qanastek/EMEA-V3 huggingface dataset:
What Actos contains The active substance in Actos 30mg tablets is pioglitazone.
Is- sustanza attiva ta ’ pilloli Actos 30mg hija pioglitazone.
Each tablet contains 30mg of pioglitazone (as hydrochloride).
Kull pillola fiha 30mg ta ’ pioglitazone (bħala hydrochloride).
What Actos looks like and contents of the pack Actos 30 mg tablets are white to off white, round, flat tablets marked ‘ 30’ on one face and ‘ ACTOS’ on the other face..
Pilloli Actos 30 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 30 ’ fuq naħa waħda u b ’ ‘ ACTOS ’ fuq in- naħa l- oħra.
60 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε.
Polska Ελλάδα Takeda Global R & D Centre (Europe), Wielka ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
61 PACKAGE LEAFLET:
61 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER ACTOS 45 MG TABLETS
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA PILLOLI ACTOS 45 MG (Pioglitazone (bħala hydrochloride))
Actos 45mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Actos 45mg huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Actos 45mg tablets helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Pilloli Actos 45mg jgħinu jikkontrollaw il- livell ta ’ żokkor fid- demm tiegħek meta jkollok dijabete tat - tip 2 billi jgħinu lill- ġismek jagħmel użu aħjar mill- insulina li qed jipproduċi.
Actos 45mg tablets may be used on their own or in combination with metformin and / or a sulphonylurea which are also oral anti-diabetic medicines.
Pilloli Actos 45mg jistgħu jintużaw waħedhom jew flimkien ma ’ metformin u / jew mediċina tat- tip sulphonylurea li huma wkoll mediċini anti- dijabetiċi mill- ħalq.
Actos 45 mg tablets may also be used in combination with insulin.
Pilloli Actos 45 mg jistgħu jintużaw ukoll flimkien ma ’ l- insulina.
Do not take Actos 45mg tablets:
Tieħux pilloli Actos 45mg:
- If you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Actos 45mg
- Jekk inti tbagħti minn sensittività eċċessiva (allerġiku/ a) għal pioglitazone jew sustanzi oħra ta ’
tablets.
pilloli Actos 45mg.
Take special care with Actos 45mg tablets:
Oqgħod attent ħafna b’ pilloli Actos 45mg
- If you are planning to become pregnant.
ta ’ wara tal- għajn).
- If you are breast-feeding.
- Jekk qed tippjana li tinqabad tqila.
62
- Jekk qed tredda ’.
- If you have a problem with your liver or heart.
- Jekk għandek problema bil- fwied jew bil- qalb tiegħek.
Taking Actos 45mg tablets with food and drink:
62 Meta tieħu pilloli Actos 45mg ma ’ l- ikel u max- xorb:
Important information about some of the ingredients of Actos 45mg tablets:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Actos 45mg:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Actos 45mg tablets.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu pilloli Actos 45mg.
You can usually continue to take other medicines whilst you are being treated with Actos 45mg tablets.
Ġeneralment int se tkun tista ’ tibqa tieħu mediċini oħra waqt li qed tiġi kkurat b’ pilloli Actos 45mg.
If you have the impression that the effect of Actos 45mg tablets is too weak, talk to your doctor.
Jekk taħseb li l- effett tal- pilloli Actos 45mg huwa dgħajjef wisq, kellem lit- tabib tiegħek.
Actos 45mg tablets can be taken with or without food.
Pilloli Actos 45mg jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
When Actos 45mg tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Meta pilloli Actos 45mg jittieħdu flimkien ma ’ mediċini oħra wżati għall- kura tad- dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it- tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal- mediċini tiegħek.
If you are following a diabetic diet, you should continue with this while you are taking Actos 45mg tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Actos 45mg.
63 In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
Fi provi kliniċi fejn pioglitazone kien imqabbel ma ’ mediċini mill- ħalq kontra d- dijabete oħrajn jew ma ’ placebo (pillola finta), kien osservat numru akbar ta ’ fratturi fl- għadam fin- nisa (iżda mhux fl - irġiel) li kienu qed jieħu pioglitazone.
If you take more Actos 45mg tablets than you should:
63 Jekk tieħu pilloli Actos 45mg aktar milli suppost:
If you forget to take Actos 45mg tablets:
Jekk tinsa tieħu pilloli Actos 45mg:
Try to take Actos 45mg tablets daily as prescribed.
Ipprova ħu pilloli Actos 45mg kuljum kif preskritt.
Like all medicines, Actos 45mg tablets can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, pilloli Actos 45mg jista ’ jkollhom effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Actos 45mg tablets:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li qed jieħdu pilloli Actos 45mg:
What Actos contains The active substance in Actos 45mg tablets is pioglitazone.
Is- sustanza attiva ta ’ pilloli Actos 45mg hija pioglitazone.
Each tablet contains 45mg of pioglitazone (as hydrochloride).
Kull pillola fiha 45mg ta ’ pioglitazone (bħala hydrochloride).
What Actos looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Actos 45 mg tablets are white to off white, round, flat tablets marked ‘ 45’ on one face and ‘ ACTOS’ on the other face..
Pilloli Actos 45 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 45 ’ fuq naħa waħda u b ’ ‘ ACTOS ’ fuq in- naħa l- oħra.
65 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε.
Polska Ελλάδα Takeda Global R & D Centre (Europe), Wielka ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
1 1.
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT 1.
Actraphane 30 40 IU/ ml suspension for injection in a vial.
Actraphane 30 40 UI/ ml suspensjoni għall- injezzjoni f' kunjett
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Insulina umana, rDNA (magħmula permezz tat- teknoloġija tad- DNA rikombinanti f' Saccharomyces cerevisiae).
1 vial contains 10 ml equivalent to 400 IU.
Millilitru fih 40 UI ta ’ insulina umana Kunjett fih 10 ml ekwivalenti għal 400 UI
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
UI (Unità Internazzjonali) waħda tikkorrispondi għal 0. 035 mg ta ’ insulina umana anidra.
Actraphane is a mixture of dissolved insulin and isophane (NPH) insulin.
Actraphane hu taħlita ta 'insulina maħlula u insulina isophane (NPH).
Actraphane 30 consists of 30% dissolved insulin and 70% isophane insulin.
Actraphane 30 jikkonsisti fi 30% ta 'insulina maħlula u 70% insulina isophane.
Suspension for injection in a vial.
Suspensjoni għall- injezzjoni f' kunjett.
Cloudy, white, aqueous suspension.
Suspensjoni akweja opaka u bajda.
Treatment of diabetes mellitus.
Kura ta ’ dijabete mellitus.
Actraphane is a dual-acting insulin.
Actraphane hu insulina li taħdem b' żewġ modi.
It is biphasic formulation containing both fast-acting and long- acting insulin.
Hu formulazzjoni bifażika li fiha kemm insulina li taħdem malajr kif ukoll insulina li taħdem fit- tul.
Premixed insulin products are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired.
Prodotti ta 'l- insulina mħalltin għal- lest normalment jingħataw darba jew darbtejn kuljum meta jkun mixtieq effett inizjali mgħaġġel flimkien ma' effett aktar fit- tul.
Dosage Dosage is individual and determined in accordance with the needs of the patient.
Dożaġġ Id- dożaġġ hu individwali u jiġi stabbilit skond il- ħtiġijiet tal- pazjent.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Il- ħtieġa individwali ta 'l- insulina normalment hi ta' bejn 0. 3 u 1. 0 UI/ 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- ħtieġa ta 'l- insulina ta' kuljum tista 'tkun ogħla f' pazjenti b' reżistenza għall- insulina (eż. waqt il- pubertà jew minħabba obeżità), u aktar baxxa f' pazjenti bi produzzjoni residwa ta' insulina endoġenika.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
F’ pazjenti bid- dijabete mellitus, l- aħjar kontroll possibbli tal- gliċemija jittardja l- bidu ta ’ kumplikazzjonijiet dijabetiċi li jseħħu tard fil- marda.
Close blood glucose monitoring is therefore recommended.
Il- monitoraġġ mill- qrib ta ’ glukosju hu għalhekk irrakkomandat.
An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.
L- injezzjoni għandha tkun segwita fi żmien 30 minuta minn ikla jew ikla ħafifa li jkun fiha l - karboidrati.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
2 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Renal or hepatic impairment may reduce insulin requirement.
L- indeboliment renali jew epatiku jista ’ jnaqqas il- ħtieġa ta ’ l- insulina.
2 Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
L- aġġustament fid- dożaġġ jista ’ jkun neċessarju wkoll jekk il- pazjenti jibdlu l- attività fiżika jew id - dieta normali tagħhom.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta 'insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
Administration For subcutaneous use.
Kif Jingħata Użu għal taħt il- ġilda.
Insulin suspensions are never to be administered intravenously.
Is- suspensjonijiet ta 'l- insulina m' għandhom qatt jingħataw minn ġol- vini.
Actraphane is administered subcutaneously in the thigh or abdominal wall.
Actraphane jingħata taħt il- ġilda fil- koxxa jew fil- membrana addominali.
If convenient, the gluteal region or the deltoid region may also be used.
Jekk ikun konvenjenti, jistgħu jintużaw iż- żoni gluteali jew tad- deltojd.
Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.
L- injezzjoni taħt il- ġilda fil- membrana addominali tiżgura assorbiment aktar mgħaġġel milli meta tingħata injezzjoni f' postijiet oħrajn.
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Jekk it- titqiba ssir fil- ġilda merfugħa, ir- riskju li wieħed jinjetta fil- muskolu bi żball jonqos.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Il- labra għandha tinżamm taħt il- ġilda għal mill- anqas 6 sekondi biex tiżgura li d- doża sħiħa tkun injettata.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Ġo kull żona anatomika l- postijiet fejn tingħata l- injezzjoni għandhom jinbidlu biex tiġi evitata l - lipodistrofija.
The vials are for use with insulin syringes with a corresponding unit scale.
Il- kunjetti huma għall- użu ma 'siringi ta ’ l- insulina bi skala ta' unità korrispondenti.
Actraphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Actraphane jiġi b' fuljett ta ’ tagħrif miegħu, bi struzzjonijiet dettaljati għall- użu li għandhom jiġu segwiti.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1).
Hypoglycaemia.
Ipogliċemija.
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia.
Dożaġġ inadegwat jew it- twaqqif tal- kura, speċjalment f' pazjenti b' dijabete tat- tip 1, jista ’ jwassal għal ipergliċemija.
Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Normalment, l- ewwel sintomi ta ’ ipergliċemija jibdew bil- mod, fuq medda ta 'żmien ta' sigħat 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 għatx, żieda fil- frekwenza li tagħmel l- awrina, tqalligħ, rimettar, ngħas, ġilda xotta u ħamra, ħalq xott, nuqqas ta ’ aptit kif ukoll riħa ta ’ acetone fin- nifs.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
F’ pazjenti b' dijabete ta ’ tip 1, avvenimenti ipergliċemiċi li ma jkunux ikkurati, eventwalment iwasslu għal ketoaċidosi 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).
Tista ’ sseħħ l- ipogliċemija jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa għall- insulina (ara sezzjoni 4. 8 u 4. 9).
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Ikla maqbuża jew eżerċizzju fiżiku mhux ippjanat u li jeħtieġ sforz kbir, jistgħu jwasslu għall - ipogliċemija.
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 tagħhom jitjieb bil- kbir, eż. permezz ta 'terapija intensifikata bl- insulina, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tagħhom ta ’ l - ipogliċemija, u għandhom jingħataw parir kif xieraq.
Usual warning symptoms may disappear in patients with longstanding diabetes.
Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt 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 li taħdem malajr, b’ żewġ funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga)
If an adjustment is needed when switching the patients to Actraphane, it may occur with the first dose or during the first several weeks or months.
Jekk ikun hemm bżonn ta 'aġġustament meta l- pazjenti jaqilbu għal Actraphane, dan jista ’ jsir ma ’ l- ewwel doża jew matul l- ewwel diversi ġimgħat jew xhur.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Bħal kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
Reactions usually resolve in a few days to a few weeks.
Li fl- istess żona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jgħin biex inaqqas jew jimpedixxi dawn ir- reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ġranet jew ġimgħat.
On rare occasions, injection site reactions may require discontinuation of Actraphane.
F’ okkażjonijiet rari, minħabba ir - reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm bżonn li Actraphane 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 ipogliċemiċi wara l- bidla minn insulina li ġejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogliċemija 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.
Qabel ma jivvjaġġa bejn żoni tal- ħin differenti, il- pazjent għandu jingħata parir biex jikkonsulta lit - tabib, għax dan jista ’ jfisser li l- pazjent irid jieħu l- insulina u l- ikel f’ ħinijiet differenti.
Insulin suspensions are not to be used in insulin infusion pumps.
Is- suspensjonijiet ta 'l- insulina m' għandhomx jintużaw f' pompi ta' l- infużjoni ta 'l- insulina.
Actraphane contains metacresol, which may cause allergic reactions.
Actraphane fih metacresol, li jista ’ jikkawża reazzjonijiet allerġiċi.
A number of medicinal products are known to interact with glucose metabolism.
Numru ta ’ prodotti mediċinali huma magħrufa li għandhom effett fuq il- metaboliżmu ta ’ glukosju.
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
Għalhekk it- tabib għandu jikkunsidra t- tibdil fl- effett li jista ’ jseħħ u għandu dejjem jistaqsi lill - pazjenti tiegħu dwar kwalunkwe prodotti mediċinali li jieħdu.
The following substances may reduce insulin requirement:
Dawn is- sustanzi li ġejjin jistgħu jnaqqsu l- ħtieġa ta ’ l- 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 ipogliċemiċi li jittieħdu mill- ħalq (OHA), inibituri ta ’ monoamine oxidase (MAOI), sustanzi li jimblukkaw ir- riċetturi beta mhux selettivi, inibituri ta ’ l- enzima li tbiddel angiotensin (ACE), salicylates u alkoħol, sterojdi anaboliċi u sulphonamides.
The following substances may increase insulin requirement:
Dawn is- sustanzi li ġejjin jistgħu jżidu l- ħtieġa ta ’ l- insulina:
Oral contraeptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Kontraċettivi orali, tijażidi, glukokortikojdi, ormoni tat- tirojde u beta- simpatomimetiċi, ormon tat - tikbir u danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Sustanzi li jimblukkaw ir- riċetturi beta jistgħu jaħbu s- sintomi ta 'l- ipogliċemija u jdewmu l- irkupru mill- ipogliċemija.
Octreotide/ lanreotide may both decrease and increase insulin requirement.
Octreotide/ lanreotide jistgħu kemm inaqqsu kif ukoll iżidu l- ħtieġa ta ’ l- insulina.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
L- alkoħol jista ’ jintensifika u jtawwal l- effetti ipogliċemiċi ta ’ l- insulina.
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
M’ hemmx restrizzjonijiet fuq il- kura tad- dijabete bl- insulina matul it- tqala, minħabba li l- insulina ma tgħaddix mill- barriera tal- plaċenta.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Kemm l- ipogliċemija kif ukoll l- ipergliċemija, li jistgħu jseħħu waqt terapija għad- dijabete li ma tkunx ikkontrollata b' mod adegwat, iżidu 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.
Għalhekk hu rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
Il- ħtiġijiet għall- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
Wara l- ħlas, il- ħtiġijiet għall- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Insulin treatment of the nursing mother presents no risk to the baby.
4 Il- kura bl- insulina fl- omm li tkun qed tredda 'ma toħloq l- ebda riskju għat- tarbija.
However, the Actraphane dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm bżonn li d- doża ta ’ Actraphane, tiġi aġġustata.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il- ħila tal- pazjent li jikkonċentra u jirreaġixxi tista ’ titnaqqas minħabba l- ipogliċemija.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista ’ joħloq riskju f’ sitwazzjonijiet meta dawn il- ħiliet huma ta ’ importanza speċjali (eż. fis- sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom jingħataw parir sabiex jieħdu prekawzjonijiet biex jevitaw l- ipogliċemija waqt is- sewqan.
This is particularly important in those who have reduced or absent awareness of the warning signs of
Dan hu partikularment importanti f’ dawk li għandhom nuqqas ta ’ għarfien jew l- ebda għarfien tas- sinjali ta ’ twissija ta ’ l- ipogliċemija, jew li għandhom episodji frekwenti ta 'ipogliċemija.
The advisability of driving should be considered in these circumstances.
Wieħed għandu jikkunsidra jekk isuqx jew le f' dawn iċ- ċirkustanzi.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
Kif jiġri bl- użu ta ’ prodotti oħrajn ta ’ l- insulina, l- ipogliċemija, ġeneralment, hi l- effett mhux mixtieq li sseħħ bl- aktar mod komuni.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Din tista ’ sseħħ jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa għall- insulina.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Waqt provi kliniċi u matul l- użu tal- mediċina meta l- prodott tqiegħed fis- suq, il- frekwenza tvarja skond il- popolazzjoni tal- pazjenti u skond ir- rutina tad- doża.
Therefore, no specific frequency can be presented.
Għalhekk l- ebda frekwenza speċifika ma tista ’ tiġi ppreżentata.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Ipogliċemija serja tista ’ twassal biex wieħed jintilef minn sensih u/ jew għal konvulżjonijiet u tista ’ tirriżulta f' indeboliment temporanju jew permanenti tal- funzjoni tal- moħħ jew anki f’ mewt.
Frequencies of adverse drug reactions from clinical trials that are considered related to Actraphane are listed below.
Il- frekwenzi tar- reazzjonijiet avversi tal- mediċina minn provi kliniċi li huma kkunsidrati li huma konnessi ma ’ Actraphane, huma elenkati hawn taħt.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Il- frekwenzi huma definiti bħala: mhux komuni (≥1/ 1, 000 sa < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Każijiet spontanji iżolati huma ppreżentati bħala rari ħafna u definiti bħala < 1/ 10, 000, li jinkludu rapporti iżolati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla f’ ordni li tibda b’ dak l- iżjed serju u tkompli sa dak l- inqas serju.
Nervous system disorders Uncommon - 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 nervuża Mhux komuni - Newropatija periferali Titjib mgħaġġel fil- kontroll ta ’ glukosju fid- demm jista ’ jkun assoċjat ma ’ kundizzjoni msejħa “ newropatija akuta bl- uġigħ ”, li normalment tkun riversibbli.
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
Disturbi fl- għajnejn Rari ħafna - Disturbi tar- rifrazzjoni Anomaliji tar- rifrazzjoni jistgħu jseħħu mal- bidu tat- terapija bl- insulina.
These symptoms are usually of transitory nature.
Dawn is- sintomi normalment ikunu ta ’ natura temporanja.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Mhux komuni - Retinopatija dijabetika Kontroll gliċemiku aħjar 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 gliċemiku, tista ’ tkun assoċjata ma ’ retinopatija dijabetika li tmur għall- agħar temporanjament.
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- ġilda u fit- tessuti ta 'taħt il- ġilda Mhux komuni - Lipodistrofija Il- lipodistrofija tista ’ sseħħ fis- sit ta ’ l- injezzjoni bħala konsegwenza li wieħed ma jibdilx is- siti ta ’ l - injezzjoni f’ żona partikolari.
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 ġenerali u kundizzjonijiet ta 'mnejn jingħata Mhux komuni - Reazzjonijiet fis- sit ta' l- injezzjoni Reazzjonijiet fis- sit ta 'l- injezzjoni (ħmura, nefħa, ħakk, uġigħ u ematoma fis- sit ta' l- injezzjoni) jistgħu jseħħu waqt il- kura bl- insulina.
Most reactions are transitory and disappear during continued treatment.
Il- biċċa l- kbira tar- reazzjonijiet normalment ikunu temporanji u jisparixxu matul it- tkomplija tal- kura.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
5 Mhux komuni - Edima L- edima tista ’ sseħħ 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 ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastro- intestinali, edima anġjonewrotika, diffikultajiet biex tieħu n- nifs, palpitazzjonijiet u tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
Generalised hypersensitivity reactions are potentially life- threatening.
Reazzjonijiet ta ’ sensittività eċċessiva ġeneralizzata huma potenzjalment ta 'periklu għall- ħajja
5 4.9 Overdose
4. 9 Doża eċċessiva
A specific overdose of insulin cannot be defined.
Doża eċċessiva speċifika ta ’ l- insulina ma tistax tiġi definita.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Madankollu, l- ipogliċemija tista ’ tiżviluppa fi stadji sekwenzjali: • Episodji ipogliċemiċi ħfief jistgħu jkunu kkurati bl- għoti mill- ħalq ta ’ prodotti ta ’ glukosju jew 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.
Għalhekk huwa rakkomandat li l- pazjent dijabetiku jżomm fuqu xi kubi taz- zokkor, ħelu, gallettini jew meraq tal- frott biz- zokkor. • Episodji ta ’ ipogliċemija severa, fejn il- pazjent jintilef minn sensih, jistgħu jiġu kkurati bil - glucagon (0. 5 sa 1 mg) mogħti fil- muskoli jew taħt il- ġilda minn persuna li tkun irċeviet struzzjonijiet xierqa, jew bil- glukosju mogħti ġol- vina minn professjonist mediku.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Glukosju għandu wkoll jingħata ġol- vini jekk il- pazjent ma jirrispondix għal glucagon bejn 10 u 15- il minuta.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Meta jerġa 'jiġi f’ sensih, l- għoti ta' karboidrati mill- ħalq lill- pazjent hu rakkomandat, biex tkun evitata rikaduta.
Insulins and analogues for injection, intermediate-acting combined with fast-acting, insulin (human).
Insulini u analogi għall- injezzjoni, li jaħdmu b' mod intermedju mħalltin ma 'dawk li jaħdmu malajr, insulina (umana).
ATC code:
Kodiċi 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 huwa minħabba l- fatt li l- insulina tingħaqad mar- riċetturi fuq iċ- ċelluli tal- muskoli u tax- xaħam u b’ hekk jiġi ffaċilitat id- dħul ta ’ glukosju kif ukoll minħabba l- inibizzjoni fl- istess ħin tal- produzzjoni ta ’ glukosju mill- fwied.
Onset of action is within ½ hour, reaches a maximum effect within 2-8 hours and the entire duration of action is up to 24 hours.
Jibda jaħdem fi żmien nofs siegħa, jilħaq l- effett massimu fi żmien 2- 8 sigħat, u l- ħin totali ta ’ kemm idum jaħdem hu sa 24 siegħa.
Insulin in the blood stream has a half-life of a few minutes.
L- insulina fiċ- ċirkolazzjoni tad- demm għandha half- life ta ’ ftit minuti.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
Konsegwentement, il- profil tal- ħin- azzjoni ta ’ preparazzjoni ta 'l- insulina jiddependi biss mill- karatteristiċi ta ’ l- assorbiment tagħha.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, il- ħxuna tax- xaħam ta 'taħt il- ġilda, it- tip tad- dijabete).
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
Għalhekk, il- farmakokinetika ta ’ prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
6 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
The maximum plasma concentration of the fast-acting insulin is reached within 1.5-2.5 hours after subcutaneous administration.
Il- konċentrazzjoni massima fil - plażma ta 'l- insulina li taħdem malajr tintlaħaq fi żmien 1. 5- 2. 5 sigħat wara l- għoti minn taħt il- ġilda.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma kien osservat l- ebda tgħaqqid b’ saħħtu mal- proteini tal- plażma, ħlief għall- antikorpi ta ’ l- insulina li kienu qed jiċċirkolaw (jekk kienu preżenti).
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metaboliżmu Hu rrappurtat li l- insulina umana tiġi degradata mill- protease insulinika jew mill- enżimi 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.
Ġew proposti numru ta ’ siti fuq il - molekula ta ’ l- insulina umana fejn jista ’ jsir il- qtugħ (idrolisi); l- ebda wieħed mill- metaboliti li jiffurmaw wara l- qtugħ 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 ’ taħt il- ġilda.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of
Għalhekk il - half- life (t½) hi kejl ta ’ l- assorbiment u mhux tat- tneħħija per se ta ’ l- insulina mill- plażma (l- insulina fiċ- ċirkolazzjoni tad- demm għandha t½ ta ’ ftit minuti).
Trials have indicated a t½ of about 5-10 hours.
L- istudji indikaw t½ ta ’ madwar 5- 10 sigħat.
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 fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
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 (għall- aġġustament tal- pH) Hydrochloric acid (għall- aġġustament tal- pH) Protamine sulphate Ilma għall- injezzjonijiet
Insulin suspensions should not be added to infusion fluids.
Prodotti ta ’ l- insulina għandhom jiġu miżjuda biss ma ’ dawk is- sustanzi li huwa magħruf li huma kompatibbli magħhom Is- suspensjonijiet ta 'l- insulina m' għandhomx jiżdiedu ma' fluwidi ta 'l- infużjoni.
30 months when stored between 2°C - 8°C.
30 xahar meta jinħażen bejn 2°C - 8°C.
6 weeks when used or stored at room temperature (below 25°C).
6 ġimgħat meta jintużaw jew jinħażnu fit- temperatura tal- kamra (taħt 25°C).
Before use: store in a refrigerator (2°C - 8°C).
Qabel l- użu: aħżen fi friġġ (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
Do not freeze.
7 Tagħmilhomx fil- friża.
During use: do not refrigerate.
Waqt l- użu: tagħmilhomx fil- friġġ.
Do not store above 25°C.
Taħżinhomx f' temperatura 'l fuq minn 25°C.
Protect from excessive heat and sunlight.
Ilqa ’ minn sħana eċċessiva u mid- dawl tax- xemx.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof cap.
Kunjett tal- ħġieġ (tip 1) ta ’ 10 ml magħluq b' tapp tal- gomma ta ’ bromobutyl/ polyisoprene u b' għatu protettiv kontra t- tbagħbis.
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 u 5 kunjetti x 10 ml u pakkett multiplu b’ 5 x (1 x 10 ml) kunjetti.
Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta 'l- insulina li kienu ffriżati m’ għandhomx jintużaw.
7 After removing Actraphane 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 tneħħi l- kunjett ta 'Actraphane mill- friġġ, hu rakkomandat li tħalli l- kunjett jilħaq it - temperatura tal- kamra (mhux iżjed minn 25°C) qabel ma' tagħmel is- suspensjoni ta 'l- insulina mill - ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
Is- suspensjonijiet ta 'l- insulina m' għandhomx jintużaw jekk ma jkunux jidhru bojod u opaki b' mod uniformi wara s- suspensjoni mill- ġdid.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Id- Danimarka
07 October 2002
07 Ottubru 2002
Date of latest renewal:
Data ta ’ l- aħħar tiġdid:
18 September 2007
18 ta ’ Settembru 2007
Actraphane 30 100 IU/ ml suspension for injection in a vial.
Actraphane 30 100 UI/ ml suspensjoni għall- injezzjoni f' kunjett
1 vial contains 10 ml equivalent to 1000 IU.
Millilitru fih 100 UI ta ’ insulina umana Kunjett fih 10 ml, ekwivalenti għal 1000 UI
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
9 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
9 Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
L- aġġustament fid- dożaġġ jista ’ jkun neċessarju wkoll jekk il- pazjenti jibdlu l- attività fiżika jew id - dieta normali tagħhom.
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 ipogliċemiċi wara l- bidla minn insulina li ġejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogliċemija kienu anqas evidenti jew differenti minn dawk li kien ikollhom bl- insulina ta ’ qabel.
The physician must therefore take possible interactions into account and should always ask hispatients about any medicinal products they take.
Għalhekk it- tabib għandu jikkunsidra t- tibdil fl- effett li jista ’ jseħħ u għandu dejjem jistaqsi lill - pazjenti tiegħu dwar kwalunkwe prodotti mediċinali li jieħdu.
Insulin treatment of the nursing mother presents no risk to the baby.
11 Il- kura bl- insulina fl- omm li tkun qed tredda 'ma toħloq l- ebda riskju għat- tarbija.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
Kif jiġri bl- użu ta ’ prodotti oħrajn ta ’ l- insulina, l- ipogliċemija, ġeneralment, hi l- effett mhux mixtieq li jseħħ bl- aktar mod komuni.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
12 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
12 4.9 Overdose
4. 9 Doża eċċessiva
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
13 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
13 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 ’ taħt il- ġilda.
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).
Għalhekk il - half- life (t½) hi kejl ta ’ l- assorbiment u mhux tat- tneħħija per se ta ’ l- insulina mill- plażma (l- insulina fiċ- ċirkolazzjoni tad- demm għandha t½ ta ’ ftit minuti).
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 (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH) Protamine sulphate Ilma għall- injezzjonijiet
30 months when stored between 2ºC - 8ºC.
30 xahar meta jinħażen f' temperatura ta 'bejn 2°C - 8°C.
6 weeks when used or stored at room temperature (below 25ºC).
6 ġimgħat meta jintużaw jew jinħażnu fit- temperatura tal- kamra (taħt 25°C).
Do not store them in or too near the freezer section or cooling element.
14 Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
Do not freeze.
Tagħmilhomx fil- friża.
14 After removing Actraphane 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 tneħħi l- kunjett ta 'Actraphane mill- friġġ, hu rakkomandat li tħalli l- kunjett jilħaq it - temperatura tal- kamra (mhux iżjed minn 25°C) qabel ma' tagħmel is- suspensjoni ta 'l- insulina mill - ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
Actraphane 10 Penfill 100 IU/ ml suspension for injection in a cartridge.
Actraphane 10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
1 cartridge contains 3 ml equivalent to 300 IU.
Millilitru fih 100 UI ta ’ insulina umana Skartoċċ fih 3 ml ekwivalenti għal 300 UI
Actraphane 10 consists of 10% dissolved insulin and 90% isophane insulin.
Actraphane 10 jikkonsisti f' 10% ta 'insulina maħlula u 90% ta' insulina isophane.
Suspension for injection in a cartridge.
Suspensjoni għall- injezzjoni fi skartoċċ.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
16 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
16 Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
L- aġġustament fid- dożaġġ jista ’ jkun neċessarju wkoll jekk il- pazjenti jibdlu l- attività fiżika jew id - dieta normali tagħhom.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
L- iskartoċċi huma maħsuba biex jintużaw mas- sistemi ta ’ l- għoti Novo Nordisk (strumenti li jservu fit- tul għall- użu ripetut) u labar NovoFine.
Detailed instruction accompanying the delivery system must be followed.
L- istruzzjonijiet dettaljati li jakkompanjaw is- sistema ta ’ l - għoti għandhom ikunu segwiti.
Actraphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Actraphane jiġi b' fuljett ta ’ tagħrif miegħu, bi struzzjonijiet dettaljati għall- użu li għandhom jiġu segwiti
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
17 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt 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 li taħdem malajr, b’ żewġ funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
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 ipogliċemiċi wara l- bidla minn insulina li ġejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogliċemija kienu anqas evidenti jew differenti minn dawk li kien ikollhom bl- insulina ta ’ qabel.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
18 Il- ħtiġijiet għall- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
Insulin treatment of the nursing mother presents no risk to the baby.
Il- kura bl- insulina fl- omm li tkun qed tredda 'ma toħloq l- ebda riskju għat- tarbija.
However, the Actraphane dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm bżonn li d- doża ta ’ Actraphane tiġi aġġustata.
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.
19 Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata Mhux komuni - Reazzjonijiet fis- sit ta' l- injezzjoni Reazzjonijiet fis- sit ta 'l- injezzjoni (ħmura, nefħa, ħakk, uġigħ u ematoma fis- sit ta' l- injezzjoni) jistgħu jseħħu waqt il- kura bl- insulina.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Mhux komuni - Edima L- edima tista ’ sseħħ 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 ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastro- intestinali, edima anġjonewrotika, diffikultajiet biex tieħu n- nifs, palpitazzjonijiet u tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Għalhekk, il- farmakokinetika ta ’
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
20 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
20 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 ’ taħt il- ġilda.
6 weeks when used or carried as a spare (below 30°C).
6 ġimgħat meta jintuża jew jinġarr bħala spare (taħt 30°C).
6.4 Special precautions for storage
21 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 30°C.
Taħżinhomx f' temperatura ’ l fuq minn 30°C.
Keep the cartridge in the outer carton in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
3 ml glass cartridge (type 1) with a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
Skartoċċ tal- ħġieġ (tip 1) ta ’ 3 ml bi planġer tal- gomma ta ’ bromobutyl u tapp tal- gomma ta ’ bromobutyl/ polyisoprene.
The cartridge contains a glass ball to facilitate the re-suspension.
L- iskartoċċ fih boċċa tal- ħġieġ biex tgħin lis- suspensjoni terġa ’ titħawwad mill- ġdid.
1, 5 and 10 cartridges x 3 ml.
1, 5 u 10 skrataċ x 3 ml.
21 6.6 Special precaustions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor