natgillin/translations-raw huggingface dataset:
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
28 V klinični študiji so bili simptomi hipoglikemije in protiregulacijski hormonski odzivi po intravenski uporabi insulina glargin in humanega insulina pri zdravih prostovoljcih in bolnikih z diabetesom tipa 1 podobni.
29 In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Analize podskupin po starosti in spolu v kliničnih študijah niso pokazale razlik v varnosti in učinkovitosti pri bolnikih, zdravljenih z insulinom glargin, v primerjavi s celotno raziskovano populacijo.
6.3 Shelf life
29 6. 3 Rok uporabnosti
The pen containing a cartridge must not be stored in the refrigerator.
Rok uporabnosti po prvi uporabi vložka Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
The pen cap must be put back on the pen after each injection in order to protect from light.
Injekcijskega peresnika z vstavljenim vložkom ne smete shranjevati v hladilniku.
Do not put Lantus next the freezer compartment or a freezer pack.
Zdravila Lantus ne shranjujte v bližini zamrzovalnega razdelka ali zamrzovalnega vložka.
In use cartridges For storage precautions, see section 6.3.
Odprt vložek Za navodila za shranjevanje glejte poglavje 6. 3.
3 ml solution in a cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber).
3 ml raztopine v vložku (iz brezbarvnega stekla tipa 1) s črnim batom (iz brombutilne gume) in prirobljeno zaporko (iz aluminija) z zamaškom (iz brombutilne gume ali laminata poliizoprena in brombutila).
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges for OptiClik are available.
Na voljo so pakiranja z 1, 3, 4, 5, 6, 8, 9 in 10 vložki OptiClik.
30 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Lantus 100 Units/ ml solution for injection in a pre-filled pen
Lantus 100 enot/ ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
OptiSet delivers insulin in increments of 2 Units up to a maximum single dose of 40 Units.
Z injekcijskim peresnikom OptiSet je mogoče insulin dajati v stopnjah po 2 enoti do največjega enkratnega odmerka 40 enot.
32 To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
32 Bolniki, ki z insulina NPH dvakrat na dan preidejo na zdravilo Lantus enkrat na dan, morajo za zmanjšanje nevarnosti nočne in zgodnje jutranje hipoglikemije dnevni odmerek bazalnega insulina v prvih tednih zdravljenja z zdravilom Lantus zmanjšati za 20 do 30%.
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6)
Pred uporabo OptiSeta natančno preberite navodila za ravnanje z OptiSetom v navodilu za uporabo (glejte poglavje 6. 6).
33 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Pri bolnikih s hudo okvaro jeter se lahko potreba po insulinu zmanjša zaradi zmanjšane zmožnosti za glukoneogenezo in zmanjšane presnove insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
33 V primeru nezadostne urejenosti glukoze ali nagnjenosti k hiper - ali hipoglikemijam je treba pred spreminjanjem odmerka preveriti, ali bolnik upošteva predpisano shemo zdravljenja, mesta injiciranja, ustrezno tehniko injiciranja in vse druge pomembne dejavnike.
34
34 Sočasne bolezni
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully.
Ravnanje z injekcijskim peresnikom Pred uporabo OptiSeta natančno preberite navodila za ravnanje z OptiSetom v navodilu za uporabo.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
Za insulin glargin ni na voljo kliničnih podatkov iz nadzorovanih kliničnih preskušanj od nosečnic, ki so bile izpostavljene zdravilu.
35 Lactation Lactating women may require adjustments in insulin dose and diet.
Pri doječih ženskah utegne biti potrebna prilagoditev odmerka insulina in prehrane.
Very rare:
Zelo redki: motnje okusa
Dysgeusia
Očesne bolezni
36 Eyes disorders
36 Redki: retinopatija Dolgoročno izboljšanje glikemične urejenosti zmanjša tveganje za napredovanje diabetične retinopatije.
38 The following graph shows the results from a study in patients:
Spodnji graf prikazuje rezultate študije pri bolnikih:
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
38 V klinični študiji so bili simptomi hipoglikemije in protiregulacijski hormonski odzivi po intravenski uporabi insulina glargin in humanega insulina pri zdravih prostovoljcih in bolnikih z diabetesom tipa 1 podobni.
39 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Zinc chloride m-cresol glycerol hydrochloric acid sodium hydroxide water for injections.
Cinkov klorid, metakrezol, glicerol, klorovodikova kislina, natrijev hidroksid, voda za injekcije.
Shelf life after first use of the pen The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
39 Rok uporabnosti po prvi uporabi injekcijskega peresnika Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
The pen cap must put back on the pen after each injection in order to protect from light.
Po vsakem injiciranju dajte pokrovček injekcijskega peresnika nazaj na injekcijski peresnik za zagotovitev zaščite pred svetlobo.
Not in-use pens Store in a refrigerator (2°C-8°C).
Injekcijski peresniki, ki jih ne uporabljate Shranjujte v hladilniku (2 °C - 8 °C).
Keep the prefilled pen in the outer carton in order to protect from light.
Napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
In-use pens For storage precautions, see section 6.3.
Injekcijski peresniki, ki jih uporabljate Za navodila za shranjevanje glejte poglavje 6. 3.
40 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
Ravnanje z injekcijskim peresnikom Pred uporabo OptiSeta natančno preberite navodila za ravnanje z OptiSetom v navodilu za uporabo.
Schematic diagram of the pen
Pomembne informacije za uporabo OptiSeta:
Important information for use of OptiSet: • Always attach a new needle before each use.
40 • Pred vsako uporabo vedno namestite novo iglo.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out. • This pen is only for the patients use.
Uporabljajte le igle, primerne za uporabo z OptiSetom. • Pred vsakim injiciranjem opravite varnostni preizkus. • Če uporabljate nov OptiSet, morate prvi varnostni preizkus narediti z odmerkom 8 enot, ki ga je nastavil že izdelovalec. • Izbirnik odmerka je mogoče vrteti le v eno smer. • Ko je gumb za injiciranje izvlečen, izbirnika odmerka ne smete več obračati (tj. ne smete več spreminjati odmerka). • Ta injekcijski peresnik uporabljajte le vi sami.
It must not be shared with anyone else. • If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
Ne delite ga z nikomer drugim. • Če vam injekcijo da druga oseba, je treba posebej paziti, da se ta oseba po naključju ne poškoduje z iglo in da ne prenese okužbe. • Ne uporabljajte OptiSeta, če je poškodovan ali če niste prepričani, da deluje pravilno. • Vedno imejte na zalogi rezervni OptiSet, če injekcijski peresnik izgubite ali se poškoduje.
41 Maintenance
Vzdrževanje
Pull out the injection button completely in order to load the dose.
41 Da boste napolnili odmerek, popolnoma izvlecite gumb za injiciranje.
42 Step 4.
Korak 4.
A clicking sound can be heard, which will stop when the injection button has been pressed. in completely.
Slišali boste klikanje, ki se bo končalo, ko bo gumb za injiciranje pritisnjen do konca.
When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast- acting insulin analogues or the dose of oral antidiabetic agents).
Pri prehodu s srednjedolgo - ali dolgodelujočega insulina na zdravljenje z zdravilom Lantus, utegneta biti potrebna sprememba odmerka bazalnega insulina in prilagoditev sočasnega antidiabetičnega zdravljenja (odmerek in časovni razpored dodatnih navadnih insulinov ali hitrodelujočih insulinskih analogov oz. odmerek peroralnih antidiabetikov).
45 To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
44 Bolniki, ki z insulina NPH dvakrat na dan prehajajo na zdravilo Lantus enkrat na dan, morajo za zmanjšanje nevarnosti nočne ali zgodnje jutranje hipoglikemije v prvih tednih zdravljenja z zdravilom Lantus zmanjšati dnevni odmerek bazalnega insulina za 20 do 30%.
Mixing or diluting can change its time/ action profile and mixing can cause precipitation.
Mešanje ali redčenje lahko spremeni profil časovnega poteka in delovanja; mešanje lahko povzroči precipitacijo.
Due to limited experience the efficacy and safety of Lantus could not be assessed in the following groups of patients: patients with impaired liver function or patients with moderate/ severe renal impairment (see section 4.4).
Zaradi omejenih izkušenj učinkovitosti in varnosti, zdravila Lantus ni bilo mogoče oceniti v naslednjih skupinah bolnikov: pri bolnikih z okvarjenim delovanjem jeter in bolnikih z zmerno/ hudo okvaro ledvic (glejte poglavje 4. 4).
46 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
45 Pri bolnikih s hudo okvaro jeter se lahko potreba po insulinu zmanjša zaradi zmanjšane zmožnosti za glukoneogenezo in zmanjšane presnove insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
V primeru nezadostne urejenosti glukoze ali nagnjenosti k hiper - ali hipoglikemijam je treba pred spreminjanjem odmerka preveriti, ali bolnik upošteva predpisano shemo zdravljenja, mesto injiciranja, ustrezno tehniko injiciranja in vse druge pomembne dejavnike.
- certain uncompensated endocrine disorders, (e. g. in hypothyroidism and in anterior pituitary or
- določene nekompenzirane endokrine motnje (npr. hipotiroidizem, insuficienca sprednjega režnja
adrenocortical insufficiency),
hipofize ali insuficienca nadledvične skorje),
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Pred uporabo SoloStarja natančno preberite navodila za ravnanje z injekcijskim peresnikom v navodilu za uporabo.
SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
SoloStar je treba uporabljati v skladu s priporočili v tem navodilu za uporabo (glejte poglavje 6. 6).
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
Zaviralci beta, klonidin, litijeve soli ali alkohol lahko hipoglikemično delovanje insulina bodisi stopnjujejo ali oslabijo.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
Nosečnost Za insulin glargin ni na voljo kliničnih podatkov iz nadzorovanih kliničnih preskušanj od nosečnic.
A limited number of exposed pregnancies from Post Marketing Surveillance indicate no adverse effects of insulin glargine on pregnancy or on the health of the foetus and newborn child.
Podatki iz nadzora po uvedbi na trg pri omenjenem številu nosečnic, ki so bile izpostavljene zdravilu, ne kažejo na možnost škodljivih vplivov insulina glargin na nosečnost ali zdravje zarodka in novorojenca.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal / foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
The available clinical data is insufficient to exclude a risk.
Na voljo ni zadostnih kliničnih podatkov, ki izključujejo tveganje.
48 Lactation Lactating women may require adjustments in insulin dose and diet.
47 Dojenje Pri doječih ženskah utegne biti potrebna prilagoditev odmerka insulina in prehrane.
The following related adverse reactions from clinical investigations were listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000).
Naslednje povezane neželene reakcije iz kliničnih raziskav so navedene spodaj po organskem sistemu in po padajoči pogostnosti (zelo pogoste: ≥ 1/ 10; pogoste: ≥ 1/ 100 do < 1/ 10; občasne: ≥ 1/ 1. 000 do < 1/ 100; redke: ≥ 1/ 10. 000 do < 1/ 1. 000; zelo redke: < 1/ 10. 000).
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Praviloma so pojav protiregulacije in njeni simptomi toliko izrazitejši, kolikor večje in hitrejše je znižanje koncentracije glukoze v krvi.
Allergic reaction Immediate-type allergic reactions to insulin are rare.
Redki: alergijska reakcija Takojšnje alergijske reakcije na insulin so redke.
In clinical studies, antibodies that cross- react with human insulin and insulin glargine were observed with the same frequency in both NPH- insulin and insulin glargine treatment groups.
V kliničnih študijah so protitelesa, ki navzkrižno reagirajo s humanim insulinom in insulinom glargin, enako pogosto ugotavljali med prejemniki insulina NPH in insulina glargin.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
V redkih primerih je zaradi takšnih protiteles proti insulinu treba prilagoditi odmerek insulina, da bi odpravili nagnjenost k hiper - ali hipoglikemiji.
Dysgeusia
Zelo redki: disgeuzija
49 Eyes disorders
Očesne bolezni
Visual impairment A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Redki: okvara vida Izrazita sprememba urejenosti glikemije lahko prehodno poslabša vid zaradi prehodno spremenjenega turgorja in lomnega količnika leče.
Retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
48 Redki: retinopatija Dolgoročno izboljšanje urejenosti glikemije zmanjša nevarnost za napredovanje diabetične retinopatije.
As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Tako kot pri vsakem zdravljenju z insulinom, se lahko na mestu injiciranja pojavi lipodistrofija in upočasni lokalno absorpcijo insulina.
Injection site reactions Such reactions include redness, pain, itching, hives, swelling, or inflammation.
Pogosti: reakcije na mestu injiciranja Med takšnimi reakcijami so pordelost, bolečine, srbenje, urtikarija, otekanje ali vnetje.
Oedema Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Redki: edemi Redko lahko insulin povzroči zadrževanje natrija in edeme; to se zlasti pojavi, če se z intenziviranim insulinskim zdravljenjem izboljša prej slaba urejenost presnove.
50 Management
Ukrepanje
Antidiabetic agent.
Pripravki za zdravljenje diabetesa.
51 The following graph shows the results from a study in patients:
Spodnji graf prikazuje rezultate študije pri bolnikih:
6
6 hitrost porabe glukoze *
4 Insulin glargine
4 (mg/ kg/ min)
NPH insulin
insulin glargin 3 insulin NPH 2
Time (h) after s. c. injection
konec opazovanja
End of observation period
čas (ure) po subkutani injekciji
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
50 V klinični študiji so bili simptomi hipoglikemije in protiregulacijski hormonski odzivi po intravenski uporabi insulina glargin in humanega insulina pri zdravih prostovoljcih in bolnikih z diabetesom tipa 1 podobni.
52 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Zinc chloride m-cresol glycerol hydrochloric acid sodium hydroxide water for injections.
Cinkov klorid, m- krezol, glicerol, klorovodikova kislina, natrijev hidroksid, voda za injekcije.
Shelf life after first use of the pen The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
51 Rok uporabnosti po prvi uporabi injekcijskega peresnika Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
3 ml solution in a cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber). The cartridge is sealed in a disposable pen injector.
3 ml raztopine v vložku (iz brezbarvnega stekla tipa 1) s črnim batom (iz brombutilne gume) in prirobljeno zaporko (iz aluminija) z zamaškom (iz brombutila ali poliizoprenskega laminata in brombutilne gume).
Needles are not included in the pack.
Vložek je zapečaten v injekcijskem peresniku za enkratno uporabo.
53 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
The Instructions for Use included in the Package Leaflet must be read carefully before using SoloStar.
Preden uporabite SoloStar, morate v navodilu za uporabo injekcijskega peresnika natančno prebrati navodila za ravnanje z njim.
Only use needles that are compatible for use with SoloStar. • Special caution must be taken to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
52 • Posebej morate paziti, da boste preprečili naključne poškodbe z iglo in prenos okužbe. • Ne uporabljajte SoloStarja, če je poškodovan ali če niste prepričani, da deluje pravilno. • Vedno imejte na zalogi rezervni SoloStar, če injekcijski peresnik izgubite ali se poškoduje.
Please check section 6.4 of this leaflet for instructions on how to store SoloStar.
Za navodila o shranjevanju SoloStarja glejte poglavje 6. 4 tega navodila.
Check the Insulin
1. korak Preverite insulin
The Lantus SoloStar is grey with a purple injection button.
Lantus SoloStar je siv in ima škrlaten gumb za injiciranje.
After removing the pen cap, the appearance of insulin should also be checked: the insulin solution must be clear, colorless, with no solid particles visible, and must have a water-like consistency.
Po odstranitvi pokrovčka injekcijskega peresnika je treba preveriti videz insulina: raztopina insulina mora biti bistra, brezbarvna, brez vidnih delcev in vodi podobne konsistence.
Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Pred vsakim injiciranjem morate opraviti varnostni preizkus, s katerim se prepričate, da injekcijski peresnik in igla pravilno delujeta, in odstranite zračne mehurčke.
While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle
Injekcijski peresnik morate prijeti tako, da je igla obrnjena navzgor, in s prstom rahlo potrkati po insulinskem rezervoarju, da se morebitni zračni mehurčki dvignejo proti igli.
Select the dose
53 4. korak Izberite odmerek
55 Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Nemčija
56 ANNEX II
54 DODATEK II
Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50 D-65926 Frankfurt / Main Germany
Sanofi- Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50 D- 65926 Frankfurt am Main Nemčija
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) odgovornega (odgovornih) za sproščanje serije
Località Valcanello 03012 Anagni (FR) Italy
Località Valcanello 03012 Anagni (FR) Italija
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO UČINKOVITO UPORABO ZDRAVILA
A PSUR covering the period 22 October 2004 – 21 October 2006 will be submitted in December 2006.
PSUR za obdobje od 22. oktobra 2004 – 21. oktobra 2006 bo vložen decembra 2006.
Subsequent PSURs will be submitted in accordance with the European legislation unless otherwise requested by the CHMP.
Naslednji PSURs bodo vloženi skladno z Evropsko zakonadajo, razen če bo CHMP zahteval drugače.
58 ANNEX III
56 DODATEK III
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
58 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Lantus 100 Units/ ml Solution for injection in a vial Insulin glargine
Lantus 100 enot/ ml raztopina za injiciranje v viali insulin glargin
1 ml contains 100 Units (3.64 mg) insulin glargine
1 ml vsebuje 100 enot (3, 64 mg) insulina glargin.
Excipients: zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections
Pomožne snovi: cinkov klorid, metakrezol, glicerol, klorovodikova kislina, natrijev hidroksid, voda za injekcije.
Solution for injection, 1 vial of 5 ml.
Raztopina za injiciranje, 1 viala s 5 ml.
Solution for injection, 2 vials of 5 ml.
Raztopina za injiciranje, 2 viali s 5 ml.
Solution for injection, 5 vials of 5 ml.
Raztopina za injiciranje, 5 vial s 5 ml.
Solution for injection, 10 vials of 5 ml.
Raztopina za injiciranje, 10 vial s 5 ml.
EXP (month/ year):
EXP (mesec/ leto):
61 Unopened vials:
Neodprte viale:
Store in a refrigerator.
59 Shranjujte v hladilniku.
Once in use, vials may be stored for a maximum of 4 weeks not above 25°C.
Ko viale začnete uporabljati, jih lahko shranjujete največ 4 tedne pri temperaturi do 25 °C.
Keep in the outer carton.
Shranjujte v zunanji ovojnini.