ’ 10 ml fih 1000UI
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Solution for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Soluzzjoni għall- injezzjoni 1 x 10 ml Dan hu parti minn parti minn pakkett multiplu u mhux għall- bejgħ ta ’ kunjetti individwali
55 PARTICULARS TO APPEAR ON THE PACKAGING
59 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT
OUTER WRAPPER LABEL ON MULTIPACKS
TIKKETTA TAL- KARTA TA ’ BARRA FUQ IL- PAKKETTI MULTIPLI
Solution for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Soluzzjoni għall- injezzjoni 5 x (1 x 10 ml Dan huwa pakkett multiplu u mhux għall- bejgħ ta ’ kunjetti individwali
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Solution for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Soluzzjoni għall- injezzjoni 1 x 10 ml Dan hu parti minn pakkett multiplu u mhux għall- bejgħ ta ’ kunjetti individwali
58 9.
62 9.
1 vial of 10 ml contains 1000 IU
Kunjett ta ’ 10 ml fih 1000 UI
59 PARTICULARS TO APPEAR ON THE PACKAGING OUTHER WRAPPER LABEL ON MULTIPACKS
TIKKETTA TAL- KARTA TA ’ BARRA FUQ IL- PAKKETTI MULTIPLI
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actrapid Penfill 100 IU/ ml solution for injection in a cartridge Insulin human (rDNA)
Actrapid Penfill 100 UI/ ml soluzzjoni għall- injezzjoni f’ skartoċċ Insulina umana (rDNA)
Solution for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Soluzzjoni għall- injezzjoni 1 x 3 ml 5 x 3 ml 10 x 3 ml
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Read the package leaflet before use Actrapid Penfill is for use by one person only
Użu għal taħt il- ġilda Skrataċ tal- Penfill huma għall- użu ma ’ sistemi ta ’ għoti ta ’ insulina Novo Nordisk Aqra l- fuljett ta ’ tagħrif qabel l- użu.
62 9.
66 9.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
Tagħmlux fil- friġġ jew taħżnu f’ temperatura ’ l fuq minn 30°C
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actrapid Penfill 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid Penfill 100 UI/ ml soluzzjoni għall- injezzjoni Insulina umana (rDNA) Użu għal taħt il- ġilda
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actrapid NovoLet 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid NovoLet 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Solution for injection 5 x 3 ml 10 x 3 ml
Soluzzjoni għall- injezzjoni 5 x 3 ml 10 x 3 ml
Subcutaneous use Actrapid NovoLet is designed to be used with NovoFine needles Read the package leaflet before use Actrapid NovoLet is for use by one person only
Actrapid NovoLet huwa għall- użu ta ’ persuna waħda biss
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
Tagħmlux fil- friġġ jew taħżnu f’ temperatura ’ l fuq minn 30°C
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NOVOLET LABEL
TIKKETTA TAN- NOVOLET
Actrapid NovoLet 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid NovoLet 100 UI/ ml soluzzjoni għall- injezzjoni Insulina umana (rDNA) Użu għal taħt il- ġilda
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actrapid InnoLet 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid InnoLet 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Actrapid InnoLet is designed to be used with NovoFine S needles Read the package leaflet before use Actrapid InnoLet is for use by one person only
Actrapid InnoLet huwa għall- użu ta ’ persuna waħda biss
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
73 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actrapid InnoLet 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid InnoLet 100 UI/ ml soluzzjoni għall- injezzjoni Insulina umana (rDNA) Użu għal taħt il- ġilda
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
74 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actrapid FlexPen 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Actrapid FlexPen 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm.
Il- labar mhumiex inklużi.
Needles are not includedRead the package leaflet before use Actrapid FlexPen is for use by one person only
Actrapid FlexPen huwa għall- użu ta ’ persuna waħda biss
72 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actrapid FlexPen 100 IU/ ml solution for injection Insulin human (rDNA) SC use
Actrapid FlexPen 100 UI/ ml soluzzjoni għall- injezzjoni Insulina umana (rDNA) Użu għal taħt il- ġilda
74 PACKAGE LEAFLET:
78 FULJETT TA ’ TAGĦRIF:
Actrapid 40 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid ta ’ 40 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana (rDNA)
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. – Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispiżjar tiegħek. – Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib lill- infermier/ a tad- dijabete jew lill- ispiżjar tiegħek.
