qanastek/EMEA-V3 huggingface dataset:
Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.
482 Tużax s- SoloStar jekk hi bil- ħsara jew mhix qed taħdem sew, din għandha tintrema u SoloStar ġdida tintuża minflok.
483 Mistakes in dosage
Żbalji fid- dożaġġ
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
483 Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
484 If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not use Insuman Rapid after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insuman Rapid wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna.
Packs of 3, 4, 5, 6, 9 and 10 pens of 3 ml are available.
Insuman Rapid huwa fornut f’ pinen mimlija għal- lest, SoloStar li fihom 3 ml ta ’ soluzzjoni (300 IU). Huwa disponibbli f’ pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen ta ’ 3 ml.
485 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ireland sanofi-aventis Ireland Ltd.
485 Ireland sanofi- aventis Ireland Ltd.
Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
486 in- nifs mgħaġġel u fil- fond, ngħas u anki telf mis- sensi jistgħu jkunu sinjali ta ’ kundizzjoni serja (kitoaċidożi) li tkun ikkaġunata minn nuqqas ta ’ insulina.
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self -control, inability to look after yourself, convulsions, loss of consciousness.
Ezempji ta ’ sintomi li jindikaw livell baxx taz- zokkor fil- moħħ:: uġigħ ta ’ ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl- irqad, nuqqas ta ’ kwiet, komportament aggressiv, nuqqas ta ’ attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid- diskors, (xi drabi it- telf komplet tad- diskors), indeboliment tal- vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir- reġjun tal- ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t- telf mis- sensi.
488 Tell your relatives, friends and close colleagues the following:
Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
489 Insuman Rapid solution for injection in a pre-filled pen.
Insuman Rapid, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
If you have any questions about SoloStar or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.
488 Jekk għandek xi diffikultajiet dwar l- użu ta ’ SoloStar jew id- dijabete tiegħek, saqsi lill- professjonist tiegħek fil- qasam tas- saħħa jew ċempel fuq in- numru lokali ta ’ Sanofi- Aventis, li ssib fuq il- faċċata ta ’ dan il- fuljett.
Check the insulin
1 Tiċċekkja l- insulina
Insuman SoloStar is white with a colour on the injection button.
L - Insuman SoloStar hija ta ’ kulur abjad b’ kulur fuq il- buttun ta ’ l- injezzjoni.
The injection button colour will vary based on the formulation of Insuman insulin used.
Il- kulur tal- buttun ta ’ l - injezzjoni jista ’ jvarja skond il- formulazzjoni tal- insulina Insuman.
490 C.
Ċ.
If you are using a suspension insulin (Insuman Basal or Insuman mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
Iċċekkja d- dehera ta ’ l- insulina tiegħek. • Jekk qed tuża insulina ċara, (Insuman Rapid) tużax din il- pinna jekk l- insulina hija mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insuman Basal jew taħlit ta ’ Insuman) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
Turn the pen gently to avoid foaming in the cartridge.
Il - pinna għandha tiġi mdawwra bilmod biex tevita r- ragħwa fl- iskartoċċ.
After mixing check the appearance of your insulin.
489 Iċċekkja d- dehera ta ’ l- insulina tiegħek wara li tħallat.
Attach the needle
2 Twaħħal il- labra
Perform a safety test
3 Tagħmel test ta ’ sigurtà
E.
490 E.
492 • Do not push the injection button while turning, as insulin will come out.
• Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
Inject the dose
Pass Nru. 5 Tinjetta d- doża
C.
491 Ċ.
493 Storage Instructions
Struzzjonijiet dwar il- ħażna
Do not soak, wash or lubricate the pen as this may damage it.
492 Ixxarrabx, taħsilx u anqas m’ għandek tillubrika l- pinna għax dawn jistgħu jagħmlulha ħsara.
494 PACKAGE LEAFLET:
493 FULJETT TA ’ TAGĦRIF:
Insuman Basal 100 IU/ml suspension for injection in a vial Insulin human
Insuman Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insuman Basal is and what it is used for 2.
X’ inhu Insuman Basal u għalxiex jintuża 2.
Before you use Insuman Basal 3.
