qanastek/EMEA-V3 huggingface dataset:
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.
94 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, taħbit tal- qalb mgħaġġel jew tibda tegħreq.
These could be symptoms of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Dawn 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
Effetti sekondarji rrapportati b’ mod komuni ħafna (jidhru f’ aktar minn pazjent 1 minn kull 10 pazjenti) • Ipogliċemija
91 Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. See the box at the end of this leaflet for important further information about hypoglycaemia and its treatment.
Ara l- kaxxa fit- tmiem ta ’ dan il- fuljett, għal aktar informazzjoni rigward l- ipogliċemija u l- kura tagħha.
Common reported side effects (experienced in more than 1 in 100 but less than 1 in 10 patients) • Skin and allergic reactions Reactions at the injection site may occur (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation).
Effetti sekondarji rrapportati b’ mod komuni (jidhru f’ aktar minn 1 minn kull 100 iżda f’ anqas minn 1 minn kull 10 pazjenti) • Reazzjonijiet tal- ġilda u dawk allerġiċi.
They can also spread around the injection site.
Dawn jistgħu wkoll jinfirxu madwar is- sit ta ’ l - injezzjoni.
Uncommon reported side effects (experienced in more than 1 in 1,000 but less than 1 in 100 patients) • Systemic allergic reactions Generalised allergy to insulin.
Effetti sekondarji rrapportati b’ mod mhux komuni (jidhru f’ aktar minn 1 minn kull 1, 000 iżda anqas minn 1 minn kull 100 pazjent) • Reazzjonijiet allerġiċi sistemiċi.
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.
Allerġija ġeneraliżżata għall- insulina Simtomi assoċjati ma ’ 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, b’ taħbit tal- qalb mgħaġġel jew tibda tegħreq.
Severe cases of generalised reactions, including anaphylactic reaction, may be life-threatening.
Każijiet severi ta ’ reazzjonijiet ġeneraliżżati, inkluża r- reazzjoni anafilattika, tista ’ tkun fatali.
Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 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.
Jekk tinjetta l- insulina tiegħek spiss wisq fl- istess sit tal- ġilda; it- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jogħlob jew jeħxien.
Insulin that you inject in such a site may not work very well.
L- insulina li tinjetta f’ dan is- sit tista ’ ma taħdimx tajjeb bizzejjed.
Changing the injection site with each injection may help to prevent such skin changes.
Jekk tibdel is- sit tal- injezzjoni ma ’ kull injezzjoni dan jgħin biex tilqa ’ kontra dawn it- tibdiliet fil- ġilda.
• Hyperglycaemia (high blood sugar) means that there is too much sugar in the blood.
• L- ipergliċemija (livell għoli ta ’ zokkor fid- demm) tfisser li hemm wisq zokkor fid- demm.
If your blood sugar level is too high, this tells you that you could have needed more insulin than you injected.
Jekk il- livell taz- zokkor fid- demm tiegħek huwa għoli wisq, dan ifisser li għandu mnejn kellek bżonn aktar insulina milli injettajt.
See the box at the end of this leaflet for further information. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor tiegħek fid- demm tista ’ tiddisturba il- vista tiegħek temporanjament.
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.
Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.
Biex
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurs suddenly or gets worse rapidly.
95 tilqa ’ minn qabel reazzjonijiet serji, kellem lit- tabib immedjatament jekk l- effett sekondarju huwa sever, jiġri f’ daqqa jew jiddeterjora malajr.
HOW TO STORE APIDRA
KIF TAĦŻEN APIDRA
Do not use Apidra after the expiry date, which is stated on the carton and on the label of the vial.
Tużax Apidra 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 Aħżen fi friġġ (2°Ċ – 8°Ċ).
Do not put Apidra next to the freezer compartment or a freezer pack.
Apidra m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża..
Opened vials Once in use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat or direct light. Do not use the vial after this time period.
Ġaladarba fl- użu, il- 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 Apidra if it does not appear clear and colourless.
Tużax Apidra jekk tinnota li mhux ċar u li m’ għadux mingħajr kulur.
