natgillin/translations-raw huggingface dataset:
Overall summary of the scientific evaluation of Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names (see annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance ter povezanih imen (glejte Prilogo I)
Residue depletion data from a study conducted in 1993 have been provided.
Predloženi so bili podatki o izločanju ostankov iz študije, izvedene leta 1993.
Name
Izmišljeno ime
• the CVMP reviewed all available data submitted by the MAH, to support the withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days;
• CVMP je pregledal vse razpoložljive podatke, ki jih je imetnik dovoljenja za promet z zdravilom predložil za utemeljitev karence za piščančje meso in drobovino pri odmerku 20 mg/kg telesne mase 4 dni zapored;
A well conducted residue depletion study using the actual product at the maximum dose for the maximum duration of treatment is considered the most appropriate way to generate data to determine a suitable withdrawal period for a product.
Najprimernejši način za pridobitev podatkov za določitev ustrezne karence za določeno zdravilo naj bi bila dobro izvedena študija o izločanju ostankov, v kateri bi uporabili dejansko zdravilo pri največjem odmerku in za najdaljši čas zdravljenja.
Residue depletion data from a study conducted in 2011 have been provided.
Predloženi so bili podatki o izločanju ostankov iz študije, izvedene leta 2011.
Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names (see annex I) contains doxycycline hyclate as active ingredient.
Zdravilo Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance ter povezana imena (glejte Prilogo I) vsebujejo zdravilno učinkovino doksiciklin hiklat.
Residue depletion data from a study conducted in 1999 have been provided.
Predloženi so bili podatki o izločanju ostankov iz študije, izvedene leta 1999.
Following the review of all the data provided, the CVMP considered that only the two later residues depletion studies (from 1999 and 2011) should be taken into account in order to establish a withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days.
Po pregledu vseh predloženih podatkov je CVMP menil, da je treba pri določanju karence za piščančje meso in drobovino pri odmerku 20 mg/kg telesne mase 4 dni zapored upoštevati samo zadnji dve študiji o izločanju ostankov (iz leta 1999 in 2011).
Determination of the withdrawal period for chicken for the dose of 20 mg/kg body weight for 4 consecutive days
Določitev karence za piščance pri odmerku 20 mg/kg telesne mase 4 dni zapored
Based on the results a chicken meat withdrawal period of 12 days was supported using the CVMP accepted statistical approach.
Glede na rezultate so z uporabo statističnega pristopa, ki ga je odobril CVMP, za piščančje meso izračunali karenco 12 dni.
Package leaflet:
Ob upoštevanju naslednjega:
Furthermore, the test product and Soludox 500 mg/g powder for use in drinking water for pigs and chickens have different composition.
Poleg tega imata preskusno zdravilo in zdravilo Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance različno sestavo.
Two residue depletion studies, one from 1999 and one from 2011, were considered by the CVMP as providing adequate data from which to derive a withdrawal period.
CVMP je menil, da študiji o ostankih iz leta 1999 in 2011 zagotavljata ustrezne podatke, na podlagi katerih je mogoče določiti karenco.
Based on the results of the study a chicken meat withdrawal period of 5 days was supported using the CVMP accepted alternative approach.
Glede na rezultate študije so z alternativnim pristopom, ki ga je odobril CVMP, za piščančje meso izračunali karenco 5 dni.
As a result, the MAH proposes a meat withdrawal period of 6 days in chickens for Soludox 500 mg/g powder for use in drinking water for pigs and chickens when medicated at a dose of 20 mg/kg for 4 consecutive days.
Zato je imetnik dovoljenja za promet za zdravilo Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance pri odmerku 20 mg/kg 4 dni zapored predlagal 6-dnevno karenco za piščance.
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, BESEDILO ZA OZNAKE, NAVODILO ZA UPORABO
It is not felt that this can be used to support the MAH's disregard for the 1999 study since birds of various breed, weight and age will be treated with this product.
Odbor je menil, da to ne more biti razlog za to, da bi imetnik dovoljenja za promet zanemaril študijo iz leta 1999, saj se bo zdravilo uporabljalo za zdravljenje perutnine različnih pasem, telesne mase in starosti.
However, it is not felt that this can be used to support the MAH's disregard for the 1999 study since birds of various weights and from different breeds will be treated with this product.
Vendar pa je Odbor menil, da to ne more biti razlog za to, da bi imetnik dovoljenja za promet z zdravilom zanemaril študijo iz leta 1999, saj se bo zdravilo uporabljalo za zdravljenje perutnine različnih telesnih mas in pasem.
In support of this, an argument has been provided regarding the aligning of the withdrawal period for the product under discussion with those for other similar products on the grounds that bioequivalence can be assumed since it is an oral solution and the active substance is fully solubilised when in aqueous solution.
Predlog je podprl z argumentom o uskladitvi karence za obravnavano zdravilo s karenco za druga podobna zdravila, saj naj bi bilo zaradi dejstva, da gre za peroralno raztopino in da je zdravilna učinkovina popolnoma topna v vodni raztopini, mogoče predvideti biološko enakovrednost.
Instead, a 9 days withdrawal period for chicken meat and offal is recommended following a dose rate of 20 mg/kg body weight for 4 consecutive days.
Namesto nje se za piščančje meso in drobovino pri odmerku 20 mg/kg telesne mase 4 dni zapored priporoča karenca 9 dni.
4.11 Withdrawal period(s)
4.11 Karence
Route of administration
Poti Uporabe
The doctor may decide to stop treatment if the condition does not improve after 16 weeks.
Zdravnik se lahko odloči za prenehanje zdravljenja, če se stanje po 16 tednih ne izboljša.
The recommended dose is 150 mg (2 injections).
Priporočeni odmerek je 150 mg (dve injekciji).
Further information on Skyrizi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Skyrizi.
Nadaljnje informacije o zdravilu Skyrizi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Skyrizi.
There are few side effects, the most important one being infection.
Neželenih učinkov je malo, najpomembnejša med njimi je okužba.
The European Medicines Agency therefore decided that Skyrizi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Skyrizi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Skyrizi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Skyrizi?
Studies have shown that Skyrizi is highly effective at clearing the skin and the positive effects are maintained with continued use.
Študije so pokazale, da je zdravilo Skyrizi zelo učinkovito pri čiščenju kože, pozitivni učinki pa so se z nadaljnjo uporabo ohranjajo.
The first two doses of 150 mg are given 4 weeks apart while subsequent doses are given every 12 weeks.
Prva dva 150-miligramska odmerka sta dana v razmiku štirih tednov, nadaljnji odmerki pa vsakih 12 tednov.
After being trained, patients may inject Skyrizi themselves if the doctor considers it appropriate.
Bolniki si lahko po opravljenem usposabljanju zdravilo Skyrizi injicirajo sami, če zdravnik meni, da je to primerno.
What benefits of Skyrizi have been shown in studies?
Kakšne koristi je zdravilo Skyrizi izkazalo v študijah?
As for all medicines, data on the use of Skyrizi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Skyrizi stalno spremljajo.
Improvements in symptoms were maintained after 52 weeks of treatment with Skyrizi.
Simptomi so se izboljšali po 52 tednih zdravljenja z zdravilom Skyrizi.
It is used in adults with moderate to severe disease and who require systemic treatment (treatment with medicines given by mouth or by injection).
Uporablja se pri odraslih z zmerno do hudo boleznijo, ki potrebujejo sistemsko zdravljenje (zdravljenje z zdravili, ki se dajejo peroralno ali z injiciranjem).
An overview of Skyrizi and why it is authorised in the EU
Pregled zdravila Skyrizi in zakaj je odobreno v EU
What is Skyrizi and what is it used for?
Kaj je zdravilo Skyrizi in za kaj se uporablja?
Why is Skyrizi authorised in the EU?
Zakaj je bilo zdravilo Skyrizi odobreno v EU?
The most common side effect with Skyrizi (which may affect more than 1 in 10 people) is upper respiratory infection (nose and throat infection).
Najpogostejši neželeni učinek zdravila Skyrizi (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) je okužba zgornjih dihal (okužba nosu in grla).
