qanastek/EMEA-V3 huggingface dataset:
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Il- glukożju (zokkor) fid- demm tal- pazjent għandu jiġi ttestjat b’ mod regolari biex tinstab l - iżgħar doża effettiva.
Insulatard is a long-acting insulin.
Insulatard hu insulina li taħdem fit- tul.
It can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Jista ’ jingħata b’ injezzjoni darba jew darbtejn kuljum, waħdu jew flimkien ma ’ insulina li taħdem malajr (waqt l- ikel), skond ir - rakkomandazzjoni tat- tabib.
How does Insulatard work?
Kif jintuża Insulatard?
Insulatard is a replacement insulin which identical to the insulin made by the pancreas.
Insulatard hu insulina li tissostitwixxi u hi identika għall- insulina magħmula mill- frixa.
The active substance in Insulatard, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Is - sustanza attiva f’ Insulatard, l- insulina tal- bniedem (rDNA), hi prodotta b’ metodu magħruf bħala ‘ teknoloġija rekombinanti ’: l- insulina hi magħmula minn ħmira li tkun irċeviet ġene (DNA), biex b’ hekk tkun tista ’ tipproduċi l- insulina.
Insulatard contains insulin mixed with another substance, protamine, in an ‘ isophane’ form which is absorbed much more slowly during the day.
Insulatard ikun fih insulina mħallta ma ’ sustanza oħra, il - protamina, f’ forma ‘ iżofana ’ li tiġi assorbita iktar bil- mod matul il- jum.
This gives Insulatard a longer duration of action.
B’ hekk Insulatard jaħdem iktar fit- tul.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Bil- kontroll tal- glukożju fid- demm, is- sintomi u l - kumplikazzjonijiet tad- dijabete jitnaqqsu.
How has Insulatard been studied?
Kif ġie studjat Insulatard?
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Insulatard ġie studjat f’ erba ’ studji kliniċi ewlenin, li fihom b’ kollox ħadu sehem 557 pazjent bid - dijabete ta ’ l- ewwel tip, li fiha l- frixa ma tkunx tista ’ tipproduċi insulina (żewġ studji bil - parteċipazzjoni ta ’ 81 pazjent), jew dijabete tat- tieni tip, meta l- ġisem ma jkunx jista ’ juża l- insulina 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
F’ ħafna mill- pazjenti, Insulatard tqabbel ma ’ tipi oħra ta ’ insulina tal- bniedem jew analogi ta ’ l- insulina.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livelli ta ’ glukożju jew fid- demm jew sustanza fid- demm magħrufa bħala emoglobina glikosalata (glycosylated haemoglobin) (HbA1c), li tagħti indikazzjoni ta ’ kemm il- glukożju fid- demm ikun ikkontrollat tajjeb.
Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
Saru iktar studji f’ 225 pazjent mqabbla ma ’ l- injezzjoni ta ’ Insulatard b’ siringa jew b’ pinna mimlija minn qabel (InnoLet, NovoPen jew FlexPen).
What benefit has Insulatard shown during the studies?
X’ inhuma l- benefiċċji ta ’ Insulatard li ntwerew f’ dawn l- istudji?
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Insulatard wassal għal tnaqqis fil- livell ta ’ HbA1c, li jindika li l- livelli ta ’ zokkor fid- demm kienu kkontrollati f’ livell simili għal dak li deher ma ’ insulini tal- bniedem oħra.
Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Insulatard kien effettiv għad- dijabete ta ’ l- ewwel u tat- tieni tip, u meta intużat injezzjoni standard jew b’ waħda mill- pinen.
What is the risk associated with Insulatard?
X’ inhu r- riskju assoċjat ma ’ Insulatard?
As with all insulins, Insulatard may cause hypoglycaemia (low blood glucose).
Bħal kull insulina oħra, Insulatard jista ’ jikkawża ipogliċemija (livell baxx ta ’ glukożju fid- demm).
For the full list of all side effects reported with Insulatard, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Insulatard, ara l- Fuljett ta ’ Tagħrif.
Insulatard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Insulatard m’ għandux jingħata lil persuni allerġiċi għall- insulina tal- bniedem (rDNA) jew għal kwalunkwe ingredjent ieħor.
Insulatard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Id- dożi ta ’ Insulatard jista ’ wkoll ikollhom jiġu aġġustati meta jingħata ma ’ għadd ta ’ mediċini oħra li jistgħu jaffettwaw il- glukożju fid- demm.
Why has Insulatard been approved?
Għaliex ġie approvat Insulatard?
The Committee for Medicinal products for Human Use (CHMP) decided that Insulatard’ s benefits are greater than its risks for the treatment of diabetes.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Insulatard fit- trattament tad- dijabete huma ikbar mir- riskji tiegħu.
The Committee recommended that Insulatard be given marketing authorisation.
Il- Kumitat irrakkomanda li Insulatard jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Insulatard:
Tagħrif ieħor dwar Insulatard:
The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard to Novo Nordisk A/ S on 7 October 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Insulatard: valida fl- Unjoni Ewropea kollha lil Novo Nordisk A/ S fis- 7 ta ’ Ottubru 2002.
The full EPAR for Insulatard is available here.
L- EPAR sħiħ għal Insulatard jinsab hawnhekk.
SUMMARY OF PRODUCT CHARACTERISTICS
SOMMARJU TAL- KARATTERISTI I TAL- PRODOTT
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDI INALI
Insulatard 40 IU/ ml suspension for injection in a vial.
Insulatard 40 UI/ ml suspensjoni g all- injezzjoni f' kunjett
QUALITATIVE AND QUANTITATIVE COMPOSITION
G AMLA KWALITATTIVA U KWANTITATTIVA
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Insulina umana, rDNA (mag mula permezz tat- teknolo ija tad- DNA rikombinanti f' Saccharomyces cerevisiae).
1 vial contains 10 ml equivalent to 400 IU.
Kunjett fih 10 ml ekwivalenti g al 400 UI.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
UI wa da (Unità Internazzjonali) tikkorrispondi g al 0. 035 mg ta ’ insulina umana anidrata.
Insulatard is a suspension of isophane (NPH) insulin.
Insulatard huwa suspensjoni ta ’ insulina isophane (NPH).
For a full list of excipients, see section 6.1.
G al- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
PHARMACEUTICAL FORM
G AMLA FARMA EWTIKA
Suspension for injection in a vial.
Suspensjoni g all- injezzjoni f' kunjett.
Cloudy, white, aqueous suspension.
Suspensjoni akweja, bajda u opaka.
CLINICAL PARTICULARS
TAG RIF KLINIKU
4.1 Therapeutic indications
4. 1 Indikazzjonijiet terapewti i
Treatment of diabetes mellitus.
Kura tad- dijabete mellitus.
4.2 Posology and method of administration
4. 2 Po olo ija u metodu ta ’ kif g andu jing ata
Insulatard is a long-acting insulin.
Insulatard huwa insulina li ta dem fit- tul.
Dosage Dosage is individual and determined in accordance with the needs of the patient.
Do a Id- do a hu individwali u ji i stabbilit skond il - ti ijiet tal- pazjent.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Normalment il - tie a individwali g all- insulina hi ta ’ bejn 0. 3 u 1. 0 IU/ kg/ kuljum.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Il - tie a ta ’ kuljum g all- insulina tista ’ tkun og la f’ pazjenti b’ re istenza g all- insulina (e. waqt il- pubertà jew min abba l- obe ità), u aktar baxxa f’ pazjenti bi produzzjoni residwa ta ’ insulina endo ena.
The physician determines whether one or several daily injections are necessary.
It- tabib ser jidde iedi jekk ikunx hemm b onn ta ’ injezzjoni wa da kuljum jew ta ’ afna injezzjonijiet kuljum.
Insulatard may be used alone or mixed with fast-acting insulin.
Insulatard jista ’ jintu a wa du jew jit allat ma ’ insulina li ta dem malajr.
In intensive insulin therapy the suspension may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
Waqt terapija intensiva bl- insulina, is- suspensjoni tista ’ tintu a b ala l- insulina ba ali (injezzjoni filg axija u/ jew filg odu) bl- insulina li ta dem malajr ting ata waqt il - in ta ’ l- ikel.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
F’ pazjenti bid- dijabete mellitus, l- a jar kontroll possibbli tal- gli emija jittardja l- bidu ta ’ kumplikazzjonijiet dijabeti i li jse u tard fil- marda.
Close blood glucose monitoring is therefore recommended.
Il- monitora mill- qrib ta ’ glukosju hu g alhekk irrakkomandat.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
A ustament fid- do a Mard fl- istess mien, spe jalment infezzjonijiet u kundizzjonijiet ta ’ deni, normalment i idu l - tie a tal- pazjent g all- insulina.
Renal or hepatic impairment may reduce insulin requirement.
2 L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a g all- insulina.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
L- a ustament fid- do a jista ’ jkun ne essarju wkoll jekk il- pazjenti jibdlu l- attività fi ika jew id - dieta normali tag hom.
2 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
Administration For subcutaneous use.
G all- u u minn ta t il - ilda.
Insulin suspensions are never to be administered intravenously.
Is- suspensjonijiet ta ’ l- insulina m’ g andhom qatt jing ataw minn ol - vina.
Insulatard is administered subcutaneously in the thigh.
Insulatard jing ata minn ta t il - ilda fil- koxxa.
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
Jekk ikunu konvenjenti, jistg u jintu aw ukoll i - aqq, i - ona gluteali jew i - ona tad- deltojd.
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
Injezzjoni ta t il - ilda fil- koxxa tirri ulta f’ assorbiment aktar bil- mod u inqas varjabbli meta mqabbel ma ’ siti o rajn ta ’ l- injezzjoni.
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Injezzjoni ol - ilda mirfug a ’ l fuq tnaqqas ir- riskju li bi ball tag ti injezzjoni ol- muskolu.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
G andek i omm il- labra ta t il - ilda g al mill- anqas 6 sekondi biex ti gura li tkun tajt id- do a kollha. o l- istess ona anatomika l- postijiet fejn ting ata l- injezzjoni g andhom jinbidlu biex ti i evitata l - lipodistrofija.
The vials are for use with insulin syringes with a corresponding unit scale.
Il- kunjetti huma g all- u u ma ’ siringi ta ’ l- insulina bi skala korrispondenti ta ’ unitajiet.
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Meta ew 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.
Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed.
Insulatard ji i b’ fuljett ta ’ tag rif mieg u, bi struzzjonijiet dettaljati g all- u u li g andhom ji u segwiti.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Sensittività e essiva g as- sustanza attiva jew g al xi sustanzi mhux attivi (ara sezzjoni 6. 1).
Hypoglycaemia.
Ipogli emija.
4.4 Special warnings and precautions for use
4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia.
Do a inadegwat jew it- twaqqif tal- kura, spe jalment f’ pazjenti b’ dijabete ta ’ tip 1, jista ’ jwassal g all- ipergli emija.
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 perijodu ta ’ sig at jew jiem.
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, nawsja, rimettar, t eddil, ilda xotta u amra, alq xott, nuqqas ta ’ aptit kif ukoll ri a ta ’ acetone fin- nifs.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
F’ pazjenti bid- dijabete ta ’ tip 1, avvenimenti ipergli emi i li ma jkunux ikkurati, eventwalment iwasslu g al ketoa idosi dijabetika, li hi potenzjalment fatali.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).
L- ipogli emija tista ’ sse jekk id- do a ta ’ l- insulina tkun g olja wisq fil- konfront tal - tie a ta ’ l - insulina (ara sezzjonijiet 4. 8 u 4. 9).
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Ikla maqbu a jew e er izzju fi iku iebes mhux ippjanat, jistg u jwasslu g all- ipogli emija.
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 accordingly.
Dawk il- pazjenti, li l- kontroll tal- glukosju fid- demm tag hom jitjieb bil- kbir, e. permezz ta ’ terapija intensifikata bl- insulina, g andhom ji u av ati li jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tag hom ta ’ l- ipogli emija.
Usual warning symptoms may disappear in patients with longstanding diabetes.
Is- sintomi normali ta ’ twissija jistg u ma jidhrux f’ pazjenti li ilhom mien twil bid- dijabete.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
It- trasferiment ta ’ pazjent g al tip ie or jew marka o ra ta ’ insulina g andu jsir ta t sorveljanza medika stretta.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, fil- marka (manifattur), fit- tip (insulina b’ azzjoni ta ’ malajr, b’ azzjoni doppja, b’ azzjoni fit- tul, e.), fl- ori ini (insulina li ejja mill- annimali, umana jew analoga) u/ jew fil -
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
Jekk ikun hemm b onn ta ’ xi a ustament meta l- pazjenti jaqilbu g al Insulatard, dan jista ’ jsir ma ’ l- ewwel do a jew matul l - ewwel img at jew xhur.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
B al kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu u ig, aqq, urtikarja, nef a u infjammazzjoni.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Li fl- istess ona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jg in biex inaqqas jew jimpedixxi dawn ir- reazzjonijiet.
Reactions usually resolve in a few days to a few weeks.
Normalment dawn ir- reazzjonijiet imorru wara xi ftit ranet jew img at.
On rare occasions, injection site reactions may require discontinuation of Insulatard.
F’ okka jonijiet rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm b onn li Insulatard jitwaqqaf.
3 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Xi pazjenti li kellhom reazzjonijiet ipogli emi i wara l- bidla minn insulina li ejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogli emija kienu anqas evidenti jew differenti minn dawk li kien ikollhom bl- insulina ta ’ qabel.
Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
Il- pazjent g andu jing ata parir biex jikkonsulta mat- tabib qabel ma jivvja a f’ pajji i li g andhom oni tal - in differenti g ax dan jista ’ jfisser li l- pazjent irid jie u l- insulina u l- ikel f ’ inijiet differenti.
Insulin suspensions are not to be used in insulin infusion pumps.
Is- suspensjonijiet ta ’ l- insulina m’ g andhomx jintu aw f’ pompi ta ’ l- infu joni ta ’ l- insulina.
Insulatard contains metacresol, which may cause allergic reactions.
Insulatard fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti medi inali o ra li ma jaqblux ma ’ dan il- prodott u affarijiet o ra li jistg u jibdlu l- effett farma ewtiku tal- prodott
A number of medicinal products are known to interact with glucose metabolism.
Hemm numru ta ’ prodotti medi inali li 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.
G alhekk it- tabib g andu jikkunsidra l- interazzjonijiet possibbli li jista ’ jkun hemm u g andu dejjem jistaqsi lill- pazjenti tieg u dwar kull prodott medi inali li jie du.
The following substances may reduce insulin requirement:
Dawn is- sustanzi li ejjin jistg u jnaqqsu l - tie a g all- insulina:
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Sustanzi ipogli emi i orali (OHA), inibituri ta ’ monamine oxidase (MAOI), sustanzi beta- blokkanti mhux selettivi, inibituri ta ’ l- enzima li tikkonverti l- an jotensin (ACE), sali ilati u alko ol.
The following substances may increase insulin requirement:
Dawn is- sustanzi li ejjin jistg u j idu l - tie a g all- insulina:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Kontra ettivi orali, tija idi, glukokortikojdi, ormoni tat- tirojde u beta- simpatomimeti i, ormon tat - tikbir u danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Sustanzi beta- blokkanti jistg u ja bu s- sintomi ta ’ l- ipogli emija u jdewmu l- irkupru mill - ipogli emija.
Octreotide/ lanreotide may both decrease and increase insulin requirement.
Octreotide/ lanreotide jistg u jnaqqsu kif ukoll i idu l - tie a g all- insulina.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
L- alko ol jista ’ j id u jtawwal l- effett ipogli emiku ta ’ l- insulina.
4.6 Pregnancy and lactation
4. 6 Tqala u treddig
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
M’ hemmx restrizzjonijiet fil- kura tad- dijabete bl- insulina matul it- tqala, min abba li l- insulina ma tg addix mill- barriera tal- pla enta.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Kemm l- ipogli emija kif ukoll l- ipergli emija, li jistg u jse u f’ terapija fejn id- dijabete 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 contemplating pregnancy.
G alhekk hu rakkomandat li jkun hemm kontroll intensifikat fil- kura ta ’ nisa bid- dijabete waqt l- ippjanar tat- tqala u matul l- istess tqala.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
Il - ti ijiet g all- insulina normalment jonqsu fl- ewwel trimester u ji diedu sussegwentement matul it - tieni u t- tielet trimestri.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
4 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, ta ’ l- omm li tkun qed tredda ’, ma to loq l- ebda riskju g at- tarbija.
However, the Insulatard dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm b onn li d- do a ta ’ Insulatard ji i a ustat.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il - ila biex issuq u t addem magni
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il - ila tal- pazjent li jikkon entra u jirrea ixxi tista ’ titnaqqas min abba l- ipogli emija.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista ’ jo loq riskju f’ sitwazzjonijiet meta dawn il - iliet huma ta ’ importanza spe jali (e. fis- sewqan ta ’ karozza jew t addim ta ’ makkinarju).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti g andhom jing ataw parir sabiex jie du prekawzjonijiet biex jevitaw l- ipogli emija waqt is- sewqan.
4 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.
The advisability of driving should be considered in these circumstances.
Wie ed g andu jikkunsidra jekk isuqx jew le f’ dawn i - irkustanzi.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
Kif ji ri bl- u u ta ’ prodotti o rajn ta ’ l- insulina, eneralment, l- ipogli emija, hi l- effett mhux mixtieq l- aktar komuni li jkun hemm.
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 fir- rigward tal - tie a ta ’ l- insulina.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Fi studji klini i u waqt l- u u meta l- prodott tqieg ed fis- suq, il- frekwenza tvarja skond il- popolazzjoni tal- pazjenti u skond l- iskeda tad- do a.
Therefore, no specific frequency can be presented.
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 g al telf mis- sensi u/ jew g al konvul jonijiet u tista ’ tirri ulta f’ indeboliment temporanju jew permanenti fil- funzjoni tal- mo jew anki f’ mewt.
Frequencies of adverse drug reactions from clinical trials that are considered related to Insulatard are listed below.
Minn studji klini i l- frekwenzi tar- reazzjonijiet avversi tal- medi ina, li huma kkunsidrati li huma konnessi ma ’ Insulatard, huma mni lin hawn ta t.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Il- frekwenzi huma definiti kif ej: 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.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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.
Nervous system disorders Very rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
Disturbi fis- sistema nervu a Rari afna - Newropatija periferali Titjib ta ’ malajr fil- kontroll tal- livell tal- glukosju fid- demm jista ’ jkun asso jat ma ’ kundizzjoni msej a “ newropatija akuta bl- u ig ”, li normalment tkun riversibbli.
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
Disturbi fl- g ajnejn Rari afna - Disturbi fir- rifrazzjoni Anomaliji tar- rifrazzjoni jistg u jse ikunu ta ’ natura temporanja.
These symptoms are usually of transitory nature.
Dawn is- sintomi normalment
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Titjib fil- kontroll gli emiku fit- tul inaqqas ir- riskju tal- progressjoni tar- retinopatija dijabetika.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Madankollu, l- intensifikazzjoni tat- terapija bl- insulina b’ titjib f’ daqqa tal- kontroll gli emiku, tista ’ tkun asso jata ma ’ retinopatija dijabetika li temporanjament tmur g all- ag ar.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Disturbi fil - ilda u fit- tessuti ta 'ta t il - ilda Mhux komuni - Lipodistrofija Il- lipodistrofija tista ’ sse fil- post ta ’ l- injezzjoni b ala konsegwenza li f’ dik i - ona wie ed ma jibdilx il- post minn fejn ting ata l- injezzjoni.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Disturbi enerali u kundizzjonijiet ta 'mnejn jing ata Mhux komuni - Reazzjonijiet fil- post ta ’ l- injezzjoni
Most reactions are transitory and disappear during continued treatment.
5 Reazzjonijiet fil- post ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fil- post ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Mhux komuni - Edima L- edima tista ’ sse fil- bidu tat- terapija bl- insulina.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
Generalised hypersensitivity reactions are potentially life- threatening.
Ir- reazzjonijiet ta ’ sensittività e essiva eneralizzata huma potenzjalment ta ’ periklu g all - ajja.
4.9 Overdose
4. 9 Do a e essiva
5 A specific overdose of insulin cannot be defined.
Livell spe ifiku ta ’ do a e essiva ta ’ l- insulina ma jistax ji i definit.
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: • Episodji ipogli emi i fief jistg u jkunu kkurati bl- g oti mill - alq ta ’ glukosju jew ta ’ prodotti li fihom iz- zokkor.
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 hu rakkomandat li pazjenti dijabeti i j ommu fuqhom xi kubi taz - zokkor, elu, gallettini jew meraq tal- frott mi juda biz- zokkor. • Episodji ta ’ ipogli emija severa, fejn il- pazjent jintilef minn sensih, jistg u ji u kkurati bi glucagon (0. 5 sa 1 mg) mog ti minn ol- muskoli jew minn ta t il - ilda minn persuna li tkun ir eviet struzzjonijiet xierqa, jew bi glukosju mog ti minn ol- vini minn professjonist mediku.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Glukosju g andu wkoll jing ata minn ol- vini jekk il- pazjent ma jirrispondix g al glucagon fi mien 10 sa 15- il minuta.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Meta jer a ’ ji i f’ sensih, hu rakkomandat li l- pazjent jing ata karboidrati mill - alq, biex tkun evitata rikaduta.
PHARMACOLOGICAL PROPERTIES
TAG RIF FARMAKOLO IKU
5.1 Pharmacodynamic properties
5. 1 Tag rif farmakodinamiku
Insulins and analogues for injection, intermediate-acting, insulin (human).
Insulini u analogi g all- injezzjoni, insulina (umana) li ta dem b’ mod intermedju.
ATC code:
Kodi i ATC:
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 output from the liver.
L- effett ta ’ l- insulina li tbaxxi l- livell ta ’ glukosju fid- demm ise min abba li l- insulina ting aqad mar- ri etturi fuq i - elluli tal- muskolu u tax- xa am u b’ hekk ti i ffa ilitata d- d ul ta ’ glukosju f’ dawn i - elluli u min abba l- inibizzjoni fl- istess in tal- produzzjoni ta ’ glukosju mill- fwied.
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
Jibda ja dem fi mien sieg a u nofs, jil aq l- effett massimu fi mien 4- 12- il sieg a, u l - in totali ta ’ kemm idum ja dem hu ta ’ madwar 24 sieg a.
5.2 Pharmacokinetic properties
5. 2 Tag rif farmakokinetiku
Insulin in the blood stream has a half-life of a few minutes.
L- insulina fi - irkolazzjoni tad- demm g andha half- life ta ’ ftit minuti.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
Konsegwentement, il- profil ta - mien ta ’ azzjoni ta ’ preparazzjoni insulinika 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).
G alhekk, il- proprjetajiet
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
6 farmakokineti i tal- prodotti ta ’ l- insulina huma influwenzati minn varjazzjonijiet sinifikanti kemm fl - individwu stess u kemm bejn individwu u ie or.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
Assorbiment Il- kon entrazzjoni massima ta ’ l- insulina fil- pla ma tintla aq fi mien 2- 18- il sieg a wara l- g oti minn ta t il - ilda.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma kien osservat l- ebda tg aqqid b’ sa tu mal- proteini tal- pla ma, lief g all- antikorpi ta ’ l- insulina li kienu qed ji irkolaw (jekk kienu pre enti).
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
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. ew proposti numru ta ’ siti fuq il - molekula ta ’ l- insulina umana fejn jista ’ jsir il- qtug (idrolisi); l- ebda wie ed mill- metaboliti li jiffurmaw wara l- qtug ma hu attiv.
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta 'ta t il - ilda.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of
G alhekk il - 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 of about 5-10 hours.
L- istudji indikaw t½ ta 'madwar 5- 10 sig at.
5.3 Preclinical safety data
5. 3 Tag rif ta ’ qabel l- u u kliniku dwar is- sigurtà tal- medi ina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhix klinika 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.
PHARMACEUTICAL PARTICULARS
TAG RIF FARMA EWTIKU
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (g all- a ustament tal- pH) Hydrochloric acid (g all- a ustament tal- pH) Protamine sulphate Ilma g all- injezzjonijiet
Insulin products should only be added to compounds with which it is known to be compatible.
Prodotti ta ’ l- insulina g andhom ji u mi juda biss ma ’ dawk is- sustanzi li huwa mag ruf li huma kompatibbli mag hom.
Insulin suspensions should not be added to infusion fluids.
Is- suspensjonijiet ta ’ l- insulina m’ g andhomx ji diedu ma ’ fluwidi ta ’ l - infu joni.
6.3 Shelf life
6. 3 mien kemm idum tajjeb il- prodott medi inali
30 months when stored between 2°C - 8°C.
30 xahar meta jin a en bejn 2°C - 8°C.
4 weeks when used or stored at room temperature (below 25°C).
4 img at meta jintu a jew jin a en f’ temperatura ambjentali tal- kamra (ta t 25°C).
6.4 Special precautions for storage
6. 4 Prekawzjonijiet spe jali g all - a na
Before use: store in a refrigerator (2°C - 8°C).
7 Qabel l- u u: a en fi fri (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
Ta inhomx ewwa jew wisq vi in is- sezzjoni tal- fri a jew l- element li jkessa.
Do not freeze.
Tag milhomx fil- fri a.
During use: do not refrigerate.
Waqt l- u u: tag milhomx fil- fri.
Do not store above 25°C.
Ta inx f' temperatura 'l fuq minn 25°C.
Keep the vial in the outer carton in order to protect from light.
omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Protect from excessive heat and sunlight.
Ipprote i minn s ana e essiva u mid- dawl tax- xemx.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
Kunjett tal - ie (tip 1) ta ’ 10 ml mag luq b’ tapp tal- gomma tal- bromobutyl/ polyisoprene u b’ g atu protettiv tal- plastik li ma jistax isir tbag bis fih.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g al skop kummer jali.
6.6 Special precautions for disposal and other handling
Prekawzjonijiet spe jali li g andhom jittie du meta jintrema u g al immani
Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta ’ l- insulina li kienu ffri ati, m’ g andhomx jintu aw.
7 After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i l- kunjett ta ’ Insulatard mill- fri, huwa rakkomandat li t alli l- kunjett jil aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
Is- suspensjonijiet ta ’ l- insulina m’ g andhomx jintu aw jekk wara s- suspensjoni mill - did ma jidhrux bojod u opaki b’ mod uniformi.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intu a jew skart li jibqa 'wara l- u u tal- prodott g andu jintrema kif jitolbu l- li ijiet lokali.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TI DID TA ’ L- AWTORIZZAZZJONI
Date of latest renewal:
Data ta ’ l- a
DATE OF REVISION OF THE TEXT
IET RIVEDUTA L- KITBA
Insulatard 100 IU/ ml suspension for injection in a vial.
Insulatard 100 UI/ ml suspensjoni g all- injezzjoni f' kunjett
1 vial contains 10 ml equivalent to 1000 IU.
Kunjett fih 10 ml, ekwivalenti g al 1000 UI.
Renal or hepatic impairment may reduce insulin requirement.
9 L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a g all- insulina.
9 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
Administration For subcutaneous use.
Kif Jing ata G all- u u minn ta t il - ilda.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, fil- marka (manifattur), fit- tip (insulina b’ azzjoni ta ’ malajr, b’ azzjoni doppja, b’ azzjoni fit- tul, e.), fl- ori ini (insulina li ejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina li ejja mid- DNA rikombinanti, kontra dik li ejja minn
On rare occasions, injection site reactions may require discontinuation of Insulatard.
F’ okka jonijiet rari, min abba ir- reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm b onn li Insulatard jitwaqqaf.
10 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Xi pazjenti li kellhom reazzjonijiet ipogli emi i wara l- bidla minn insulina li ejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogli emija kienu anqas evidenti jew differenti minn dawk li kien ikollhom bl- insulina ta ’ qabel.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
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.
11 Il- kura bl- insulina, ta ’ l- omm li tkun qed tredda ’, ma to loq l- ebda riskju g at- tarbija.
11 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti g andhom jing ataw parir sabiex jie du prekawzjonijiet biex jevitaw l- ipogli emija waqt is- sewqan.
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.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Disturbi enerali u kundizzjonijiet ta 'mnejn jing ata Mhux komuni - Reazzjonijiet fil- post ta ’ l- injezzjoni Reazzjonijiet fil- post ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fil- post ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
Most reactions are transitory and disappear during continued treatment.
Il- bi a l- kbira tar- reazzjonijiet huma temporanji u jmorru wa idhom matul it- tkomplija tal- kura.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
12 Mhux komuni - Edima L- edima tista ’ sse fil- bidu tat- terapija bl- insulina.
12 4.9 Overdose
4. 9 Do a e essiva
A specific overdose of insulin cannot be defined.
Livell spe ifiku ta ’ do a e essiva ta ’ l- insulina ma jistax ji i definit.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Dan il- pro ess hu influwenzat minn diversi fatturi (e. id- do a ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xa am ta t il - ilda, it- tip tad- dijabete).
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
G alhekk, il- proprjetajiet farmakokineti i tal- prodotti ta ’ l- insulina huma influwenzati minn varjazzjonijiet sinifikanti kemm fl - individwu stess u kemm bejn individwu u ie or.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
13 Il- kon entrazzjoni massima ta ’ l- insulina fil- pla ma tintla aq fi mien 2- 18- il sieg a wara l- g oti minn ta t il - ilda.
13 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta 'ta t il - ilda.
The 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).
G alhekk il - 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).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhix klinika, 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.
6 weeks when used or stored at room temperature (below 25°C).
6 img at meta jintu a jew jin a en f’ temperatura ambjentali tal- kamra (ta t 25°C).
Before use: store in a refrigerator (2°C - 8°C).
Qabel l- u u: a en fi fri (2°C - 8°C).
During use: do not refrigerate.
14 Waqt l- u u: tag milhomx fil- fri.
14 Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta ’ l- insulina li kienu ffri ati, m’ g andhomx jintu aw.
After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i l- kunjett ta ’ Insulatard mill- fri, huwa rakkomandat li t alli l- kunjett jil aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge.
Insulatard Penfill 100 UI/ ml Suspensjoni g all- injezzjoni fi skarto
1 cartridge contains 3 ml equivalent to 300 IU.
Skarto fih 3 ml ekwivalenti g al 300 UI.
Suspension for injection in a cartridge.
Suspensjoni g all- injezzjoni fi skarto.
Renal or hepatic impairment may reduce insulin requirement.
16 L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a g all- insulina.
16 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
L- iskarto i huma mag mula biex jintu aw mas- sistemi ta ’ l- g oti ta ’ l- insulina Novo Nordisk (strumenti li jservu fit- tul g all- u u ripetut) u labar NovoFine.
Detailed instruction accompanying the delivery system must be followed.
L- istruzzjonijiet dettaljati li jakkompanjaw is- sistema ta ’ l- g oti g andhom ikunu segwiti.
17 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Xi pazjenti li kellhom reazzjonijiet ipogli emi i wara l- bidla minn insulina li ejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogli emija kienu anqas evidenti jew differenti minn dawk li kien ikollhom bl- insulina ta ’ qabel.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
18 Wara l - las, il - ti ijiet g all- insulina jer g u lura malajr g al- livelli ta ’ qabel it- tqala.
18 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti g andhom jing ataw parir sabiex jie du prekawzjonijiet biex jevitaw l- ipogli emija waqt is- sewqan.
Most reactions are transitory and disappear during continued treatment.
19 Reazzjonijiet fil- post ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fil- post ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
19 4.9 Overdose
4. 9 Do a e essiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
20 farmakokineti i tal- prodotti ta ’ l- insulina huma influwenzati minn varjazzjonijiet sinifikanti kemm fl - individwu stess u kemm bejn individwu u ie or.
20 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta 'ta t il - ilda.
6 weeks when used or carried as a spare (below 30°C).
6 img at meta jkun qed jintu a jew jin arr g al li jista ’ jinqala ’ (ta t 30°C).
Do not store them in or too near the freezer section or cooling element.
21 Qabel l- u u: a en fi fri (2°C - 8°C) Ta inhomx ewwa jew wisq vi in is- sezzjoni tal- fri a jew l- element li jkessa.
Do not store above 30°C.
Ta inx f' temperatura ’ l fuq minn 30°C.
Keep the cartridge in the outer carton in order to protect from light.
omm l- iskarto fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.