qanastek/EMEA-V3 huggingface dataset:
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
L- iskartoċċi għandhom jintużaw biss ma 'prodotti li jkunu kompatibbli magħhom u li jippermettu li l - iskartoċċ jaħdem b' mod sikur u b' mod effettiv.
Actraphane Penfill is for single person use only.
Actraphane Penfill hu maħsub biex jintuża minn persuna waħda biss.
The container must not be refilled.
Il- kontenitur m’ għandux jimtela mill- ġdid.
After removing Actraphane Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Actraphane Penfill mill- friġġ, hu rakkomandat li tħalli l- Penfill 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 20 Penfill 100 IU/ ml suspension for injection in a cartridge.
Actraphane 20 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
Actraphane 20 consists of 20% dissolved insulin and 80% isophane insulin.
Actraphane 20 jikkonsisti f' 20% ta 'insulina maħlula u 80% ta' insulina isophane.
Close blood glucose monitoring is therefore recommended.
Il- monitoraġġ mill- qrib ta ’ glukosju hu għalhekk irrakkomandat..
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
24 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
23 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.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
25 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
24 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.
26 Il- ħtiġijiet għall- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
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.
27 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.
26 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
28 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
27 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.
6.4 Special precautions for storage
29 6. 4 Prekawzjonijiet speċjali għall- ħażna
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali
28 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actraphane 30 Penfill 100 IU/ ml suspension for injection in a cartridge.
Actraphane 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
32 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
30 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.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
33 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
Continuous rotation of the injection site within a given area may help to
Bħal kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
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.
34 Il- ħtiġijiet għall- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
32 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 hypoglycaemia or have frequent episodes of hypoglycaemia.
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.
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.
35 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.
33 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
36 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
34 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.
6.4 Special precautions for storage
37 6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in a refrigerator (2°C - 8°C).
Qabel l- użu: aħżen fi friġġ (2°C - 8°C).
35 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actraphane 40 Penfill 100 IU/ ml suspension for injection in a cartridge.
Actraphane 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
1 ml contains 100 IU of insulin human.
Millilitru fih 100 UI ta ’ insulina umana.
1 cartridge contains 3 ml equivalent to 300 IU.
Skartoċċ fih 3 ml ekwivalenti għal 300 UI.
Actraphane 40 consists of 40% dissolved insulin and 60% isophane insulin.
Actraphane 40 jikkonsisti f' 40% ta 'insulina maħlula u 60% ta' insulina isophane.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
40 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
37 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.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
41 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
42 Il- ħtiġijiet għall- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
39 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.
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.
43 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.
40 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
44 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
6.4 Special precautions for storage
45 6. 4 Prekawzjonijiet speċjali għall- ħażna
42 Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta 'l- insulina li kienu ffriżati m’ għandhomx jintużaw.
Date of forst authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
Date of lates renewal:
Data ta ’ l- aħħar tiġdid:
Actraphane 50 Penfill 100 IU/ ml suspension for injection in a cartridge.
Actraphane 50 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ
Actraphane 50 consists of 50% dissolved insulin and 50% isophane insulin.
Actraphane 50 jikkonsisti f' 50% ta 'insulina maħlula u 50% ta' insulina isophane.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
48 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
44 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.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
49 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
45 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.
50 Il- ħtiġijiet għall- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
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.
51 Reazzjonijiet fis- sit ta 'l- injezzjoni (ħmura, nefħa, ħakk, uġigħ u ematoma fis- sit ta' l- injezzjoni) jistgħu jseħħu waqt il- kura bl- insulina.
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
52 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.
Do not freeze.
53 Tagħmilhomx fil- friża.
49 Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta 'l- insulina li kienu ffriżati m’ għandhomx jintużaw.
Actraphane 10 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 10 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
1 pre-filled pen contains 3 ml equivalent to 300 IU.
Pinna mimlija għal- lest fiha 3 ml ekwivalenti għal 300 UI.
Suspension for injection in a pre-filled pen.
Suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
55 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
51 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.
Actraphane NovoLet is designed to be used with NovoFine needles.
Actraphane NovoLet hi maħsuba biex tintuża mal- labar NovoFine.
NovoLet delivers 2-78 units in increments of 2 units.
NovoLet tipprovdi 2- 78 unità f' inkrementi ta '2 unitajiet.
The pens should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle top.
Il- pinen għandhom ikunu pprajmati qabel l- injezzjoni biex is- selettur tad- doża jmur lura fuq iż- żero u qatra ta 'insulina tidher fit- tarf tal- labra.
The dose is set by turning the selector, which returns to zero during the injection.
Id- doża tiġi ssettjata billi ddawwar is- selettur, li jerġa 'jmur lura fuq iż- żero waqt l- injezzjoni.
Usual warning symptoms may disappear in patients with longstanding diabetes.
56 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
52 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.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Għalhekk hu
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
57 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.
53 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
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.
58 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.
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
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.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
59 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
55 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
60 6. 4 Prekawzjonijiet speċjali għall- ħażna
Protect from excessive heat and sunlight.
