natgillin/translations-raw huggingface dataset:
Aspartate aminotransferase increased; alanine aminotransferase increased; blood bilirubin increased; blood creatinine phosphokinase increased * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients 
zvišana raven aspartataminotransferaze; zvišana raven alanin-aminotransferaze; zvišana raven bilirubina v krvi; zvišana raven kreatin-fosfokinaze v krvi
For your convenience, the medicine can be removed from such storage for one single period of maximum 3 months at room temperature (up to 25°C). 
Za lažje ravnanje z zdravilom smete zdravilo vzeti iz hladilnika za eno samo obdobje, ki ne sme biti daljše od 3 mesecev, pri sobni temperaturi (do 25 ºC).
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU or 2000 IU powder in a 10 mL vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 mL of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad. 
ReFacto AF 250 i.e., 500 i.e., 1000 i.e., 2000 i.e. prašek in vehikel za raztopino za injiciranje 250 i.e., 500 i.e., 1.000 i.e. ali 2.000 i.e. praška v 10-mililitrski viali (steklo tipa I) z zamaškom (butilnim) in snemljivo zaporko (iz aluminija) in 4 ml vehikla v napolnjeni injekcijski brizgi (steklo tipa I) z batom (butilnim), pokrovčkom (butilnim) in sterilnim rekonstitucijskim nastavkom za vialo, sterilen infuzijski sistem, alkoholni zloženci, obliž in blazinica iz gaze.
Use the reconstituted solution within 3 hours of reconstitution. 
Zdravilo ReFacto AF morate uporabiti v 3 urah po pripravi.
The solution should appear clear to slightly opalescent and colourless. 
Raztopina mora biti bistra do rahlo opalescentna in brezbarvna.
The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF. 
V nadaljevanju so opisana navodila za pripravo raztopine in način uporabe zdravila ReFacto AF.
Dizziness 
Preobčutljivost
N=13 32 IU/kg 
n = 14 36 i.e/kg n = 13 32 i.e./kg n = 22 46 i.e./kg
Attach the plunger rod to the solvent syringe by inserting the rod into the opening in the syringe stopper and pushing and turning the rod firmly until it is securely seated in the stopper. 
Namestite bat v brizgo z vehiklom tako, da vstavite bat v odprtino zamaška injekcijske brizge in ga čvrsto potisnete ter zasukate, da se varno usede v zamašek.
% of bleeds treated successfully with ≤ 2 infusions a The dose and frequency of ReFacto AF prescribed throughout the study were at the investigator's discretion as per local standard of care. 
Odmerek in pogostnost odmerjanja predpisanega zdravila ReFacto AF v času trajanja študije je določil raziskovalec po lastni presoji v skladu z lokalnim standardom oskrbe.
ReFacto AF is given by injection into a vein lasting several minutes. 
Zdravilo ReFacto AF vam bo zdravnik v obdobju več minut injiciral v veno.
The reconstituted ReFacto AF product should be injected intravenously over several minutes. 
Pripravljeno zdravilo ReFacto AF injicirajte intravensko več minut.
Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. 
Spojite nastavek za vialo z brizgo z vehiklom: konico brizge potisnite v odprtino nastavka in jo hkrati zasučite v smeri urnega kazalca, dokler se ne zaskoči.
Hypotension; thrombophlebitis; flushing 
Žilne bolezni krvavitev; hematom hipotenzija; tromboflebitis; vročinski oblivi
The contents of the pack are: - one vial of moroctocog alfa 250, 500, 1000, or 2000 IU powder - one pre-filled syringe of solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection for reconstitution, with one plunger rod - one sterile vial adapter reconstitution device - one sterile infusion set - two alcohol swabs - one plaster - one gauze pad 
Pakiranje vsebuje: - eno vialo z 250, 500, 1000 ali 2000 i.e. moroktokoga alfa v obliki praška, - eno napolnjeno injekcijsko brizgo vehikla, 4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje za pripravo, z enim batom, - en sterilen nastavek za vialo za rekonstitucijo, - en sterilen infuzijski sistem, - dva alkoholna zloženca, - en obliž, - eno gazo.
During your treatment, your doctor may decide to change the dose of ReFacto AF you receive. 
Zdravnik se bo med samim zdravljenjem z zdravilom ReFacto AF morda odločil tudi za spremembo odmerka.
You can use the peel-off label found on the ReFacto AF pre-filled syringe to record the lot number. 
Za zapisovanje številke serije lahko uporabite nalepko, ki se nahaja na napolnjeni injekcijski brizgi zdravila ReFacto AF in se lahko odstrani.
A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is also supplied for reconstitution. 
Za pripravo raztopine je priložen tudi vehikel [9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje].
The contents of the pack are: - one pre-filled syringe containing moroctocog alfa 250, 500, 1000, 2000, or 3000 IU powder and solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection for reconstitution - one plunger rod - one protective blue vented sterile cap - one sterile infusion set - two alcohol swabs - one plaster - one gauze pad 
Pakiranje vsebuje: - eno napolnjeno injekcijsko brizgo z 250, 500, 1000, 2000 ali 3000 i.e. moroktokoga alfa v obliki praška, ter vehikel, 4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje za pripravo - en bat - eno zaščitno modro sterilno zaporko z odprtinami - en sterilen infuzijski sistem - dva alkoholna zloženca - en obliž - eno gazo
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled syringe 
ReFacto AF 250 i.e., 500 i.e., 1000 i.e., 2000 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 250 i.e., 500 i.e., 1000 i.e., 2000 i.e., 3000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
Total ABR for subjects who reported following a Prophylaxis regimen at Baseline c median (min, max) 
Skupna ABR pri preskušancih, ki so ob izhodišču navedli, da sledijo profilaktičnemu režimu mediana vrednost (največja, najmanjša)
Discard the vial with the adapter attached. 
Vialo z nameščenim nastavkom zavrzite.
Remove any air in the infusion set tubing by drawing back on the syringe. 
Odstranite morebitni zrak iz infuzijskega sistema, tako da izvlečete bat brizge.
IV use, after reconstitution. 
uporaba, po rekonstituciji
ReFacto AF is administered by intravenous (IV) infusion after reconstitution. 
Zdravilo ReFacto AF se daje v obliki intravenske (i.v.)
250 IU, 500 IU, 1000 IU, 2000 IU or 3000 IU lyophilised powder in top chamber and 4 mL of solvent in bottom chamber of the pre-filled syringe (type 1 glass) with butyl rubber plungers and closure, one plunger rod for assembly, a polypropylene vented sterile cap, a sterile infusion set, alcohol swabs, a plaster and a gauze pad. 
250 i.e., 500 i.e., 1.000 i.e., 2.000 i.e. ali 3.000 i.e. liofiliziranega praška v zgornjem razdelku in 4 ml vehikla v spodnjem razdelku napolnjene injekcijske brizge (steklo tipa I) s tesniloma in zaporko iz butilne gume, bat za sestavljanje, sterilna polipropilenska zaporka z odprtinami, sterilen infuzijski sistem, alkoholni zloženci, obliž in blazinica iz gaze.
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled syringe 
ReFacto AF 250 i.e., 500 i.e., 1000 i.e., 2000 i.e., 3000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
You can use one of the peel-off labels found on the pre-filled syringe to document the batch number in your diary or for reporting any side effects. 
Lahko odlepite eno od nalepk, nalepljenih na napolnjeni injekcijski brizgi, in z njo zabeležite številko serije v svojem dnevniku ali jo uporabite pri poročanju o morebitnih neželenih učinkih.
After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa. 
Po rekonstituciji vsebuje en ml raztopine približno 62,5 i.e. moroktokoga alfa.
Total ABR for subjects who reported following an On Demand regimen at Baseline c median (min, max) 
Skupna ABR pri preskušancih, ki so ob izhodišču navedli, da sledijo režimu zdravljenja po potrebi mediana vrednost (največja, najmanjša)
ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe 
ReFacto AF 250 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 500 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 1000 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 2000 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 250 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 500 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 1000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 2000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 3000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
Reconstitution 
Priprava
Attach the syringe to the luer end of the infusion set tubing. 
Brizgo pritrdite na luer priključek infuzijskega sistema.
Please see package leaflet, section 3, for additional information on reconstitution and administration. 
Za dodatne informacije glede rekonstitucije in dajanja zdravila, prosimo, glejte poglavje 3 navodila za uporabo.
Reconstitute all ReFacto AF pre-filled syringes according to instructions shown above in the reconstitution directions (see Reconstitution and Administration). 
Vse napolnjene injekcijske brizge zdravila ReFacto AF pripravite za uporabo po zgornjih navodilih za pripravo zdravila za uporabo (glejte naslova »Priprava zdravila za dajanje« in »Dajanje zdravila (Intravensko infundiranje)«).
ReFacto AF 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU* moroctocog alfa**. 
ReFacto AF 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e.* moroktokoga alfa**.
After reconstitution, each mL of solution contains approximately 750 IU moroctocog alfa. 
