qanastek/EMEA-V3 huggingface dataset:
3 ml glass cartridge (type 1) with a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
Skarto tal - ie (tip 1) ta ’ 3 ml bi plan er tal- gomma tal- bromobutyl u tapp tal- gomma tal - bromobutyl/ polyisoprene.
The cartridge contains a glass ball to facilitate the re-suspension.
L- iskarto fih bo a tal - ie biex tg in sabiex ter a ’ ti i mag mula mill - did is- suspensjoni.
1, 5 and 10 cartridges x 3 ml.
1, 5 u 10 skarto i x 3 ml.
21 Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
L- iskarto i g andhom jintu aw biss ma ’ prodotti li jkunu kompatibbli mag hom u li jippermettu li l - iskarto ja dem b’ mod sikur u b’ mod effettiv.
Insulatard Penfill is for single person use only.
Insulatard Penfill hu g all- u u ta ’ persuna wa da biss.
The container must not be refilled.
Il- kontenitur m’ g andux jimtela mill - did.
After removing Insulatard 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 tne i Insulatard Penfill mill- fri, huwa rakkomandat li t alli l- Penfill jil aq it- temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
DATE OF REVISION OF THE TEXT
META IET RIVEDUTA L- KITBA
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard NovoLet 100 UI/ ml Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest
1 pre-filled pen contains 3 ml equivalent to 300 IU.
Pinna mimlija g al- lest fiha 3 ml ekwivalenti g al 300 UI.
Suspension for injection in a pre-filled pen.
Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest.
Renal or hepatic impairment may reduce insulin requirement.
24 L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a g all- insulina.
23 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
Insulatard NovoLet is designed to be used with NovoFine needles.
Insulatard NovoLet hi mag mula biex tintu a mal- labar NovoFine.
NovoLet delivers 2-78 units in increments of 2 unitsThe 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 g andhom ikunu ppreparati qabel kull injezzjoni b’ tali mod li s- selettur tad- do a jmur fuq i - ero 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- do a ti i ssettjata billi ddawwar is- selettur, li jer a ’ jmur lura fuq i - ero waqt l- injezzjoni.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
25 It- trasferiment ta ’ pazjent g al tip ie or jew marka o ra ta ’ insulina g andu jsir ta t sorveljanza medika stretta.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, fil- marka (manifattur), fit- tip (insulina b’ azzjoni ta ’ malajr, b’ azzjoni doppja, b’ azzjoni fit- tul, e.), fl- ori ini (insulina li ejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina li ejja mid- DNA rikombinanti, kontra dik li ejja minn sors ta ’ l- annimali), jista ’ jirri ulta li jkun hemm b onn ta ’ tibdil fid- do a.
Continuous rotation of the injection site within a given area may help to
Li fl- istess ona partikulari jkun hemm tibdil kontinwu tal- post ta ’ l- injezzjoni jista ’ jg in biex inaqqas jew jimpedixxi dawn ir- reazzjonijiet.
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Xi pazjenti li kellhom reazzjonijiet ipogli emi i wara l- bidla minn insulina li ejja minn sors ta ’ l - annimali, irrappurtaw li s- sinjali bikrija ta ’ twissija ta ’ l- ipogli emija kienu anqas evidenti jew differenti minn dawk li kien ikollhom bl- insulina ta ’ qabel.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
G alhekk hu
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
26 rakkomandat li jkun hemm kontroll intensifikat fil- kura ta ’ nisa bid- dijabete waqt l- ippjanar tat- tqala u matul l- istess tqala.
25 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il - ila tal- pazjent li jikkon entra u jirrea ixxi tista ’ titnaqqas min abba l- ipogli emija.
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 enerali u kundizzjonijiet ta 'mnejn jing ata Mhux komuni - Reazzjonijiet fil- post ta ’ l- injezzjoni Reazzjonijiet fil- post ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fil- post ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
26 Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
28 Dan il- pro ess hu influwenzat minn diversi fatturi (e. id- do a ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xa am ta t il - ilda, it- tip tad- dijabete).
6.4 Special precautions for storage
29 6. 4 Prekawzjonijiet spe jali g all - a na
Do not store them in or too near the freezer section or cooling element.
Qabel l- u u: a en fi fri (2°C - 8°C) Ta inhomx ewwa jew wisq vi in is- sezzjoni tal- fri a jew l- element li jkessa.
Protect from excessive heat and sunlight.
omm l- g atu fuq il- pinna sabiex tilqa ’ mid- dawl Ipprote i minn s ana e essiva u mid- dawl tax- xemx.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Pinna mimlija g al- lest (pinna b ’ afna do i li tintrema wara li tintu a) li tinkludi injettur pinna bi skarto (3 ml).
28 bromobutyl/ polyisoprene rubber stopper.
L- iskarto hu tal - ie (tip 1), li fih plan er tal- gomma tal- bromobutyl u tapp tal - gomma tal- bromobutyl/ polyisoprene.
The cartridge contains a glass ball to facilitate the re- suspension.
L- iskarto fih bo a tal - ie biex tg in lis- suspensjoni ter a ’ tit awwad mill - did.
The pen injector is made of plastic.
L- injettur hu tal- plastik.
5 and 10 pre-filled pens x 3 ml.
5 u 10 pinen mimlija g al- lest x 3 ml.
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 g andhom jintu aw biss ma ’ prodotti li jkunu kompatibbli mag hom u li jippermettu li l - pinen ja dmu b’ mod sikur u b’ mod effettiv.
Insulatard NovoLet is for single person use only.
Insulatard NovoLet hi g all- u u minn persuna wa da biss.
After removing Insulatard 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 tne i Insulatard NovoLet mill- fri, huwa rakkomandat li t alli n- NovoLet til aq it - temperatura ambjentali tal- kamra qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l - istruzzjonijiet g all- ewwel u u.
Date of first authorisation:
30 Data ta ’ l- ewwel awtorizzazzjoni:
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard InnoLet 100 IU/ ml Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest
Renal or hepatic impairment may reduce insulin requirement.
32 L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a g all- insulina.
30 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
G andek i omm il- labra ta t il - ilda g al mill- anqas 6 sekondi biex ti gura li tkun tajt id- do a kollha. o l- istess ona anatomika l- postijiet fejn ting ata l- injezzjoni g andhom jinbidlu biex ti i evitata l - lipodistrofija.
Insulatard InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard InnoLet hi mag mula biex tintu a ma 'labar NovoFine bl- g atu qasir ta' 8 mm jew iqsar.
InnoLet delivers 1-50 units in increments of 1 unit.
InnoLet tforni 1- 50 unitajiet f' inkrementi ta 'unità wa da.
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 g andhom ikunu ppreparati qabel kull injezzjoni b’ tali mod li s- selettur tad- do a jmur fuq i - ero u qatra ta ’ insulina tidher fit- tarf tal- labra.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
33 It- trasferiment ta ’ pazjent g al tip ie or jew marka o ra ta ’ insulina g andu jsir ta t sorveljanza medika stretta.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, fil- marka (manifattur), fit- tip (insulina b’ azzjoni ta ’ malajr, b’ azzjoni doppja, b’ azzjoni fit- tul, e.), fl- ori ini (insulina li ejja mill- annimali, umana jew analoga) u/ jew fil - metodu tal- manifattura (insulina li ejja mid- DNA rikombinanti, kontra dik li ejja minn sors ta ’ l - annimali), jista ’ jirri ulta li jkun hemm b onn ta ’ tibdil fid- do a.
31 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
B al kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu u ig, aqq, urtikarja, nef a u infjammazzjoni.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
34 rakkomandat li jkun hemm kontroll intensifikat fil- kura ta ’ nisa bid- dijabete waqt l- ippjanar tat- tqala u matul l- istess tqala.
32 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il - ila tal- pazjent li jikkon entra u jirrea ixxi tista ’ titnaqqas min abba l- ipogli emija.