92 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Apidra contains
X’ fih Apidra:
- The active substance is insulin glulisine.
- Is- sustanza attiva hi insulina glulisine.
One millilitre of the solution contains 100 Units of the
Millilitru wieħed ta ’ soluzzjoni fih 100 Unità tas -
active substance insulin glulisine (equivalent to 3.49 mg).
sustanza attiva insulina glulisine (ekwivalenti għal 3. 49 mg).
- The other ingredients are: metacresol, sodium chloride, trometamol, polysorbate 20,
- Is- sustanzi l- oħra huma: metacresol, sodium chloride, trometamol, polysorbate 20, hydrochloric
concentrated hydrochloric acid, sodium hydroxide, water for injections
acid ikkonċentrat, sodium hydroxide, ilma għall- injezzjonijiet.
What Apidra looks like and contents of the pack
Id- Dehra ta ’ Apidra u l- kontenuti tal- pakkett:
Apidra 100 Units/ ml solution for injection in a vial is a clear, colourless solution with no particles visible.
Apidra 100 Unità/ ml soluzzjoni għall- injezzjoni f’ kunjett, hija ċara, mingħajr kulur u bla frak viżibbli.
Each vial contains 10 ml solution (1000 Units).
Kull kunjett fih soluzzjoni ta’ 10 ml (1000 Unità).
Packs of 1, 2, 4 and 5 vials of 10 ml are available.
Pakketti ta ’ 1, 2, 4 u 5 kunjetti ta ’ 10 ml huma disponibbli.
Sanofi-Aventis Deutschland GmbH Brüningstraße 50, D-65926 Frankfurt am Main Germany.
Sanofi- Aventis Deutschland GmbH Brüningstraße 50, D- 65926 Frankfurt am Main Il- Ġermanja
Manufacturer:
96 Manifattur:
93 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Italia sanofi-aventis S. p. A.
97 Italia sanofi- aventis S. p. A.
This leaflet was last approved on {date}
Dan il- fuljett kien l- aħħar approvat fi {data}
95 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
98 IPERGLIĊEMIJA U IPOGLIĊEMIJA
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, il- bżonn akbar biex tgħaddi l- awrina, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħaġġla u glukosju u ketoni fl- awrina.
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 l- awrina tiegħek għall- ketoni hekk kif iseħħ xi wieħed mis- sintomi t’ hawn fuq.
substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
sustanzi simili għaz- zokkor jissejjħu karboidrati; madankollu, l- ħlewwiet artifiċjali M’ HUMIEX karboidrati),
- your blood sugar levels are almost normal or are unstable,
- int għandek il- livelli taz- zokkor fid- demm tiegħek kważi normali jew mhux stabbli,
- 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 ipotirojdiżmu
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.
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 and loss of consciousness.
dardir, remettar, għeja, ngħas, disturbi fl- irqad, nuqqas ta ’ kwiet, mġieba aggressiva, nuqqas ta ’ konċentrazzjoni, 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.
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if:
L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
- you are elderly,
- int anzjan,
- you have had diabetes for a long time,
- int kellek id- dijabete għal żmien twil,
- you suffer from a certain type of nervous disease (diabetic autonomic neuropathy),
- inti tbati minn ċertu tip ta ’ mard tas- sistema nervuża (newropatija awtonomika dijabetika),
- you are taking or have taken certain other medicines (see section 2, "Using other medicines.)
- int qed tieħu jew ħadt ċerti mediċini oħrajn (ara sezzjoni 2, “ Meta tuża mediċini oħra ”).
In such a case, you may develop severe hypoglycaemia (and evenfaint) before you are aware of the problem.
F’ dan il- kaz, tista ’ tiżviluppa ipogliċemija severa (u anki jħossok ħażin) qabel tintebaħ bil- problema.
97 PACKAGE LEAFLET:
100 FULJETT TA ’ TAGĦRIF:
Apidra 100 Units/ ml solution for injection in a cartridge Insulin glulisine
Apidra 100 Unità/ ml soluzzjoni għall- injezzjoni fi skartoċċ Insulina glulisine
Read all of this leaflet carefully before you start using this medicine. 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 ta ’ l- insulina tiegħek.
Before you use Apidra 3.
Qabel ma tuża Apidra Kif għandek tuża Apidra 3.
Take special care with Apidra
Oqgħod attent/ a ħafna b’ Apidra
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
101 M’ hemmx informazzjoni klinika adegwata dwar l- użu ta ’ Apidra fit- tfal u l- adolexxenti.
Before travelling consult your doctor.
Safar – Qabel tivvjaġġa 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 għal saħħtek fil- pajjiż li tkun qiegħed żżur, – x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
- supplies of insulin, injection syringes etc,
Mard u feriti
- timing of meals and insulin administration while travelling,
F’ dawn is- sitwazzjonijiet li ġejjin, l- immaniġġar tad- dijabete tiegħek, jista ’ jkollha bżonn ta ’ ħafna attenzjoni:
Tell your doctor or pharmacist if you are taking or have taken recently 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.
- angiotensine converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high
- l- inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE) (użati għall- kura ta ’ ċerti -
- diuretics (used to treat high blood pressure or excessive fluid retention),
102
- glucagon (pancreas hormone used to treat severe hypoglycaemia),
-
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew l- akkumulazzjoni eċċessiva ta ’ fluwidi),
- phenothiazine derivatives (used to treat psychiatric disorders),
- - - - - -
- sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to
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),
99
- - -
- you have hypoglycaemia (low blood sugar levels),
- għandek l- ipogliċemija( livelli baxxi ta ’ zokkor fid- demm)
- you have hyperglycaemia (high blood sugar levels).
- għandek l- ipergliċemija( livelli għoljin ta ’ zokkor fid- demm)
Important information about some of the ingredients of Apidra
103 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Apidra
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i. e. it is essentially ‘ sodium-free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ ħieles minn sodium ’.
HOW TO USE APIDRA
KIF GĦANDEK TUŻA APIDRA Dożaġġ
Your doctor may tell you to use it in combination with an intermediate, long acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
It- tabib tiegħek jista ’ jagħtik parir biex tieħdu flimkien ma ’ insulina li taħdem fuq perijodu intermedju twil, ma ’ insulina bażika, jew ma ’ pilloli użati għall- kura ta ’ livelli għoljin ta ’ zokkor fid- demm.
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Apidra cartridges, and as recommended in the information provided by the device manufacturer.
L- iskartoċċi għandhom jiġu użati flimkien ma ’ pinna ta ’ l- isulina bħal OptiPen jew pinen oħra li jaqblu ma ’ l- iskartoċċi Apidra u skond kif irrakkomandat fil- fuljett ta ’ tagħrif ipprovdut 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 bħal kif iddaħħal l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni.
Before insertion of the cartridge into the reusable pen, the cartridge must be stored at room temperature for 1 to 2 hours.
Qabel ma jiddaħħal l- iskartoċċ fil- pinna, li terġa ’ tintuża, l- iskartoċċ għandu jinżamm f’ temperatura tal- kamra għal minn siegħa sa sagħtejn.
Only use it if the solution is clear, colourless and has no visible particles in it.
Użah biss jekk is- soluzzjoni hija ċara, mingħajr kulur u m’ għandux frak viżibbli fiha.
Do not shake or mix it before use.
M’ għandekx tħawdu jew tħalltu qabel l- użu.
Special care before injection
104 Attenzjoni speċjali qabel l- injezzjoni
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Il- bżieżaq ta ’ l- arja jridu jitneħħew mill- iskartoċc qabel l- injezzjoni (ara l- istruzzjonijiet dwar l- użu tal- pinna).
Empty cartridges must not be refilled.
L- iskartoċċi vojta m’ għandhomx jerġgħu jimtlew.
To prevent any kind of contamination, the reusable pen should be used only by you.
Biex telimina kull tip ta ’ kontaminazzjoni, il- pinna li terġa ’ tintuża, għandha tintuża minnek biss.
101 Problems with the insulin pen?
Għandek problemi bil- pinna ta ’ l- insulina?
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 jogħġbok, ara l- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna. Jekk il- pinna ta ’ l - insulina għandha l- ħsara jew m’ hijiex taħdem tajjeb (minħabba xi difetti mekkaniċi) għandha tintrema u tintuża pinna ta ’ l- insulina ġdida.
If the pen does not function well, you can draw the insulin from the cartridge into an injection syringe.
Jekk il- pinna ma taħdimx tajjeb, is- soluzzjoni tista ’ tinġibed lura mill- iskartoċċ ġewwa siringa għall - injezzjoni.
Therefore, keep injection syringes and needles as well.
Għalhekk għandu jkollok 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 siringi għall- injezzjoni li huma magħmulin għal insulina b’ konċentrazzjoni ta ’ 100 Unità għal kull millilitru.
Mistakes in dosage
Żbalji fid- dożaġġ.
- If you have missed a dose of Apidra or if you have not injectedenough insulin, your blood sugar
- Jekk tlift doża ta ’ Apidra jew jekk ma injettajtx biżżejjed insulina, il- livell tiegħek taz- zokkor fid -
If you stop using Apidra 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 ’ aċidu fid- demm minħabba li l- ġisem qiegħed ikisser x- xaħam minflok iz- zokkor).
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 generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
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, taħbit tal- qalb mgħaġġel
Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia Hypoglycaemia (low blood sugars) means that there is not enough sugar in the blood.
Effetti sekondarji rrapportati b’ mod komuni ħafna (jidhru f’ aktar minn pazjent 1 minn kull 10 pazjenti) • Ipogliċemija
See the box at the end of this leaflet for important further information about hypoglycaemia and its treatment.
Ara l- kaxxa fit- tmiem ta ’ dan il- fuljett, għal aktar informazzjoni rigward l- ipogliċemija u l- kura tagħha.
102 Common reported side effects (experienced in more than 1 in 100 but less than 1 in 10 patients) • Skin and allergic reactions Reactions at the injection site may occur (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation).
Effetti sekondarji rrapportati b’ mod komuni (jidhru f’ aktar minn 1 minn kull 100 iżda f’ anqas minn 1 minn kull 10 pazjenti) • Reazzjonijiet tal- ġilda u dawk allerġiċi.
Uncommon reported side effects (experienced in more than 1 in 1,000 but less than 1 in 100 patients) • Systemic allergic reactions Generalised allergy to insulin. 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.
Effetti sekondarji rrapportati b’ mod mhux komuni (jidhru f’ aktar minn 1 minn kull 1, 000 iżda anqas minn 1 minn kull 100 pazjent) • Reazzjonijiet allerġiċi sistemiċi.
Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 patients) • Skin changes at the injection site (lipodystrophy) Ifyou inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken.
Jekk tinjetta l- insulina tiegħek spiss wisq fl- istess sit tal- ġilda; it- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jogħlob jew jeħxien.
Other side effects include: • Hyperglycaemia (high blood sugar) means that there is too much sugar in the blood.
• L- ipergliċemija (livell għoli ta ’ zokkor fid- demm) tfisser li hemm wisq zokkor fid- demm.
Do not use Apidra after the expiry date, which is stated on the carton and on the label of the cartridge.
Tużax Apidra 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). Do not freeze. Do not put Apidra next to the freezer compartment or a freezer pack.
Apidra m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
In use cartridges Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light and must not be stored in a refrigerator. Do not use it after this time period.
Tużahomx wara dan il- perijodu ta ’ żmien.
103 What Apidra contains
X’ fih Apidra:
Apidra 100 Units/ ml solution for injection in a cartridge is a clear, colourless solution with no particles visible.
Apidra 100 Unità/ ml soluzzjoni għall- injezzjoni f’ skartoċċ, li hija ċara, mingħajr kulur u bla frak viżibbli.
Each cartridge contains 3 ml solution (300 Units).
Kull skartoċċ fih soluzzjoni ta ’ 3 ml (300 Unità).
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges of 3 ml are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi ta ’ 3 ml huma disponibbli.
104 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
België/ Belgique/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
107 België/ Belgique/ Belgien sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
108 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
106 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
109 IPERGLIĊEMIJA U IPOGLIĊEMIJA
- you are recovering from an illness or fever,
- int qed tirkupra minn marda jew mid- deni
- 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 ipotirojdiżmu.
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 and 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, mġieba aggressiva, nuqqas ta ’ konċentrazzjoni, 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.
What should you do if you experience hypoglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipogliċemija
108 PACKAGE LEAFLET:
111 FULJETT TA ’ TAGĦRIF:
Apidra 100 Units/ ml solution for injection in a cartridge for OptiClik Insulin glulisine
Apidra 100 Unità/ ml soluzzjoni għall- injezzjoni fi skartoċċ għal OptiClik Insulina glulisine
Insulin glulisine is produced by biotechnology.
L - insulina glulisine hija magħmula permezz tal- bijoteknoloġija..
Special patient groups
112 Gruppi speċjali ta ’ pazjenti
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
M’ hemmx informazzjoni klinika adegwata dwar l- użu ta ’ Apidra fit- tfal u l- adolexxenti.
You may need to talk about
Safar Qabel tivvjaġġa tkellem mat- tabib tiegħek.
- the availability of your insulin in the country you are visiting,
Għandu mnejn ikollok tiddiskuti fuq – 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- possibbiltà ta ’ riskji ġodda għal saħħtek fil- pajjiż li tkun qiegħed iżżur. – x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
113 Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
- thyroid hormones (used to treat thyroid gland disorders),
- ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde),
- protease inhibitors (used to treat HIV),
- l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV)
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).
114 Żomm din il- problema f’ moħħok f’ kull sitwazzjoni fejn tista ’ tpoġġi lilek innifsek jew lil ħaddieħor f’ riskju (bħal fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
Many factors may influence your blood sugar level.
Hemm ħafna fatturi li jistgħu jinfluwenzaw il- livell taz- zokkor fid- demm tiegħek.
You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Għandek tkun taf liema huma dawn il- fatturi biex tkun tista ’ tirreaġixxi korrettament għall- bidliet fil- livelli taz- zokkor fid- demm tiegħek u tevita li z- zokkor jitla ’ jew jinżel wisq.
See the box at the end of this leaflet for further information.
Ara l- kaxxa fit- tmiem ta ’ dan il- fuljett għal aktar tagħrif
How to handle the cartridges for OptiClik Apidra in cartridge for OptiClik has been developed for use in OptiClik only.
Kif timmaniġġa l- iskartoċċi għal OptiClik Apidra f‘ skartoċċ għal OptiClik kienet żviluppata 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 għall- ikkargar ta ’ l - iskartoċċ, it - twaħħil tal- labra u l- għoti ta ’ l- injezzjoni ta ’ l- insulina.
Before insertion of the cartridge into the reusable pen OptiClik the cartridge must be stored at room temperature for 1 to 2 hours.
Qabel ma jiddaħħal l- iskartoċċ fil- pinna OptiClik, li terġa ’ tintuża, l- iskartoċċ għandu jinżamm f’ temperatura tal- kamra għal minn siegħa sa sagħtejn.
Air bubbles must be removed from the cartridge before injection (see instruction for using pen).
Il- bżieżaq ta ’ l- arja jridu jitneħħew qabel l - injezzjoni (ara l- istruzzjonijiet dwar l- użu tal- pinna).
Only use it if the solution is clear, colourless and has no visible particles in it.
Użah biss jekk is- soluzzjoni hija ċara, mingħajr kulur u m’ għandhiex frak viżibbli fiha..
Do not shake or mix it before use.
115 M’ għandekx tħawdu jew tħaltu qabel l- użu.
Refer to the manufacturer’ s instructions for using the pen.
Ara l- istruzzjonijiet mill- manifattur dwar l- użu tal- pinna.
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 hija bil- ħsara jew m’ hiex qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u tintuża OptiClik ġdida.
If OptiClik does not function well, you can draw the insulin from the cartridge into a syringe for injection.
Jekk OptiClik ma taħdimx sew, is- soluzzjoni tista ’ tinġibed lura mill- iskartoċċ ġewwa siringa għall - injezzjoni.
112 Mistakes in dosage
Żbalji fid- dożaġġ.
If you experience the following symptoms, contact your doctor immediately:
Jekk ikollok dawn is- sintomi li ġejjien, ikkuntattja b’ mod immedjat it- tabib tiegħek:
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 generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Dawn 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 Hypoglycaemia (low blood sugars) means that there is not enough sugar in the blood.
Effetti sekondarji rrapportati b’ mod komuni ħafna (jidhru f’ aktar minn pazjent 1 minn kull 10 pazjenti)
113 Uncommon reported side effects (experienced in more than 1 in 1,000 but less than 1 in 100 patients) • Systemic allergic reactions Generalised allergy to insulin.
Effetti sekondarji rrapportati b’ mod mhux komuni (jidhru f’ aktar minn 1 minn kull 1, 000 iżda anqas minn 1 minn kull 100 pazjent) • Reazzjonijiet allerġiċi sistemiċi.
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.
Allerġija ġeneraliżżata għall- insulina Simtomi assoċjati ma ’ 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, taħbit tal- qalb mgħaġġel jew tibda tegħreq.
Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 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.
Jekk tinjetta l- insulina tiegħek spiss wisq fl- istess sit tal- ġilda; it- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jew jogħlob jew jeħxien.
• Hyperglycaemia (high blood sugars) means that there is too much sugar in the blood.
• L- ipergliċemija (livell għoli ta ’ zokkor fid- demm) tfisser li hemm wisq zokkor fid- demm.
Unopened cartridges Store in a refrigerator (2°C – 8°C).
Skartoċċi mhux miftuħa Aħżen fi friġġ (2°Ċ – 8°Ċ).
Do not put Apidra next to the freezer compartment or a freezer pack.
Apidra m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin pakkett tal- friża.
Keep the cartridge in the outer carton in order to protect from light.
Żomm l - iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
In use cartridges Cartridges in use(in the insulin pen) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light and must not be stored in the refrigerator.
Skartoċċi fl- użu (fil- pinna ta ’ l- insulina) jistgħu jinħażnu sa massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ l bogħod mis- sħana diretta jew mid- dawl dirett u m’ għandhomxjinżammu fi friġġ.
Do not use it after this time period.
Tużahomx wara dan il- perijodu ta ’ żmien.
This cartridge is for use with OptiClik only.
Dan l- iskartoċċ huwa għall- użu b’ OptiClik biss.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
118 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
119 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
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 /
116 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
120 IPERGLIĊEMIJA U IPOGLIĊEMIJA
If your blood sugar is too high (hyperglycaemia), you may have not injected enough insulin.
Jekk iz- zokkor f’ demmek huwa għoli wisq (ipergliċemija), għandu mnejn ma injettajtx biżżejjed insulina
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, il- bżonn akbar biex tgħaddi l- awrina, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħaġġla u glukosju u ketoni fl- awrina.
- 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 - ipotirojdiżmu.
- you, suffer from a certain type of nervous disease (diabetic autonomic neuropathy),
- inti tbati minn ċertu tip ta ’ mard tas- sistema nervuża (newropatija awtonomika dijabetika),
118 PACKAGE LEAFLET:
122 FULJETT TA ’ TAGĦRIF:
Insulin glulisine
Apidra 100 Unità/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina glulisine
Read all of this leaflet carefully including the Instructions for Use of Apidra, pre-filled pen, OptiSet before using this medicine.
Aqra bir- reqqa dan il- fuljett kollu inklużi l- Istruzzjonijiet dwar l- Użu ta’ Apidra, pinna mimlija għal- lest, OptiSet qabel tibda tuża din il- mediċina.
Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older.
Apidra huwa sustanza mediċinali kontra d- dijabete, użata biex tnaqqas il- livell taz- zokkor għoli fid - demm f ’ pazjenti li jbatu bid- dijabete mellitus: dan jista ’ jingħata lill- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin jew akbar.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
123 M’ hemmx informazzjoni klinika adegwata dwar l- użu ta ’ Apidra fit- tfal u l- adolexxenti.
Before travelling consult your doctor.
Safar Qabel ma ssiefer 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 għal saħħtek fil- pajjiż li tkun qiegħed żżur, – x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad. –
- diuretics (used to treat high blood pressure or excessive fluid retention),
124
- glucagon(pancreas hormone used to treat severe hypoglycaemia),
-
- phenothiazine derivatives(used to treat psychiatric disorders),
- - - - - -
- sympathomimetic medicines (such as epinephrine [adrenaline]or salbutamol, terbutaline used to
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),
120 Your blood sugar level may either rise or fall if you take:
Il- livell taz- zokkor f’ demmek jista ’ jogħla jew jinżel jekk tieħu
Important information about some of the ingredients of Apidra
125 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Apidra
Dosage Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Skond l- istil tal- ħajja tiegħek u r- riżultati tat- testijiet taz- zokkor (glukosju) fid- demm u l- użu preċedenti ta ’ l- insulina, it- tabib tiegħek ser jikkalkula kemm ser ikollok bżonn Apidra
121 If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Jekk taqleb minn insulina oħra għall- insulina glulisine, id- dożaġġ tiegħek jista ’ jkollu jiġi aġġustat mit- tabib tiegħek.
OptiSet is a pre-filled disposable pen containing insulin glulisine.
OptiSet hija pinna li hija mimlija għal- lest, li tintrema wara li tinħela u li fiha l- insulina glulisine.
Read carefully the "OptiSet Instructions for Use" included in this package leaflet.
Aqra sew “ Struzzjonijiet dwar l- Użu ta ’ OptiSet ” li jinsabu f’ dan il- fuljett ta ’ tagħrif.
You must use the pen as described in these Instructions for Use.
Għandek tuża l- pinna kif deskritt f ’ dawn l- Istruzzjonijiet dwar l- Użu.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Biex tevita l- possibbilità tat- trasmissjoni tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Before use always attach a new needle, and perform a safety test.
Qabel l- użu dejjem waħħal labra ġdida, u agħmel test ta ’ sigurtà.
Only use needles that have been approved for use with OptiSet.
Uża biss labar li huma approvati għall- użu bl- OptiSet.
Look at the cartridge sealed in the disposable pen injector before you use it.
Eżamina l- iskartoċċ issiġillat fil- pinna, li tintrema wara li tinħela, fil- parti tagħha li ttaqqab, qabel ma tużha.
Only use it if the solution is clear, colourless and has no visible particles in it.
Użha biss jekk is- soluzzjoni hija ċara, mingħajr kulur u m’ għandhiex frak viżibbli fiha.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
Dejjem uża pinna ġdida jekk tinnota li l- kontroll taz- zokkor f’ demmek qiegħed imur għal agħar, bla mistenni.
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 jista ’ jkun hemm problema bl- OptiSet, jekk jogħġbok, ara s- sezzjoni 126 Mistoqsijiet u Tweġibiet, ta ’ l- Istruzzjonijiet dwar l- Użu ta ’ l- OptiSet, li huwa inkluż mal- pinna, jew ħudha lit- tabib jew lill- ispiżjar tiegħek biex jiċċekjahielek.
122 If you forget to use Apidra
Jekk tinsa tuża Apidra
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. They could be symptoms of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Jistgħu jkunu sintomi ta ’ allerġija ġeneralizzata għall- insulina, inkluża r - reazzjoni anafilattika, li tista ’ tkun fatali.
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.
Allerġija ġeneraliżżata għall- insulina Simtomi assoċjati ma ’ 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 tibda tegħreq.
123 Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 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.
Jekk tinjetta l- insulina tiegħek spiss wisq fl- istess sit tal- ġilda; it- tessut xaħmi taħt il- ġilda f’ dan is- sit jista ’ jew jogħlob jew jeħxien.
• Hyperglycaemia (high blood sugars) means there is too much sugar in the blood If your blood sugar level is too high, this tells you that you could have needed more insulin than you injected.
• L- ipergliċemija (livell għoli ta ’ zokkor fid- demm) tfisser li hemm wisq zokkor fid- demm.
Not in-use pens Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°Ċ – 8°Ċ).
Do not put the pre-filled pen next to the freezer compartment or a freezer pack.
Tpoġġix il- pinna mimlija għal- lest viċin tal- kompartiment tal- friża jew viċin xi pakk tal- friża.
In use pens In use pre-filled pens may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light and must not be stored in the refrigerator. Do not use it after this time period.
Tużahomx wara dan il- perijodu ta ’ żmien.
Apidra 100 Units/ ml, solution for injection in a pre-filled pen, OptiSet.
Apidra 100 Unità/ ml, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, OptiSet.
It is a clear, colourless solution with no particles visible.
Hija soluzzjoni ċara, mingħajr kulur u bla frak viżibbli.
124 Each pen contains 3 ml solution (300 Units).
Kull pinna fiha soluzzjoni ta ’ 3 ml (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 mimlija għal - lest, ta ’ 3 ml, huma disponibbli.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Danmark sanofi-aventis Denmark A/ S Tlf: +45 45 16 70 00
129 Danmark sanofi- aventis Denmark A/ S Tlf: +45 45 16 70 00
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Dan il- fuljett kien l- aħħar approvat fi {data} Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA):): http: // www. emea. europa. eu /
126 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
130 IPERGLIĊEMIJA U IPOGLIĊEMIJA
HYPERGLYCAEMIA (too high blood sugar levels)
IPERGLIĊEMIJA (livell għoli ta ’ zokkor fid- demm)
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, il- bżonn akbar biex tgħaddi l- awrina, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mgħaġġla u glukosju u ketoni fl- awrina.
127
131
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
128 OPTISET INSTRUCTIONS FOR USE
132 STRUZZJONIJIET DWAR L- UŻU TA ’ OPTISET
Doses from 2 to 40 units can be set in steps of 2 units.
Dożi minn 2 sa 40 unità jistgħu jkunu ssettjati, f’ qabżiet ta ’ 2 unità il- waħda.
Talk with your healthcare professional about proper injection technique before using OptiSet.
Kellem lill- professjonist tiegħek fil- qasam tas- saħħa dwar it- teknika adatta ta ’ l- injezzjoni qabel ma tuża OptiSet.
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 OptiSet jew id- dijabete, saqsi lill- professjonist tiegħek fil- qasam tas- saħħa jew ċempel fuq in- numru lokali ta ’ sanofi- aventis, li ssib fuq il- faċċata ta ’ dan il- fuljett.
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 konpatibbli 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 (iġifieri qatt m’ għandek tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni jkun inġibed ’ 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.
Taqsamhiex ma ’ ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed il- kawtela speċjali minn din il- persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti l- infezzjoni. • Qatt m’ għandek tuża OptiSet jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm OptiSet żejda f’ każ li l- OptiSet tiegħek tintilef jew jiġrilha l- ħsara.
Check the label on the pen and insulin reservoir to make sure you have the correct insulin.
Iċċekkja t- tikketta tal- pinna u r- riżervwar ta ’ l- insulina biex tiżgura li qed tuża t- tip korrett ta ’ insulina.
Apidra is a clear insulin.
Apidra huwa insulina ċara.
Do not use this OptiSet if the insulin is cloudy, coloured or has particles.
Tużax din l- OptiSet jekk l- insulina hija mdardra, ikkulurita jew fiha xi frak.
129 Step 2.
133 Pass Nru.
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 tevita l- kontaminazzjoni, u s- sadd potenzjali tal- labra.