FrancophonIA/ELRC3.0 huggingface dataset:
English: The solution should be protected from light until the end of administration.
Slovenian: Raztopino je treba do konca dajanja zaščititi pred sončno svetlobo.
English: A repeat course of Carmustine Obvius should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3, leukocytes above 4,000/mm3), and this is usually in six weeks.
Slovenian: Ponovni cikel zdravljenja z zdravilom Karmustin Obvius se ne sme začeti, dokler se niso elementi krvi v obtoku vrnili na sprejemljive ravni (trombociti nad 100 000/mm3, levkociti nad
English: On one hand, their carbamoylating activity was reported to contribute to the cytotoxic properties of their parent drugs by inhibiting DNA repair enzymes.
Slovenian: Po eni strani naj bi njihovo karbamoilirajoče delovanje z zaviranjem encimov za popravljanje DNA prispevalo k citotoksičnim lastnostim matičnega zdravila.
English: Liver, kidney and lung function should be checked and monitored regularly during therapy (see section 4.8).
Slovenian: Med zdravljenjem je treba redno spremljati in nadzorovati delovanje jeter, ledvic in pljuč (glejte poglavje 4.8).
English: The resulting ready-to-use solution for infusion should then be administered immediately by intravenous drip over a one- to two-hour period protected from light.
Slovenian: Nastalo, za uporabo pripravljeno raztopino za infundiranje je treba nato takoj intravensko infundirati s kapalno infuzijo eno do dve uri, zaščiteno pred svetlobo.
English: The following table includes adverse reactions of carmustine listed by MedDRA system organ class and frequency convention presented in order of decreasing seriousness: 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), not known (frequency cannot be estimated from the available data).
Slovenian: 1/100), redki (od ≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000) in neznana pogostnost (iz razpoložljivih podatkov je ni mogoče oceniti).
English: Paediatric population Carmustine is contraindicated in children and adolescents aged <18 years (see section 4.3)
Slovenian: Karmustin je kontraindiciran pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 4.3.).
English: Avoid skin contact with concentrate for solution for infusion.
Slovenian: Izogibajte se stiku koncentrata za raztopino za infundiranje s kožo.
English: Not known Infertility, teratogenesis.
Slovenian: Neplodnost, teratogenost.
English: This may occur within 3 years of therapy and appears to be dose related with cumulative doses of 1,200-1,500 mg/m2 being associated with increased likelihood of lung fibrosis.
Slovenian: Ta se lahko pojavi v treh letih po zdravljenju in se zdi povezana z odmerkom, pri čemer so z večjo verjetnostjo za fibrozo pljuč povezani kumulativni odmerki od 1 200 do 1 500 mg/m2.
English: The Ready-to-Use solution should be administered over 1-2 hours and administration should be finalised within 3 hours from reconstitution of the product.
Slovenian: Za uporabo pripravljeno raztopino je treba dajati od ene do dve uri, dajanje pa končati v treh urah od rekonstitucije zdravila.
English: Risk factors include smoking, the presence of a respiratory condition, pre-existing radiographic abnormalities, sequential or concomitant thoracic irradiation and association with other agents that cause lung damage.
Slovenian: Dejavniki tveganja vključujejo kajenje, prisotnost bolezni dihal, predhodne radiografske nepravilnosti, zaporedno ali sočasno obsevanje prsnega koša in povezanost z drugimi učinkovinami, ki povzročajo okvaro pljuč.
English: Baseline pulmonary function studies and chest X-ray should be conducted along with frequent pulmonary function tests during treatment.
Slovenian: Ob začetku zdravljenja je treba opraviti preiskave pljučne funkcije in rentgensko slikanje prsnega koša, nato pa še pogoste teste pljučne funkcije med zdravljenjem.
English: One pack contains one vial with 100 mg of powder for concentrate for solution for infusion and one ampoule with 3 ml of solvent.
Slovenian: Eno pakiranje vsebuje eno vialo s 100 mg praška za koncentrat za raztopino za infundiranje in eno ampulo s 3 ml vehikla.
English: The injected area should be monitored during the administration.
Slovenian: Injicirani predel je treba med dajanjem zdravila opazovati.
English: The Carmustine Obvius powder for concentrate for solution for infusion contains no preservative and is not intended as multiple dose vial.
Slovenian: Zdravilo Karmustin Obvius prašek za koncentrat za raztopino za infundiranje ne vsebuje konzervansov in ni namenjen kot viala za večkratno odmerjanje.
English: Paediatric population Carmustine must not be used in children aged <18 years because of safety concerns.
Slovenian: Zaradi pomislekov o varnosti se karmustin ne sme uporabljati pri otrocih, mlajših od 18 let.
English: Gynecomastia.
Slovenian: Ginekomastija.
English: After reconstitution and dilution, one mL of solution contains 3.3 mg carmustine.
Slovenian: Po rekonstituciji in redčenju vsebuje en ml raztopine 3,3 mg karmustina.
English: Complete blood count should be monitored frequently for at least six weeks after a dose.
Slovenian: Vsaj šest tednov po odmerku je treba pogosto spremljati celotno krvno sliko.
English: Risk factors include smoking, respiratory disease, existing radiographic abnormalities, sequential or concomitant thoracic radiation, as well as combination with other active substances that can cause lung damage.
Slovenian: Dejavniki tveganja vključujejo kajenje, bolezni dihal, predhodne radiografske nepravilnosti, zaporedno ali sočasno obsevanje prsnega koša in povezanost z drugimi učinkovinami, ki povzročajo okvaro pljuč.
English: Symptoms may include: fluid accumulation in the abdomen, enlargement of spleen, severe bleeding of the oesophgus, yellow-coulouring of skin and whites of the eyes; - Breathing problems caused by interstitial fibrosis (with lower doses); - Kidney problems; - Gynecomastia (breast growth in males)
Slovenian: Simptomi lahko vključujejo: nabiranje tekočine v trebuhu, povečanje vranice, hude krvavitve v požiralniku, rumeno obarvanje kože in očesnih beločnic; - težave z dihanjem, ki jih povzroča intersticijska fibroza (pri manjših odmerkih);
English: - Solvent: Ethanol, anhydrous.
Slovenian: - Vehikel: etanol, brezvodni.
English: Carmustine is carcinogenic in rats and mice at doses less than the recommended human dose based on body surface area.
Slovenian: Karmustin je pri podganah in miših v odmerkih, manjših od odmerka na površino telesa,
English: Tell your doctor immediately if you experience any of the following symptoms: shortness of breath, persistent cough, chest pain, persistent weakness/tiredness.
Slovenian: Če imate katerega koli od naslednjih simptomov, o tem takoj obvestite svojega zdravnika: zadihanost, trdovraten kašelj, bolečina v prsnem košu, nenehna šibkost ali utrujenost; - huda slabost in bruhanje; - pri uporabi na koži, vnetje kože (dermatitis);
English: What Carmustine Obvius looks like and contents of the pack
Slovenian: Izgled zdravila Karmustin Obvius in vsebina pakiranja
English: The antineoplastic and toxic activities of carmustine may be due to its metabolites.
Slovenian: Farmakodinamični učinki Antineoplastični in toksični učinki karmustina bi lahko bili povezani z njegovimi presnovki.
English: 3 years.
Slovenian: Neodprta viala 3 leti.
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and the glomerular filtration rate should be monitored and the dose reduced according to this.
Slovenian: Ker je pri starejših bolnikih večja verjetnost, da imajo zmanjšano delovanje ledvic, je potrebna previdnost pri izbiri odmerka in spremljati je treba hitrost glomerulne filtracije ter glede na to zmanjšati odmerek.
English: Solvent for Carmustine Obvius ethanol anhydrous IV
Slovenian: Vehikel za zdravilo Karmustin Obvius etanol, brezvodni i.v.
