natgillin/translations-raw huggingface dataset:
Uncommon side effects itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, sore throat, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, increase in enzymes that track liver function, reduced percentage of red blood cells and pain in the upper abdomen or lower chest.
Občasni neželeni učinki Srbenje, povečano potenje, neobičajen okus v ustih, navali vročine, migrene, motnje spomina, mrzlica, driska, slabost, bruhanje, težko dihanje, vnetje žrela, okužba limfatičnega žilja, bela koža, vnetje očesa, izpuščaji, prekomerno potenje, otekanje stopal in nog, zvišanje vrednosti encimov, po katerih spremljamo delovanje jeter, zmanjšan odstotek rdečih krvničk in bolečine v zgornjem delu trebuha oziroma spodnjem delu prsi.
144 Rare side effects Since the medicine has been on the market, there have been rare reports of severe and potentially life-threatening reactions (anaphylaxis) and other allergic reactions (see above).
144 Redki neželeni učinki Odkar je zdravilo v prometu, so opazili redke primere hudih in potencialno smrtno nevarnih reakcij (anafilaksija) ter drugih alergijskih reakcij (glejte zgoraj).
Each powder vial contains 3000 IU octocog alfa.
Vsaka viala s praškom vsebuje 3000 i. e. oktokoga alfa.
Marketing Authorisation Holder Baxter AG Industriestrasse 67 A-1221 Vienna
Baxter AG Industriestrasse 67 A- 1221 Dunaj Avstrija
1 45 Manufacturer Baxter SA Boulevard René Branquart 80 B-7860 Lessines Belgium
Boulevard René Branquart 80 B- 7860 Lessines Belgija
146 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
146 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Malta Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK Tel.: + 44 1635 206345
Wallingford Road, Compton Newbury Opletalova 55 Berkshire RG20 7QW - UK CZ- 110 00 Praha 1 Tel.: +44 1635 206345 Tel.: +420 225774111
România FARMACEUTICA REMEDIA SA B-dul Metalurgiei nr.
147 România France FARMACEUTICA REMEDIA SA Baxter SAS B- dul Metalurgiei nr.
148 INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION
148 NAVODILA ZA PRIPRAVO IN UPORABO
149 Instructions for injection For administration the use of a luer-lock syringe is required.
149 Navodila za injiciranje Pri dajanju uporabljamo brizgo s sistemom luer- lock.
150 In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in% of normal or IU/dl) in the corresponding period.
150 V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno stopnjo plazemske aktivnosti (v% od normale ali i. e. / dl) v ustreznem časovnem obdobju.
151 ANNEX IV
151 DODATEK IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
UTEMELJITEV ZAHTEVE PO ENI DODATNI OBNOVI
152 GROUNDS FOR ONE ADDITIONAL RENEWAL
152 UTEMELJITEV ZAHTEVE PO ENI DODATNI OBNOVI
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit/risk balance of Advate remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Kljub temu pa je treba skrbno spremljati profil varnosti zdravila iz naslednjih razlogov:
- to follow the implementation of the registry/surveillance system further to the findings of the
- za spremljanje uvedbe sistema registracije oziroma nadzora glede na ugotovitve
pharmacovigilance Inspection
farmakovigilančne inšpekcije,
- to ensure appropriate implementation of the pharmacovigilance system / risk management plan
- za zagotovitev ustrezne uvedbe sistema farmakovigilance in načrta za obvladovanje tveganja.
Therefore, based upon the safety profile of Advate, which requires the submission of 6-monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Na podlagi profila varnosti zdravila Advate, zaradi katerega je zahtevano predajanje poročil o varnosti zdravila (PSUR) na vsakih 6 mesecev, je CHMP sklenil, da mora imetnik dovoljenja za promet poleg tega predložiti še eno dodatno vlogo za obnovo čez 5 let.
Ref.
London, 22. 01. 09 Sklic na dok.
EMEA/ 690893/ 2008
EMEA/ 86067/ 2009
On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer.
Družba Gendux Molecular Limited je dne 17. decembra 2008 obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Advexin, namenjenim za zdravljenje Li- Fraumeni raka.
Advexin was expected to be used to treat Li-Fraumeni cancer in patients from the age of 18 years.
Zdravilo Advexin naj bi se uporabljalo za zdravljenje Li- Fraumeni raka pri bolnikih, starejših od 18 let.
Li-Fraumeni cancer is a type of cancer that occurs in patients with Li-Fraumeni syndrome, a condition where a gene called p53 is defective because of a mutation.
Li- Fraumeni rak je vrsta raka, ki se pojavi pri bolnikih s Li- Fraumeni sindromom, stanjem, pri katerem je gen, imenovan p53, poškodovan zaradi mutacije.
Li-Fraumeni cancer can occur in many areas of the body but usually affects the breast, brain, bone or soft tissue (tissue that connects, surrounds and supports other structures in the body).
Li- Fraumeni rak se lahko razvije skoraj kjer koli v telesu, vendar navadno prizadene prsi, možgane, kosti ali mehko tkivo (tkivo, ki povezuje, obdaja ali podpira druge strukture v telesu).
The active substance in Advexin, contusugene ladenovec, is a ‘ viral vector’.
Zdravilna učinkovina v zdravilu Advexin, contusugene ladenovec, je virusni vektor.
The virus in Advexin is an ‘ adenovirus ’ that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Virus, uporabljen pri zdravilu Advexin, je „ adenovirus “, ki je bil gensko spremenjen tako, da se ne more podvajati in posledično pri ljudeh ne more povzročiti okužbe.
In Li-Fraumeni cancer, where the p53 gene is defective, the p53 protein does not work properly and the cancer cells can continue to grow and divide.
Pri Li- Fraumeni raku, kjer je gen p53 poškodovan, protein p53 ne deluje pravilno in zato rakave celice lahko rastejo in se delijo.
The company presented information from a study on one patient with Li-Fraumeni cancer in the lower abdomen, the bones and the brain.
Družba je predstavila podatke iz študije na enem bolniku z Li- Fraumeni rakom v spodnjem delu trebuha, kosteh in možganih.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Potem ko CHMP izda svoje mnenje, navadno traja približno dva meseca, preden Evropska komisija dovoljenje odobri.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Advexin could not have been approved for the treatment of Li-Fraumeni cancer.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je imel Odbor zadržke in je začasno menil, da zdravila Advexin ni mogoče odobriti za zdravljenje Li- Fraumeni raka.
The CHMP was concerned that there was not enough evidence to show that the injection of Advexin into Li-Fraumeni tumours led to benefits for patients.
CHMP je skrbelo, da ni dovolj dokazov, ki bi potrjevali, da je injiciranje zdravila Advexin v tumorje Li- Fraumeni za bolnike koristno.
Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg).
Aerinaze je zdravilo, ki vsebuje zdravilni učinkovini desloratadin (2, 5 mg) in psevdoefedrin (120 mg).
It is available as blue and white modified-release tablets. ‘ Modified-release ’ means that the tablets have been made to allow one of the active substances to be released immediately and the other one released over a few hours.
Modificirano sproščanje pomeni, da so tablete izdelane tako, da omogočajo sprostitev ene zdravilne učinkovine takoj, druga pa se sprošča več ur.
Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).
Zdravilo Aerinaze se uporablja za zdravljenje simptomov sezonskega alergijskega rinitisa (senenega nahoda, vnetja nosnih poti zaradi preobčutljivosti na cvetni prah pri bolnikih s kongestijo nosne sluznice (zamašenim nosom).
In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water, with or without food.
Pri odraslih in mladostnikih, starejših od 12 let, je priporočen odmerek zdravila Aerinaze ena tableta dvakrat dnevno, ki jo je treba pogoltniti celo, s polnim kozarcem vode, s hrano ali brez.
Treatment should continue for as short a time as possible and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared.
Zdravljenje naj bo čim krajše in ga je treba ustaviti, kakor hitro simptomi, predvsem kongestija (zamašen nos), izginejo.
Treatment for more than 10 days is not advisable, as the medicine ’ s effects on nasal congestion may wear off.
Zdravljenje, daljše od 10 dni, ni priporočljivo, ker lahko učinki zdravila na kongestijo nosne sluznice pojenjajo.
Once the nose has cleared, patients can use desloratadine alone.
Ko se nos očisti, lahko bolniki uporabljajo samo desloratadin.
Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Desloratadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin tj. snov v telesu, ki povzroča alergijske simptome.
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Če so receptorji blokirani, histamin ne more učinkovati, to pa vodi do zmanjšanja simptomov alergije.
Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine.
Tablete zdravila Aerinaze so dvoplastne, ena plast vsebuje desloratadin, druga psevdoefedrin.
Desloratadine is released from its layer immediately after it is taken, while pseudoephedrine is released slowly over 12 hours.
Desloratadin se sprosti iz plasti takoj po zaužitju, psevdoefedrin pa se počasi sprošča 12 ur.
This means that patients only need to take the tablet twice a day.
To pomeni, da morajo bolniki vzeti tableto samo dvakrat dnevno.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is widely used in medicines that have been available over-the-counter for many years.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Aerinaze raziskano?
The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients.
Učinkovitost zdravila Aerinaze so preučevali v dveh glavnih študijah s skupno 1248 odraslimi in mladostniki.
In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone.
V obeh študijah so zdravilo Aerinaze primerjali s samim desloratadinom in s samim psevdoefedrinom.
The main measures of effectiveness were the change in the severity of hayfever symptoms reported by the patients between before treatment started, and over the entire 15 days of treatment.
Glavno merilo učinkovitosti je bila sprememba resnosti simptomov senenega nahoda, o katerih so bolniki poročali pred začetkom zdravljenja in v celotnem 15- dnevnem obdobju zdravljenja.
The patients recorded their symptoms in a diary every 12 hours during the study, scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour period.
Bolniki so med študijo beležili simptome v dnevnik vsakih 12 ur in ocenjevali njihovo resnost v preteklem 12- urnem obdobju s pomočjo standardne lestvice za ocenjevanje simptomov.
What benefit has Aerinaze shown during the studies?
Kakšne koristi je zdravilo Aerinaze izkazalo med raziskavami?
Aerinaze was more effective in reducing symptoms than either of the two active substances taken alone.
Zdravilo Aerinaze je bilo pri zmanjševanju simptomov učinkovitejše od obeh zdravilnih učinkovin, dajanih samostojno.
When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone.
Z vidika obravnave vseh simptomih senenega nahoda z izjemo kongestije nosne sluznice so bolniki, ki so jemali zdravilo Aerinaze, poročali o zmanjšanju simptomov za 46, 0% v primerjavi z zmanjšanjem za 35, 9% pri bolnikih, ki so jemali samo psevdoefedrin.
When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone.
Z vidika obravnave kongestije nosne sluznice je bilo pri bolnikih, ki so jemali zdravilo Aerinaze, zmanjšanje simptomov za 37, 4% v primerjavi z zmanjšanjem za 26, 7% pri bolnikih, ki so jemali samo desloratadin.
Similar results were seen in the second study.
Podobni rezultati so bili ugotovljeni v drugi študiji.
The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
Najpogostejši neželeni učinki zdravila Aerinaze (opaženi pri 1 do 10 bolnikih od 100) so tahikardija (hitro utripanje srca), suha usta, omotica, psihomotorična hiperaktivnost (nemir), faringitis (vneto žrelo), anoreksija (izguba teka), zaprtje, glavobol, utrujenost, nespečnost, zaspanost, motnje spanja in živčnost.
For the full list of all side effects reported with Aerinaze, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Aerinaze, glejte Navodilo za uporabo.
Aerinaze should not be used in people who may be hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies).
Zdravila Aerinaze ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) desloratadin, psevdoefedrin ali katero koli drugo sestavino zdravila, adrenergične učinkovine ali loratadin (drugo zdravilo za zdravljenje alergij).
Aerinaze should also not be taken by people who have narrow- angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Prav tako zdravila Aerinaze ne smejo jemati osebe, ki imajo glavkom ozkega zakotja (povečan tlak v notranjosti očesa), zastoj seča (težave pri izločanju seča), srčnožilne bolezni, vključno s hipertenzijo (visokim krvnim tlakom), hipertiroidizem (povečano delovanje ščitnice) ali anamnezo oziroma tveganjem za hemoragično možgansko kap (kap zaradi krvavitve v možganih).
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze’ s benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Aerinaze pri simptomatskem zdravljenju sezonskega alergijskega rinitisa, ki ga spremlja kongestija nosne sluznice, večje od z njim povezanih tveganj.
The Committee recommended that Aerinaze be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Aerinaze odobri dovoljenje za promet.
Other information about Aerinaze:
Druge informacije o zdravilu Aerinaze:
The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze to SP Europe on 30 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom Aerinaze, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 30. julija 2007.
The full EPAR for Aerinaze can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aerinaze je na voljo tukaj.
This summary was last updated in 06-2007.
Povzetek je bil nazadnje posodobljen 06- 2007.
EU Number
Številka EU EU/ 1/ 07/ 399/ 001
Invented name
sproščanjem
Pharmaceutical Form
Peroralna uporaba
Route of Administration
Pretisni omot (PCTFE/ PVC/ Alu)
Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet
2, 5 mg / 120 mg
Oral use Oral use Oral use Oral use Oral use Oral use
tableta s prirejenim sproščanjem
Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu)
Pretisni omot (PCTFE/ PVC/ Alu)
2 tablets 4 tablets 7 tablets 10 tablets 14 tablets 20 tablets
tableta s prirejenim sproščanjem
∗ 2.5 mg desloratadine/ 120 mg pseudoephedrine sulphate
∗ 2, 5 mg desloratadina/ 120 mg pseudoefedrinijevega sulfata
Aerinaze 2.5mg/ 120 mg modified-release tablets
Aerinaze 2, 5 mg/ 120 mg tablete s podaljšanim sproščanjem
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
Vsaka tableta vsebuje 2, 5 mg desloratadina in 120 mg psevdoefedrina (v obliki sulfata).
Blue and white bilayer oval tablet with “ D12” branded to blue layer.
Tableta s podaljšanim sproščanjem Modro- bela ovalna dvoplastna tableta z oznako “ D12 ” na modri plasti tablete
Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Simptomatsko zdravljenje sezonskega alergijskega rinitisa, ki ga spremlja kongestija nosne sluznice.
Adults and adolescents 12 years of age and over:
Odrasli in mladostniki, stari 12 let ali več:
The tablet may be taken with a full glass of water but must be swallowed entirely (without crushing, breaking or chewing it).
Tableto lahko bolnik popije s polnim kozarcem vode, vendar jo mora pogoltniti celo, brez drobljenja, lomljenja ali žvečenja.
The tablet may be taken with or without food.
Tablete se lahko jemljejo s hrano ali brez.
Aerinaze should not be used in children below the age of 12 years due to a lack of data on safety and efficacy (see section 5.1).
Zdravila Aerinaze ne smete predpisovati otrokom, mlajšim od 12 let, ker ni podatkov o varnosti in učinkovitosti zdravila pri njih (glejte poglavje 5. 1).
The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared.
Zdravljenje naj bo čimbolj kratko in ga je treba ustaviti takoj po izginotju simptomov.
It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine may diminish.
Priporočljivo je, da dolžino zdravljenja omejite na približno 10 dni, saj lahko pri kronični uporabi aktivnost psevdoefedrina postopoma upada.
After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if necessary.
Po zmanjšanju kongestije sluznice zgornjih dihal lahko zdravljenje nadaljujete tudi samo z desloratadinom, če je potrebno.
Hypersensitivity to the active substance, to any of the excipients, to adrenergic agents or to loratadine.
Preobčutljivost za zdravilno učinkovino, katero od pomožnih snovi, adrenergična zdravila ali loratadin.
As Aerinaze contains pseudoephedrine, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment.
Ker zdravilo Aerinaze vsebuje psevdoefedrin, je njegova uporaba kontraindicirana tudi pri bolnikih, ki se zdravijo z zaviralci monoaminooksidaze (MAO) oziroma v času 2 tednov po prenehanju zdravljenja z njimi.
Aerinaze is also contraindicated in patients with: • narrow-angle glaucoma, • urinary retention, • cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension, • hyperthyroidism,
Zdravilo Aerinaze je kontraindicirano tudi pri bolnikih z: • glavkomom ozkega zakotja, • zastojem seča, • srčnožilnimi boleznimi, na primer ishemično srčno boleznijo, tahiaritmijo in hudo hipertenzijo, • hipertiroidizmom,
2 • a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke.
2 • hemoragično možgansko kapjo v pretekli anamnezi ali dejavniki, ki bi lahko povečali tveganje za hemoragično možgansko kap.
This is due to the alpha-mimetic activity of pseudoephedrine in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…).
To je posledica alfa- mimetične aktivnosti psevdoefedrina v kombinaciji z drugimi vazokonstriktorji, na primer z bromokripitinom, pergolidom, lizuridom, kabergolinom, ergotaminom, dihidroergotaminom ali katerimkoli drugim dekongestivom, ki se uporablja kot nosni dekongestiv, bodisi po peroralni ali po nazalni poti (fenilpropanolamin, fenilefrin, efedrin, oksimetazolin, nafazolin itn.).
Do not exceed the recommended dosage and the duration of treatment (see section 4.2).
Ne prekoračite priporočenega odmerka in dolžine zdravljenja (glejte poglavje 4. 2).
Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medicinal products, such as pseudoephedrine.
Bolniki, stari 60 let ali več, imajo večjo verjetnost za pojav neželenih učinkov pri jemanju simpatikomimetičnih zdravil, kakršen je psevdoefedrin.
Therefore the combination product should be used with caution in patients above 60 years of age.
Ker varnost in učinkovitost te kombinacije pri omenjeni skupini bolnikov še ni bila ugotovljena in ker ni zadostnih podatkov za oblikovanje priporočil za odmerjanje zdravila pri njih, to kombinirano zdravilo uporabljajte previdno pri vseh bolnikih, ki so starejši od 60 let.
Renal or hepatic impairment:
Ledvična ali jetrna okvara:
The safety and efficacy of Aerinaze has not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
Varnost in učinkovitost zdravila Aerinaze še ni bila ugotovljena pri bolnikih z zmanjšanim delovanjem ledvic ali jeter in ni zadostnih podatkov, da bi podali ustrezna priporočila za odmerjanje zdravila pri njih.
The combination product is not recommended for use in patients with impaired renal or hepatic function.
Uporaba kombiniranega zdravila torej ni priporočljiva pri bolnikih z ledvično ali jetrno okvaro.
Aerinaze should not be used in children below the age of 12 years (see section 4.2).
Zdravila Aerinaze ne smete uporabljati pri bolnikih, ki so mlajši od 12 let (glejte poglavje 4. 2).
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Simpatikomimetični amini lahko povzročijo stimulacijo osrednjega živčevja s konvulzijami ali srčnožilnim kolapsom ter spremljajočo hipotenzijo.