qanastek/EMEA-V3 huggingface dataset:
Once in-use, cartridges may be kept for up to 4 weeks.
Ġaladarba fl- użu, l- skartoċċi jistgħu jinżammu sa 4 ġimgħat.
Do not store above 25°C and protect from direct heat and light.
Taħżinx ’ il fuq minn 25°Ċ u żommhom ’ il bogħod mis- sħana diretta u d- dawl dirett.
When in use (in the pen), do not store in a refrigerator.
Meta jkunu fl- użu (fil- pinna), m’ għandhomx jinżammu fi friġġ.
Do not freeze.
Aħżen fi friġġ Tagħmlux fil- friza.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, il- Ġermanja.
EU/ 1/ 06/ 368/ 088 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 013 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 014 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 093 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 098 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 015 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 088 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 013 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 014 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 093 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 098 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 015 (10 skartoċċi ta ’ 3 ml)
321 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
322 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT TO APPEAR ON THE ALUMINIUM FOIL WHICH IS USED FOR SEALING TRANSPARENT PLASTIC TRAY CONTAINING THE CARTRIDGE
TAGĦRIF LI GĦANDU JIDHER FUQ IL- FOJL TA ’ L- ALUMINJU LI HIJA UŻATA GĦAS - SIĠILL TA ’ TILAR TAL- PLASTIK TRASPARENTI LI FIH L- ISKARTOĊĊ
After inserting a new cartridge:
Wara li ddaħħal skartoċċ ġdid:
You must check that your insulin pen is working properly before you inject the first dose.
Għandek tiżgura li l- pinna tiegħek ta ’ l- insulina qed taħdem kif suppost qabel ma tinjetta l- ewwel doża.
Consult your insulin pen instruction booklet for further details.
Ara l- fuljett ta ’ tagħrif dwar il- pinna tiegħek ta ’ l- insulina għal aktar dettalji.
322 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
323 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIGE LABEL
TIKKETTA TA ’ L- ISKARTOĊĊ
Insulin human
Insulina umana.
Subcutaneous or intravenous use.
Użu għal taħt il- gilda jew ġol- vina.
323 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
324 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 3 ML PRE-FILLED PEN OPTISET
KARTUNA TA ’ BARRA / PINNA MIMLIJA GĦAL- LEST TA ’ 3 ML OPTISET
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a pre-filled pen.
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest
OptiSet.
Soluzzjoni għall- injezzjoni, f’ pinna mimlija għal- lest, OptiSet.
3 pens of 3 ml 4 pens of 3 ml 5 pens of 3 ml 6 pens of 3 ml 9 pens of 3 ml 10 pens of 3 ml
3 pinen ta ’ 3 ml 4 pinen ta ’ 3 ml 5 pinen ta ’ 3 ml 6 pinen ta ’ 3 ml 9 pinen ta ’ 3 ml 10 pinen ta ’ 3 ml
Only use injection needles that have been approved for use with OptiSet.
Uża biss labar ta ’ l- injezzjoni li huma approvati għall- użu ma ’ OptiSet.
324 IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
INFORMAZZJONI IMPORTANTI L- ewwel dejjem waħħal labra ġdida qabel ma tuża OptiSet.
Always perform a safety test before using OptiSet.
Dejjem agħmel test ta ’ sigurtà qabel ma tuża OptiSet.
Read the package leaflet fully before using OptiSet for the first time
Aqra l- fuljett ta ’ tagħrif kollu qabel tuża OptiSet għall- ewwel darba.
New information for use: • Name of the insulin is printed on the pen. • Dosage selector can only be turned in one direction.
325 Informazzjoni ġdida dwar l- użu: • L- isem ta ’ l- insulina hija stampata fuq il- pinna. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda biss.
Once in-use, pens may be kept for up to 4 weeks.
EXP Ġaladarba fl- użu, il- pinen jistgħu jinżammu sa 4 ġimgħat.
When in-use, do not store in a refrigerator.
Meta l- pinna tkun fl- użu, m’ għandhiex tinżamm fil- friġġ.
Store in a refrigerator.
Aħżenfi friġġ.
Keep the pen in the outer carton in order to protect from light.