Side effects reported with Skyrizi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Skyrizi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skyrizi have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Skyrizi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about using Skyrizi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Skyrizi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Interleukin 23 is a messenger molecule of the body's immune system (the body's natural defences) and is involved in causing inflammation that is linked to the formation of plaque psoriasis.
Interlevkin 23 je sporočilna molekula imunskega sistema telesa (naravne obrambe telesa) in sodeluje pri povzročanju vnetja, povezanega z nastankom psoriaze v plakih.
Skyrizi must not be used in patients who have an ongoing infection that the doctor considers important.
Zdravila Skyrizi ne smejo uporabljati bolniki z obstoječo okužbo, ki jo je zdravnik ocenil za resno.
In 4 main studies involving over 2,100 patients with moderate to severe disease who required systemic treatment, Skyrizi was more effective than placebo (a dummy treatment) and comparator medicines at improving symptoms.
V štirih glavnih študijah, v katerih je sodelovalo več kot 2 100 bolnikov z zmerno do hudo boleznijo, ki so potrebovali sistemsko zdravljenje, je bilo zdravilo Skyrizi pri izboljševanju simptomov učinkovitejše od placeba (zdravila brez učinkovine) in primerjalnih zdravil.
It is injected under the skin in an area that is clear of psoriasis, usually in the thighs or belly.
Injicira se pod kožo v predel brez psoriaze, običajno v stegno ali trebuh.
What are the risks associated with Skyrizi?
Kakšna tveganja so povezana z zdravilom Skyrizi?
By blocking the action of interleukin 23, risankizumab reduces inflammation and symptoms associated with the disease.
Risankizumab z zaviranjem delovanja interlevkina 23 zmanjša vnetje in simptome, povezane z boleznijo.
Skyrizi can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Predpisovanje in izdaja zdravila Skyrizi je le na recept, uporabljati pa se mora pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze v plakih.
In a second part of this study, some patients who first received Skyrizi were then switched to placebo after 28 weeks while others remained on Skyrizi.
V drugem delu te študije so nekateri bolniki, ki so najprej prejemali zdravilo Skyrizi, po 28 tednih prešli na placebo, drugi pa so nadaljevali z jemanjem zdravila Skyrizi.
The active substance in Skyrizi, risankizumab, is a monoclonal antibody (a type of protein) that is designed to attach to interleukin 23 and block its activity.
Učinkovina v zdravilu Skyrizi, risankizumab, je monoklonsko protitelo (vrsta beljakovine), ki je zasnovano tako, da se pritrdi na interlevkin 23 in zavira njegovo delovanje.
Skyrizi is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Zdravilo Skyrizi se uporablja za zdravljenje psoriaze v plakih, tj. bolezni, ki povzroča rdeče, luskaste spremembe na koži.
Other information about Skyrizi
Druge informacije o zdravilu Skyrizi
Skyrizi is available in pre-filled syringes.
Zdravilo Skyrizi je na voljo v napolnjenih injekcijskih brizgah.
How is Skyrizi used?
Kako se zdravilo Skyrizi uporablja?
In addition, around 86% of patients receiving Skyrizi had clear or almost clear skin, compared with around 62% of those receiving ustekinumab and around 6% of those receiving placebo.
Poleg tega je imelo približno 86 % bolnikov, ki so prejemali zdravilo Skyrizi, čisto ali skoraj čisto kožo, v primerjavi s približno 62 % bolnikov, ki so prejemali ustekinumab, in okoli 6 % tistih, ki so prejemali placebo.
In addition, 84% of patients receiving Skyrizi had clear or almost clear skin, compared with 60% of those receiving adalimumab.
Poleg tega je imelo 84 % bolnikov, ki so prejemali zdravilo Skyrizi, čisto ali skoraj čisto kožo, v primerjavi s 60 % bolnikov, ki so prejemali adalimumab.
Around 84% of patients receiving Skyrizi had clear or almost clear skin, compared with around 7% of those receiving placebo.
Približno 84 % bolnikov, ki so prejemali zdravilo Skyrizi, je imelo čisto ali skoraj čisto kožo, v primerjavi s približno 7 % bolnikov, ki so prejemali placebo.
How does Skyrizi work?
Kako zdravilo Skyrizi deluje?
In the first two studies in a total of 997 patients, after 16 weeks of treatment around 75% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores (a measure of how severe and widespread the skin lesions are), compared with around 45% of those receiving ustekinumab and around 4% of those receiving placebo.
V prvih dveh študijah, ki sta skupaj zajeli 997 bolnikov, se je po 16 tednih zdravljenja ocena PASI (merilo, kako hude in razširjene so kožne lezije) znižala za vsaj 90 % pri približno 75 % bolnikov, ki so prejemali zdravilo Skyrizi, v primerjavi s približno 45 % bolnikov, ki so prejemali ustekinumab, in približno 4 % tistih, ki so prejemali placebo.
In the third study involving 605 patients, after 16 weeks of treatment 72% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 47% of those receiving adalimumab.
V tretji študiji, v katero je bilo vključenih 605 bolnikov, se je po 16 tednih zdravljenja ocena PASI znižala za vsaj 90 % pri 72 % bolnikov, ki so prejemali zdravilo Skyrizi, v primerjavi s 47 % bolnikov, ki so prejemali adalimumab.
At week 52, more patients who remained on Skyrizi had had clear or almost clear skin than those who were switched to placebo.
V 52. tednu je imelo čisto ali skoraj čisto kožo več bolnikov, ki so nadaljevali z jemanjem zdravila Skyrizi, kot tistih, ki so prešli na jemanje placeba.
Finally, in the fourth study involving 507 patients, after 16 weeks of treatment 73% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 2% of those receiving placebo.
V četrti študiji, v katero je bilo vključenih 507 bolnikov, se je po 16 tednih zdravljenja ocena PASI znižala za vsaj 90 % pri 73 % bolnikov, ki so prejemali zdravilo Skyrizi, v primerjavi z 2 % bolnikov, ki so prejemali placebo.
(Invented) name Strength
(Izmišljeno) ime Jakost
ATC vet code: QI07AD04.
Oznaka ATC vet: QI07AD04.
A good immune response is reliant on a fully competent immune system.
Dober imunski odziv je odvisen od popolnoma kompetentnega imunskega sistema.
Such reactions may evolve to a more severe condition, which may be life-threatening.
Take reakcije se lahko razvijejo v težja stanja, ki lahko ogrožajo življenje.
If protection against rabies is required:
Če je potrebna zaščita pred steklino:
Can be used during the second and third stages of pregnancy.
Lahko se uporablja v drugem in tretjem obdobju brejosti.
Use immediately after reconstitution.
Uporabite takoj po rekonstituciji.
Store and transport refrigerated (2 °C - 8 °C).
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C)
Date of last renewal: 27/03/2019.
Datum zadnjega podaljšanja dovoljenja za promet: 27/03/2019.
In situations where very high maternally derived antibody levels are expected, the vaccination protocol should be planned accordingly.
V primerih, ko se pričakuje zelo visoka raven maternalnih protiteles, je potrebno pri načrtovanju protokola cepljenja to upoštevati.
This can be painful, warm or reddened.
Oteklina je lahko boleča, topla ali rdeča.
Anorexia and decreased activity are rarely observed.
Redko se pojavita anoreksija in zmanjšana aktivnost.
Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.
Vsaka taka oteklina bodisi izgine ali pa se znatno zmanjša v 14 dneh po cepljenju.
However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated dogs separated from nonvaccinated dogs and domestic cats.
Zaradi nizke patogenosti teh sevov ločevanje cepljenih psov od necepljenih psov in domačih mačk ni potrebno.
MARKETING AUTHORISATION NUMBER(S) EU/2/14/169/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/169/001
Leptospira:
Leptospiroza:
Active immunisation of dogs from 6 weeks of age:
Aktivna imunizacija psov, starejših od 6 tednov:
− 3 weeks after the first vaccination for CDV, CAV, CPV, and
− 3 tedne po prvem cepljenju proti CDV, CAV, CPV, in
Do not mix with any veterinary medicinal products except those mentioned in section 4.8.
Ne mešajte z nobenimi drugimi zdravili za uporabo v veterinarski medicini, razen s tistimi navedenimi v poglavju 4.8.
Safety of the product during the early stage of pregnancy and during lactation have not been investigated.
Varnost zdravila v prvem obdobju brejosti in v obdobju laktacije ni bila ugotovljena.
Shelf life after reconstitution according to directions: use immediately.
Rok uporabnosti po rekonstituciji v skladu z navodili: uporabite takoj.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera do primera.
Systemic reactions such as lethargy, hyperthermia and general malaise may occur very rarely.
Sistemske reakcije kot so letargija, hipertermija in splošno slabo počutje se pojavljajo zelo redko.
Solvent: Water for injections
Vehikel: voda za injekcije
Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Imunokompetenco živali lahko ogrožajo različni dejavniki, vključno s slabim zdravstvenim stanjem, stanjem prehranjenosti, genetskimi dejavniki, sočasnim zdravljenjem z drugimi zdravili in stresom.
Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years.
Zaščitni imunski odgovor proti CAV-2 pridruženim respiratornim virusom traja vsaj 3 leta.
Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protected when challenged.
Titer protiteles pade v obdobju triletnega trajanja imunosti, kljub temu so psi zaščiteni, če so izpostavljeni okužbi.
The duration of immunity against CAV-2 was not established by challenge.
Trajanje imunosti proti CAV-2 virusu z izzivom ni bilo ugotovljeno.
Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae), živa virusna cepiva.
It was shown that 3 years after the vaccination CAV-2 antibodies are still present.
Dokazano je bilo, da so 3 leta po cepljenju, protitelesa proti CAV-2 še vedno prisotna.
A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs.
Prehodna oteklina (do 5 cm) se lahko pogosto pojavi na mestu injiciranja po subkutani aplikaciji pri psih.
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies.
Učinkovitost komponente za steklino po enkratnem odmerku v starosti od 12 tednov naprej je dokazana v laboratorijskih študijah.
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/).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
At least one year following the primary vaccination course for canine parainfluenza virus.
Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence.
However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Študije na terenu so pokazale, da pri 10 % serološko negativnih psov ne pride do serološke konverzije (> 0,1 i.e./ml) 3-4 tedne po enkratnem cepljenju proti steklini.
If such a reaction occurs, appropriate treatment should be administered without delay.
V primeru pojava je potrebno takojšnje ustrezno zdravljenje.
However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine.
Pri manjšem številu živali so opazili bolečino na mestu injiciranja takoj po dajanju 10-krat prevelikega odmerka cepiva.
A single dose of Versican Plus DHPPi should be given every 3 years.
Enkratni odmerek Versican Plus DHPPi je potrebno dati vsaka 3 leta.
VIAL (1 ML SOLVENT)
VIALA (1 ML VEHIKEL)
Annual re-vaccination is required for Parainfluenza, therefore a single dose of compatible vaccine Versican Plus Pi can be used annually as required.
Vsako leto je treba ponoviti cepljenje proti virusu parainfluence, za kar se lahko uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi.
Solvent: clear colourless liquid.
Vehikel: bistra brezbarvna tekočina.
Solve nt: Water for injections (Aqua ad iniectabilia)
voda za injekcije (Aqua ad iniectabilia)
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
Immunological responses to the CDV, CAV and CPV components of the vaccine may be delayed due to maternally derived antibody interference.
Imunski odgovor na komponente cepiva CDV, CAV in CPV je lahko zapoznel zaradi navzkrižnega delovanja maternalnih protiteles.
The mixed vaccines should be injected immediately via the subcutaneous route.
Zmešani cepivi je treba takoj injicirati subkutano.
The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
Vakcinalni sev CPV-2b ni bil preizkušen na drugih mesojedih (z izjemo psov in domačih mačk), ki so dovzetni za pasje parvoviruse, zato je po cepljenju treba cepljene pse od njih ločiti.
Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely.
Preobčutljivostne reakcije (gastrointestinalni znaki, kot so driska in bruhanje, anafilaksa, angioedem, dispneja, cirkulatorni šok, kolaps) se redko pojavljajo.