WHAT ACTRAPID IS AND WHAT IT IS USED FOR
X’ INHU ACTRAPID U GĦALXIEX JINTUŻA
Actrapid is human insulin to treat diabetes.
Actrapid hu insulina umana għall- kura tad- dijabete.
Actrapid is a fast-acting insulin.
Actrapid hu insulina li taħdem b’ mod malajr.
This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 8 hours.
Dan ifisser li jibda jbaxxilek il- livell taz- zokkor fid- demm madwar nofs siegħa wara li tieħdu, u l - effett idum għal madwar 8 sigħat.
Actrapid is often given in combination with longer-acting insulin products.
Actrapid ta ’ spiss jingħata flimkien ma ’ prodotti ta ’ l- insulina li jaħdmu b’ mod aktar fit- tul.
BEFORE YOU USE ACTRAPID
QABEL MA TUŻA ACTRAPID
Do not use Actrapid
Tużax Actrapid
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Oqgħod attent/ a għas- sinjali ta ’ l- allerġija f’ 5 Effetti sekondarji li jista ’ jkollu ► Jekk tħoss li ġejja ipo (ipo hija taqsira għal reazzjoni ipogliċemika u hija ġabra ta ’ sintomi ta ’ livell baxx ta ’ zokkor fid- demm).
Take special care with Actrapid
Oqgħod attent ħafna b’ Actrapid
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
► Jekk għandek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - tirojde ► Jekk qed tixrob l- alkoħol: oqgħod attent/ a għas- sinjali ta ’ xi ipo u qatt m’ għandek tixrob l - alkoħol fuq stonku vojt ► Jekk qed tagħmel eżerċizzju fiżiku aktar mis- soltu jew jekk trid tibdel id- dieta normali tiegħek ► Jekk inti marid/ a: kompli ħu l- insulina tiegħek ► Jekk ser issiefer: li tivvjaġġa bejn żoni tal- ħin differenti, jista ’ jaffettwa l- ħtiġijiet tiegħek ta ’ l - insulina u l- ħin meta tieħu l- injezzjonijiet.
Many medicines affect the way glucose works in your body and they may influence your insulin dose.
Il- mod kif jaħdem glukosju fil- ġisem tiegħek huwa affettwat minn ħafna mediċini. u dan jista ’ jinfluwenza d- doża tiegħek ta ’ insulina.
Listed below are the most common medicines which may affect your insulin treatment.
Hawn taħt hawn imniżżlin l- aktar mediċini komuni li jistgħu jaffettwaw il- kura tiegħek bl- insulina.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
79 anaboliċi; sulfonamidi; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimetiċi; ormon tat- tkabbir, danazol; octreotide jew lanreotide.
75 Driving and using machines
Sewqan u tħaddim ta ’ magni
If you drive or use tools or machines: watch out for signs of a hypo.
Jekk issuq jew tuża għodda jew magni: oqgħod attent/ a għas sinjali ta ’ ipo.
Never drive or use machinery if you feel a hypo coming on.
Qatt issuq jew tuża makkinarju jekk tħoss li ġejja xi ipo.
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Iddiskuti mat- tabib tiegħek jekk għandekx issuq jew tħaddem magni jekk ikollok episodji frekwenti ta ’ ipos jew jekk issibha bi tqila biex tagħraf l- ipos.
HOW TO USE ACTRAPID
KIF GĦANDEK TUŻA ACTRAPID
Follow their advice carefully.
Segwi l- parir tagħhom b’ attenzjoni.
This leaflet is a general guide.
Dan il- fuljett iservi ta ’ gwida ġenerali.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Jekk it- tabib tiegħek biddlek minn tip jew għamla ta ’ insulina għal oħra, id- doża tiegħek tista ’ tkun trid tiġi aġġustata mit- tabib tiegħek.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li b’ mod regolari tiċċekkja l- livell ta ’ glukosju fid- demm tiegħek.
Before using Actrapid
Qabel tuża Actrapid
► Check the label to make sure it is the right type of insulin ► Disinfect the rubber membrane with a medicinal swab.
► Iċċekkja t- tikketta biex taċċerta li hija t- tip korrett ta ’ insulina ► Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali
Each vial has a protective, tamper-proof plastic cap.
Kull kunjett fih għatu protettiv tal - plastik li ma jistax isir tbagħbis fih.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
Jekk il- kunjett ma jkunx f’ kundizzjoni perfetta meta tirċivih, erġa ’ agħtih lura lil min tahulek. ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Actrapid) ► Jekk ma jidhirx ċar bħall- ilma u mingħajr kulur.
Actrapid is for injection under the skin (subcutaneously).
Actrapid hu magħmul biex ikun injettat taħt il- ġilda.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Dejjem ibdel il- post fejn tinjetta, biex tevita li jifformaw l- għoqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
L- aħjar postijiet minn fejn tinjetta lilek innifsek huma: in- naħa ta ’ quddiem ta ’ qaddek (iż- żaqq); il- warrani; in- naħa ta ’ quddiem tal- koxox jew n- naħa ta ’ fuq ta ’ dirgħajk.
Actrapid vials are for use with insulin syringes with the corresponding unit scale.
Il- kunjetti huma għall- użu ma ’ siringi ta ’ l- insulina bl- iskala korrispondenti ta ’ unitajiet.
Actrapid may also be administered intravenously in special situations by medical professionals.
F’ sitwazzjonijiet speċjali, Actrapid jista ’ wkoll jingħata minn ġol- vini minn professjonisti fil- qasam mediku.
To inject Actrapid on its own
Biex tinjetta Actrapid waħdu
Draw air into the syringe, in the same amount as the dose of insulin you need 2.
Iġbed l- arja ġos- siringa, daqs kemm hi d- doża ta ’ l- insulina li għandek tinjetta 2.
Inject the air into the vial: push the needle through the rubber stopper and press the plunger 3.
Injetta l- arja ġol- kunjett: imbotta l- labra minn ġot- tapp tal- gomma u agħfas il- planġer 3.
Turn the vial and syringe upside down 4.
Dawwar il- kunjett u s- siringa ta ’ taħt fuq 4.
Draw the right dose of insulin into the syringe 5.
Iġbed id- doża korretta ta ’ l- insulina ġos- siringa 5.
Pull the needle out of the vial 6.
Iġbed il- labra ’ l barra mill- kunjett 6.
Make sure there is no air left in the syringe: point the needle upwards and push the air out 7.
Aċċerta ruħek li ma jkunx baqa ’ arja fis- siringa: ipponta l- labra ’ l fuq u imbotta l- arja ’ l barra
To mix Actrapid with long-acting insulin
Biex tħallat Actrapid ma ’ l- insulina li taħdem fit- tul
Roll the vial of long-acting insulin between your hands.
Irrombla l- kunjett ta ’ l- insulina li taħdem fit- tul bejn idejk.
Do this until the liquid is uniformly white and cloudy 2.
Agħmel dan sakemm il- likwidu jkun abjad u opak b’ mod uniformi 2.
Draw as much air into the syringe as the dose of long-acting insulin you need.
Iġbed ammont ta ’ arja ġos- siringa daqs id- doża ta ’ insulina li taħdem fit- tul li teħtieġ.
Inject the air into the long-acting insulin vial, then pull out the needle
Injetta l - arja ġol- kunjett ta ’ l- insulina li taħdem fit- tul, imbagħad iġbed il- labra ’ l barra 3.
Draw as much air into the syringe as the dose of Actrapid you need.
Iġbed ammont ta ’ arja ġos- siringa daqs id- doża ta ’ Actrapid li teħtieġ.
Inject the air into the Actrapid vial.
Injetta l- arja ġol- kunjett ta ’ Actrapid.
Then turn the vial and syringe upside down 4.
Imbagħad dawwar il- kunjett u s- siringa ta ’ taħt fuq 4.
Draw the right dose of Actrapid into the syringe.
Iġbed id- doża korretta ta ’ Actrapid ġos- siringa.
Pull the needle out of the vial.
Iġbed il- labra ’ l barra mill- kunjett.
Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Aċċerta ruħek li ma jkunx baqa ’ arja fis- siringa: ipponta l - labra ’ l fuq u imbotta l- arja ’ l barra.
Check the dose 5.
Iċċekkja d- doża 5.
Now push the needle into the vial of long-acting insulin 6.
