natgillin/translations-raw huggingface dataset:
Liprolog Pen is a sterile, clear, colourless, aqueous solution.
Zdravilo Liprolog Pen je sterilna, bistra, brezbarvna vodna raztopina.
Liprolog Pen is also indicated for the initial stabilisation of diabetes mellitus.
Zdravilo Liprolog Pen je indicirano tudi za začetno stabilizacijo diabetesa.
When administered subcutaneously care should be taken when injecting Liprolog Pen to ensure that a blood vessel has not been entered.
Pri subkutanem injiciranju zdravila Liprolog Pen je potrebna previdnost, da zdravila ne vbrizgamo v žilo.
Liprolog Pen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
Subkutano dano zdravilo Liprolog Pen začne delovati hitro in deluje krajši čas (2 do 5 ur) v primerjavi z navadnim insulinom.
As with all insulin preparations, the duration of action of Liprolog Pen is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Kakor velja za vse pripravke insulina, je trajanje delovanja zdravila Liprolog Pen odvisno od odmerka, mesta injiciranja, prekrvitve tkiva, temperature in telesne dejavnosti.
39 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
Po nasvetu zdravnika se lahko zdravilo Liprolog uporabi hkrati s humanim insulinom z dolgotrajnejšim delovanjem ali peroralnimi pripravki s sulfonilsečnino.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
39 Za infundiranje insulina lispro lahko uporabljamo samo določene insulinske infuzijske črpalke, označene s CE.
40 Insulin requirements may be increased during illness or emotional disturbances.
Potrebe po insulinu se lahko povečajo v času bolezni ali čustvenih težav.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
40 Odmerjanje je morda treba prilagoditi tudi, če bolnik poveča telesno dejavnost ali spremeni običajni način prehrane.
The physician should be consulted when using other medications in addition to Liprolog Pen.
Pri sočasni uporabi zdravila Liprolog Pen in drugih zdravil se je potrebno posvetovati z zdravnikom.
41 Local allergy in patients is common (1/ 100 to < 1/ 10).
Lokalna alergijska reakcija je pogost (> 1/ 100, < 1/ 10) neželen učinek.
In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Sistemska alergijska
Systemic allergy, which is rare (1/ 10,000 to < 1/ 1,000) but potentially more serious, is a generalised allergy to insulin.
41 reakcija, ki je redka (> 1/ 10. 000, < 1/ 1. 000), a potencialno nevarnejša, je generalizirana alergija na insulin.
42 As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Odvisen je od odmerka, mesta injiciranja, prekrvitve tkiva, temperature in telesne dejavnosti.
Insulin lispro Humulin R Hypoglycemic Activity
Humulin R Hypoglycaemic Activity
When considering the clinical
Farmakokinetika insulina lispro kaže na spojino, ki se hitro absorbira in doseže najvišjo raven v krvi 30 do 70 minut po subkutanem injiciranju.
43 relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
Za oceno kliničnega pomena te kinetike je bolj primerno upoštevati krivulji utilizacije glukoze (glejte poglavje 5. 1).
5.3 Preclinical safety data
43 5. 3 Predklinični podatki o varnosti
44 5 x 3 ml Pens 2 x (5 x 3 ml) Pens
5 x 3 ml injekcijski peresniki Pen 2 x (5 x 3 ml) injekcijski peresniki Pen
Instructions for use and handling a) Preparing a dose
44 Navodila za pripravo in ravnanje z zdravilom a) Priprava odmerka
Inspect the Liprolog Pen solution.
Preglejte raztopino zdravila Liprolog Pen.
Do not use Liprolog Pen if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Raztopine zdravila Liprolog Pen ne uporabite, če je videti motna, zgoščena ali rahlo obarvana ali če so v njej vidni trdni delci.
Liprolog Mix25 100 U/ ml Pen, suspension for injection
Liprolog Mix25 100 i. e. / ml Pen suspenzija za injiciranje
Liprolog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Zdravilo Liprolog Mix25 vsebuje 25% raztopine insulina lispro in 75% suspenzije insulina lispro - protamin.
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog Mix25 is similar to that of a basal insulin (NPH).
Trajanje delovanja sestavine zdravila Liprolog Mix25 suspenzije insulina lispro- protamin (Basal) je podobno kot pri bazalnem insulinu (NPH).
47 Hypoglycaemia.
47 Hipoglikemija.
48 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.
48 Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje zarodka/ novorojenca.
49 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
49 Če je bolnik komatozen, damo glukagon intramuskularno ali subkutano.
Liprolog Mix25 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).
Zdravilo Liprolog Mix25 je suspenzija mešanice, ki je sestavljena iz insulina lispro (analog humanega insulina s hitrim delovanjem) in suspenzije insulina lispro- protamin (analog humanega insulina s srednje dolgim delovanjem).
50 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
50 Zgornji diagram ponazarja časovni potek učinkov obeh insulinov na presnovo glukoze, ki je potrebna za vzdrževanje koncentracije glukoze v polni krvi blizu ravni na tešče.
In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin, received 4 months of treatment with Liprolog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomised sequence.
V dveh 8- mesečnih, odprtih, navzkrižnih študijah, so bolniki z diabetesom tipa 2, ki so bodisi začeli zdravljenje z insulinom ali pa so že uporabljali eno ali dve injekciji insulina, 4 mesece v naključnem zaporedju prejemali zdravljenje z zdravilom Liprolog Mix25 (dvakrat na dan z metforminom) in insulinom glargin (enkrat na dan z metforminom).
the first crossover period
zdravilom Liporlog Mix25
51 Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
51 Insulin lispro v študijah na živalih ni povzročil zmanjšane plodnosti, embriotoksičnosti ali teratogenosti.
2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml Pens.
5 x 3 ml Liprolog Mix25 100 i. e. / ml injekcijski peresniki Pen 2 x (5 x 3 ml) Liprolog Mix25 100 i. e. / ml injekcijski peresniki Pen
Inspect the Liprolog Mix25 100 U/ ml Pen.
Preglejte zdravilo Liprolog Mix25 100 i. e. / ml Pen.
The Pen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
52 Injekcijski peresnik Pen je treba tik pred uporabo desetkrat zavrteti med dlanmi rok in desetkrat obrniti za 180°, da ponovno suspendirate insulin, dokler ni enakomerno motnega ali mlečnega videza.
Do not
Vložki vsebujejo majhno stekleno kroglico, ki je v pomoč pri mešanju.
52 shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
Ne stresajte močno, ker lahko to povzroči penjenje, ki lahko ovira pravilno odmerjanje odmerka.
5 x 3 ml Liprolog Mix25 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml Pens
5 x 3 ml Liprolog Mix25 100 i. e. / ml injekcijski peresniki Pen 2 x (5 x 3 ml) Liprolog Mix25 100 i. e. / ml injekcijski peresniki Pen
Liprolog Mix50 100 U/ ml Pen, suspension for injection
Liprolog Mix50 100 i. e. / ml Pen suspenzija za injiciranje
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog Mix50 is similar to that of a basal insulin NPH.
Trajanje delovanja sestavine zdravila Liprolog Mix50 suspenzije insulina lispro- protamin (Basal) je podobno kot pri bazalnem insulinu (NPH).
55 Hypersensitivity to insulin lispro or to any of the excipients.
55 Hipoglikemija.
56 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.
56 Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje zarodka/ novorojenca.
57 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
57 Če je bolnik komatozen, damo glukagon intramuskularno ali subkutano.
Liprolog Mix50 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).
Zdravilo Liprolog Mix50 je suspenzija mešanice, ki je sestavljena iz insulina lispro (analog humanega insulina s hitrim delovanjem) in suspenzije insulina lispro- protamin (analog humanega insulina s srednje dolgim delovanjem).
Liprolog Liprolog Basal
Liprolog Mix50 Basal
58 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Zgornji diagram ponazarja časovni potek učinkov obeh insulinov na presnovo glukoze, ki je potrebna za vzdrževanje koncentracije glukoze v polni krvi blizu ravni na tešče.
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
58 Za insulin lispro je bilo dokazano, da je na molarni osnovi enako močan kot humani insulin, a je njegov učinek hitrejši in bolj kratkotrajen.
59 Two years.
Dve leti.
6.4 Special precautions for storage
59 6. 4 Posebna navodila za shranjevanje
5 x 3 ml Liprolog Mix50 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml Pens.
5 x 3 ml Liprolog Mix50 100 i. e. / ml injekcijski peresniki Pen 2 x (5 x 3 ml) Liprolog Mix50 100 i. e. / ml injekcijski peresniki Pen
Inspect the Liprolog Mix50 Pen.
Preglejte zdravilo Liprolog Mix50 Pen.
(d) Hold the pen with needle pointing up and tap the clear cartridge holder gently with your finger so any air bubbles collect near the top.
Pritisnite na gumb
Depress the injection button fully until you feel or hear a 60 click.
60 za injiciranje do konca, dokler ne začutite ali zaslišite klika.
5 x 3 ml Liprolog Mix50 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml Pens
5 x 3 ml Liprolog Mix50 100 i. e. / ml injekcijski peresniki Pen 2 x (5 x 3 ml) Liprolog Mix50 100 i. e. / ml injekcijski peresniki Pen
Liprolog Basal 100 U/ ml Pen, suspension for injection
Liprolog Basal 100 i. e. / ml Pen suspenzija za injiciranje
Liprolog Basal may be used alone or in combination with oral agents.
Zdravilo Liprolog Basal se lahko se lahko uporablja samostojno ali v kombinaciji s peroralnimi zdravili.
63 4.4 Special warnings and precautions for use
63 4. 4 Posebna opozorila in previdnostni ukrepi
The physician should be consulted when using other medications in addition to Liprolog Basal 100 U/ ml Pen.
Pri sočasni uporabi zdravila Liprolog Basal 100 i. e. / ml Pen in drugih zdravil se je potrebno posvetovati z zdravnikom.
64 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
64 trimesečju nosečnosti in se povečajo v drugem in tretjem trimesečju.
65 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
65 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] 66 Phenol [0.80 mg/ ml] 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 66 Metakrezol [1, 76 mg/ ml] Fenol [0, 80 mg/ ml] 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 Liprolog Basal 100 U/ ml Pens 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml Pens
5 x 3 ml Liprolog Basal 100 i. e. / ml injekcijski peresniki Pen 2 x (5 x 3 ml) Liprolog Basal 100 i. e. / ml injekcijski peresniki Pen
Inspect the Liprolog Basal 100 U/ ml Pen.
Preglejte zdravilo Liprolog Basal 100 i. e. / ml Pen.
67 Wipe the rubber seal with alcohol.
67 Gumijasto zaporko obrišite z alkoholom.
This will ensure sterility, and prevent leakage, re-entry of air, and potential needle clogs.
68 vstop zraka in morebitno zamašitev igle.
5 x 3 ml Liprolog Basal Pen for a 3 ml pen 2 x (5 x 3 ml) Liprolog Basal Pen for a 3 ml pen
5 x 3 ml Liprolog Basal injekcijski peresniki Pen 2 x (5 x 3 ml) Liprolog Basal injekcijski peresniki Pen
Liprolog KwikPen 100 U/ ml, solution for injection
Liprolog 100 i. e. / ml KwikPen raztopina za injiciranje
70 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
Po nasvetu zdravnika se lahko zdravilo Liprolog uporabi hkrati s humanim insulinom z dolgotrajnejšim delovanjem ali peroralnimi pripravki s sulfonilsečnino.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
70 Za infundiranje insulina lispro lahko uporabljamo samo določene insulinske infuzijske črpalke, označene s CE.
71 Insulin requirements may be increased during illness or emotional disturbances.
Potrebe po insulinu se lahko povečajo v času bolezni ali čustvenih težav.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
71 Odmerjanje je morda treba prilagoditi tudi, če bolnik poveča telesno dejavnost ali spremeni običajni način prehrane.
The physician should be consulted when using other medications in addition to Liprolog KwikPen.
Pri sočasni uporabi zdravila Liprolog KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom.
72 Local allergy in patients is common (1/ 100 to < 1/ 10).
Lokalna alergijska reakcija je pogost (> 1/ 100, < 1/ 10) neželen učinek.
In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
72 primer z dražili v sredstvih za čiščenje kože ali nepravilno tehniko injiciranja.
73 As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Hipoglikemična aktivnost mesta injiciranja, prekrvitve tkiva, temperature in telesne dejavnosti.
When considering the clinical
Za oceno kliničnega pomena te kinetike je bolj primerno upoštevati krivulji utilizacije glukoze (glejte poglavje 5. 1).
74 relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
74 neodvisnost od ledvične funkcije.
The 3 ml cartridges are sealed in a disposable pen injector.
3 ml vložki so zaprti v injekcijskem peresniku za enkratno uporabo, imenovanem “ KwikPen ”.
75 5 x 3 ml Liprolog 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog 100 U/ ml KwikPen
5 x 3 ml Liprolog 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog 100 i. e. / ml injekcijski peresniki KwikPen
6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom 75 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
5 x 3 ml Liprolog 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog 100 U/ ml KwikPen
5 x 3 ml Liprolog 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog 100 i. e. / ml injekcijski peresniki KwikPen
Liprolog Mix25 100 U/ ml KwikPen, suspension for injection
Liprolog Mix25 100 i. e. / ml KwikPen suspenzija za injiciranje
77 Hypoglycaemia.
77 Hipoglikemija.
The physician should be consulted when using other medications in addition to Liprolog Mix25.