Żomm il- pinna fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 06/ 368/ 016 (3 pens of 3 ml) EU/ 1/ 06/ 368/ 017 (4 pens of 3 ml) EU/ 1/ 06/ 368/ 018 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 103 (6 pens of 3 ml) EU/ 1/ 06/ 368/ 108 (9 pens of 3 ml) EU/ 1/ 06/ 368/ 019 (10 pens of 3 ml)
EU/ 1/ 06/ 368/ 016 (3 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 017 (4 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 018 (5 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 103 (6 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 108 (9 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 019 (10 pinen ta ’ 3 ml)
326 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
326 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PEN LABEL OPTISET
TIKKETTA TAL- PINNA OPTISET
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a pre-filled pen
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest
327 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
327 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 3 ML CARTRIDGES FOR OPTICLIK
KARTUNA TA ’ BARRA / SKARTOĊĊI TA ’ 3 ML GĦAL OPTICLIK
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a cartridge
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Soluzzjoni għall- injezzjoni, f’ skartoċċ 3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
The cartridges for OptiClik are to be used in conjuction with OptiClik only.
L- skartoċċi għal OptiClik għandhom jintużaw flimkien ma ’ OptiClik biss.
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
Jekk l- OptiClik hija bil- ħsara jew mhix taħdem sew (dovut għal xi difetti mekkaniċi) għandha tintrema, u OptiClik ġdida għandha tintuża.
When in-use (in the pen), do not store in a refrigerator.
Meta jkunu fl- użu (fil- pinna), m’ għandhomx jinżammu fi friġġ.
EU/ 1/ 06/ 368/ 058 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 059 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 060 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 061 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 062 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 063 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 058 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 059 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 060 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 061 (6 skartoċċi ta 3 ml) EU/ 1/ 06/ 368/ 062 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 063 (10 skartoċċi ta ’ 3 ml)
329 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
329 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIGE FOR OPTICLIK LABEL
TIKKETTA TA ’ L- ISKARTOĊĊ GĦAL OPTICLIK
To be used with OptiClik
Għal użu f’ OptiClik
330 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
330 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 3 ML PRE-FILLED PEN SOLOSTAR
KARTUNA TA ’ BARRA / PINNA MIMLIJA GĦAL- LEST TA ’ 3 ML SOLOSTAR
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a pre-filled pen
Insulin Human Winthrop Rapid 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Excipients: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet.
Solution for injection in a pre-filled pen.
Suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
3 pens of 3 ml 4 pens of 3 ml 5 pens of 3 ml 6 pens of 3 ml 9 pens of 3 ml 10 pens of 3 ml
3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
Only use injection needles that have been approved for use with SoloStar.
Uża biss il- labar li huma kompatibbli ma ’ l- użu ta ’ SoloStar.
EXP
331 EXP
Once in-use, pens may be kept for up to 4 weeks.
Ġaladarba fl- użu, l- skartoċċi jistgħu jinżammu sa 4 ġimgħat.
When in-use, do not store in a refrigerator.
Meta fl- użu, taħżinx fi friġġ.
Keep the pen in the outer carton in order to protect from light.
Żomml- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 06/ 368/ XXX (3 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (4 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (5 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (6 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (9 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (10 pens of 3 ml)
EU/ 1/ 06/ 368/ XXX (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (10 skartoċċi ta ’ 3 ml)
332 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
332 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PEN LABEL SOLOSTAR
TIKKETTA TAL- PINNA SOLOSTAR
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a pre-filled pen
Insulin Human Winthrop Rapid 100 Unità/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
333 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
333 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 5 ML VIAL
KARTUNA TA ’ BARRA / KUNJETT TA ’ 5 ML
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
Insulin with a gradual onset and long duration of action.
Insulina li tibda taħdem bil- mod u ddum taħdem għall- perijodu twil.
Excipients: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet
Suspension for injection in a vial.
Suspensjoni għall- injezzjoni f’ kunjett.
1 vial of 5 ml 5 vials of 5 ml
Kunjett 1 ta ’ 5 ml 5 kunjetti ta ’ 5 ml
Mix thoroughly.
Ħawwad sew.
EXP
334 EXP
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
EU/ 1/ 06/ 368/ 020 (1 vial of 5 ml) EU/ 1/ 06/ 368/ 021 (5 vials of 5 ml)
EU/ 1/ 06/ 368/ 020 (Kunjett 1 ta ’ 5 ml) EU/ 1/ 06/ 368/ 021 (5 kunjetti ta ’ 5 ml)
335 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
335 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
336 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
336 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Basal 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Basal 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
Insulin with a gradual onset and long duration of action.
Insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil
Excipients: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet.
1 vial of 10 ml 5 vials of 10 ml
Suspensjoni għall- injezzjoni, f’ kunjett Kunjett 1 ta ’ 10 ml 5 kunjetti ta ’ 10 ml
Once in-use, vials may be kept for up to 4 weeks.
337 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 003 (1 vial of 10 ml) EU/ 1/ 06/ 368/ 004 (5 vials of 10 ml)
EU/ 1/ 06/ 368/ 003 (kunjett 1 ta ’ 10 ml) EU/ 1/ 06/ 368/ 004 (5 kunjetti ta ’ 10 ml)
338 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
338 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Subcutaneous use.
Użu għal taħt il- gilda.
339 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
339 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS/ 3 ML CARTRIDGE
KARTUNA TA ’ BARRA / SKARTOĊĊ TA ’ 3 ML
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Suspensjoni għall- injezzjoni f’ skartoċċ 3 skartoċċi ta ’ 3ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta’ 3 ml
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insulin Human Winthrop cartridges.
L- skartoċċi għandhom jitużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- skartoċċi ta ’ Insulin Human Winthrop.
Mix thoroughly.
340 Ħawwad sew.
When in-use (in the pen), do not store in a refrigerator.
Meta fl- użu (fil- pinna), taħżinx fi friġġ.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
ISEM U INDIRIZZ TAD- DETENTUR L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, il- Ġermanja.
EU/ 1/ 06/ 368/ 089 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 022 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 023 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 094 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 099 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 024 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 089 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 022 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 023 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 094 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 099 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 024 (10 skartoċċi ta ’ 3 ml)
341 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
341 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
342 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
342 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE LABEL
TIKKETTA TA ’ L- ISKARTOĊĊ
343 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
343 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija ghal- lest
3 pens of 3 ml 4 pens of 3 ml 5 pens of 3 ml 6 pens of 3 ml 9 pens of 3 ml 10 pens of 3 ml
Suspensjoni għall- injezzjoni, f’ pinna mimlija għal- lest, OptiSet 3 pinen ta ’ 3 ml 4 pinen ta ’ 3 ml 5 pinen ta ’ 3 ml 6 pinen ta ’ 3 ml 9 pinen ta ’ 3 ml 10 pinen ta ’ 3 ml
Only use injection needles that have been approved for use with OptiSet.
Uża biss il- labar ta ’ l- injezzjoni approvati għall- użu ma ’ OptiSet.
344 IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
344 INFORMAZZJONI IMPORTANTI L- ewwel dejjem waħħal labra ġdida qabel tuża OptiSet.
Always perform a safety test before using OptiSet.
Dejjem agħmel test ta ’ sigurtà qabel tuża OptiSet.
Read the package leaflet fully before using OptiSet for the first time.
Aqra l- fuljett ta ’ tagħrif qabel tuża OptiSet għall- ewwel darba.
New information for use: • Name of the insulin is printed on the pen. • Dosage selector can only be turned in one direction.
Informazzjoni ġdida għall- użu: • L- isem ta ’ l- insulina huwa stampat fuq il- pinna. • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda biss.
Once in-use, pens may be kept for up to 4 weeks.
Ġaladarba fl- użu, l- pinen jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 025 (3 pens of 3 ml) EU/ 1/ 06/ 368/ 026 (4 pens of 3 ml) EU/ 1/ 06/ 368/ 027 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 104 (6 pens of 3 ml) EU/ 1/ 06/ 368/ 109 (9 pens of 3 ml) EU/ 1/ 06/ 368/ 028 (10 pens of 3 ml)
EU/ 1/ 06/ 368/ 025 (3 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 026 (4 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 027 (5 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 104 (6 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 109 (9 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 028 (10 pinen ta ’ 3 ml)
346 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
346 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
347 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
347 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS/ 3 ML CARTRIDGE FOR OPTICLIK
KARTUNA TA ’ BARRA / SKARTOĊĊ TA ’ 3 ML GĦAL OPTICLIK
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Suspensjoni għall- injezzjoni f’ skartoċċ 3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta’ 3 ml
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
348 Jekk l- OptiClik hija bil- ħsara jew mhix taħdem sew (dovut għal xi difetti mekkaniċi) għandha tintrema, u OptiClik ġdida għandha tintuża.
