qanastek/EMEA-V3 huggingface dataset:
Do not freeze.
Tagħmilhomx fil- friza.
Once in use the pens may be stored for a maximum of 4 weeks not above 25°C.
Ġaladarba fl- użu, l- pinen jistgħu jinżammu għal massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ.
When in use, the pen must not be stored in the refrigerator.
Meta tkun fl- użu, il- pinna m’ għandhiex tinżamm fil- friġġ.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, Ġermanja.
EU/ 1/ 00/ 134/ 018 1 pen of 3 ml EU/ 1/ 00/ 134/ 008 3 pens of 3 ml EU/ 1/ 00/ 134/ 009 4 pens of 3 ml EU/ 1/ 00/ 134/ 010 5 pens of 3 ml EU/ 1/ 00/ 134/ 019 6 pens of 3 ml EU/ 1/ 00/ 134/ 020 8 pens of 3 ml EU/ 1/ 00/ 134/ 021 9 pens of 3 ml EU/ 1/ 00/ 134/ 011 10 pens of 3 ml
EU/ 1/ 00/ 134/ 018 pinna 1 ta ’ 3 ml EU/ 1/ 00/ 134/ 008 3 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 009 4 pinen ta ’ 3 ml EU/ 1/ 00/ 134010 5 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 019 6 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 020 8 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 021 9 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 011 10 pinen ta ’ 3 ml
78 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
- 78 -
PEN LABEL (OptiSet)
TIKKETTA TAL- PINNA (OptiSet)
Lantus 100 Units/ ml Solution for injection in a pre-filled pen.
Lantus 100 Unità/ ml Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Insulin glargine Subcutaneous use.
Użu għal taħt il- ġilda.
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
- 79 -
SoloStar)
KARTUNA TA ’ BARRA (PINNA MIMLIJA GĦAL- LEST, SoloStar)
10 pens of 3 ml.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar Pinna 1 ta ’ 3 ml 3 pinen ta ’ 3 ml 4 pinen ta ’ 3 ml 5 pinen ta ’ 3 ml 6 pinen ta ’ 3 ml 8 pinen ta ’ 3 ml 9 pinen ta ’ 3 ml 10 pinen ta ’ 3 ml
Only use needles that are compatible for use with SoloStar.
Uża biss il- labar li huma kompatibbli ma ’ l- użu ta ’ SoloStar.
80 EXP (month/ year):
EXP (XX/ SSSS):
Unopened Store in a refrigerator (2°C-8°C).
Mhux miftuħa Aħżen fi friġġ (2°Ċ- 8°Ċ).
In use conditions After its first use, the product may be stored for a maximum of 4 weeks not above 25°C.
Kundizzjonijiet fl- użu Wara l- ewwel użu, l- prodott jista ’ jinżamm għal massimu ta ’ 4 ġimgħat mhux ’ il fuq minn 25°Ċ.
Do not refrigerate.
Iżżhomx fil- friġġ.
Keep the pen protected from light.
Żomm il- pinna barra mid- dawl.
EU/ 1/ 00/ 134/ 037 10 pens of 3 ml.
EU/ 1/ 00/ 134/ 030 pinna 1 ta ’ 3 ml EU/ 1/ 00/ 134/ 031 3 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 032 4 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 033 5 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 034 6 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 035 8 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 036 9 pinen ta ’ 3 ml EU/ 1/ 00/ 134/ 037 10 pinen ta ’ 3 ml
81 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PEN LABEL (SoloStar)
TIKKETTA TAL- PINNA (SoloStar)
83 PACKAGE LEAFLET:
- 83 -
Lantus 100 Units/ ml solution for injection in a vial Insulin glargine
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina glargine
What Lantus is and what it is used for 2.
X’ inhu Lantus u għalxiex jintuża 2.
Before you use Lantus 3.
Qabel ma tuża Lantus 3.
How to use Lantus 4.
Kif għandek tuża Lantus 4.
How to store Lantus 6.
Kif taħżen Lantus 6.
WHAT LANTUS IS AND WHAT IT IS USED FOR
X’ INHU LANTUS U GĦALXIEX JINTUŻA
Lantus is a clear, colourless solution for injection containing insulin glargine.
Lantus huwa soluzzjoni, ċara u bla kulur, għal injezzjoni, li għandha Insulin glargine.
Insulin glargine is a modified insulin, very similar to human insulin.
Insulin glargine huwa insulina modifikata, simili ħafna għal dik tal- bniedem.
It is made by a biotechnology process.
Huwa magħmul permezz ta ’ proċess bijoteknoloġiku.
Insulin glargine has a long and steady blood-sugar-lowering action.
Insulin glargine għandu effett kostanti u fit- tul, 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 li jbatu minn diabetes mellitus.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Diabetes mellitus hija marda fejn ġismek ma jipproduċix ammont biżżejjed ta ’ insulina biex tikkontrolla l- livell taz- zokkor fid- demm.
BEFORE YOU USE LANTUS
QABEL MA TUŻA LANTUS
Do not use Lantus
Tużax Lantus:
If you are allergic (hypersensitive) to insulin glargine or 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.
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) as discussed with your doctor.
Segwi sew l- istruzzjonijiet għad- dożaġġ, monitoraġġ (tad- demm u l- urina permezz tat- testijiet), id- dieta u l - attività fiżika (xogħol fiżiku u eżerċizzju) 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.
Hemm esperjenza limitata bl- użu ta ’ Lantus fit- tfal taħt is- 6 snin u f’ pazjenti li għandhom il- fwied jew il - kliewi mhux jiffunzjonaw sew.
- 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,
- possible new health risks in the countries to be visited,
- il- possibbiltà ta ’ riskji ġodda għal saħħtek fil- pajjiż li tkun qiegħed iżżur.
- If you are not eating enough your blood sugar level may become too low (hypoglycaemia).
- Jekk m’ intix qed tiekol biżżejjed, il- livell taz- zokkor fid- demm tiegħek jista ’ jinżel iżżejjed
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Xi mediċini jikkawżaw tibdil fil- livell taz- zokkor fid- demm (tnaqqis, żieda jew it- tnejn li huma, skond iċ - ċirkostanzi).
In each case, it may be necessary to adjust your insulin dosage to avoid blood sugar levels that are either too low or too high.
F’ kull każ, jista ’ jkun meħtieġ li taġġusta d- doża tiegħek ta ’ l- insulina biex tevita livelli taz - zokkor fid- demm li jkunu baxxi wisq jew għoljin wisq.
Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Qabel tieħu xi mediċina staqsi lit- tabib tiegħek jekk tistax teffettwalek il- livell tiegħek taz - zokkor fid- demm, u x’ għandek tagħmel, jekk meħtieġ.
- sympathomimetic medicines (such as epinephrine [adrenaline], or salbutamol, terbutaline used
- il- mediċini simpatomimetiċi (bħal epinephrine [adrenaline] jew salbutamol, terbutaline użat għall -
to treat asthma),
kura ta ’ l- ażma),
- thyroid hormones (used to treat thyroid gland disorders),
- 86 -
- atypical antipsychotic medications (such as clozapine, olanzapine),
- - -
- protease inhibitors (used to treat HIV).
ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde), l- mediċini hekk imsejħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine) l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV)
85 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
- lithium salts (used to treat psychiatric disorders),
- is- sustanzi tal- lithium (użati għall- kura ta ’ disturbi psikjatriċi)
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.
Using Lantus with food and drink
Meta tuża Lantus ma ’ l- ikel u max- xorb
Your blood sugar levels may either rise or fall if you drink alcohol.
Il- livelli taz- zokkor fid- demm tiegħek jistgħu jogħlew jew jitbaxxew jekk tixrob l- alkoħol
Pregnancy and breast feeding
Tqala u Treddigħ
Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Għarraf lit- tabib tiegħek jekk inti qed tippjana toħroġ tqila, jew diġà tqila.
Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Il- kontroll għaqli tad- dijabete tiegħek, u l - prevenzjoni ta ’ l- ipogliċemija, huma importanti għas- saħħa tat- tarbija tiegħek.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Jekk int qed tredda ’, iddiskutiha mat- tabib tiegħek għax jista ’ jagħti l- każ li teħtieġ tibdiliet fid- dożi ta ’ l - insulina u d- dieta tiegħek.
- you have problems with your sight.
- għandek problemi tal- vista tiegħek
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).
Żomm din il- problema f’ moħħok f’ kull sitwazzjoni fejn tista ’ tpoġġi lilek innifsek jew lil ħaddieħor f’ riskju (e. ż. fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
- you have frequent episodes of hypoglycaemia,
- għandek episodji spissi ta` ipogliċemija,
- 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.
Important information about some of the ingredients of Lantus
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Lantus
HOW TO USE LANTUS
KIF GĦANDEK TUŻA LANTUS
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will:
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,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- jgħidlek meta teżamina l- livell taz- zokkor f’ demmek, u jekk għandekx tagħmel it- testijiet fuq l- urina,
- tell you when you may need to inject a higher or lower dose of Lantus.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Lantus.
86 Lantus is a long-acting insulin.
Lantus huwa tip ta ’ insulina li taħdem fit- tul.
Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
It- tabib tiegħek għandu mnejn jgħidlek biex tużah flimkien ma ’ insulina li taħdem għal żmien qasir jew ma ’ pilloli użati għall- kura ta ’ livelli għoljin ta ’ zokkor fid- demm.
Frequency of administration
Kemmil- darba jingħata
You need one injection of Lantus every day, at the same time of the day.
Għandek bżonn ta ’ injezzjoni waħda ta ’ Lantus kuljum, fl- istess ħin tal- ġurnata.
In children, only evening injection has been studied.
Fit- tfal, id- doża li tingħata filgħaxija biss kienet studjata.
Lantus is injected under the skin.
Lantus huwa injettat taħt il- ġilda.
Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.
TINJETTAX Lantus fil- vina għax dan jibdillu l- effett u jista ’ jikkaġuna ipogliċemija.
Your doctor will show you in which area of the skin you should inject Lantus.
It- tabib tiegħek sejjer jurik f’ liema post fil- ġilda għandek tinjetta Lantus.
With each injection, change the puncture site within the particular area of skin that you are using.
B’ kull injezzjoni, biddel is- sit tat - titqiba, fiż- żona partikolari tal- ġilda li qed tuża.
Look at the vial before you use it.
Ifli l- kunjett qabel ma tużah.
Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it.
Użah biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah l- ilma, u ma jkunx jidher xi frak fiha.
Do not shake or mix it before use.
M’ għandekx tħawdu jew tħalltu qabel ma tużah.
Do not mix Lantus with any other insulins or medicines.
Tħallatx Lantus ma ’ insulini oħra jew ma ’ xi mediċini.
Do not dilute it.
Tiddilwihx.
Mixing or diluting may change the action of Lantus.
Jekk tħalltu jew tiddilwih jista ’ jinbidel l- effett ta ’ Lantus.
Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża kunjett ġdid jekk tinduna li f’ daqqa waħda l- kontroll taz- zokkor fid- demm tiegħek imur għall - agħar.
This is because the insulin may have lost some of its effectiveness.
Dan jista ’ jkun minħabba li l- insulina tkun tilfet xi ftit mill- qawwa tagħha.
If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist
Jekk taħseb li għandek xi problema b’ Lantus, ħudu għand it- tabib jew l- ispiżjar tiegħek biex jeżaminah
Mistakes in dosage
Żbalji fid- dożaġġ:
If you use more Lantus than you should
Jekk tuża Lantus aktar milli suppost
- If you have injected too much Lantus, your blood sugar level may become too low
- Jekk injettajt aktar Lantus milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq
For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Għal informazzjoni fuq il- kura ta ’ l- ipogliċemija, ara l- kaxxa fit - tmiem ta ’ dan il- fuljett.
If you forget to use Lantus
Jekk tinsa tuża Lantus
- If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar
- Jekk tlift doża ta ’ Lantus jew jekk ma injettajtx biżżejjed insulina, il- livell taz- zokkor fid- demm jista ’
level may become too high (hyperglycaemia).
jogħla wisq (ipergliċemija).
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 stop using Lantus 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).
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 Lantus without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Lantus mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Lantus can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Lantus jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Hypoglycaemia (low blood sugar) can be very serious.
L- ipogliċemija (livell baxx ta ’ zokkor fid- demm) tista ’ tkun serja ħafna.
If your blood sugar level falls too much you may become unconscious.
Jekk il- livell taz- zokkor fid - demm tiegħek jinżel wisq tista ’ tintilef minn sensik.
Serious hypoglycaemia may cause brain damage and may be life- threatening.
Ipogliċemija serja tista ’ tikkawża ħsara fil- moħħ u jista ’ jkun hemm ir- riskju li titlef ħajtek.
If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Jekk għandek sintomi li juru li l- livell ta ’ zokkor fid- demm huwa baxx, ħu dawk l- azzjonijiet li jżidu b’ mod immedjat il- livell taz- zokkor fid- demm.
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- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tkun għarqan.
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.
Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Effetti sekondarji rrapportati b’ mod komuni ħafna (jidhru f’ aktar minn pazjent 1 minn kull 10 pazjenti) • Ipogliċemija
Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood.
Ipogliċemija (livell baxx ta ’ zokkor fid- demm) tfisser li m’ hemmx biżżejjed zokkor fid- demm.
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Ara l - kaxxa fit- tmiem ta ’ dan il- fuljett għal aktar informazzjoni dwar l- effeti sekondarji ta ’ livell baxx ta ’ zokkor fid- demm jew ta ’ livell għoli ta ’ zokkor fid- demm.
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)
Thickening of fatty tissue may occur in 1 to 2% of patients while shrinking may occur uncommonly.
It- tħaxxin tat- tessut xaħmi jista ’ jseħħ f’ 1 sa 2% tal- pazjenti, waqt li t- tnixxif jista ’ jseħħ mhux ta ’ spiss.
Insulin that you inject in such a site may not work very well.
L- insulina li tinjetta f’ sit bħal dan tista ’ ma taħdimx sew.
Changing the injection site with each injection may help to prevent such skin changes. • Skin and allergic reactions 3 to 4% of patients may experience reactions at the injection site (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation).
3 sa 4% tal- pazjenti jistgħu jkollhom reazzjonijiet fis- sit ta ’ l- injezzjoni (bħal ħmura, uġigħ qawwi mhux tas- soltu meta ssir l- injezzjoni, ħakk, urtikarja, nefħa jew infjammazzjoni).
They can also spread around the injection site.
Dawn jistgħu wkoll jinfirxu madwar is- sit ta ’ l- injezzjoni.
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Il- biċċa l- kbira tar- reazzjonijiet żgħar għall- insulini normalment jgħaddu fi żmien ftit jiem sa ftit ġimgħat.
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.
Sintomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), jinkludu nefħa severa fil- ġilda jew fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs,, taqa ’ l- pressjoni fid- demm, polz
If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
mgħaġġel jew tibda tegħreq. Każijiet severi ta ’ reazzjonijiet ġeneraliżżati, inkluża r- reazzjoni anafilattika, tista ’ tkun fatali.
Other side effects include:
Effetti sekondarji oħrajn jinkludu:
Insulin 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).
Rarely, this may require a change to your insulin dosage.
Madankollu, huwa biss rari ħafna li din tista ’ tirrikjedi bidla fid- doża tiegħek ta ’ l- insulina.
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
F’ każijiet rari, it- trattament bl- insulina jista ’ wkoll jikkaġuna żieda temporanja ta ’ l- ilma fil- ġisem b’ nefħa tal- pxiexen u ta ’ l- egħkiesi.
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
F’ każijiet rari ħafna, jista ’ jkollok dysgeusia (disturbi fit- togħma) u majalġja (uġigħ muskolari)
88 Paediatric patients
Pazjenti pedjatriċi
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.
Complaints of injection site reactions and skin reactions are reported relatively more frequently in patients of 18 years of age or less than in adult patients.
Ilmenti ta ’ reazzjonijiet fis- sit ta ’ l- injezzjoni u reazzjonijiet tal- ġilda huma rrapportati relattivament aktar spiss f’ pazjenti fl- età ta ’ 18- il sena, jew anqas, milli fl- adulti.
No clinical study safety data are available in patients below 6 years of age.
M’ hemmx data tas- sigurta ’ minn studji kliniċi fi tfal taħt 6 snin.
HOW TO STORE LANTUS
KIF TAĦŻEN LANTUS
Do not use Lantus after the expiry date which is stated on the carton and on the label of the vial.
Tużax Lantus wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
Unopened vials Store in a refrigerator (2°C-8°C).
Kunjetti mhux miftuħa Aħzen fil- friġġ (2°Ċ- 8°Ċ).
Do not put Lantus next to the freezer compartment or next to a freezer pack.
Lantus m’ għandux jitpoġġa viċin il- kompartiment tal - friża jew viċin xi pakkett tal- friża.
Keep the vial in the outer carton in order to protect from light. Opened vials Once in use, the vial may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light in the outer carton.
Ġaladarba fl- użu, l- kunjett jista jinħażen sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ fil - kartuna ta ’ barra u ’ l bogħod mis- sħana diretta jew mid- dawl dirett..
Do not use it after this time period.
Tużax il- kunjett wara dan il- perijodu ta ’ żmien.
It is recommended that the date of the first use be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu titniżżel fuq it - tikketta.
Do not use Lantus if you notice particles in it.
Tużax Lantus jekk tinnota xi frak fih.
Only use Lantus if the solution is clear, colourless and waterlike.
Uża Lantus biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah lill- ilma.
What Lantus contains
Millilitru wieħed ta ’ soluzzjoni fih 100 Unità tas- sustanza attiva
• The active substance is Insulin glargine.
insulina glargine.
One millilitre of the solution contains 100 Units of the active substance insulin glargine. • The other ingredients of Lantus are: zinc chloride, m-cresol, glycerol, sodium hydroxide, hydrochloric acid, polysorbate 20 (10 ml vial only) and water for injections.
acid, polysorbate 20 (kunjett ta ’ 10 ml biss) u ilma għall- injezzjonijiet.
What Lantus looks like and contents of the pack
Id- dehra ta ’ Lantus u l- kontenuti tal- pakkett:
Lantus 100 Units/ ml solution for injection in a vial is a clear, colourless and waterlike solution.
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ kunjett huwa soluzzjoni ċara, mingħajr kulur u tixbah l - ilma.
Each vial contains 5 ml solution (500 Units) or 10 ml solution (1000 Units) and they are available in packs of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.
Kull kunjett fih 5 ml ta ’ soluzzjoni (500 Unità) jew 10 ml ta ’ soluzzjoni (1000 Unità) u huwa disponibbli f’ pakketti ta ’ 1, 2, 5 u 10 kunjetti ta ’ 5 ml jew kunjett 1 ta ’ 10 ml.
89 Manufacturer:
Il- Manifattur:
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Il- Ġermanja.
Gruppo Lepetit S. r. l., Località Valcanello, 03012 Anagni (FR), Italy.
Località Valcanello 03012 Anagni (FR) L- Italja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott, 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
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Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
91 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
Carry some information with you to show you are diabetic.
Dejjem ġorr miegħek xi zokkor (għallinqas 20 gramma) Ġorr miegħek xi informazzjoni biex turi li inti dijabetiku/ a.
- you have not injected your insulin or not injected enough, or if it has become less effective, for
- int ma injettajtx l- insulina tiegħekjew ma injettajtx biżżejjed, jew jekk saret anqas effettiva, per
- 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, eċċitament),
you have an injury, operation, infection or fever,
jew għandek xi ferita, saritlek xi operazzjoni, għandek xi infezzjoni jew għandek id- deni.
Warning symptoms of hyperglycaemia Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine.
Sintomi ta ’ twissija ta ’ ipergliċemija Għatx, tħoss il- bżonn miżjud biex tgħaddi l- awrina aktar spiss miss- soltu, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħaġġel u glukosju u ketoni fl- awrina.
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.
Uġigħ fl - istonku, 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.
What should you do if you experience hyperglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipergliċemija?
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
Ittestja l- livell taz- zokkor fid- demm tiegħek u fl- awrina tiegħek għall- ketoni hekk kif iseħħ xi wieħed mis - sintomi t’ hawn fuq.
Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
L- ipergliċemija severa jew il- kitoaċidożi għandhom dejjem ikunu kkurati minn tabib, normalment fi sptar.
- you do not eat enough, or eat food containing less carbohydrate than normal (sugar and
- int ma tiekolx biżżejjed, jew qed tiekol ikel li fih anqas karboidrati minn normal, (zokkor u sustanzi
substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
simili għaz- zokkor li jissejħu karboidrati; madankollu, l- ħlewwiet artifiċjali M’ HUMIEX karboidrati),
- you lose carbohydrates due to vomiting or diarrhoea,
- int qed titlef il- karboidrati minħabba remettar jew dijarea,
- you are recovering from an illness or from fever,
- int qed tirkupra minn marda jew mid- deni,
92 Hypoglycaemia is also more likely to occur if
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you have just begun insulin treatment or changed to another insulin preparation, (when
- int għadek tibda t- trattament bl- insulina jew qlibt għal preparat ieħor ta ’ insulina, (meta tbiddel mill -
changing from your previous basal insulin to Lantus hypoglycaemia, 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.)
- you change the area of skin where you inject insulin (for example from the thigh to the upper
- int bdilt iż- żona tal- ġilda fejn tinjetta l- insulina (per eżempju mill- koxxa għall- parti ta ’ fuq tad- driegħ),
arm),
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- you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
- int issofri minn mard sever tal- kliewi jew mard tal- fwied, jew xi marda oħra bħal tnaqqis fil- funzjoni
-In your body Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Eżempji ta ’ sintomi li juruk li l- livell taz- zokkor fid- demm tiegħek qed jaqa ’ wisq, jew qiegħed jinżel wisq malajr: għaraq żejjed, ġilda twaħħal, l- ansjetà, il- qalb tħabbat mgħaġġla, pressjoni għolja tad- demm, palpitazzjonijiet u l- qalb tħabbat b’ mod irregolari.
-In your brain 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.
- you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of
- int anzjan, int kellek id- dijabete għal żmien twil, inti tbati minn ċertu tip ta ’ mard tas- sistema nervuża
nervous disease (diabetic autonomic neuropathy),
(newropatija awtonomika dijabetika),
- you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,
- int batejt dan l- aħħar mill- ipogliċemija (per eżempju il- jum ta ’ qabel) jew jekk tiżviluppa bil- mod,
- you have almost normal or, at least, greatly improved blood sugar levels,
- int għandek livelli ta ’ zokkor fid- demm li huma kważi normali jew, ta ’ l- inqas, marru għall- aħjar
- you have recently changed from an animal insulin to a human insulin such as Lantus,
- dan l- aħħar biddilt minn tip ta ’ insulina ġejja mill- annimali għal dik tat- tip umana bħal Lantus,
Be familiar with your warning symptoms.
Kun familjari mas- sintomi ta ’ twissija għalik.
93 What should you do if you experience hypoglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?
Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Immedjatament ħu madwar 10 sa 20 g zokkor, bħal glukosju, dadi taz- zokkor, jew xi xarba ħelwa li fiha z- zokkor.
Your doctor or nurse should have discussed this with you previously.
Suppost it- tabib jew l- infermier tiegħek kienu iddiskutew din il- ħaġa miegħek qabel.
The recovery of hypoglycaemia may be delayed because Lantus has a long action.
L- irkuprar mill - ipogliċemija tista ’ ddum minħabba li Lantus jibqa ’ jaħdem fit- tul.
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Jekk int ma tistax tibla ’ jew jekk int mitluf minn sensik, int teħtieġ injezzjoni tal- glukosju jew tal- glukagon (mediċina li tgħolli l- livell taz- zokkor fid- demm).
These injections are justified even if it is not certain that you have hypoglycaemia.
Dawn l- injezzjonijiet huma ġustifikati anki jekk mhux ċerti li għandek l- ipogliċemija.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Huwa rrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l- glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
94 PACKAGE LEAFLET:
- 94 -
INFORMATION FOR THE USER Lantus 100 Units/ ml solution for injection in a cartridge Insulin glargine
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni fi skartoċċ Insulina glargine
The instructions for using the insulin pen are provided with your insulin pen.
L- istruzzjonijiet dwar l- użu tal- pinna ta ’ l- insulina huma pprovduti mal- pinna tiegħek ta ’ l- insulina.
Refer to them before using your medicine.
Irreferi għalihom qabel ma tuża l - mediċina tiegħek.
- This medicine has been prescribed for you. Do not pass it on to others.
M’ għandekx tgħaddiha lil persuni oħra.
their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. -
It is made by a biotechnology process.
Huwa magħmul permezz ta ’ proċess bijoteknoloġiku rikombinanti.
BEFORE YOU USE LANTUS
QABEL TUŻA LANTUS
Take special care with Lantus
Oqgħod attent/ a ħafna b’ Lantus:
95 Travel
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In each case, it may be necessary to adjust your insulin dosage to avoid blood sugar levels that are too low or too high.
F’ kull każ, jista ’ jkun meħtieġ li taġġusta d- doża tiegħek ta ’ l- insulina biex tevita livelli taz - zokkor fid- demm li jkunu baxxi wisq jew għoljin wisq.
- monoamine axydase (MAO) inhibitors (used to treat depression),
- l- inibituri ta ’ monoamine oxidase (MAO) (użati għall- kura tad- depressjoni)
- corticosteroids (such as "cortisone" used to treat inflammation),
- l- kortikosterojdi (bħal "cortisone", użat għall- kura ta ’ l- infjammazzjoni)
96
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- 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)
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
L- imblokkaturi tar- riċetturi beta, bħall- mediċini oħra simpatolitiċi, (bħal clonidine, guanethidine, u reserpine) jistgħu jdgħajjfu sintomi ta ’ twissija li jgħinuk tagħraf xi ipogliċemija.
- you have problems with your sight.
- għandek problemi bil- vista tiegħek
- you have frequent episodes of hypoglycaemia,
- għandek eposodji spissi ta ’ ipogliċemija,
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:
Lantus is a long-acting insulin.
Lantus huwa tip ta ’ insulina li taħdem fit- tul.
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 għal aktar dettalji.
How to handle the cartridges
Kif timmaniġġa l- iskartoċċi
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Lantus cartridges, and as recommended in the information provided by the device manufacturer.
L- iskartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall - iskartoċċi ta ’ Lantus u kif inhu rrakkomandat fit- tagħrif ipprovdut mal- pinna mill- manifattur.
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 tingħata l- injezzjoni.
Keep the cartridge at room temperature for 1 or 2 hours before inserting it in the pen.
Żomm l- iskartoċċ fit- temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn, qabel ma ddaħħlu fil- pinna.
Look at the cartridge before you use it.
Eżamina l- iskartoċċ qabel tużah.
Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it.
Użah biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah ’ l- ilma, u m’ għandhiex xi frak jidher fiha.
Do not shake or mix it before use.
Tħawdux jew tħalltu qabel l- użu..
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, ħudu għand it- tabib jew l- ispiżjar tiegħekbiex jeżaminah.
Before injection remove any air bubbles (see instructions for using the pen).
Qabel tinjetta neħħi l- bżieżaq ta ’ l- arja (ara l- istruzzjonijiet dwar l- użu tal- pinna).
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Kun żgur li la l- alkoħol u lanqas disinfettanti oħra, jew xi sustanzi oħra, ma jikkontaminaw l- insulina.
Do not re-fill and re-use empty cartridges. Do not add any other insulin to the cartridge.
Iżżidx xi insulina oħra fl- iskartoċċ.
Do not dilute it.
Tiddilwiehx.
Mixing or diluting may change the action of Lantus.
Jekk tħalltu jew tiddilwieh jista ’ jinbidel l- effett ta ’ Lantus.
98 Problems with the insulin pen?
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Refer to the manufacturer’ s instructions for using the pen.
Jekk jogħġbok, ara l- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Jekk il- pinna ta ’ l- insulina bil- ħsara jew mhix qed taħdem sew (minħabba difetti mekkaniċi), għandha tintrema, u tintuża pinna ġdida ta ’ l- insulina minflok.
If the insulin pen does not function well, you can draw the insulin from the cartridge into a syringe for injection.
Jekk il- pinna ta ’ l- insulina ma taħdimx sew, is- soluzzjoni tista ’ tinġibed lura mill- iskartoċċ ġewwa siringa għall- injezzjoni.
Therefore, keep injection syringes and needles as well.
Għalhekk, għandu jkollok kemm is- siringi għall- injezzjoni kif ukoll il- labar.
However, use only injection syringes which are designed for an insulin concentration of 100 Units per millilitre.
Madankollu, uża biss dawk is- siringi għall- injezzjoni li huma magħmulin għal insulina b ’ konċentrazzjoni ta ’ 100 Unità għal kull millilitru.
- If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar
- Jekk tlift doża ta ’ Lantus jew jekk ma injettajtx biżżejjed insulina, il- livell tiegħek taz- zokkor fid- demm
level may become too high (hyperglycaemia).
jista ’ jogħla wisq (ipergliċemija).
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. 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.
99 Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Effetti sekondarji rrapportati b’ mod komuni ħafna (jidhru f’ aktar minn pazjent 1 minn kull 10 pazjenti) • Ipogliċemija
For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Ara l - kaxxa fit- tmiem ta’ dan il- fuljett, għal aktar informazzjoni dwar l- effeti sekondarji ta ’ livell baxx ta ’ zokkor fid- demm jew ta ’ livell għoli ta ’ zokkor fid- demm.
Insulin that you inject in such a site may not work very well.
L- insulina li njettajt f’ sit bħal dan tista ’ ma taħdimx sew.
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.
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
100 5.
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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.
Unopened cartridges Store in a refrigerator (2°C-8°C).
Aħżen fil- friġġ (2°Ċ- 8°Ċ).
Do not put Lantus next to the freezer or a freezer pack.
Lantus m’ għandux jitpoġġa viċin il- kompartiment tal - friża jew viċin xi pakkett tal- friża.
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.
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 jew mid- dawl dirett.
The cartridge in use must not be stored in a refrigerator.
L- iskartoċċ li qed intuża m’ għandux jinżamm fi friġġ.
Do not use it after this time period.
Tużahx wara dan il- perijodu ta ’ żmien
Only use Lantus if the solution is clear, colourless and waterlike.
Uża Lantus biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah l- ilma.
What Lantus contains
X’ fih Lantus:
- The active substance is Insulin glargine.
- Is- sustanza attiva hi insulina glargine.
One millilitre of the solution contains 100 Units of the
Millilitru wieħed ta ’ soluzzjoni fih 100 Unità tas- sustanza attiva
active substance insulin glargine.
insulina glargine.
- 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 acid and water for injections.
hydrochloric acid, u ilma għall- injezzjonijiet.
Lantus 100 Units/ ml solution for injection in a cartridge is a clear and colourless solution.
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni fi skartoċċ hija soluzzjoni ċara u minghajr kulur.
Lantus comes in a special cartridge for use in an Insulin Pen such as OptiPen and other pens suitable for Lantus cartridges.
Lantus huwa fornut f’ skartoċċ speċjali għall- użu f’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- iskartoċċi ta ’ Lantus.
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 huwa disponibbli f’ pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi.
101 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
България sanofi-aventis Bulgaria EOOD Тел.: +359 (0)2 970 53 00
sanofi- aventis Bulgaria EOOD
Magyarország sanofi-aventis zrt., Magyarország Tel.: +36 1 505 0050
sanofi- aventis zrt., Magyarország
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
103 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
- your insulin pen does not work properly,
eżempju minħabba ħażna ħażina,
Why does hypoglycaemia occurs?
Għaliex isseħħ l- ipogliċemija?
medicines ").
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
104 Hypoglycaemia is also more likely to occur if
- 103 -
- you have just begun insulin treatment or changed to another insulin preparation (when changing
- int għadek tibda t- trattament bl- insulina jew qlibt għal preparat ieħor ta ’ insulina, (meta tbiddel mill -
from your previous basal insulin to Lantus hypoglycaemia, 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.)
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Eżempji ta ’ sintomi li juruk li l- livell taz- zokkor fid- demm tiegħek qed jaqa ’ wisq, jew qiegħed jinżel wisq malajr: għaraq żejjed, ġilda twaħħal, l- ansjetà, il- qalb tħabbat mgħaġġla, pressjoni għolja tad- demm, palpitazzjonijiet u l- qalb tħabbat b’ mod irregolari.
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.
- you have almost normal or, at least, greatly improved blood sugar levels,
- int għandek livelli ta ’ zokkor fid- demm li huma kważi normali jew, ta ’ l- inqas, marru għall - aħjar
- you have recently changed from an animal insulin to a human insulin such as Lantus,
- dan l- aħħar biddilt minn tip ta ’ insulina ġejja mill- annimali għal dik tat- tip umana bħal- Lantus,
Be familiar with your warning symptoms.
Kun familjari mas- sintomi ta ’ twissijagħalik.
105 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 ddum minħabba li Lantus jibqa ’ jaħdem fit- tul.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Huwa irrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l- glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
106 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
Lantus 100 Units/ ml solution for injection in a cartridge for OptiClik Insulin glargine
Lantus 100 Unità/ ml soluzzjoni għall- injezzjoni f’ skartoċċ għal OptiClik Insulina glargine
It may harm them, even if
Tista ’ tagħmlilhom il- ħsara,
their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
Before you use Lantus 3.
Qabel ma tuża Lantus Kif għandek tuża Lantus 3.
Lantus is a clear, colourless solution for injection containing insulin glargine.
Lantus huwa soluzzjoni akweja, ċara u mingħajr kulur, għall- injezzjoni, li fiha l- insulina glargine.