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 enerali u kundizzjonijiet ta 'mnejn jing ata Mhux komuni - Reazzjonijiet fil- post ta ’ l- injezzjoni Reazzjonijiet fil- post ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fil- post ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
33 Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
36 Dan il- pro ess hu influwenzat minn diversi fatturi (e. id- do a ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xa am ta t il - ilda, it- tip tad- dijabete).
6.4 Special precautions for storage
37 6. 4 Prekawzjonijiet spe jali g all - a na
35 bromobutyl/ polyisoprene rubber stopper.
L- iskarto hu tal - ie (tip 1), li fih plan er tal- gomma tal- bromobutyl u tapp tal - gomma tal- bromobutyl/ polyisoprene.
The cartridge contains a glass ball to facilitate the re- suspension.
L- iskarto fih bo a tal - ie biex tg in sabiex ter a ’ ti i mag mula mill - did is- suspensjoni.
1, 5 and 10 pre-filled pens x 3 ml.
1, 5 u 10 pinen mimlija g al- lest x 3 ml.
Insulatard InnoLet is for single person use only.
Insulatard InnoLet hi mag mula biex tintu a minn persuna wa da biss.
After removing Insulatard 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 tne i Insulatard InnoLet mill- fri, huwa rakkomandat li t alli l- InnoLet til aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Date of first authorisation:
38 Data ta ’ l- ewwel awtorizzazzjoni:
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard FlexPen 100 UI/ ml Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Normalment il - tie a individwali g all- insulina hi ta ’ bejn 0. 3 u 1. 0 UI/ kg/ kuljum.
Renal or hepatic impairment may reduce insulin requirement.
40 L- indeboliment renali jew epatiku jista ’ jnaqqas il - tie a g all- insulina.
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
L- a ustament fid- do a jista ’ jkun me tie meta l- pazjenti jaqilbu minn tip ta ’ insulina g all- o ra (ara sezzjoni 4. 4 Twissijiet spe jali u prekawzjonijiet g all- u u).
Insulatard FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard FlexPen hi mag mula biex tintu a ma ’ labar NovoFine S 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 'unità 1.
The dose is set by turning the selector, which returns to zero during the injection.
Id- do a ti i ssettjata billi ddawwar is- selettur, li jer a ’ jmur lura fuq i - ero waqt l- injezzjon.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
41 It- trasferiment ta ’ pazjent g al tip ie or jew marka o ra ta ’ insulina g andu jsir ta t sorveljanza medika stretta.
38 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
B al kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu u ig, aqq, urtikarja, nef a u infjammazzjoni.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
42 rakkomandat li jkun hemm kontroll intensifikat fil- kura ta ’ nisa bid- dijabete waqt l- ippjanar tat- tqala u matul l- istess tqala.
39 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Il - ila tal- pazjent li jikkon entra u jirrea ixxi tista ’ titnaqqas min abba l- ipogli emija.
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 enerali u kundizzjonijiet ta 'mnejn jing ata Mhux komuni - Reazzjonijiet fil- post ta ’ l- injezzjoni Reazzjonijiet fil- post ta ’ l- injezzjoni (mura, nef a, akk, u ig u ematoma fil- post ta ’ l- injezzjoni) jistg u jse u waqt il- kura bl- insulina.
40 Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
44 Dan il- pro ess hu influwenzat minn diversi fatturi (e. id- do a ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xa am ta t il - ilda, it- tip tad- dijabete).
6 weeks when used or carried as a spare (below 30°C).
6 img at meta jkun qed jintu a jew jin arr g al li jista ’ jinqala ’ (ta t 30°C)..
6.4 Special precautions for storage
45 6. 4 Prekawzjonijiet spe jali g all - a na
42 bromobutyl/ polyisoprene rubber stopper.
L- iskarto hu tal - ie (tip 1), li fih plan er tal- gomma tal- bromobutyl u tapp tal - gomma tal- bromobutyl/ polyisoprene.
Insulatard FlexPen is for single person use only.
Insulatard FlexPen hi mag mula biex tintu a minn persuna wa da biss.
After removing Insulatard 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 tne i Insulatard FlexPen mill- fri, huwa rakkomandat li t alli l- FlexPen til aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Date of first authorisation:
46 Data ta ’ l- ewwel awtorizzazzjoni:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLO IKA ATTIVA U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA' L- AWTORIZZAZZJONI G AT - TQEG ID FIS- SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLO IKA ATTIVA U DETENTURI TA' L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL - LOTT
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manifattur tas- sustanza bijolo ika attiva
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifatturi responsabbli g all - ru tal- lott
Insulatard Penfill and FlexPen
Insulatard Penfill u FlexPen
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 ’ tag rif tal- prodott medi inali g andu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill - ru tal- lott kon ernat.
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA' L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- U U • IMPOSTI FUQ ID- DETENTUR TA' L- AWTORIZZAZZJONI G AT- TQEG ID FIS - SUQ
Medicinal product subject to medical prescription
Prodott medi inali jing ata bir- ri etta tat- tabib
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- U U • MING AJR PERIKLU U EFFETTIV TAL- PRODOTT MEDI INALI
Not applicable.
Ma jg oddx f’ dan il- ka.
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA ’ TAG RIF
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 UI/ ml suspensjoni g all- injezzjoni f' kunjett Insulina umana (rDNA)
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
Millilitru ta ’ suspensjoni fih 40 UI (1. 4 mg) ta ’ insulina umana (rDNA)
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 g all- injezzjonijiet
PHARMACEUTICAL FORM AND CONTENTS
G AMLA FARMA EWTIKA U KONTENUT
Suspension for injection 1 x 10 ml 5 x 10 ml
Suspensjoni g all- injezzjoni 1 x 10 ml 5 x 10 ml
METHOD AND ROUTE OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JING ATA
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
U u g al ta t il - ilda Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta ’ tag rif qabel l- u u.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPE JALI LI L- PRODOTT MEDI INALI G ANDU JIN AMM FEJN MA JINTLA AQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children
omm fejn ma jintla aqx u ma jidhirx mit- tfal
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPE JALI O RA, JEKK ME TIE A
EXP/ During use: use within 4 weeks
JIS / Waqt l- u u: u a fi mien 4 img at
SPECIAL STORAGE CONDITIONS 48 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
A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPE JALI G AR- RIMI TA ’ PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINN DAWN IL- PRODOTTI MEDI INALI, JEKK HEMM B ONN
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
GENERAL CLASSIFICATION FOR SUPPLY
ENERALI TA ’ KIF JING ATA
Medicinal product subject to medical prescription
medi inali jing ata bir- ri
INSTRUCTIONS ON USE
STRUZZJONIJIET DWAR L- U U
Insulatard vial 40 IU/ ml
Insulatard kunjett 40 UI/ ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
ISEM TAL- PRODOTT MEDI INALI U MNEJN G ANDU JING ATA
Insulatard 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 40 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
METHOD OF ADMINISTRATION
METODU TA ’ KIF G ANDU JING ATA
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PI, VOLUM, JEW PARTI INDIVIDWALI
OTHER
O RAJN
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Insulatard 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 100 UI/ ml suspensjoni g all- injezzjoni f' kunjett Insulina umana (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
Millilitru ta ’ suspensjoni fih 100 UI (3. 5 mg) ta ’ insulina umana (rDNA)
EXP/ During use: use within 6 weeks
JIS / Waqt l- u u: u a fi mien 6 img at
SPECIAL STORAGE CONDITIONS 51 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
A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
Insulatard vial 100 IU/ ml
Insulatard kunjett 100 UI/ ml
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
Insulatard 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Suspensjoni g all- injezzjoni 1 x 10 ml Dan huwa parti minn pakkett multiplu u l- kunjetti ma jistg ux jinbieg u individwalment.
SPECIAL STORAGE CONDITIONS 54 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
A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
55 PARTICULARS TO APPEAR ON THE PACKAGING
59 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETTI
OUTER WRAPPER LABELON 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 g all- injezzjoni 5 x (1 x 10 ml) Dan huwa pakkett multiplu u l- kunjetti ma jistg ux jinbieg u individwalment
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPE JALI TA' KIF JIN A EN
56 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
60 A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SPECIAL STORAGE CONDITIONS 58 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
A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
59 PARTICULARS TO APPEAR ON THE PACKAGING
63 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETTI
OUTER WRAPPER LABELON MULTIPACKS
TIKKETTA TAL- PAKKETT TA ’ BARRA FUQ IL- PAKKETTI MULTIPLI
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
U u g al ta t il - ilda Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta 'tag rif qabel l- u u.
60 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
64 A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
65 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Insulatard Penfill 100 UI/ ml suspensjoni g all- injezzjoni fi skarto Insulina umana (rDNA)
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Suspensjoni g all- 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 Insulatard Penfill is for use by one person only
U u g al ta t il - ilda L- iskarto i Penfill huma g all- u u ma ’ sistemi ta ’ l- g oti ta ’ insulina Novo Nordisk Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta 'tag rif qabel l- u u.
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
A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm l- iskarto fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag milx fil- fri jew ta en f’ temperatura ta ’ ’ l fuq minn 30°C
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
67 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
Insulatard Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard Penfill 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
68 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard NovoLet 100 UI/ ml suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Suspension for injection 5 x 3 ml 10 x 3 ml
Suspensjoni g all- injezzjoni 5 x 3 ml 10 x 3 ml
Subcutaneous use Insulatard NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Insulatard NovoLet is for use by one person only
Insulatard NovoLet huwa g all- u u minn persuna wa da biss.
SPECIAL STORAGE CONDITIONS
A en fi fri (2°C - 8°C) Tag mlux fil- fri a Tag mlux fid- dawl Waqt l- u u: tag mlux fil- fri
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
jew ta en f’ temperatura ’ l fuq minn 30°C
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
70 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
Insulatard NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard NovoLet 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
71 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard InnoLet 100 UI/ ml uspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Subcutaneous use Insulatard InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Insulatard InnoLet is for use by one person only
Insulatard InnoLet hi g all- u u minn persuna wa da biss
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
73 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
INNOLET LABEL
TIKKETTA TA ’ L- INNOLET
Insulatard InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard InnoLet 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
74 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard FlexPen 100 UI/ ml suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Subcutaneous use
U u g al ta t il - ilda
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Resuspend according to instructions Read the package leaflet before use Insulatard FlexPen is for use by one person only
Insulatard FlexPen huwa g all- u u minn persuna wa da biss.
71 EXP/ During use: use within 6 weeks
75 JIS / Waqt l- u u: u a fi mien 6 img at
72 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
76 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
Insulatard FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard FlexPen 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
PACKAGE LEAFLET
FULJETT TA' TAG RIF
74 PACKAGE LEAFLET:
78 FULJETT TA' TAG RIF:
INFORMATION FOR THE USER
INFORMAZZJONI G AL MIN QED JAG MEL U U MINNU
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 UI/ ml suspensjoni g all- injezzjoni f 'kunjett Insulina umana (rDNA)
Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tu a din il- medi ina. – omm dan il- fuljett.
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Jista ’ jkollok b onn ter a ’ taqrah. – Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, infermier/ a tad- dijabete jew lill- ispi jar tieg ek. – Din il- medi ina iet mog tija lilek.
Do not pass it on to others.
M’ g andekx tg addiha lil persuni o ra.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
Tista ’ tag mlilhom il - sara, anki jekk ikollhom l- istess sintomi b al tieg ek. – Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, l- infermier/ a tad- dijabete jew lill - ispi jar tieg ek.
WHAT INSULATARD IS AND WHAT IT IS USED FOR
X’ INHU INSULATARD U G ALXIEX JINTU A
Insulatard is human insulin to treat diabetes.
Insulatard hu insulina umana g all- kura tad- dijabete.
Insulatard is often given in combination with fast-acting insulin products.
Dan ifisser li jibda jbaxxilek il- livell taz- zokkor fid- demm madwar sieg a u nofs wara li tie du, u l- effett idum g al madwar 24 sieg a. afna drabi Insulatard jing ata flimkien ma ’ prodotti ta ’ l- insulina li ja dmu b’ mod malajr.
BEFORE YOU USE INSULATARD
QABEL MA TU A INSULATARD
Do not use Insulatard
Tu ax Insulatard
► If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Jekk inti aller iku/ a (tbati minn sensittività e essiva) g al dan il- prodott ta ’ l- insulina, metacresol jew g al xi wie ed mill- ingredjenti l- o ra (ara 7 Aktar tag rif).
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Oqg od attent g as - sinjali ta ’ l- aller ija f' 5 Effetti sekondarji li jista ’ jkollu Jekk t oss li ejja ipo (ipo hi taqsira ta ’ reazzjoni ipogli emika u hija abra ta ’ sintomi li jindikaw livell baxx ta 'zokkor fid- demm).
See 4 What to do in an emergency for more about hypos.
Ara 4 X’ g andek tag mel f’ emer enza, g al aktar informazzjoni dwar l- ipos.
Take special care with Insulatard
Oqg od attent afna b’ Insulatard
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Jekk g andek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - tirojde Jekk qed tixrob l- alko ol: oqg od attent/ a g as- sinjali ta ’ xi ipo u qatt m' g andek tixrob l - alko ol fuq stonku vojt Jekk tag mel e er izzju fi iku aktar mis- soltu jew jekk trid tibdel id- dieta normali tieg ek Jekk inti marid/ a: kompli u l- insulina tieg ek Jekk ser issiefer: li tivvja a bejn oni tal - in differenti, jista 'jaffettwa l - ti ijiet tieg ek g all- insulina u l - in meta tie u l- injezzjonijiet.
Using other medicines
Meta tu a medi ini ohra
Many medicines affect the way glucose works in your body and they may influence your insulin dose.
Il- mod kif ja dem glukosju fil - isem tieg ek huwa affetwat minn afna medi ini, u dawn jistg u jinfluwenzaw id- do a tieg ek ta ’ l- insulina.
Listed below are the most common medicines which may affect your insulin treatment.
Hawn ta t hawn elenkati l- aktar medi ini komuni li jistg u jaffettwaw il- kura tieg ek bl- insulina.
Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek jekk qieg ed tie u jew adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Il - tie a tieg ek g all- insulina tista ’ tinbidel jekk inti tie u wkoll: prodotti medi inali kontra d - dijabete li jittie du mill - alq; inibituri ta ’ monamine oxidase (MAOI); beta- blokkanti; inibituri ta ’ l - enzima li tikkonverti l- an jotensin (ACE- inhibitors); acetylsalicylic acid; sterojdi anaboli i; 79 sulfonamidi; kontra ettivi orali; tija idi; glukokortikojdi; terapija bl- ormoni tat- tirojde; beta - simpatomimeti i, ormon tat- tikbir danazol; octreotide jew lanreotide.
Pregnancy and breast-feeding
Tqala u treddig
75 If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
Jekk inti tqila, qed tippjana li to ro tqila, jew qed tredda ’: jekk jog bok ikkuntattja lit- tabib tieg ek g al parir.
Driving and using machines
Sewqan u t addim ta ’ magni
If you drive or use tools or machines: watch out for signs of a hypo.
Jekk issuq jew tu a g odda jew magni: oqg od attent/ a g al sinjali ta ’ ipo.
Your ability to concentrate or to react will be less during a hypo.
Il - ila tieg ek li tikkon entra jew li tirrea ixxi ser tonqos waqt ipo.
Never drive or use machinery if you feel a hypo coming on.
Qatt issuq jew tu a makkinarju jekk t oss li ejja xi ipo.
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Iddiskuti mat- tabib tieg ek jekk g andekx issuq jew t addem magni jekk ikollok episodji frekwenti ta ’ ipos jew jekk issibha bi tqila biex tag raf l- ipos.
HOW TO USE INSULATARD
KIF G ANDEK TU A INSULATARD
Talk about your insulin needs with your doctor and diabetes nurse.
Tkellem dwar il - ti ijiet tieg ek ta ’ l- insulina mat- tabib u ma ’ l- infermier/ a tad- dijabete tieg ek.
Follow their advice carefully.
Segwi l- parir tag hom bl- attenzjoni.
This leaflet is a general guide.
Dan il- fuljett hu gwida enerali.
If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Jekk it- tabib tieg ek biddillek l- insulina minn tip jew marka ta ’ insulina g al o ra, jista 'jkun li d- do a tieg ek tkun trid ti i a ustata mit- tabib tieg ek.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li ti ekkja l- livell ta ’ glukosju fid- demm tieg ek regolarment.
Before using Insulatard
Qabel tu a Insulatard
► Check the label to make sure it is the right type of insulin ► Disinfect the rubber membrane with a medicinal swab.
Iddi infetta l- membrana tal- gomma b’ tajjara medi inali
► In insulin infusion pumps ► If the protective cap is loose or missing.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- g atu prottetiv ma jkunx issikkat jew ikun nieqes.
Each vial has a protective, tamper-proof plastic cap.
Jekk il- kunjett ma jkunx f’ kundizzjoni perfetta meta tir ivih, er a ’ ag tih lura lil min tahulek.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Insulatard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Insulatard)
How to use this insulin
Jekk ma jkunx abjad u opak b '
Insulatard is for injection under the skin (subcutaneously).
Insulatard hu mag mul biex ikun injettat ta t il - ilda.
Never inject your insulin directly into a vein or muscle.
Qatt m’ g andek tinjetta l- insulina tieg ek direttament o vina jew o muskolu.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Dejjem ibdel i - ona tal - isem fejn tinjetta, biex tevita li jifformaw l- g oqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms may be used.
L- a jar postijiet minn fejn tinjetta lilek innifsek huma: in- na a ta ’ quddiem ta ’ qaddek (i - aqq); il- warrani; in- na a ta ’ quddiem tal- koxox jew in- na a ta ’ fuq ta ’ dirg ajk.
Your insulin will work more quickly if you inject it around the waist.
L- insulina tieg ek ta dem aktar malajr jekk tinjetta madwar il- qadd.
Insulatard vials are for use with insulin syringes with the corresponding unit scale.
Il- kunjetti ta 'Insulatard huma g all- u u ma' siringi ta ’ l- insulina bi skala korrispondenti ta ’ unitajiet.
To inject Insulatard on its own
Meta tinjetta Insulatard wa du
Just before injecting this insulin, roll the vial between your hands until the liquid is uniformly white and cloudy.
E att qabel ma tinjetta din l- insulina, irrombla l- kunjett bejn idejk sakemm il- likwidu jkun abjad u opak b' mod uniformi.
Resuspending is easier if the insulin has reached room temperature 2.
Ikun iktar fa li li tifforma suspensjoni mill - did jekk l- insulina tkun la qet it- temperatura tal- kamra 2.
Draw air into the syringe, in the same amount as the dose of insulin you need 3.
I bed l- arja os- siringa, fl- istess ammont b ad- do a ta 'l- insulina li te tie 3.
Inject the air into the vial: push the needle through the rubber stopper and press the plunger 4.
Injetta l- arja ol- kunjett: imbotta l- labra minn ot- tapp tal- gomma u ag fas il- plan er 4.
Turn the vial and syringe upside down 5.
Imbag ad dawwar il- kunjett u s- siringa ta ’ ta t fuq 80 5.
Draw the right dose of insulin into the syringe 6.
I bed os- siringa d- do a korretta ta 'insulina 6.
Pull the needle out of the vial 7.
I bed il- labra ’ l barra mill- kunjett 7.
Make sure there is no air left in the syringe: point the needle upwards and push the air out 8.
A erta ru ek li ma jkunx baqa 'arja fis- siringa: ipponta l- labra ’ l fuq u imbotta l- arja ’ l barra 8.
Roll the vial of Insulatard between your hands.
Irrombla l- kunjett ta 'Insulatard bejn idejk.
Do this until the liquid is uniformly white and cloudy.
Ag mel dan sakemm il- likwidu jkun abjad u opak b' mod uniformi.
Draw as much air into the syringe as the dose of Insulatard you need.
Injetta l- arja ol- kunjett ta 'Insulatard, u mbag ad i bed il- labra' l barra.
Draw as much air into the syringe as the dose of fast-acting insulin you need.
I bed ammont ta 'arja os- siringa daqs id- do a ta' l- insulina li ta dem malajr li te tie.
Inject the air into the fast-acting insulin vial.
Injetta l - arja ol- kunjett ta 'l- insulina li ta dem malajr.
Then turn the vial and syringe upside down 4.
Imbag ad dawwar il- kunjett u s- siringa ta ’ ta t fuq 4.
Pull the needle out of the vial.
I bed id- do a korretta ta 'l- insulina li ta dem malajr os- siringa I bed il- labra ’ l barra mill - kunjett.
Make sure there is no air left in the syringe: point the needle upwards and push the air out.
A erta ru ek li ma jkunx baqa 'arja fis- siringa: ipponta l- labra ’ l fuq u imbotta l- arja ’ l barra.
Now push the needle into the vial of Insulatard.
Issa imbotta l- labra ol- kunjett ta 'Insulatard.
Then turn the vial and syringe upside down 6.
Imbag ad dawwar il- kunjett u s- siringa ta ’ ta t fuq 6.
Draw the right dose of Insulatard into the syringe.
I bed id- do a korretta ta 'Insulatard os- siringa.
Pull the needle out of the vial.
I bed il- labra ’ l barra mill- kunjett.
Inject the mixture straight away.
Injetta t- ta lita immedjatament.
Always mix fast-acting and long-acting insulin in this order.
Dejjem allat insulina li ta dem malajr u insulina li ta dem fit- tul f’ din is- sekwenza.
► Inject the insulin under the skin.
Injetta l- insulina ta t il - ilda.
Use the injection technique advised by your doctor or diabetes nurse ► Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
U a t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l - infermier/ a tad- dijabete tieg ek omm il- labra ta t il - ilda tieg ek g al mill- anqas 6 sekondi biex ti gura li d- do a s i a tkun ing atat.
WHAT TO DO IN AN EMERGENCY
X’ G ANDEK TAG MEL F’ EMER ENZA
A hypo means your blood sugar level is too low.
Ipo jfisser li l- livell taz- zokkor fid- demm tieg ek hu baxx wisq.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistg u ji u g al g arrieda u jistg u jinkludu: g araq kiesa; ilda kies a u pallida; u ig ta ’ ras; ta bit mg a el tal- qalb; t ossok imqalla ’; t oss u kbir; tibdil temporanju fil- vista; ng as; g eja u debbulizza mhux tas- soltu; nervo ità jew rog da; t ossok ansju / a; t ossok konfu / a; diffikultà biex tikkon entra.
If you get any of these signs. eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jekk ikollok xi wie ed minn dawn is- sinjali, u pilloli tal- glukosju jew ikla afifa li fiha afna zokkor (elu, gallettini, meraq tal- frott), u mbag ad strie.
Don’ t take any insulin if you feel a hypo coming on.
Ti ux insulina jekk t oss li ejja ipo. omm fuqek pilloli tal- glukosju, elu, gallettini jew meraq tal- frott, fil- ka li jkollok b onnhom.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
G id lill- qraba, il - bieb u l- kollegi tieg ek li jekk tintilef minn sensik (i ossok a in), huma g andhom: idawruk fuq enbek u j ibu g ajnuna medika immedjatament.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Jekk ipogli emija severa ma tkunx ikkurata, din tista ’ tikkaw a sara fil- mo (temporanja jew permanenti) u anki l- mewt
They must not give you any food or drink as it could choke you. ► If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death ► If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
81 Jekk ikollok ipo li ieg lek tintilef minn sensik, jew afna ipos, kellem lit- tabib tieg ek.
The amount or timing of insulin, food or exercise may need to be adjusted.
L - ammont jew il - in li fih tie u l- insulina, l- ikel jew l- e er izzju fi iku, jista ’ jkun li jkollhom b onn li ji u a ustati.
Using glucagon
Kif tu a glucagon