qanastek/EMEA-V3 huggingface dataset:
Insulin glargine is a modified insulin, very similar to human insulin.
L- insulina glargine hija insulina immodifikata, simili ħafna għall- insulina tal- bniedem.
It is made by a biotechnology process.
Hija magħmula bi proċess bijoteknoloġiku.
Insulin glargine has a long and steady blood-sugar-lowering action.
L- insulina glargine għandha effett fit tul u miżmum li jbaxxi l- livell taz- zokkor fid- demm.
Lantus is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus.
Lantus huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fl- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin u akbar bid- dijabete mellitus.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Id- dijabete mellitus hija marda fejn il- ġisem ma jagħmilx biżżejjed insulina biex jikkontrolla l- livell taz- zokkor fid- demm.
Do not use Lantus
Tużax Lantus
Take special care with Lantus
Oqgħod attent/ a ħafna b’ Lantus
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 bir- reqqa l- istruzzjonijiet għad- dożaġġ, l- immoniterjar (testijiet tad- demm u ta ’ l- awrina), id- dieta u l - attività fiżika (kemm fuq ix- xogħol u kemm l- eżerċizzju), kif spjegalek it- tabib tiegħek.
There is limited experience with the use of Lantus in children less than 6 years old and in patients whose liver or kidneys do not function well.
Hemm esperjenza limitata fl- użu ta ’ Lantus fit- tfal taħt l- età ta 6 snin u f’ pazjenti fejn il- fwied jew il- kliewi mhux jaħdmu sew.
107 Travel
Safar
Before travelling consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tieghek.
You may need to talk about
Għandek mnejn trid tkellmu dwar:
- the availability of your insulin in the country you are visiting,
- id- disponibbiltà ta ’ l- insulina tiegħek fil pajjiż li qiegħed iżżur,
- supplies of insulin, syringes etc.,
- il- forniment ta ’ l- insulina, siringi eċċ.,
- timing of meals and insulin administration while travelling,
- il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar,
- possible new health risks in the countries to be visited,
- il- possibbiltà ta ’ riskji ġodda għal saħħtek fil- pajjiżi li ser iżżur.
In the following situations, the management of your diabetes may require a lot of care: − If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia). − If you are not eating enough your blood sugar level may become too low (hypoglycaemia).
F’ dawn is- sitwazzjonijiet li ġejjin, l- immaniġġar tad- dijabete tiegħek, jista ’ jkollha bżonn ta ’ ħafna attenzjoni:
Tell your doctor and pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: − all other medicines to treat diabetes, − angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), − disopyramide (used to treat certain heart conditions), − fluoxetine (used to treat depression), − fibrates (used to lower high levels of blood lipids), − monoamine oxidase (MAO) inhibitors (used to treat depression), − pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), − sulfonamide antibiotics.
- id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew iż- żamma eċċessiva ta ’ fluwidi),
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: − corticosteroids (such as "cortisone" used to treat inflammation), − danazol (medicine acting on ovulation), − diazoxide (used to treat high blood pressure), − diuretics (used to treat high blood pressure or excessive fluid retention), − glucagon (pancreas hormone used to treat severe hypoglycaemia), − isoniazid (used to treat tuberculosis), − oestrogens and progestogens (such as in the contraceptive pill used for birth control), − phenothiazine derivatives (used to treat psychiatric disorders), − somatropin (growth hormone), − sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to treat asthma), − thyroid hormones (used to treat thyroid gland disorders), − atypical antipsychotic medications (such as clozapine, olanzapine),
l- estroġeni u l- proġesteni (bħal fil- pillola kontraċettiva, użata għall- kontroll tat- twelid), id- derivattivi ta ’ phenothiazine (użati għall- kura ta ’ disturbi psikjatriċi), somatropin (ormon tat- tkabbir), il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall - kura ta ’ l- ażma),
108 − protease inhibitors (used to treat HIV).
ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde), l- mediċini hekk imsejjħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine) l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV)
Your blood sugar level may either rise or fall if you take: − beta-blockers (used to treat high blood pressure), − clonidine (used to treat high blood pressure), − lithium salts (used to treat psychiatric disorders).
- imblokkaturi tar- riċetturi beta (użati għall- kura ta ’ pressjoni għolja fid- demm),
You should contact your doctor for advice ondriving if:
Għandek tikkuntatja lit- tabib tiegħek għal parir fuq is- sewqan jekk:
- you have frequent episodes of hypoglycaemia,
- għandek episodji spissi ta ’ ipogliċemija,
Frequency of administration
Kemm il- darba jingħata
Lantus in cartridge for OptiClik has been developed for use in OptiClik only.
Lantus f’ skartoċċ għal OptiClik kien żviluppat għall- użu ma ’ OptiClik biss.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa: kif iddaħħal l- iskartoċċ, twaħħal il- labra, u tagħti l - injezzjoni ta ’ l- insulina.
Look at the cartridge before you use it.
Eżamina l- iskartoċċ qabel ma tużah.
Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. Do not shake or mix it before use.
Tħawdux jew tħalltu qabel l- użu.
Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża skartoċċ ġdid jekk tinnota li l- kontroll taz- zokkor tiegħek fid- demm qiegħed bla mistenni imur għall- agħar.
If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.
Jekk taħseb li għandek problema b’ Lantus għid lit- tabib jew lill- ispiżjar tiegħek biex jiċċekkjah.
Special care before injection
Attenzjoni speċjali qabel – l- użu
Before injection remove any air bubbles (see instructions for using the pen).
Qabel l- injezzjoni neħħi l- bżieżaq ta ’ l- arja (ara l- istruzzjonijiet dwar l- użu tal- pinna).
Do not re-fill and re-use empty cartridges.
Terġax timla jew tuża skartoċċi vojta.
Do not add any other insulin to the cartridge.
Iżżidx insulina oħra fl- iskartoċċ.
Do not mix Lantus with any other insulins or medicines.
Tħallatx Lantus ma ’ ebda tipi ta insulina oħra jew ma ’ xi mediċini.
Mixing or diluting may change the action of Lantus.
Meta tħallat jew tiddilwixxi, l- effett ta ’ Lantus jista ’ jinbidel
110 Problems with OptiClik?
Għandek problemi b’ OptiClik?
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
Jekk OptiClik bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi), għandha tintrema, u pinna ġdida ta ’ l- insulina għandha tintuża minflok.
If OptiClik does not function well, you can draw the insulin from the cartridge into a syringe for injection.
Jekk OptiClik ma taħdimx sew, tista ’ ttella ’ l- insulina mill- iskartoċċ f’ siringa għall- injezzjoni.
Therefore, keep injection syringes and needles as well.
Għalhekk, żomm kemm siringi għall- injezzjoni kif ukoll labar.
However, use only injection syringes which are designed for an insulin concentration of 100 Units per millilitre.
Madankollu, uża biss is- siringi li huma magħmulin għal konċentrazzjoni ta ’ insulina ta ’ 100 Unità għal kull millilitru.
− If you have injected too much Lantus, your blood sugar level may become too low (hypoglycaemia).
- Jekk injettajt aktar Lantus milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq
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
If you experience the following symptoms, contact your doctor immediately: 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.
Reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- ġilda jew fil - membrana mukuża (anġioedema), qtugħ ta ’ nifs, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tkun għarqan.
111 Common reported side effects (experienced in more than 1 in 100 but less than 1 in 10 patients) • 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.
Effetti sekondarji rrapportati b’ mod komuni (jidhru f’ aktar minn 1 minn kull 100 iżda f’ anqas minn 1 minn kull 10 pazjenti)
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Jekk tibdel is- sit ma ’ kull injezzjoni dan jgħin biex tilqa ’ kontra dawn it- tibdiliet fil- ġilda.
In general, the side effects in patients of 18 years of age or less are similar to those seen in adults.
Ġeneralment, l- effetti sekondarji, f’ pazjenti taħt it- 18- il sena huma l- istess bħal dawk li jiġru fl- adulti.
Unopened cartridges Store in a refrigerator (2°C-8°C).
Aħzen fil- friġġ (2°Ċ- 8°Ċ).
Do not put Lantus next to the freezer compartment or a freezer pack.
Tagħmilhomx fil- friża Lantus m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
112 In-use cartridges Cartridges 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 or direct light. The cartridge in use in the insulin pen must not be stored in the refrigerator.
Skartoċċi fl- użu (fil- pinna ta ’ l- insulina) jew li qed jinġarru bħala sper jistgħu jinħażnu għall- massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Do not use it after this time period.
Tużahx wara dan il- perijodu ta ’ żmien.
Do not use Lantus if you notice particles in it.
Tużax Lantus jekk tinnota li fih xi partikuli.
Only use Lantus if the solution is clear, colourless and waterlike.
Uża Lantus biss jekk is- soluzzjoni hija ċara, mingħajr kulur u tixbaħ l- ilma.
- Other ingredients of Lantus are: zinc chloride, m-cresol, glycerol, sodium hydroxide,
- Is- sustanzi l- oħra ta ’ Lantus huma: zinc chloride, m- cresol, glycerol, sodium hydroxide, hydrochloric
hydrochloric acid and water for injections.
acid, u ilma għall- injezzjonijiet.
Lantus 100 Units/ ml solution for injection in a cartridge is a clear, colourless solution.
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ skartoċċ huwa soluzzjoni ċara u minghajr kulur.
Lantus comes in a cartridge sealed in a plastic container, which is the disposable part of OptiClik, an Insulin Pen.
Lantus huwa fornut fi skartoċċ issiġillat f’ kontenitur tal- plastik, li huwa l- parti ta ’ OptiClik, pinna ta ’ l - insulina, li tintrema.
Each cartridge contains 3 ml solution (300 Units) and they are available in packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges.
Kull skartoċċ fih 3 ml ta ’ soluzzjoni (300 Unità) u huma disponibbli f’ pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi.
113 Eesti Österreich sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Tel: +371 67 33 24 51
This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}:
114 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet, eċitament),
substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
simili għaz- zokkor li jissejjħu karboidrati; madankollu, l- ħlewwiet artifiċjali M’ HUMIEX karboidrati),
115 Hypoglycaemia is also more likely to occur if:
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
from your previous basal insulin to Lantus hyopglycaemia, if it occurs, may be more likely to occur in the morning than at night),
insulina bażika li kellek għal- Lantus, l- ipogliċemija, jekk isseħħ, hija aktar probabbli li isseħħ filgħodu milli billejl.)
116 What should you do if you experience hypoglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?
117 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Lantus 100 Units/ ml solution for injection in a pre-filled pen Insulin glargine
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina glargine
Read all of this leaflet carefully including the Instructions for Use of Lantus, pre-filled pen, OptiSet before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Lantus, u pinna mimlija għal- lest, OptiSet, qabel ma tibda tuża din il- mediċina.
WHAT LANTUS IS AND WHAT IT IS USED FOR
X’ INHU LANTUS OPTISET U GĦALXIEX JINTUŻA
It is made by a biotechnology process.
Huwa magħmul permezz ta ’ proċess bijoteknoloġiku..
Lantus is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus.
Lantus huwa wżat biex inaqqas il- livell għoli taz- zokkor fid- demm fl- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin u akbar li jbatu mid- dijabete mellitus.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Id- dijabete mellitus hija marda fejn il- ġisem ma jipproduċix ammont biżżejjed ta ’ insulina biex tikkontrolla l- livell taz- zokkor fid- demm.
BEFORE YOU USE LANTUS
QABEL MA TUŻA LANTUS OPTISET
If you are allergic (hypersensitive) to insulin glargine or any of the other ingredients of Lantus.
Tużax Lantus Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina glargine jew għal xi waħda mis- sustanzi l- oħra ta ’ Lantus.
Take special care with Lantus
Oqgħod attent ħafna b ’ Lantus
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Segwi bir reqqa l- istruzzjonijiet għad- dożaġġ, monitoraġġ (tad- demm u l- urina permezz tat- testijiet), id- dieta u l- attività fiżika (xogħol u eżerċizzju), it- teknika addattata ta ’ injezzjoni kif diskuss mat- tabib tiegħek.
There is limited experience with the use of Lantus in children less than 6 years old and in patients whose liver or kidneys do not function well.
Gruppi speċjali ta ’ pazjenti Hemm esperjenza limitata bl- użu ta ’ Lantus fit- tfal taħt is- 6 snin u f’ pazjenti li għandhom il- fwied jew il - kliewi mhux jaħdmu sew.
118 Travel
Safar
Be careful when you start or stop taking another medicine. Tell your doctor about all medicines that you are taking, including those you have bought without a prescription.
Oqgħod attent/ a meta tibda jew tieqaf tieħu xi mediċina oħra.
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: − all other medicines to treat diabetes, − angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), − disopyramide (used to treat certain heart conditions), − fluoxetine (used to treat depression), − fibrates (used to lower high levels of blood lipids), − monoamine oxidase (MAO) inhibitors (used to treat depression), − pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), − sulfonamide antibiotics.
l- estroġeni u l- proġesteni (bħal fil- pillola kontraċettiva, użata għall- kontroll tat- twelid), id- derivattivi ta ’ phenothiazine (użati għall- kura ta ’ disturbi psikjatriċi), somatropin (ormon tat- tkabbir), il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall - kura ta ’ l- ażma),
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: − corticosteroids (such as "cortisone" used to treat inflammation), − danazol (medicine acting on ovulation), − diazoxide (used to treat high blood pressure), − diuretics (used to treat high blood pressure or excessive fluid retention), − glucagon (pancreas hormone used to treat severe hypoglycaemia), − isoniazid (used to treat tuberculosis), − oestrogens and progestogens (such as in the contraceptive pill used for birth control), − phenothiazine derivatives (used to treat psychiatric disorders), − somatropin (growth hormone), − sympathomimetic medicines (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma), − thyroid hormones (used to treat thyroid gland disorders), − atypical antipsychotic medications (such as clozapine, olanzapine),
ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde), l- mediċini hekk imsejjħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine) l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV)
119 − protease inhibitors (used to treat HIV).
- is- sustanzi tal- lithium (użati għall- kura ta ’ disturbi psikjatriċi)
Your blood sugar level may either rise or fall if you take: − beta-blockers (used to treat high blood pressure), − clonidine (used to treat high blood pressure), − lithium salts (used to treat psychiatric disorders), Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Pentamidine (użat għall- kura ta ’ xi infezzjonijiet ikkawżati mill- parassiti) jista ’ jikkawża l- ipogliċemija li kultant tkun segwita mill- ipergliċemija.
Your ability to concentrate or react may be reduced if: − you have hypoglycaemia (low blood sugar levels), − you have hyperglycaemia (high blood sugar levels), − you have problems with your sight. − Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machinery).
Għandek tikkuntatja lit- tabib tiegħek għal parir fuq is- sewqan jekk:
You should contact your doctor for advice on driving if: − you have frequent episodes of hypoglycaemia, − the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
- l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf ipogliċemija huma ridotti jew m’ humiex preżenti.
In children, only evening injection has been studied. OptiSet delivers insulin in increments of 2 units up to a maximum single dose of 40 units.
OptiSet tagħti l- insulina f’ żidiet ta ’ 2 unitajiet sa massimu ta ’ 40 unità f’ doża waħda.
How to handle OptiSet
Kif timmaniġġa Optiset
Lantus comes in cartridges sealed in disposable pen injectors, OptiSet
Lantus jiġi f’ skartoċċi issiġġillati f’ pinen għall- injezzjoni, OptiSet, li jintremew wara l- użu.
Read carefully the "OptiSet Instructions for Use" included in this package leaflet.
Aqra bir reqqa “ L- Istruzzjonijiet dwar l- Uzu ta ’ OptiSet ”, li jinsabu f’ dan il- fuljett ta ’ tagħrif.
You must use the pen as described in these Instructions for Use.
Int għandek tuża l- pinna kif deskritt f’ dawn l- Istruzzjonijiet dwar l- Użu.
A new needle must be attached before each use.
Labra ġdida ghandha titwaħħal qabel kull darba li tużha.
Only use needles that have been approved for use with OptiSet.
Uża biss labar li huma approvati għall- użu b’ OptiSet.
Do not use Lantus if you notice particles in it.
Tużax Lantus jekk tinnota li fih il- partikuli.
Only use Lantus if the solution is clear, colourless and waterlike.
Uża biss Lantus jekk is - soluzzjoni hija ċara, bla kulur u tixbah l- ilma.
Do not shake or mix it before use.
Tħawdux jew tħalltu qabel l- użu.
If you think you may have a problem with OptiSet, please refer to the Questions and Answers section of the attached OptiSet Instructions for Use, or have it checked by your doctor or pharmacist.
Jekk taħseb li għandek xi problema b’ OptiSet, jekk jogħġbok, ara s- sezzjoni dwar Mistoqsijiet u Tweġibiet, ta ’ l- Istruzzjonijiet dwar l- Użu ta ’ OptiSet,, li huwa inkluż mal- pinna, jew ħudha lit- tabib jew lill- ispiżjar tiegħek biex jiċċekjahielek.
Empty pens must not be re-filled and must be properly discarded.
Il- pinen vojta m’ għandhomx jerġgħu jimtlew u għandhom jintremew kif jixraq.
Do not use the OptiSet if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new OptiSet has to be used.
Tużax OptiSet jekk fiha l- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi); din għandha tintrema u minflok tuża OptiSet ġdida.
121 If you use more Lantus than you should
Jekk tuża Lantus 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.
If you experience the following symptoms, contact your doctor immediately: 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.
Reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- ġilda jew fil - membrana mukuża (angioedema), qtugħ ta ’ nifs,, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tkun għarqan.
Common reported side effects (experienced in more than 1 in 100 but less than 1 in 10 patients) • 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.
Effetti sekondarji rrapportati b’ mod komuni (jidhru f’ aktar minn 1 minn kull 100 iżda f’ anqas minn 1 minn kull 10 pazjenti) • Tibdiliet fil- ġilda fis- sit tal- injezzjoni (lipodistrofija) Jekk tinjetta l- insulina tiegħek spiss wisq fl- istess sit tal- ġilda; it- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jinxtorob jew jeħxien.
122 Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 patients) • Severe allergic reactions to insulins 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. These could be symptoms of severe allergic reactions to insulins and may become life-threatening. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Każijiet severi ta ’ reazzjonijiet ġeneraliżżati, inkluża r- reazzjoni anafilattika, tista ’ tkun fatali.
Do not use Lantus after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Lantus wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l- iskartoċċ Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
The expiry date refers to the last day of that month.
Pinen mhux fl- użu:
Do not put the pre-filled pen next to the freezer compartment of your refrigerator or a freezer pack.
Tpoġġix il- pinna mimlija għal- lest viċin tal- kompartiment tal- friża jew viċin xi pakk tal- friża.
In-use pens 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 or direct light.
Pinen fl- użu jew li qed jinġarru bħala sper jistgħu jinħażnu għall- massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The pen in use must not be stored in a refrigerator.
Il- pinna li qed tintuża m’ għandhiex tinżamm fil- friġġ.
Do not use it after this time period.
Tużahiex wara dan il- perijodu ta ’ żmien.
Remove the needle after the injection and store the pen without the needle.
Neħħi l- labra wara l- injezzjoni u aħżen il- pinna mingħajr labra.
Also, be sure to remove the needle before disposing of the pen.
Kun żgur ukoll li tneħħi l- labra qabel ma tarmi l- pinna.
Needles must not be re-used.
Il- labar m’ għandhomx jerġgħu jintużaw.
Lantus 100 Units/ ml solution for injection in a pre-filled pen, OptiSet, is a clear colourless solution.
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, OptiSet, huwa soluzzjoni ċara u mingħajr kulur.
Each pen contains 3 ml solution (300 Units) and they are available in packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens.
Kull pinna fiha 3 ml ta ’ soluzzjoni (300 Unità) u huma disponibbli f’ pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 pinen.
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
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125 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
126 Hypoglycaemia is also more likely to occur if
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
arm),
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127 What should you do if you experience hypoglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?
The recovery of hypoglycaemia may be delayed because Lantus has a long action.
L- irkuprar mill - ipogliċemija tista ’ tkun imtawla minħabba li Lantus jibqa ’ jaħdem fit- tul.
128 OPTISET INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU TA ’ OptiSet
If you are not able to follow all the instructions completely on your own, use OptiSet only if you have help from a person who is able to follow the instructions.
Jekk m’ intix kapaċi ssegwi l- istruzzjonijiet kollha waħdek, uża OptiSet biss jekk issib għajnuna minn persuna oħra li tista ’ ssegwi l- istruzzjonijiet.
If you have any questions about OptiSet or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.
Jekk għandek xi diffikultajiet dwar l- użu ta ’ l- OptiSet jew id- dijabete tiegħek, staqsi 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.
New information for use: • Name of the insulin is printed on the pen • Dosage selector can only be turned in one direction
Tagħrif ġdid dwar l- użu: • L- isem ta ’ l- insulina huwa stampat fuq il- pinna. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (i. e. never change the dose) after injection button has been pulled out. • This pen is only for your use.
Uża biss labar li huma kompatibbli ma ’ l- użu ta ’ OptiSet. • Dejjem agħmel test ta ’ sigurtà qabel kull injezzjoni. • Jekk qed tuża OptiSet ġdida it- test inizjali ta ’ sigurtà għandu jsir bi 8 unitajiet issettjati minn qabel mill- manifattur. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar is- selettur tad- dożaġġ (jiġifieri qatt m’ għandek tibdel id- doża) wara li l - buttun ta ’ l- injezzjoni huwa miġbud ’ il barra. • Din il- pinna hija għall- użu tiegħek biss.
Do not share it with anyone else. • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
Pass Nru.
Take off the pen cap.
Neħħi l- kappa
Lantus is a clear insulin.
Lantus huwa insulina ċara.
Attach the needle 129 Always use a new sterile needle for each injection.
Dejjem uża labra sterili u ġdida għal- kull injezzjoni.
This helps prevent contamination, and potential needle blocks.
Dan jgħin biex telimina l- kontaminazzjoni, u tnaqqas ir - riskju li tistadt il- labra.
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Iddritta l- labra fuq il- pinna, u żommha dritta waqt li qed tqabbadha (bil- kamin jew b’ għafsa, skond it - tip ta ’ labra).
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or the needle can be bent.
• Jekk il- labra ma tinżammx dritta waqt li qed tqabbadha, din tista ’ tagħmel ħsara ’ il- woxer tal- lastku, u bħala riżultat ta ’ dan, il- pinna tibda tqattar, jew il- labra titgħawweġ.
This ensures that you get an accurate dose by: • making sure that pen and needle work properly • removing air bubbles If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer, otherwise the pen will not function properly.
Jekk qed tuża OptiSet ġdida t- test inizjali ta ’ sigurtà għandu jsir bi 8 unitajiet kif inhu ssettjat mill- manifattur, inkella l- pinna mhux ser taħdem sew.
Select the dose for the Safety Test. • New and unused OptiSet: a dose of 8 units is already preset by the manufacturer for the first safety test. • In-use OptiSet: select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
Agħżel id- doża għat- Test tas- Sigurtà. • Għal OptiSet ġdida u mhux użata: doża ta ’ 8 unitajiet diġa tkun issettjata mill- manifattur għall- ewwel test ta ’ sigurtà. • Għal OptiSet fl- użu: agħżel doża ta ’ 2 unitajiet billi ddawwar is- selettur tad- dożaġġ ’ il quddiem sakemm il- vleġġa tipponta lejn in- numru “ 2 ”.
Never turn the dosage selector after injection button has been pulled out.
Qatt m’ għandek iddawwar is - selettur tad- dożaġġ wara li tkun ġbidt il- buttun ta ’ l- injezzjoni ’ l barra.
Take off the inner needle cap and discard it.
Neħħi l - kappa ta ’ ġewwa tal- labra u armiha.
discard keep
żomm
Hold the pen with the needle pointing upwards.
Żomm il- pinna bil- labra ppuntata ’ l fuq.
Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Taptap fuq ir- riżervwar ta ’ l- insulina biex jekk hemm xi bżieżaq ta ’ l- arja dawn jitilgħu ’ l fuq lejn il - labra.
Press the injection button all the way in.
Agħfas il- buttun ta ’ l- injezzjoni sa ġewwa.
Check if insulin comes out of the needle tip.
Iċċekkja jekk l- insulina toħroġx mill- ponta tal- labra.
• 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 r- riservwar trasparenti għall- insulina turik bejn wieħed u ieħor kemm fadal insulina fl- OptiSet.
This scale must not be used to set the insulin dose.
Din l- iskala m’ għandhiex tintuża biex tkejjel id - doża ta ’ l- insulina.
• If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
• Jekk il- planġer iswed qiegħed fil- bidu ta ’ l- istrixxa kkulurita, allura hemm madwar 40 Unità t’ insulina disponibbli.
• If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available
• Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- istrixxa ikkulurita, allura hemm madwar 20 Unità t’ insulina disponibbli.
Select your required dose by turning the dose selector forward.
Agħżel id- doża li għandek bżonn billi ddawwar is- selettur tad- doża ’ l quddiem.
If you turned past your dose, • and you have not yet pulled the injection button, you can keep turning forward till you reach your dose again, • and you have already pulled the injection button out, you must discard the dose that has been loaded before you turn the dosage selector again.
Jekk qbiżt id- doża tiegħek, • u għadek ma ġbidtx il- buttun ta ’ l- injezzjoni, tista ’ tibqa ’ ddawwar ’ l quddiem sakemm issib d- doża tiegħek mill- ġdid, • u diġà ġbidt il- buttun ta ’ l- injezzjoni ’ l barra, għandek tarmi d- doża li tellajt qabel ma ddawwar is - selettur tad- dożaġġ mill- ġdid.
Load the dose
Tella ’ d- doża
Note that the injection button only goes out as far as the amount of insulin that is left in the reservoir. • The injection button must be held out under tension during this check. • The last thick line visible on the injection button shows the amount of insulin loaded.
• Waqt li qed isir dan l- iċċekkjar il- buttun ta ’ l- injezzjoni għandu jinżamm miġbud ’ il barra. • Linja ħoxna viżibbli fuq il- buttun ta ’ l- injezzjoni turi l- ammont t’ insulina li telgħet.
When the injection button is held out only the top part of this thick line can be seen. • In this example, 12 units are loaded.
Meta l- buttun ta ’ l - injezzjoni jkun miġbud ’ il barra, il- parti ta ’ fuq biss ta ’ din il- linja ħoxna tkun tidher. • Nieħdu eżempju fejn 12- il Unità ttellgħet.
o if you have selected 12 units you can inject your dose. o if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.
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 - o insulina tista ’ tkun injettata b’ din il- pinna.
Use the injection method as instructed by your health care professional.
ta ’ l- injezzjoni kif uriek il- professjonist fil- qasam tas- saħħa.
A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
Tista ’ tisma ’ ċekċika, li tieqaf meta l - buttun ta ’ l- injezzjoni jingħafas kollu ’ l ġewwa.
Always remove the needle after each injection and store OptiSet without a needle attached.
Dejjem neħħi l- labra wara kull injezzjoni u aħżen l- OptiSet mingħajr labra fil- post.
To reduce the risk of accidental needle injury, never replace the inner needle cap.
Biex jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra, qatt m’ għandek tpoġġi lura l- kappa ta ’ ġewwa tal- labra.
• If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle.
• 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. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri rrakkomandati ta ’ sigurtà għat- tneħħija u r - rimi tal- labar (e. g. tintuża id waħda biex tpoġġi l- kappa lura fuq il- labra) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess xi mard infettiv.
Please check Section 5 -How to store Lantus- of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
Jekk jogħġbok ara Sezzjoni 5 - “ Kif taħżen Lantus ”, fuq il- faċċata ta ’ wara (ta ’ l- insulina) ta ’ dan il - fuljett għal struzzjonijiet dwar il- ħażna ta ’ OptiSet.
133 Maintenance
Manutenzjoni
Protect your Optiset from dust and dirt.
Żomm l- Optiset tiegħek ’ il bogħod mit- trab u l- ħmieġ.
You can clean the outside of your OptiSet by wiping it with a damp cloth.
Tista ’ tnaddaf l- OptiSet tiegħek minn barra billi timsaħha b’ ċarruta niedja.
Follow the instructions in Step 4 to select the correct
4 biex tagħżel id- doża korretta.
Dose has been selected and the injection button has been pulled out and
Id- doża hija magħżula
pressed in again without a
barra u wara magħfus
The d osage selector can only be turned forward.
Is- selettur tad- dożaġġ jista ’ jdur ’ il quddiem biss.
o You are turning forward while the injection button is pulled out.
Qiegħed iddawwar ’ il quddiem waqt li l- buttun ta ’ l- injezzjoni huwa miġbud ’ il barra.
Discard insulin, then set your dose and check again.
Id- differenza hi ta ’ żewġ (2) unitajiet.
OptiSet is damaged, use a new OptiSet.
il- buttun ta ’ l- injezzjoni huwa ogħla mid- doża magħżula.
The amount indicated on the injection button is
L- ammont indikat fuq
There •
Armi l- insulina, mbagħad issettja d- doża u erġa ’ ċċekkja.
is not enough insulin in the reservoir you can inject the amount indicated on the injection
Jekk jerġa ’ jiġri l- istess żball, l- OptiSet jista ’ jkollha l- ħsara, uża OptiSet ġdida. • Id- differenza hija aktar minn żewġ (2) unitajiet.
lower than the dose selected
il- buttun ta ’ l- injezzjoni huwa anqas mid- doża magħzula.
button from this OptiSet and then inject the remaining dose using a new pen, or you can inject the entire dose using a new pen.
Tista ’ tinjetta l- ammont indikat fuq il- buttun ta ’ l- injezzjoni minn din l- OptiSet u wara tinjetta l- bqija tad- doża minn pinna ġdida, jew • Tista ’ tinjetta d- doża sħiħa minn pinna ġdida.
The injection button cannot be pressed in.
Il- buttun ta ’ l - injezzjoni ma jistax jingħafas ’ il ġewwa.
134
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Do not try to repair nor use tools on it.
Tipprovax tirranġaha jew tuża l- għodda fuqha.
OptiSet has been dropped or subjected to impact.
L- OptiSet twaqqgħet jew ħabbattha ma xi ħaġa
If in any doubt whether the pen is working correctly use a new OptiSet.
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135 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
Insulin glargine
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina glargine
Read all of this leaflet carefully including the Instructions for Use of Lantus, pre -filled pen, SoloStar before you start using this medicine.
Aqra sew dan il- fuljett kollu, inkluż l- Istruzzjonijiet dwar l- Użu ta ’ Lantus, u pinna mimlija għal- lest, SoloStar, qabel tibda tuża din il- mediċina.
It may harm them, even
M’ għandekx tgħaddiha lil persuni oħra.
if their symptoms are the same as yours.
Tista ’ tagħmlilhom il -
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. - Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Lantus is a clear, colourless solution for injection containing insulin glargine.
Lantus huwa soluzzjoni ċara u mingħajr kulur, għall- injezzjoni, li fiha l- insulina glargine.
Insulin glargine has a long and steady blood-sugar-lowering action.
L- insulina glargine għandha effett fit tul u miżmum li tbaxxi l- livell taz- zokkor fid- demm.
Lantus is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus.
Lantus hija użata biex tnaqqas il- livell għoli taz- zokkor fid- demm fl- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin u akbar bid- dijabete mellitus.
If you are allergic (hypersensitive) to insulin glargine or to any of the other ingredients of Lantus.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina glargine jew għal xi waħda mis- sustanzi l- oħra ta ’ Lantus.
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Segwi bil- preċiż l- istruzzjonijiet għad- dożaġġ, l- immoniterjar (testijiet tad- demm u ta ’ l- awrina), id- dieta, l - attività fiżika (xogħol fiżiku u eżerċizzju) u t- teknika ta ’ l- injezzjoni, kif spjegalek it- tabib tiegħek.
There is limited experience with the use of Lantus in children less than 6 years old and in patients whose liver or kidneys do not function well.
Hemm esperjenza limitata fl- użu ta ’ Lantus fit- tfal taħt l- età ta 6 snin u f’ pazjenti fejn il- fwied jew il- kliewi mhux jiffunzjonaw sew.
136 Travel
Safar
Before travelling consult your doctor.
Qabel tivjaġġa tkellem mat- tabib tiegħek.
- the availability of your insulin in the country you are visiting,
– id- disponibbiltà ta ’ l- insulina tiegħek fil- pajjiż li qiegħed iżżur, – il- forniment ta ’ l- insulina, siringi eċċ – il- ħażna korretta ta ’ l- insulina tiegħek waqt l- ivvjaġġar – il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar, – l- effetti possibbli fit- tibdil minn żona ta ’ ħin għal oħra differenti – il- possibiltà ta ’ riskji ġodda għas- saħħek fil- pajjiż li tkun qiegħed żżur, – – x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
- If you are ill or have a major injury then your blood sugar level may increase
- Jekk ma tiflaħx jew għandek xi ferita serja, il- livell taz- zokkor fid- demm tiegħek jista ’ jogħla
(hyperglycaemia).
(ipergliċemija)
Tell your doctor about all medicines that you are taking, including those you have bought without a prescription.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or
- l- inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE) (użati għall- kura ta ’ ċerti - kundizzjonijiet
high blood pressure),
tal- qalb jew ta ’ pressjoni għolja fid- demm)
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower
- pentoxifylline, propoxyphene, salicylates (bħall- aspirina, użata biex ittaffi l- uġigħ u tbaxxi d- deni)
137 Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
- glucagon (pancreas hormone used to treat severe hypoglycaemia),
- 135 -
- isoniazid (used to treat tuberculosis),
- - - - - -
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
glukagon (ormon tal- frixa użat għall- kura ta ’ ipogliċemija severa), isoniazid (użat għall- kura tat- tuberkulożi), l- estroġeni u l- proġesteni (bħal fil- pillola kontraċettiva, użata għall- kontroll tat- twelid), id- derivattivi ta ’ phenothiazine (użati għall- kura ta ’ disturbi psikjatriċi), somatropin (ormon tat- tkabbir), il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall - kura ta ’ l- ażma),
- thyroid hormones (used to treat thyroid gland disorders),
ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde), l- mediċini hekk imsejjħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine) l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV)
- lithium salts (usedto treat psychiatric disorders).
- is- sustanzi tal- lithium (użati għall- kura ta ’ disturbi psikjatriċi)
138 Driving and using machines
Sewqan u tħaddim ta ’ magni
Your ability to concentrate or react may be reduced if: − you have hypoglycaemia (low blood sugar levels), − you havehyperglycaemia (high blood sugar levels), − you have problems with your sight.
- għandek l- ipergliċemija (livell għoli ta ’ zokkor fid- demm)
Dosage Based on your life -style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will
Dożaġġ Skond l- istil ta ’ ħajtek u r- riżultati tat- testijiet taz- zokkor (glukożju) fid- demm u l- użu preċedenti tiegħek ta ’ l- insulina, it- tabib tiegħek sejjer:
- determine how much Lantus per day you will need and at what time.
- jikkalkula kemm għandek bżonn Lantus kuljum u f’ liema ħin trid tieħdu,
See the box at the end of this leaflet for further information.
Ara l- informazzjoni f’ kaxxa li ssib fi tmiem ta ’ dan il- fuljett.
139 How to handle SoloStar
Kif timmaniġġa SoloStar
SoloStar is a pre-filled disposable pen containing insulin glargine.
SoloStar hija pinna mimlija għal- lest, li tintrema wara li tinħela, u fiha l- insulina glargine.
Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for Use”).
Uża biss labar li huma kompatibbli għall- użu ma ’ SoloStar (ara “ Istruzzjonijiet għall- użu ta ’ SoloStar ”).
Do not use SoloStar if you notice particles in it.
Tużax SoloStar jekk tinnota li fiha l- partikuli.
Only use SoloStar if the solution is clear, colourless and waterlike.
Uża biss SoloStar jekk is- soluzzjoni hija ċara, mingħajr kulur u tixbaħ l- ilma.
If you think you may have a problem with SoloStar, consult your Health Care Professional.
Jekk taħseb li għandek xi problema b’ SoloStar, kellem lill Professjonist fil Qasam tas- Saħħa.
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 SoloStar jekk fiha l- ħsara jew mhix qed taħdem sew; din għandha tintrema u minflokha uża SoloStar ġdida.
If you r blood sugar level falls too much you may become unconscious.
Jekk il- livell taz- zokkor fid - demm tiegħek jinżel wisq tista ’ tintilef minn sensik.
If you experience the following symptoms, contact your doctor immediately: 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.These could be symptoms of severe allergic reactions to insulins and may become life- threatening.
Jistgħu jkunu sintomi ta ’ allerġija ġeneralizzata għall- insulina, inkluża r- reazzjoni anafilattika, li tista ’ tkun fatali.
Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 patients) • Severe allergic reactions to insulins 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.These could be symptoms of severe allergic reactions to insulins and may become life-threatening. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Każijiet severi ta ’ reazzjonijiet ġeneraliżżati, inkluża r- reazzjoni anafilattika, tista ’ tkun fatali.
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
In sulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
It- trattament bl- insulina jista ’ jġiegħel il- ġisem biex jagħmel l- antikorpi għall- insulina (sustanzi li jaħdmu kontra l- insulina).
141 Paediatric patients
Pazjenti pedjatriċi
Do not use Lantus after the expiry date which is stated on the carton and on the label of the pen.
Tużax Lantus wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna.
Not in-use pens Store in a refrigerator (2°C-8°C).
Aħzen fi friġġ (2°Ċ- 8°Ċ).
Do not put SoloStar next to the freezer compartment or a freezer pack.
Tagħmilx SoloStar viċin tal- kompartiment tal- friża jew ma ’ ġenb pakkett tal- friża.
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 or direct light.The pen in use must not be stored in the refrigerator Do not use it after this time period.
Pinen mimlijin għal- lest li qed jintużaw jew li qed jinġarru bħala sper jistgħu jinħażnu sa massimu ta ’ 4 ġimgħat, f’ temperatura mhux iżjed minn 25 °C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Lantus 100 Units/ml solution for injection in a pre-filled pen, SoloStar, is a clear and colourless solution.
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar, huwa soluzzjoni ċara u minghajr kulur.
Each pen contains 3 ml solution (300 Units).
Kull pinna fiha 3 ml ta ’ soluzzjoni (300 Unità).
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens of 3 ml are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 pinen ta ’ 3 ml, mimlija għal- lest, huma disponibbli.
142 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
Sími: +354 535 7000
Sími: +354 535 7000 Italia sanofi- aventis S. p. A.
Suomi/Finland sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
Tel: +421 2 57 103 777 Suomi/ Finland sanofi- aventis Oy Puh/ Tel: +358 (0) 201 200 300