FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion for subcutaneous use for HyQvia hyaluronidase
Slovenian: Infuzija za subkutano uporabo za HyQvia hialuronidaza samo za subkutano uporabo
English: These reactions have not been seen with HyQvia, but there is a small possibility that someone using HyQvia may get them: Blood clots in blood vessels (thromboembolic reactions) leading to heart attack, stroke, blockage of deep veins, or of blood vessels supplying the lung (pulmonary embolism), kidney disorder or failure, destruction of red blood cells (haemolysis).
Slovenian: Teh neželenih učinkov niso ugotovili pri zdravilu HyQvia, vendar obstaja možnost, da se pojavijo pri osebi, ki uporablja zdravilo HyQvia: krvni strdki v žilah (tromboembolične reakcije), ki privedejo do srčnega infarkta, kapi, zamašitve globokih ven ali zamašitve žil v pljučih (pljučna embolija), ledvična bolezen ali odpoved, uničenje eritrocitov (hemoliza).
English: Recombinant human hyaluronidase is a clear, colourless solution.
Slovenian: Rekombinantna humana hialuronidaza je bistra, brezbarvna raztopina.
English: Pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise)
Slovenian: pireksija, astenična stanja (vključno z astenijo, utrujenostjo, letargijo, splošnim slabim počutjem)
English: If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: • Secure the needle(s) in place by putting a sterile clear bandage over the needle.
Slovenian: • Iglo(e) potrdite tako, da jo (jih) prekrijete s sterilnim prozornim obližem.
English: • Allow vials to reach room temperature.
Slovenian: • Počakajte, da se ogreje na sobno temperaturo.
English: Human normal immunoglobulin
Slovenian: Humani polispecifični imunoglobulin
English: Immune system disorders: Hypersensitivity General disorders and administration site conditions: Influenza-like illness, infusion site leakage
Slovenian: Splošne težave in spremembe na mestu aplikacije: bolezen, podobna gripi, iztekanje na mestu infundiranja
English: The active substance of HyQvia is human normal immunoglobulin.
Slovenian: Učinkovina HyQvia je humani polispecifični imunoglobulin.
English: Erythema, rash (including erythematous, papular, maculo-papular), pruritus, urticaria
Slovenian: Bolezni kože in podkožja eritem, izpuščaj (vključno z eritematoznim, papularnim in makulopapularnim), pruritus, urtikarija
English: The human normal immunoglobulin 10% is a clear and colourless or pale yellow solution.
Slovenian: Humani polispecifični imunoglobulin 10 % je bistra in brezbarvna ali bledo rumena raztopina.
English: Infuse first the recombinant human hyaluronidase.
Slovenian: Najprej infundirajte rekombinantno humano hialuronidazo.
English: Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash, may frequently occur.
Slovenian: Lokalne reakcije na mestu infundiranja: otekanje, bolečnost, pordelost, zatrdlina, lokalni občutek toplote, srbenje, pojav podplutb in izpuščaj.
English: Prepare the needle set with the recombinant human hyaluronidase (HY):
Slovenian: Pripravite komplet injekcijske igle z rekombinantno humano hialuronidazo (HY):
English: Replacement therapy The medicinal product should be administered via the subcutaneous route.
Slovenian: Nadomestno zdravljenje Zdravilo morate dajati subkutano.
English: No adverse effects on pregnancy and foetal development were associated with anti-rHuPH20 antibodies.
Slovenian: Z anti-rHuPH20 protitelesi niso bili povezani nobeni neželeni učinki na nosečnost in razvoj plodu.
English: HyQvia is a dual vial unit containing: - a solution of recombinant human hyaluronidase (Step 1 of HyQvia/Infuse first) and - a solution of human normal immunoglobulin 10% (Step 2 of HyQvia/Infuse second).
Slovenian: Zdravilo HyQvia je enota z dvema vialama, ki vsebujeta: - raztopino rekombinantne humane hialuronidaze (1. korak zdravila HyQvia/infundirajte kot prvo komponento) in - raztopino humanega polispecifičnega imunoglobulin 10 %
English: Typical signs or symptoms include: feeling light-headed, dizzy or faint, skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing, abnormal heart rate, chest pain, blueness of lips or fingers and toes, blurred vision.
Slovenian: Običajni znaki in simptomi so: omotica, vrtoglavica ali omedlevica, kožni izpuščaj ali srbenje, otekanje v ustih ali žrelu, oteženo dihanje, sopenje, nenormalen srčni utrip, bolečine v prsnem košu, pomodrele ustnice ali prsti na rokah ali nogah, zamegljen vid.
English: Dosing
Slovenian: Dojenje
English: • Throw away the needle(s) into the sharps container.
Slovenian: • Iglo(e) odvrzite v posodo za ostre predmete.
English: Cases of transient aseptic meningitis, transient hemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin, see section 4.4.
Slovenian: Pri uporabi humanega polispecifičnega imunoglobulina so ugotovili primere prehodnega aseptičnega meningitisa, prehodnih hemolitičnih reakcij, zvišanja serumske ravni kreatinina in/ali akutne ledvične odpovedi.
English: VIAL LABEL HUMAN NORMAL IMMUNOGLOBULIN (2.5 G)
Slovenian: NALEPKA NA VIALI HUMANEGA POLISPECIFIČNEGA IMUNOGLOBULINA (2,5 G)
English: • Check infusion site(s) occasionally throughout the infusion for dislodgement or leaking.
Slovenian: • Med infuzijo občasno preverite mesto(a) infundiranja, da se komplet injekcijske igle ni premaknil in da ne pušča.
English: The recombinant human hyaluronidase is a clear and colourless solution.
Slovenian: Rekombinantna humana hialuronidaza je bistra in brezbarvna raztopina.
English: No adverse effects on fertility were observed in mice, rabbits and cynomolgus monkeys exposed to antibodies that bind to recombinant human hyaluronidase and species-specific hyaluronidase.
Slovenian: Pri miših, kuncih in opicah vrste cynomolgus, izpostavljenih protitelesom, ki se vežejo na rekombinantno humano hialuronidazo in vrstno specifično hialuronidazo, niso opazili neželenih učinkov na plodnost.
English: Human normal immunoglobulin vial: 100 mg/ml, at least 98% is IgG Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.
Slovenian: Viala humanega polispecifičnega imunoglobulina: 100 mg/ml, od tega vsaj 98 % IgG Največja vsebnost imunoglobulina A (IgA): 140 mikrogramov/ml.
English: Infusion site discoloration, infusion site bruising (including hematoma, haemorrhage), infusion site mass (including nodule), infusion site warmth, infusion site induration, gravitational oedema/genital swelling b (including genital oedema, scrotal and, vulvovaginal swelling)
Slovenian: lokalne reakcije (skupne): razbarvanje kože na mestu infundiranja, podplutbe na mestu infundiranja (vključno s hematomom, krvavitvijo), zatrdlina na mestu infundiranja (vključno z vozličem), toplota na mestu infundiranja, zatrdlina na mestu infundiranja, gravitacijski edem/otekanje genitalij (vključno z genitalnim edemom, otekanje skrotuma in vulvovaginalnim otekanjem)
English: • Turn the vial upside down, with the needle/non-vented transfer device remaining in the vial.
Slovenian: • Vialo obrnite na glavo z iglo/neprezračevanim pripomočkom za prenos, pritrjenim na vialo.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: ► Please tell your vaccinating doctor or nurse about your treatment with HyQvia.
Slovenian: ► Zdravnika ali medicinsko sestro, ki vas cepita, obvestite o zdravljenju z zdravilom
English: If you have an infusion site leakage
Slovenian: Če zdravilo izteka na mestu infundiranja
English: Efficacy and safety of HyQvia was assessed in a phase 3 study (160603) in 83 patients with PID.
Slovenian: Učinkovitost in varnost zdravila HyQvia je bila ocenjena v študiji 3. faze (160603) pri 83 bolnikih s PID. Bolniki, zdravljeni z zdravilom HyQvia bodisi s tri-bodisi s štiritedenskimi presledki skupno 12 mesecev (po kratkem obdobju titriranja).
English: - feeling light-headed, dizzy or faint, - skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing, - abnormal heart rate, chest pain, blueness of lips or fingers and toes, - blurred vision.
Slovenian: - omotica, vrtoglavica ali omedlevica, - kožni izpuščaj ali srbenje, otekanje v ustih ali žrelu, oteženo dihanje, sopenje, - nenormalen srčni utrip, bolečine v prsnem košu, pomodrele ustnice ali prsti na rokah ali nogah, - zamegljen vid.
English: Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of -D-glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product.
Slovenian: Uporaba zdravil z imunoglobulini lahko povzroči lažno pozitivne rezultate testov, ki temeljijo na zaznavanju beta‑D‑glukanov za diagnostiko glivnih okužb.
English: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Slovenian: HyQvia 100 mg/ml raztopina za infundiranje za subkutano uporabo
English: The vials should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Pred dajanjem vialo vizualno preglejte glede spremenjene barve in prisotnosti delcev.
English: Avoid bony prominences, or scarred areas.
Slovenian: Izognite se koščenim izboklinam in brazgotinam.
English: Vomiting, nausea, abdominal pain (including abdominal upper and lower pain and tenderness), diarrhoea
Slovenian: Bolezni prebavil bruhanje, navzea, bolečine v trebuhu (vključno z bolečinami v zgornjem in spodnjem delu trebuha in občutljivostjo), driska napihnjenost v trebuhu
English: • Remove the cap of needle/non-vented transfer device.
Slovenian: • Snemite zaporko igle/neprezračevanega pripomočka za prenos.
English: Infusion site erythema, infusion site swelling (including local swelling and oedema), infusion site pruritus (including vulvovaginal pruritus)
Slovenian: lokalne reakcije: (skupne): eritem na mestu infundiranja, oteklina na mestu infundiranja (vključno z lokalno oteklino in edemom), pruritus na mestu infundiranja (vključno z vulvovaginalnim pruritusom)
English: Human normal immunoglobulin (IG 10%) vial Glycine
Slovenian: Viala humanega polispecifičnega imunoglobulina (IG 10 %) glicin voda za injekcije
English: • When using HyQvia at home, you must perform the infusion in the presence of an assigned guardian person who will help you watch out for allergic reactions, stop the infusion, and get help if necessary.
Slovenian: • Če uporabljate zdravilo HyQvia doma, morate dati infuzijo v prisotnosti določenega skrbnika,
English: Myalgia, musculoskeletal chest pain
Slovenian: Bolezni živčevja glavobol migrena, omotica parestezija
English: Gravitational oedema/genital swelling was observed subsequent to lower abdominal quadrants administration.
Slovenian: Po infundiranju v spodnja trebušna kvadranta so opazili gravitacijski edem/otekanje genitalij.
English: Headache, tiredness, nausea, vomiting, diarrhoea, abdominal pain, muscle or joint pain, chest pain, fever, feeling weak or unwell.
Slovenian: Glavobol, utrujenost, navzea, bruhanje, driska, bolečine v trebuhu, bolečine v mišicah in sklepih, bolečine v prsnem košu, vročina, oslabljenost ali slabo počutje.
English: HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin SC use only.
Slovenian: HyQvia 100 mg/ml infuzija za subkutano uporabo humani polispecifični imunoglobulin samo za s.c. uporabo
English: You are at increased risk of allergic reactions if you have IgA deficiency with anti-IgA antibodies.
Slovenian: Pri pomanjkljivosti IgA s protitelesi proti IgA je večje tveganje za alergijske reakcije.
English: What HyQvia is
Slovenian: Kaj je zdravilo HyQvia
English: Administer the recombinant human hyaluronidase infusion first:
Slovenian: Aplicirajte infuzijo rekombinantne humane hialuronidaze:
English: Recombinant human hyaluronidase
Slovenian: Rekombinantna humana hialuronidaza
English: Hemosiderinuria
Slovenian: Bolezni sečil hemosiderinurija
English: The following side effects have been observed with infusion of medicines like human normal immunoglobulin 10% given under the skin (subcutaneously).
Slovenian: Neželeni učinki, ugotovljeni pri podobnih zdravilih Naslednji neželeni učinki so bili ugotovljeni pri podkožnih (subkutanih) infuzijah zdravil, ki so podobna humanemu polispecifičnemu imunoglobulinu 10 %.
English: Chills,migraine, increasedblood pressure, dizziness, abdominal bloating, skin rash/allergic rash/redness, itching, pain in chest, arms and/or legs, genital swelling (resulting from spread of swelling from the infusion site), swelling of the legs, feet and ankles, positive blood tests for antibodies.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 infuzij): Mrzlica, migrena, zvišan krvni tlak, omotica, napenjanje v trebuhu, kožni izpuščaj/alergijski izpuščaj/pordelost, srbenje, bolečine v prsnem košu, rokah in/ali nogah, oteklina spolovila (zaradi širjenja otekline iz mesta infundiranja), oteklina nog, stopal in gležnjev, pozitivna krvna preiskava na protitelesa.
English: HyQvia administration scheme Recombinant human hyaluronidase
Slovenian: Shema uporabe zdravila HyQvia Rekombinantna humana hialuronidaza
English: Infusion site leakage can occur during or after subcutaneous administration of immunoglobulin, including HyQvia.
Slovenian: Med ali po subkutanen dajanju imunoglobulina, vključno z zdravilom HyQvia, lahko pride do iztekanja na mestu infundiranja.
English: Development of non-neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies.
