natgillin/translations-raw huggingface dataset:
Infections and infestations Common: sinusitis, upper respiratory tract infection Uncommon: urinary tract infection
Infekcijske in parazitske bolezni Pogosti: sinuzitis, okužba zgornjih dihal Obcasni: okužbe secil
Pharmacodynamic interactions
Farmakodinamicno medsebojno delovanje
Renal and urinary disorders Very rare: acute renal failure, interstitial nephritis
Bolezni secil Zelo redki: akutna odpoved ledvic, intersticijski nefritis
Based on conventional studies, genotoxicity or carcinogenicity, no special hazard for humans was observed, beyond those addressed in other sections of the SmPC.
Na podlagi konvencionalnih raziskav toksicnosti, genotoksicnosti ali kancerogenosti veckratnih odmerkov zdravila menijo, da zdravilo ne pomeni posebnega tveganja za ljudi, t.j.
Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Študij o izlocanju celekoksiba v materinem mleku pri cloveku ni. Celekoksib se izloca v mleku dojecih podgan v koncentraciji, podobni koncentraciji v plazmi.
Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (See 4.5).
Uporaba celekoksiba v kombinaciji z varfarinom ali drugimi peroralnimi antikoagulansi zato zahteva previdnost (glejte poglavje
Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Zato je treba celekoksib previdno uporabljati pri bolnikih z anamnezo srcnega popušcanja, disfunkcijo levega prekata ali hipertenzijo, ter pri bolnikih z edemi zaradi kakšnega drugega vzroka.
Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Klinicna preskušanja so pokazala, da ima celekoksib na ledvice podobne ucinke kot primerjalni nesteroidni antirevmatiki.
In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see 5.1).
Tako kot za druge nesteroidne antirevmatike, so v predloženih študijah tudi za celekoksib ugotovili, da njegovo socasno uporabo z majhnimi odmerki acetilsalicilne kisline spremlja vecje tveganje za ulkuse in druge zaplete na prebavilih kot uporabo celekoksiba samega (glejte poglavje 5.1)
There is little experience of celecoxib in renal impairment.
Izkušenj s celekoksibom pri okvari jeter je malo.
Thus caution is advised when treating patients with renal impairment.
Pri zdravljenju bolnikov z okvaro ledvic je potrebna previdnost.
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
Pri bolnikih, ki so dobivali celekoksib, so bile opisane resne preobcutljivostne reakcije (anafilaksija in angioedem) (glejte poglavje 4.8).
Opaque, white with two gold bands marked 7767 and 200 (INVENTED NAME 200 mg).
Motno bele kapsule z zlato crto in oznakama 7767 in 200.
Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200mg BID and 400mg BID compared to placebo (see 5.1).
V primerjavi s placebom, so povecano število nevarnih srcnožilnih dogodkov, v glavnem miokardni infarkt, ugotovili pri dolgotrajni, s placebom nadzirani študiji odkrili, pri osebah s sporadicnimi adenomatoznimi polipi, zdravljenih s celekoksibom, v odmerkih po 200 mg dvakrat dnevno in 400 mg dvakrat na dan (glejte poglavje 5.1).
There is no clinical experience of overdose.
Presežka možganskih kapi ni bilo.
Area
Podrocje
Clinical 2
Klinicni vidik 2
Coadministration of NSAIDs and cyclosporin or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Socasna uporaba nesteroidnih antirevmatikov in ciklosporina ali takrolimusa domnevno poveca nefrotoksicni ucinek teh dveh zdravil.
Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Motno bele kapsule z modro crto in oznakama 7767 in 100.
Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in Cmax of 53% and in AUC of 26% of celecoxib.
Pri bolnikih z blago okvaro jeter je bila Cmax celekoksiba v povprecju za 53 % vecja, AUC pa za 26 % vecja kot pri preiskovancih z normalnim delovanjem jeter.
Musculoskeletal and connective tissue disorders Uncommon: leg cramps
Bolezni mišicno-skeletnega sistema in vezivnega tkiva Obcasni: krci v nogah
Germany
Nemcija
5.1 Pharmacodynamic properties
5.1 Farmakodinamicne lastnosti
Clinical 4
Klinicni vidik 4
These effects are expected following inhibition of prostaglandin synthesis.
Pri inhibiciji sinteze prostaglandinov so takšni ucinki pricakovani.
No clinical data on exposed pregnancies are available for celecoxib.
Za celekoksib ni na voljo klinicnih podatkov od nosecnic, ki so bile izpostavljene zdravilu.
Clinical 3
Klinicni vidik 3
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Bolniki morajo biti dovolj hidrirani in po zacetku ali spremljajocem zdravljenju ter obcasno še potem je treba poskrbeti za spremljanje in nadziranje delovanja ledvic.
In one of the three studies, the APC (Prevention of Sporadic Colorectal Adenomas with Celecoxib), there was a dose-related increase in cardiovascular events (mainly myocardial infarction, MI) at celecoxib doses of 200 mg BID and 400 mg BID compared to placebo.
V eni od treh študij, APC (Preprecevanje sporadicnih kolorektalnih adenomov s celekoksibom), so pri celekoksibu v odmerkih 200 mg dvakrat na dan in 400 mg dvakrat na dan v primerjavi s placebom, ugotovili z odmerkom povezano povecanje srcnožilnih incidentov (predvsem miokardnega infarkta, MI).
Hepatic impairment: Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l.
Jetrna okvara: Pri bolnikih z ugotovljeno zmerno jetrno okvaro (serumski albumin 25-35 g/l) zacnemo zdravljenje s polovicnim priporocenim odmerkom.
No clinically significant differences were found in PK parameters of celecoxib between elderly African-Americans and Caucasians.
Med starejšimi Afroamericani in starejšimi belci niso ugotovili klinicno pomembnih razlik v farmakokineticnih parametrih celekoksiba.
Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Pri bolnikih, zdravljenih s celekoksibom, so se na zgornjih prebavilih pojavljali zapleti (perforacije, ulkusi in krvavitve), ki so bili v nekaterih primerih usodni.
Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications.
Pri bolnikih, ki jemljejo varfarin ali druge antikoagulanse, je treba nadzirati antikoagulantno aktivnost, še posebej prve dni po zacetku zdravljenja s celekoksibom ali spremembi njegovega odmerka.
The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
Po uvedbi zdravljenja s celekoksibom utegne biti potrebno zmanjšanje odmerka zdravil, katerih odmerek se titrira individualno, po koncu zdravljenja s celekoksibom pa utegne biti potrebno povecanje odmerka teh zdravil.
Common: abdominal pain, diarrhoea, dyspepsia, flatulence Uncommon: constipation, eructation, gastritis, stomatitis, vomiting, aggravation of gastrointestinal inflammation
Pogosti: bolecine v trebuhu, driska, dispepsija, flatulenca Obcasni: zaprtje, spahovanje, gastritis, stomatitis, bruhanje, poslabšanje želodcnocrevesnega vnetja Redki: razjeda na dvanajstniku, želodcu, požiralniku, tankem in debelem crevesju , disfagija, predrtje crevesa, ezofagitis, melena
{INVENTED NAME, see Annex I } 200 mg capsule, hard.
200 mg trde kapsule
Hepato-biliary disorders Uncommon: abnormal hepatic function Very rare: hepatitis, jaundice, hepatic failure.
Bolezni jeter, žolcnika in žolcevodov Obcasni: nenormalno delovanje jeter Zelo redki: hepatitis, odpoved jeter, zlatenica
Uncommon: urticaria
Pogosti: omotica
Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal.
Predvsem pri starejših bolnikih in bolnikih, ki so celekoksib dobivali socasno z varfarinom, so bile opisane krvavitve, povezane s podaljšanjem protrombinskega casa; nekatere teh krvavitev so bile usodne.
Renal function should be monitored when celecoxib and any of these drugs are combined.
Med uporabo celekoksiba s katerim od teh zdravil je treba nadzirati delovanje ledvic.
Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Zaradi velike vezave na beljakovine ni verjetno, da bi bilo zdravilo mogoce ucinkovito odstraniti z dializo.
As with other drugs known to inhibit prostaglandin synthesis fluid retention and oedema have been observed in patients taking celecoxib.
Pri bolnikih, ki so jemali celekoksib, so zabeležili zastajanje tekocine in edeme, tako kot pri drugih zdravilih, ki zavirajo sintezo prostaglandinov.
Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/L).
Pri bolnikih z zmerno okvaro jeter (albumin v serumu od 25 do 35 g/l) je treba zdravljenje zaceti s polovico priporocenega odmerka.
8 MARKETING AUTHORISATION NUMBER(S) [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]
Tocka bo dopolnjena s strani imetnika dovoljenja za promet, po izdaji odlocbe.
Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
Peroralno uporabljeni celekoksib v obmocju klinicnih odmerkov selektivno zavira ciklooksigenazo-2 (COX-2).
6.4 Special precautions for storage Do not store above 30
6.4 Posebna navodila za shranjevanje
Nervous system disorders
Psihiatricne motnje
Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.
Ledvicna okvara: Izkušnje z uporabo celekoksiba pri bolnikih z blago do zmerno ledvicno okvaro so omejene, zato takšne bolnike zdravimo previdno (glejte polgavja 4.3, 4.4 in 5.2).
A dose dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Po velikih odmerkih celekoksiba so opažali od odmerka odvisen ucinek na nastajanje TxB2.
mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects.
Klinicnih izkušenj s prevelikim odmerjanjem ni. Zdravim preiskovancem so devet dni aplicirali posamicne odmerke 1.200 mg in veckratne odmerke do 1.200 mg dvakrat na dan brez klinicno pomembnih neželenih ucinkov.
Respiratory, thoracic and mediastinal disorders Common: pharyngitis, rhinitis Uncommon: cough, dyspnoea Very rare: bronchospasm.
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: faringitis, rinitis
In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy.
Po potrebi lahko bolniki jemljejo tudi odmerek 200 mg dvakrat na dan.
Strength Pharmaceutical Form
Pharmaceutical Form
Immediate Packaging
Stična ovojnina Pakiranje
The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Evropska komisija je dovoljenje za promet z zdravilom Copalia HCT, veljavno po vsej Evropski uniji, odobrila dne 4. novembra 2009.
This is a summary of the European public assessment report (EPAR) for Copalia HCT.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Copalia HCT.
Copalia HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Zdravilo Copalia HCT se jemlje peroralno, in sicer se zaužije ena tableta enkrat na dan ob isti uri, če je le mogoče, zjutraj.
The main study showed the benefit of the highest strength of Copalia HCT in lowering the blood pressure.
Glavna študija je pokazala koristnost uporabe največjega odmerka zdravila Copalia HCT pri zniževanju krvnega tlaka.
The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Copalia HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The three active substances in Copalia HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Tri zdravilne učinkovine v zdravilu Copalia HCT so zdravila proti zvišanemu krvnemu tlaku, ki se že uporabljajo v Evropski uniji (EU).
For all doses, Copalia HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Pri vseh odmerkih je zdravilo Copalia HCT izpolnilo tudi zahteve, s katerimi je bilo dokazano, da je primerljivo s kombinacijami posameznih zdravilnih učinkovin, vzetih ločeno.
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 Copalia HCT.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Copalia HCT, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Copalia HCT shown during the studies?
Kakšne koristi je zdravilo Copalia HCT izkazalo med študijami?
Copalia HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Zdravilo Copalia HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih, pri katerih je krvni tlak že ustrezno uravnan z uporabo kombinacije amlodipina, valsartana in hidroklorotiazida.
The most common side effects with Copalia HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Copalia HCT (opaženi pri 1 do 10 bolnikih od 100) so hipokaliemija (nizka raven kalija v krvi), omotica, glavobol, hipotenzija (nizek krvni tlak), dispepsija (zgaga), polakiurija (neobičajno pogosto uriniranje), utrujenost in edem (zadrževanje tekočine).
The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Copalia HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Povprečno znižanje krvnega tlaka je bilo okrog 39,7/24,7 mmHg pri bolnikih, ki so prejemali zdravilo Copalia HCT, v primerjavi z 32/19,7 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/hidroklorotiazid, 33,5/21,5 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/amlodipin, in 31,5/19,5 mmHg pri bolnikih, ki so prejemali kombinacije hidroklorotiazid/amlodipin.
For the full list of all side effects reported with Copalia HCT, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Copalia HCT, glejte navodilo za uporabo.
Copalia HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Copalia HCT je zdravilo, ki vsebuje tri zdravilne učinkovine: amlodipin, valsartan in hidroklorotiazid.
Patients received either Copalia HCT or one of the three combinations containing only two of the active substances for eight weeks.
Bolniki so osem tednov prejemali bodisi zdravilo Copalia HCT bodisi eno od treh kombinacij, ki so vsebovale le dve zdravilni učinkovini.
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Copalia HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Poleg tega je bila izvedena glavna študija, v kateri so proučevali 2 271 bolnikov z zmerno do hudo hipertenzijo, ki so prejemali največji odmerek zdravila Copalia HCT (320 mg valsartana, 10 mg amlodipina in 25 mg hidroklorotiazida).
The daily dose of Copalia HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Dnevni odmerek učinkovin zdravila Copalia HCT ne sme biti večji od 10 mg amlodipina, 320 mg valsartana in 25 mg hidroklorotiazida.
Other information about Copalia HCT
Druge informacije o zdravilu Copalia HCT
The dose of Copalia HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Odmerek učinkovin zdravila Copalia HCT mora biti enak odmerkom treh posameznih zdravilnih učinkovin, ki jih je bolnik prejemal pred tem.
Copalia HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
Zdravila Copalia HCT ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine zdravila, druge sulfonamide, derivate dihidropiridina ali katero koli drugo sestavino zdravila Copalia HCT.
Treatment with the highest strength of Copalia HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Zdravljenje z največjim odmerkom zdravila Copalia HCT je bilo pri zdravljenju hipertenzije učinkovitejše od zdravljenja z dvojnimi kombinacijami, ki so vsebovale po dve zdravilni učinkovini.
The full EPAR for Copalia HCT 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 Copalia HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Za več informacij o zdravljenju z zdravilom Copalia HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce.
Ker valsartan ustavi njegovo delovanje z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, hormonu prepreči učinkovanje, zaradi česar se krvne žile lahko razširijo, krvni tlak pa zniža.Hidroklorotiazid je diuretik.
Finally, Copalia HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Zdravila Copalia HCT poleg tega ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
What is the risk associated with Copalia HCT?
Kakšna tveganja so povezana z zdravilom Copalia HCT?
Copalia HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Prav tako se ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
Why has Copalia HCT been approved?
Zakaj je bilo zdravilo Copalia HCT odobreno?
The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Copalia HCT which combines the three substances in a single tablet.
CHMP je menil, da bi uporaba zdravila Copalia HCT, pri katerem so tri zdravilne učinkovine prisotne v eni tableti, bolnikom, ki tri zdravilne učinkovine že prejemajo ločeno, omogočila doslednejše jemanje zdravila.
What is Copalia HCT?
Kaj je zdravilo Copalia HCT?
How has Copalia HCT been studied?
Kako je bilo zdravilo Copalia HCT raziskano?
What is Copalia HCT used for?
Za kaj se zdravilo Copalia HCT uporablja?
How does Copalia HCT work?
Kako zdravilo Copalia HCT deluje?
How is Copalia HCT used?
Kako se zdravilo Copalia HCT uporablja?
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku Koordinacijske skupine.
b L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology c adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
ahumani papilomavirus = HPV bL1 protein v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C-5 (sev 1895)) cadsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (225 mikrogramov Al)
Human Papillomavirusa Type 6 L1 proteinb,c
1 odmerek (0,5 ml) vsebuje približno: L1 proteinb,c humanega papilomavirusaa tipa 6
1 pre-filled syringe
1 napolnjena injekcijska brizga + 2 igli
This protein is often found on the surface of cells where it plays a role in regulating cell multiplication.
Ta beljakovina je pogosto prisotna na površini celic, kjer ima vlogo pri uravnavanju razmnoževanja celic.
What measures are being taken to ensure the safe and effective use of Lartruvo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lartruvo?
This is a summary of the European public assessment report (EPAR) for Lartruvo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lartruvo.
The most serious side effects were neutropenia and musculoskeletal pain.
Najresnejša neželena učinka sta bila nevtropenija in mišično-skeletna bolečina.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Lartruvo večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
During the infusion, patients should be monitored for signs and symptoms of infusion-related reactions and trained staff and equipment for emergency resuscitation should be available.
Med infuzijo je treba bolnike spremljati zaradi pojava znakov in simptomov reakcij, povezanih z infuzijo, na voljo pa morata biti usposobljeno osebje in oprema za oživljanje v nujnem primeru.
Other information about Lartruvo
Druge informacije o zdravilu Lartruvo
The summary of the opinion of the Committee for Orphan Medicinal Products for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Lartruvo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.