Żomm l- għatu fuq il- pinna sabiex tilqa ’ mid- dawl Ilqa ’ minn sħana eċċessiva u mid- dawl tax- xemx.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Pinna mimlija għal- lest (pinna b' ħafna dożi li tintrema wara li tintuża) li tinkludi injettur pinna bi skartoċċ (3 ml).
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
L- iskartoċċ hu tal- ħġieġ (tip 1), li fih 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.
The pen injector is made of plastic.
L- injettur pinna hu tal- plastik.
5 and 10 pre-filled pens x 3 ml.
5 u 10 pinen mimlija għal- lest x 3 ml.
56 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Il- pinen għandhom jintużaw biss ma 'prodotti li jkunu kompatibbli magħhom u li jippermettu li l- pinen jaħdmu b' mod sikur u b' mod effettiv.
Actraphane NovoLet is for single person use only.
Actraphane NovoLet hi maħsuba biex tintuża minn persuna waħda biss.
After removing Actraphane NovoLet from the refrigerator it is recommended to allow the NovoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Actraphane NovoLet mill- friġġ, hu rakkomandat li tħalli n- NovoLet tilħaq 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 20 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 20 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
63 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
58 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.
Usual warning symptoms may disappear in patients with longstanding diabetes.
64 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
65 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.
60 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.
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.
66 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.
61 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
67 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
62 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.
6.4 Special precautions for storage
68 6. 4 Prekawzjonijiet speċjali għall- ħażna
63 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
64 1.
70 1.
Actraphane 30 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 30 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
71 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
65 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.
Usual warning symptoms may disappear in patients with longstanding diabetes.
72 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
73 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.
67 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.
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.
74 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.
68 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
75 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
69 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.
6.4 Special precautions for storage
76 6. 4 Prekawzjonijiet speċjali għall- ħażna
70 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actraphane 40 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 40 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
79 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
72 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.
Usual warning symptoms may disappear in patients with longstanding diabetes.
80 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
81 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.
74 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.
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.
82 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.
75 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
83 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
76 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.
6.4 Special precautions for storage
84 6. 4 Prekawzjonijiet speċjali għall- ħażna
77 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actraphane 50 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 50 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
87 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
79 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.
Usual warning symptoms may disappear in patients with longstanding diabetes.
88 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
89 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.
81 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.
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.
90 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.
82 4.9 Overdose
4. 9 Doża eċċessiva
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
91 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
6.4 Special precautions for storage
92 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 30°C.
Waqt l- użu: tagħmilhomx fil- friġġ.
Keep the pen cap on in order to protect from light.
Taħżinhomx f' temperatura ’ l fuq minn 30°C.
84 Actraphane NovoLet is for single person use only.
Actraphane NovoLet hi maħsuba biex tintuża minn persuna waħda biss.
85 1.
94 1.
Actraphane 30 InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 30 InnoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
95 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
86 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.
Actraphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Actraphane NovoLet hi maħsuba biex tintuża mal- labar NovoFine.
InnoLet delivers 1-50 units in increments of 1 unit.
NovoLet tipprovdi 2- 78 unità f' inkrementi ta '2 unitajiet.
Usual warning symptoms may disappear in patients with longstanding diabetes.
96 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
87 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.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
97 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.
88 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
The frequencies are defined as:
Il- frekwenzi huma definiti bħala:
Uncommon (≥ 1/ 1,000 to < 1/ 100).
Mhux komuni (≥1/ 1, 000 sa < 1/ 100).
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.
98 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.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
99 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
90 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.
6.4 Special precautions for storage
100 6. 4 Prekawzjonijiet speċjali għall- ħażna
1, 5 and 10 pre-filled pens x 3 ml.
1, 5 u 10 pinen mimlija għal- lest x 3 ml.
91 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actraphane InnoLet is for single person use only.
Actraphane InnoLet hu maħsub biex jintuża minn persuna waħda biss.
After removing Actraphane InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Actraphane InnoLet mill- friġġ, hu rakkomandat li tħalli l- InnoLet tilħaq 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.
92 1.
102 1.
Actraphane 30 FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Actraphane 30 FlexPen 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
103 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
93 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.
Actraphane FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Actraphane FlexPen hi maħsuba biex tintuża ma 'labar NovoFine bl- għatu qasir ta' 8 mm jew iqsar.
The needle box is marked with an S.
Il - kaxxa tal- labar hi mmarkata b' S.
FlexPen delivers 1-60 units in increments of 1 unit.
FlexPen tforni 1- 60 unitajiet f' inkrementi ta '1 unità.
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.
104 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.
94 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.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
105 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.
95 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
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.
106 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.
5.2 Pharmacokinetic properties
107 5. 2 Tagħrif farmakokinetiku
97 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.
6.3 Shelf life
108 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
98 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actraphane FlexPen is for single person use only.
Actraphane FlexPen hi maħsuba biex tintuża minn persuna waħda biss.
After removing Actraphane Flexpen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Actraphane FlexPen mill- friġġ, hu rakkomandat li tħalli l- FlexPen tilħaq 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.
99 ANNEX II
110 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA 'L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA 'L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg Denmark
Novo Nordisk A/ S Hallas Allé DK - 4400 Kalundborg Id- Danimarka
Actraphane 30 Penfill and FlexPen:
Actraphane 30 Penfill u FlexPen:
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
Novo Nordisk Production SAS 45, Avenue d’ Orléans F- 28002 Chartres Franza
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
101 ANNEX III
112 ANNESS III
102 A.
113 A.
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
114 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 40 IU/ ml suspension for injection in a vial Insulin human (rDNA),
Actraphane 30 40 UI/ ml suspensjoni għall- injezzjoni f' kunjett Insulina umana (rDNA),
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA) (30% as soluble insulin and 70% as isophane insulin).
1 ml ta 'suspensjoni fih 40 UI (1. 4 mg) ta' insulina umana, (rDNA) (30% bħala insulina li tinħall u 70% bħala insulina isophane).
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate u ilma għall- injezzjonijiet
Suspension for injection 1 x 10 ml 5 x 10 ml
Suspensjoni għall- injezzjoni 1 x 10 ml 5 x 10 ml
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
Użu għal taħt il- ġilda Erġa 'ifforma s- suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta' tagħrif qabel l- użu.
EXP/ During use: use within 6 weeks
JIS / Waqt l- użu: uża fi żmien 6 ġimgħat
104 9.
115 9.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- użu: tagħmlux fil- friġġ jew taħżen f’ temperatura ’ l fuq minn 25°C
Actraphane 30 vial 40 IU/ ml
Actraphane 30 kunjett 40 UI/ ml
105 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
116 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 30 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 30 40 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
EXP/
JIS /
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Actraphane 30 100 UI/ ml suspensjoni għall- injezzjoni f' kunjett Insulina umana (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (30% as soluble insulin and 70% as isophane insulin).
1 ml ta 'suspensjoni fih 100 UI (3. 5 mg) ta' insulina umana, (rDNA) (30% bħala insulina li tinħall u 70% bħala insulina isophane).
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate u ilma għall- injezzjonijiet.
Actraphane 30 vial 100 IU/ ml
Actraphane 30 kunjett 100 UI/ ml
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
119 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 30 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 30 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Actraphane 30 40 UI/ ml suspensjoni għall- injezzjoni f' kunjett Insulina umana (rDNA)
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Suspensjoni għall- injezzjoni 1 x 10 ml Dan hu parti minn pakkett multiplu u mhux għall- bejgħ ta 'kunjetti individwali
110 9.
121 9.
111 PARTICULARS TO APPEAR ON THE PACKAGING
122 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT
OUTER WRAPPER LABEL ON MULTIPACKS
TIKKETTA TAL- KARTA TA’ BARRA FUQ IL- PAKKETTI MULTIPLI
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Suspensjonig ħall- injezzjoni 5 x (1 x 10 ml) Dan hu pakkett multiplu u mhux għall- bejgħ ta 'kunjetti individwali
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
124 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (30% as soluble insulin and 70% as isophane insulin).
1 ml ta 'suspensjoni fih 100 UI (3. 5 mg) ta' insulina umana, (rDNA) (30% bħala insulina li tinħall u 70% bħala insulina isophane)
114 9.
125 9.
115 PARTICULARS TO APPEAR ON THE PACKAGING
126 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT
OUTHER WRAPPER LABEL ON MULTIPACKS
TIKKETTA TAL- KARTA TA ’ BARRA FUQ IL- PAKKETTI MULTIPLI
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Suspensjoni għall- injezzjoni 5 x (1 x 10 ml) Dan hu pakkett multiplu u mhux għall- bejgħ ta 'kunjetti individwali
116 9.
127 9.
117 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
128 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 10 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Actraphane10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (10% as soluble insulin and 90% as isophane insulin).
1 ml ta 'suspensjoni fih 100 UI (3. 5 mg) ta' insulina umana, (rDNA) (10% bħala insulina li tinħall u 90% bħala insulina isophane).
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Suspensjoni għall- injezzjoni 1 x 3 ml 5 x 3 ml 10 x 3 ml
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Actraphane 10 Penfill is for use by one person only
Actraphane 10 Penfill hu għall- użu minn persuna waħda biss
118 9.
129 9.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- użu: tagħmilx fil- friġġ jew taħżen f’ temperatura ta ’ ’ l fuq minn 30°C
119 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
130 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PENFILL LABEL
TIKKETTA TAL- PENFILL
Actraphane 10 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
131 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 20 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Actraphane 20 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (20% as soluble insulin and 80% as isophane insulin).
1 ml ta 'suspensjoni fih 100 UI (3. 5 mg) ta' insulina umana, (rDNA) (20% bħala insulina li tinħall u 80% bħala insulina isophane).
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Actraphane 20 Penfill is for use by one person only
Actraphane 20 Penfill hu għall- użu minn persuna waħda biss
122 229MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
133 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 20 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 20 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
123 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
134 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Actraphane 30 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA),
Actraphane 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA),
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Actraphane 30 Penfill is for use by one person only
Actraphane 30 Penfill hu għall- użu minn persuna waħda biss
124 9.
135 9.
125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
136 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Actraphane 30 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Actraphane 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
137 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT