natgillin/translations-raw huggingface dataset:
An individual carton box contains a single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap.
V eni zloženki je en napolnjen injektor za enkratno uporabo v igli za podkožno dajanje z zaščitnim pokrovčkom
The supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of the preferred injection volumes for fish of widely varying body weights.
S priloženim vehiklom razredčimo koncentrat do ustrezne razredčitve, s katero lahko pripravimo optimalni volumen raztopine za injiciranje za ribe z najrazličnejšimi telesnimi masami.
Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate.
Azagli-nafarelin, 1600 g/ml, v obliki azagli-nafarelin acetata
EXP {month/year} After dilution, the product should be used immediately.
EXP {mesec/leto} Razredčen izdelek morate takoj uporabiti.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
Solvent vial: 100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap.
Viala z vehiklom: viala po 100 ml iz prozornega stekla, ki vsebuje 100 ml raztopine; gumijasti zamašek in zaporka brez navoja.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE
ADMINISTRATION:
DAJANJE:
Position the dog as described for administration of the implant.
Psico namestimo v enak položaj kot pri vnašanju implantata.
Concentrate vial: 3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap.
Viala s koncentratom: viala po 3 ml iz rjavega stekla, ki vsebuje 2 ml raztopine; gumijasti zamašek in zaporka brez navoja.
For animal treatment only- to be supplied only on veterinary prescription.
Izdaja zdravila je le na veterinarski recept.
<Batch> <Lot> <BN> {number}
<Serija> <lot><številka serije>{številka}
Personal protective equipment, consisting of gloves, should be worn when handling the veterinary medicinal product.
Osebe, ki dajejo zdravilo živalim, morajo pri mešanju koncentrata z vehiklom uporabljati zaščitne rokavice.
Marketing authorisation holder and manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec:
Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered continuously.
Azagli-nafarelin, agonist GnRH, deluje pri trajnem dajanju dvofazno na hipofizo.
Operators should wear gloves when mixing the concentrate solution with the solvent.
Osebe, ki dajejo zdravilo živalim, morajo pri mešanju koncentrata s topilom uporabljati zaščitne rokavice.
Owing to their pharmacological activity (inhibition of the production of sex steroids), administration of GnRH agonists to bitches might be associated with vaginitis.
Pri dajanju agonistov GnRH psicam se lahko zaradi njihovega farmakološkega delovanja (zaviranja nastajanja spolnih steroidov) pojavi vaginitis.
VIAL CONTAINING SOLVENT:
VIALA Z VEHIKLOM:
Fig.4
Slika 4
Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout.
Azagli-nafarelin se pri kalifornijskih postrvih (šarenkah) po intraperitonealnem dajanju hitro absorbira.
With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion (Fig. 2).
Iglo držimo tako, da je njena konica obrnjena navzgor in jo z eno potezo vbodemo pod kotom 30 stopinj podkožno v kožno gubo (slika 2).
After dilution, the product should be used immediately.
Razredčeni izdelek morate takoj uporabiti.
Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
6.1 Seznam pomožnih snovi benzilni alkohol natrijev acetat (trihidrat) ocetna kislina, koncentrirana; ledocet natrijev klorid / klorovodikova kislina 4N (za uravnavo pH)
Vial containing solvent
Viala z vehiklom
A reduction in the egg quality is seen after administration of doses above the recommended therapeutic dose.
Po dajanju odmerkov nad priporočenim terapevtskim odmerkom so zasledili manjšo kakovost iker.
Acetic acid, glacial
ocetna kislina (ledocet)
Active substance: Azagly-nafarelin 18.5 mg per implant
Azagli-nafarelin 18,5 mg v implantatu
An empty sterile mixing vial is supplied separately.
Posebej je priložena prazna, sterilna mešalna viala.
Remove the needle cap.
Snamemo igelni pokrovček.
Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin too early in the spawning season.
Pri ribah, ki so jim dajali azagli-nafarelin prezgodaj v sezoni mrestenja, so zasledili manjšo plodnost, slabšo kakovost iker in slabše preživetje do stopnje z očmi.
With the bevel of the needle facing upwards, insert the needle at a 30 degree angle to the tented skin in a single motion, subcutaneously.
Iglo držimo tako, da je njena konica obrnjena navzgor in jo z eno potezo vbodemo pod kotom 30 stopinj podkožno v kožno gubo.
Active substance(s)
Zdravilna(e) učinkovina(e):
Medical advice should be sought immediately in cases in which the concentrated solution or several ml of the diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection.
Če na kožo ali v oči nanesete koncentrirano raztopino ali več mililitrov razredčene raztopine ali si raztopino nenamerno samo-injicirate, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout.
Pri kalifornijskih postrvih (šarenkah) se azagli-nafarelin po intraperitonealnem dajanju hitro izloči iz plazme.
The dose should be administered in the preferred volume for the particular body weight of fish.
Odmerek dajemo v volumnu, ki ustreza telesni masi ribe.
Solvent for solution for injection.
Vehikel za raztopino za injiciranje
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
Sachet
KARENCA
ATC vet code: QH01CA
Farmakoterapevtska skupina: gonadotropin sproščajoči hormon Oznaka ATCvet: QH01CA
WITHDRAWAL PERIOD
Povprečno trajanje blokade
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Avoid self injection.
Pazite, da si izdelka ne bi injicirali.
Sodium acetate (tri-hydrate)
Ni za uporabo pri ribah, katerih ikre so namenjene za prehrano natrijev acetat (trihidrat)
Strength Pharmaceutical Form Route of Administration
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
23 October 2000
23. oktober 2000
See the Module “All authorised presentations”
Glejte modul ”All authorised presentations”
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
type 2 (MEF 1)
tipa 2 (MEF 1)
type 3 (Saukett)
tipa 3 (Saukett)
These studies showed the protective efficacy of Hexavac against the above diseases in infants.
Te študije so pokazale zaščitno učinkovitost zdravila Hexavac proti zgoraj omenjenim otroškim boleznim.
For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules.
Podrobnosti o pogojih uporabe tega zdravila, znanstvene informacije in postopkovne vidike najdete v ustreznih modulih.
type 1 (Mahoney)
tipa 1 (Mahoney)
AVENTIS PASTEUR MSD, SNC 8, rue Jonas Salk
Imetnik dovoljenja za promet z zdravilom: AVENTIS PASTEUR MSD, SNC 8 rue Jonas Salk
The CHMP, on the basis of quality, efficacy and safety data submitted, consideres that the overall benefit /risk ratio for Hexavac remains favourable in the approved indication.
Na podlagi predloženih podatkov o kakovosti, učinkovitosti in varnosti CHMP meni, da vsesplošno razmerje med koristmi in tveganji za zdravilo Hexavac ostaja ugodno za odobreno indikacijo.
Bacterial and viral vaccines, combined (J07CA)
Kombinacije bakterijskih in virusnih cepiv (JO7CA)
Pharmaco-therapeutic group (ATC Code):
Farmakoterapevtska skupina (ATC oznaka):
The most common adverse events were transient local reactions (pain, redness, swelling at the injection site) and systemic reactions (loss of appetite, fever, drowsiness, irritability).
Najpogostejši neželeni učinki so bile prehodne lokalne reakcije (bolečina, rdečina, oteklina na mestu injiciranja) in sistemske reakcije (izguba apetita, telesna temperatura, zaspanost, razdražljivost).
The approval was based on results from clinical trials, which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules.
Odobritev je temeljila na kliničnih preizkušanjih, v katerih so raziskovali imunogenost in reaktogenost zdravila Hexavac, kadar se ga daje v skladu z določeno shemo osnovnega in obnovitnega cepljenja.
The following adverse effects were reported very rarely: allergic reaction, chills, fatigue, hypotonichyporesponsive episode, malaise, oedema, pallor, swelling or oedema of the entire limb(s), transient local lymph node swelling, convulsions (febrile and non febrile), encephalitis, encephalopathy with acute brain oedema, eyes rolling, Guillain Barré Syndrome, hypotonia, neuritis, abdominal pain, meteorism, nausea, petechiae, purpura, purpura thrombocytopenic, thrombocytopenia, agitation, sleep disorder, dyspnoea or Stridor inspiratory, angioedema, erythema, pruritus, rash, urticaria and flushing.
Zelo redko pa poročajo o naslednjih neželenih učnikih: alergične reakcije, mrzlica, utrujenost, hipotonična-hipoodzivna epizoda, splošna slabost, edem bledica, otekanje ali edem celotnega uda(ov), prehodno otekanje lokalnih limfnih vozljev, krči (vročinski in nevročinski), encefalitis, encefalopatija za akutnim edemom v možganih, vrtenje oči, sindrom Guillain Barré hipotonija, nevritis, bolečine v trebuhu meteorizem, slabost, petehije, purpura, trombocitopenična purpura, trombocitopenija, razburjenje, motnje spanja, oteženo dihanje ali škripavo vdihovanje, angioedem, rdeč kožni madeži, srbečica, izpuščaj, urtikarija in rdenje.
Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, polio virus and Haemophilus influenzae type b. It is developed for primary and booster vaccination of children against the viruses and bacteria mentioned above.
Hexavac je heksavalentno cepivo, ki vsebuje kombinirane antigene, ki izhajajo iz Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virusa hepatitisa B, virusa polia ter Haemophilusu influenzae typa b. Razvito je za osnovno in obnovitveno cepljenje otrok proti zgoraj omenjenim virusom in bakterijam.
This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Kombinirano cepivo je indicirano za osnovno in obnovitveno cepljenje otrok proti davici, tetanusu, pertusisu, hepatitisu B, ki ga povzročajo vsi znani podtipi virusov, otroški ohromelosti in invazivnim okužbam, ki jih povzroča Haemophilus influenzae
Purified adsorbed diptheria toxoid (PDT) Purified tetanus toxoid (PTT) Purified pertussis toxoid (PTxT) Purified pertussis filamentous haemagglutinin (FHA) Hepatitis B S surface antigen recombinant (HBsAG) Inactivated poliovirus (IPV):
Prečiščen adsorbiran davični toksoid (PDT) Prečiščen tetanusni toksoid (PTT) Prečiščen toksoid pertusisa (PTxT) Prečiščen filamentozni hemaglutinin pertusisa (FHA) Rekombinantni površinski antigen virusa hepatitisa B S (HBsAG)
Haemophilus influenzae type b polysaccharide, conjugated to tetanus protein (PRP-T)
Polisaharid bakterije Hemofilius influenzae tipa b, konjugiran na tetanusni protein (PRP-T)
International Nonproprietary Name (INN): Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
Mednarodno nelastniško ime (INN): Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno), otroški ohromelosti (inaktivirano), hepatitisu B (rekombinantno) in proti Hemofilius influenzae tipa b (konjugirano cepivo), z adjuvansom
Oral use sachet (LDPE/Alu/LDPE/paper)
60 mg zrnca za peroralno raztopino peroralna uporaba vrečka (LDPE/Alu/LDPE/papir)
1 sachet
1 vrečka
Granules for oral suspension
Pot uporabe Stična ovojnina
Pack size
Vsebina
Frequencies are defined as: very common (≥1/10), common (1/100 to 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Some medicines may increase the effects of Airexar Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Nekatera zdravila lahko povečajo učinek zdravila Airexar Spiromax in zdravnik vas bo morda želel skrbno spremljati, če jemljeta ta zdravila (vključno z nekaterimi zdravili za HIV: ritonavirjem,
• Airexar Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
• Zdravilo Airexar Spiromax lahko vpliva na normalno nastajanje steroidnih hormonov v telesu, zlasti če dalj časa jemljete visoke odmerke.
If you are not using Airexar Spiromax properly and/or you are not breathing in forcefully enough, this may mean that you are not getting enough of the medicine into your lungs.
Če zdravila Airexar Spiromax ne uporabljate pravilno in/ali če ne vdihujete dovolj močno, lahko to pomeni, da ne dobite dovolj zdravila v pljuča.
Airexar Spiromax is not available on the market at strengths lower than 50/500 microgram.
Zdravilo Airexar Spiromax na trgu ni na voljo v jakosti, manjši od 50/500 mikrogramov.
• Diabetes mellitus (Airexar Spiromax may increase your blood sugar)
• sladkorno bolezen (zdravilo Airexar Spiromax lahko zviša krvni sladkor)
The safety and efficacy of Airexar Spiromax in this young population have not been established.
Varnost in učinkovitost zdravila Airexar Spiromax pri tej mladi populaciji še nista bili dokazani.
Two children on salmeterol/fluticasone propionate/ and 5 children on fluticasone propionate withdrew because of worsening asthma.
Dva otroka na salmeterolu/flutikazonpropionatu in 5 otrok na flutikazonproprionatu je zaradi poslabšanja astme izstopilo iz študije.
Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Salmeterol je selektiven, dolgodelujoč (12 ur) agonist adrenergičnih receptorjev β2; ima dolgo stransko verigo, ki se veže na ekso-mesto receptorja.
Administration of Airexar Spiromax to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Zato naj se zdravilo Airexar Spiromax pri nosečnicah uporablja samo, če so pričakovane koristi za mater večje od vseh možnih tveganj za plod.
• Use your Airexar Spiromax every day until your doctor advises you to stop.
• Zdravilo Airexar Spiromax uporabljajte vsak dan, dokler vam zdravnik ne svetuje, da nehate.
If you are using Airexar Spiromax for asthma, your doctor will want to check your symptoms regularly.
Če uporabljate zdravilo Airexar Spiromax za astmo, bo zdravnik redno spremljal vaše simptome.
If you get any of these effects or if they happen suddenly after using Airexar Spiromax, stop using Airexar Spiromax and tell your doctor straight away.
Če se pojavi kateri koli od teh neželenih učinkov ali če se ti pojavijo nenadoma po uporabi zdravila Airexar Spiromax, takoj prenehajte uporabljati zdravilo Airexar Spiromax in to takoj povejte zdravniku.
The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Airexar Spiromax.
Študije, opisane v nadaljevanju (GOAL, TORCH in SMART), so bile izvedene z enako fiksno kombinacijo odmerkov salmeterolijevega ksinafoata in flutikazonpropionata, vendar s predhodno odobrenim zdravilom; opisane študije niso bile izvedene z zdravilom Airexar Spiromax.
Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Airexar Spiromax.
Alergijske reakcije: opazite lahko, da se dihanje poslabša takoj po uporabo zdravila Airexar Spiromax.
Before using your Airexar Spiromax for the first time, you need to prepare it for use as follows:
Pred prvo uporabo zdravila Airexar Spiromax ga morate na uporabo pripraviti na naslednji način:
Tell your doctor if you notice any of the following symptoms while taking Airexar Spiromax as they could be symptoms of a lung infection: fever or chills; increased mucus production, changes in mucus colour; increased cough or increased breathing difficulties.
Zdravniku povejte, če med uporabo zdravila Airexar Spiromax opazite kar koli od naslednjega, saj so lahko to simptomi okužbe pljuč: zvišano telesno temperaturo ali mrzlico; obilnejše nastajanje sluzi, spremenjeno barvo sluzi; močnejši
You must use Airexar Spiromax every day as directed by your doctor.
Zdravilo Airexar Spiromax morate uporabljati vsak dan, kot vam je predpisal zdravnik.
In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
Pri bolnikih z astmo ali KOPB so opažali manjšo stopnjo sistemske izpostavljenosti flutikazonpropionatu.
• Airexar Spiromax should be inhaled through the mouth into the lungs.
• Zdravilo Airexar Spiromax inhalirajte v pljuča skozi usta.
The use of Airexar Spiromax follows three simple steps: open, breathe and close which are outlined below.
Zdravilo Airexar Spiromax se uporablja v treh preprostih korakih: odprite, vdihnite in zaprite, kot je
A decision must be made whether to discontinue breastfeeding or to discontinue Airexar Spiromax therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Airexar Spiromax, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
If Airexar Spiromax therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered.
Če je treba zdravljenje z zdravilom Airexar Spiromax prekiniti zaradi prevelikega odmerjanja agonista β v zdravilu, morate pretehtati ustrezno nadomestno terapijo s steroidom.
The data presented below refer to a lower dose of the fixed-dose combination containing these two actives, a dose and strength which is not available for Airexar Spiromax.
Podatki, predstavljeni v nadaljevanju, se nanašajo na manjši odmerek fiksne kombinacije odmerka, ki vsebuje ti dve zdravilni učinkovini; odmerek in jakost, v kateri zdravilo Airexar Spiromax ni na voljo.
If you forget to use Airexar Spiromax Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Airexar Spiromax Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Each Airexar Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow
En inhalator zdravila Airexar Spiromax vsebuje 60 inhalacij in ima belo telo s polprozornim rumenim
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Airexar Spiromax.
Bolnikom je treba naročiti, naj z zdravljenjem nadaljujejo, vendar naj se posvetujejo z zdravnikom, če simptomi astme niso pod nadzorom ali če se po uvedbi zdravila Airexar Spiromax poslabšajo.
Keep the mouthpiece closed all the times unless you are about to use your inhaler.
Ustnik naj bo vedno zaprt, razen če nameravate inhalator uporabiti.
- if you are allergic (hypersensitive) to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Airexar Spiromax: - če ste alergični (preobčutljivi) na salmeterol, flutikazonpropionat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What Airexar Spiromax looks like and contents of the pack Airexar Spiromax is an inhalation powder.
Izgled zdravila Airexar Spiromax in vsebina pakiranja Zdravilo Airexar Spiromax je prašek za inhaliranje.
In a study in 158 children aged 6 to 16 years with symptomatic asthma, the combination of salmeterol/ fluticasone propionate/ is as efficacious as doubling the dose of fluticasone propionate in respect of symptom control and lung function.
V študiji na 158 otrocih, starih od 6 do 16 let, s simptomatsko astmo, je v smislu nadzora simptomov in pljučne funkcije kombinacija salmeterola/flutikazonpropionata enako učinkovita kot podvojitev odmerka flutikazonpropionata.
Cardiac arrhythmias (including supraventricular
Pogostnost motnje srčnega ritma (vključno s supraventrikularno tahikardijo in ekstrasistolami)
What Airexar Spiromax is and what it is used for
Kaj je zdravilo Airexar Spiromax in za kaj ga uporabljamo
If a patient with severe COPD has experienced pneumonia, treatment with Airexar Spiromax should be re-evaluated.
Če je bolnik s hudo obliko KOPB zbolel za pljučnico, je treba zdravljenje z zdravilom Airexar Spiromax ponovno oceniti.
The study showed that doubling the inhalations of each strength of salmeterol/fluticasone propionate for up to 14 days resulted in a small increase in β agonistrelated adverse events (tremor - 1 patient [1%] vs 0, palpitations - 6 [3%] vs 1 [<1%], muscle cramps -6 [3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily.
Študija je pokazala, da je podvojitev obeh jakosti, salmeterola/flutikazonpropionata za do 14 dni povzročila majhno povečanje neželenih učinkov, povezanih z agonisti β (tremor - 1 bolnik [1 %] v primerjavi z 0, palpitacije - 6 [3 %] v primerjavi z 1 [< 1 %], mišični krči - 6 [3 %] v primerjavi z 1 [< 1 %]) in podobno pojavnost neželenih učinkov, povezanih z inhalacijo kortikosteroidov (npr. kandidazo ustne votline - 6 [6 %] v primerjavi s 16 [8 %], hripavost - 2 [2 %] v primerjavi s 4 [2 %]) v primerjavi z enim inhaliranjem dvakrat na dan.
There are no data available from clinical trials on overdose with Airexar Spiromax, however data on overdose with both active substances are given below:
Podatkov o prevelikem odmerjanju zdravila Airexar Spiromax iz kliničnih preskušanj ni; podatki o prevelikem odmerjanju z obema zdravilnima učinkovinama so navedeni spodaj:
Airexar Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Zdravilo Airexar Spiromax ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 4.2).
Airexar Spiromax should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Uporabo zdravila Airexar Spiromax je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je potrebno.
The safety and efficacy of Airexar Spiromax in children and adolescents aged less than 18 years of age has not been established.
Varnost in učinkovitost zdravila Airexar Spiromax pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.