natgillin/translations-raw huggingface dataset:
The full EPAR for Evicel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Evicel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Evicel has been studied in two main studies involving a total of 282 patients.
Zdravilo Evicel so raziskali v dveh glavnih študijah, v kateri je bilo vključenih skupaj 282 bolnikov.
What measures are being taken to ensure the safe use of Evicel?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Evicel?
Other information about Evicel
Druge informacije o zdravilu Evicel
When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin.
Kadar se ti dve zdravilni učinkovini zmešata, trombin razreže fibrinogen v manjše enote, imenovane fibrin.
This is a summary of the European public assessment report (EPAR) for Evicel.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Evicel.
Evicel human clottable protein / human thrombin
Evicel humana koagulacijska beljakovina/humani trombin
For more information about treatment with Evicel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Evicel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is available as two solutions, one containing the active substance human clottable protein (50 to 90 mg/ml), and the other containing the active substance human thrombin (800 to 1200 international units per millilitre).
Na voljo je v obliki dveh raztopin, od katerih ena vsebuje zdravilno učinkovino humano koagulacijsko beljakovino (od 50 do 90 mg/ml), druga pa zdravilno učinkovino humani trombin (od 800 do 1200 mednarodnih enot na mililiter).
The volume of Evicel to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Količina uporabljenega zdravila Evicel je odvisna od več dejavnikov, med drugim vrste kirurškega posega, velikosti rane in števila nanosov.
Because the thrombin solution of Evicel is also used in another medicine, Quixil, the company used some data from Quixil to support the use of Evicel.
Ker se trombinska raztopina zdravila Evicel uporablja tudi v drugem zdravilu, imenovanem Quixil, je družba v podporo uporabi zdravila Evicel uporabila nekatere podatke o zdravilu Quixil.
In order to reduce the risk of gas embolism with spray application, the company will provide educational material and training to all surgeons who will use Evicel as a spray.
Za zmanjševanje tveganja plinske embolije pri uporabi pršila, bo družba priskrbela izobraževalno gradivo in organizirala usposabljanja za vse kirurge, ki bodo zdravilo Evicel uporabljali v obliki pršila.
What benefit has Evicel shown during the studies?
Kakšne koristi je zdravilo Evicel izkazalo med študijami?
In addition, the company will ensure that Evicel is used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that the regulators contain labels stating the recommended pressure and distance for the spray application.
Poleg tega bo podjetje zagotovilo, da se zdravilo Evicel uporablja z regulatorjem tlaka, ki ne presega največjega tlaka, potrebnega za odmerjanje fibrinskega sredstva za zapiranje ran, ter da so regulatorji opremljeni z nalepko z navedbo priporočenega tlaka in razdalje za uporabo zdravila v pršilu.
Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient.
Zdravilo Evicel uporabljajo kirurgi med operacijami, saj pomaga zmanjšati lokalne krvavitve, kadar običajne tehnike ne zadoščajo.
Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients.
Zdravila Evicel ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humano koagulacijsko beljakovino, trombin ali katero koli drugo sestavino zdravila.
The CHMP decided that Evicel's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Evicel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evicel.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Evicel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Evicel has also been studied in one further main study involving 139 patients undergoing brain surgery and whose dura mater was leaking fluid following suturing of the dural incision.
Zdravilo Evicel so proučevali še v dodatni glavni študiji s 139 bolniki, ki so bili operirani na možganih in pri katerih je dura mater po šivanju kirurškega reza v duro prepuščala tekočino.
In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting.
V redkih primerih se lahko pri bolnikih razvijejo protitelesa na beljakovine v zdravilu Evicel, kar lahko moti strjevanje krvi.
As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly.
Kot druga tesnila lahko tudi zdravilo Evicel povzroči resno alergijsko reakcijo, zlasti pri večkratni uporabi.
What is the risk associated with Evicel?
Kakšna tveganja so povezana z zdravilom Evicel?
The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Fibrin se nato združi (medsebojno zlepi) in ustvari fibrinski strdek, ki pomaga ozdraviti rano, saj preprečuje krvavenje.
Evicel is a medicine that is used as a sealant (glue).
Evicel je zdravilo, ki se uporablja kot tesnilno sredstvo (lepilo).
The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Zdravilni učinkovini zdravila Evicel, humana koagulacijska beljakovina in trombin, sta naravni snovi, pridobljeni iz človeške plazme (tekočega dela krvi).
The human clottable protein contains as its main component, fibrinogen, a protein involved in the natural clotting process.
Glavna sestavina humane koagulacijske beljakovine je fibrinogen, beljakovina, ki sodeluje pri naravnem procesu strjevanja krvi.
Why has Evicel been approved?
Zakaj je bilo zdravilo Evicel odobreno?
When used in endoscopic procedures (procedures that use an endoscope for viewing internal organs),
Kadar se zdravilo Evicel uporablja pri endoskopskih posegih (postopkih, pri katerih se endoskop uporabi za ogled notranjih organov), se ne sme uporabiti v obliki pršila.
Cases of gas embolism (gas bubbles in the blood that affect the blood flow) have occurred when Evicel was applied as spray.
Primeri plinske embolije (plinski mehurčki v krvi, ki motijo njen pretok) so bili opaženi pri uporabi zdravila Evicel v obliki pršila.
For the full list of all side effects reported with Evicel, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Evicel, glejte navodilo za uporabo.
The main measure of effectiveness was the number of patients whose dura mater closure was watertight with no leakage.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila dura mater vodotesna in ni prepuščala tekočine.
Evicel should only be used by an experienced surgeon who has been trained in the use of Evicel.
Zdravilo Evicel lahko uporablja samo izkušen kirurg, ki je bil usposobljen za dajanje tega zdravila.
It must not be given as an injection into a blood vessel.
Zdravilo se ne sme dati v obliki injekcije v žilo.
Evicel was more effective than the comparator treatments in reducing the bleeding at the site of application.
Zdravilo Evicel je bilo pri zmanjšanju krvavitve na mestu uporabe učinkovitejše od zdravljenja s primerjalnimi zdravili.
The main measure of effectiveness was the number of patients with no bleeding (haemostasis) at the site of application, four minutes after having received Evicel or manual compression.
Glavno merilo učinkovitosti je bilo število bolnikov brez krvavitve (hemostaza) na mestu uporabe štiri minute po prejetju zdravila Evicel ali ročni kompresiji.
The main measure of effectiveness was the number of patients with no bleeding at the site of application, 10 minutes after having received Evicel or Surgicel.
Glavno merilo učinkovitosti je bilo število bolnikov brez krvavitve na mestu uporabe deset minut po prejetju zdravila Evicel ali snovi Surgicel.
In dura mater closure, 92% of patients treated with Evicel (82 out of 89) had a watertight closure compared with 38% of the patients who did not receive Evicel (19 out of 50).
Celjenje dure mater je bilo pri 92 % (82 od 89) bolnikov, ki so prejemali zdravilo Evicel, vodotesno v primerjavi z 38 % (19 od 50) bolnikov, ki tega zdravila niso prejeli.
Evicel can also be used in addition to sutures to obtain a watertight closure of the dura mater (a thin fluid-filled membrane surrounding the brain and the spinal cord) during brain surgery.
Zdravilo Evicel se lahko uporabi poleg šivov za vodotesno zaporo dure mater (tanke, s tekočino napolnjene ovojnice, ki obkroža možgane in hrbtenjačo) med možgansko operacijo.
Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine.
Pred uporabo se raztopini zdravila Evicel zmešata s posebnim pripomočkom, ki je priložen zdravilu.
The second study compared Evicel with Surgicel (a material used to help control bleeding) in reducing bleeding during abdominal surgery (surgery of organs in the tummy).
V drugi študiji so zdravilo Evicel primerjali s snovjo Surgicel (snovjo, ki se uporablja za nadzorovanje krvavitev) pri zmanjšanju krvavenja med abdominalnim kirurškim posegom (operacijo trebušnih organov).
For further details see the package leaflet.
Za več informacij glejte navodilo za uporabo.
In vascular surgery, 85% of the patients had no bleeding four minutes after treatment with Evicel (64 out of 75), compared with 39% of the patients treated with manual compression (28 out of 72).
Pri vaskularnem kirurškem posegu je pri 85 % (64 od 75) bolnikov krvavitev prenehala v štirih minutah po zdravljenju z zdravilom Evicel , v primeru zdravljenja z ročno kompresijo pa je krvavitev prenehala pri 39 % (28 od 72) bolnikov.
The first study compared Evicel with manual compression (applying direct pressure) in reducing bleeding during vascular surgery.
V prvi študiji so zdravilo Evicel primerjali z metodo ročne kompresije (neposrednim pritiskanjem) pri zmanjševanju krvavitve med vaskularnim kirurškim posegom.
What is Evicel used for?
Za kaj se zdravilo Evicel uporablja?
The study compared the effectiveness of Evicel in addition to sutures with sutures alone in sealing the dura mater.
V študiji so primerjali učinkovitost zdravila Evicel kot podporo šivom s samimi šivi pri celjenju dure mater.
During abdominal surgery, 95% of the patients had no bleeding 10 minutes after treatment with Evicel (63 out of 66), compared with 81% of the patients treated with Surgicel (56 out of 69).
Pri abdominalnem kirurškem posegu je pri 95 % (63 od 66) bolnikov krvavitev prenehala v desetih minutah po zdravljenju z zdravilom Evicel, v primeru zdravljenja s snovjo Surgicel pa je krvavitev prenehala pri 81 % (56 od 69) bolnikov.
Evicel must also not be used in dura mater closure if the dura mater cannot be sutured, or if there are gaps greater than 2 mm after suturing.
Zdravilo Evicel se prav tako ne sme uporabljati pri celjenju dure mater, če se te ne da zašiti ali če so po šivanju odprtine še vedno večje od 2 mm. Ne sme se uporabljati niti kot lepilo za pritrditev duralnih obližev (materiala, ki se prišije prek odprtine v duri mater).
What is Evicel?
Kaj je zdravilo Evicel?
How has Evicel been studied?
Kako je bilo zdravilo Evicel raziskano?
It can also be used in addition to sutures (stitching) during vascular surgery (surgery on the blood vessels).
Uporabi se lahko poleg šivov med vaskularnim kirurškim posegom (operacijo ožilja).
How is Evicel used?
Kako se zdravilo Evicel uporablja?
How does Evicel work?
Kako zdravilo Evicel deluje?
Thromboembolic complications (blood clots) may occur if Evicel is unintentionally injected into a blood vessel.
Če se zdravilo Evicel vbrizga v krvno žilo nenamerno, lahko pride do tromboembolijskih zapletov (krvnih strdkov v žili).
This transformation is responsible for the potency of the therapeutic class.
Ta transformacija je odgovorna za učinkovitost terapevtskega razreda.
ATC vet code: QD07AC16.
Oznaka ATC vet: QD07AC16.
The diesters are transformed inside the skin structures.
Diestri se transformirajo znotraj kožnih struktur.
Do not store above 25 °C.
Ne shranjujte pri temperaturi nad 25 C.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
Oostkamp Belgium
Oostkamp Belgija
This particularity will increase the ratio between the desired local antiinflammatory effect in the skin and the undesirable systemic effects.
Ta posebnost poveča razmerje med želenim lokalnim protivnetnim učinkom v koži in neželenimi sistemskimi učinki.
10 DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
<{MM/LLLL}> <{DD/MM/LLLL}> <{DD mesec LLLL}>
Cardboard box containing 1 bottle of 76 ml.
Kartonasta škatla vsebuje 1 plastenko s 76 ml.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/230/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/18/230/001
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/08/2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 27/08/2018
Care should be taken to avoid spraying into the eyes of the animal.
Potrebna je pazljivost, da se izognete pršenju v oči živali.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno sposameznimi primeri).>
Marketing authorisation holder: Ecuphar NV
Imetnik dovoljenja za promet z zdravilom: ECUPHAR NV
Pharmacotherapeutic group: Corticosteroids, dermatological preparations.
Farmakoterapevtska skupina: Kortikosteroidi, dermatološki preparati.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.
Če po 7 dneh ni nobenih znakov izboljšanja, mora veterinar ponovno oceniti pristop k zdravljenju.
The solvent in this product may stain certain materials including painted, varnished or other household surfaces or furnishings.
Topilo, ki se nahaja v izdelku, lahko na določenih materialih, vključno s pobarvanimi, lakiranimi in drugimi gospodinjskimi površinami ali pohištvom, pusti madež.
Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.
Rezultat lokalne uporabe diestrov je širok terapevtski indeks: močno lokalno delovanje z zmanjšanimi sekundarnimi sistemskimi učinki.
Allow the application site to dry before permitting contact with such materials.
Omogočite, da se mesto nanosa posuši, preden pride do stika s takšnimi materiali.
Avoid contact with eyes.
Preprečiti je potrebno stik z očmi.
Do not smoke while handling the product.
Pri ravnanju z zdravilom ne kadite.
Do not spray on naked flame or any incandescent material.
Ne pršite na odprti ogenj ali na žareče snovi.
In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Pri laboratorijskih živalih se hidrokortizon aceponat izloča na enak način kot hidrokortizon (drugo ime za endogeni kortizol) z urinom in blatom.
Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment.
Študije tolerance, pri katerih so uporabljali odmerke 3 in 5 krat večje od priporočenih, v obdobju zdravljenja, ki je trajalo dvakrat dlje od priporočenega, so pokazale zmanjšano sposobnost proizvajanja kortizola, ki pa je bila v obdobju 7 do 9 tednov po končanem zdravljenju popolnoma reverzibilna.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the riskbenefit assessment and subject to regular clinical evaluations.
Ker je znano, da glukokortikosteroidi upočasnjujejo rast, se mora pri mladih živalih (mlajših od 7 mesecev) zdravilo uporabljati v skladu z oceno razmerja korist/tveganje in ob rednem kliničnem ocenjevanju.
Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Flammable.
Vnetljivo.
In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such condition.
V primeru sočasne mikrobne ali parazitarne infestacije, je treba psa na ustrezen način zdraviti tudi proti tem boleznim.
Hydrocortisone aceponate thus accumulates in the dog's skin allowing local efficacy at low dosage.
Na ta način se hidrokortizon aceponat akumulira v koži psa in pri nizkih odmerkih omogoča lokalno učinkovitost.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a low plasma availability.
Diestri so lipofilne komponente, ki zagotavljajo izboljšano penetracijo v kožo, kar je povezano z nizko plazemsko dostopnostjo.
In 12 dogs suffering from atopic dermatitis, after topical application on the skin at the recommended therapeutic dosage for 28 to 70 consecutive days, no noticeable effect on the systemic cortisol level was observed.
Pri 12 psih, obolelih za atopičnim dermatitisom, po lokalnem nanosu predpisanega odmerka na kožo v obdobju od 28 do 70 zaporednih dni, ni bilo opaznega učinka na sistemsko raven kortizola.
Clear colourless to slightly yellow solution.
Bistra brezbarvna do rahlo rumenkasta raztopina.
The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm2 of affected skin per day.
Priporočeni odmerek je 1,52 µg hidrokortizon aceponata/cm prizadete kože na dan.
This veterinary medicinal product is flammable.
To zdravilo za uporabo v veterinarski medicini je vnetljivo.
Do not use after the expiry date stated on the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
Transient local reactions at the application site (erythema and/or pruritus) can occur in very rare cases.
Prehodne lokalne reakcije (eritem in/ali pruritus) se lahko na mestu aplikacije pojavijo v zelo redkih primerih.
EXP {month/year} Once opened, use within 6 months.
EXP {mesec/leto} Odprto zdravilo uporabite v 6 mesecih.
Bioglan AB Borrgatan 31 211 24 Malmo Sweden
Bioglan AB Borrgatan 31, Malmö,
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
Za simptomatsko zdravljenje vnetnih in pruritičnih dermatoz pri psih.
In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Spray preferably in a well ventilated area.
Če je le mogoče, pršite v dobro prezračenem prostoru.
Hydrocortisone aceponate is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis.
Hidrokortizon aceponat je dermokortikoid z močnim intrinzičnim glukokortikoidnim delovanjem, ki pomeni olajšanje tako vnetja kot pruritisa in vodi do hitrega izboljšanja kožnih poškodb, povezanih z vnetnimi in pruritičnimi dermatozami.
The veterinary medicinal product contains the active substance hydrocortisone aceponate.
Zdravilo vsebuje učinkovino hidrokortizon aceponat.
This dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm. Repeat the treatment daily for 7 consecutive days.
Ta odmerek se lahko doseže z dvakratnim aktiviranjem zaporke z mehanskim pršilnikom na del kože, ki ustreza kvadratu 10 cm x 10 cm. Zdravljenje ponavljajte dnevno, 7 zaporednih dni.
Hydrocortisone aceponate belongs to the diesters class of the glucocorticosteroids.
Hidrokortizon aceponat spada v diestrsko skupino glukokortikosteroidov.
Hydrocortisone aceponate applications on the skin lesions provide rapid reduction of the skin redness, irritation and scratching while minimising the general effects.
Nanos hidrokortizon aceponat na kožne poškodbe zagotavlja hitro zmanjšanje kožne rdečine, draženja in praskanja ob minimalnih splošnih učinkih.
In the absence of specific information, the use in animal suffering from Cushing's syndrome shall be based on the risk-benefit assessment.
Če ne razpolagamo s specifičnimi podatki, se živali, ki imajo Cushingov sindrom, zdravi v skladu z oceno razmerja korist/tveganje.
Shelf-life after first opening the container: 6 months
Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev.
After topical application on the skin at the recommended therapeutic dosage and twice the recommended duration of treatment and at up to a body surface corresponding to the two flanks, from the spine to the mammary chains including the shoulder and the thighs, no systemic effects are observed.
Po uporabi zdravila na koži v priporočenih odmerkih in v obdobju dvakrat daljšem od priporočenega, na površini telesa, ki ustreza obema bočnima stranema, od hrbtenice do verige seskov, vključno s pleči in stegni, niso zaznavni nobeni sistemski učinki.
Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
Sistemska absorpcija hidrokortizon aceponata je zanemarljiva, zato je ob uporabi priporočenih odmerkov za zdravljenje psov malo verjetnosti za pojav teratogenih, fetotoksičnih ali za mater toksičnih učinkov.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
V primeru, da stanje zahteva zdravljenje daljše od 7 dni, mora odgovorni veterinar o uporabi zdravila presojati v skladu z oceno razmerja korist-tveganje.
Medicines should not be disposed of via wastewater or household waste.
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Ne odvrzite zdravila v odpadno vodo ali med gospodinjske odpadke.
METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
NAČIN IN POT(I) UPORABE
Before administration, screw the pump spray on the bottle.
Pred uporabo na vsebnik privijte zaporko z mehanskim pršilnikom na plastenko.