qanastek/EMEA-V3 huggingface dataset:
The patient should read and follow the instructions that accompany the infusion pump and use the ng correct reservoir and catheter for the pump (see section 6.6).
kateter li suppost g all- pompa (ara sezzjoni 6. 6). li
The infusion set should be changed every 48 hours using aseptic technique when inserting the lo
Is- sett ta ’ l- infu joni jrid jinbidel kull 48 sieg a, bl- u u tat- teknika asettika meta jidda al is- sett ta ’ l - a
infusion set.
infu joni. in
When filling a new syringe, no large air bubbles should be left in either the syringe or the catheter. no
Il- pazjent g andu jsegwi l- istruzzjonijiet tat- tabib dwar ir- rata ta ’ l- infu joni ba ali u l- boluses ta ’ l - iċ
The patient should follow the instructions from the physician about the basal infusion rate and the mealtime insulin boluses to be taken. ct
insulina fil - in ta ’ l- ikel li g andhom jittie du. ed
To get the benefit of insulin infusion, and to detect possible malfunction of the pump, the patient du
Biex jibbenefika mill- infu joni ta ’ l- insulina, u biex jinduna b’ xi sara fil- pompa, il- pazjent g andu tm
should measure his blood glucose level regularly.
ji ekkja l- livell tal- glukosju fid- demm tieg u regolarment.
In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. ro
F’ ka ta ’ episodju ta ’ ipoglikemiku, l- infu joni g andha titwaqqaf sakemm l- episodju jg addi.
If repeated or severe low blood glucose levels occur, the patient should notify the health care professional and the need to reduce or stop the insulin administration should be considered.
fil- qasam tas- sa a, u g andha tkun ikkunsidrata l - tie a ta ’ jekk l- g oti ta ’ l- insulina g andux jitnaqqas jew jitwaqqaf.
A pump lp
Il - sara fil- pompa jew l- imblukkar fis- sett ta ’ l- infu joni jista ’ jwassal g al od
malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
ieda f’ daqqa tal- livelli tal- glukosju fid- demm.
If the patient suspects an interruption to insulin flow the patient should notify the health care professional. a in
Pr
Patients administering Velosulin by CSII must have injection syringes and alternative insulin readily available in case of emergency or pump interruption or failure, in order that insulin can be ic
Il- pazjenti li qed jie du Velosulin permezz tas- CSII, g andu jkollhom siringi g all- injezzjoni u insulina alternattiva li jkunu lesti biex jintu aw f’ ka ta ’ emer enza jew f’ ka li ta ’ interruzzjoni jew sara fil- pompa, biex b’ hekk l- insulina tkun tista ’ ting ata b’ injezzjoni ta t il - ilda.
M
Injezzjoni ta ’ l- insulina:
Administration of Velosulin is also possible by subcutaneous or intravenous injection.
L- g oti ta ’ Velosulin hu wkoll possibbli permezz ta ’ injezzjoni ta t il - ilda jew ol- vina.
Intravenous administration should only be carried out by health care professionals.
Injezzjoni minn ol- vini g andha ssir biss minn professjonisti fil- kura tas- sa a.
Velosulin is administered subcutaneously in the abdominal wall.
Normalment, Velosulin jing ata ta t il - ilda fil- wi c ta ’ l- addome.
The thigh, the gluteal region or the deltoid region may also be used.
Il- koxxa, i - ona gluteali jew il - parti tad- deltojd jistg u jintu aw ukoll.
Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.
ta ’ l- addome ti gura assorbiment aktar mg a el milli meta ting ata
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Injezzjoni o parti mill - ilda merfug a ’ l fuq tnaqqas ir- riskju ta ’ injezzjoni li ting ata ol- muskoli bi ball.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Il- labra g andha tin amm ta t il - ilda g al mill- anqas 6 sekondi biex ti gura li d- do a s i a tkun injettata.
3 Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Il- postijiet fejn ting ata l- injezzjoni g andhom jinbidlu f ’ ona anatomika biex ti i evitata l - lipodistrofija.
The vials may be used with insulin syringes with a corresponding unit scale.
Meta ew
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
za tipi ta ’ insulina jit alltu, l- ewwel i bed l- ammont ta ’ insulina li ta dem malajr, imbag ad i bed l - insulina li ta dem fit- tul.
Velosulin is accompanied by a package leaflet with detailed instruction for use to be followed.
riz Velosulin ji i b’ fuljett ta ’ tag rif mieg u, bi struzzjonijiet dettaljati g all- u u li g andhom ji u
4.3 Contraindications
to segwiti.
Hypoglycaemia.
aw 4. 3 Kontra- indikazzjonijiet
is 4.4 Special warnings and precautions for use
Sensittività e essiva g as- sustanza attiva jew g al xi sustanzi mhux attivi (ara sezzjoni 6. 1).
or Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to
du 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u ħa Do a inadegwat jew it- twaqqif tal- kura, spe jalment f’ pazjenti b’ dijabete tat- tip 1, jista ’ jwassal ’ g
th hyperglycaemia.
g al ipergli emija.
au Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Normalment, l- ewwel sintomi ta ’ ipergli emija jibdew bil- mod, fuq medda ta ’ mien ta ’ sig at jew m
They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Dawn jinkludu g atx, ieda fil- frekwenza li tag mel l- awrina, tqallig, rimettar, ng as, ilda xotta u amra, alq xott, nuqqas ta ’ aptit kif ukoll ri a ta ’ acetone fin- nifs. li
er In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. ng Due to the lack of long-acting insulin, patients receiving continuous subcutaneous insulin infusion via lo
F’ pazjenti b’ dijabete ta ’ tip 1, avvenimenti ipergli emi i li ma jkunux ikkurati, eventwalment iwasslu li
an insulin pump are at risk of fast development of ketoacidosis in case of prolonged interruption of continuous subcutaneous insulin infusion. no
Min abba n- nuqqas ta ’ insulina li ta dem fit- tul, il- pazjenti li jkunu qed jir ievu infu joni kontinwa ta ’ insulina ta t il - ilda permezz ta ’ pompa ta ’ l- insulina, ikunu f’ riskju li ji viluppaw l- ketoa idosi iċ
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9). ct
malajr fil- ka ta ’ interruzzjoni fit- tul ta ’ l- infu joni kontinwa ta ’ l- insulina ta t il - ilda. ed
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. du
Tista ’ sse l- ipogli emija jekk id- do a ta ’ l- insulina tkun g olja wisq meta mqabbla mal - tie a tm
Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised ro
Li taqbe ikla jew li tag mel e er izzju fi iku li je tie sforz qawwi, jista '
accordingly.
jwassal g al ipogli emija
Usual warning symptoms may disappear in patients with longstanding diabetes. lp
Dawk il- pazjenti, li l- kontroll tal- glukosju fid- demm tag hom jitjieb bil- kbir, e. permezz ta ’ terapija ot
Transferring a patient to another type or brand of insulin should be done under strict medical a
intensifikata bl- insulina, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tag hom ta ’ l - ipogli emija, u g andhom jing ataw parir kif xieraq. od
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), in
Pr
If an adjustment is needed when ic
Tibdil fil- qawwa, fil- marka (manifattur), fit- tip (insulina li ta dem malajr, b ’ ew funzjonijiet, li ta dem fit- tul, e.), fl- ori ini (insulina li ejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ejja minn sors ta ’ l- annimali), jista ’ jirri ulta fi tie a g al tibdil fid- do a.
switching the patients to Velosulin, it may occur with the first dose or during the first several weeks ed
Jekk ikun hemm b onn ta ’ a ustament meta l- pazjenti jaqilbu g al Velosulin, dan jista ’ jsir ma ’ l- ewwel do a jew matul l- ewwel diversi img at jew xhur.
Reactions usually resolve in a few days to a few weeks.
4 Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
On rare occasions, injection site reactions may require discontinuation of Velosulin.
F’ okka jonijiet rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni, ikun hemm b onn li Velosulin jitwaqqaf.
4 Patients using CSII may be more prone to infection at the site of infusion.
t Il- pazjenti li ju aw is- CSII jistg u ikunu iktar suxxettibbli g all- infezzjonijiet fis- sit ta ’ l- infu joni.
Infections can be minimised by careful attention to personal hygiene of the hands and infusion site and by frequent changes of catheter (maximum usage 2 days).
za Dawn l- infezzjonijiet jistg u jitnaqqsu jekk ting ata attenzjoni lill- indafa personali ta ’ l- idejn u tas- sit ta ’ l- infu joni, u billi l- kateter jinbidel ta ’ spiss (u u massimu ta ’ jumejn).
Velosulin contains metacresol, which may cause allergic reactions.
riz Velosulin fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
4.5 Interaction with other medicinal products and other forms of interaction
to 4. 5 Prodotti medi inali o ra li ma jaqblux ma ’ dan il- prodott u affarijiet o ra li jistg u
A number of medicinal products are known to interact with glucose metabolism.
Numru ta ’ prodotti medi inali huma mag rufa li g andhom effett fuq il- metaboli mu ta ’ glukosju.
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
x G alhekk it- tabib g andu jikkunsidra t- tibdil fl- effett li jista ’ jse u g andu dejjem jistaqsi lill -
ed The following substances may reduce insulin requirement:
du pazjenti tieg u dwar kwalunkwe prodotti medi inali li jie du. ħa Dawn is- sustanzi li ejjin jistg u jnaqqsu l - tie a ta ’ l- insulina:
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-
Sustanzi ipogli emi i li jittie du mill - alq (OHA), inibituri ta ’ monoamine oxidase (MAOI), sustanzi ’ g
is blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.
li jimblukkaw ir- ri etturi beta mhux selettivi, inibituri ta ’ l- enzima li tbiddel angiotensin (ACE), salicylates, alko ol, sterojdi anaboli i jew sulphonamides. m
or The following substances may increase insulin requirement:
Dawn is- sustanzi li ejjin jistg u j idu l - tie a ta ’ l- insulina: li
th Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth
Konta ettivi orali, tija idi, glukokortikojdi, ormoni tat- tirojde u beta- simpatomimeti i, ormon tat - li
au hormone and danazol.
tikbir u danazol. a in
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from
Sustanzi li jimblukkaw ir- ri etturi beta jistg u ja bu s- sintomi ta ’ l- ipogli emija u jdewmu l- irkupru mill- ipogli emija. iċ ed
Octreotide/ lanreotide may both decrease and increase insulin requirement. lo
Octreotide/ lanreotide jistg u kemm inaqqsu kif ukoll i idu l - tie a ta ’ l- insulina. tm
Alcohol may intensify and prolong the hypoglycaemic effect of insulin. no
L- alko ol jista ’ jintensifika u jtawwal l- effetti ipogli emi i ta ’ l- insulina.