Qabel ma tuża Insuman Basal 3.
How to use Insuman Basal 4.
Kif għandek tuża Insuman Basal 4.
How to store Insuman Basal 6.
Kif taħżen Insuman Basal 6.
WHAT INSUMAN BASAL IS AND WHAT IT IS USED FOR
X’ INHU INSUMAN BASAL U GĦALXIEX JINTUŻA
Insuman Basal is a fluid (suspension) for injection under the skin.
Insuman Basal huwa likwidu (suspensjoni) għall- injezzjoni taħt il- ġilda.
The insulin contained in Insuman Basal is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li tinsab f ’ Insuman Basal, hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina tal - ġisem stess.
Insuman Basal is an insulin preparation with a gradual onset and long duration of action.
Insuman Basal hija preparat ta ’ l- insulina li tibda taħdem bil- mod u ddum taħdem għal żmien twil.
The insulin is present as tiny crystals of insulin protamine.
L - insulina tikkonsisti f’ kristalli ċkejknin ta ’ l- insulina protamine.
Insuman Basal is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Basal hija użata biex tbaxxi l- livell għoli taz- zokkor fid- demm tal- pazjenti li qed ibatu minn diabetes mellitus.
BEFORE YOU USE INSUMAN BASAL
QABEL MA TUŻA INSUMAN BASAL
Do not use Insuman Basal
Tużax Insuman Basal:
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Basal.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina jew għal xi sustanzi oħra ta ’ Insuman Basal.
Do not inject Insuman Basal into a vein (blood vessel).
Tinjettax Insuman Basal fil- vina (sistema vaskulari).
Do not use it in insulin pumps or other infusion pumps - special insulin preparations are available for use in such devices.
Tużahiex fil- pompi għall- insulina jew pompi oħra għal- infużjoni – hemm preparazzjonijiet apposta t’ insulina disponibbli għall- użu ma ’ dan l - apparat.
Take special care with Insuman Basal
Oqgħod attent ħafna b ’ Insuman Basal
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Segwi sew l- istruzzjonijiet fuq id- dożaġġ, il- moniteraġġ (permezz ta ’ analiżi tad- demm u ta ’ l- awrina), id- dieta, u l- eżerċizju fiżiku (xogħol fiżiku u eżerċizju), kif diskuss mat- tabib tiegħek.
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
494 Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
495 Travel
Safar
Using Insuman Basal with food and drink
Meta tuża Insuman Basal ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insuman Basal in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insuman Basal waqt it- tqala.
Important information about some of the ingredients of Insuman Basal
496 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Basal
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium - free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ nieqes minn sodium ’.
HOW TO USE INSUMAN BASAL
KIF GĦANDEK TUŻA INSUMAN BASAL
- determine how much Insuman Basal per day you will need,
- jikkalkula kemm għandek bżonn tieħu Insuman Basal kuljum,
- tell you when you may need to inject a higher or lower dose of Insuman Basal.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Basal,
497 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Basal is injected under the skin 45 to 60 minutes before a meal.
Insuman Basal huwa injettat taħt il- ġilda 45 sa 60 minuta qabel ikla.
Do NOT inject Insuman Basal into a vein.
TINJETTAX Insuman Basal fil- vina.
Insuman Basal contains 100 IU insulin per ml.
Insuman Basal fih 100 IU insulina kull millilitru.
Only injection syringes designed for this insulin concentration (100 IU per ml) must be used.
Għandhom jintużaw biss dawk is- siringi għall - injezzjoni li huma magħmulin għall- qawwa ta ’ din l- insulina (100 IU kull ml).
The injection syringes must not contain any other medicines or traces of medicines (such as traces of heparin).
Is- siringi ta ’ l - injezzjoni m’ għandhomx ikollhom ebda mediċini oħrajn jew xi traċċi tagħhom (bħal traċċi ta ’ eparina).
Before the first withdrawal of insulin you must remove the safety tear-off lid on the vial.
Qabel ittella ’ l- ewwel doża ta ’ l- insulina għandek tneħħi l- għatu ta ’ sigurtà tal- kunjett billi ċċarrtu.
Special care before injection
497 Attenzjoni speċjali qabel l- injezzjoni
Insuman Basal may be mixed with all Sanofi-Aventis human insulin preparations, EXCEPT those specially designed for use in insulin pumps.
Insuman Basal jista ’ jitħallat mal- preparazzjonijiet ta ’ l- insulini umani kollha ta ’ Sanofi- Aventis, ĦLIEF għal dawk li huma magħmulin speċifikament għall- użu ma ’ pompi ta ’ l- insulina.
If you need to inject a mixture, draw the other insulin into the injection syringe before Insuman Basal.
Jekk għandek bżonn tinjetta taħlita, l- ewwel tella ’ l- insulina l- oħra fis- siringa ta ’ l- injezzjoni qabel Insuman Basal.
If you use more Insuman Basal than you should
Jekk tuża aktar Insuman Basal milli suppost
- If you have injected too much Insuman Basal, your blood sugar level may become too low
- Jekk injettajt Insuman Basal aktar milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’
If you forget to use Insuman Basal
Jekk tinsa tuża Insuman Basal
- If you have missed a dose of Insuman Basal or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Basal jew ma injettajtx biżżejjed insulina, il- livell taz- zokkor
If you stop using Insuman Basal This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insuman Basal Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Insuman Basal without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insuman Basal mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insuman Basal can cause side effects, although not eveybody gets them.
Bħal kull mediċina oħra, Insuman Rapid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
499 Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk tinnota kwalunkwe waħda minn dawn l- effetti sekondarji elenkati hawn fuq jew kwalunkwe effetti mhux mixtieqa jew mhux mistennija.
HOW TO STORE INSUMAN BASAL
KIF TAĦŻEN INSUMAN BASAL
Do not use Insuman Basal after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Basal wara d- data ta ’ skadenza li hija murija fuq il- kaxxa u fuq it- tikketta tal- kunjett.
Do not put Insuman Basal next to the freezer compartment or a freezer pack.
Insuman Basal m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
Medicines should not be disposed of via wastewater or household waste.
499 Il- mediċini m’ ghandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma l- iskart domestiku.
What Insuman Basal contains
X’ fih Insuman Basal
One ml of Insuman Basal contains 100 IU (International
Millilitru wieħed ta ’ Insuman Basal fih 100 IU (Unita
- The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen
- Is- sustanzi l- oħra huma: protamine sulphate, meta- cresol, phenol, zinc chloride, sodium
phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment) and water for injections.
dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall - aġġustament tal- pH), u ilma għall- injezzjonijiet.
What Insuman Basal looks like and contents of the pack After mixing, Insuman Basal is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Basal u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Basal huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, bla ebda partikuli jew trofof viżibbli.
Insuman Basal is supplied in vials containing 5 ml suspension (500 IU).
Insuman Basal huwa fornut f’ kunjetti ta ’ 5 ml ta ’ suspensjoni (500 IU).
Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
500 Ελλάδα sanofi- aventis AEBE Τηλ: +30 210 900 16 00
501 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
501 IPERGLIĊEMIJA U IPOGLIĊEMIJA
502 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
503 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?
Tell your relatives, friends and close colleagues the following:
503 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
504 PACKAGE LEAFLET:
504 FULJETT TA ’ TAGĦRIF:
Insuman Basal 40 IU/ml suspension for injection in a vial Insulin human
Insuman Basal 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
505 Travel
505 Safar
- corticosteroids (such as "cortisone", used to treat the inflammation),
- l- kortikosterojdi (bħal "cortisone", użat għall- kura ta ’ l- infjammazzjoni)
Important information about some of the ingredients of Insuman Basal
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Basal
3.
507 3.
507 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Basal contains 40 IU insulin per ml.
Insuman Basal fih 40 IU insulina kull millilitru.
Only injection syringes designed for this insulin concentration (40 IU per ml) must be used.
Għandhom jintużaw biss dawk is- siringi għall - injezzjoni li huma magħmulin għall- qawwa ta ’ din l- insulina (40 IU kull ml).
Your doctor will tell you if you have to mix Sanofi-Aventis human insulins.
508 It- tabib tiegħek sejjer jgħidlek jekk għandekx bżonn tħallat l- insulini umani ta ’ Sanofi- Aventis.
If you use more Insuman Basal than you should
Jekk tuża Insuman Basal aktar milli suppost
- If you have injected too much Insuman Basal, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Basal, il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq
(hypoglycaemia).
(ipogliċemija).
Like all medicines, Insuman Basal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Rapid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
509 Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
509 Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk tinnota kwalunkwe waħda minn dawn l- effetti sekondarji elenkati hawn fuq jew kwalunkwe effetti mhux mixtieqa jew mhux mistennija.
One ml of Insuman Basal contains 40 IU (International Units)
Millilitru wieħed ta ’ Insuman Basal fih 40 IU (Unita
of the active substance insulin human.
Internazzjonali) tas- sustanza attiva insulina umana.
Insuman Basal is supplied in vials containing 10 ml suspension (400 IU).
Insuman Basal huwa fornut f’ kunjetti ta ’ 10 ml ta ’ suspensjoni (400 IU).
511 This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Warning symptoms of hyperglycaemia
512 Sintomi ta ’ twissija ta ’ ipergliċemija
512 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self -control, inability to look after yourself, convulsions, loss of consciousness.
Ezempji ta ’ sintomi li jindikaw livell baxx taz- zokkor fil- moħħ:: uġigħ ta ’ ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl- irqad, nuqqas ta ’ kwiet, komportament aggressiv, nuqqas ta ’ attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid- diskors, (xi drabi it- telf komplet tad- diskors), indeboliment tal- vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni
513 What should you do if you experience hypoglycaemia
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
514 PACKAGE LEAFLET:
514 FULJETT TA ’ TAGĦRIF:
Insuman Basal 100 IU/ml suspension for injection in a cartridge Insulin human
Insuman Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
The insulin contained in Insuman Basal is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Basal hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insuman Basal is an insulin preparation with a gradual onset and long duration of action.
Insuman Basal huwa preparat ta ’ l- insulina li jibda jaħdem bilmod u jdum jaħdem għal żmien twil.
It comes in cartridges designed for use in an injection device of the OptiPen series.
L - insulina hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine. Huwa disponibbli f’ skartoċċi magħmulin għall- użu f’ sistema ta ’ injezzjoni fis- serje ta ’ l- OptiPen.
Insuman Basal is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Basal huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.
Do not use Insuman Basal
Tużax Insuman Basal
Do not use it in insulin pumps or other infusion pumps – special insulin preparations are available for use in such devices.
Tużahiex fil- pompi għall- insulina jew pompi oħra għal- infużjoni – hemm preparazzjonijiet apposta t’ insulina disponibbli għall- użu ma ’ dan l - apparat.
515 Travel
515 Gruppi speċjali ta ’ pazjenti
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti - kundizzjonijiet
pressure),
tal- qalb jew ta ’ pressjoni għolja fid- demm)
- sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to
- il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall -
treat asthma),
kura ta ’ l- ażma),
Important information about some of the ingredients of Insuman Basal
517 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Insuman Basal
- determine how much Insuman Basal per day you will need,
- jikkalkula kemm għandek bżonn Insuman Basal kuljum,
517 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman cartridges and as recommended in the information provided by the device manufacturer.
L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- skartoċċi ta ’ Insuman u kif inhu irrakkomandat fl- informazzjoni ipprovduta mill- manifattur tal - pinna.
Special care before injection
518 Attenzjoni speċjali qabel l- injezzjoni
- Do not mix insulin with any other medicines.
- Tħallatx l- insulina ma ’ ebda mediċini oħra. skartoċċi
Problems with the pen?
Diffikultajiet bil- pinna?
518 If you use more Insuman Basal than you should
Jekk tuża Insuman Basal aktar milli suppost
- If you have injected too much Insuman Basal, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Basal milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’
- If you have missed a dose of Insuman Basal or if you have not injected enough insulin, your blood
- Jekk qbiżt doża ta ’ Insuman Basal jew ma injettajtx biżżejjed insulina, il- livell taz- zokkor
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
519 fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Jekk qed tbati minn retinopatija proliferattiva (marda ta ’ l- għajnejn relatata mad- dijabete) attakki severi ta ’ l- ipogliċemija jistgħu jirriżultaw f’ telf temporanju tal- vista • Tibdiliet fil- ġilda fis- sit tal- injezzjoni (lipodistrofija) Jekk tinjetta l- insulina spiss wisq fl- istess sit tal- ġilda, t- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jogħlob jew jeħxien.
519 • Skin changes at the injection site (lipodystrophy) If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Insulin that you inject in such a site may not work very well.
Bidla l fis- sit tal - injezzjoni ma ’ kull injezzjoni jgħin biex dawn il- bidliet fil- ġilda ma jiġrux. • Reazzjonijiet tal- ġilda u dawk allerġiċi.
Do not use Insuman Basal after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insuman Basal wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l- iskartoċċ.
In-use cartridges Cartridge in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
520 Skartoċċi fl- użu Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
What Insuman Basal looks like and contents of the pack After mixing, Insuman Basal is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Basal u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Basal huwa likwidu uniformi jixbaħ il- ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insuman Basal is supplied in cartridges containing 3 ml suspension (300 IU).
Insuman Basal huwa fornut f’ skartoċċi li fihom 3 ml ta ’ soluzzjoni (300 IU).
Marketing Authorisation Holder and Manufacturer Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Il- Ġermanja.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
521 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
522 IPERGLIĊEMIJA U IPOGLIĊEMIJA
522 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Hypoglycaemia is also more likely to occur if:
523 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
524 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
524 PACKAGE LEAFLET:
525 FULJETT TA ’ TAGĦRIF:
Insuman Basal 100 IU/ml suspension for injection in a pre -filled pen Insulin human
Insuman Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully including the Instructions for use of Insuman Basal, pre-filled pen, OptiSet, before you start using this medicine.
Aqra sew dan il- fuljett kollu kif ukoll l- Istruzzjonijiet dwar l- Użu ta ’ Insuman Basal, pinna mimlija għal- lest, OptiSet, qabel tibda tuża din il- mediċina.
How to use Insuman Basal 4.
Kif għandek tuża Insuman Basal4.
Insuman Basal is a fluid (suspension) for injection under the skin.
Insuman Basal huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
The insulin is present as tiny crystals of insulin protamine.
L - insulina hija taħt għamla ta ’ kristalli ċkejknin ta ’ insulina protamine.
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Basal.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi wieħed mill- sustanzi l - oħra ta ’ Insuman Basal.
Take special care with Insuman Basal
Oqgħod attent ħafna b’ Insuman Basal
525 Travel
526 Safar
527 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Insuman Basal comes in cartridges sealed in disposable pen injectors, OptiSet.
Insuman Basal huwa fornut f’ skartoċċi ssiġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara li jinħlew.
To prevent the possible transmission of disease, each pen must be used by one patient only.
529 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman Basal, pre -filled pen, OptiSet, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Basal, pinna mimlija għal- lest, OptiSet, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
528 If you use more Insuman Basal than you should
Jekk tuża Insuman Basal aktar milli suppost
- If you have injected too much Insuman Basal, your blood sugar level may become too low
- Jekk injettajt aktarInsuman Basal milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’
Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients) • Oedema Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles. • Injection site reactions
530 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi • Reazzjonijiet fis- sit ta ’ l- injezzjoni
529 If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
What Insuman Basal looks like and contents of the pack After mixing, Insuman Basal is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Id- Dehra ta ’ Insuman Basal u l- kontenuti tal- pakkett Wara li jitħallat, Insuman Basal huwa likwidu uniformi qisu ħalib (suspensjoni għall- injezzjoni), mingħajr ċapep, partikuli jew trofof viżibbli.
Insuman Basal is supplied in pre-filled pens, OptiSet, containing 3 ml suspension (300 IU).
Insuman Basal huwa fornut f’ pinen mimlija għal- lest, OptiSet, li fiha 3 ml ta ’ suspensjoni (300 IU).
530 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
532 Ελλάδα sanofi- aventis AEBE Τηλ: +30 210 900 16 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
533 IPERGLIĊEMIJA U IPOGLIĊEMIJA
532 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Tell your relatives, friends and close colleagues the following:
535 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
534 Step 1.
536 Pass Nru.
Check and mix the insulin
1 Iċċekkja l- insulina
535 C.
Ċ.
You may have to perform the safety test several times before insulin is seen. • If no insulin comes out, check for air bubbles and repeat the safety test two more times. • If still no insulin comes out, the needle may be blocked.
Jekk ebda insulin ma titfaċċa, iċċekkja jekk hemmx bżieżaq ta ’ l- arja u erġa ’ irrepeti t- test ta ’ sigurtà darbtejn oħra. • Jekk xorta ma toħroġx l- insulina, il- labra tista ’ tkun miżduda.
536 • The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet.
• L- iskala li turi kemm fadal insulina fuq ir- riżervwar trasparenti ta ’ l- insulina turik bejn wieħed u ieħor kemm fadal insulina fl- OptiSet.
if you have selected 12 units you can inject your dose. if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.
Meta l- buttun ta ’ l- injezzjoni jkun miġbud ’ il barra l- parti ta ’ fuq biss ta ’ din il- linja ħoxna tkun tidher. • Nieħdu eżempju fejn 12- il Unità ttellgħet. o jekk int għażilt 12- il Unità tista ’ tinjetta d- doża tiegħek. o Jekk int għażilt aktar minn 12- il Unità allura 12- il Unità biss mid- doża sħiħa tiegħek ta ’ l- insulina tista ’ tkun injettata b’ din il- pinna.
In this case what should you do: • either you can inject what is remaining in the pen and complete your dose with a new OptiSet. • or use a new OptiSet for your full dose.
539 F’ każ bħal dan x’ għandek tagħmel: • jew tinjetta dak li fadal fil- pinna u tkompli tieħu li fadallek għad- doża sħiħa minn OptiSet ġdida. • jew tuża OptiSet ġdida għad- doża sħiħa.
Step 6.
6 Tinjetta d- doża
Storage Instructions
540 Struzzjonijiet dwar il- ħażna
Please check section 5 – How to store Insuman Basal - of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - Kif taħżen Insuman Basal - fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il- fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
538 Maintenance
Manutenzjoni
• Difference is more than 2 units.
541 M’ hemmx biżżejjed insulina fir- riżervwar.
539 The injection button cannot be pressed in.
Il- buttun ta ’ l - injezzjoni ma jistax
OptiSet is damaged, use a new OptiSet.
L- OptiSet hija bil- ħsara, uża waħda ġdida.
540 PACKAGE LEAFLET:
542 FULJETT TA ’ TAGĦRIF:
Insuman Basal 100 IU/ml suspension for injection in a cartridge for OptiClik Insulin human
Insuman Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina umana
This cartridge is for use with OptiClik only.
Dan l - iskartoċċ huwa għall- użu ma ’ OptiClik biss.
Special patient groups
543 Gruppi speċjali ta ’ pazjenti
541 Travel
Safar
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
544 Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
- somatropin (growth hormone),
- somatropin (ormon tat- tkabbir), - il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline]
treat asthma),
jew salbutamol, terbutaline użat għall- kura ta ’ l- ażma),
Important information about some of the ingredients of Insuman Basal
545 Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insuman Basal
543 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
How to handle the cartridges for OptiClik
Kif timmaniġġa l- iskartoċċi għal OptiClik
Insuman Basal in cartridges for OptiClik has been developed for use with OptiClik only.The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa biex jitgħabba l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
Special care before injection
546 Attenjoni speċjali qabel l- injezzjoni
- Do not mix insulin with any other medicines.
- Tħallatx l- insulina ma ’ ebda mediċini oħra. skartoċċi.
544 If you use more Insuman Basal than you should
Jekk tuża Insuman Basal aktar milli suppost
For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Għal informazzjoni fuq il- kura ta ’ l- ipergliċemija, ara l- kaxxa li tinsab fit- tmiem ta ’ dan il- fuljett ta ’ dan il- fuljett.
Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
547 fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq.
545 • Skin and allergic reactions Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Reazzjonijiet oħrajn ħfief fis- sit ta ’ l- injezzjoni (bħal ħmura fis- sit ta ’ l- injezzjoni, uġigħ qawwi mhux tas- soltu fis- sit ta ’ l- injezzjoni wara li din tingħata, ħakk, nefħa jew infjammazzjoni post ta ’ l - injezzjoni), jistgħu jiġru..
Keep the cartridge in the outer carton in order to protect from light.
Insuman Rapid m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
The cartridge in-use must not be stored in a refrigerator.
L- iskartoċċ li qed jintuża m’ għandux jinżamm fi friġġ.
What Insuman Basal looks like and contents of the pack After mixing, Insuman Basal is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Wara li jitħallat, Insuman Basal huwa likwidu uniformi jixbaħ il- ħalib (suspensjoni għall- injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
Insuman Basal comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an insulin pen.
Insuman Basal huwa fornut f’ skartoċċ issiġillat f’ kontenitur tal- plastik, li hija l- parti li tintrema, ta ’ OptiClik, pinna ta ’ l- insulina.
Insuman Basal is supplied in cartridges for OptiClik containing 3 ml suspension (300 IU).
Insuman Basal huwa fornut f’ skartoċċi għal OptiClik li fihom 3 ml ta ’ soluzzjoni (300 IU).
Marketing Authorisation Holder and Manufacturer Sanofi-Aventis Deutschland GmbH
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
546 D-65926 Frankfurt am Main Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Il- Ġermanja.
Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
549 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
550 IPERGLIĊEMIJA U IPOGLIĊEMIJA
548 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Hypoglycaemia is also more likely to occur if:
551 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
Tell your relatives, friends and close colleagues the following:
552 Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
550 PACKAGE LEAFLET:
553 FULJETT TA ’ TAGĦRIF:
Insuman Basal 100 IU/ml suspension for injection in a pre-filled pen Insulin human
Insuman Basal 100 Unità/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana
Read all of this leaflet carefully including the Instructions for Use of Insuman Basal, pre-filled pen, SoloStar, before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Insuman Basal, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
Insuman Basal is a fluid (suspension) for injection under the skin.
Insuman Basal huwa suspensjoni għall- injezzjoni għal taħt il- ġilda.
The insulin contained in Insuman Basal is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Basal hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu
Insuman Basal is an insulin preparation with a gradual onset and long duration of action.
Insuman Basal huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil.
Take special care with Insuman Basal
Oqgħod attent ħafna b’ Insuman Basal:
551 Travel
554 Safar
Important information about some of the ingredients of Insuman Basal
Tagħrif importanti dwar xi wħud mis- sustanzi ta’ Insuman Basal
3.
556 3.
553 Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jeffettwaw il- livelli taz- zokkor f’ demmek.
Do NOT inject Insuman Basal into a vein.
TINJETTAX l- Insulina Basal fil- vina.
To prevent the possible transmission of disease, each pen must be used by one patient only.
557 Biex tilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Insuman Basal, pre-filled pen, SoloStar, is not designed to allow any other insulin to be mixed in the cartridge.
Insuman Basal, pinna mimlija għal- lest, SoloStar, mhix magħmula biex tippermetti li żżid insulina oħra biex titħallat fl- iskartoċċ.
Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.
Tużax s- SoloStar jekk hi bil- ħsara jew mhix qed taħdem sew, din għandha tintrema u SoloStar ġdida tintuża minflok.
554 If you use more Insuman Basal than you should
Jekk tuża Insuman Basal aktar milli suppost
Like all medicines, Insuman Basal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Basal jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients) • Oedema Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles. • Injection site reactions
558 Effetti sekondarji komunement rapportati (Jidhru f’ anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent) • Edima It- trattament bl- insulina jista ’ jikkawża ġemgħa temporanja ta ’ ilma fil- ġisem b’ nefħa tal- pxiexen u l - egħkiesi • Reazzjonijiet fis- sit ta ’ l- injezzjoni
555 If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx tajjebsew.
Do not use Insuman Basal after the expiry date which is stated on the carton and on the label of the pen.
Tużax Insuman Basal wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna.
In-use pens Pre-filled pens in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp).
559 Pinen mimlija għal- lest fl- użu jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta (eż. viċin heater) jew id- dawl dirett (ix- xemx diretta jew viċin lampa).
One ml of Insuman Basal contains 100 IU (International
Millilitru wieħed ta ’ Insuman Basal fih 100 IU (Unit
- The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen
- Is- sustanzi l- oħra huma: protamine sulphate, metacresol, phenol, zinc chloride, sodium
Insuman Basal is supplied in pre-filled pens, SoloStar, containing 3 ml suspension (300 IU).
Insuman Basal huwa fornut f’ pinen mimlija għal- lest, SoloStar, li fiha 3 ml ta ’ suspensjoni (300 IU).
556 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
560 Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
561 IPERGLIĊEMIJA U IPOGLIĊEMIJA
558 Why does hypoglycaemia occur?
Għaliex isseħħ l- ipogliċemija?
Hypoglycaemia is also more likely to occur if:
562 L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
563 Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
SoloStar.
Insuman Basal, suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
561 C.
Ċ.
If you are using a suspension insulin (Insuman Basal or Insuman mixtures), turn the pen up and down at least 10 times to resuspend the insulin.
Iċċekkja d- dehera ta ’ l- insulina tiegħek. • Jekk qed tuża insulina ċara, (Insuman) tużax din il- pinna jekk l- insulina hija mdardra, ikkulurita jew għandha xi partikuli. • Jekk qed tuża suspensjoni ta ’ l- insulina (Insuman Basal jew taħlit ta ’ Insuman) l- insulina għandha titħallat billi ddawwar il- pinna ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
B.
566 B.
563 • Do not push the injection button while turning, as insulin will come out.
• Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
567 • Jekk l- injezzjoni tiegħek ser tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il- persuna waqt li tneħħi u tarmi l- labra.
Follow recommended safety measures for removal and disposal of needles (e.g. contact your healthcare professional) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri irrakkomandati ta’ sigurtà għat- tneħħija u r- rimi tal- labar (e. g. kellem lill- professjonist tiegħek fil- qasam tas- saħħa) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess xi mard infettiv.
564 Storage Instructions
Struzzjonijiet dwar il- ħażna
565 PACKAGE LEAFLET:
568 FULJETT TA ’ TAGĦRIF:
Insuman Comb 15 100 IU/ml suspension for injection in a vial Insulin human
Insuman Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett Insulina umana
What Insuman Comb 15 is and what it is used for 2.
X’ inhu Insuman Comb 15 u għalxiex jintuża 2.
Before you use Insuman Comb 15 3.
Qabel ma tuża Insuman Comb 15 3.
How to use Insuman Comb 15 4.
Kif għandek tuża Insuman Comb 15 4.
How to store Insuman Comb 15 6.
Kif taħżen Insuman Comb 15 6.
WHAT INSUMAN COMB 15 IS AND WHAT IT IS USED FOR
X’ INHU INSUMAN COMB 15 U GĦALXIEX JINTUŻA
Insuman Comb 15 is a fluid (suspension) for injection under the skin.
Insuman Comb 15 huwa likwidu (suspensjoni) għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
The insulin contained in Insuman Comb 15 is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Comb 15 hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insuman Comb 15 is an insulin preparation with a gradual onset and long duration of action.
Insuman Comb 15 huwa preparat ta ’ l- insulina li jibda jaħdem b’ mod gradwali u jdum jaħdem għal żmien twil.
Insuman Comb 15 is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Comb 15 huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSUMAN COMB 15
QABEL MA TUŻA INSUMAN COMB 15
Do not use Insuman Comb 15
Tużax Insuman Comb 15
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Comb 15.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insuman Comb 15.
Do not inject Insuman Comb 15 into a vein (blood vessel).
Tinjettax Insuman Comb 15 ġewwa vina (sistema vaskulari).
Do not use it in insulin pumps or other infusion pumps - special insulin preparations are available for use in such devices.
Tużaħx f’ pompi ta ’ l- insulina jew pompi oħra għall- infuzzjoni - hemm preparazzjonijiet apposta ta ’ insulina disponibbli għall- użu ma ’ dan l - apparat.