Po rekonstituciji vsebuje en ml raztopine približno 750 i.e. moroktokoga alfa.
Keep in the original package in order to protect from light. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa. 
Po rekonstituciji vsebuje en ml raztopine približno 125 i.e. moroktokoga alfa.
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper. 
Čvrsto pritisnite navzdol, da se zaskoči na svoje mesto na vrhu viale in konica nastavka predre zamašek viale.
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**. 
ReFacto AF 250 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje nominalno 250 i.e.* moroktokoga alfa**.
ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the powder with the solvent (0.9% sodium chloride). 
infuzije, potem ko se prašek raztopi v vehiklu (0,9 % raztopini natrijevega klorida).
The solvent syringe should be removed, leaving the vial adapter in place, and a single large luer lock syringe may be used to draw back the reconstituted contents of each of the individual vials. 
Pripravljeno vsebino lahko iz vsake posamezne viale povlečete z eno samo veliko brizgo z nastavkom Luer lock.
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ReFacto AF. 
Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom ReFacto AF, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
ReFacto AF 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU* moroctocog alfa**. 
ReFacto AF 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2.000 i.e.* moroktokoga alfa**.
Total ABR all subjects b median (min, max) 
Skupna letna stopnja krvavitev (ABR - Annual Bleeding Rate) pri vseh preskušancih mediana vrednost (največja, najmanjša)
ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII) 
ReFacto AF 250 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 500 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 1000 i.e. prašek in vehikel za raztopino za injiciranje ReFacto AF 2000 i.e. prašek in vehikel za raztopino za injiciranje moroktokog alfa (rekombinantni humani koagulacijski faktor VIII)
ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 3000 IU* moroctocog alfa**. 
ReFacto AF 3000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje nominalno 3.000 i.e.* moroktokoga alfa**.
Calcium chloride dihydrate L-Histidine 
Saharoza, kalcijev klorid dihidrat,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
It is recommended to record the lot number from the ReFacto AF pre-filled syringe label every time you use ReFacto AF. 
Vsakokrat ko uporabite zdravilo ReFacto AF, je priporočljivo, da si zapišete številko serije z nalepke na napolnjeni injekcijski brizgi zdravila ReFacto AF.
Early haemarthrosis, muscle bleeding or oral bleeding 
Začetna krvavitev v sklep, krvavitev v mišice in krvavitev v ustih
Metabolism and nutrition disorders 
Presnovne in prehranske motnje pomanjkanje apetita
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Moroctocog alfa (recombinant human coagulation factor VIII) 
ReFacto AF 500 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 1000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 2000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi ReFacto AF 3000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi moroktokog alfa (rekombinantni humani koagulacijski faktor VIII)
ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**. 
ReFacto AF 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1.000 i.e.* moroktokoga alfa**.
Vascular disorders 
Nastanek zaviralcev
Ensuring that the syringe plunger rod is still fully depressed, invert the vial. 
Prepričajte se, da je bat injekcijske brizge še vedno do konca potisnjen v brizgo, in obrnite vialo s spodnjim koncem navzgor.
ReFacto AF 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU* moroctocog alfa**. 
ReFacto AF 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e.* moroktokoga alfa**.
After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa. 
Po rekonstituciji vsebuje en ml raztopine približno 250 i.e. moroktokoga alfa.
ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 500 IU* moroctocog alfa**. 
ReFacto AF 500 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje nominalno 500 i.e.* moroktokoga alfa**.
ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 2000 IU* moroctocog alfa**. 
ReFacto AF 2000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje nominalno 2.000 i.e.* moroktokoga alfa**.
Multiple ReFacto AF in Pre-filled Syringe Reconstitution to a 10 cc or Larger Luer Lock Syringe (10 cc or larger luer lock syringes not provided) 
3 ali večji brizgi z nastavkom Lock (10 cm
After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa. 
Po rekonstituciji vsebuje en ml raztopine približno 500 i.e. moroktokoga alfa.
Slovenská republika Pfizer Luxembourg SARL, organizačná zložka 
Luxembourg/Luxemburg Pfizer S.A.
1 vial: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution). 
1 viala: 250 i.e. moroktokoga alfa (pribl.
ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 1000 IU* moroctocog alfa**. 
ReFacto AF 1000 i.e. prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje nominalno 1.000 i.e.* moroktokoga alfa**.
AUCt (IU·h/mL) 
Cmax, i.e./ml
Keep the vial in the original package in order to protect from light. 
Vialo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Do not remove the adapter from the package. 
Nastavka ne vzemite ven.
A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is included within the ReFacto AF pre-filled syringe for reconstituting moroctocog alfa. 
Za pripravo raztopine moroktokoga alfa je v injekcijski brizgi tudi vehikel [9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje].
The product may not be returned to refrigerated storage after storage at room temperature. 
Potem ko ste zdravilo hranili pri sobni temperaturi, ga ne smete ponovno shranjevati v hladilniku.
Asthenia; injection site reaction; injection site pain; injection site inflammation 
Splošne težave in spremembe na mestu aplikacije pireksija mrzlica; reakcija, povezana z mestom katetra astenija; reakcija na mestu injiciranja; bolečina na mestu injiciranja; vnetje na mestu injiciranja
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection Powder and solvent for solution for injection 
ReFacto AF 250 i.e., 500 i.e., 1000 i.e., 2000 i.e. prašek in vehikel za raztopino za injiciranje Zdravilo ne vsebuje konzervansa.
PK parameter 
farmakokinetični parameter povprečje
Use the reconstituted solution within 3 hours of reconstitution or removal of the grey tip cap. 
Pripravljeno raztopino porabite v 3 urah po pripravi oziroma po odstranitvi sive zaporke.
Number of subjects 
DRUGI PODATKI
Discard the pre-filled syringe if visible particulate matter or discolouration is observed. 
Prepričati se morate, da pripravljena raztopina ne vsebuje vidnih delcev oziroma ni obarvana.
ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the lyophilised powder for injection with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution] syringe. 
Potem, ko liofilizirani prašek za injiciranje zdravila ReFacto AF pripravimo s priloženim vehiklom [9 mg/ml (0,9 %) raztopina natrijevega klorida] iz priložene brizge, ga dajemo z intravensko (i.v.)
1 pre filled syringe (250 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (500 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (1000 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (2000 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (3000 IU powder in top chamber and 4 ml solvent in bottom chamber) 
1 napolnjena injekcijska brizga (1.000 i.e. praška v zgornjem razdelku in 4 ml vehikla v spodnjem razdelku)
While holding the adapter package, place the vial adapter over the vial. 
Primite ohišje z nastavkom in ga namestite nad vialo.
Dyspnoea 
Odmerjanje
The product does not contain a preservative, and the reconstituted product should be used immediately, or within 3 hours after reconstitution or removal of the grey tip cap. Other in-use storage times and conditions are the responsibility of the user. 
Pripravljeno zdravilo morate porabiti takoj, najpozneje pa v 3 urah po rekonstituciji ali odstranitvi sivega pokrovčka.
1 pre-filled syringe: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution). 
1 napolnjena injekcijska brizga: 250 i.e. moroktokoga alfa (pribl.
Package size perforated unit dose blister (PVC/Alu) 5 x 2 tablets l t o r 
Peroralno Perforiran pretisni omot za enkratni odmerek (PVC/Alu)
(See section 5.3). 
(glejte poglavje 5.1).
Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007 
Datum pridobitve dovoljenja za promet: 27. avgust 1997 Datum zadnjega podaljšanja dovoljenja: 27. avgust 2007
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established. 
Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
Patients with high blood pressure 
Bolniki z visokim krvnim tlakom
However, no proper explanation for these findings in women has been identified. 
Za te ugotovitve pri ženskah niso našli ustrezne razlage.
The patient should be closely monitored, and the treatment should be symptomatic and supportive. 
Bolnika se mora skrbno nadzorovati, zdravljenje pa mora biti simptomatsko in podporno.
None of these increases were associated with identifiable clinical musculoskeletal events. 
Nobeno od teh povečanj ni bilo povezano s prepoznavnimi kliničnimi mišičnoskeletnimi pojavi.
Similar effects have been very rarely reported with irbesartan so far. 
O podobnih učinkih do sedaj poročajo pri irbesartanu zelo redko.
The volume of distribution is 53-93 litres. 
Volumen porazdelitve je 53-93 litrov.
These adverse reactions are derived from spontaneous reports. 
Ti neželeni učinki izhajajo iz spontanih poročil.
Therefore, this combination is not recommended (see section 4.4). 
Zato se takšne kombinacije ne priporoča (glejte poglavje 4.4).
The safety and efficacy of Aprovel in children aged 0 to 18 has not been established. 
Varnost in učinkovitost zdravila Aprovel pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. 
Izkušnje pri odraslih, ki so bili 8 tednov izpostavljeni odmerkom do 900 mg/dan, niso odkrile toksičnosti.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components. 
Vezava na plazemske beljakovine je približno 96%, z zanemarljivo vezavo na krvne celice.