English: Women of childbearing potential are advised to use effective contraception to avoid becoming pregnant whilst being treated with this medicine and for at least 6 months after treatment.
Slovenian: Ženskam v rodni dobi se priporoča uporaba učinkovite kontracepcije, da v času zdravljenja s tem zdravilom in še najmanj šest mesecev po njem ne bi zanosile.
English: it has been speculated that the carbamoylating species may mediate some of toxic effects of carmustine.
Slovenian: Po drugi strani pa se domneva, da lahko nekatere toksične učinke karmustina posredujejo karbamoilirajoče vrste.
English: Phlebitis.
Slovenian: Flebitis.
English: Powder for concentrate for solution for infusion 100 mg
Slovenian: Prašek za koncentrat za raztopino za infundiranje 100 mg
English: Renal toxicity.
Slovenian: Toksičnost za ledvice.
English: After the intravenous infusion over 1 hour, the carmustine-plasma level drops in a biphasic manner.
Slovenian: Po enournem intravenskem infundiranju se plazemska koncentracija karmustina zniža na dvofazen način.
English: Male patients should use adequate contraceptive measures while on treatment with Carmustine Obvius and for at least 6 months after treatment to prevent their partners becoming pregnant.
Slovenian: Moški bolniki morajo med zdravljenjem z zdravilom Karmustin Obvius in še vsaj šest mesecev po njem uporabljati učinkovite kontracepcijske ukrepe za preprečevanje zanositve svojih partnerk.
English: The pH and osmolarity of ready-to-use solutions for infusion: pH 4.0 to 5.0 and 385-397 mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection) and pH 4.0 to 6.8 and 370-378 mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Slovenian: PH in osmolarnost za uporabo pripravljenih raztopin za infundiranje: pH od 4,0 do 5,0 in 385-397 mOsm/l (pri redčenju s 50-mg/ml (5-odstotno) raztopino glukoze za injiciranje) in pH od 4,0 do 6,8 in 370-378 mOsm/l (pri redčenju z 9-mg/ml (0,9-odstotno) raztopino natrijevega klorida za injiciranje).
English: Male patients should be advised to use adequate contraceptive measures while on treatment with carmustine and for at least 6 months after treatment.
Slovenian: Moškim bolnikom je treba svetovati, da med zdravljenjem s karmustinom in še vsaj šest mesecev po njem uporabljajo učinkovite kontracepcijske ukrepe.
English: Powder and solvent for concentrate for solution for infusion 1 vial of 100 mg powder
Slovenian: Prašek in vehikel za koncentrat za raztopino za infundiranje 1 viala s 100 mg praška
English: The pH and osmolarity of ready-to-use solutions for infusion are: pH 4.0 to 5.0 and 385-397mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection), and pH 4.0 to 6.8 and 370-378mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Slovenian: PH in osmolarnost za uporabo pripravljenih raztopin za infundiranje sta: pH od 4,0 do 5,0 in 385-397 mOsm/l (pri redčenju s 50-mg/ml (5-odstotno) raztopino glukoze za injiciranje) in pH od 4,0 do 6,8 in 370-378 mOsm/l (pri redčenju z 9-mg/ml (0,9-odstotno) raztopino natrijevega klorida za injiciranje).
English: Following reconstitution and dilution Carmustine Obvius is given into a vein by a drip (intravenously) over a one- to two-hour period protected from light.
Slovenian: Zdravilo Karmustin Obvius se po rekonstituciji in redčenju daje s kapalno infuzijo v veno (intravensko) v času ene do dveh ur, z zaščito pred svetlobo.
English: Carmustine affected the fertility of male rats at doses higher than the human dose.
Slovenian: Karmustin je v odmerkih, večjih od odmerka za človeka, vplival na plodnost samcev podgan.
English: Carmustine crosses the blood-brain barrier readily because of its lipophilic nature.
Slovenian: Karmustin zaradi svoje lipofilne narave dobro prehaja skozi krvno-možgansko pregrado.
English: Administration of the infusion should be performed using a PVC free PE infusion set.
Slovenian: Infuzijo je treba dati s polietilenskim kompletom za infuzijo, ki ne vsebuje PVC.
English: - The active substance is carmustine.
Slovenian: - Učinkovina je karmustin.
English: in children and adolescents if you are breast-feeding.
Slovenian: Otroci in mladostniki Dojenje.
English: Then aseptically add 27 ml of sterile water for injections to the alcohol solution.
Slovenian: Alkoholni raztopini nato aseptično dodajte 27 ml sterilne vode za injekcije.
English: Not known (frequency cannot be estimated from the available data) - Muscular pain; - Seizures (fits) including status epilepticus; - Tissue damage due to leakage in injection area; - Infertility; - Carmustine has been shown to adversely affect the development of unborn babies
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - bolečine v mišicah; - epileptični napadi (krči), vključno z epileptičnim statusom;
English: Frequency Adverse reactions
Slovenian: Neznana pogostnost
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml 5% glucose or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Slovenian: 30 ml osnovne raztopine takoj razredčite tako, da 30 ml osnovne raztopine dodate 500 ml 5-odstotne glukoze ali 500 ml 9-mg/ml (0,9-odstotne) raztopine natrijevega klorida za injiciranje v steklenih vsebnikih.
English: Doses subsequent to the initial dose should be adjusted according to the haematologic response of the patient to the preceding dose in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products.
Slovenian: Odmerke po začetnem odmerku je treba tako pri monoterapiji kot pri kombinirani terapiji z drugimi mielosupresivnimi zdravili prilagoditi glede na hematološki odziv bolnika na prejšnji odmerek.
English: Your blood count will be monitored frequently to avoid toxicity in your bone marrow and the dose adjusted if necessary.
Slovenian: Da bi se izognili toksičnosti za vaš kostni mozeg in po potrebi prilagodili odmerek, bo pogosto pregledovana vaša krvna slika.
English: Common (may affect up to 1 in 10 people) - Acute leukaemias and bone marrow dysplasias (abnormal development of the bone marrow).Symptoms may include bleeding from the gums, bone pain, fever, frequent infections, frequent or severe nosebleed, lumps caused by swollen lymph nodes in and around the neck, underarm, abdomen or groin, pale skin, shortness of breath, weakness, fatigue or a general decrease in energy; - Anaemia (decrease in the amount of red blood cells in the blood); - Encephalopathy (disorder of brain).
Slovenian: Simptomi lahko vključujejo krvavenje iz dlesni, bolečine v kosteh, povišano telesno temperaturo, pogoste okužbe, pogoste ali hude krvavitve iz nosu, vozliče zaradi oteklih bezgavk v predelu vratu in okoli njega, pod pazduho, na trebuhu ali v dimljah, bledo kožo, zasoplost, šibkost, utrujenost ali splošno pomanjkanje energije;
English: Carmustine was embryotoxic and teratogenic in rats and embryotoxic in rabbits at dose levels equivalent to the human dose.
Slovenian: Karmustin je bil v odmerku, enakovrednem človeškemu odmerku, embriotoksičen in teratogen pri podganah ter embriotoksičen pri kuncih.
English: Package leaflet: Information for the user Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Slovenian: Navodilo za uporabo: informacije za uporabnika Karmustin Obvius 100 mg prašek in vehikel za koncentrat za raztopino za infundiranje karmustin
English: Reconstitution and dilution of the powder for concentrate for solution for infusion: Dissolve the 100 mg Carmustine powder for concentrate for solution for infusion with 3 ml of the supplied sterile refrigerated ethanol solvent in the primary packaging (brown glass vial).
Slovenian: 100 mg zdravila Karmustin Obvius prašek za koncentrat za raztopino za infundiranje raztopite s 3 ml dobavljenega sterilnega ohlajenega etanolnega vehikla v primarni ovojnini (viala iz rjavega stekla).
English: Carmustine may impair male fertility.
Slovenian: Karmustin lahko zmanjša plodnost pri moških.
English: Biotransformation It is presumed that the metabolites of carmustine cause its antineoplastic and toxic activity.
Slovenian: Domneva se, da antineoplastično in toksično delovanje karmustina povzročajo njegovi presnovki.
English: Not known Extravasation hazard: vesicant
Slovenian: Nevarnost ekstravazacije: mehurjevec.
English: Solvent Ethanol, anhydrous.
Slovenian: Vehikel Etanol, brezvodni.
English: EXP After reconstitution/dilution: See package leaflet for the shelf life of the reconstituted medicine.
Slovenian: Po rekonstituciji/redčenju: Za rok uporabnosti rekonstituiranega zdravila glejte navodilo za uporabo.
English: Myelosuppression.
Slovenian: Mielosupresija.
English: Reconstitution and dilution of the powder for concentrate for solution for infusion Dissolve the Carmustine (100 mg powder) with 3 ml of the supplied sterile refrigerated ethanol solvent in the primary packaging (brown glass vial).
Slovenian: Karmustin (100 mg prašek) raztopite s 3 ml dobavljenega sterilnega ohlajenega etanolnega vehikla v primarni ovojnini (viala iz rjavega stekla).
English: Common Anaemia.
Slovenian: Anemija.
English: Dexamethasone, used as an anti-inflammatory and immunosuppressive agent Cimetidine, used for stomach problems like indigestion Digoxin, used if you have abnormal heart rhythm Melphalan, an anticancer medicine
Slovenian: fenitoin, uporablja se pri epilepsiji; deksametazon, uporablja se kot protivnetno in imunosupresivno sredstvo; cimetidin, uporablja se pri težavah z želodcem, npr. prebavnih motnjah;
English: Very common (may affect more than 1 in 10 people) - Delayed myelosuppression (decrease in blood cells in bone marrow) which can increase the chance of infections if white blood cells are decreased - Ataxia (lack of voluntary coordination of muscle movements); - Dizziness; - Headache; - Transient redness in the eye, blurred vision due to retinal bleeding; - Hypotension (fall in blood pressure); - Phlebitis (inflammation of the veins) associated with pain, swelling, redness, tenderness; - Respiratory disorders (lung related disorders) with breathing problems;
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - zapoznela mielosupresija (zmanjšanje števila krvnih celic v kostnem mozgu), ki lahko poveča verjetnost okužb, če je znižano število belih krvnih celic; - ataksija (pomanjkanje hotne koordinacije mišičnih gibov);
English: Symptoms may include muscle weakness in one area, poor decision-making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures; - Anorexia; - Constipation; - Diarrhoea; - Inflammation of the mouth and lips; - Reversible liver toxicity in high-dose therapy.
Slovenian: Simptomi lahko vključujejo oslabelost mišic na enem predelu, poslabšanje sposobnosti razmišljanja ali koncentracije, nehoteno trzanje, drgetanje, težave z govorom ali požiranjem, epileptične napade;
English: Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
Slovenian: možganskih tumorjih (glioblastomih, gliomih možganskega debla, meduloblastomih, astrocitomih in ependimomih), metastazah v možganih sekundarni terapiji ne-Hodgkinovega limfoma in Hodgkinove bolezni
English: Powder and solvent for concentrate for solution for infusion.
Slovenian: Prašek in vehikel za koncentrat za raztopino za infundiranje.
English: - Severe nausea and vomiting - When used on the skin, inflammation of the skin (dermatitis); - Accidental contact with skin may cause transient hyperpigmentation (darkening of an area of skin or nails)
Slovenian: - naključen stik s kožo lahko povzroči prehodno hiperpigmentacijo (potemnitev predela kože ali nohtov).
English: During treatment, lung function tests (FVC, DLCO) should be performed regularly.
Slovenian: Med zdravljenjem je treba redno opravljati teste pljučne funkcije (forsirana vitalna kapaciteta, difuzijska kapaciteta za ogljikov monoksid).
English: Tell your doctor or nurse immediately if you notice any of the following:
Slovenian: Če opazite kar koli od naslednjega, se takoj posvetujte z zdravnikom ali medicinsko sestro:
English: After reconstitution and dilutionthe solution should be administered within 3 hours after reconstitution and dilution of the product.
Slovenian: Raztopino, dobljeno z rekonstitucijo in redčenjem, je treba bolniku dati v treh urah po rekonstituciji in redčenju.
English: Powder No excipients.
Slovenian: Prašek Brez pomožnih snovi.
English: How to store Carmustine Obvius
Slovenian: Shranjevanje zdravila Karmustin Obvius
English: Carmustine is embryotoxic in rats and rabbits and teratogenic in rats when given in doses equivalent to the human dose.
Slovenian: Karmustin je v odmerkih, enakovrednih odmerku za človeka, pri podganah in kuncih embriotoksičen, pri podganah pa tudi teratogen.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING POWDER VIAL
Slovenian: PODATKI NA PRIMARNI OVOJNINI VIALA S PRAŠKOM
English: All plastic coming into contact with the carmustine solution for infusion (e.g. infusion set, etc.) should be PVC-free polyethylene plastic, otherwise glass ware should be used.
Slovenian: Vsa plastika, ki pride v stik z raztopino karmustina za infundiranje (npr. infuzijski komplet idr.
English: Reconstitution, as recommended, results in a clear, colourless to light yellow stock solution.
Slovenian: Z rekonstitucijo, kot se priporoča, nastane bistra,
English: Carmustine Obvius is a powder and solvent for concentrate for solution for infusion.
Slovenian: Zdravilo Karmustin Obvius zajema prašek in vehikel za koncentrat za raztopino za infundiranje.
English: Carmustine Obvius 100 mg powder for concentrate for solution for infusion carmustine
Slovenian: Karmustin Obvius 100 mg prašek za koncentrat za raztopino za infundiranje karmustin
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Karmustin Obvius Vsebina pakiranja in dodatne informacije
English: The duration of infusion should not be less than one hour to avoid burning and pain at the injected area.
Slovenian: Da bi se izognili pekočemu občutku in bolečini v injiciranem predelu, infuzija ne sme trajati manj kot eno uro.
English: - Excipients: - Powder: No excipients.
Slovenian: - Pomožne snovi: - Prašek: brez pomožnih snovi.
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion
Slovenian: Karmustin Obvius 100 mg prašek in vehikel za koncentrat za raztopino za infundiranje
English: All plastic coming into contact with the carmustine solution for infusion (e.g. infusion set etc.) should be PVC free polyethylene plastic, otherwise glass ware should be used.
Slovenian: ), mora biti polietilenska plastika, ki ne vsebuje PVC, sicer je treba uporabiti steklene pripomočke.
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Slovenian: Karmustin Obvius 100 mg prašek in vehikel za koncentrat za raztopino za infundiranje karmustin
English: Women of childbearing potential/contraception in males and females Women should use effective contraception to avoid becoming pregnant while on treatment and for at least 6 months after treatment.
Slovenian: Ženske morajo uporabljati učinkovito kontracepcijo, da se izognejo zanositvi med zdravljenjem in še najmanj šest mesecev po njem.
English: Reconstitution and dilution, as recommended, results in a clear, colourless to light yellow stock solution which has to be further diluted with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection, or glucose 50 mg/ml (5%) solution for injection.
Slovenian: Z rekonstitucijo in redčenjem, kot se priporočata, nastane bistra, brezbarvna do svetlorumena osnovna raztopina, ki jo je treba dodatno razredčiti s 500 ml
English: Medicinal product subject to restricted medical prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.
English: Talk to your doctor, pharmacist or nurse before using Carmustine Obvius.
Slovenian: Pred začetkom jemanja zdravila Karmustin Obvius se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Unopened vial
Slovenian: Neznana t t