Issa imbotta l- labra ġol- kunjett ta ’ l- insulina li taħdem fit- tul 6.
Then turn the vial and syringe upside down 7.
Imbagħad dawwar il- kunjett u s- siringa ta ’ taħt fuq 7.
Draw the right dose of long-acting insulin into the syringe 8.
Iġbed id- doża korretta ta ’ l- insulina li taħdem fit- tul ġos- siringa 8.
Pull the needle out of the vial 9.
Iġbed il- labra ’ l barra mill- kunjett 9.
Make sure there is no air left in the syringe, and check the dose 10.
Aċċerta ruħek li m’ hemm ebda arja fis- siringa, u iċċekkja d- doża 10.
Inject the mixture straight away.
Injetta t- taħlita immedjatament.
Always mix fast-acting and long-acting insulin in this order.
Dejjem ħallat insulina li taħdem malajr u insulina li taħdem fit- tul f’ din is- sekwenza.
Inject the insulin
Kif tinjetta l- insulina
Use the injection technique advised by your doctor or diabetes nurse ► Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Uża t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l - infermier/ a tad- dijabete tiegħek ► Żomm il- labra taħt il- ġilda tiegħek għal mill- anqas 6 sekondi biex tiżgura li d- doża sħiħa tkun ingħatat.
A hypo means your blood sugar level is too low.
Ipo tfisser li l- livell taz- zokkor fid- demm tiegħek hu baxx wisq.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistgħu jiġu għal għarrieda u jistgħu jinkludu: għaraq kiesaħ ġilda kiesħa u pallida; uġigħ ta ’ ras; taħbit mgħaġġel tal- qalb; tħossok imqalla ’; tħoss ġuħ kbir; tibdil temporanju fil- vista; ngħas; għeja u debbulizza mhux tas- soltu; nervożità jew rogħda; tħossok ansjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jekk ikollok xi wieħed minn dawn is- sinjali, kul xi pilloli tal- glukosju jew ikla ħafifa li jkun fiha ħafna zokkor (ħelu, gallettini, meraq tal- frott), imbagħad strieħ.
Don’ t take any insulin if you feel a hypo coming on.
Tiħux insulina jekk tħoss li ġejja xi ipo.
They must not give you any food or drink as it could choke you. ► If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death ► If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
M’ għandhomx jagħtuk ikel jew xorb, għax tista ’ tifga. ► Jekk l- ipogliċemija severa ma tkunx ikkurata, din tista ’ tikkawża ħsara fil- moħħ (temporanja jew permanenti) u anki l- mewt ► Jekk ikollok ipo li ġġiegħlek tintilef minn sensik, jew ħafna ipos, kellem lit- tabib tiegħek.
Using glucagon
Kif tuża glucagon
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Jekk tintilef minn sensik tista ’ tirkupra aktar malajr b’ injezzjoni ta ’ l- ormon glucagon mogħti minn xi ħadd li jaf kif jużah.
If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Jekk tingħata glucagon, ser ikollok bżonn glukosju jew ikla ħafifa li jkun fiha z -
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
Fittex parir mediku wara injezzjoni ta ’ glucagon; ikollok bżonn issib ir- raġuni għall- ipo tiegħek biex tevita li jkollok aktar minnhom.
Causes of a hypo
Il- kawżi ta ’ ipo
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
Dan jista ’ jiġri: • Jekk tieħu wisq insulina • Jekk tiekol ftit wisq jew taqbeż xi ikla • Jekk tagħmel aktar eżerċizzju mis- soltu.
77 If your blood sugar gets too high
Jekk il- livell taz- zokkor fid- demm tiegħek jitla ’ żżejjed
Your blood sugar may get too high (this is called hyperglycaemia).
Il- livell taz- zokkor fid- demm tiegħek jista ’ jitla ’ żżejjed (din tissejjah ipergliċemija).
The warning signs appear gradually.
Is- sinjali ta ’ twissija jidhru gradwalment.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
Dawn jinkludu: tagħmel l- awrina aktar ta ’ spiss; tħossok bil- għatx; titlef l- aptit; tħossok imdardar (nawsja jew rimettar); tħossok bi ngħas jew għajjien/ a; ħmura u ġilda xotta; ħalq xott u nifs li jkollu riħa ta ’ frott (acetone).
