natgillin/translations-raw huggingface dataset:
If a vial is showing damage, syringes for the injection should not be prepared and the injection procedure should be postponed and rescheduled.
Če je viala videti poškodovana, ne smete pripraviti brizg za injiciranje, injiciranje pa je treba prestaviti in bolnika ponovno naročiti.
Following intramuscular administration of Glybera to mice, vector DNA was transiently detected in the circulation.
Po intramuskularnem injiciranju zdravila Glybera pri miših se je DNK vektorja prehodno zaznala v krvnem obtoku.
This information is also provided in the Glybera Patient's Alert Card.
Te informacije vsebuje tudi kartica zdravila Glybera z opozorili za bolnika.
In mice local cellular infiltrates and signs of degeneration and regeneration without necrosis, were seen at the clinical dose in the injected muscle upon histopathological examination.
Pri miših so pri histopatološki preiskavi opazili lokalne celične infiltrate in znake degeneracije ter regeneracije brez nekroze v mišici, v katero je bil injiciran klinični odmerek.
Only clear and colourless solutions without visible particles should be used.
Uporabiti smete samo bistro in brezbarvno raztopino brez vidnih delcev.
Glybera therapy must be prescribed by and administered under the supervision of a physician with expertise in treating LPLD patients and in gene therapy administration, in full consultation with the patient.
Zdravljenje z zdravilom Glybera je treba predpisati in uporabljati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z LPLD in z uporabo genske terapije, pri čemer se mora o podrobnostih posvetovati z bolnikom.
This is the number of injection sites and the total number of syringes (each filled with 0.5ml) required for the patient's treatment.
Tako dobite število mest injiciranja in skupno število injekcijskih brizg (vsaka je napolnjena z 0,5 ml), potrebnih za zdravljenje bolnika.
Glybera should under no circumstances be administered intravascularly (see section 4.4).
Zdravilo Glybera se ne sme nikoli injicirati intravaskularno (glejte poglavje 4.4).
In clinical trials with Glybera, antibodies against the adeno-associated virus (AAV) protein shell were present prior to treatment, in 18 out of 27 subjects; anti-AAV antibodies appeared or increased after Glybera administration, in all of the subjects.
V kliničnih preskušanjih zdravila Glybera so pri 18 od 27 preskušancev ugotovili protitelesa proti beljakovinski kapsuli adenoasociiranega virusa (AAV), protitelesa proti AAV pa so se po uporabi zdravila Glybera pojavila ali povečala pri vseh preskušancih.
Glybera contains sodium and potassium.
Zdravilo Glybera vsebuje natrij in kalij.
From three days prior to and for 12 weeks following Glybera administration an immunosuppressive regimen should be administered: ciclosporin (3 mg/kg/day) and mycophenolate mofetil (2 x 1 g/day) is recommended.
Tri dni pred zdravljenjem z zdravilom Glybera in 12 tednov po njem je treba dajati imunosupresivno terapijo: priporočata se ciklosporin (3 mg/kg/dan) in mofetilmikofenolat (2 x 1 g/dan).
Obligation to conduct post-authorisation measure
Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
In CT-AMT-01102 faeces was also collected.
V študiji CT-AMT-01102 so odvzeli tudi blato.
However in toxicity studies, no increase in tumour was identified.
Študij kancerogenosti niso izvedli, vendar v študijah toksičnosti niso opazili povečanja pogostnosti tumorjev.
They only last a short time.
Izginejo zelo hitro.
Like all medicines, Glybera can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Glybera neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In the event two doses are administered by mistake to the identical injection site this might lead to more local reaction such as bruising or sensitivity.
Če se na isto mesto injiciranja pomotoma injicirata dva odmerka, lahko to povzroči več lokalnih reakcij, kot sta podplutba ali občutljivost.
Intramuscular use
Serija intramuskularna uporaba
T-cell responses against AAV were detected in approximately half of the subjects post therapy only.
Odziv limfocitov T proti AAV se je po zdravljenju zaznal samo pri približno polovici preskušancev.
To ensure intramuscular injection, ultrasound or electrophysiological guidance of injections is advised.
Da zagotovite intramuskularno injiciranje, se priporoča ultrazvočno in elektrofiziološko spremljanje injiciranja.
Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test.
Zdravilo Glybera se sme uporabljati samo, če se je diagnoza LPLD potrdila z ustreznimi genskimi preiskavami.
Blue Box
PODATKI NA ZUNANJI OVOJNINI ŠKATLA „Blue Box“
1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal.
1 ml raztopine v 2-mililitrski (stekleni) viali z injekcijskim zamaškom iz silikoniziranega klorobutila in zaporko.
There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Izkušnje z uporabo zdravila Glybera pri bolnikih z ledvično ali jetrno okvaro so omejene.
Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector.
Alipogentiparvovek vsebuje humano različico gena lipoproteinske lipaze LPLS447X v vektorju.
High levels of vector DNA were observed up to 12 months after dosing in the target tissue for Glybera, injected leg muscle, but not in non-injected muscle.
Visoke ravni DNK vektorja so do 12 tednov po odmerjanju zaznavali v tkivu, na katero je bilo usmerjeno zdravilo Glybera, injicirani nožni mišici, vendar pa tega niso opazili v mišicah, kamor zdravilo ni bilo injicirano.
QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
2.1 Splošen opis
The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X at baseline as well as 6 and 12 months after treatment.
Zdravljenje je treba nadzorovati z merjenjem nevtralizirajočih protiteles in odziva limfocitov T proti AAV1 in LPLS447X ob izhodišču ter 6 in 12 mesecev po zdravljenju.
▼ This medicinal product is subject to additional monitoring.
Za to zdravilo se izvaja dodatno spremljanje varnosti.
Pack size 2 vials
Velikost pakiranja po 2 viali
No neutralising assay was used.
Nevtralizirajoči test se ni uporabil.
Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Zdravilo Glybera je indicirano za odrasle bolnike z diagnozo družinskega pomanjkanja lipoproteinske lipaze (LPLD) in multiplimi napadi pankreatitisa kljub omejevanju vnosa maščobe s hrano.
It is important that at the time of first Glybera administration, your body's immune (defence) system is not activated.
Pomembno je, da vaš imunski sistem v času prve uporabe zdravila Glybera ni aktiviran.
T-cell responses were seen in roughly half of the patients without clinical sequelae.
Odziv limfocitov T brez kliničnih posledic so opazili pri približno polovici bolnikov.
As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Če ste prejeli večji odmerek zdravila Glybera, kot bi smeli Ker vam bo to zdravilo injiciral zdravnik, ni verjetno, da boste prejeli prevelik odmerek.
The opportunity to treat diabetic patients suffering from LPLD should be carefully considered by the physician.
Zdravnik mora skrbno pretehtati možnost zdravljenja sladkornih bolnikov z LPLD.
No data on re-administration of Glybera are available, therefore Glybera should not be re-administered.
Podatkov o ponovni uporabi zdravila Glybera ni, zato se zdravilo Glybera ne sme uporabiti ponovno.
During administration of Glybera appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration.
Med dajanjem zdravila Glybera morajo biti vedno pri roki ustrezna zdravila za zdravljenje in spremljanje, če se po uporabi zdravila pojavi anafilaktični dogodek.
In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered (see section 4.4).
Poleg tega je treba pol ure pred injiciranjem zdravila Glybera uporabiti intravenski bolus z 1 mg/kg metilprednizolona (glejte poglavje 4.4).
The product contains less than 1 mmol (39 mg) potassium per administration of 27-60 injection sites ; i.e. essentially potassium-free.
Zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na uporabo na 27-60 mestih injiciranja, tj. je skoraj brez kalija.
In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed.
V kliničnih študijah so pri posameznih bolnikih opazili prehodno zmanjšanje trigliceridov do 12 tednov.
After the amount of Glybera to be administered has been calculated (see section posology) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Ko se izračuna količina zdravila Glybera, ki jo je treba injicirati (glejte poglavje Odmerjanje), vzemite ustrezno število vial za enkratno uporabo iz zamrzovalnika in počakajte, da se odtajajo na sobni temperaturi (15 °C do 25 °C), približno 30-45 minut pred polnjenjem injekcijskih brizg.
No dose adjustment of Glybera is required.
Prilagajanje odmerka zdravila Glybera ni potrebno.
Present this card to health care professionals (doctor, nurse) upon consultation or hospitalization!
V primeru obiska zdravnika ali hospitalizacije to kartico pokažite zdravstvenemu delavcu (zdravniku, medicinski sestri)!
Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX10.
Farmakoterapevtska skupina: zdravila za zmanjšanje ravni serumskih lipidov, druga zdravila za zmanjšanje ravni holesterola in serumskih lipidov, oznaka ATC: C10AX10.
What Glybera looks like and contents of the pack
Izgled zdravila Glybera in vsebina pakiranja
• It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant.
• Če ste noseči, menite, da bi bili lahko noseči, ali načrtujete zanositev, se posvetujte z zdravnikom.
Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg body weight.
Vsako za bolnika specifično pakiranje vsebuje zadostno količino vial za odmerjanje 1 x 1012 gk/kg telesne mase bolnika.
People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should not drink alcohol.
Priporočljivo je, da ljudje z diagnozo pomanjkanja lipoproteinske lipaze skrbno upoštevajo dieto pred zdravljenjem z zdravilom Glybera in po njem ter se izogibajo alkoholu.
Glybera is used to treat a specific inherited condition known as “lipoprotein lipase deficiency (LPLD)”.
Zdravilo Glybera se uporablja za zdravljenje dedne bolezni, imenovane „pomanjkanje lipoproteinske lipaze (LPLD)“.
Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test (see section 5.1).
4.2 Odmerjanje in način uporabe Zdravilo Glybera se sme uporabljati samo, če se je diagnoza LPLD potrdila z ustreznimi genskimi preiskavami (glejte poglavje 5.1).
After time, residual vector DNA levels remained high in the injected muscle and inguinal lymph nodes while decreasing steadily in the other organs.
Rezidiualne ravni DNK vektorja so ostale visoke v injicirani mišici in dimeljskih bezgavkah, medtem ko so se v drugih organih enakomerno zniževale.
Very limited data on pregnancies exposed to Glybera is available.
Podatki o nosečnicah, izpostavljenih zdravilu Glybera, so zelo omejeni.
Glybera Patient Alert Card
Glybera Kartica z opozorili za bolnika
Glybera is authorised for single treatment only.
Zdravilo Glybera je odobreno samo za enkratno zdravljenje.
Male patients, including vasectomised males, are advised to practise barrier contraception methods for at least 12 months following Glybera administration.
Pri moških bolnikih, vključno z bolniki, pri katerih je bila opravljena vazektomija, se priporoča uporaba pregradnih kontracepcijskih metod vsaj 12 mesecev po injiciranju zdravila Glybera.
If not stored in a refrigerator the medicinal product can be stored in syringes at not more than 25°C, and protected from light for a maximum of 8 hours.
Če se zdravilo ne shranjuje v hladilniku, se lahko največ 8 ur shranjuje v injekcijskih brizgah, zaščitenih pred svetlobo, pri temperaturi do 25 °C.
Standard genetic analysis (sequencing) was used in the clinical studies of Glybera.
V kliničnih študijah zdravila Glybera se je uporabila standardna genetska analiza (določanje zaporedja).
There is the theoretical risk that the co-administration of the immunosuppressant regime leads to longer persistence of virus DNA in serum and as well to longer shedding in saliva, urine and semen.
Obstaja teoretično tveganje, da sočasna uporaba imunosupresivnega režima povzroči daljšo persistenco DNK
The European Medicines Agency has waived the obligation to submit the results of studies with Glybera in all subsets of the paediatric population in the treatment of lipoprotein lipase deficiency (see section 4.2 for information on paediatric use).
Glybera za vse podskupine pediatrične populacije za zdravljenje pomanjkanja lipoproteinske lipaze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF
IME ZDRAVILA IN POT(I) UPORABE
It is not known whether Glybera is excreted in human milk.
Ni znano, ali se zdravilo Glybera izloča v materino mleko.
From the triglyceride data the 1 x 1012 gc/kg dose appears the most optimal.
Glede na podatke o trigliceridih se zdi, da je najoptimalnejši odmerek 1 x 1012 gk/kg.
• Hypersensitivity to the active substance or any of the excipients of Glybera listed in section
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov zdravila Glybera,
Immunosuppressant co-treatment did not influence the biodistribution pattern neither at low dose nor at high dose in mice.
Sočasno imunosupresivno zdravljenje v majhnih in velikih odmerkih ni vplivalo na vzorec biološke porazdelitve pri miših.
This medicine contains genetically modified organisms.
To zdravilo vsebuje gensko spremenjene organizme.
• Information about the signs and symptoms to be monitored after treatment including:
• Informacije o znakih in simptomih, ki jih je treba spremljati po zdravljenju, vključno z: o informacijami o znakih in simptomih zmanjšanja/izgube učinkovitosti;
VIAL LABEL
OVOJNINAH OZNAKA NA VIALI
• Advice on the need to continue on a low-fat diet and avoid drinking alcohol
• Svetovanje o potrebi po nadaljevanju diete z majhnim vnosom maščob in potrebi po
Spinal or regional anaesthesia is advised prior to intramuscular administration, due to the number of injections required.
Pred intramuskularnim injiciranjem se zaradi velikega števila injiciranj priporoča spinalna ali regionalna anestezija.
Eight days after administration, high levels of vector DNA sequence were detected in injected muscle and the draining lymph nodes.
Osem dni po injiciranju so v injiciranih mišicah in mezgovnih bezgavkah ugotovili visoke ravni zaporedja DNK vektorja.
Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Ob prevelikem odmerjanju je priporočeno simptomatsko in podporno zdravljenje, ki ga določi lečeči zdravnik.
Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 LPLS447X gc/kg bodyweight.
Vsako za bolnika specifično pakiranje vsebuje zadostno količino vial za odmerjanje 1 x 1012 LPLS447X
There is very limited information about the safety of Glybera in pregnant women.
Podatki o varnosti zdravila Glybera pri nosečnicah so zelo omejeni.
Patient Alert Card
Kartica z opozorili za bolnika
The clear to slightly opalescent and colourless solution must be free of visible particles.
Bistra do rahlo opalescentna in brezbarvna raztopina ne sme vsebovati vidnih delcev.
In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered.
Poleg tega je treba pol ure pred injiciranjem zdravila Glybera uporabiti intravenski bolus z 1 mg/kg metilprednizolona.
Clinical pharmacokinetics and shedding
Klinična farmakokinetika in razsejanje
This medicine contains potassium, less than 1 mmol (39 mg) per administration at 27 injection sites to 60 injection sites, i.e. essentially ‘potassium-free'.
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na uporabo na 27 do 60 mestih injiciranja, tj. je skoraj „brez kalija“.
• Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease (such as myositis), must not be treated in view of the large number of intramuscular injections
• Bolniki s povečanim tveganjem za krvavitev (kot je trombocitopenija) in mišično boleznijo
Correction of bleeding parameters should be instituted prior to Glybera administration.
Pred uporabo zdravila Glybera je treba popraviti parametre krvavitve.
Therefore, use of barrier contraception methods for at least 12 months following Glybera administration is recommended.
Uporaba pregradnih kontracepcijskih sredstev se zato priporoča vsaj 12 mesecev po injiciranju zdravila Glybera.
Posology The maximum total dose of Glybera for administration is 1 x 1012 gc/kg body weight.
Odmerjanje Največji skupni odmerek zdravila Glybera za administracijo je 1 x 1012 gk/kg telesne mase.
The MAH shall set up a disease registry to collect information on the epidemiology of the disease and the demographics, safety and effectiveness outcomes of patients with familial LPLD treated with Glybera.
Imetnik dovoljenja za promet z zdravilom bo vzpostavil register bolezni, s katerim bo zbiral podatke o epidemiologiji bolezni in izidih glede demografije, varnosti ter učinkovitosti pri bolnikih z družinskim
The patient-specific pack contains a variable number of casings based on the patient's body weight.
Za bolnika specifično pakiranje vsebuje različno število ovojev, ki je odvisno od bolnikove telesne mase.
Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Vsaka viala alipogentiparvoveka vsebuje 1 ml raztopine, ki vsebuje 3 x 1012 genomskih kopij (gk).
All patients treated with Glybera shall be enrolled in the registry.
V register se bodo vključili vsi bolniki, ki se bodo zdravili z zdravilom Glybera.
After administration of Glybera to the participants, the highest vector DNA concentrations were detected in the serum, with clearance by one to two logs per week.
DNK vektorja zaznali v serumu, z očistkom enega do dveh logaritmov na teden.
Potassium dihydrogen phosphate Sodium chloride
kalijev klorid kalijev dihidrogenfosfat natrijev klorid dinatrijev fosfat saharoza voda za injekcije
Glybera will be given to you in a single therapy administration session in a hospital.
Zdravilo Glybera boste prejeli kot enkratno zdravljenje v bolnišnici.
The final outer carton contains a variable number of casings according to the patient specific dose required.
Zunanja škatla vsebuje različno število ovojev, kar je odvisno od odmerka, ki ga potrebuje posamezni bolnik.
Product manufacturer and license holder: uniQure biopharma B.V.
Izdelovalec zdravila in imetnik licence: uniQure biopharma B.V.
• A medicine impacting blood coagulation e.g. acetylsalicylic acid (e.g.aspirin), a substance present in many medicines used to relieve pain and lower fever, as well as medicines used to prevent blood clotting eg anticoagulants such as warfarin, heparin.
• Zdravila, ki vplivajo na strjevanje krvi, npr. acetilsalicilna kislina (npr. Aspirin), ki je prisotna v mnogih zdravilih za lajšanje bolečine in zniževanje povišane telesne temperature, ter zdravila, ki se uporabljajo za preprečevanje strjevanja krvi, npr. antikoagulanti, kot sta Teh zdravil ne smete jemati vsaj en teden pred injiciranjem v nogo ali en dan po njem.
Vials must be stored and transported frozen at -25ºC to -15ºC.
Viale je treba shranjevati in prevažati zamrznjene pri temperaturi -25 °C do -15 °C.
Immunosuppressants (see section 5.2) Immediately prior to initiation of the immunosuppressant regimen and prior to Glybera injection the patient must be checked for symptoms of active infectious disease of any nature, and in case of such infection the start of treatment must be postponed until after the patient has recovered.
Tik pred uvedbo imunosupresivnega režima in pred injiciranjem zdravila Glybera je treba preveriti, ali ima bolnik simptome aktivne okužbe kakršnega koli tipa.
Glybera is injected as a one-time series into the muscle of the lower extremities where it is taken up by myocytes.
Zdravilo Glybera se injicira kot enkratni niz injiciranj v mišico na spodnjih okončinah, kjer ga privzamejo miociti.
Renal impairment or hepatic impairment
Ledvična ali jetrna okvara
Breast-feeding is not recommended during treatment with Glybera.
Med zdravljenjem z zdravilom Glybera dojenje ni priporočeno.
Diabetic patients
Starejši bolniki
No drug-related serious adverse events occurred and no dose-limiting toxicity was observed.
Pojavili se niso nobeni resni neželeni učinki, povezani z zdravilom.
Hair growth abnormal, Palmar-plantar erythrodysaesthesia syndrome, Rash
Bolezni kože in podkožja nenormalna rast dlak, sindrom eritrodisestezije dlani in stopal, izpuščaj
With the exception of a case of fever (39.9 °C) in study CT-AMT-011-01 which reversed within a day, no Glybera or immunosuppression related serious adverse events occurred.
Pojavili se niso nobeni resni neželeni učinki, povezani z zdravilom Glybera ali imunosupresijo, razen enega primera povišane telesne temperature (39,9 °C) v študiji CT-AMT-011-01, ki je izginila v enem dnevu.
Pain in extremity Arthritis, Limb discomfort, Muscle spasms, Muscle strain, Musculoskeletal stiffness, Myalgia, Muscle pain, Neck pain, Sensation of heaviness, Acute myositis and chronic myositis
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v udu artritis, neugodje v udu, mišični spazmi, napetost mišic, mišično-skeletna togost,
Chills, Injection site pain, Oedema peripheral, Pyrexia
periferni edem, pireksija
To calculate the number of vials, the patient's weight is determined to the nearest whole kg.
Pri izračunu števila vial se bolnikova telesna masa zaokroži na najbližji kilogram.
Subjects also received a daily oral dose of 3 mg/kg/day cyclosporine and 2 g/day of mycophenolate mofetil starting three days before administration of alipogene tiparvovec through week 12.
mg/kg/dan ciklosporina in 2 g/dan mofetilmikofenolata , kar se je začelo tri dni pred injiciranjem alipogentiparvoveka in trajalo do 12. tedna.
- You should present this card to your health care professionals (doctor, nurse) upon consultation or hospitalisation.
- V primeru obiska zdravnika ali hospitalizaciji morate to kartico pokazati zdravstvenemu delavcu(zdravniku, medicinski sestri).
No T-cell response to LPL was detected in any subject.
Pri nobenem preskušancu se ni ugotovil odziv limfocitov T proti LPL.
• Information on the need for long term follow-up for Glybera, including the registry
• Informacije o potrebi po dolgotrajnem sledenju zdravljenja z zdravilom Glybera, vključno z • Informacije o potrebi po preprečevanju nosečnosti
Individual lot number: Date of treatment:
Številka posamezne serije:
Manufacturer uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Izdelovalec uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
• The necessity to carry the patient alert card, that is included in each pack, with them at all
• Nujnost, da ima bolnik vedno pri sebi kartico z opozorili za bolnika, priloženo vsakemu
Non-clinical biodistribution
Predklinična biološka porazdelitev
There is limited experience in the use of Glybera in elderly subjects.
Izkušnje z uporabo zdravila Glybera pri starejših bolnikih so omejene.
• Guidance on the aftercare of the patient including monitoring for fever
• Smernice o negi bolnika po injiciranju, vključno s preverjanjem, ali ima bolnik povišano telesno temperaturo
Store frozen at -25°C to -15°C.
Shranjujte zamrznjeno pri temperaturi -25 °C do -15 °C.