Slovenian: Pri bolnikih, ki so prejemali zdravilo HyQvia v kliničnih študijah, so poročali o pojavu nenevtralizirajočih protiteles proti komponenti z rekombinantno humano hialuronidazo.
English: Oedema has been reported most frequently in association with large volume subcutaneous fluid administration.
Slovenian: V povezavi z subkutanim dajanjem tekočin velikih volumnov so najpogosteje poročali o edemu.
English: Anaphylactic shock, anaphylactic/anaphylactoid reaction, tremor, tachycardia, hypotension, flushing, pallor, peripheral coldness, dyspnea, paraesthesia oral, swelling face, dermatitis allergic, musculoskeletal stiffness, injection site urticaria, injection site rash, alanine aminotransferase increased.
Slovenian: Poleg zgoraj navedenih neželenih učinkov so pri subkutani uporabi imunoglobulinskih zdravil poročali o naslednjih neželenih učinkih: anafilaktični šok, anafilaktična/anafilaktoidna reakcija, tremor, tahikardija, hipotenzija, rdečica, bledica, mrzle dlani ali stopala, dispneja, oralna parestezija, otekanje obraza, alergijski dermatitis, mišično-skeletna togost, koprivnica na mestu infundiranja, izpuščaj na mestu infundiranja, zvišana raven alanin-aminotransferaze.
English: Common (≥1/100 to <1/10)
Slovenian: Pogosti (≥1/100 do
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Slovenian: Viala rekombinantne humane hialuronidaze (rHuPH20) natrijev klorid dinatrijev fosfat humani albumin dinatrijev edetat kalcijev klorid natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH) voda za injekcije
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of viruses/infections.
Slovenian: ki bi lahko bile prenašalci okužb, - preiskave vsake darovane enote in združene plazme na viruse in druge okužbe.
English: Attach the pump tubing or, the larger syringe containing human normal immunoglobulin 10% to the needle set.
Slovenian: Na komplet injekcijske igle namestite cevje črpalke ali večjo brizgo s humanim polispecifičnim imunoglobulinom 10 %.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin
Slovenian: HyQvia 100 mg/ml infuzija za subkutano uporabo humani polispecifični imunoglobulin
English: Treatment with HyQvia will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your guardian) have been adequately trained.
Slovenian: Ko boste prvih nekaj infuzij prejeli pod zdravniškim nadzorom in boste vi (in/ali vaš skrbnik) ustrezno usposobljena, vam bo zdravnik lahko dovolil, da se začnete zdraviti sami doma.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: Frequency of Adverse Reactions (ADRs) with HyQvia
Slovenian: Pogostnost neželenih učinkov zdravila HyQvia
English: There is reassuring clinical evidence regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Slovenian: Obstajajo spodbudne klinične izkušnje o tem, da se virusi hepatitisa A in parvovirusa B19 ne prenašajo z imunoglobulini.
English: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have been rarely observed with IV and SC administration of immunoglobulin products.
Slovenian: Pri intravenski in subkutani uporabi imunoglobulinskih zdravil so v redkih primerih ugotovili tromboembolične reakcije, kot so miokardni infarkt, možganska kap, pljučna embolija in globoka venska tromboza.
English: Immunogenicity of recombinant human hyaluronidase
Slovenian: Preobčutljivost na rekombinantno humano hialuronidazo
English: A 24 gauge needle may be required to allow patients to infuse at flow rates of 300 mL/hr/infusion site.
Slovenian: Bolniki bodo za infundiranje s hitrostjo 300 ml/uro/mesto infundiranja morda potrebovali iglo velikosti 24.
English: Always use this medicine exactly as your doctor has told you.
Slovenian: Pri uporabi tega zdravila HyQvia natančno upoštevajte navodila svojega zdravnika.
English: Solution for infusion for subcutaneous use
Slovenian: Raztopina za infundiranje za subkutano uporabo
English: What HyQvia is used for
Slovenian: Za kaj uporabljamo zdravilo HyQvia
English: The ability to drive and operate machines may be impaired by some adverse reactions associated with HyQvia.
Slovenian: Nekateri neželeni učinki, povezani z zdravilom HyQvia, lahko poslabšajo sposobnost vožnje in upravljanja strojev.
English: Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins.
Slovenian: A, B, D), ki lahko delujejo kot hemolizini.
English: • Tell your doctor or nurse immediately if you notice any of these signs during the infusion.
Slovenian: • Če med infuzijo opazite katerega koli od navedenih znakov, morate nemudoma obvestiti zdravnika ali medicinsko sestro.
English: Infuse 2
Slovenian: Infundirajte kot 2. komponento.
English: What HyQvia contains
Slovenian: Kaj vsebuje zdravilo HyQvia
English: Open HyQvia dual vial unit(s):
Slovenian: Odprite enoto(e) z dvema vialama zdravila HyQvia:
English: Reversible infertility has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase.
Slovenian: Pri budrah moškega in ženskega spola, ki so bile cepljene, da so se tvorila protitelesa proti hialuronidazi, so opazili reverzibilno neplodnost.
English: Paresthesia
Slovenian: Odmerjanje
English: • Follow up with physician as directed.
Slovenian: • Po zdravnikovih navodilih se dogovorite za kontrolne obiske.
English: There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to recombinant human hyaluronidase.
Slovenian: Pri bolnikih s protitelesi proti rekombinantni humani hialuronidazi ni bilo povečane pojavnosti ali resnosti neželenih učinkov.
English: Infuse 1
Slovenian: Infundirajte kot 1. komponento.
English: Infusion speed
Slovenian: Hitrost infundiranja
English: How to store HyQvia
Slovenian: Shranjevanje zdravila HyQvia
English: - there has been a long interval (e.g., more than 2 or 3 infusion intervals) since you last received
Slovenian: Določeni neželeni učinki so pogostejši, če: - zdravilo HyQvia uporabljate prvič, - ste prej prejemali drug imunoglobulin, ki ste ga sedaj zamenjali z zdravilom HyQvia, - je od zadnjega prejema zdravila HyQvia preteklo več časa (npr. več kot 2 ali 3 presledki med infuzijami).
English: Insert the needle:
Slovenian: Vbodite injekcijsko iglo:
English: 10-15 cm 2.0 - 2.5 bar
Slovenian: 10 cm-15 cm 2,0 bar-2,5 bar
English: Recommended distance from target tissue
Slovenian: Priporočena razdalja od ciljnega tkiva
English: Do not refreeze.
Slovenian: Ne zamrzujte ponovno.
English: Do not use solutions that are cloudy or have deposits.”
Slovenian: Ne uporabite raztopin, ki so motne ali imajo usedline.«
English: The text of this section should be read as follows: “For epilesional use.
Slovenian: Besedilo tega poglavja se mora glasiti: »Za epilezijsko uporabo.
English: The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6).
Slovenian: Zdravilo se mora rekonstituirati in nanašati samo po navodilih in s pripomočki, priporočenimi za to zdravilo (glejte poglavje 6.6).
English: When BAC and Thrombin have been drawn up into the administration device they must be used immediately.”
Slovenian: Po vnosu BAC in trombina v aplikator ju morate porabiti nemudoma.«
English: 6 cm Yellow Flexible Tip
Slovenian: Rumeni prožni nastavek dolžine 6 cm
English: The following text should be added at the end of the section:
Slovenian: Na konec poglavja je treba dodati naslednje besedilo:
English: The solution should be clear or slightly opalescent.
Slovenian: Raztopina mora biti bistra ali rahlo motna.
English: After thawing, unopened vials can be stored at 2 - 8C and protected from light, for up to 30 days.
Slovenian: Po odtalitvi lahko neodprte viale shranjujemo zaščitene pred svetlobo pri temperaturi 2C-8C do 30 dni.
English: Omrix Pressure Regulator
Slovenian: Regulator tlaka Omrix
English: Prior to applying Quixil the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Slovenian: Pred nanosom zdravila Quixil je treba površino rane osušiti s standardnimi tehnikami (npr. z večkratno aplikacijo kompres, blazinic, z uporabo sesalnih pripomočkov).
English: The entire section should read as follows, in bold and underlined format where indicated: “To avoid the risk of life threatening gas or air embolism, Quixil should only be sprayed using pressurised CO2
Slovenian: Celotno poglavje se mora glasiti, kot sledi, v krepkem tisku in podčrtano, kjer je tako označeno: »Da bi se izognili tveganju za življenjsko nevarno plinsko ali zračno embolijo, pršite zdravilo Quixil samo s plinom CO2 pod tlakom.
English: The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Slovenian: Zdravilo nato pršite na površino tkiva v kratkih razprških (0,1 ml-0,2 ml), da nastane tanek, enakomeren sloj.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Priloga III Dopolnitve, ki jih je treba vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
English: The following contra-indication should be added at the end of the section:
Slovenian: Na konec poglavja je treba dodati naslednjo kontraindikacijo:
English: BEFORE YOU ARE TREATED WITH QUIXIL You must not be treated with Quixil:
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO QUIXIL Ne smete se zdraviti z zdravilom Quixil: