qanastek/EMEA-V3 huggingface dataset:
Actraphane 40 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Actraphane 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (40% as soluble insulin and 60% as isophane insulin).
1 ml ta 'suspensjoni fih 100 UI (3. 5 mg) ta' insulina umana, (rDNA) (40% bħala insulina li tinħall u 60% bħala insulina isophane).
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Actraphane 40 Penfill is for use by one person only
Actraphane 40 Penfill hu għall- użu minn persuna waħda biss
128 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
139 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 40 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
129 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
140 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 50 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Actraphane 50 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (50% as soluble insulin and 50% as isophane insulin).
1 ml ta 'suspensjoni fih 100 UI (3. 5 mg) ta' insulina umana, (rDNA) (50% bħala insulina li tinħall u 50% bħala insulina isophane).
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Actraphane 50 Penfill is for use by one person only
Actraphane 50 Penfill hu għall- użu minn persuna waħda biss
131 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
142 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 50 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 50 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
143 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 10 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 10 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Suspension for injection 5 x 3 ml 10 x 3 ml
Suspensjoni għall- injezzjoni 5 x 3 ml 10 x 3 ml
Subcutaneous use Actraphane 10 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Actraphane 10 NovoLet is for use by one person only
Actraphane 10 NovoLet hu għall- użu minn 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
Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża Tagħmlux fid- dawl Waqt l- użu: tagħmlux fil- friġġ jew taħżen f’ temperatura ’ l fuq minn 30°C
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
145 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NOVOLET LABEL
TIKKETTA TA ’ NOVOLET
Actraphane 10 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 10 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
135 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
146 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 20 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 20 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Actraphane 20 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Actraphane 20 NovoLet is for use by one person only
Actraphane 20 NovoLet hu għall- użu minn persuna waħda biss
137 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
148 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 20 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 20 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
138 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
149 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 30 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Actraphane 30 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Actraphane 30 NovoLet is for use by one person only
Actraphane 30 NovoLet hu għall- użu minn persuna waħda biss
139 9.
150 9.
140 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
151 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 30 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 30 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu taħt il- ġilda
141 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
152 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 40 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 40 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Actraphane 40 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Actraphane 40 NovoLet is for use by one person only
Actraphane 40 NovoLet hu għall- użu minn persuna waħda biss
143 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
154 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 40 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 40 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
144 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
155 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 50 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 50 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Actraphane 50 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Actraphane 50 NovoLet is for use by one person only
Actraphane 50 NovoLet hu għall- użu minn persuna waħda biss
145 9.
156 9.
146 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
157 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 50 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 50 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
147 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
158 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 30 InnoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Actraphane 30 InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Actraphane 30 InnoLet is for use by one person only
Actraphane 30 InnoLet hu għall- użu minn persuna waħda biss
148 9.
159 9.
149 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
160 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
INNOLET LABEL
TIKKETTA TA ’ INNOLET
Actraphane 30 InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 30 InnoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
150 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
161 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Actraphane 30 FlexPen 100 UI/ ml suspensjoni 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 Needles are not included Resuspend according to instructions Read the package leaflet before use Actraphane 30 FlexPen is for use by one person only
Actraphane 30 FlexPen hi għall- użu minn persuna waħda biss
151 8.
162 8.
152 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
163 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
FLEXPEN LABEL
TIKKETTA TAL- FLEXPEN
Actraphane 30 FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 30 FlexPen 100 UI/ m suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
153 B.
164 B.
154 PACKAGE LEAFLET:
165 FULJETT TA 'TAGĦRIF:
Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tuża l- insulina tiegħek. – Żomm dan il- fuljett.
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, jekk jogħġbok 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 mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib lill- infermier/ a tad- dijabete jew lill - ispiżjar tiegħek.
WHAT ACTRAPHANE IS AND WHAT IT IS USED FOR
X’ INHU ACTRAPHANE U GĦALXIEX JINTUŻA
Actraphane is human insulin to treat diabetes.
Actraphane hu insulina umana għall- kura tad- dijabete.
