natgillin/translations-raw huggingface dataset:
As the evidence suggests that all human FVIII products carry a risk of inhibitor development, within the frequency of ‘very common' and ‘uncommon' for PUPs and PTPs respectively, the PRAC recommends that the SmPCs should be aligned with these frequencies unless justified by product specific data.
Ker dokazi kažejo, da imajo vsa zdravila s FVIII v humani medicini tveganje za pojav zaviralcev v kategoriji pogostnosti „zelo pogosti“ pri predhodno nezdravljenih in „občasni“ pri predhodno zdravljenih bolnikih, odbor PRAC priporoča, da se povzetki glavnih značilnosti zdravila uskladijo s temi pogostnostmi, razen če jih je mogoče utemeljiti s podatki, ki so specifični za zdravilo.
• The PRAC noted that the SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products in total.
• odbor PRAC je ugotovil, da študija SIPPET ni bila zasnovana za ocenjevanje tveganja za pojav zaviralcev za posamezna zdravila in zajema majhno število zdravil s FVIII.
When you must withdraw blood before an infusion, use an administration set without a filter, then infuse this medicine through an injection filter.
Kadar morate pred infundiranjem odvzeti kri, uporabite pribor brez filtra in nato infundirajte zdravilo KOGENATE Bayer skozi injekcijski filter.
1 venipuncture set
1 pribor za vensko punkcijo
Besides, as the evidence suggests that all human FVIII products carry a risk of inhibitor development, within the frequency of ‘very common' and ‘uncommon', for PUPs and PTPs respectively, the PRAC recommended that the product information of these products should be aligned with these frequencies unless justified by product specific data.
Poleg tega dokazi kažejo, da imajo vsa zdravila s FVIII v humani medicini tveganje za pojav zaviralcev v kategoriji pogostnosti „zelo pogosti“ pri predhodno nezdravljenih in „občasni“ pri predhodno zdravljenih bolnikih, zato je odbor PRAC priporočil, da se informacije o zdravilu za ta zdravila uskladijo s temi pogostnostmi, razen če jih je mogoče utemeljiti s podatki, ki so specifični za zdravilo.
• your weight
• vaša telesna masa
Place product vial on a firm, non-skid surface.
Vialo z zdravilom postavite na trdno, nedrsečo površino.
Infusion related febrile reaction (pyrexia)
Splošne težave in spremembe na mestu aplikacije reakcije na mestu infudiranja z infundiranjem povezane febrilne reakcije (pireksija)
If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Če se z odmerkom zdravila ne doseže pričakovane aktivnosti faktorja VIII v plazmi, ali se krvavitev kljub primernemu odmerku ne ustavi, je treba preveriti ali je v bolnikovi krvi prisoten zaviralec faktorja VIII.
Determine the point of injection, clean the skin with an alcohol swab, and prepare site of injection antiseptically as advised by your doctor.
Določite mesto injiciranja in kožo očistite z alkoholnim tamponom.
• rash/itchy rash
• osip/srbečica
The referral focuses on the risk of inhibitor development in PUPs.
Napotitev se osredotoča na tveganje za pojav zaviralcev pri predhodno nezdravljenih bolnikih.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
Za ugotavljanje primernega odmerka in pogostosti dajanja infuzij se med zdravljenjem svetuje redno določanje ravni faktorja VIII.
• The SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products.
• študija SIPPET ni bila zasnovana za ocenjevanje tveganja za pojav zaviralcev za posamezna zdravila in zajema majhno število zdravil s FVIII.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 • znane alergijske reakcije na beljakovine miši ali hrčkov
Attach the syringe to the venipuncture set by screwing it clockwise and ensure that no blood enters the syringe (J).
Injekcijsko brizgo privijte v smeri urinega kazalca na pribor za vensko punkcijo in preverite, da v injekcijski brizgi ni krvi (J).
It is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Za doseganje in vzdrževanje ustreznih ravni faktorja VIII je priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave plazme.
During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
V študijah ni pri nobenem od bolnikov nastal klinično pomembnih titrov protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
Package Leaflet: Information for the user
Vsebina pakiranja in dodatne informacije
Finally, apply a small pressure dressing to the injection site and consider if a plaster is necessary.
Nato mesto injiciranja prekrijte z majhno kompresijsko obvezo in, če je potrebno, tudi z obližem.
Specifically, the findings from the SIPPET study, as well as those from the individual clinical trials and observational studies included in the MAH responses, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between the rFVIII and pdFVIII product classes.
Natančneje, ugotovitve iz študije SIPPET in tudi iz posameznih kliničnih preskušanj in opazovalnih študij, vključenih v odzive imetnikov dovoljenj za promet z zdravilom, ne zadostujejo za potrditev doslednih statistično in klinično pomembnih razlik v tveganju za pojav zaviralcev med razredi zdravil z rFVIII in pdFVIII.
KOGENATE Bayer is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Zdravilo KOGENATE Bayer je na voljo kot prašek (suh, bel do rahlo rumen prašek ali pogača) in vehikel za raztopino za injiciranje.
After reconstitution, the chemical and physical in-use stability has been demonstrated for 3 hours in in vitro studies.
V in vitro študijah je bilo zdravilo po rekonstituciji kemijsko in fizikalno stabilno 3 ure.
Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).
Bat vstavite v injekcijsko brizgo s privijanjem v gumijast zamašek (E).
• the factor VIII level that is needed.
• želena raven faktorja VIII.
250 IU (octocog alfa) (100 IU/mL after reconstitution).
250 i.e. (oktokog alfa) (100 i.e./ml po rekonstituciji).
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with KOGENATE Bayer.
Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom KOGENATE Bayer, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
V kliničnih preskušanjih pri nobenem izmed bolnikov niso opazili klinično pomembnega titra protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 1000 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 2000 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
KOGENATE Bayer 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
KOGENATE Bayer 250 i.e. vsebuje (250 i.e./2,5 ml) = 100 i.e. oktokoga alfa na ml po rekonstituciji.
KOGENATE Bayer 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
KOGENATE Bayer 3000 i.e. vsebuje (3000 i.e./5 ml) = 600 i.e. oktokoga alfa na ml po rekonstituciji.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH 2.5 mL or 5 mL WATER FOR INJECTIONS
NAPOLNJENA INJEKCIJSKA BRIZGA Z 2,5 ML ali 5 ML VODE ZA INJEKCIJE
3000 IU (octocog alfa) (600 IU/mL after reconstitution).
3000 i.e. (oktokog alfa) (600 i.e./ml po rekonstituciji).
KOGENATE Bayer 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
KOGENATE Bayer 2000 i.e. vsebuje (2000 i.e./5 ml) = 400 i.e. oktokoga alfa na ml po rekonstituciji.
KOGENATE Bayer 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
KOGENATE Bayer 500 i.e. vsebuje (500 i.e./2,5 ml) = 200 i.e. oktokoga alfa na ml po rekonstituciji.
500 IU (octocog alfa) (200 IU/mL after reconstitution).
500 i.e. (oktokog alfa) (200 i.e./ml po rekonstituciji).
• The PRAC noted that the efficacy and safety of Factor VIII products as indicated in the treatment and prophylaxis of bleeding in patients with haemophilia A have been established.Based on the available data, the PRAC considered that SmPC updates for the FVIII products are warranted: section 4.4 should be amended to include a warning on the clinical importance of monitoring patients for FVIII inhibitor development.
Glede na razpoložljive podatke je odbor PRAC menil, da so potrebne spremembe povzetka glavnih značilnosti zdravila za zdravila s FVIII: poglavje 4.4 je treba spremeniti, da se vključi opozorilo o kliničnem pomenu spremljanja bolnikov za pojav zaviralcev FVIII.
If the factor VIII level in your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dose, you may have developed factor VIII inhibitors.
Če želena raven faktorja VIII v plazmi ni dosežena, oziroma se krvavitev kljub ustreznemu odmerku ne ustavi, je prišlo do nastanka zaviralcev faktorja VIII.
KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection
KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 1000 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 2000 i.e. prašek in vehikel za raztopino za injiciranje KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje
Minor including tooth extraction
Kirurški posegi manjši posegi tudi izdrtje zob
Detailed instructions for reconstitution and administration of KOGENATE Bayer using vial with reconstitution cap (Bio-Set System): Wash your hands thoroughly using soap and warm water.
Podrobnejša navodila za rekonstitucijo in uporabo zdravila KOGENATE Bayer v viali z nastavkom za rekonstitucijo (sistem Bio-Set):
Inject the diluent by slowly pushing down on the plunger rod (G).
S počasnim potiskanjem bata injekcijske brizge navzdol vbrizgajte vehikel (G).
Dissolve the powder by gently swirling the vial (G).
Nežno obračajte vialo, da se prašek raztopi (G).
KOGENATE Bayer 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
KOGENATE Bayer 1000 i.e. vsebuje (1000 i.e./2,5 ml) = 400 i.e. oktokoga alfa na ml po rekonstituciji.
2000 IU (octocog alfa) (400 IU/mL after reconstitution).
2000 i.e. (oktokog alfa) (400 i.e./ml po rekonstituciji).
• two plasters
• 2 obliža.
PRAC conclusions
Zaključki odbora PRAC
Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Za ugotavljanje biološke aktivnosti faktorja VIII se običajno uporablja in vitro metoda določanja aktiviranega parcialnega tromboplastinskega časa (APTČ), ki je pri vseh hemofilikih podaljšan.
1 vial with Bio-Set system with powder for solution for injection.
Adapter za vialo viala s praškom za raztopino za injiciranje
Unscrew the syringe to disconnect the vial (I).
Odvijte injekcijsko brizgo z viale (I).
1000 IU (octocog alfa) (400 IU/mL after reconstitution).
1000 i.e. (oktokog alfa) (400 i.e./ml po rekonstituciji).
Attach the pre-filled syringe to the threaded vial adapter by turning clockwise (F).
Z obračanjem v smeri urinega kazalca pritrdite napolnjeno injekcijsko brizgo v navoj adapterja za vialo (F).
Posology
Zaviralci
Treatment of bleeding
• stopnja motnje strjevanja krvi
Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Injekcijsko brizgo držite za valjasti del in s konice odstranite zaporko (D).
• One mL KOGENATE Bayer 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila KOGENATE Bayer 3000 i.e. vsebuje približno 600 i.e. (3000 i.e./ 5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
• One mL KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila KOGENATE Bayer 250 i.e. vsebuje približno 100 i.e. (250 i.e./ 2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
• One mL KOGENATE Bayer 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila KOGENATE Bayer 500 i.e. vsebuje približno 200 i.e. (500 i.e./ 2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.http://www.bloodjournal.org/content/121/20/4046.full.pdf study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
V študiji FranceCoag, tako kot v študiji UKHCDO, niso odkrili statistično pomembnega povečanega tveganja za nobeno zdravilo z rFVIII v primerjavi z zdravilom Advate, če so izključili bolnike iz Francije (ki so bili tudi vključeni v študijo RODIN/Pednet).
• One mL KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila KOGENATE Bayer 1000 i.e. vsebuje približno 400 i.e. (1000 i.e./ 2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
• One mL KOGENATE Bayer 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila KOGENATE Bayer 2000 i.e. vsebuje približno 400 i.e. (2000 i.e./ 5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
Blood and the Lymphatic System Disorders
Bolezni krvi in limfatičnega sistema zaviranje faktorja VIII (PNB)*
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Pred uporabo je treba zdravilo za paranteralno uporabo vizualno pregledati, če so v njem delci in če se je spremenila barva.
• syringe plunger rod
• bat brizge
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
After reconstitution, the solution is drawn back into the syringe.
Po rekonstituciji raztopino potegnite nazaj v injekcijsko brizgo.
Immune System Disorders
MedDRA Standard Organski sistem
Use only the items (powder vial with Bio-Set cap, pre-filled syringe containing solvent and venipuncture set) that are provided with each package of this medicine.
Kako pripraviti zdravilo KOGENATE Bayer za uporabo Uporabite samo pribor, ki je priložen v vsakem pakiranju tega zdravila (viala s praškom in Bio-Set zaporko, napolnjena injekcijska brizga z vehiklom in pribor za vensko punkcijo).
How to store KOGENATE Bayer
Shranjevanje zdravila KOGENATE Bayer
• one venipuncture set
• 1 pribor za vensko punkcijo
The responses of MAHs referred to a range of published observational studies (the CANAL, RODIN, FranceCoag, UKHCDO, amongst others) which have sought to evaluate any differential risks of inhibitor development between the classes of pdFVIII and rFVIII, as well as any differential risk of inhibitor development between products within the rFVIII class.
Odgovori imetnikov dovoljenja za promet so se nanašali na vrsto objavljenih opazovalnih študij (CANAL, RODIN, FranceCoag, UKHCDO idr.
Only the provided components (powder vial with Bio-Set system, pre-filled syringe containing solvent and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Za rekonstitucijo in injiciranje zdravila se sme uporabiti samo priloženi pribor (vialo s praškom in sistem Bio-Set, z vehiklom napolnjeno injekcijsko brizgo in pribor za vensko punkcijo).
Remove tourniquet.
Odstranite prevezo.
Swirl vial gently until all material is dissolved (H).
Nežno obračajte vialo, da se prašek raztopi (H).
The adapter will snap over the vial cap. Do not remove the adapter housing at this point.
Ohišja adapterja še ne odstranite.
Use only the items (vial adapter, pre-filled syringe containing solvent and venipuncture set) that are provided with each package of this medicine.
Kako pripraviti zdravilo KOGENATE Bayer za uporabo Uporabite samo pribor, ki je priložen v vsakem pakiranju tega zdravila (adapter za vialo, napolnjena injekcijska brizga z vehiklom in pribor za vensko punkcijo).
How KOGENATE Bayer is given
Kaj vsebuje zdravilo KOGENATE Bayer
Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Za rekonstitucijo in injiciranje zdravila se sme uporabiti samo priloženi pribor (vialo s praškom, z vehiklom napolnjeno injekcijsko brizgo, adapter za vialo in pribor za vensko punkcijo).
initiation pack: 14 tablets + 14 tablets + 14 tablets +14 tablets
pakiranje za začetek zdravljenja: 14 tablet + 14 tablet + 14 tablet +14 tablet
The European Commission granted a marketing authorisation valid throughout the European Union for Picato on 15 November 2012.
Evropska komisija je dovoljenje za promet z zdravilom Picato, veljavno po vsej Evropski uniji, odobrila dne 15. novembra 2012.
The patient's response to treatment can be assessed approximately eight weeks after treatment.
Bolnikov odziv na zdravljenje je mogoče oceniti v približno osmih tednih po zdravljenju.
The content of one tube covers a treatment area of 25 cm2.
Vsebina ene tube zadošča za območje zdravljenja velikosti 25 cm2.
The full EPAR for Picato 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 Picato je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is the risk associated with Picato?
Kakšna tveganja so povezana z zdravilom Picato?
The effects of Picato were first tested in experimental models before being studied in humans.
Učinki zdravila Picato so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Other information about Picato
Druge informacije o zdravilu Picato
The most frequently reported side effects are skin reactions at the application site of Picato, including erythema (reddening of the skin), flaking or scaling, crusting, swelling, vesiculation or pustulation (blisters), and erosion or ulceration (wearing away of outer skin layer or open sore of the skin).
Najpogostejši neželeni učinki, o katerih so poročali, so kožne reakcije na mestu nanosa zdravila Picato, vključno z eritemom (pordelostjo kože), luščenje ali luskavica, tvorjenje krast, otekanje, mehurjenje ali tvorba pustul (mehurjev) in erozija ali ulceracija (lupljenje zunanje kožne plasti ali odprte razjede kože).
This is a summary of the European public assessment report (EPAR) for Picato.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Picato.
For more information about treatment with Picato, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Picato preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Picato shown during the studies?
Kakšne koristi je zdravilo Picato izkazalo med študijami?
Following the application of Picato, most patients (more than 95%) experienced one or more local skin responses.
Po nanosu zdravila Picato je večina bolnikov (več kot 95 %) opazila enega ali več lokalnih kožnih odzivov.
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 Picato.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Picato, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The exact way Picato works is not fully understood.
Natančen način delovanja zdravila Picato ni v celoti znan.
It is available as a gel in two strengths (150 micrograms/g and 500 micrograms/g).
Na voljo je v obliki gela dveh jakosti (150 mikrogramov/g in 500 mikrogramov/g).
It is thought that the active substance in Picato, ingenol mebutate, works in two different ways.
Predvideva se, da zdravilna učinkovina v zdravilu Picato, ingenol mebutat, deluje na dva različna načina.
Actinic keratosis is a skin lesion that develops after too much exposure to sunlight.
Aktinična keratoza je kožna lezija, ki se razvije po čezmerni izpostavljenosti sončni svetlobi.
In all four studies, Picato was compared with vehicle (a gel without active substance).
V vseh štirih študijah so zdravilo Picato primerjali z vehiklom (gelom brez zdravilne učinkovine).
Picato must not be used in people who are hypersensitive (allergic) to ingenol mebutate or any of the other ingredients.
Zdravila Picato ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) ingenol mebutat ali katero koli drugo sestavino zdravila.
There were no major safety concerns with Picato and the side effects seen were mostly local skin reactions which, although they affected most patients, usually resolved within two to four weeks of treatment depending on the location.
V zvezi z zdravilom Picato niso opazili pomembnejših varnostnih zadržkov, opaženi neželeni učinki pa so bili večinoma lokalne kožne reakcije, ki so kljub temu, da so prizadele večino bolnikov, izzvenele v dveh do štirih tednih zdravljenja, odvisno od mesta zdravljenja.