If you get any of these signs, test your blood sugar level and test your urine for ketones if you can.
Jekk ikollok xi wieħed minn dawn is- sinjali, ittestja l- livell taz- zokkor fid- demm tiegħek u jekk tista ’, ittestja l- awrina tiegħek għall- ketoni.
Like all medicines, Actrapid can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Actrapid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Actrapid may cause hypoglycaemia (low blood sugar).
Actrapid jista ’ jikkawża ipogliċemija (livell baxx ta ’ zokkor fid- demm).
Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b’ mod mhux komuni (anqas minn pazjent 1 minn kull 100):
When you first start your treatment, it may disturb your vision, but the reaction usually disappears.
Fil- bidu tal- kura, jista ’ jkollok xi problemi fil- vista tiegħek, iżda normalment din ir- reazzjoni tisparixxi.
Changes at the injection site (Lipodystrophy).
Tibdil fis- sit fejn tingħata l- injezzjoni (Lipodistrofija).
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Jekk tinjetta lilek innifsek wisq ta ’ spiss fl - istess sit, it- tessut tax- xaħam taħt il- ġilda f’ dan is- sit jista ’ jinxtorob (lipoatrofija) jew jeħxien (lipoipertrofija).
Changing the site with each injection may help to prevent such skin changes.
Li tibdel is- sit ma ’ kull injezzjoni jista ’ jgħin biex jiġi evitat dan it- tibdil fil- ġilda.
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Jekk tinnota ħofor fil- ġilda tiegħek jew li l- ġilda qed teħxien fis- sit ta ’ l- injezzjoni, għid lit- tabib tiegħek jew lill- infermier/ a tad- dijabete, għax dawn ir- reazzjonijiet jistgħu jsiru aktar serji, jew jekk tinjetta f’ sit bħal dan jistgħu jbiddlu l- assorbiment ta ’ l- insulina tiegħek.
These usually disappear after a few weeks of taking your insulin.
Dawn normalment imorru wara ftit ġimgħat minn meta tibda tieħu l - insulina.
If they do not disappear, see your doctor.
Jekk ma jmorrux, kellem lit- tabib tiegħek.
Seek medical advice immediately: • if signs of allergy spread to other parts of the body, or • if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.
Fittex parir mediku immedjatament: • jekk is- sinjali ta ’ l- allerġija jinfirxu għal partijiet oħra ta ’ ġismek, jew • jekk f’ daqqa waħda ma tħossokx tajjeb u: tibda tegħreq tibda tħossok imdardar/ imdardra (tirremetti); ikollok diffikultà biex tieħu n- nifs; ikollok taħbit mgħaġġel tal- qalb; tħossok stordut/ a; tħossok li ġej xi ħass ħażin.
You may have a very rare serious allergic reaction to Actrapid or one of its ingredients (called a systemic allergic reaction).
82 Inti jista ’ jkollok reazzjoni allerġika rari ħafna u serja għal Actrapid jew għal xi wieħed mill - ingredjenti tiegħu (imsejħa reazzjoni allerġika sistemika).
See also warning in 2 Before you use Actrapid.
Ara wkoll it- twissija f’ 2 Qabel ma tuża Actrapid.
When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Meta tibda tieħu l- insulina, iż- żamma ta ’ l- ilma tista ’ tikkawżalek nefħa madwar l - għekiesi u ġogi oħra.
This soon disappears.
Normalment dan imur malajr.
78 Side effects reported very rarely (in less than 1 patient in 10,000)
Effetti sekondarji rrappurtati b’ mod rari ħafna (anqas minn pazjent 1 minn kull 10, 000):
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispiżjar tiegħek.
HOW TO STORE ACTRAPID
KIF TAĦŻEN ACTRAPID
Do not use Actrapid after the expiry date which is stated on the label and the carton.
Tużax Actrapid wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa tal- kartun.
The vials that are not being used are to be stored in a refrigerator (2°C - 8°C).
Il- kunjetti li ma jkunux qed jintużaw għandhom jinħażnu fi friġġ (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta ’ l- element li jkessaħ, u għandhom jinżammu fil- pakkett oriġinali.
The vials that are being used or about to be used are not to be kept in a refrigerator.
Il- kunjetti li jkunu qed jintużaw jew li waslu biex jintużaw, m’ għandhomx jinżammu fil- friġġ.
Always keep the vial in the outer carton when you’ re not using it in order to protect it from light.
Tista ’ ġġorrhom miegħek u żżommhom fit- temperatura ambjentali tal- kamra (mhux aktar minn 25ºC) sa perijodu ta ’ 4 gimgħat.. Dejjem żomm il- kunjett fil- kartuna ta ’ barra meta ma tkunx qed tużah sabiex tilqa ’ mid- dawl.
Actrapid must be protected from excessive heat and sunlight.
Actrapid għandu jkun protett minn sħana eċċessiva u mid- dawl tax- xemx.
Actrapid should not be disposed of via wastewater or household waste.
Actrapid m’ għandux jintrema ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Actrapid contains
X’ fih Actrapid
– The active substance is insulin human made by recombinant biotechnology.
– Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti.
– The other ingredients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.
– Is- sustanzi l- oħra huma zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid u ilma għall- injezzjonijiet.
What Actrapid looks like and contents of the pack The solution for injection comes as a clear, colourless, aqueous solution.
83 Id- Dehra ta ’ Actrapid u l- kontenuti tal- pakkett Is- soluzzjoni għall- injezzjoni tiġi bħala soluzzjoni akweja, ċara u bla kulur.
It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials.
Issibu f’ pakketti ta ’ 1 jew 5 kunjetti ta ’ 10 ml jew f’ pakkett multiplu ta ’ 5 x (1 x 10 ml) kunjetti.
79 PACKAGE LEAFLET:
84 FULJETT TA ’ TAGĦRIF:
Actrapid 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Actrapid ta ’ 100 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana (rDNA)
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
85 anaboliċi; sulfonamidi; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimetiċi; ormon tat- tkabbir, danazol; octreotide jew lanreotide.
80 Driving and using machines
Sewqan u tħaddim ta ’ magni
If you drive or use tools or machines: watch out for signs of a hypo.
Jekk issuq jew tuża għodda jew magni: oqgħod attent/ a għas- sinjali ta ’ ipo.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistgħu jiġu għal għarrieda u jistgħu jinkludu: għaraq kiesaħ; ġilda kiesħa u pallida; uġigħ ta ’ ras; taħbit mgħaġġel tal- qalb; tħossok imqalla ’; tħoss ġuħ kbir; tibdil temporanju fil- vista; ngħas; għeja u debbulizza mhux tas- soltu; nervożità jew rogħda; tħossok ansjuż/ a; tħossok konfuż/ a; diffikultà biex tikkonċentra.
82 If your blood sugar gets too high
Jekk il- livell taz- zokkor fid- demm tiegħek jitla ’ żżejjed
You may have a very rare serious allergic reaction to Actrapid or one of its ingredients (called a systemic allergic reaction).
88 Inti jista ’ jkollok reazzjoni allerġika rari ħafna u serja għal Actrapid jew għal xi wieħed mill - ingredjenti tiegħu (imsejħa reazzjoni allerġika sistemika).
83 Side effects reported very rarely (in less than 1 patient in 10,000)
Effetti sekondarji rrappurtati b’ mod rari ħafna (anqas minn pazjent 1 minn kull 10, 000):
Always keep the vial in the outer carton when you’ re not using it in order to protect it from light.
Tista ’ ġġorrhom miegħek u żżommhom fit- temperatura ambjentali tal- kamra (mhux aktar minn 25ºC) sa perijodu ta ’ 6 gimgħat.. Dejjem żomm il- kunjett fil- kartuna ta ’ barra meta ma tkunx qed tużah sabiex tilqa ’ mid- dawl.
It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials.
89 Id- Dehra ta ’ Actrapid u l- kontenuti tal- pakkett Is- soluzzjoni għall- injezzjoni tiġi bħala soluzzjoni akweja, ċara u bla kulur Issibu f’ pakketti ta ’ 1 jew 5 kunjetti ta ’ 10 ml jew f’ pakkett multiplu ta ’ 5 x (1 x 10 ml) kunjetti.
Not all packs may be marketed.
Mhux il- pakketti kollha jistgħu jkunu għal skop kummerċjali..
84 PACKAGE LEAFLET:
90 FULJETT TA ’ TAGĦRIF:
Actrapid Penfill 100 IU/ ml solution for injection in a cartridge Insulin human (rDNA)
Actrapid Penfill 100 UI/ ml soluzzjoni għall- injezzjoni fi skartoċċ Insulina umana
This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 8 hours.
Dan ifisser li jibda jbaxxilek il- livell taz- zokkor fid- demm madwar nofs siegħa wara li tieħdu, u l- effett idum għal madwar 8 sigħat.
Actrapid is often given in combination with longer-acting insulin products.
Actrapid ta ’ spiss jingħata flimkien ma ’ prodotti ta ’ l- insulina li jaħdmu aktar fit- tul.
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Oqgħod attent/ a għas- sinjali ta ’ l- allerġija f’ 5 Effetti sekondarji li jista ’ jkollu. ► Jekk tħoss li ġejja ipo (ipo hi taqsira għal reazzjoni ipogliċemika u hija ġabra ta ’ sintomi ta ’ livell baxx ta ’ zokkor fid- demm).
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
► Jekk għandek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - tirojde ► Jekk qed tixrob l- alkoħol: oqgħod attent/ a għas- sinjali ta ’ xi ipo u qatt m’ għandek tixrob l - alkoħol fuq stonku vojt ► Jekk tagħmel eżerċizzju fiżiku aktar mis- soltu jew jekk trid tibdel id- dieta normali tiegħek ► Jekk inti marid/ a: kompli ħu l- insulina tiegħek ► Jekk ser issiefer: li tivvjaġġa bejn żoni tal- ħin differenti, jista ’ jaffettwa l- ħtiġijiet tiegħek ta ’ l - insulina u l- ħin meta tieħu l- injezzjonijiet.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel jekk inti tieħu wkoll: prodotti mediċinali kontra d - dijabete li jittieħdu mill- ħalq; inibituri ta ’ monoamine oxidase (MAOI),), sustanzi li jibblukkaw ir - riċetturi beta, inibituri ta ’ l- enzima li tikkonverti l- angjotensin (ACE), acetylsalicylic acid; sterojdi anaboliċi; sulfonamidi; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimetiċi; ormon tat- tkabbir, danazol; octreotide jew lanreotide.
Pregnancy and breast-feeding
91 Tqala u treddigħ
85 Driving and using machines
Sewqan u tħaddim ta ’ magni
► Check the label to make sure it is the right type of insulin ► Always check the cartridge, including the rubber plunger (stopper).
► Iċċekkja t- tikketta biex tiżgura li hi t- tip korrett ta ’ insulina. ► Dejjem iċċekkja l- iskartoċċ, inkluż il- planġer tal- gomma (tapp).
See your delivery system manual for further instructions ► Disinfect the rubber membrane with a medicinal swab ► Always use a new needle for each injection to prevent contamination.
Ara l- manwal tas- sistema li biha tingħata l- insulina għal aktar struzzjonijiet ► Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali ► Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni
► In insulin infusion pumps ► If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk Penfill jew it- tagħmir li jkun fih l- Penfill jitwaqqa ’, jiġrilu l- ħsara jew jitgħaffeġ, hemm ir- riskju ta ’ ħruġ ta ’ insulina ► Jekk ma jkunx inħażen kif suppost jew kien iffriżat (ara 6 Kif taħżen Actrapid) ► Jekk ma jidhirx ċar bħall- ilma u bla kulur.
Do not refill Actrapid Penfill.
Timliex mill- ġdid Actrapid Penfill.
Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
L- iskartoċċi Penfill huma magħmula biex jintużaw ma ’ sistemi ta ’ l- għoti ta ’ l- insulina Novo Nordisk u mal- labar NovoFine.
If you are treated with Actrapid Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Actrapid Penfill u bi skartoċċ Penfill ta ’ insulina oħra, għandek tuża żewġ sistemi ta ’ - għoti ta ’ insulina, waħda għal kull tip ta ’ insulina.
Your insulin will work more quickly if you inject it around the waist.
L- insulina tiegħek taħdem aktar malajr jekk tinjetta madwar il- qadd
How to inject this insulin
92 Kif tinjetta din l- insulina
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual ► Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered ► After each injection be sure to remove and discard the needle and store Actrapid without the needle attached.
Uża teknika ta ’ l- injezzjoni li jkun tak parir dwarha t- tabib jew l- infermier/ a tad- dijabete tiegħek u li hi deskritta fil- manwal tas- sistema ta ’ l- għoti ta ’ l- insulina. ► Żomm il- labra taħt il- ġilda tiegħek għal mill- anqas 6 sekondi biex tiżgura li d- doża sħiħa tkun ingħatat ► Wara kull injezzjoni aċċerta ruħek li tneħħi u tarmi l- labra u aħżen Actrapid mingħajr ma l - labra tkun imwaħħla.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, il- likwidu jista ’ jnixxi ’ l barra li tista ’ tkun il- kawża ta ’ teħid ta ’ doża żbaljata.
These may be signs of a very serious condition called diabetic ketoacidosis.
93 Dawn jistgħu jkunu sinjali ta ’ kundizzjoni serja ħafna li tissejjaħ ketoaċidosi.
Like all medicines, Actrapid can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Actrapid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You may have a very rare serious allergic reaction to Actrapid or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni allerġika rari ħafna u serja għal Actrapid jew għal xi wieħed mill - ingredjenti tiegħu (imsejħa reazzjoni allerġika sistemika).
Side effects reported very rarely (in less than 1 patient in 10,000)
Effetti sekondarji rrappurtati b’ mod rari ħafna (anqas minn pazjent 1 minn kull 10, 000):
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
94 Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispiżjar tiegħek.
The Penfill that is not being used is to be stored in a refrigerator (2°C - 8°C).
Actrapid Penfill li ma jkunx qed jintuża għandu jinħażen fi friġġ (2°C - 8°C).
Keet the Penfill in the original package.
Tagħmilhomx fil- friża Żomm il- Penfill fil- pakkett oriġinali..
The Penfill that is being used or about to be used is not to be kept in a refrigerator.
Actrapid Penfill li jkun qed jintuża jew li ser jintuża, m’ għandux jinżamm fil- friġġ.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
Tista ’ ġġorru miegħek u żżommu fit- temperatura ambjentali tal- kamra (mhux aktar minn 30ºC) sa perjodu ta ’ 6 ġimgħat.
Always keep your cartridge in the outer carton when you’ re not using it in order to protect it from light.
Dejjem żomm l- iskartoċċ tiegħek fil- kartuna ta ’ barra meta ma tkunx qed tużah sabiex tilqa ’ mid - dawl.
88 Actrapid must be protected from excessive heat and sunlight.
Actrapid għandu jkun protett minn sħana eċċessiva u mid- dawl tax- xemx.
1 cartridge contains 3 ml equivalent to 300 IU
Skartoċċ fih 3 ml ekwivalenti għal 300 UI.
What Actrapid looks like and contents of the pack The solution for injection comes as a clear, colourless, aqueous solution.
Id- dehra ta ’ Actrapid u d- daqs tal- pakkett Is- soluzzjoni għall- injezzjoni tiġi bħala soluzzjoni akweja ċara u bla kulur.
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
Issibu f’ pakketti ta ’ 1, 5 jew 10 skartoċċi ta ’ 3 ml.
Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id -- Danimarka
89 PACKAGE LEAFLET:
95 FULJETT TA ’ TAGĦRIF:
Actrapid NovoLet 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
Insulina umana (rDNA)
1.
Din in- naħa tal- fuljett 1.
What Actrapid is and what it is used for 2.
X’ inhu Actrapid u għalxiex jintuża 2.
Before you use Actrapid 3.
Qabel ma tuża Actrapid 3.
How to use Actrapid 4.
Kif għandek tuża Actrapid 4.
Possible side effects 6.
Effetti sekondarji li jista ’ jkollu 6.
How to store Actrapid 7.
Kif taħżen Actrapid 7.
Using other medicines
96 Meta tuża mediċini oħra
90 Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel jekk inti tieħu wkoll: prodotti mediċinali kontra d - dijabete li jittieħdu mill- ħalq; inibituri ta ’ monoamine oxidase (MAOI),), sustanzi li jibblukkaw ir - riċetturi beta, inibituri ta ’ l- enzima li tikkonverti l- angjotensin (ACE), acetylsalicylic acid; sterojdi anaboliċi; sulfonamidi; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimetiċi; ormon tat- tkabbir, danazol; octreotide jew lanreotide.