natgillin/translations-raw huggingface dataset:
6.5 Nature and contents of container ic
Napolnjene injekcijske brizge iz stekla tipa I z gumijastim zamaškom iz bromobutila, igla dimenzije m
Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with ed
27 (gauge) iz nerjavnega jekla, ki je zaščitena z naravno trdo gumo in polistirenom, bat iz polistirena in zaščitni pokrovček za iglo.
24 The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Injekcijska brizga je opremljena z zaščitnim pokrovčkom za iglo, ki preprečuje vbode z iglo.
or EU/ 1/ 02/ 211/ 003
et EU/ 1/ 02/ 211/ 003
10.
za 10.
DATE OF REVISION OF THE TEXT no
DATUM ZADNJE REVIZIJE BESEDILA
Dynepo 4,000 IU/ 0.4 ml solution for injection in a pre-filled syringe.
Dynepo 4. 000 i. e. / 0, 4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Pre-filled syringe containing 4,000 IU per 0.4 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 4. 000 i. e. učinkovine, epoetina delta, na 0, 4- ml odmerek (10. 000 i. e. / ml).
Solution for injection in a pre-filled syringe
pr Raztopina za injiciranje v napolnjeni injekcijski brizgi.
It may be used in patients on dialysis and in patients not on dialysis. ng lo 4.2 Posology and method of administration no
Uporablja se lahko pri bolnikih, ki so na dializi, in pri tistih, ki niso. do
The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the target range of 10 to 12g/ dl. du
Odmerjanje Dynepa je treba prilagoditi individualno, tako da koncentracija hemoglobina ostaja v ciljnem območju od 10 do 12 g/ dl. a m
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a ro
Simptomi in posledice anemije se lahko razlikujejo glede na starost, spol in celotno breme bolezni, zato je zdravnikova ocena kliničnega poteka bolezni in splošnega stanja posameznega bolnika nujna. ni
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
Zdravilo Dynepo se lahko daje subkutano ali intravensko, da se zviša raven hemoglobina do največ 12 g/ dl (7, 5 mmol/ l).
Dynepo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not lp
Pri bolnikih, ki niso na dializi, dajemo prednost subkutanemu dajanju, saj se tako ilo
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. a in
izognemo punkciji perifernih ven.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi variabilnosti med bolniki se lahko pri posameznih bolnikih občasno pojavijo vrednosti v
through dose management, with consideration for the haemoglobin target range of 10 g/ dL ed
Razlike v ravni hemoglobina se urejajo z uravnavanjem ra
A sustained haemoglobin level of greater than 12 g/ dL (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin M
Smernice za Zd
values exceeding 12 g/ dL (7.5mmol/ l) are observed, are described below (see Dose Management section below).
ustrezno prilagajanje odmerkov, ko raven hemoglobina preseže 12 g/ dl (7, 5 mmol/ l) so opisana v nadaljevanju (glejte razdelek Prilagajanje odmerjanja).
50 IU/ kg twice a week if administered subcutaneously.
26 Prilagajanje odmerjanja Pri intravenski uporabi je začetni odmerek 50 i. e. / kg trikrat na teden, pri subkutani pa 50 i. e. / kg dvakrat na teden.
The experience in children is limited Due to limited experience, the safety and efficacy of Dynepo could not be assessed in patients with M
Zaradi omejenih izkušenj učinkovitosti in varnosti Dynepa ni mogoče oceniti pri bolnikih z okvarjenim delovanjem jeter. v
27 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
V kliničnih preskušanjih so ugotovili povečano tveganje za smrt in resne srčno- žilne dogodke, če je bila ciljna raven hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
27 Kontrolirana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih pripisali dajanju epoetinov, če so ravni hemoglobina povečane nad raven, ki je potrebna za kontrolo simptomov anemije in izognitev transfuzijam krvi.
Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications like hypertensive encephalopathy and related complications (seizures,
Za preprečitev akutnih zapletov, npr. hipertenzivne encefalopatije in sorodnih zapletov
is stroke).
et (epileptoidnih napadov, možganske kapi), mora biti krvni tlak ustrezno nadzorovan pred začetkom zdravljenja in med njim.
th Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of existing anti-hypertensive medications.
o Zaradi zvišanja krvnega tlaka utegne biti potrebno zdravljenje z antihipertenzivnimi zdravili ali
au needs to be considered.
