natgillin/translations-raw huggingface dataset:
Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 ml sterile water for injections, yielding a deliverable volume of 0.5 ml.
Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0, 72 ml sterilne vode za injekcije, s čimer dobimo 0, 5 ml uporabne količine.
The reconstituted solution should be clear and colourless and should not be administered if particulate matter and/ or discolouration are observed.
Če opazite delce in/ ali spremembo barve, raztopine ne smete uporabiti.
For the storage condition of the reconstituted product see section 6.3.
Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6. 3.
Any unused product or waste material should be disposed of in accordance with local requirements.
12 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
After reconstitution, a deliverable volume of 1 ml solution contains 500 µg of romiplostim (500 µg/ ml).
Po pripravi uporabna količina 1 ml raztopine vsebuje 500 µg romiplostima (500 µg/ ml).
An additional overfill is included in each vial to ensure that 500 µg of romiplostim can be delivered.
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 µg romiplostima.
Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e. g. corticosteroids, immunoglobulins).
Nplate je indiciran pri odraslih splenektomiranih bolnikih s Nplate je indiciran za zdravljenje kronične imunske (idiopatične) trombocitopenične purpure (ITP) pri odraslih splenektomiranih bolnikih, ki se niso ustrezno odzvali na druga zdravila (npr. kortikosteroide, imunoglobuline).
Example:
14 Primer:
14 *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
* Za izračun odmerka romiplostima morate vedno uporabiti dejansko telesno maso na začetku zdravljenja.
Elderly patients (≥ 65 years)
15 Starejši bolniki (≥ 65 let)
15 Children and adolescents (< 18 years)
Otroci in mladostniki (< 18 let)
It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
V primeru prenehanja zdravljenja z romiplostimom je priporočljivo, da začnete ITP znova začeti zdraviti skladno z veljavnimi terapevtskimi smernicami.
If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed.
Če se učinkovitost ohrani, pojavi pa se nenormalen razmaz periferne krvi, je treba slediti ustrezni klinični presoji: v poštev pride biopsija kostnega mozga in znova je treba oceniti tveganje in koristi uporabe romiplostima ter pretehtati alternativne možnosti zdravljenja ITP.
Thrombotic/ thromboembolic complications
16 Trombotični/ trombembolični zapleti
16 Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS)
Napredovanje obstoječih hematopoetskih malignomov ali mielodisplastičnega sindroma (MDS)
Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).
V primeru zmanjševanja ali prekinitve drugih zdravil za ITP je treba redno spremljati število trombocitov, da se ne bi zmanjšalo pod priporočeni razpon (glejte poglavje 4. 2).
Studies in animals have shown reproductive toxicity, such as transplacental passage and increased foetal platelet counts in rats (see section 5.3).
17 Študije na živalih so pokazale reproduktivne toksične učinke, npr. prehajanje skozi placento in večje število trombocitov pri plodovih podgan (glejte poglavje 5. 3).
17 A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with romiplostim should be made taking into account the benefit of breast-feeding to the child and the benefit of romiplostim therapy to the woman.
Pri odločitvi za nadaljevanje/ prekinitev dojenja oz. za nadaljevanje/ prekinitev terapije z romiplostimom je treba upoštevati korist dojenja za otroka in korist zdravljenja z romiplostimom za mater.
18 MedDRA system organ class General disorders and administration site conditions
18
In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
Pri 6 nadaljnih bolnikih so retikulin ugotovili z biopsiio kostnega mozga (glejte poglavje 4. 4).
19 In the event of overdose, platelet counts may increase above the normal range.
19 Po prevelikem odmerjanju se lahko število trombocitov poveča nad normalne vrednosti.
20 platelet response.
20 ugotavljali s povečanjem deleža bolnikov, ki so dosegli trajen odziv trombocitov.
21
33%)
Study 1
74%)
Study 2
vrednost p
Combined
0, 001
splenectomised patients
0, 0175
studies 1 & 2
< 0, 0001
(%) patients with durable
(%) bolnikov s trajnim odzivom trombocitov s stabilnim odmerkome
Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products. d Rescue therapies defined as any therapy administered to raise platelet counts.
21 kakršnekoli rešilne terapije. d Za rešilno terapijo velja vsaka terapija, uvedena z namenom povečanja števila trombocitov.
In both placebo-controlled, double-blind studies, patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the study (corticosteroids, danazol and/ or azathioprine).
V obeh s placebom kontroliranih, dvojno slepih študijah so lahko bolniki, ki so že dobivali zdravila za ITP po stalni odmerni shemi, ta zdravila ves čas študije jemali še naprej (kortikosteroidi, danazol in/ ali azatioprin).
The serum concentrations varied among patients and did not correlate with the dose administered.
Koncentracija v serumu se je med bolniki razlikovala in bila v sorazmerju z uporabljenim odmerkom.
Elimination
22 Odstranjevanje
Additionally, in the phase 3 pivotal studies, romiplostim did not affect the red blood cell and white blood cells lineages relative to placebo treated subjects.
V dolgotrajnejši kronični študiji pri opicah so romiplostim uporabljali 6 mesecev, pri čemer so dajanje zmanjšali iz trikrat na teden na enkrat na teden; med to 6- mesečno študijo niso ugotovili vpliva na eritroidno in levkocitno vrsto Poleg tega romiplostim v ključnih študijah 3. faze pri preiskovancih v primerjavi s placebom ni vplival na rdečo in belo celično vrsto.
Mannitol (E421) Sucrose L-histidine Hydrochloric acid (for pH adjustment) Polysorbate 20
23 L- histidin Klorovodikova kislina (za prilagoditev pH) Polisorbat 20
Carton containing 1 or 4 vials of 500 µg of romiplostim.
Škatla, ki vsebuje 1 ali 4 viale s 500 µg romiplostima.
24 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 ml sterile water for injections, yielding a deliverable volume of 1 ml.
Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1, 2 ml sterilne vode za injekcije, s čimer dobimo 1 ml uporabne količine.
Any unused product or waste material should be disposed of in accordance with local requirements.
24 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Amgen Inc One Amgen Center Drive Thousand Oaks, CA 91320 USA
Amgen Inc One Amgen Center Drive Thousand Oaks, CA 91320 ZDA
5550 Airport Boulevard Boulder, CO 80301 USA
5550 Airport Boulevard Boulder, CO 80301 ZDA
4000 Nelson Road Longmont, CO 80503 USA
4000 Nelson Road Longmont, CO 80503 ZDA
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: • Educational material • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Takšen program mora izvesti na nacionalni ravni, da bodo pred predpisovanjem zdravila vsi zdravniki dobili informacijski komplet za zdravstveno osebje, ki vsebuje: • Izobraževalno gradivo • Povzetek glavnih značilnosti zdravila (SmPC) in navodilo za uporabo
27 of action of reticulin deposition in response to romiplostim.
27
The incidence in clinical trials of thrombotic/ thromboembolic complications.
Incidenco trombotičnih/ trombemboličnih zapletov v kliničnih preskušanjih.
Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Ponoven poudarek, da koristi in tveganja zdravljenja trombocitopenije niso ugotovljen pri bolnikih brez ITP.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3, dated 26 June 2008 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 vzpostavljen sistem farmakovigilance (opisan v verziji 3 z datumom 26. junij 2008, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet), ki mora delovati pred in med časom trženja z zdravilom.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5, dated 14 November 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Te so podrobno opisane v načrtu farmakovigilance, kot je dogovorjen v verziji 5 (z datumom 14. november 2008) načrta o obvladovanju tveganja (NOT), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet, ter morebitnih poznejših posodobitvah NOT, v dogovoru z Odborom za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP o sistemih upravljanja s tveganji za zdravila za uporabo v humani medicini je treba posodobljeni NOT vložiti hkrati z naslednjim periodičnim posodobljenim varnostnim poročilom (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljeni NOT vložiti, kadar so prejete nove informacije, ki bi lahko vplivale na veljavno specifikacijo varnosti, • farmakovigilančni načrt ali dejavnosti za minimizacijo tveganja v 60 dneh po tem, ko je bil dosežen pomemben mejnik (farmakovigilančni ali za minimizacijo • tveganja), na zahtevo EMEA •
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 micrograms of romiplostim (500 micrograms/ ml).
Po pripravi vsebuje uporabna količina 0, 5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ ml).
Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Manitol (E421), saharoza, l- histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
4 vials.
4 viale.
24 hours when stored at 25°C or in a refrigerator (2°C – 8°C) if kept in the original vial and protected from light.
24 ur v primeru shranjevanja pri 25 °C ali v hladilniku (2 °C do 8 °C), če je zdravilo v originalni viali in zaščiteno pred svetlobo.
Nplate 250 µg powder for injection romiplostim SC
Nplate 250 µg prašek za injiciranje romiplostim s. c.
After reconstitution, a deliverable volume of 1 ml solution contains 500 micrograms of romiplostim (500 micrograms/ ml).
Po pripravi vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ ml).
Nplate 500 µg powder for injection romiplostim SC
Nplate 500 µg prašek za injiciranje romiplostim s. c.
Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection Romiplostim
Nplate 250 mikrogramov prašek za raztopino za injiciranje Nplate 500 mikrogramov prašek za raztopino za injiciranje Romiplostim
What Nplate is and what it is used for 2.
Kaj je zdravilo Nplate in za kaj ga uporabljamo 2.
Before you use Nplate 3.
Kaj morate vedeti, preden boste uporabili zdravilo Nplate 3.
How to use Nplate 4.
Kako uporabljati zdravilo Nplate 4.
How to store Nplate 6.
Shranjevanje zdravila Nplate 6.
WHAT NPLATE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NPLATE IN ZA KAJ GA UPORABLJAMO
Nplate is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP).
Zdravilo Nplate je beljakovina, ki jo uporabljamo za zdravljenje premajhnega števila trombocitov pri bolnikih z imunsko (idiopatično) trombocitopenično purpuro (ki jo s kratico označujemo ITP).
ITP is a disease in which your body’ s immune system destroys its own platelets.
ITP je bolezen, pri kateri telesni imunski sistem uničuje svoje lastne trombocite.
Nplate is used to treat adult patients (aged 18 years and over) who have had their spleen removed for chronic ITP and who have been previously treated with corticosteroids or immunoglobulins, where these drugs don ’ t work.
Zdravilo Nplate uporabljamo za zdravljenje odraslih bolnikov (starih 18 let in več), ki so jim zaradi kronične ITP odstranili vranico in so pred tem dobivali kortikosteroide ali imunoglobuline, ki pri njih niso učinkoviti.
Nplate may also be used in previously treated adult patients (aged 18 years and over) with chronic ITP in whom surgery is not an option.
Zdravilo Nplate se lahko uporabi tudi pri odraslih bolnikih (starih18 let in več) s kronično ITP, pri katerih odstranitev vranice ne pride v poštev.
BEFORE YOU USE NPLATE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO NPLATE
DO NOT use Nplate
NE UPORABLJAJTE zdravila Nplate
• if you are allergic (hypersensitive) to romiplostim or to any of the other ingredients of Nplate.
• če ste preobčutljivi na (alergični na) romiplostim ali katerokoli sestavino zdravila Nplate.
• if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
• če ste preobčutljivi na druga zdravila, pridobljena s tehnologijo DNA in uporabo mikroorganizmov Escherichia coli (E. coli).
Take special care with Nplate
Bodite posebno pozorni pri uporabi zdravila Nplate
• If you stop taking Nplate a low blood platelet count (thrombocytopenia) is likely to reoccur.
če nehate jemati zdravilo Nplate, se bo premajhno število trombocitov (trombocitopenija) • verjetno znova pojavilo.
If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
Spremljati vam bo treba število trombocitov in zdravnik se bo z vami pogovoril o ustreznih previdnostnih ukrepih.
38 • If you have very high blood platelet counts, as this may increase the risk of blood clotting.
38 če imate zelo veliko trombocitov v krvi, ker to lahko poveča tveganje za nastanek krvnih • strdkov.
If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding.
Če jemljete tudi zdravila za preprečevanje nastanka krvnih strdkov (antikoagulantna ali antiagregacijska sredstva), obstaja večje tveganje za krvavitve.
If you are taking corticosteroids, danazol, and/ or azathioprine these may be reduced or stopped when given together with Nplate.
Če jemljete kortikosteroide, danazol in/ ali azatioprin, vam bodo med sočasno uporabo zdravila Nplate njihov odmerek morda zmanjšali ali jih celo povsem opustili.
It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Pomembno je, da zdravnika obvestite, če ste noseči, mislite, da ste noseči, ali nameravate zanositi.
You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Nekateri neželeni učinki namreč lahko poslabšajo vašo sposobnost za varno izvajanje teh dejavnosti.
HOW TO USE NPLATE
KAKO UPORABLJATI ZDRAVILO NPLATE
Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Zdravilo Nplate boste prejeli pod nadzorstvom svojega zdravnika, ki bo natančno kontroliral dano količino zdravila Nplate.
Nplate is administered as an injection under the skin (subcutaneous).
Zdravilo Nplate uporabljamo z injiciranjem pod kožo (subkutano injiciranje).
If you have been given more Nplate than you should, contact your doctor immediately.
Če ste dobili več zdravila Nplate, kot bi smeli, se takoj posvetujte z zdravnikom.
It is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Priporočljivo je, da vas klinično spremljajo glede znakov in simptomov neželenih učinkov in da ste takoj deležni ustreznega zdravljenja.
39 If you forget to use Nplate
39 Če ste pozabili uporabiti zdravilo Nplate
Like all medicines, Nplate can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Nplate neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects (seen in more than 1 in 10 people taking Nplate): • headache.
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 oseb, ki dobivajo zdravilo Nplate): • glavobol.
Common side effects (seen in more than 1 in 100 people taking Nplate): • bone marrow disorder, including increased bone marrow fibres (reticulin); • trouble sleeping (insomnia); • dizziness; • tingling or numbness of the hands or feet (paraesthesia); • migraine; • redness of the skin (flushing); • blood clot in a lung artery (pulmonary embolism); • nausea; • diarrhoea; • abdominal pain; • indigestion (dyspepsia); • constipation; • itching of the skin (pruritis); • bleeding under the skin (ecchymosis); • bruising (contusion); • rash; • joint pain (arthralgia); • muscles pain or weakness (myalgia); • pain in your hands and feet; • muscle spasm; • back pain; • bone pain; • tiredness (fatigue); • injection site bruising; • injection site pain; • injection site swelling; • swelling in the hands and feet (oedema peripheral); • flu like symptoms (influenza like illness); • pain; • weakness (asthenia); • fever (pyrexia); • chills; • contusion; • low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia) after stopping Nplate; • higher than normal platelet counts (thrombocytosis).
Pogosti neželeni učinki (pojavijo se pri več kot 1 od 100 oseb, ki dobivajo zdravilo Nplate): • motnja kostnega mozga, vključno s povečanim nastajanjem vlaken kostnega mozga (retikulin), • težave s spanjem (nespečnost), • omotica, • mravljinčenje ali omrtvelost rok ali nog (parestezije), • migrena, • pordelost kože (zardevanje), • krvni strdek v pljučni arteriji (pljučna embolija), • siljenje na bruhanje, • driska, • bolečine v trebuhu, • težave z želodcem (dispepsija), • zaprtje, • srbenje kože (pruritus), • krvavitve pod kožo (ekhimoze), • podplutbe, • izpuščaj, • bolečine v sklepih (artralgija), • bolečine v mišicah ali šibkost mišic (mialgija), • bolečine v rokah in nogah, • mišični spazem, • bolečine v hrbtu, • bolečine v kosteh, • utrujenost (izčrpanost), • podplutba na mestu injiciranja, • bolečina na mestu injiciranja, • oteklost na mestu injiciranja, • oteklost rok in nog (periferni edemi), • gripi podobni bolezenski znaki (gripi podobna bolezen), • bolečine, • šibkost (astenija), • zvišana telesna temperatura (pireksija), • mrzlica, • udarnina, • nizko število trombocitov (trombocitopenija) in nizko število trombocitov (trombocitopenija) po prenehanju uporabe zdravila Nplate, • število trombocitov, večje od normalnega (trombocitoza).
40 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
40 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE NPLATE
SHRANJEVANJE ZDRAVILA NPLATE
Do not use Nplate after the expiry date which is stated on the carton and vial label after EXP.
Zdravila Nplate ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale za oznako "Upor. do." in "EXP".
Each vial of Nplate 250 micrograms powder for solution for injection contains 250 micrograms of romiplostim.
Ena viala Nplate 250 mikrogramov prašek za raztopino za injiciranje vsebuje 250 mikrogramov romiplostima.
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 micrograms of romiplostim (500 micrograms/ ml).
Po pripravi vsebuje uporabna količina 0, 5- ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ ml).
Each vial of Nplate 500 micrograms powder for solution for injection contains 500 micrograms of romiplostim.
Ena viala Nplate 500 mikrogramov prašek za raztopino za injiciranje vsebuje 500 mikrogramov romiplostima.
After reconstitution, a deliverable volume of 1 ml solution contains 500 micrograms of romiplostim (500 micrograms/ ml).
Po pripravi vsebuje uporabna količina 1- ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ ml).
- The other ingredients are mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH
- Pomožne snovi so manitol (E421), saharoza, L- histidin, klorovodikova kislina (za prilagoditev
adjustment) and polysorbate 20.
pH) in polisorbat 20.
Nplate is a white powder for solution for injection supplied in a 5 ml glass vial.
Zdravilo Nplate je bel prašek za raztopino za injiciranje v 5- ml stekleni viali.
Marketing Authorisation Holder and Manufacturer Amgen Europe B. V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Amgen Europe B. V.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
41 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Kύπρος Amgen Ελλάς Φαρμακευτικά Ε .Π .Ε.
42 Kύπρος Amgen Ελλάς Φαρμακευτικά Ε. Π. Ε.
This leaflet was last approved in {MM/ YYYY}.
LLLL}.
Nplate should be reconstituted in accordance with good aseptic practice.
Nplate je treba pripraviti skladno z dobro aseptično prakso.
• Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 ml sterile water for injections, yielding a deliverable volume of 0.5 ml.
• Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0, 72 ml sterilne vode za injekcije, s čimer dobimo 0, 5 ml uporabne količine.
An additional overfill is included in each vial to ensure that 250 µg of romiplostim can be delivered. or • Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 ml sterile water for injections, yielding a deliverable volume of 1 ml.
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 µg romiplostima. ali • Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1, 2 ml sterilne vode za injekcije, s čimer dobimo 1 ml uporabne količine.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 25°C or 24 hours in a refrigerator (2°C – 8°C), protected from light.
Čas običajno ne sme presegati 24 ur pri temperaturi 25 °C ali 24 ur v hladilniku (2 °C do 8 °C), zaščiteno pred svetlobo.
43 ANNEX IV
43 DODATEK IV
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, KI MORAJO BITI ZAGOTOVLJENI S STRANI DRŽAVE ČLANICE