EU/ 1/ 06/ 368/ 064 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 065 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 066 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 067 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 068 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 069 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 064 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 065 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 066 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 067 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 068 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 069 (10skartoċċi ta ’ 3 ml)
349 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
349 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ Insulina umana
350 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
350 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTONS / 3 ML PRE-FILLED PEN SOLOSTAR
KARTUNA TA ’ BARRA / PINNA MIMLIJA GĦAL- LEST TA ’ 3ML, SOLOSTAR
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Basal 100 IU / ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
1 ml contains 100 IU (3.5 mg) insulin human.
1 ml fih 100 Unità (ekwivalenti għal 3. 5 mg) insulina umana.
Insulin with a gradual onset and long duration of action.
Insulina li tibda taħdem malajr u ddum taħdem għall- perijodu qasir.
SoloStar.
Suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
3 pens of 3 ml 4 pens of 3 ml 5 pens of 3 ml 6 pens of 3 ml 9 pens of 3 ml 10 pens of 3 ml
SoloStar 3 pinen ta ’ 3 ml 4 pinen ta ’ 3 ml 5 pinen ta ’ 3 ml 6 pinen ta ’ 3 ml 9 pinen ta ’ 3 ml 10 pinen ta ’ 3 ml
Once in-use, pens may be kept for up to 4 weeks.
Ġaladarba fl- użu, il- pinen jistgħu jinżammu sa 4 ġimgħat.
Do not freeze.
Tagħmilhiex fil- friza.
Keep the pen in the outer carton in order to protect from light.
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 06/ 368/ XXX (3 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (4 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (5 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (6 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (9 pens of 3 ml) EU/ 1/ 06/ 368/ XXX (10 pens of 3 ml)
EU/ 1/ 06/ 368/ XXX (3 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (4 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (5 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (6 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (9 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ XXX (10 pinen ta ’ 3 ml)
352 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
352 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
353 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
353 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
15% dissolved insulin, 85% crystalline protamine insulin
15% insulina maħlula, 85% insulina kristallina protamine
1 vial of 5 ml 5 vials of 5 ml
Suspensjoni għall- injezzjoni f’ kunjett Kunjett 1 ta ’ 5 ml 5 kunjetti ta ’ 5 ml
354 Once in-use, vials may be kept for up to 4 weeks.
354 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 029 (1 vial of 5 ml) EU/ 1/ 06/ 368/ 030 (5 vials of 5 ml)
EU/ 1/ 06/ 368/ 029 (Kunjett 1 ta ’ 5 ml) EU/ 1/ 06/ 368/ 030 (5 kunjetti ta ’ 5 ml)
355 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
355 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
356 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
356 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 15 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 15 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
1 vial of 10 ml 5 vials of 10 ml
Suspensjoni għall- injezzjoni f’ kunjett Kunjett 1 ta ’ 10 ml 5 kunjetti ta ’ 10 ml
357 Once in-use, vials may be kept for up to 4 weeks.
357 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 005 (1 vial of 10 ml) EU/ 1/ 06/ 368/ 006 (5 vials of 10 ml)
EU/ 1/ 06/ 368/ 005 (Kunjett 1 ta ’ 10 ml) EU/ 1/ 06/ 368/ 006 (5 kunjetti ta ’ 10 ml)
358 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
358 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
359 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
359 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 3 ML CARTRIDGE
KARTUNA TA ’ BARRA / SKARTOĊĊ TA ’ 3 ML
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Suspensjoni għall- injezzjoni f’ skartoċċ 3 skartoċċi ta ’ 3ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
360 Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u pinna ġdida ta ’ l- insulina tintuża minflok.
Keep the cartridge in the outer carton in order to protect from light.
Żomml- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 06/ 368/ 090 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 031 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 032 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 095 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 100 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 033 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 090 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 031 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 032 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 095 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 100 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 033 (10 skartoċċi ta ’ 3 ml)
362 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
361 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
363 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
362 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
364 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
363 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
3 pens of 3 ml 4 pens of 3 ml 5 pens of 3 ml 6 pens of 3 ml 9 pens of 3 ml 10 pens of 3 ml
Suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest, OptiSet 3 pinen ta ’ 3 ml 4 pinen ta ’ 3 ml 5 pinen ta ’ 3 ml 6 pinen ta ’ 3 ml 9 pinen ta ’ 3 ml 10 pinen ta ’ 3 ml
Only use injection needles that have been approved for use with OptiSet.
Uża biss il- labar ta ’ l- injezzjoni li huma approvati għall- użu ma ’ OptiSet.
365 IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
364 INFORMAZZJONI IMPORTANTI L- ewwel dejjem waħħal labra ġdida qabel tuża OptiSet.
Read the package leaflet fully before using OptiSet for the first time.
Aqra l- fuljett ta ’ tagħrif kollu qabel tuża OptiSet għall- ewwel darba.
New information for use: • Name of the insulin is printed on the pen. • Dosage selector can only be turned in one direction.
Informazzjoni ġdida għall- użu: • L- isem ta ’ l- insulina huwa stampat fuq il- pinna • Is- selettur tad- dożaġġ jista ’ jdur f’ direzzjoni waħda.
Store in a refrigerator.
Aħżen friġġ.
Keep the pen in the outer carton in order to protect from light.
Żommil- pinna fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 06/ 368/ 034 (3 pens of 3 ml) EU/ 1/ 06/ 368/ 035 (4 pens of 3 ml) EU/ 1/ 06/ 368/ 036 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 105 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 110 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 037 (10 pens of 3 ml)
EU/ 1/ 06/ 368/ 034 (3 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 035 (4 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 036 (5 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 105 (6 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 110 (9 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 037 (10 pinen ta ’ 3 ml)
15.
365 15.
367 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
366 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
368 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
367 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 3 ML CARTRIDGE FOR OPTICLIK
KARTUNA TA ’ BARRA / SKARTOĊĊ TA ’ 3 ML GĦAL OPTICLIK
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Suspensjoni għall- injezzjoni f’ skartoċċ 3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
368 Jekk l- OptiClik hija bil- ħsara jew mhix taħdem sew (dovut għal xi difetti mekkaniċi) għandha tintrema, u OptiClik ġdida għandha tintuża.
EU/ 1/ 06/ 368/ 070 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 071 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 072 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 073 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 074 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 075 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 070 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 071 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 072 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 073 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 074 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 075 (10 skartoċċi ta ’ 3 ml)
371 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
369 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
372 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
370 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
When in-use, do not store in a refrigerator.
Meta fl- użu (fil- pinna), taħżinx fi friġġ.
374 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
372 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
375 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
373 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
25% dissolved insulin, 75% crystalline protamine insulin
25% insulina maħlula, 75% insulina kristallina protamine
376 Once in-use, vials may be kept for up to 4 weeks.
374 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
Keep the vial in the outer carton in order to protect from light.
Żommil- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
EU/ 1/ 06/ 368/ 038 (1 vial of 5 ml) EU/ 1/ 06/ 368/ 039 (5 vials of 5 ml)
EU/ 1/ 06/ 368/ 038 (Kunjett 1 ta ’ 5 ml) EU/ 1/ 06/ 368/ 039 (5 kunjetti ta ’ 5 ml)
377 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
375 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
378 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
376 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 25 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 25 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
379 Once in-use, vials may be kept for up to 4 weeks.
377 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 007 (1 vial of 10 ml) EU/ 1/ 06/ 368/ 008 (5 vials of 10 ml)
EU/ 1/ 06/ 368/ 007 (Kunjett 1 ta ’ 10 ml) EU/ 1/ 06/ 368/ 008 (5 kunjetti ta ’ 10 ml)
380 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
378 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
381 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
379 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insulin Human Winthrop cartridges Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
380 Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u pinna ġdida ta ’ l- insulina tintuża minflok.
When in-use (in the pen), do not store in a refrigerator.
Meta jkunu fl- użu (fil- pinna), taħżinx fi friġġ.
EU/ 1/ 06/ 368/ 091 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 040 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 041 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 096 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 101 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 042 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 091 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 040 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 041 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 096 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 101 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 042 (10 skartoċċi ta ’ 3 ml)
384 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
381 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
385 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
382 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
386 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
383 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
387 IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
384 INFORMAZZJONI IMPORTANTI L- ewwel dejjem waħħal labra ġdida qabel tuża OptiSet.
EU/ 1/ 06/ 368/ 043 (3 pens of 3 ml) EU/ 1/ 06/ 368/ 044 (4 pens of 3 ml) EU/ 1/ 06/ 368/ 045 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 106 (6 pens of 3 ml) EU/ 1/ 06/ 368/ 111 (9 pens of 3 ml) EU/ 1/ 06/ 368/ 046 (10 pens of 3 ml)
EU/ 1/ 06/ 368/ 043 (3 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 044 (4 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 045 (5 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 106 (6 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 111 (9 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 046 (10 pinen ta ’ 3 ml)
388 15.
385 15.
389 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
386 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
390 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
387 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Suspension for injection in a cartridge.
Suspensjoni għall- injezzjoni f’ skartoċċ
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
3 skartoċċi ta ’ 3 ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
Mix thoroughly.
388 Ħawwad sew.
EU/ 1/ 06/ 368/ 076 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 077 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 078 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 079 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 080 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 081 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 076 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 077 (4skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 078 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 079 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 080 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 081 (10 skartoċċi ta ’ 3 ml)
393 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
389 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
394 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
390 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
395 8.
391 8.
396 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
392 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
OUTER CARTONS / 5 ML VIAL
393 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT EWLIENI KARTUNA TA ’ BARRA / KUNJETT TA ’ 5 ML
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
50% dissolved insulin, 50% crystalline protamine insulin
50% insulina maħlula, 50% insulina kristallina protamine
Insulin with a rapid onset and moderately long duration of action.
Insulina li tibda taħdem malajr u ddum taħdem għal żmien moderatament twil
398 Once in-use, vials may be kept for up to 4 weeks.
394 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 047 (1 vial of 5 ml) EU/ 1/ 06/ 368/ 048 (5 vials of 5 ml)
EU/ 1/ 06/ 368/ 047 (Kunjett 1 ta ’ 5 ml) EU/ 1/ 06/ 368/ 048 (5 kunjetti ta ’ 5 ml)
399 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
395 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
400 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
396 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 50 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 50 40 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
401 Once in-use, vials may be kept for up to 4 weeks.
397 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
EU/ 1/ 06/ 368/ 009 (1 vial of 10 ml) EU/ 1/ 06/ 368/ 010 (5 vials of 10 ml)
EU/ 1/ 06/ 368/ 009 (Kunjett 1 ta ’ 10 ml) EU/ 1/ 06/ 368/ 010 (5 kunjetti ta ’ 10 ml)
402 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
398 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
403 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTONS / 3 ML CARTRIDGE
KARTUNA TA ’ BARRA / SKARTOĊĊ TA ’ 3 ML
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ skartoċċ
Excipients: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: protamine sulphate, metacresoll, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet.
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insulin Human Winthrop cartridges.
L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- skartoċċi ta ’ Insulin Human Winthrop.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
400 Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u pinna ġdida ta ’ l- insulina tintuża minflok.
EU/ 1/ 06/ 368/ 092 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 049 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 050 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 097 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 102 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 051 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 092 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 049 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 050 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 097 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 102 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 051 (10 skartoċċi ta ’ 3 ml)
406 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
401 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
407 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
402 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
408 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
403 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a pre-filled pen
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
409 IMPORTANT INFORMATION Always first attach a new needle before using OptiSet.
404 INFORMAZZJONI IMPORTANTI L- ewwel dejjem waħħal labra ġdida qabel tuża OptiSet.
EU/ 1/ 06/ 368/ 052 (3 pens of 3 ml) EU/ 1/ 06/ 368/ 053 (4 pens of 3 ml) EU/ 1/ 06/ 368/ 054 (5 pens of 3 ml) EU/ 1/ 06/ 368/ 107 (6 pens of 3 ml) EU/ 1/ 06/ 368/ 112 (9 pens of 3 ml) EU/ 1/ 06/ 368/ 055 (10 pens of 3 ml)
EU/ 1/ 06/ 368/ 052 (3 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 053 (4 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 054 (5 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 107 (6 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 112 (9 pinen ta ’ 3 ml) EU/ 1/ 06/ 368/ 055 (10 pinen ta ’ 3 ml)
410 15.
405 15.
411 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
406 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
412 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
407 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
408 Jekk l- OptiClik hija bil- ħsara jew mhix taħdem sew (dovut għal xi difetti mekkaniċi) għandha tintrema, u OptiClik ġdida għandha tintuża.
EU/ 1/ 06/ 368/ 082 (3 cartridges of 3 ml) EU/ 1/ 06/ 368/ 083 (4 cartridges of 3 ml) EU/ 1/ 06/ 368/ 084 (5 cartridges of 3 ml) EU/ 1/ 06/ 368/ 085 (6 cartridges of 3 ml) EU/ 1/ 06/ 368/ 086 (9 cartridges of 3 ml) EU/ 1/ 06/ 368/ 087 (10 cartridges of 3 ml)
EU/ 1/ 06/ 368/ 082 (3 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 083 (4 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 084 (5 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 085 (6 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 086 (9 skartoċċi ta ’ 3 ml) EU/ 1/ 06/ 368/ 087 (10 skartoċċi ta ’ 3 ml)
415 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
409 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
416 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
410 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Insulin with a rapid onset and moderately long duration of action.
Insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil
417 8.
411 8.
418 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
412 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
419 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
413 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Insulin Human Winthrop Infusat 100 IU/ ml solution for injection in a vial.
Insulin Human Winthrop Infusat 100 IU/ ml suspensjoni għall- injezzjoni f’ kunjett
Excipients: phenol, zinc chloride, trometamol, glycerol, poloxamer 171, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: phenol, zinc chloride, trometamol, glycerol, poloxamer 171, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet.
3 vials of 10 ml
Soluzzjoni għall- injezzjoni f’ kunjett 3 kunjetti ta ’ 10 ml
For use in insulin pumps, which are suitable for insulins containing 100 IU/ ml.
Għall- użu ma ’ pompi ta ’ l- insulina, li huma adattati għal insulini li fihom 100 IU/ ml.
420 10.
414 10.
421 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
415 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Insulin Human Winthrop Infusat 100 IU/ ml solution for injection in a vial.
Insulin Human Winthrop Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett
422 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
416 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT EWLIENI
OUTER CARTONS / 3.15 ML CARTRIDGE
KARTUNA TA ’ BARRA / SKARTOĊĊ TA ’ 3. 15 ML
Insulin Human Winthrop Infusat 100 IU/ ml solution for injection in a cartridge.
Insulin Human Winthrop Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ
5 cartridges of 3.15 ml
Soluzzjoni għall- injezzjoni f’ skartoċċ 5 skartoċċi ta ’ 3. 15 ml
Do not freeze.
417 Tagħmlux fil- friza.
424 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
418 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
425 B.
419 B.
426 PACKAGE LEAFLET:
420 FULJETT TA ’ TAGĦRIF:
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a vial Insulin human
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana
Do not pass it on to others.
- Din il- mediċina ġiet mogħtija lilek. M’ għandekx tgħaddiha lil persuni oħra.
What Insulin Human Winthrop Rapid is and what it is used for 2.
X’ inhu Insulin Human Winthrop Rapid u għalxiex jintuża 2.
Before you use Insulin Human Winthrop Rapid 3.
Qabel ma tuża Insulin Human Winthrop Rapid 3.
How to use Insulin Human Winthrop Rapid 4.
Kif għandek tuża Insulin Human Winthrop Rapid 4.
How to store Insulin Human Winthrop Rapid 6.
Kif taħżen Insulin Human Winthrop Rapid 6.
WHAT INSULIN HUMAN WINTHROP RAPID IS AND WHAT IT IS USED FOR
X’ INHU INSULIN HUMAN WINTHROP RAPID U GĦALXIEX JINTUŻA
Insulin Human Winthrop Rapid is a solution for injection under the skin or, in exceptional circumstances, into a vein (blood vessel).
Insulin Human Winthrop Rapid hija soluzzjoni għall- injezzjoni taħt il- ġilda tiegħek jew, f’ ċirkostanzi rari, tingħata fil- vina (sistema vaskulari).
The insulin contained in Insulin Human Winthrop Rapid is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li tinsab f ’ Insulin Human Winthrop Rapid, hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina tal- ġisem stess.
Insulin Human Winthrop Rapid is an insulin preparation with a rapid onset and short duration of action.
Insulin Human Winthrop Rapid hija preparat ta ’ l- insulina li tibda taħdem malajr u ddum taħdem għal żmien qasir.
Insulin Human Winthrop Rapid is used to reduce high blood sugar in patients with diabetes mellitus.
Insulin Human Winthrop Rapid hija użata biex tbaxxi l- livell għoli taz- zokkor fid- demm tal- pazjenti li qed ibatu min diabetes mellitus.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Id- Dijabete mellitus hija marda meta ġismek ma jistax jipproduċi biżżejjed insulina biex jikkontrolla l- livell taz- zokkor fid- demm.
Insulin Human Winthrop Rapid may also be used for treating severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery.
Insulin Human Winthrop Rapid tista ’ wkoll tintuża biex tikkura l- ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u l- ketoaċidożi (akkumulazzjoni t’ aċidu fid- demm għaliex il- ġisem qiegħed jutilizza x- xaħam minflok iż- żokkor), kif ukoll għall- kontroll taz- zokkor fid- demm qabel, waqt u wara li ssirlek operazzjoni.
BEFORE YOU USE INSULIN HUMAN WINTHROP RAPID
QABEL MA TUŻA INSULIN HUMAN WINTHROP RAPID
Do not use Insulin Human Winthrop Rapid
Tużax Insulin Human Winthrop Rapid:
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insulin Human Winthrop Rapid.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- insulina Insulin Human Winthropjew għal xi waħda mis- sustanzi l- oħra ta ’ Insulin Human Winthrop Rapid.
Do not use Insulin Human Winthrop Rapid in insulin pumps – special insulin preparations are available for use in such devices.
Tużax Insulin Human Winthrop Rapid fil- pompi għall- insulina – hemm preparazzjonijiet apposta t’ insulina disponibbli għall- użu ma ’ dan l- apparat.
Also do not use it in peristaltic pumps with silicone tubing.
Hekk ukoll, tużahx għall- pompi peristaltiċi li għandhom tubi tas- silicone.
Take special care with Insulin Human Winthrop Rapid
Oqgħod attent ħafna b’ Insulin Human Winthrop Rapid:
Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Segwi sew l- istruzzjonijiet fuq id- dożaġġ, il- moniteraġġ (permezz ta ’ analiżi tad- demm u ta ’ l - awrina), id- dieta, u l- eżerċizju fiżiku (xogħol fiżiku u eżerċizju), kif diskuss mat- tabib tiegħek.
427 Special patient groups
421 Gruppi speċjali ta ’ pazjenti
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
Jekk għandek problemi fil- fwied jew fil- kliewi jew jekk inti anzjan, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn tnaqqis fid- doża.
Travel
Safar
Before travelling, consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
You may need to talk about
Għandu mnejn ikollok tiddiskuti fuq
- the availability of your insulin in the country you are visiting,
- id- disponibbiltà ta ’ l- insulina tiegħek fil- pajjiżi li qiegħed iżżur,
- supplies of insulin, injection syringes etc.,
- il- forniment ta ’ l- insulina, siringi ta ’ l- injezzjoni eċċ,
- correct storage of your insulin while travelling,
- il- ħażna korretta ta ’ l- insulina tiegħek waqt l- ivvjaġġar,
- timing of meals and insulin administration while travelling,
- il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar
- the possible effects of changing to different time zones,
- l- effetti possibbli fit- tibdil minn żona ta ’ ħin għal oħra differenti,
- possible new health risks in the countries to be visited,
- il- possibbiltà ta ’ riskji ġodda għal saħħtek fil- pajjiżii li tkun qiegħed iżżur.
- what you should do in emergency situations when you feel unwell or become ill.
- x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
Illnesses and injuries
Mard u feriti
In the following situations, the management of your diabetes may require a lot of care:
F’ dawn is- sitwazzjonijiet li ġejjin, l- immaniġġar tad- dijabete tiegħek, jista ’ jkollha bżonn ta ’ ħafna attenzjoni:
- If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
- Jekk ma tiflaħx jew għandek xi ferita serja, il- livell taz- zokkor fid- demm tiegħek jista ’ jogħla
- If you are not eating enough, your blood sugar level may become too low (hypoglycaemia).
- Jekk m’ intix qed tiekol biżżejjed, il- livell taz- zokkor fid- demm tiegħek jista ’ jinżel iżżejjed
In most cases you will need a doctor.
Fil- parti l- kbira tal- każijiet ikollok bżonn tabib.
Make sure that you contact a doctor early.
Kun ċert li tkellem tabib kmieni.
If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates.
Jekk għandek id- dijabete tat- tip 1 (dijabete mellitus dipendenti fuq l- insulina), twaqqafx l- insulina tiegħek u kompli ħu biżżejjed karboidrati.