Pri sočasni uporabi zdravila Liprolog Mix25 KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom.
78 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.
78 Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje zarodka/ novorojenca.
79 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
79 Če je bolnik komatozen, damo glukagon intramuskularno ali subkutano.
80 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
80 Zgornji diagram ponazarja časovni potek učinkov obeh insulinov na presnovo glukoze, ki je potrebna za vzdrževanje koncentracije glukoze v polni krvi blizu ravni na tešče.
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
81 Insulin lispro v študijah na živalih ni povzročil zmanjšane plodnosti, embriotoksičnosti ali teratogenosti.
The 3 ml cartridges are sealed in a disposable pen injector, called the “ Pen”.
3 ml vložki so zaprti v napolnjenem injekcijskem peresniku/ injekcijskem peresniku za enkratno uporabo, imenovanem “ KwikPen ”.
2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml KwikPens.
5 x 3 ml Liprolog Mix25 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog Mix25 100 i. e. / ml injekcijski peresniki KwikPen
Cartridges contain a small glass bead to assist mixing.
Vložki 82 vsebujejo majhno stekleno kroglico, ki je v pomoč pri mešanju.
82 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 Liprolog Mix25 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix25 100 U/ ml KwikPens
5 x 3 ml Liprolog Mix25 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog Mix25 100 i. e. / ml injekcijski peresniki KwikPen
Liprolog Mix50 100 U/ ml KwikPen, suspension for injection
Liprolog Mix50 100 i. e. / ml KwikPen suspenzija za injiciranje
84 Hypoglycaemia.
84 Hipoglikemija.
The physician should be consulted when using other medications in addition to Liprolog Mix50.
Pri sočasni uporabi zdravila Liprolog Mix50 KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom.
85 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.
85 Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje zarodka/ novorojenca.
86 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
86 Če je bolnik komatozen, damo glukagon intramuskularno ali subkutano.
87 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Zgornji diagram ponazarja časovni potek učinkov obeh insulinov na presnovo glukoze, ki je potrebna za vzdrževanje koncentracije glukoze v polni krvi blizu ravni na tešče.
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
87 Za insulin lispro je bilo dokazano, da je na molarni osnovi enako močan kot humani insulin, a je njegov učinek hitrejši in bolj kratkotrajen.
88 Two years.
Dve leti.
6.4 Special precautions for storage
88 6. 4 Posebna navodila za shranjevanje
5 x 3 ml Liprolog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml KwikPens.
5 x 3 ml Liprolog Mix50 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog Mix50 100 i. e. / ml injekcijski peresniki KwikPen
5 x 3 ml Liprolog Mix50 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Mix50 100 U/ ml KwikPens
5 x 3 ml Liprolog Mix50 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog Mix50 100 i. e. / ml injekcijski peresniki KwikPen
Liprolog Basal 100 U/ ml KwikPen, suspension for injection
Liprolog Basal 100 i. e. / ml KwikPen suspenzija za injiciranje
91 4.4 Special warnings and precautions for use
91 4. 4 Posebna opozorila in previdnostni ukrepi
The physician should be consulted when using other medications in addition to Liprolog Basal 100 U/ ml KwikPen.
Pri sočasni uporabi zdravila Liprolog Basal 100 i. e. / ml KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom.
92 It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
92 trimesečju nosečnosti in se povečajo v drugem in tretjem trimesečju.
93 Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
93 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] 94 Phenol [0.80 mg/ ml] 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 94 Metakrezol [1, 76 mg/ ml] Fenol [0, 80 mg/ ml] 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 Liprolog Basal 100 U/ ml KwikPens 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml KwikPens
5 x 3 ml Liprolog Basal 100 i. e. / ml injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog Basal 100 i. e. / ml injekcijski peresniki KwikPen
5 x 3 ml Liprolog Basal 100 U/ ml KwikPen 2 x (5 x 3 ml) Liprolog Basal 100 U/ ml KwikPen
5 x 3 ml Liprolog Basal injekcijski peresniki KwikPen 2 x (5 x 3 ml) Liprolog Basal injekcijski peresniki KwikPen
96 ANNEX II
96 DODATEK II
97 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
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
98 • OTHER CONDITIONS
98 • DRUGI POGOJI
Pharmacovigilance System The MAH must ensure that the system of Pharmacovigilance, as described in version 2.1 presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2. 1, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje pred prihodom zdravila na trg in dokler bo zdravilo na tržišču.
99 ANNEX III
99 DODATEK III
LABELLING
100 A - OZNAČEVANJE
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI