natgillin/translations-raw huggingface dataset:
98 Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje zarodka/ novorojenca.
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
98 Dobra kontrola bolnic, ki se zdravijo z insulinom (od insulina odvisni ali gestacijski diabetes), je bistvenega pomena ves čas trajanja nosečnosti.
99 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Če je bolnik komatozen, damo glukagon intramuskularno ali subkutano.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
99 Morda bosta potrebna vzdrževan vnos ogljikovih hidratov in opazovanje, ker se lahko hipoglikemija po navideznem kliničnem okrevanju ponovno pojavi.
1 1
100 Za insulin lispro je bilo dokazano, da je na molarni osnovi enako močan kot humani insulin, a je njegov učinek hitrejši in bolj kratkotrajen.
101 Two years.
Dve leti.
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje 101 Shranjujte v hladilniku (2 °C - 8 °C).
5 x 3 ml Humalog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix50 100 U/ ml KwikPens.
5 x 3 ml Humalog Mix50 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Humalog Mix50 100 i. e. / ml injekcijski peresniki KwikPen
Handling of the pre-filled pen Before using the KwikPen the user manual included in the package leaflet must be read carefully.
Pred uporabo KwikPena morate skrbno prebrati Priročnik za uporabo, ki je priložen Navodilu za uporabo.
5 x 3 ml Humalog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog Mix50 100 U/ ml KwikPens
5 x 3 ml Humalog Mix50 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Humalog Mix50 100 i. e. / ml injekcijski peresniki KwikPen
DATE OF REVISION OF THE TEXT 102 1.
102 1.
Humalog BASAL 100 U/ ml KwikPen, suspension for injection
Humalog BASAL 100 i. e. / ml KwikPen suspenzija za injiciranje
4.4 Special warnings and precautions for use 103 Under no circumstances should Humalog BASAL be given intravenously.
103 Pod nobenim pogojem se zdravila Humalog BASAL ne sme dati intravensko.
The physician should be consulted when using other medications in addition to Humalog BASAL 100 U/ ml KwikPen.
Pri sočasni uporabi zdravila Humalog BASAL 100 i. e. / ml KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom.
104 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Dobra kontrola bolnic, ki se zdravijo z insulinom (od insulina odvisni ali gestacijski diabetes), je bistvenega pomena ves čas trajanja nosečnosti.
Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
104 svetovati, naj obvestijo svojega zdravnika, če zanosijo ali načrtujejo zanositev.
105 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Morda bosta potrebna vzdrževan vnos ogljikovih hidratov in opazovanje, ker se lahko hipoglikemija po navideznem kliničnem okrevanju ponovno pojavi.
Protamine sulphate m-cresol [1.76 mg/ ml] Phenol [0.80 mg/ ml] 106 Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 – 7.8.
Protamin sulfat Metakrezol [1, 76 mg/ ml] Fenol [0, 80 mg/ ml] 106 Glicerol Natrijev hidrogenfosfat heptahidrat Cinkov oksid Voda za injekcije Za uravnavanje pH na 7, 0- 7, 8 sta morda bila uporabljena klorovodikova kislina in natrijev hidroksid.
5 x 3 ml Humalog BASAL 100 U/ ml KwikPens 2 x (5 x 3 ml) Humalog BASAL 100 U/ ml KwikPens
5 x 3 ml Humalog BASAL 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Humalog BASAL 100 i. e. / ml injekcijski peresniki KwikPen
7.
107 7.
5 x 3 ml Humalog BASAL 100 U/ ml KwikPen 2 x (5 x 3 ml) Humalog BASAL 100 U/ ml KwikPen
5 x 3 ml Humalog BASAL injekcijski peresniki KwikPen 2 x (5 x 3 ml) Humalog BASAL injekcijski peresniki KwikPen
108 ANNEX II
108 DODATEK II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
109 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
Fermentation:
Fermentacija:
Eli Lilly and Company, Lilly Technology Center Building 333 and 324, Indianapolis, Indiana, USA Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12.3 KM (PR05), 65th Infantry Road, Carolina, Puerto Rico 00985 Granule Recovery:
Eli Lilly and Company, Lilly Technology Center Building 333 and 324, Indianapolis, Indiana, ZDA Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12. 3 KM (PR05), 65th Infantry Road, Carolina, Portoriko 00985 Ponovna granulacija:
Eli Lilly and Company, Lilly Technology Center Building 130, Indianapolis, Indiana, USA Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12.3 KM (PR05), 65th Infantry Road, Carolina, Puerto Rico 00985
Eli Lilly and Company, Lilly Technology Center Building 130, Indianapolis, Indiana, ZDA Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12. 3 KM (PR05), 65th Infantry Road, Carolina, Portoriko 00985
Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, France.
Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Francija.
KG, Teichweg 3, 35396 Giessen, Germany.
KG, Teichweg 3, 35396 Giessen, Nemčija.
Cartridges and disposable pens called the „ Pen“
Vložki in injekcijski peresniki, imenovani “ Pen ”
Gramsci 731-733, 50019 Sesto Fiorentino, Florence, Italy.
Gramsci 731- 733, 50019 Sesto Fiorentino, Firence, Italija.
Disposable pens called the „ KwikPen“
Injekcijski peresniki, imenovani “ KwikPen ”
110 ANNEX III
110 DODATEK III
LABELLING
111 A - OZNAČEVANJE
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog 100 U/ ml solution for injection in vial Insulin lispro (rDNA origin)
Humalog 100 i. e. / ml raztopina za injiciranje v viali insulin lispro (izdelan s pomočjo rekombinantne DNA)
Insulin lispro (rDNA origin) 100 U/ ml (3.5 mg/ ml)
insulin lispro (izdelan s pomočjo rekombinantne DNA) 100 i. e. / ml (3, 5 mg/ ml)
Contains glycerol, zinc oxide, dibasic sodium phosphate 7H20 with m-cresol as a preservative in water for injection.
Vsebuje glicerol, cinkov oksid, natrijev hidrogenfosfat heptahidrat z metakrezolom kot konzervansom v vodi za injekcije.
Sodium hydroxide and/ or hydrochloric acid may have been used to adjust acidity.
Za uravnavanje kislosti sta morda bila uporabljena natrijev hidroksid in/ ali klorovodikova kislina.
READ ENCLOSED PACKAGE LEAFLET
PREBERITE PRILOŽENO NAVODILO ZA UPORABO
Once in use, vials may be used for up to 28 days.
113 Po tem, ko viale začnete uporabljati, so te uporabne še 28 dni.
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Solution for injection, Part of a multi-pack of 5 x (1 x 10 ml) vials.
Raztopina za injiciranje Del večjega pakiranja 5 x (1 x 10 ml) viale.
Once in use, vials may be used for up to 28 days.
117 Po tem, ko viale začnete uporabljati, so te uporabne še 28 dni.
118 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
118 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog 100 U/ ml solution for injection in vial Insulin lispro Subcutaneous and intravenous use
Humalog 100 i. e. / ml raztopina za injiciranje v viali insulin lispro Za subkutano in intravensko uporabo
119 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog 100 U/ ml solution for injection in cartridge Insulin lispro (rDNA origin)
Humalog 100 i. e. / ml raztopina za injiciranje v vložku insulin lispro (izdelan s pomočjo rekombinantne DNA)
If the 40 U/ ml vial is the product normally prescribed, do not take insulin from a 100 U/ ml cartridge using a 40 U/ ml syringe.
Če je običajno predpisan izdelek 40 i. e. / ml viala, ne jemljite insulina iz 100 i. e. / ml vložka z 40 i. e. / ml injekcijsko brizgo.
Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.
Ne shranjujte ju v hladilniku.
To open, lift here and pull CARTON HAS BEEN OPENED
Če hočete odpreti, dvignite tukaj in potegnite ŠKATLA JE BILA ODPRTA
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Solution for injection Part of a multi-pack of 2 x (5 x 3ml) cartridges.
Raztopina za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) vložki.
122 Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
123 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
123 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog 100 U/ ml solution for injection in cartridge Insulin lispro Subcutaneous and intravenous use
Humalog 100 i. e. / ml raztopina za injiciranje v vložku insulin lispro Za subkutano in intravensko uporabo
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix25 100 U/ ml suspension for injection in vial 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Humalog Mix25 100 i. e. / ml suspenzija za injiciranje v viali Suspenzija 25% insulina lispro in 75% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
Suspenzija 25% insulina lispro in 75% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA) 100 i. e. / ml (3, 5 mg/ ml)
Suspension for injection 1 X 10 ml vial
Suspenzija za injiciranje 1 x 10 ml viala
125 Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
126 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
126 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog Mix25 100 U/ ml suspension for injection in vial 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Humalog Mix25 100 i. e. / ml suspenzija za injiciranje v viali Suspenzija 25% insulina lispro in 75% insulina lispro- protamin Za subkutano uporabo
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix25 100 U/ ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Humalog Mix25 100 i. e. / ml suspenzija za injiciranje v vložku Suspenzija 25% insulina lispro in 75% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
Suspension for injection 5 x 3ml cartridges
Suspenzija za injiciranje 5 x 3 ml vožki
128 Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
129 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Suspension for injection Part of a multi-pack of 2 x (5 x 3ml) cartridges.
Suspenzija za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) vložki.
Humalog Mix25 100 U/ ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Humalog Mix25 100 i. e. / ml suspenzija za injiciranje v vložku Suspenzija 25% insulina lispro in 75% insulina lispro- protamin Za subkutano uporabo
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix50 100 U/ ml suspension for injection in vial 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Humalog Mix50 100 i. e. / ml suspenzija za injiciranje v viali Suspenzija 50% insulina lispro in 50% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
Suspenzija 50% insulina lispro in 50% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA) 100 i. e. / ml (3, 5 mg/ ml)
Humalog Mix50 100 U/ ml suspension for injection in vial 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Humalog Mix50 100 i. e. / ml suspenzija za injiciranje v viali Suspenzija 50% insulina lispro in 50% insulina lispro- protamin Za subkutano uporabo
135 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix50 100 U/ ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Humalog Mix50 100 i. e. / ml suspenzija za injiciranje v vložku Suspenzija 50% insulina lispro in 50% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
137 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
139 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
139 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog Mix50 100 U/ ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Humalog Mix50 100 i. e. / ml suspenzija za injiciranje v vložku Suspenzija 50% insulina lispro in 50% insulina lispro- protamin Za subkutano uporabo
140 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
OUTER CARTON TEXT
BESEDILO NA ZUNANJI OVOJNINI (5 x 3 ml vložki)
Humalog BASAL 100 U/ ml suspension for injection in cartridge Insulin lispro protamine suspension (rDNA origin)
Humalog BASAL 100 i. e. / ml suspenzija za injiciranje v vložku Suspenzija insulina lispro- protamin (izdelanega s pomočjo rekombinantne DNA)
Insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
Suspenzija insulina lispro- protamin (izdelanega s pomočjo rekombinantne DNA) 100 i. e. / ml (3, 5 mg/ ml)
5 X 3ml cartridges
Suspenzija za injiciranje 5 x 3 ml vložki
142 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Part of a multi-pack of 2 x (5 x 3ml) cartridges.
Suspenzija za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) vložki.
143 Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
144 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
144 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog BASAL 100 U/ ml suspension for injection in cartridge Insulin lispro protamine suspension Subcutaneous use
Humalog BASAL 100 i. e. / ml suspenzija za injiciranje v vložku Suspenzija insulina lispro- protamin Za subkutano uporabo
145 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Pen 100 U/ ml solution for injection Insulin lispro (rDNA origin)
Humalog Pen 100 i. e. / ml raztopina za injiciranje insulin lispro (izdelan s pomočjo rekombinantne DNA)
Solution for injection 5 x 3ml Pens
Raztopina za injiciranje 5 x 3 ml injekcijski peresniki
Once in use pens may be used for up to 28 days.
146 Po tem, ko injekcijske peresnike začnete uporabljati, so ti uporabni še 28 dni.
Pens in use should be stored below 30°C and should not be refrigerated.
Po tem, ko injekcijske peresnike začnete uporabljati, jih shranjujte pri temperaturi do 30 °C.
Follow priming instructions.
Sledite navodilom za pripravo.
147 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Solution for injection Part of a multi-pack of 2 x (5 x 3ml) Pens.
Raztopina za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) injekcijski peresniki.
Store in a refrigerator (2°C - 8°C).
148 Shranjujte v hladilniku (2 °C - 8 °C).
Humalog Pen 100 U/ ml solution for injection Insulin lispro Subcutaneous and intravenous use
Humalog Pen 100 i. e. / ml raztopina za injiciranje insulin lispro Za subkutano in intravensko uporabo
150 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix25 100 U/ ml Pen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Humalog Mix25 100 i. e. / ml Pen suspenzija za injiciranje Suspenzija 25% insulina lispro in 75% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
Suspension for injection 5 x 3ml Pens
Suspenzija za injiciranje 5 x 3 ml injekcijski peresniki
152 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Suspension for injection Part of a multi-pack of 2 x (5 x 3ml) Pens.
Suspenzija za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) injekcijski peresniki.
154 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
154 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog Mix25 100 U/ ml Pen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Humalog Mix25 100 i. e. / ml Pen suspenzija za injiciranje Suspenzija 25% insulina lispro in 75% insulina lispro- protamin Za subkutano uporabo
155 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix50 100 U/ ml Pen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Humalog Mix50 100 i. e. / ml Pen suspenzija za injiciranje Suspenzija 50% insulina lispro in 50% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
157 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix50 100 U/ ml Pen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Humalog Mix50 100 i. e. / ml Pen suspenzija za injiciranje Suspenzija 50% insulina lispro in 50% insulina lispro- protamin Za subkutano uporabo
160 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
OUTER CARTON TEXT
BESEDILO NA ZUNANJI OVOJNINI (5 x 3 ml injekcijski peresniki)
Humalog BASAL 100 U/ ml Pen suspension for injection Insulin lispro protamine suspension (rDNA origin)
Humalog BASAL 100 i. e. / ml Pen suspenzija za injiciranje Suspenzija insulina lispro- protamin (izdelanega s pomočjo rekombinantne DNA)
Suspension for injection 5 X 3ml Pens
Suspenzija za injiciranje 5 x 3 ml injekcijski peresniki
Store in a refrigerator (2°C - 8°C).
161 Shranjujte v hladilniku (2 °C - 8 °C).
162 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
164 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
164 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog BASAL 100 U/ ml Pen suspension for injection Insulin lispro protamine suspension Subcutaneous use
Humalog BASAL 100 i. e. / ml Pen suspenzija za injiciranje Suspenzija insulina lispro- protamin Za subkutano uporabo
165 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog 100 U/ ml KwikPen, solution for injection Insulin lispro (rDNA origin)
Humalog KwikPen 100 i. e. / ml raztopina za injiciranje insulin lispro (izdelan s pomočjo rekombinantne DNA)
Solution for injection 5 x 3ml pre-filled pens
Raztopina za injiciranje 5 x 3 ml napolnjeni injekcijski peresniki
Grootslag 1-5, 3991 RA Houten, The Netherlands
Grootslag 1- 5, 3991 RA Houten Nizozemska
167 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Solution for injection Part of a multi-pack of 2 x (5 x 3ml) pre-filled pens.
Raztopina za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) napolnjeni injekcijski peresniki.
169 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
169 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog 100 U/ ml KwikPen, solution for injection Insulin lispro Subcutaneous and intravenous use
Humalog KwikPen 100 i. e. / ml raztopina za injiciranje insulin lispro Za subkutano in intravensko uporabo
170 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix25 100 U/ ml KwikPen, suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Humalog Mix25 100 i. e. / ml KwikPen suspenzija za injiciranje Suspenzija 25% insulina lispro in 75% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
Suspension for injection 5 x 3ml pre-filled pens
Suspenzija za injiciranje 5 x 3 ml napolnjeni injekcijski peresniki
171 9.
9.
172 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Suspension for injection Part of a multi-pack of 2 x (5 x 3ml) pre-filled pens.
Suspenzija za injiciranje Del večjega pakiranja 2 x (5 x 3 ml) napolnjeni injekcijski peresniki.
174 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
174 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humalog Mix25 100 U/ ml KwikPen, suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Humalog Mix25 100 i. e. / ml KwikPen suspenzija za injiciranje Suspenzija 25% insulina lispro in 75% insulina lispro- protamin Za subkutano uporabo
175 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix50 100 U/ ml KwikPen, suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Humalog Mix50 100 i. e. / ml KwikPen suspenzija za injiciranje Suspenzija 50% insulina lispro in 50% insulina lispro- protamin (izdelanih s pomočjo rekombinantne DNA)
177 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog Mix50 100 U/ ml KwikPen, suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Humalog Mix50 100 i. e. / ml KwikPen suspenzija za injiciranje Suspenzija 50% insulina lispro in 50% insulina lispro- protamin Za subkutano uporabo
180 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humalog BASAL 100 U/ ml KwikPen, suspension for injection Insulin lispro protamine suspension (rDNA origin)
Humalog BASAL 100 i. e. / ml KwikPen suspenzija za injiciranje Suspenzija insulina lispro- protamin (izdelanega s pomočjo rekombinantne DNA)
Suspension for injection 5 X 3ml pre-filled pens
Suspenzija za injiciranje 5 x 3 ml napolnjeni injekcijski peresniki