4.6 Pregnancy and lactation
4. 6 Tqala u treddig ot
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not ct
M’ hemmx restrizzjonijiet fuq il- kura tad- dijabete bl- insulina matul it- tqala, min abba li l- insulina ma od
pass the placental barrier. du
Pr
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes ro
Kemm l- ipogli emija kif ukoll l- ipergli emija, li jistg u jse u waqt terapija g ad- dijabete li ma tkunx ikkontrollata b’ mod adegwat, i idu r- riskju ta ’ malformazzjonijiet u mewt in utero.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when lp
G alhekk hu rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li g andhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li to ro tqila.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and a
Il - ti ijiet g all- insulina normalment jonqsu fl- ewwel tliet xhur u ji diedu sussegwentement matul it - tieni u t- tielet tliet xhur.
After delivery, insulin requirements return rapidly to pre-pregnancy values. ic
Wara l - las, il - ti ijiet g all- insulina jer g u lura malajr g al- livelli ta ’ qabel it- tqala.
Insulin treatment of the nursing mother presents no risk to the baby.
Il- kura bl- insulina fl- omm li tkun qed tredda ’ ma to loq l- ebda riskju g at- tarbija.
However, the Velosulin dosage ed
Madankollu, jista ’ jkun hemm b onn li d- do a ta ’ Velosulin, id- dieta jew it- tnejn li huma, ikunu a ustati.
4.7 Effects on ability to drive and use machines
5 4. 7 Effetti fuq il - ila biex issuq u t addem magni
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan hu partikularment importanti f’ dawk li g andhom nuqqas ta ’ g arfien jew l- ebda g arfien tas- sinjali ta ’ twissija ta ’ l- ipogli emija, jew li g andhom episodji frekwenti ta ’ ipogli emija.
5 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
t za Kif ji ri bl- u u ta ’ prodotti o rajn ta ’ l- insulina, l- ipogli emija, eneralment, hi l- effett mhux mixtieq li sse bl- aktar mod komuni.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Din tista ’ sse jekk id- do a ta ’ l- insulina tkun g olja wisq meta
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Waqt provi klini i u matul l- u u tal- medi ina meta l- prodott tqieg ed fis- suq, il- frekwenza tvarja skond il- popolazzjoni tal- pazjenti u skond ir- rutina tad- do a.
Therefore, no specific frequency can be presented.
to G alhekk l- ebda frekwenza spe ifika ma tista ’ ti i ppre entata.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Ipogli emija serja tista ’ twassal biex wie ed jintilef minn sensih u/ jew g al konvul jonijiet u tista ’ tirri ulta f’ indeboliment temporanju
Frequencies of adverse drug reactions from clinical trials that are considered related to fast-acting ≥ human insulin (Actrapid) are listed below.
Il- frekwenzi tar- reazzjonijiet avversi tal- medi ina minn provi klini i, li huma kkunsidrati li huma
The frequencies are defined as: uncommon (≥ 1/ 1,000 to
x konnessi ma ’ insulina umana li ta dem malajr (Actrapid) huma elenkati hawn ta t.
ed < 1/ 100).
du definiti b ala: mhux komuni (1/ 1, 000 sa < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Ka ijiet spontanji i olati huma ppre entati b ala rari afna u definiti b ala < 1/ 10, 000, li jinkludu rapporti i olati. ħa F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mni la f’ ordni li tibda b’ dak l- i jed serju u tkompli sa dak l- inqas serju. ’ g m
is Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Disturbi fis- sistema nervu a Mhux komuni - Newropatija periferali li
or Nervous system disorders Uncommon - Peripheral neuropathy
Titjib mg a el fil- kontroll ta ’ glukosju fid- demm jista ’ jkun asso jat ma ’ kundizzjoni msej a li
th Fast improvement in blood glucose control may be associated with a condition termed “ acute painful
“ newropatija akuta bl- u ig ”, li normalment tkun riversibbli. a in
au neuropathy”, which is usually reversible.
Disturbi fl- g ajnejn Mhux komuni - Disturbi tar- rifrazzjoni iċ
Eye disorders
Dawn is- sintomi ed
These symptoms are usually of ng transitory nature. lo
normalment ikunu ta ’ natura temporanja. tm
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. no
Madankollu, l- intensifikazzjoni tat- terapija bl- insulina b’ titjib f’ daqqa tal- kontroll gli emiku, tista ’ ot
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. ct
tkun asso jata ma ’ retinopatija dijabetika li tmur g all- ag ar temporanjament. od
Skin and subcutaneous tissue disorders du
Disturbi fil - ilda u fit- tessuti ta ’ ta t il - ilda Mhux komuni – Lipodistrofija Pr
Uncommon – Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites ro
Il- lipodistrofija tista ’ sse fis- sit ta ’ l- injezzjoni b ala konsegwenza li wie ed ma jibdilx is- siti ta ’ l - injezzjoni f ’ ona partikolari.
General disorders and administration site conditions Uncommon - Injection site reactions a
Disturbi enerali u kundizzjonijiet ta ’ mnejn jing ata Mhux komuni - Reazzjonijiet fis- sit ta ’ l- injezzjoni Reazzjonijiet fis- sit ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fis- sit ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may in
Il- bi a l- kbira tar- reazzjonijiet normalment ikunu temporanji u jisparixxu matul it- tkomplija tal- kura.
occur during treatment with insulin.
6 Mhux komuni - Edema L- edima tista ’ sse fil- bidu tat- terapija bl- insulina.
Most reactions are transitory and disappear during continued treatment. ic ed
Dawn is- sintomi normalment ikunu ta ’ natura temporanja.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastro- intestinali, edima an jonewrotika, diffikultajiet biex tie u n- nifs, palpitazzjonijiet u tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
These symptoms are usually of transitory M
Reazzjonijiet ta ’
Generalised hypersensitivity reactions are potentially life- threatening.
t sensittività e essiva eneralizzata huma potenzjalment ta ’ periklu g all - ajja
6 4.9 Overdose
za riz 4. 9 Do a e essiva
A specific overdose of insulin cannot be defined.
to Do a e essiva spe ifika ta ’ l- insulina ma tistax ti i definita.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Madankollu, l- ipogli emija tista ’ ti viluppa fi stadji sekwenzjali:
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
G alhekk huwa rakkomandat li l- pazjent dijabetiku j omm fuqu xi kubi taz- zokkor, elu, gallettini jew meraq tal- frott biz- zokkor.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to
x • Episodji ta ’ ipogli emija severa, fejn il- pazjent jintilef minn sensih, jistg u ji u kkurati bil -
ed 15 minutes.
du glucagon (0. 5 sa 1 mg) mog ti fil- muskoli jew ta t il - ilda minn persuna li tkun ir eviet struzzjonijiet xierqa, jew bil- glukosju mog ti ol- vina minn professjonist mediku.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the
Glukosju ħa g andu wkoll jing ata ol- vini jekk il- pazjent ma jirrispondix g al glucagon bejn 10 u 15- il minuta. ’ g
is patient in order to prevent relapse.
Meta jer a ’ ji i f’ sensih, l- g oti ta ’ karboidrati mill - alq lill- pazjent hu rakkomandat, biex tkun evitata rikaduta. m li
PHARMACOLOGICAL PROPERTIES
TAG RIF FARMAKOLO IKU li a
th au 5.1 Pharmacodynamic properties
5. 1 Tag rif farmakodinamiku in
ATC
Kategorija farmakoterapewtika: insulini u analogi g all- injezzjoni, insulina (umana) li ta dem malajr. iċ
er code:
Kodi i ATC:
A10A B01.
A10A B01. ed
ng
L- effett ta ’ l- insulina li tbaxxi l- livell ta ’ glukosju fid- demm huwa min abba l- fatt li l- insulina tm
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose lo
ting aqad mar- ri etturi fuq i - elluli tal- muskoli u tax- xa am u b’ hekk ji i ffa ilitat id- d ul ta ’ glukosju kif ukoll min abba l- inibizzjoni fl- istess in tal- produzzjoni ta ’ glukosju mill- fwied. ot
output from the liver. no
Prova klinika f’ unità wa da ta ’ kura intensiva fejn issir il- kura ta ’ l- ipergli emija (livell ta ’ glukosju fid- demm og la minn 10 mmol/ l) li saret fuq 204 pazjent dijabetiku u 1344 pazjent mhux dijabetiku li od
A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/ l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 – 6.1 mmol/ l) induced by intravenous treatment with another fast ct
kellhom operazzjoni ma uri, uriet li n- normogli emija (livell ta ’ glukosju fid- demm ta ’ 4. 4 – 6. 1 mmol/ l) ikkaw ata minn kura fil- vini b’ insulina umana o ra li ta dem malajr (Actrapid), naqqset il - Pr
acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%). du
mortalita ’ bi 42% (8% kontra 4. 6%).
Velosulin is a fast-acting insulin. ro
Velosulin hu insulina li ta dem malajr.
When Velosulin is administered as a bolus injection onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours. lp
Meta Velosulin jing ata b ala injezzjoni bolus, jibda ja dem fi mien nofs sieg a, jil aq l- effett massimu fi mien 1. 5- 3. 5 sig at, u l - in totali ta ’ kemm idum ja dem hu ta ’ madwar 7- 8 sig at.
5.2 Pharmacokinetic properties a in
5. 2 Tag rif farmakokinetiku
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. ic ed
Konsegwentement, il- profil tal - in- azzjoni ta ’ preparazzjoni ta ’ l- insulina jiddependi biss mill- karatteristi i ta ’ l- assorbiment tag ha.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
7 Dan il- pro ess hu influwenzat minn diversi fatturi (e. id- do a ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, il - xuna tax- xa am ta ’ ta t il - ilda, it- tip tad- dijabete).
The pharmacokinetics of insulin products are therefore affected M
G alhekk, il- farmakokinetika ta ’ prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ie or.
by significant intra- and inter-individual variation.
L- assorbiment relattivament mg a el ta ’ l- insulina li tin all, ti gura provvista kontinwa ta ’ insulina fid- demm minn g adira relattivament g ira ta t il - ilda.
Continuous subcutaneous infusion eliminates some of the variations/ fluctuations inherent to injection therapy.
t Assorbiment
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
za Il- kon entrazzjoni massima fil- pla ma tintla aq fi mien 1. 5- 2. 5 sig at wara l- g oti ta t il - ilda.
7 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
riz Distribuzzjoni Ma kien osservat l- ebda twa il profond mal- proteini tal- pla ma, lief g all- antikorpi ta ’ l- insulina li
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
aw Metaboli mu Hu rrappurtat li l- insulina umana ti i degradata mill- protease insulinika jew mill- enzimi degradanti ta ’ l- insulina u possibbilment mill- proteina disulfide isomerase.
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
x il- molekula ta ’ l- insulina umana ew proposti; l- ebda wie ed mill- metaboliti li ffurmaw wara l -
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
du cleavage ma kienu attivi. ħa Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta ’ ta t il - ilda.
The
G alhekk il - ’ g
ed terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
half- life (t½) hi kejl ta ’ l- assorbiment u mhux tat- tne ija per se ta ’ l- insulina mill- pla ma (l- insulina fi - irkolazzjoni tad- demm g andha t½ ta ’ ftit minuti).
Trials have indicated a t½
Il- provi indikaw t½ ta ’ madwar 2- 5 sig at. m
is of about 2-5 hours.
Tfal u adolexxenti li
or Chrildren and adolescents The pharmacokinetic profile has been studied in a small number (n=18) of diabetic children (aged 6-
Il- profil farmakokinetiku kien studjat f’ numru g ir (n=18) ta ’ tfal dijabeti i (6- 12- il sena) u li
th 12 years) and adolescents (aged 13-17 years) using another fast-acting human insulin, (Actrapid).
adolexxenti (13- 17- il sena) li kienu qed ju aw insulina umana o ra li ta dem malajr, (Actrapid).
The
L - a
au data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
informazzjoni hi limitata i da tissu erixxi li l- profil farmakokinetiku fit- tfal u fl- adolexxenti jista ’ in
However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Madankollu, kien hemm differenzi fis- Cmax bejn il- gruppi ta ’ l- età, u dan jenfasizza l- importanza tat- titrazzjoni individwali. iċ ed
5.3 Preclinical safety data er ng Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo
5. 3 Tag rif ta ’ qabel l- u u kliniku dwar is- sigurtà tal- medi ina tm
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. no
Informazzjoni li mhix klinika b’ Velosulin, mag mula fuq studji konvenzjonali ta ’ sigurtà farmakolo ika, effett tossiku minn do i ripetuti, effett tossiku fuq il - eni, riskju ta ’ kan er, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu spe jali g all- bnedmin. ot od
PHARMACEUTICAL PARTICULARS ct
TAG RIF FARMA EWTIKU Pr
6.1 List of excipients du
6. 1 Lista ta ’ sustanzi mhux attivi
Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) a
Zinc chloride Glycerol Metacresol Disodium phosphate dihydrate Sodium hydroxide (g all- a ustament tal- pH) Hydrochloric acid (g all- a ustament tal- pH) Ilma g all- injezzjonijiet
6.2 Incompatibilities ed
8 6. 2 Inkompatibilitajiet
M
Prodotti ta ’ l- insulina g andhom ji u mi juda biss ma ’ dawk is- sustanzi li huwa mag ruf li huma kompatibbli mag hom.
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
Il- prodotti medi inali li ji diedu mas- soluzzjoni ta ’ l- insulina jistg u jikkaw aw id- degradazzjoni ta ’ l - insulina, e. jekk il- prodotti medi inali jkun fihom thiols jew sulphites.
Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section 6.6.
Rigward il- kompatibilità ma ’ pompi ta ’ l- infu joni, tankijiet, kateters u labar, ara sezzjoni 6. 6 Prekawzjonijiet g all- u u u mmani ar
6.3 Shelf life
t 6. 3 mien kemm idum tajjeb il- prodott medi inali
30 months when stored between 2°C - 8°C.
za 30 xahar meta jin a en bejn 2°C - 8°C.
6 weeks when used or stored at room temperature (below 25°C).
riz 6 img at meta jintu a jin a en f’ temperatura ambjentali tal- kamra (ta t 25°C).
8 After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
to Wara l- ewwel u u b ala infu joni, is- soluzzjoni ta ’ l- insulina tista ’ tin a en fit- tank tal- pompa g al sitt ijiem f’ temperatura mhux i jed minn 37°C (qrib it- temperatura tal - isem).
6.4 Special precautions for storage
aw 6. 4 Prekawzjonijiet spe jali g all - a na
Before use: store in a refrigerator (2°C - 8°C).
x Qabel l- u u: a en fi fri (2°C - 8°C).
Do not freeze.
du Ta inhomx fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
During use: do not refrigerate.
Tag milhomx fil- fri a. ħa Waqt l- u u: tag milhomx fil- fri.
Do not store above 25°C.
Ta inx f’ temperatura ’ l fuq minn 25°C. ’ g
After first use as infusion: the insulin solution may be stored in the pump reservoir at up to 37°C (close to the body).
Wara l- ewwel u u b ala infu joni: is- soluzzjoni ta ’ l- insulina tista ’ tin a en fit- tank tal- pompa g al 6 ijiem f’ temperatura mhux i jed minn 37°C (qrib it- temperatura tal - isem). m
ed Keep the vial in the outer carton in order to protect from light.
omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl. li
is Protect from excessive heat and sunlight.
Ilqa ’ minn s ana e essiva u mid- dawl tax- xemx. li a
or 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih in
th 10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective
Kunjett tal - ie (tip 1) ta ’ 10 ml mag luq b’ tapp tal- gomma ta ’ bromobutyl/ polyisoprene u b’ g atu iċ
au tamper-proof cap.
protettiv kontra t- tbag bis. ed
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g al skop kummer jali. tm
6.6 Special precautions for disposal and other handling er ng Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to lo
Prekawzjonijiet spe jali li g andhom jittie du meta jintrema u g al immani ot
the infusion material.
Meta t allat Velosulin mal- fluwidi ta ’ l- infu joni, ammont imprevidibbli ta ’ insulina ser ji i assorbit mill- materjal ta ’ l- infu joni.
Monitoring of the patient's blood glucose during infusion is therefore recommended. no
G alhekk, il- monitora tal- glukosju fid- demm tal- pazjent waqt l - od
When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin. ct du
Meta jing ata bis- CSII, l- ebda prodotti medi inali jew prodotti o rajn ta ’ l- insulina m’ g andhom jit alltu ma ’ Velosulin fit- tank tal- pompa ta ’ l- infu joni.
Velosulin should not be mixed with insulin zinc suspensions ro
Meta jkun hemm b onn jing ata flimkien ma ’ insulina li ta dem fit- tul, hu biss possibbli li t allat Velosulin ma ’ isophane jew insulini im allta minn qabel.
since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way. lp
Velosulin m’ g andux jit allat ma ’ suspensjonijiet ta - ingu ta ’ l- insulina min abba li l- phosphate buffer jista ’ jintera ixxi ma - ingu fis - suspensjoni u jibdel il - in tal- azzjoni ta ’ l- insulina b’ mod imprevedibbli.
Insulin preparations which have been frozen must not be used. a
Preparazzjonijiet ta ’ l- insulina li kienu ffri ati, m’ g andhomx jintu aw.
Insulin solutions should not be used if they do not appear water clear and colourless. in
Is- soluzzjonijiet ta ’ l- insulina m’ g andhomx jintu aw jekk ma jidhrux ari qishom ilma u bla kulur.
Insulin infusion (CSII): ic
9 Infu joni ta ’ l- insulina (CSII):
Use only syringes made of polyethylene, polypropylene or glass. ed
U a biss siringi tal- polyethylene, polypropylene jew tal - ie. u u biss kateters fejn il- materjal li jmiss ma ’ l- insulina jkun tal- polyethylene jew tal- polypropylene.
Use only teflon-coated or stainless steel needles.
U u biss labar miksija bit- teflon jew li jkunu ta ’ azzar li ma jsaddadx.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
za Novo Allé DK- 2880 Bagsværd
EU/ 1/ 02/ 232/ 001-003
aw EU/ 1/ 02/ 232/ 001- 003
9.
x du 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TI DID TA ’ L- AWTORIZZAZZJONI ħa Data ta ’ l- ewwel awtorizzazzjoni:
07 October 2002
07 Ottubru 2002 ’ g
18 September 2007
18 ta ’ Settembru 2007 m
is or th au er ng lo no ct du ro ed M
IET RIVEDUTA L- KITBA li li a
ic
in iċ ed tm ot od Pr
10 ed is or th au ANNEX II er ng
10 t za riz to aw x du ANNESS II ħa
MANUFACTURER OF THE BIOLOGICAL ACTIVE lo
MANIFATTUR TAS- SUSTANZA BIJOLO IKA ATTIVA U ’ g
SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE no
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT m
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI G AT - li
in ic ed M
TQEG ID FIS- SUQ li a in iċ ed tm ot od Pr
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLO IKA ATTIVA U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL - LOTT
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK-2880 Bagsværd Denmark Denmark
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK- 2880 Bagsværd
Name and address of the manufacturers responsible for batch release
t Isem u indirizz tal- manifatturi responsabbli g all - ru tal- lott
ed Novo Nordisk A/ S
za Novo Nordisk A/ S
or Denmark
to Id- Danimarka
th au B.
aw B.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
x KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- U U •
THE MARKETING AUTHORISATION HOLDER
du IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS - SUQ ħa Prodott medi inali jing ata bir- ri etta tat- tabib ’ g
Medicinal product subject to medical prescription lo
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- U U • m
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT no
MING AJR PERIKLU U EFFETTIV TAL- PRODOTT MEDI INALI li
Not applicable. ct du ro ed M
Ma jg oddx f’ dan il- ka. li a in iċ ed tm ot od Pr
12 ed is or th au ANNEX III er ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
12 t za riz to aw x du ANNESS III ħa TIKKETTA U FULJETT TA ’ TAG RIF ’ g m li li a in iċ ed tm ot od Pr
13 M ed ic in alp ro du ct
13 Pr od ot tm ed iċ in ali li
14 no
14 m A.
LABELLING lo ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA ’ g ħa du x aw to riz za t TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 UI/ ml soluzzjoni g all- injezzjoni jew infu joni f’ kunjett Insulina umana (rDNA)
is 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
riz 1 ml tas- soluzzjoni fiha 100 UI (3. 5 mg) ta ’ insulina umana (rDNA),
au zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric
PHARMACEUTICAL FORM AND CONTENTS lo
G AMLA FARMA EWTIKA U KONTENUT ’ g
Solution for injection or infusion no
Soluzzjoni g all- injezzjoni jew infu joni 1 x 10 ml m
1 x 10 ml 5 x 10 ml ct du
5 x 10 ml li li
METHOD AND ROUTE(S) OF ADMINISTRATION ro
MOD TA ’ KIF U MNEJN JING ATA a in
Subcutaneous or intravenous use Read the package leaflet before use
G all- u u ta t il - ilda jew ol- vini iċ
a
Aqra l- fuljett ta ’ tag rif qabel l- u u. ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT in
TWISSIJA SPE JALI LI L- PRODOTT MEDI INALI G ANDU JIN AMM FEJN MA tm
OF THE REACH AND SIGHT OF CHILDREN ic
JINTLA AQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children ed M
omm fejn ma jintla aqx u ma jidhirx mit- tfal ot od
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPE JALI O RA, JEKK ME TIE A Pr
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C May be kept in an infusion pump at up to 37°C for 6 days
Tag mlux fil- fri jew ta nu f’ temperatura ’ l fuq minn 25°C Jista ’ jin amm f’ pompa ta ’ l- infu joni f’ temperatura sa 37°C g al 6 ijiem
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
PREKAWZJONIJIET SPE JALI G AR- RIMI TA ’ PRODOTTI MEDI INALI MHUX
ed APPROPRIATE
za B ONN
th Novo Nordisk A/ S
aw Novo Nordisk A/ S Novo Allé
au Novo Allé DK-2880 Bagsværd Denmark
x DK- 2880 Bagsværd
er ng 12.
du Id- Danimarka ħa 12.
MARKETING AUTHORISATION NUMBERS lo
NUMRI TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ ’ g
EU/ 1/ 02/ 232/ 001 1 x 10 ml EU/ 1/ 02/ 232/ 002 5 x 10 ml no
EU/ 1/ 02/ 232/ 001 1 x 10 ml m
BATCH NUMBER ct du
NUMRU TAL- LOTT a in
Batch: ro
Lott: iċ ed
GENERAL CLASSIFICATION FOR SUPPLY lp
ENERALI TA ’ KIF JING ATA
Medicinal product subject to medical prescription a in ic
Prodott medi inali jing ata bir- ri etta tat- tabib ot
INSTRUCTIONS ON USE ed
STRUZZJONIJIET DWAR L- U U od Pr
VIAL LABEL
TIKKETTA
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDI INALI U MNEJN G ANDU JING ATA
Velosulin 100 IU/ ml solution for injection or infusion Insulin human (rDNA) SC, IV use
Velosulin 100 UI/ ml soluzzjoni g all- injezzjoni jew infu joni Insulina umana (rDNA) Jing ata ta t il - ilda jew ol- vina
is or 3.
riz to 3.
th au EXP/
aw JIS /
er 4.
x 4.
ng
du Lott: ħa ’ g
CONTENTS BY WEIGHT, BY VOLUME OR
IL- KONTENUT SKOND IL- PI, VOLUM, JEW PARTI INDIVIDWALI m
10 ml ct du
10 ml li li
OTHER ro
O RAJN a in
Novo Nordisk A/ S
Novo Nordisk A/ S iċ ed tm ot od Pr
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
17 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human( rDNA)
Velosulin 100 UI/ ml soluzzjoni g all- injezzjoni jew infu joni f’ kunjett Insulina umana (rDNA)
Solusion for injection or infusion 1 x 10 ml no
Soluzzjoni g all- injezzjoni jew infu joni 1 x 10 ml m
This is part of a multipack and not for sale of individual vials ct
Dan hu parti minn pakkett multiplu u mhux g all- bejg ta ’ kunjetti individwali li li
METHOD AND ROUTE(S) OF ADMINISTRATION du
MOD TA ’ KIF U MNEJN JING ATA a in
Subcutaneous or intravenous use ro
G all- u u ta t il - ilda jew ol- vini iċ
Read the package leaflet before use lp
Aqra l- fuljett ta ’ tag rif qabel l- u u. ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT a
TWISSIJA SPE JALI LI L- PRODOTT MEDI INALI G ANDU JIN AMM FEJN MA tm
OF THE REACH AND SIGHT OF CHILDREN in ic
JINTLA AQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children ed
omm fejn ma jintla aqx u ma jidhirx mit- tfal ot od
OTHER SPECIAL WARNING(S), IF NECESSARY M
TWISSIJA/ IET SPE JALI O RA, JEKK ME TIE A Pr
EU/ 1/ 02/ 232/ 003 no
EU/ 1/ 02/ 232/ 003 m li
BATCH NUMBER ct
NUMRU TAL- LOTT li a
Batch: du ro
Lott: in iċ
Medicinal product subject to medical prescription a in
Prodott medi inali jing ata bir- ri etta tat- tabib tm
INSTRUCTIONS ON USE ic ed
STRUZZJONIJIET DWAR L- U U ot od
19 PARTICULARS TO APPEAR ON THE PACKAGING
19 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT
OUTER WRAPPER LABLE ON MULTIPACKS
TIKKETTA TAL- KARTA TA ’ BARRA FUQ IL- PAKKETTI MULTIPLI
Velosulin 100 IU/ ml Solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 UI/ ml soluzzjoni g all- injezzjoni jew infu joni f’ kunjett Insulina umana (rDNA)
ed 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
t za 1 ml tas- soluzzjoni fiha 100 UI (3. 5 mg) ta ’ insulina umana (rDNA),
th zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric
aw zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid u ilma g all- injezzjonijiet
Solusion for injection or infusion 5 x (1 x 10 ml) lo
G AMLA FARMA EWTIKA U KONTENUT ħa Soluzzjoni g all- injezzjoni jew infu joni 5 x (1 x 10 ml) ’ g
This is a multipack and not for sale of individual vials no
Dan hu pakkett multiplu u mhux g all- bejg ta ’ kunjetti individwali m
METHOD AND ROUTE(S) OF ADMINISTRATION ct
MOD TA ’ KIF U MNEJN JING ATA li li
Subcutaneous or intravenous use du
G all- u u ta t il - ilda jew ol- vini a
Read the package leaflet before use ro
Aqra l- fuljett ta ’ tag rif qabel l- u u. in iċ
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
TWISSIJA SPE JALI LI L- PRODOTT MEDI INALI G ANDU JIN AMM FEJN MA ed
OF THE REACH AND SIGHT OF CHILDREN a
JINTLA AQX U MA JIDHIRX MIT- TFAL tm
Keep out of the reach and sight of children in ic
omm fejn ma jintla aqx u ma jidhirx mit- tfal ot
OTHER SPECIAL WARNING(S), IF NECESSARY ed M
TWISSIJA/ IET SPE JALI O RA, JEKK ME TIE A od Pr
MARKETING AUTHORISATION NUMBER(S) lo
NUMRU( I) TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ ’ g
21 M ed ic in alp ro du ct
21 Pr od ot tm ed iċ in ali li
22 no lo B.
22 m ’ g B.
PACKAGE LEAFLET ng er au th or is ed PACKAGE LEAFLET:
FULJETT TA ’ TAG RIF ħa du x aw to riz za t FULJETT TA ’ TAG RIF:
Velosulin 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Velosulin 100 UI/ ml soluzzjoni g all- injezzjoni f’ kunjett Insulina umana (rDNA)
Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tu a l- insulina tieg ek. – omm dan il- fuljett.
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
M’ g andekx tg addiha lil persuni o ra.
Do not pass it on to others.
Tista ’ tag mlilhom il - sara, anki jekk ikollhom l- istess sintomi b al tieg ek.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
za imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a jew lill- ispi jar tieg ek.
ed is 1.
riz to 1.
WHAT VELOSULIN IS AND WHAT IT IS USED FOR
X’ INHU VELOSULIN U G ALXIEX JINTU A
or Velosulin is human insulin to treat diabetes.
aw Velosulin hu insulina umana g all- kura tad- dijabete.
Velosulin is a fast-acting insulin.
Velosulin hu insulina li ta dem malajr.
This means that it will start to lower your blood sugar about half an hour after you take it.
Dan ifisser li jibda jbaxxilek il- livell taz- zokkor fid- demm madwar nofs sieg a wara li tie du.
th au 2.
x du 2.
BEFORE YOU USE VELOSULIN
QABEL MA TU A VELOSULIN ħa Tu ax Velosulin ’ g
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Oqg od attent g as - m
Look out for the signs of allergy in 5 Possible side lo
sinjali ta ’ l- aller ija f’ 5 Effetti sekondarji li jista ’ jkollu Jekk t oss li ejja ipo (ipo hi taqsira ta ’ reazzjoni ipogli emika u hija sintomu ta ’ livell baxx li
of low blood sugar).
ta ’ zokkor fid- demm).
See 4 What to do in an emergency for more about hypos.
Ara 4 X’ g andek tag mel f’ emer enza, g al aktar informazzjoni dwar l - li
Take special care with Velosulin ct du
Oqg od attent afna b’ Velosulin iċ
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty ro
Jekk g andek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - ed
stomach If you are exercising more than usual or if you want to change your usual diet lp
tirojde Jekk qed tixrob l- alko ol: oqg od attent/ a g as- sinjali ta ’ xi ipo u qatt m’ g andek tixrob l - tm
If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the a
alko ol fuq stonku vojt Jekk tag mel e er izzju fi iku aktar mis- soltu jew jekk trid tibdel id- dieta normali tieg ek Jekk inti marid/ a: kompli u l- insulina tieg ek ot
timing of your injections. in
Jekk ser issiefer: li tivvja a bejn oni tal - in differenti, jista ’ jaffettwa l - ti ijiet tieg ek g all- insulina u l - in meta tie u l- injezzjonijiet. od
Using other medicines ic ed
Meta tu a medi ini ohra Pr
Many medicines affect the way glucose works in your body and they may influence your insulin dose.
Il- mod kif ja dem glukosju fil - isem tieg ek huwa affettwat minn afna medi ini, u dawn jistg u jinfluwenzaw id- do a tieg ek ta ’ l- insulina.
Talk to your M
Hawn ta t hawn elenkati l- aktar medi ini komuni li jistg u jaffettwaw il- kura tieg ek bl- insulina.
doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek jekk qieg ed tie u jew adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Il - tie a tieg ek g all- insulina tista ’ tinbidel jekk inti tie u wkoll: inibituri ta ’ monamine oxidase (MAOI); beta- blokkanti; inibituri ta ’ l- enzima li tikkonverti l- an jotensin (ACE- inhibitors); acetylsalicylic acid; sterojdi anaboli i; sulphonamides; kontra ettivi orali; tija idi; glukokortikojdi; terapija bl- ormoni tat- tirojdi; beta- simpatomimeti i; ormon tat- tkabbir; danazol; octreotide jew lanreotide.
23 Driving and using machines
23 Tqala u treddig
Your ability to concentrate or to react will be less during a hypo.
Il - ila tieg ek li tikkon entra jew li tirrea ixxi ser tkun anqas waqt ipo.
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Iddiskuti mat- tabib tieg ek jekk wara kollox g andekx issuq jew tu a magni, jekk ikollok afna ipos jew jekk issibha bi tqila biex tag raf l- ipos.
3.
t za 3.
HOW TO USE VELOSULIN
KIF G ANDEK TU A VELOSULIN
Talk about your insulin needs with your doctor and diabetes nurse.
riz Tkellem dwar il - ti ijiet tieg ek ta ’ l- insulina mat- tabib u ma ’ l- infermier/ a tad- dijabete tieg ek.
Follow their advice carefully.
to Segwi l- parir tag hom bl- attenzjoni.
ed If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Jekk it- tabib tieg ek biddillek l- insulina minn tip jew marka ta ’ insulina g al o ra, jista ’ jkun li d -
is Eat a meal or snack containing carbohydrates within 30 minutes of administration.
Kul ikla jew ikla afifa li jkun fiha l- karboidrati fi mien 30 minuta mill- injezzjoni.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li tkejjel il- glukosju fid- demm tieg ek regolarment.
or Before using Velosulin
Tu ax Velosulin m
th au Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Kull kunjett fih g atu protettiv li
er Do not use Velosulin ng If the protective cap is loose or missing.
tal- plastik li ma jistax isir tbag bis fih.
Each vial has a protective, tamper-proof plastic cap.
Jekk il- kunjett ma jkunx f’ kundizzjoni perfetta meta li
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier lo
tir ivih, er a ’ ag tih lura lil min tahulek. a
If it hasn’ t been stored correctly or been frozen (see 6 How to store Velosulin) If it does not appear water clear and colourless. no
Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (ara 6 Kif ta en Velosulin) in
Use in infusion pump ct
L- u u f’ pompa ta ’ l- infu joni ed