natgillin/translations-raw huggingface dataset:
• Choose an injection site on your belly.
• Izberite mesto za injiciranje na trebuhu, najbolje okoli popka.
• take out the grey needle slowly at the same angle
• Počasi izvlecite sivo iglo pod istim kotom.
Do not use this medicine after the expiry date which is stated on the carton, vial and pre-filled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli, viali in napolnjeni injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• Hold the syringe with the grey needle pointing upwards and check for any air bubbles.
• Brizgo s sivo iglo držite obrnjeno navzgor in preverite ali so v njej zračni mehurčki.
Preparing the injection site and injecting your medicine
Priprava mesta injiciranja in injiciranje zdravila
The powder vial contains 0.25 mg cetrorelix and the pre-filled syringe contains 1 ml solvent.
Viala praška vsebuje 0,25 mg cetroreliksa, napolnjena injekcijska brizga pa vsebuje 1 ml vehikla.
• use your second alcohol swab to gently apply pressure where you have just pierced your skin
• Z drugo alkoholno blazinico nežno pritisnite na mesto, kjer ste prebodli kožo.
This medicine must be at room temperature prior to injection.
Zdravilo mora pred injiciranjem imeti sobno temperaturo.
Ovarian Hyperstimulation Syndrome (OHSS) This may occur due to the other medicines that you are using to stimulate your ovaries.
Do OHSS lahko pride zaradi uporabe drugih zdravil, ki jih jemljete za stimuliranje jajčnikov.
Cetrotide blocks a natural hormone in your body called LHRH (‘luteinising hormone releasing hormone').
Zdravilo Cetrotide blokira naravni hormon v vašem telesu, imenovan LHRH ('gonadotropin sproščajoči hormon').
• one pre-filled syringe with sterile water (solvent)
• eno napolnjeno injekcijsko brizgo s sterilno vodo (vehikel)
• Mild and short-lasting skin irritation may occur at the injection site like redness, itching or swelling.
• blago in kratkotrajno draženje kože se lahko pojavi na mestu injiciranja, kot je pordela koža,
Cetrotide should only be reconstituted with the solvent provided, using a gentle, swirling motion.
Zdravilo Cetrotide smete rekonstituirati samo s priloženim vehiklom, z rahlim vrtenjem.
Uncommon: Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis.
Sistemske alergijske/psevdoalergijske reakcije, vključno z življenjsko nevarno anafilaktično reakcijo.
• one needle with a yellow mark - for injecting the sterile water into the vial and drawing the made-up medicine out from the vial
• eno iglo z rumeno oznako - za injiciranje sterilne vode v vialo in za odvzem pripravljenega zdravila iz viale
1 injection needle (20 gauge)
1 injekcijsko iglo (20 G)
7 injection needles (20 gauge) 7 hypodermic injection needles (27 gauge) 14 alcohol swabs.
7 injekcijskih igel (20 G) 7 subkutanih injekcijskih igel (27 G) 14 alkoholnih blazinic
How to use Cetrotide
Kako uporabljati zdravilo Cetrotide
Mild to moderate OHSS (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure (see section 4.4).
stopnje po SZO), ki je intrinzično tveganje postopka stimulacije (glejte poglavje 4.4).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
If you notice any of the side effects above, contact your doctor immediately.
Če opazite katerega koli od zgoraj navedenih neželenih učinkov, o tem nemudoma obvestite svojega zdravnika.
When it is mixed, it will look clear and have no particles in it.
Ko sta voda in prašek zmešana, bo vsebina bistra in ne bo vsebovala delcev.
Remove the cap from the vial
Z viale odstranite zaporko
This medicinal product must be allowed to reach room temperature prior to injection.
Zdravilo mora pred injiciranjem doseči sobno temperaturo.
Do not use the prepared solution in the vial if it is not clear and colourless or if it has particles in it. Do not throw any medicines via wastewater or household waste.
Ne uporabljajte pripravljene raztopine v viali, če ni več bistra in brezbarvna ali če vsebuje delce.
Cetrorelix has not been studied in patients with renal impairment and caution is therefore warranted.
Cetroreliksa niso preučili pri bolnicah z ledvično okvaro, zato je pri njih potrebna previdnost.
Unscrew the yellow needle from the syringe and lay down the syringe.
Rumeno iglo odvijte z brizge in brizgo odložite.
• Use your second alcohol swab to gently apply pressure where you have just injected.
• Z drugo alkoholno blazinico nežno pritisnite na mesto, kjer ste injicirali zdravilo.
Cetrotide contains a medicine called ‘cetrorelix'.
Cetrotide je zdravilo, ki vsebuje učinkovino cetroreliks.
Remove the cap from the needle.
Z igle odstranite zaporko.
• You start by using another medicine on day 1 of your treatment cycle.
• Na začetku, prvi dan cikla zdravljenja, vzamete drugo zdravilo.
How Cetrotide works
Kako deluje zdravilo Cetrotide
• Unwrap the needle with the yellow mark on it.
• Odvijte iglo, ki ima rumeno oznako.
• one needle with a grey mark - for injecting the medicine into your belly
• eno iglo s sivo oznako - za injiciranje zdravila v trebuh
Cetrotide is used together with other medicines that stimulate your ovaries to develop more eggs ready to be released.
Sindrom hiperstimulacije jajčnikov (OHSS, Ovarian Hyperstimulation Syndrome) Zdravilo Cetrotide se uporablja skupaj z drugimi zdravili, ki stimulirajo jajčnike, da proizvedejo več jajčec za sprostitev.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 VIAL AND 1 PRE-FILLED SYRINGE CARTON OF 7 VIALS AND 7 PRE-FILLED SYRINGES
KARTONSKA ŠKATLA Z 1 VIALO IN 1 NAPOLNJENO INJEKCIJSKO BRIZGO KARTONSKA ŠKATLA S 7 VIALAMI IN 7 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI
1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
1 injekcijska igla (20 G) 1 subkutana injekcijska igla (27 G) 2 alkoholni blazinici
Allergies Tell your doctor before using Cetrotide if you have an active allergy or have had allergies in the past.
Preden začnete uporabljati zdravilo Cetrotide, obvestite zdravnika, če imate oz. ste v preteklosti imeli alergije.
Hepatic impairment Cetrorelix has not been studied in patients with hepatic impairment and caution is therefore warranted.
Jetrna okvara Cetroreliksa niso preučili pri bolnicah z jetrno okvaro, zato je pri njih potrebna previdnost.
Tell your doctor before using Cetrotide if you have a kidney disease.
Pred uporabo zdravila Cetrotide obvestite zdravnika, če imate ledvično bolezen.
Vigorous shaking with bubble formation should be avoided.
Izogibati se morate močnemu stresanju zdravila s tvorbo mehurčkov.
Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
stopnje po SZO), ki ga je treba upoštevati kot intrinzično tveganje postopka stimulacije.
Tell your doctor before using Cetrotide if you have a liver disease.
Pred uporabo zdravila Cetrotide obvestite zdravnika, če imate jetrno bolezen.
What Cetrotide is used for
Za kaj se uporablja zdravilo Cetrotide
• Ask your pharmacist how to safely dispose of used needles, vial and syringe.
• O varnem odstranjevanju uporabljenih igel, vial in brizg se posvetujte s farmacevtom.
Each vial contains 0.25 mg cetrorelix (as acetate).
Vsaka viala vsebuje 0,25 mg cetroreliksa (v obliki acetata).
Cetrorelix dose-dependently inhibits the secretion of LH and FSH from the pituitary gland.
Cetroreliks zavira izločanje LH in FSH iz hipofize v odvisnosti od odmerka.
No target organ toxicity could be observed from acute, subacute and chronic toxicity studies in rats and dogs following subcutaneous administration of cetrorelix.
V študijah akutne, subakutne in kronične toksičnosti pri podganah in psih po subkutani aplikaciji cetroreliksa niso opazili toksičnosti za ciljne organe.
Common (may affect up to 1 in 10 women):
Pogosti (pojavijo se lahko pri največ 1 od 10 žensk):
1 hypodermic injection needle (27 gauge)
1 subkutano injekcijsko iglo (27 G)
Bad effects are not expected if you accidentally inject more of this medicine than you should.
Če ste uporabili večji odmerek zdravila Cetrotide, kot bi smeli Ni verjetno, da bi prišlo do neželenih učinkov, če bi si pomotoma injicirali več zdravila Cetrotide, kot bi smeli.
• Remove the cap from the pre-filled syringe and screw the yellow needle onto it.
• Z napolnjene brizge odstranite zaporko in nanjo privijte rumeno iglo.
After reconstitution with the solvent provided, each mL of the solution contains 0.25 mg cetrorelix.
Po rekonstituciji s priloženim vehiklom vsebuje en ml raztopine 0,25 mg cetroreliksa.
1 powder vial with 0.25 mg cetrorelix.
1 viala praška z 0,25 mg cetroreliksa.
Cetrotide has not been investigated in patients with hepatic disease.
Zdravila Cetrotide niso preučili pri bolnicah z jetrno boleznijo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 0.25 mg cetrorelix (as acetate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 0,25 mg cetroreliksa (v obliki cetroreliksijevega acetata).
Cetrotide has not been investigated in patients with kidney disease.
Zdravila Cetrotide niso preučili pri bolnicah z ledvično boleznijo.
Cetrotide 0.25 mg powder and solvent for solution for injection Cetrorelix
Cetrotide 0,25 mg prašek in vehikel za raztopino za injiciranje cetroreliks
7 powder vials with 0.25 mg cetrorelix.
7 vial praška z 0,25 mg cetroreliksa.
7 pre-filled syringes with 1 mL of solvent.
7 napolnjenih injekcijskih brizg z 1 ml vehikla.
Immune system disorders
Bolezni imunskega sistema Občasni:
PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Zdravilo Cetrotide je prašek in vehikel za raztopino za injiciranje.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cetrotide 0.25 mg powder for solution for injection cetrorelix
IME ZDRAVILA IN POT(I) UPORABE Cetrotide 0,25 mg prašek za raztopino za injiciranje cetroreliks subkutana uporaba
Uncommon (may affect up to 1 in 100 women):
Občasni (pojavijo se lahko pri največ 1 od 100 žensk):
What Cetrotide is
Kaj je zdravilo Cetrotide
Elderly There is no relevant use of Cetrotide in the geriatric population.
Starejši bolniki Zdravilo Cetrotide ni namenjeno za uporabo pri starejši populaciji.
Nervous system disorders
Bolezni živčevja Občasni:
2 ml vials (Type I glass) with a stopper (bromobutyl rubber) and flip-off aluminium cap. 1 vial contains 0.25 mg cetrorelix.
2-ml viale (steklo tipa I) z zamaškom (bromobutilna guma) in snemno aluminijasto zaporko.
This event is common (may affect up to 1 in 10 women).
Ta pojav je pogost (pojavi se lahko pri največ 1 od 10 žensk).
At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
Učinek cetroreliksa se vzdržuje z injiciranjem odmerka 0,25 mg, vsakih 24 ur.
Posology
Vehikel
Reproductive system and breast disorders
Motnje reprodukcije in dojk Pogosti:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Cetrotide 0.25 mg
IME ZDRAVILA IN POT(I) UPORABE vehikel za zdravilo Cetrotide 0,25 mg voda za injekcije
How to store Cetrotide
Shranjevanje zdravila Cetrotide
1 pre-filled syringe with 1 mL of solvent.
1 napolnjena injekcijska brizga z 1 ml vehikla.
This is uncommon (may affect up to 1 in 100 women).
To se zgodi občasno (pojavijo se lahko pri največ 1 od 100 žensk).
This event is uncommon (may affect up to 1 in 100 women).
Ta pojav je občasen (pojavi se lahko pri največ 1 od 100 žensk).
Solvent
navzea
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial with powder contains 0.25 mg cetrorelix (as acetate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala s praškom vsebuje 0,25 mg cetroreliksa (v obliki cetroreliksijevega acetata).
General disorders and administration site conditions Common:
hud OHSS (III. stopnje po SZO) Splošne težave in spremembe na mestu aplikacije Pogosti:
• Gently pull back the plunger of the syringe.
• Bat brizge nežno povlecite nazaj.
What Cetrotide contains - The active substance is cetrorelix.
• Učinkovina je cetroreliks.
NAME OF THE MEDICINAL PRODUCT Cetrotide 0.25 mg powder and solvent for solution for injection
Cetrotide 0,25 mg prašek in vehikel za raztopino za injiciranje
• Unwrap the needle with the grey mark on it. Screw the grey needle onto the syringe and remove the cap from the grey needle.
Sivo iglo privijte na brizgo in odstranite zaporko z igle.
Uncommon: Headache
glavobol Bolezni prebavil: Občasni:
In the future, if the animals are exposed to these infections, the immune system will be able to respond more quickly.
Če so živali kasneje izpostavljene tem okužbam, se lahko imunski sistem nanje hitreje odzove.
Responses in puppies were lower than in adult dogs in some cases, because of antibodies inherited from their mothers.
Odzivi pri pasjih mladičih so bili v določenih primerih slabši kot pri odraslih psih, kar je posledica protiteles, ki so jih podedovali od mater.
The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100%, for parainfluenza virus 73 to 97% and for leptospira 59 to 96%.
Zaščitne ravni protiteles proti parvovirusu je razvilo od 73 do 100 % psov, proti virusu parainfluence od 73 do 97 % psov in proti leptospiri od 59 do 96 % psov.
In situations where puppies are expected to inherit very high antibody levels from the bitch, the vaccination protocol should be planned accordingly.
Kadar je mogoče pričakovati, da bodo mladiči od psice podedovali zelo visoke ravni protiteles, je treba načrtovani protokol cepljenja ustrezno prilagoditi.
The effectiveness of Versican Plus DHPPi/L4 was initially investigated in a field study involving 129 dogs.
Učinkovitost cepiva Versican Plus DHPPi/L4 so najprej raziskali v terenski študiji, v katero so vključili 129 psov.
The dogs were either vaccinated twice with a three to four week interval or they received a single annual booster vaccination.
Psi so bili bodisi cepljeni dvakrat v razmiku od treh do štirih tednov bodisi so prejeli enkraten letni obnovitveni odmerek cepiva.
• leptospirosis, a bacterial disease that may be transmitted via infected urine and results in bleeding,
• leptospirozo, tj. bakterijsko boleznijo, ki se lahko prenaša z okuženim urinom in povzroči krvavitve,
The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi/L4 on 7 May 2014.
Evropska komisija je dovoljenje za promet z zdravilom Versican Plus DHPPi/L4, veljavno po vsej Evropski uniji, izdala 7. maja 2014.
• canine adenovirus type 1, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
• pasjim adenovirusom tipa 1, ki povzroča akutno okužbo jeter, pri kateri se lahko pojavijo znaki zlatenice (porumenelost kože in oči);
The vaccine is given to puppies from six weeks of age as an injection, under the skin, repeated three to four weeks later.
Cepivo se daje pasjim mladičem, starejšim od šest tednov, z injiciranjem v podkožje, cepljenje pa je treba ponoviti tri do štiri tedne kasneje.
The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4 is a shortlived swelling of up to 5 cm which may occur at the injection site after vaccination.
Najpogostejši neželeni učinek cepiva Versican Plus DHPPi/L4 (opažen pri več kot 1 psu od 100) je kratkotrajna oteklina v velikosti do 5 cm, ki se lahko po cepljenju pojavi na mestu injiciranja.
• canine distemper, an infectious disease which is sometimes called ‘hard pad' since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting, diarrhoea, excessive salivation and in some cases fits;
• pasjo kugo, tj. infekcijsko boleznijo, ki jo včasih imenujemo tudi bolezen trdih blazinic, saj se lahko pri psih pojavi odebeljena koža na blazinicah na šapah, poleg tega pa tudi izcedek iz smrčka, kašelj, povišana telesna temperatura, bruhanje, driska, čezmerno slinjenje ter v nekaterih primerih krči;
When Versican Plus DHPPi/L4 is given to dogs, the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them.
Ko psi prejmejo cepivo Versican Plus DHPPi/L4, imunski sistem živali viruse in bakterije prepozna kot „tujke“ ter začne proti njim tvoriti protitelesa.
Versican Plus DHPPi/L4 is used to protect dogs against:
Zdravilo Versican Plus DHPPi/L4 se uporablja za zaščito psov pred:
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4 exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4 be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Versican Plus DHPPi/L4 večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
Versican Plus DHPPi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria.
Zdravilo Versican Plus DHPPi/L4 je cepivo za uporabo v veterinarski medicini, ki vsebuje živ atenuiran (oslabljen) virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus tipa 2b in virus pasje parainfluence tipa 2 ter inaktivirane (uničene) seve bakterij Leptospira.
• canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough;
• virusom pasje parainfluence in pasjim adenovirusom tipa 2, ki povzročata kužni kašelj;
In these studies dogs were vaccinated twice with a three week interval and were challenged with canine distemper virus, canine adenovirus and canine parvovirus three years after the second vaccination.
V teh študijah so bili psi cepljeni dvakrat v razmiku treh tednov, zatem pa so bili tri leta po drugem cepljenju izpostavljeni virusu pasje kuge, pasjemu adenovirusu in pasjemu parvovirusu.
The field study showed that vaccination with Versican Plus DHPPi/L4 resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Terenska študija je pokazala, da so bile po cepljenju s cepivom Versican Plus DHPPi/L4 ravni protiteles pri vseh psih dovolj visoke za zaščito pred virusom pasje kuge in pasjim adenovirusom.
Annual revaccination is required for protection against parainfluenza virus and leptospirosis.
Za zaščito pred virusom parainfluence in leptospirozo je ponovno cepljenje potrebno vsako leto.
This will help protect them against distemper, adenovirus liver infection, parvovirosis, kennel cough and leptospirosis.
To pomaga zaščititi pse pred kugo, okužbo jeter z adenovirusom, parvovirozo, kužnim kašljem in leptospirozo.
Versican Plus DHPPi/L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Cepivo Versican Plus DHPPi/L4 vsebuje adjuvans (aluminijev hidroksid), ki spodbuja imunski odziv.
Versican Plus DHPPi/L4 is a vaccine.
Zdravilo Versican Plus DHPPi/L4 je cepivo.
Canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine
cepivo proti pasji kugi, pasjemu adenovirusu, pasji parvovirozi, virusu pasje parainfluence (živo, atenuirano) in pasji leptospirozi (inaktivirano)
What benefit has Versican Plus DHPPi/L4 shown during the studies?
Kakšne koristi je zdravilo Versican Plus DHPPi/L4 izkazalo med študijami?
Versican Plus DHPPi/L4 is available as a lyophilisate (freeze-dried pellet) with a solvent for injection.
Zdravilo Versican Plus DHPPi/L4 je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) z vehiklom za injiciranje.
The viruses in Versican Plus DHPPi/L4 are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria.
Virusi v cepivu Versican Plus DHPPi/L4 so živi, vendar so atenuirani (oslabljeni), tako da ne povzročajo bolezni.
Other information about Versican Plus DHPPi/L4:
Druge informacije o zdravilu Versican Plus DHPPi/L4:
What is the risk associated with Versican Plus DHPPi/L4?
Kakšna tveganja so povezana z zdravilom Versican Plus DHPPi/L4?
Why has Versican Plus DHPPi/L4 been approved?
Zakaj je bilo zdravilo Versican Plus DHPPi/L4 odobreno?
For revaccination, a single dose of Versican Plus DHPPi/L4 is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus.
Za zaščito pred pasjo kugo, pasjim adenovirusom (tipa 1 in 2) ter pasjim parvovirusom je vsaka tri leta potrebno ponovno cepljenje z enkratnim odmerkom cepiva Versican Plus DHPPi/L4.
How has Versican Plus DHPPi/L4 been studied?
Kako je bilo zdravilo Versican Plus DHPPi/L4 raziskano?
What is Versican Plus DHPPi/L4?
Kaj je zdravilo Versican Plus DHPPi/L4?
What is Versican Plus DHPPi/L4 used for?
Za kaj se zdravilo Versican Plus DHPPi/L4 uporablja?
How does Versican Plus DHPPi/L4 work?
Kako zdravilo Versican Plus DHPPi/L4 deluje?
Both groups had similar demographics.
Obe skupini sta imeli podobne demografske značilnosti.
It's especially important to mention:
Posebej pomembno je, da omenite:
Date of first authorisation: 22 March 2002 Date of latest renewal: 24 January 2012
Datum prve odobritve: 22 marec 2002 Datum zadnjega podaljšanja: 24 januar 2012
You will not be given more than 80 mg in 24 hours.
V 24 urah ne boste dobili več kot 80 mg.
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Navodilo je bilo nazadnje revidirano <{MM/LLLL}> <{mesec LLLL}>
Medicines can sometimes interfere with each other.
Pri zdravilih lahko včasih pride do medsebojnih delovanj.
These effects are usually reversible.
Ti učinki so običajno reverzibilni.
No formal interaction studies have been done.
Formalnih študij o medsebojnem delovanju niso opravili.
It is to be reconstituted only with one of the following:
Rekonstituira se ga lahko le z naslednjim:
The clinical relevance of these observations has not been established.
Klinični pomen teh opažanj ni znan.
This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6.
Zdravila ni dovoljeno mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6.
If a dose lower than 40 mg is required, excess medicine should be discarded.
Če je potreben odmerek, manjši od 40 mg, je treba presežek zdravila zavreči.
Additional studies in other surgical settings provided similar observations.
Dodatne študije v drugih kirurških okoliščinah so privedle do podobnih opažanj.
The solution is for single use only and must not be stored in a refrigerator or freezer.
Raztopina je namenjena samo za enkratno uporabo in se je ne sme shranjevati v hladilniku ali zmrzovalniku.
Children and adolescents Children and adolescents under the age of 18 should not be given Dynastat.
Otroci in mladostniki Otrokom in mladostnikom, mlajšim od 18 let, se zdravila Dynastat ne sme dajati.
The carcinogenic potential of parecoxib has not been evaluated.
Karcinogenega potenciala parekoksiba niso ocenili.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Such effects may occur shortly after treatment initiation and are usually reversible.
Taki učinki se lahko pojavijo kmalu po uvedbi zdravljenja in so običajno reverzibilni.
The physician should be prepared to treat severe hypotension.
Zdravnik naj bo pripravljen na zdravljenje hude hipotenzije.
All patients received standard of care analgesia during treatment.
Vsi bolniki so med zdravljenjem prejemali standardno analgezijo.
It may also play a role in ulcer healing.
Morda igra vlogo tudi pri celjenju ulkusov.