Actraphane is a mixture of fast-acting insulin and long-acting insulin.
Actraphane hu taħlita ta 'insulina li taħdem malajr u insulina li taħdem fit- tul.
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 24 hours.
Dan ifisser li jibda jbaxxilek il- livell taz- zokkor fid- demm madwar nofs siegħa wara li tieħdu, u l- effett idum għal madwar 24 siegħa.
BEFORE YOU USE ACTRAPHANE
QABEL MA TUŻA ACTRAPHANE
Do not use Actraphane
Tużax Actraphane
► If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
► Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal dan il- prodott ta ’ l- insulina, għal metacresol jew sustanzi oħra (ara 7 Aktar tagħrif).
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 għas- sinjali ta ’ l- allerġija f' 5 Effetti sekondarji li jista ’ jkollu ► Jekk tħoss li ġejja ipo (ipo hi taqsira ta ’ reazzjoni ipoglikemika u hija ġabra ta ’ sintomi li jindikaw livell baxx ta 'zokkor fid- demm).
See 4 What to do in an emergency for more about hypos.
Ara 4 X’ għandek tagħmel f’ emerġenza, għal aktar informazzjoni dwar l- ipos.
Take special care with Actraphane
Oqgħod attent ħafna b’ Actraphane
► 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 għall - insulina u l- ħin meta tieħu l- injezzjonijiet.
Using other medicines
Meta tuża mediċini ohra
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 affetwat minn ħafna mediċini, u dawn jistgħu jinfluwenzaw id- doża tiegħek ta ’ l- insulina.
Listed below are the most common medicines which may affect your insulin treatment.
Hawn taħt hawn elenkati l- aktar mediċini komuni li jistgħu jaffettwaw il- kura tiegħek bl- insulina.
Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
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: inibituri ta ’ monamine oxidase (MAOI); beta- blokkanti; inibituri ta ’ l- enzima li tikkonverti l- anġjotensin (ACE- inhibitors); acetylsalicylic acid; sterojdi anaboliċi; sulphonamides; kontraċettivi orali; tijażidi; glukokortikojdi; terapija bl- ormoni tat- tirojdi; beta- simpatomimetiċi; ormon tat- tkabbir; danazol; octreotide jew lanreotide.
Pregnancy and breast-feeding
166 Tqala u treddigħ
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
Jekk inti tqila, qed tippjana li toħroġ tqila, jew qed tredda ’: jekk jogħġbok ikkuntattja lit- tabib tiegħek għal parir.
155 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 għal sinjali ta ’ ipo.
Your ability to concentrate or to react will be less during a hypo.
Il- ħila tiegħek li tikkonċentra jew li tirreaġixxi ser tkun anqas waqt ipo.
Never drive or use machinery if you feel a hypo coming on.
Qatt issuq jew tuża makkinarju jekk tħoss li ġej 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 wara kollox għandekx issuq jew tuża magni jew le, jekk ikollok ħafna ipos jew jekk issibha bi tqila biex tagħraf l- ipos.
HOW TO USE ACTRAPHANE
KIF GĦANDEK TUŻA ACTRAPHANE
Talk about your insulin needs with your doctor and diabetes nurse.
Tkellem dwar il- ħtiġijiet tiegħek ta ’ l- insulina mat- tabib u ma ’ l- infermier/ a tad- dijabete tiegħek.
Follow their advice carefully.
Segwi l- parir tagħhom bl- attenzjoni.
This leaflet is a general guide.
Dan il- fuljett hu 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 biddillek l- insulina minn tip jew marka ta ’ insulina għal oħra, jista 'jkun li d- doża tiegħek tiġi aġġustata mit- tabib tiegħek.
Eat a meal or snack containing carbohydrates within 30 minutes of the injection.
Kul ikla jew ikla ħafifa li jkun fiha l- karboidrati fi żmien 30 minuta mill- injezzjoni.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li tkejjel il- glukosju fid- demm tiegħek regolarment.
Before using Actraphane
Qabel tuża Actraphane
► 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 tiżgura li hija t- tip korrett ta ’ insulina ► Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali
► In insulin infusion pumps ► If the protective cap is loose or missing.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk l- għatu prottetiv ma jkunx issikkat jew ikun nieqes.
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 Actraphane) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
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 Actraphane) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
How to use this insulin
Kif għandek tuża din l- insulina
Actraphane is for injection under the skin (subcutaneously).
Actraphane hu magħmul biex ikun injettat taħt il- ġilda.
Never inject your insulin directly into a vein or muscle.
Qatt m’ għandek tinjetta l- insulina tiegħek direttament ġo vina jew ġo muskolu.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Dejjem ibdel iż- żona tal- ġisem 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 in- naħa ta ’ fuq ta ’ dirgħajk.
Your insulin will work more quickly if you inject it around the waist.
L- insulina tiegħek taħdem aktar malajr jekk tinjetta madwar il- qadd.
Actraphane vials are for use with insulin syringes with the corresponding unit scale.
Il- kunjetti ta 'Actraphane huma għall- użu ma' siringi ta ’ l- insulina bi iskala korrispondenti ta 'unitajiet.
Just before injecting this insulin
Eżatt qabel ma tinjetta din l- insulina
Roll the vial between your hands until the liquid is uniformly white and cloudy.
Irrombla l- kunjett bejn idejk sakemm il- likwidu jkun abjad u opak b' mod uniformi.
Draw air into the syringe, in the same amount as the dose of insulin you need 3.
Iġbed l- arja ġos- siringa, fl- istess ammont bħad- doża ta 'l- insulina li teħtieġ 3.
Inject the air into the vial: push the needle through the rubber stopper and press the plunger 4.
Injetta l- arja ġol- kunjett: imbotta l- labra minn ġot- tapp tal- gomma u agħfas il- planġer 4.
Turn the vial and syringe upside down 5.
Dawwar il- kunjett u s- siringa ta 'taħt fuq 5.
Draw the right dose of insulin into the syringe 6.
Iġbed ġos- siringa d- doża korretta ta 'insulina 6.
Pull the needle out of the vial 7.
Iġbed il- labra ’ l barra mill- kunjett 7.
Make sure there is no air left in the syringe: point the needle upwards and push the air out 8.
Aċċerta ruħek li ma jkunx baqa 'arja fis- siringa: ipponta l- labra ’ l fuq u imbotta l- arja ’ l barra 8.
Check you have the right dose 9.
Iċċekkja li għandek id- doża korretta.
Inject straight away.
Injetta immedjatament.
Inject the insulin
Kif tinjetta din l- insulina
► Inject the insulin under the skin.
► Injetta l- insulina taħt il- ġilda.
156 ► 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.
WHAT TO DO IN AN EMERGENCY
X’ GĦANDEK TAGĦMEL F’ EMERĠENZA
If you get a hypo
Jekk ikollok ipo
A hypo means your blood sugar level is too low.
Ipo jfisser 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 mhux tas- soltu u dgħjufija; 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 pilloli tal- glukosju jew ikla ħafifa li fiha ħafna zokkor (ħelu, gallettini, meraq tal- frott), u mbagħad strieħ.
Don’ t take any insulin if you feel a hypo coming on.
Tiħux insulina jekk tħoss li ġejja ipo.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Żomm fuqek pilloli tal- glukosju, ħelu, gallettini jew meraq tal- frott, fil- każ li jkollok bżonnhom.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Għid lill- qraba, il- ħbieb u l- kollegi tiegħek li jekk tintilef minn sensik (iħossok ħażin), huma għandhom: idawruk fuq ġenbek u jġibu għajnuna medika immedjatament.
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.
The amount or timing of insulin, food or exercise may need to be adjusted.
L - ammont jew il- ħin li fih tieħu l- insulina, l- ikel jew l- eżerċizzju fiżiku, jista ’ jkun li jkollhom bżonn li jiġu aġġustati.
Using glucagon
Kif tuża l- 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 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 l- glucagon, ser ikollok bżonn il- glukosju jew ikla ħafifa li jkun fiha z - zokkor malli terġa ’ tiġi f’ sensik.
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Jekk ma tirrispondix għall- kura bi glucagon, ser ikollok bżonn ta ’ kura fi sptar.
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 tal- glucagon; ikollok bżonn issib ir- raġuni għall- ipo tiegħek biex tevita li jkollok aktar minnhom.
Causes of a hypo
Il- kawżi ta 'ipo
You get a hypo if your blood sugar gets too low.
Ikollok ipo jekk il- livell taz- zokkor fid- demm tiegħek jitbaxxa żżejjed.
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 eżercizzju mis- soltu.
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 tissejjaħ 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 imqalla ’ (nawsja jew rimettar); tħossok bi ngħas jew għajjien/ a; fwawar, ġilda xotta; ħalq xott u nifs li jkollu riħa ta ’ frott (acetone).
If you get any of these signs and test your blood sugar level; test your urine for ketones if you can.
Jekk ikollok xi wieħed minn dawn is- sinjali, iċċekkja l- livell taz- zokkor fid- demm tiegħek u jekk tista ’ iċċekkja l- awrina tiegħek għall- ketoni.
Then seek medical advice straight away.
Imbagħad fittex parir mediku immedjatament.
These may be signs of a very serious condition called diabetic ketoacidosis.
Dawn jistgħu jkunu sinjali ta ’ kundizzjoni serja ħafna li tissejjaħ ketoaċidosi.
If you don’ t treat it, this could lead to diabetic coma and death.
Jekk ma tikkurahiex, din tista ’ twassal għal koma dijabetika u għal mewt.
Causes of hyperglycaemia
168 Il- kawżi ta ’ ipergliċemija
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever
• Tkun insejt tieħu l- insulina tiegħek • Li ripetutament tieħu anqas insulina milli għandek bżonn • Ikollok infezzjoni jew deni • Tiekol aktar mis- soltu • Tagħmel eżerċizzju fiżiku anqas mis- soltu.
Like all medicines, Actraphane can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Actraphane jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Actraphane may cause hypoglycaemia (low blood sugar).
Actraphane jista 'jikkawża l- ipogliċemija (livell baxx ta' zokkor fid- demm).
See the advice in 4 What to do in an emergency.
Ara l- pariri f’ 4 X’ għandek tagħmel f’ emerġenza.
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)
Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ 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 ta ’ spiss wisq fl - istess sit, it- tessut tax- xaħam taħt il- ġilda f' dan is- sit jista 'jirqaq (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 il- kambjament 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 li- fis- sit ta ’ l- injezzjoni l- ġilda qiegħda titħaffer jew qiegħda teħxien, għid lit- tabib tiegħek jew lill- infermier/ a tad- dijabete, għax dawn ir- reazzjonijiet jistgħu jsiru aktar serji, jew jekk l - injezzjoni ssir f’ sit bħal dan jistgħu jbiddlu l- assorbiment ta ’ l- insulina tiegħek.
Signs of allergy.
Sinjali ta ’ allerġija.
Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions).
Jistgħu jseħħu reazzjonijiet (ħmura, nefħa, ħakk) fis- sit ta ’ l- injezzjoni (reazzjonijiet allerġiċi lokali).
These usually disappear after a few weeks of taking your insulin.
Dawn normalment jgħibu wara ftit ġimgħat minn meta tibda tieħu l - insulina.
If they do not disappear, see your doctor.
Jekk ma jgħibux, 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/ tajba 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 Actraphane or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni allerġika rari ħafna u serja għal Actraphane jew għal xi wieħed mill - ingredjenti tiegħu (imsejħa reazzjoni allerġika sistemika).
See also warning in 2 Before you use Actraphane.
Ara wkoll it- twissija f’ 2 Qabel ma tuża Actraphane.
Diabetic retinopathy (eye background changes).
Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
Jekk għandek retinopatija dijabetika u l- livelli tal- glukosju fid- demm tiegħek jitjiebu b’ mod malajr ħafna, ir- retinopatija tista ’ tmur għall- agħar.
Ask your doctor about this.
Staqsi lit- tabib tiegħek dwar dan.
Swollen joints.
Ġogi minfuħin.
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 fil- ġisem tista' tikkawża nefħa madwar l- għekiesi u ġogi oħrajn.
This soon disappears.
Din malajr tmur.
Painful neuropathy (nerve related pain).
Newropatija bl- uġigħ (uġigħ li ġej min- nervaturi).
If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain.
Jekk il- livelli tal- glukosju fid- demm tiegħek jitjiebu b’ mod malajr ħafna, dan jista ’ jikkawża ħruq, tnemnim jew uġigħ qisu ta ’ xokk elettriku.
This is called acute painful neuropathy and it usually disappears.
Din il- kundizzjoni hi msejħa newropatija akuta bl- uġigħ, u normalment tispiċċa fix- xejn.
If it does not disappear, see your doctor.
Jekk tibqa ’ hemm kellem lit- tabib tiegħek.
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)
Vision problems.
Problemi tal- vista.
When you first start your treatment, it may disturb your vision, but the reaction usually disappears.
Għall- ewwel li tibda l- kura bl- insulina, dan jista ’ jikkawża disturb fil- vista tiegħek, iżda din ir- reazzjoni iżda din ir- reazzjoni normalment tgħaddi waħidha.
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 mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispiżjar tiegħek.
HOW TO STORE ACTRAPHANE
KIF TAĦŻEN ACTRAPHANE
Do not use Actraphane after the expiry date which is stated on the label and the carton.
Tużax Actraphane wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
Do not freeze.
Il- kunjetti li ma jkunux qed jintużaw għandhom jinħażnu fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ Tagħmilhomx fil- friża.
Keep the vials in the original package.
Żomm il- kunjetti 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.
After removing the vial from the refrigerator it is recommended to let it reach room temperature before resuspending
Wara li tneħħi l- kunjett mill- friġġ, hu rakkomandat li tħallih jilħaq it- temperatura tal- kamra qabel ma 'terġa ’ tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
See 3 How to use Actraphane.
Ara 3 Kif għandek tuża Actraphane.
You can carry them with you and keep them at room temperature (not above 25°C) for up to 6 weeks.
Tista ’ ġġorrhom miegħek u żżommhom fit- temperatura tal- kamra (mhux aktar minn 25°C) sa perjodu ta ’ 6 gimgħat.
Always keep the vial in the outer carton when you’ re not using it in order to protect it from light.
Dejjem żomm il- kunjett fil- kartuna ta ’ barra meta ma tkunx qed tużah sabiex tilqa 'mid- dawl.
Actraphane must be protected from excessive heat and sunlight.
Actraphane għandu jkun protett minn sħana eċċessiva u mid- dawl tax- xemx.
Actraphane should not be disposed of via wastewater or household waste.
Actraphane m’ għandux jintrema ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l - ambjent.
What Actraphane 30 contains – The active substance is insulin human made by recombinant biotechnology (30% as soluble insulin and 70% as isophane insulin).
X' fih Actraphane 30 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (30% bħala insulina li tinħall u 70% bħala insulina isophane).
1 ml contains 40 IU of insulin human.
Millilitru fih 40 UI ta ’ insulina umana.
1 vial contains 10 ml equivalent to 400 IU
Kunjett fih 10 ml, ekwivalenti għal 400 UI
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
– Is- sustanzi l- oħra huma zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate u ilma għall- injezzjonijiet.
What Actraphane looks like and contents of the pack The suspension for injection comes as a cloudy, white, aqueous suspension.
Id- dehra ta 'Actraphane u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja, bajda u opaka Issibu f' pakketti ta ’ 1 jew 5 kunjetti ta' 10 ml jew f' pakkett multiplu ta '5 x (1 x 10 ml) kunjetti.
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. not all packs may be marketed.
Mhux il- pakketti kollha jistgħu jkunu għall- skop kummerċjali..
Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar fi
159 PACKAGE LEAFLET:
170 FULJETT TA 'TAGĦRIF:
Pregnancy and breast-feeding
171 Tqala u treddigħ
160 Driving and using machines
Sewqan u tħaddim ta ’ magni
161 ► 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.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Għid lill- qraba, il- ħbieb u l- kollegi tiegħek li jekk iħossok ħażin (tintilef minn sensik), huma għandhom: idawruk fuq ġenbek u jġibu għajnuna medika immedjatament.
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, iċċekkja l- livell taz- zokkor fid- demm tiegħek u jekk tista ’ iċċekkja l- awrina tiegħek għall- ketoni.
Causes of hyperglycaemia
173 Il- kawżi ta ’ ipergliċemija
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/ tajba 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.
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)
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta 'dak ix- xahar.
163 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.
After removing the vial from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tneħħi l- kunjett mill- friġġ, hu rakkomandat li tħallih jilħaq it- temperatura tal- kamra qabel ma 'terġa ’ tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
1 vial contains 10 ml equivalent to 1000 IU
Kunjett fih 10 ml, ekwivalenti għal 1000 UI
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.
Id- dehra ta 'Actraphane u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja, bajda u opaka 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 għall- skop kummerċjali.
164 PACKAGE LEAFLET:
175 FULJETT TA 'TAGĦRIF:
Actraphane 10 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Actraphane 10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
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 għas- sinjali ta ’ l- allerġija f' 5 Effetti sekondarji li jista ’ jkollu ► Jekk tħoss li ġejja ipo (ipo hi taqsira ta ’ reazzjoni ipogliċemika u hija ġabra ta ’ sintomi li jindikaw livell baxx ta 'zokkor fid- demm).
Pregnancy and breast-feeding
176 Tqala u treddigħ
165 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 hija t- tip korrett ta ’ insulina. ► Dejjem iċċekkja l- iskartoċċ, inkluż il- planġer (tapp) tal- gomma.
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
Tużahx jekk tkun tidher xi ħsara jew jekk ikun hemm xi spazju bejn il- planġer tal- gomma u l- istrixxa bajda tat- tikketta.
Take it back to your supplier.
Ħudu lura mingħand min xtrajtu.
See your delivery system manual for further instructions ► Disinfect the rubber membrane with a medicinal swab ► Always use a new needle for each imjection to prevent contamination.
Ara l- manwal tas- sistema tal- forniment tiegħek 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 Actraphane) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk Penfill jew it- tagħmir li jkun fih Penfill jitwaqqa ’, jiġrilu l- ħsara jew jitgħaffeġ, hemm ir- riskju ta ’ tnixxija ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Actraphane) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
Do not refill Actraphane 10 Penfill.
Timliex mill- ġdid Actraphane 10 Penfill.
Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
L- iskartoċċi Penfill huma maħsuba biex jintużaw mas- sistemi tal- forniment ta ’ l- insulina Novo Nordisk u mal- labar NovoFine.
If you are treated with Actraphane 10 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’ Actraphane 10 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.
Resuspending the insulin
Kif tagħmel suspensjoni ta 'l- insulina mill- ġdid
Resuspending is easier when the insulin has reached room temperature.
Is- suspensjoni mill- ġdid tkun eħfef meta l- insulina tkun laħqet it- temperatura tal- kamra.
Before you put the Penfill cartridge into the insulin delivery system, move it up and down between positions a and b and back (see the picture) so that the glass ball moves from one end of the cartridge to the other at least 20 times.
Qabel ma tqiegħed l- iskartoċċ Penfill ġos- sistema li biha tingħata l- insulina, ċaqalqu ’ l fuq u ’ l isfel bejn pożizzjonijiet a u b u lura (ara l- istampa) biex b’ hekk il- boċċa tal- ħġieġ tiċċaqlaq minn tarf għall - ieħor ta ’ l- iskartoċċ għal mill- anqas 20 darba.
Repeat this movement at least 10 times before each injection.
Irrepeti dan il- moviment mill- anqas 10 darbiet qabel kull injezzjoni.
The movement must always be repeated until the liquid appears uniformly white and cloudy.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi.
Complete the other stages of injection without delay.
Wettaq l- istadji l- oħrajn ta ’ injezzjoni mingħajr telf ta ’ żmien
166 Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
177 Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tagħmel suspensjoni mill- ġdid b’ mod uniformi.
If there are less than 12 units left, use a new one.
Jekk ikun baqa ’ anqas minn 12- il unità, uża wieħed ġdid.
How to inject this insulin
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 Actraphane without the needle attached.
Uża t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l - infermier/ a tad- dijabete tiegħek u li hi deskritta fil- manwal tiegħek tas- sistema tal- forniment. ► 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 taħżen Actraphane mingħajr ma l - labra tkun imwaħħla.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, il- likwidu jista ’ jnixxi li tista ’ tkun il- kawża ta ’ teħid ta ’ doża żbaljata.
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 mgħoti 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 l- glucagon, ser ikollok bżonn il- glukosju jew ikla ħafifa li jkun fiha z- zokkor malli terġa ’ tiġi f’ sensik.
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Jekk ma tirrispondix għall- kura bi glucagon, ser ikollok bżonn ta ’
167 If your blood sugar gets too high
Jekk il- livell taz- zokkor fid- demm tiegħek jitla ’ żżejjed
Causes of hyperglycaemia
Il- kawżi ta ’ ipergliċemija
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
• Tkun insejt tieħu l- insulina tiegħek • Li ripetutament tieħu anqas insulina milli għandek bżonn • Ikollok infezzjoni jew deni • Tiekol aktar mis- soltu • Tagħmel eżerċizzju fiżiku anqas mis- soltu.
Diabetic retinopathy (eye background changes).
179 Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
168 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 mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispiżjar tiegħek.
Do not freeze.
Il- Penfill li ma jkunx qed jintuża għandhu jinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ Tagħmilhomx fil- friża.
Keep the Penfill in the original package.
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.
Il- Penfill li jkun qed jintuża jew li wasel biex jintuża, m' għandux jinżamm fil- friġġ.
After removing the Penfill from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Wara li tneħħi l - Penfill mill- friġġ, hu rakkomandat li tħallih jilħaq it- temperatura tal- kamra qabel ma 'terġa ’ tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
Tista ’ ġġorrhom miegħek u żżommhom fit- temperatura tal- kamra (mhux aktar minn 25°C) sa perjodu ta ’ 6 gimgħat.
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.
What Actraphane 10 contains – The active substance is insulin human made by recombinant biotechnology (10% as soluble insulin and 90% as isophane insulin).
X' fih Actraphane 10 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (10% bħala insulina li tinħall u 90% bħala insulina isophane).
1 cartridge contains 3 ml equivalent to 300 IU
Skartoċċ fih 3 ml ekwivalenti għal 300 UI
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
180 Id- dehra ta 'Actraphane u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni opaka, bajda u akweja Issibu f’ pakketti ta ’ 1, 5 jew 10 skrataċ ta ’ 3 ml.
Not all packs may be marketed.
Mhux il- pakketti kollha jistgħu jkunu għal skop kummerċjali.
169 PACKAGE LEAFLET:
181 FULJETT TA 'TAGĦRIF:
Pregnancy and breast-feeding
182 Tqala u treddigħ
170 Driving and using machines
Sewqan u tħaddim ta ’ magni
See your delivery system manual for further instructions ► Disinfect the rubber membrane with a medicinal swab ► Always use a needle for each injection to prevent contamination
Ara l- manwal tas- sistema tal- forniment tiegħek għal aktar struzzjonijiet. ► Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali. ► Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni.
Do not refill Actraphane 20 Penfill.
Timliex mill- ġdid Actraphane 20 Penfill.
If you are treated with Actraphane 20 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’ Actraphane 20 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.