Razmisliti je treba tudi o zmanjšanju odmerka Dynepa.
ferritin should be at least 100 ng/ ml.
Nasičenost transferina mora biti vsaj vo 20% in koncentracija feritina vsaj 100 ng/ ml.
If transferrin saturation falls below 20%, or if ferritin falls below 100 ng/ ml, iron should be administered.
Če se nasičenost transferina zniža pod 20% ali koncentracija feritina upade pod 100 ng/ ml, je treba dati železo.
Virtually all patients will eventually require supplemental iron du
Skoraj vsi bolniki bodo lahko potrebovali dodatno železo za zvečanje ali ohranitev nasičenosti transferina in koncentracije feritina na do
to increase or maintain transferrin saturation and ferritin to levels that will adequately support erythropoiesis stimulated by Dynepo. ro
ravni, potrebni za ustrezno eritropoezo, ki jo spodbudi Dynepo.
Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/ week should be investigated, including referral to a haematologist. lp
Anemijo pri bolnikih, ki so na epoetin odporni ali premalo odzivni ter se ne odzovejo na 20. 000 i. e. / teden, je treba raziskati in jih napotiti k hematologu. ā ve
In the iron-replete patient with an inadequate response to Dynepo therapy, the following conditions a
Pri bolnikih, ki imajo zaloge železa napolnjene, a se na zdravljenje z Dynepom ne odzovejo ustrezno, je treba raziskati možnost naslednjih bolezni in jih po potrebi zdraviti: okužba/ vnetje • a
• Infection/ inflammation ic
okultno izgubljanje krvi • m
• Occult blood loss • Hyperparathyroidism/ Osteitis fibrosa cystica ed
hiperparatiroidizem/ osteitis fibrosa cystica • zastrupitev z aluminijem • ni
• Aluminium intoxication • Haemoglobinopathies such as thalassaemia or sickle cell anaemia M
hemoglobinopatije, npr. talasemija ali anemija s srpastimi celicami • pomanjkanje vitaminov, tj. pomanjkanje folne kisline ali vitamina B12 • ilo
• Vitamin deficiencies, i. e., folic acid or vitamin B12 deficiencies • Haemolysis • Malignant diseases including multiple myeloma and myelodysplastic syndrome • Malnutrition
hemoliza • maligne bolezni, vključno z multiplim mielomom in mielodisplastičnim sindromom • v
28 The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
Koncentracijo hemoglobina je treba določiti vsak teden, dokler se ne ustali v priporočenem ciljnem območju in ni določen vzdrževalni odmerek.
Other:
Med uporabo Dynepa takšnih reakcij sicer ni bilo, vendar je prvi odmerek kljub temu priporočljivo uporabiti pod zdravniškim nadzorom.
Although it has not been observed with Dynepo, since anaphylactoid reactions may occur with erythropoietin, it is recommended that the first dose be administered under medical supervision.
Pri bolnikih z nefrosklerozo, ki se še ne zdravijo z dializo, je treba uporabo Dynepa pretehtati posamezno, ker ni mogoče z gotovostjo izključiti možne pospešitve napredovanja odpovedi ledvic.
ed The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
Bolniki, zdravljeni z Dynepom, utegnejo med hemodializo potrebovati več antikoagulantov za preprečitev zapore arteriovenskega šanta.
is or During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
Posledica so lahko smrtno nevarni kardiovaskularni zapleti.
th Misuse of epoetin by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
m 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
au This may be associated with life-threatening cardiovascular complications.
o pr Študije o medsebojnem delovanju niso bile izvedene.
er 4.5 Interaction with other medicinal products and other forms of interaction ng No interaction studies have been performed. lo No interactions have been reported during treatment with Dynepo in the course of clinical trials. no
Med zdravljenjem z Dynepom v kliničnih preskušanjih ni bilo opisanih medsebojnih delovanj.
4.6 Pregnancy and lactation
za 4. 6 Nosečnost in dojenje
The ct
Študije na živalih ne nudijo zadostnih podatkov, da bi lahko ugotovili, kakšne učinke ima
potential risk for humans is unknown.
nj zdravilo med nosečnostjo (glejte poglavje 5. 3).
In case of its use during pregnancy, concomitant iron substitution should be considered in the du
Pri uporabi med nosečnostjo je treba pretehtati lje sočasno nadomeščanje železa pri materi.
are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding women. lp
Številne spojine se izločajo v materinem vo mleku, zato je treba Dynepo pri doječih ženskah uporabljati previdno.
4.7 Effects on ability to drive and use machines a in
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji do
Dynepo has no or negligible influence on the ability to drive and use machines. ic
Dynepo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji. ā
4.8 Undesirable effects ed
4. 8 Neželeni učinki ve
The most M
Klinične raziskave z epoetinom kažejo, da je a
common are hypertension, access related thrombosis and headache.
tveganje v zvezi s zvišanim krvnim tlakom in trombozo mogoče zmanjšati s titracijo odmerka, da m
Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/ dl.
raven hemoglobina ohranimo med 10 in 12 g/ dl. ni
30 During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
V kliničnih preskušanjih pri ljudeh glede na klinični odziv ni bilo znakov razvoja nevtralizirajočih protiteles proti epoetinu delta.
Dynepo is not indicated for the management of anaemia associated with cancer.
30 Bolniki, oboleli za rakom Zdravilo Dynepo ni indicirano za obravnavo anemije, ki je povezana z rakom.
31 5.3 Preclinical safety data
31 Pri nekliničnih študijah je bilo negativne učinke moč zaznati samo pri odmerkih, ki so bili neprimerljivo višji od največje izpostavljenosti pri človeku, kar kaže na majhen pomen za klinično uporabo.
Keep the syringes in the outer carton to protect from light. du
Injekcijske brizge shranjujte v zunanji ovojnini za vo zaščitito pred svetlobo.
32 The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Injekcijska brizga je opremljena z zaščitnim pokrovčkom za iglo, ki preprečuje vbode z iglo.
or EU/ 1/ 02/ 211/ 004
et EU/ 1/ 02/ 211/ 004
Dynepo 5,000 IU/ 0.5 ml solution for injection in a pre-filled syringe.
Dynepo 5. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Pre-filled syringe containing 5,000 IU per 0.5 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
Ena napolnjena injekcijska brizga vsebuje 5. 000 i. e. učinkovine, epoetina delta, na 0, 5- ml odmerek (10. 000 i. e. / ml).
is Solution for injection in a pre-filled syringe.
pr Raztopina za injiciranje v napolnjeni injekcijski brizgi.
or Clear, colourless and waterlike.
za Bistra, brezbarvna, podobna vodi.
Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure(CRF) in adult patients.
nj 4. 1 Terapevtske indikacije lje Zdravilo Dynepo je indicirano za zdravljenje simptomatske anemije, ki je povezana s kronično vo ledvično odpovedjo pri odraslih bolnikih.
50 IU/ kg twice a week if administered subcutaneously.
34 Prilagajanje odmerjanja Pri intravenski uporabi je začetni odmerek 50 i. e. / kg trikrat na teden, pri subkutani pa 50 i. e. / kg dvakrat na teden.
Because of the time required for erythropoiesis, an interval of approximately 4 weeks may occur between the time of a dose adjustment (initiation, increase, decrease or discontinuation) and a significant change in haemoglobin.
et približno 4 tedni.
ed Dose should be decreased by 25% – 50% or treatment temporarily withdrawn and then re-introduced
m Odmerek je treba zmanjšati za 25% - 50% ali pa zdravljenje začasno prekiniti in nato znova uvesti z
M
Zaradi omejenih izkušenj učinkovitosti in varnosti Dynepa ni mogoče oceniti pri bolnikih z okvarjenim delovanjem jeter. v
35 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
V kliničnih preskušanjih so ugotovili povečano tveganje za smrt in resne srčno- žilne dogodke, če je bila ciljna raven hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
35 Kontrolirana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih pripisali dajanju epoetinov, če so ravni hemoglobina povečane nad raven, ki je potrebna za kontrolo simptomov anemije in izognitev transfuzijam krvi.
th Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of
o Zaradi zvišanja krvnega tlaka utegne biti potrebno zdravljenje z antihipertenzivnimi zdravili ali
• Occult blood loss Hyperparathyroidism/ Osteitis fibrosa cystica ed
hiperparatiroidizem/ osteitis fibrosa cystica • zastrupitev z aluminijem • ni
• • Aluminium intoxication • Haemoglobinopathies such as thalassaemia or sickle cell anaemia M
hemoglobinopatije, npr. talasemija ali anemija s srpastimi celicami • pomanjkanje vitaminov, tj. pomanjkanje folne kisline ali vitamina B12 • ilo
is During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment
et Zloraba epoetina pri zdravih osebah lahko čezmerno zviša hemoglobin in hematokrit.
or to prevent clotting of the arterio-venous shunt.
Posledica so lahko smrtno nevarni kardiovaskularni zapleti.
au 4.5 Interaction with other medicinal products and other forms of interaction
o pr Študije o medsebojnem delovanju niso bile izvedene.
No interaction studies have been performed. er ng No interactions have been reported during treatment with Dynepo in the course of clinical trials. lo
Med zdravljenjem z Dynepom v kliničnih preskušanjih ni bilo opisanih medsebojnih delovanj.
4.6 Pregnancy and lactation no
za 4. 6 Nosečnost in dojenje
Caution should be exercised when prescribing to pregnant ct
Morebitno tveganje za ljudi ni znano, moramo pa biti previdni pri predpisovanju zdravila nosečnicam.
In case of its use during pregnancy, concomitant iron substitution should be considered in the mother. du
Pri uporabi med nosečnostjo je treba pretehtati lje sočasno nadomeščanje železa pri materi.
Since many compounds are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding ro
Številne spojine se izločajo v materinem vo mleku, zato je treba Dynepo pri doječih ženskah uporabljati previdno.
4.7 Effects on ability to drive and use machines a
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji do
Dynepo has no or negligible influence on the ability to drive and use machines. in ic
Dynepo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji. ā
Clinical experience with epoetins M
Klinične raziskave z epoetinom kažejo, da je a
suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/ dl.
tveganje v zvezi s zvišanim krvnim tlakom in trombozo mogoče zmanjšati s titracijo odmerka, da m
38 When administration is halted, the eyrthropoietic parameters return toward baseline levels within the recovery period of 1-3 months.
Po prenehanju uporabe se eritropoetski parametri vrnejo na izhodiščno raven v obdobju okrevanja od 1 do 3 mesecev.
Dynepo is not indicated for the management of anaemia associated with cancer.
38 Bolniki, oboleli za rakom Zdravilo Dynepo ni indicirano za obravnavo anemije, ki je povezana z rakom.
ed Survival and tumour progression have been examined in five large controlled studies of epoetin alfa, beta and darbepoetin alfa involving a total of 2,833 patients, of which four were double-blind placebo- controlled studies and one was an open-label study.
Štiri študije so bile dvojno slepe in kontrolirane s placebom, ena pa je bila odprta.
Two of the studies recruited patients who were
V dve študiji so vključili bolnike,
is being treated with chemotherapy.
Ciljna koncentracija hemoglobina v dveh študijah je bila > 13 g/ dl, v ostalih treh pa 12- 14 g/ dL.
or in the remaining three studies it was 12-14 g/ dL.
m so prejemali rekombinantni humanim eritropoetin, in kontrolno skupino.
th four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
pr umrljivost bolnikov, pri katerih je bila anemija povezana z različnimi, pogostimi vrstami raka in ki so prejemali rekombinantni humani eritropoetin, v primerjavi s kontrolno skupino.
au mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
za v kontrolni skupini, ni dalo zadovoljivo razložiti s pomočjo razlik v incidenci tromboze in sorodnih zapletov.
Overall survival outcome in the trials could
a Opravljen je bil tudi sistematični pregled podatkov več kot 9. 000 bolnikov z rakom, ki so sodelovali v
er not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group. ng A systematic review has also been performed involving more than 9000 cancer patients participating lo in 57 clinical trials.
nj 57 kliničnih preskušanjih.
An increased relative risk no
0, 99, 1, 18; 42 preskušanj in 8. 167 lje bolnikov).
of thromboembolic events (RR 1.67, 95% CI:
Pri bolnikih, ki so se zdravili z rekombinantnim humanim eritropoetinom, so ugotovili zvišano relativno tveganje za tromboembolične dogodke (RR 1, 67; 95 -% IZ:
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1, 35, 2, 06, 35 preskušanj vo in 6. 769 bolnikov).
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant ct
To pomeni, da obstajajo trdni dokazi, ki kažejo, da je lahko zdravljenje z rekombinantnim humanim eritropoetinom zelo škodljivo za bolnike z rakom.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve du
V kakšni meri ti rezultati veljajo za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom na kemoterapiji za do
Survival outcomes and tumour progression in ro
V kakšni meri rezultati iz ā
The extent to which the outcomes observed in the clinical studies lp
zgoraj opisanih kliničnih preskušanj veljajo za to populacijo bolnikov ni jasno, zlasti če upoštevamo, ve
discussed above may apply to this patient population is unclear, specifically considering that the dosages administered in the renal indication are lower than in the cancer indication.. a in
da so odmerki, ki se uporabljajo za ledvično indikacijo, nižji od odmerkov, ki so indicirani pri raku.
5.2 Pharmacokinetic properties ic
5. 2 Farmakokinetične lastnosti a m
The pharmacokinetics of erythropoietin following administration of epoetin delta has been examined ed
Farmakokinetiko eritropoetina po uporabi epoetina delta so raziskali pri zdravih prostovoljcih in bolnikih s kronično odpovedjo ledvic.
elimination half-life ranges from 4.7 to 13.2 hours in patients.
Eliminacijski razpolovni čas je pri bolnikih od 4, 7 do 13, 2 ure.
39 5.3 Preclinical safety data
39 Pri nekliničnih študijah je bilo negativne učinke moč zaznati samo pri odmerkih, ki so bili neprimerljivo višji od največje izpostavljenosti pri človeku, kar kaže na majhen pomen za klinično uporabo.
ed Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
natrijev dihidrogenfosfat monohidrat
is Polysorbate 20
et natrijev hidrogenfosfat heptahidrat polisorbat 20
or Sodium chloride Water for injections
m natrijev klorid voda za injekcije
th 6.2 Incompatibilities
o pr 6. 2 Inkompatibilnosti
au In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Ker študije kompatibilnosti še niso bile izvedene, se to zdravilo ne sme mešati z drugimi zdravili.
er products.
za 6. 3 Rok uporabnosti
6.3 Shelf-life 2 years
2 leti
Store in a refrigerator (2 C – 8 C).
a nj 6. 4 Posebna navodila za shranjevanje lje Shranjujte v hladilniku (2 C – 8 C).
Keep the syringes in the outer carton to protect from ct
Injekcijske brizge shranjujte v zunanji ovojnini za zaščitito pred svetlobo. vo
The revised expiry date for storage at below 25oC must not exceed the expiry date set in ro
Spremenjeni rok uporabnosti za do
accordance with the 24 month shelf-life.
shranjevanje brizg izven hladilnika, pri temperaturi, nižji od 25°C, ne sme preseči roka uporabnosti, ki naveden na ovojnini.
Following 5 days storage at below 25oC the pre-filled syringes must be discarded. lp
Če napolnjene injekcijske brizge hranite izven hladilnika, pri temperaturi, nižji od 25°C, jih morate po preteku petih dni zavreči. ā ve
6.5 Nature and contents of container a in
Napolnjene injekcijske brizge iz stekla tipa I z gumijastim zamaškom iz bromobutila, igla dimenzije a
Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with ic
27 (gauge) iz nerjavnega jekla, ki je zaščitena z naravno trdo gumo in polistirenom, bat iz polistirena m
rigid natural rubber and polystyrene needle shield, polystyrene plunger rod and a needle safety guard.
in zaščitni pokrovček za iglo.
Packs of 6 pre-filled syringes are available. ed
Na voljo so pakiranja s 6 napolnjenimi injekcijskimi brizgami. ni
such medicinal product and other handling of the product
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom ilo
When given subcutaneously, the site of injection should be rotated with each administration.
Pri subkutani uporabi je treba mesto injiciranja za vsako aplikacijo izmenično menjati. v ra
It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Zd
This does not
To ne vpliva na uporabo brizge, brizgo pa lahko v pripravi vrtite.
40 affect normal operation of the syringe and the syringe can be rotated in the device.
Vbrizgajte si določeni odmerek.
is or EU/ 1/ 02/ 211/ 010
et EU/ 1/ 02/ 211/ 010
Date of first authorisation:
pr Datum prve pridobitve dovoljenja za promet: