natgillin/translations-raw huggingface dataset:
This dose adjustment should be based on FXIII activity levels.
Prilagoditev odmerka se mora opirati na raven aktivnosti faktorja XIII.
Dose volume in millilitres = 0.042 x your body weight in kilograms.
odmerek v mililitrih = 0,042 x vaša telesna masa v kilogramih.
The antibodies had no inhibitory action and the patients did not experience any adverse events or bleeding in association with these antibodies.
Ta protitelesa pri bolniku niso delovala zaviralno in preiskovanec v zvezi s temi protitelesi ni imel neželenih učinkov ali krvavitev.
NovoThirteen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
NovoThirteen is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Zdravilo NovoThirteen je podenota A rekombinantnega koagulacijskega faktorja XIII, pridobljenega v kvasovkah (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA.
Click the vial adapter, still attached to the syringe onto the powder vial.
S klikom pritrdite nastavek za vialo, ki je še vedno nameščen na brizgo, na vialo s praškom.
In the F13CD-1725 extension trial F13CD-3720, the age-adjusted rate of bleeds that required treatment with a FXIII-containing product was estimated to be 0.021 bleeds per subject year with a 95% CI of [0.0062; 0.073] (model-based estimate corresponding to a mean age of the trial population of 31.0 years).
V F13CD-1725, podaljšanju preskušanja F13CD-3720, je bil ocenjeni za starost korigirani delež krvavitev, ki so zahtevale zdravljenje z zdravili s FXIII, 0,021 krvavitve na preiskovanca na leto (95 % interval zaupanja: od 0,0062 do 0,073) (ocena na podlagi modela, ki ustreza povprečni starosti populacije v preskušanju 31,0 let).
• Embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
• embolične in trombembolične dogodke, vključno z večjim tveganjem za zaporo žile pri bolnikih, ki imajo tveganje za trombozo • kako ukrepati v primeru nepravilnega shranjevanja, tromboze ali embolije
Push the plunger slowly to inject the solvent into the powder vial.
Počasi potiskajte bat in tako vbrizgajte vehikel v vialo s praškom.
DK-2880 Bagsværd
DK-2820 Gentofte Danska
Once prepared, NovoThirteen for injection should be used immediately.
Ko je zdravilo NovoThirteen pripravljeno za injiciranje, ga je treba takoj uporabiti.
It is structurally identical to the human FXIII A-subunit [A2].
Po zgradbi je identična podenoti A človeškega FXIII [A2].
INFORMATION IN BRAILLE NovoThirteen
PODATKI V BRAILLOVI PISAVI
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology and repeated dose toxicity.
Na osnovi študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih neklinični podatki ne kažejo posebnega tveganja za ljudi.
NovoThirteen is given as an injection into a vein.
Zdravilo NovoThirteen se injicira v veno.
For instructions on reconstitution of the medicinal product prior to administration, see section 6.6.
Za navodila o pripravi zdravila pred uporabo glejte poglavje 6.6. 4.3 Kontraindikacije
What NovoThirteen is and what it is used for
Kaj je zdravilo NovoThirteen in za kaj ga uporabljamo Kaj je zdravilo NovoThirteen
In plasma, FXIII circulates as a heterotetramer [A2B2] composed of 2 FXIII A-subunits and 2 FXIII Bsubunits held together by strong non-covalent interactions.
Mehanizem delovanja V plazmi FXIII kroži kot heterotetramer [A2B2], sestavljen iz 2 podenot A in 2 podenot B FXIII,
In patients with FXIII deficiency, NovoThirteen is not effective if used for monthly prophylactic treatment of bleeding in patients with congenital FXIII B-subunit deficiency.
Zdravilo NovoThirteen ni učinkovito kot mesečno profilaktično zdravljenje pri bolnikih s pomanjkanjem FXIII, ki imajo prirojeno pomanjkanje podenote B FXIII.
In a pharmacokinetic trial 6 children (age 1 to less than 6 years old) with congenital FXIII A-subunit deficiency were exposed to one single i.v.
Pediatrična populacija V farmakokinetičnem preskušanju je 6 otrok (starih med 1 in 6 let) s prirojenim pomanjkanjem podenote A FXIII prejelo en intravenski odmerek 35 i.e./kg zdravila NovoThirteen.
The solution is clear and colourless.
Raztopina je bistra in brezbarvna.
Dose adjustment can be considered necessary by the physician in certain situations where the prevention of bleeding is not appropriately covered by the recommended 35 IU/kg/month dose.
Zdravnik lahko v redkih primerih, če preprečevanje krvavitev ni ustrezno doseženo s priporočenim odmerkom 35 i.e./kg/mesec, presodi, da je treba odmerek prilagoditi.
Five bleeding episodes requiring treatment with a FXIII-containing product have been observed in four patients during treatment with rFXIII in the trial.
V preskušanju so med zdravljenjem z rFXIII pri štirih bolnikih zabeležili pet krvavitev, ki so zahtevale zdravljenje z zdravilom s FXIII.
In the event that inhibitors are suspected analysis for antibodies should be performed.
V primeru suma na zaviralce je treba opraviti analizo glede protiteles.
Attach the vial adapter to the solvent vial (water for injections).
Nastavek za vialo namestite na vialo z vehiklom (voda za injekcije).
What NovoThirteen looks like and contents of the pack NovoThirteen is supplied as a powder and solvent for solution for injection (2500 IU powder in a vial and 3.2 ml solvent in a vial, with a vial adapter).
Zdravilo NovoThirteen je na voljo kot prašek in vehikel za raztopino za injiciranje (2500 i.e. praška v viali in 3,2 ml vehikla v viali, z nastavkom za vialo).
One healthy subject developed low-titer, transient non-neutralising antibodies after receiving the first dose of NovoThirteen.
Enemu zdravemu preiskovancu se je po prvem odmerku zdravila NovoThirteen prehodno pojavil nizek titer nenevtralizirajočih protiteles.
NovoThirteen is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit).
Za kaj uporabljamo zdravilo NovoThirteen Zdravilo NovoThirteen uporabljamo za preprečevanje krvavitev pri bolnikih, ki jim primanjkuje ali nimajo dela faktorja XIII, imenovanega podenota A.
• The active substance is catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml, after reconstitution, corresponding to a concentration of 833 IU/ml.
• Učinkovina je katridekakog (rekombinantni koagulacijski faktor XIII): 2500 i.e./3 ml, kar po pripravi ustreza koncentraciji 833 i.e./ml.
Thromboembolic risk:
Tveganje za trombembolične dogodke
Use in children and adolescents (weighing more than 24 kg) NovoThirteen can be used in children and adolescents in the same way as in adults.
Zdravilo NovoThirteen se lahko pri mladostnikih in otrocih uporablja na enak način kot pri odraslih.
What NovoThirteen contains
Kaj vsebuje zdravilo NovoThirteen
The subunit deficiency of patients should be determined prior to treatment by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Preden se začne zdravljenje pri bolnikih, je torej treba določiti, katera podenota FXIII bolniku primanjkuje z ustreznimi diagnostičnimi postopki, vključno z merjenjem aktivnosti FXIII in imunološkim preizkusom ter z genotipizacijo, če pride v poštev.
Carefully draw exactly 6 ml sodium chloride 0.9%, solution for injection, into the 10 ml syringe.
Previdno izvlecite 6 ml 0,9 % raztopine natrijevega klorida za injiciranje v 10-ml brizgo.
Four cases of non-neutralising antibodies were reported at the start of the treatment in patients from 6 to 18 years of age.
Pri bolnikih, starih med 6 in 18 let, so na začetku zdravljenja opazili štiri primere pojava nenevtralizirajočih protiteles.
In case a dilution of the reconstituted NovoThirteen is needed proceed to the section ‘Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection'.
Če je treba pripravljeno zdravilo NovoThirteen razredčiti, pojdite na poglavje "Razredčenje pripravljenega zdravila z 0,9 % raztopino natrijevega klorida za injiciranje".
Dose volume in ml = 0.042 x subject bw (kg)
velikost odmerka v ml = 0,042 x bolnikova telesna masa (kg)
No treatment requiring bleeding episodes have been detected in patients below 6 years during 17 years of cumulative follow-up, representing a total of 214 doses.
Pri bolnikih, mlajših od 6 let, med 17 let trajajočim kumulativnim spremljanjem (to pomeni v celoti 214 odmerkov) niso zabeležili epizod krvavitev, ki bi zahtevale zdravljenje.
Powder and solvent for solution for injection 2500 IU powder in a vial, 3.2 ml solvent in a vial, 1 vial adapter
prašek in vehikel za raztopino za injiciranje 2500 i.e. praška v viali 3,2 ml vehikla v viali nastavek za vialo za pripravo zdravila
NovoThirteen user instructions
Navodila za uporabnika zdravila NovoThirteen
FXIII activity levels should be monitored in patients with severe hepatic impairment.
Bolnikom s hudo boleznijo jeter je treba spremljati raven aktivnosti FXIII.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for powder vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• Pain where the injection is given
• bolečina na mestu injiciranja
Slowly inject the 6 ml sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen vial.
Počasi injicirajte 6 ml 0,9 % raztopine natrijevega klorida za injiciranje v vialo s pripravljenim zdravilom NovoThirteen.
However, if the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to handle the dosing of small children (see section 6.6 ‘Special precautions for disposal and other handling - Use in the paediatric population').
Toda če pediatrični bolnik tehta manj kot 24 kg, je treba pripravljeno zdravilo NovoThirteen za ustrezno odmerjanje pri majhnih otrocih dodatno razredčiti s 6 ml 0,9 % raztopine natrijevega klorida za injiciranje (glejte poglavje 6.6, "Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom - Uporaba pri pediatrični populaciji").
Before you can use NovoThirteen for injection you need to reconstitute the product.
Preden se zdravilo NovoThirteen uporabi za injiciranje, ga je treba pripraviti.
Remove the empty solvent vial by tipping the syringe with the vial adapter.
Odstranite prazno vialo z vehiklom, tako da nagnete brizgo skupaj z nastavkom za vialo.
Once attached, remove the protective cap from the vial adapter.
Ko je nastavek za vialo nameščen, z njega odstranite zaščitni pokrovček.
NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (recombinant coagulation factor XIII)
Navodilo za uporabo NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje katridekakog (rekombinantni koagulacijski faktor XIII)
Pull the plunger to draw in a volume of air equal to the total amount of solvent in the solvent vial.
Izvlecite bat brizge, da boste vanjo potegnili toliko zraka, kolikor je vehikla v viali z vehiklom.
Inhibitor formation:
Injiciranje raztopine
Dose volume in ml = 0.117 x body weight in kilograms.
Velikost odmerka v ml = 0,117 x bolnikova telesna masa v kilogramih.
Do not use this medicine if there are particles in it or it is discoloured when reconstituted.
Če so po pripravi zdravila v njem delci ali je obarvano, zdravila ne uporabite.
Although expressed in the same unit (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4).
Čeprav se odmerki zdravila NovoThirteen izražajo z enakimi enotami (i.e.), kot so v uporabi pri odmernih shemah drugih zdravil, ki vsebujejo FXIII, je njegovo odmerjanje drugačno (glejte poglavje
One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA) 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Ena viala vsebuje 2500 i.e. katridekakoga (rekombinantni koagulacijski faktor XIII) (rDNA) v 3 ml, kar po pripravi ustreza koncentraciji 833 i.e./ml.
Dose volume in millilitres = 0.117 x body weight in kilograms.
Velikost odmerka v mililitrih = 0,117 x bolnikova telesna masa v kilogramih.
NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (rDNA factor XIII)
NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje katridekakog (rDNA faktor XIII)
Talk to your doctor before using NovoThirteen:
Kaj morate vedeti, preden boste uporabili zdravilo NovoThirteen Ne uporabljajte zdravila NovoThirteen:
The enzymatic activity resides with the FXIII A-subunit.
Za encimsko delovanje je odgovorna podenota A FXIII.
In the event of either being observed, discard the medicinal product.
Če opazite kar koli od tega, zdravilo zavrzite.
The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 ml/minute.
Zdravilo je treba aplicirati s počasno bolusno intravensko injekcijo; hitrost dajanja ne sme preseči
For children weighing less than 24 kg the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children.
Pri otrocih, ki tehtajo manj kot 24 kg, je treba pripravljeno zdravilo NovoThirteen za ustrezno odmerjanje pri majhnih otrocih dodatno razredčiti s 6 ml 0,9 % raztopine natrijevega klorida za injiciranje.
• A drop in the number of some types of white blood cells.
• zmanjšanje števila nekaterih vrst belih krvnih celic; to pomeni, da je lahko vaše telo dovzetnejše za okužbe
Fertility
NovoThirteen
Polysorbate 20
natrijev klorid saharoza polisorbat 20
When the FXIII Asubunit is bound to the FXIII B-subunit [A2B2], the half-life of the FXIII A-subunit [A2] is prolonged.
Ko je podenota A FXIII vezana na podenoto B [A2B2],
If the patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection (refer to the section Use in the paediatric population for further detailed instructions on the dilution step).
Če bolnik tehta manj kot 24 kg, je treba pripravljeno zdravilo NovoThirteen razredčiti s 6 ml 0,9 % raztopine natrijevega klorida za injiciranje (za dodatna navodila o razredčevanju glejte poglavje "Uporaba v pediatrični populaciji").
Gently swirl the vial to mix the solution.
Previdno vrtite vialo, da boste premešali raztopino.
NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection
NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje
Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection
Uporaba v pediatrični populaciji Razredčenje pripravljenega zdravila z 0,9 % raztopino natrijevega klorida za injiciranje
A pivotal prospective, open-label, single-arm phase 3 trial (F13CD-1725) including 41 patients with FXIII A-subunit deficiency was conducted to investigate the haemostatic efficacy of rFXIII in patients with congenital FXIII deficiency as reflected by the rate of bleeding episodes requiring treatment with a FXIII-containing product.
Preskušanje je zajelo 41 bolnikov s pomanjkanjem podenote A FXIII, hemostatsko učinkovitost pa so ocenjevali z deležem krvavitev, ki so zahtevale zdravljenje z zdravilom s FXIII.
There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
Z uporabo zdravila NovoThirteen pri starejših bolnikih s prirojenim pomanjkanjem FXIII je malo kliničnih izkušenj.
Inhibitor formation to NovoThirteen therapy has not been detected in clinical trials.
V kliničnih preskušanjih niso odkrili nastajanja zaviralcev v odziv na zdravljenje z zdravilom NovoThirteen.
Allergic reactions
Bolezni živčevja
If either is noticed, please discard.
Če opazite delce ali obarvanje, raztopino zavrzite.
Screw the syringe tightly onto the vial adapter on the solvent vial.
Brizgo trdno privijte na nastavek za vialo, nameščen na viali z vehiklom.
Powder:
Vehikel:
NovoThirteen 2500 IU powder for injection catridecacog
NovoThirteen 2500 i.e. prašek za injiciranje katridekakog i.v.
Pull the plunger to draw the solvent into the syringe.
Izvlecite bat, da boste vehikel potegnili v brizgo.
Renal insufficiency Patients with renal insufficiency requiring dialysis have not been studied in clinical trials.
V kliničnih preskušanjih niso raziskali uporabo zdravila pri bolnikih z insuficienco ledvic, ki potrebujejo dializno zdravljenje.
NovoThirteen should be inspected visually for extraneous (for any foreign) particulate matter and discoloration prior to administration.
Pripravljeno zdravilo NovoThirteen je treba pred injiciranjem pregledati za vsebnost tujih delcev ali obarvanj.
How to store NovoThirteen
Shranjevanje zdravila NovoThirteen
Patients with hepatic impairment have not been studied.
Okvara jeter Raziskave niso vključevale bolnikov z okvaro jeter.
Common (≥ 1/100 to < 1/10)
EU/1/12/775/001
FXIII containing products (the recommended dose of NovoThirteen is 35 IU/kg body weight
• opozorilo o razlikah v odmerjanju in koncentraciji med zdravilom NovoThirteen in drugimi zdravili, ki vsebujejo FXIII (Priporočeni odmerek zdravila NovoThirteen je 35 i.e./kg telesne mase enkrat na mesec v intravenski bolusni injekciji.
METHOD AND ROUTE OF ADMINISTRATION Intravenous use
za intravensko uporabo
The antibodies had no inhibitory activity, and the subject did not experience any adverse events or bleeding in association with these antibodies.
Prav tako v zvezi s temi protitelesi ni bilo neželenih učinkov ali krvavitev.
Injection site pain
Pogosti bolečina na mestu injiciranja
PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Sestavina vehikla je voda za injekcije.
Solvent: Water for injections
Vehikel za NovoThirteen voda za injekcije
Preparing the solution
Priprava raztopine
Unscrew the vial adapter with the vial.
Odvijte nastavek za vialo skupaj z vialo.
Contact your doctor if you have injected more NovoThirteen than you have been instructed.
Če ste si injicirali več zdravila NovoThirteen, kot vam je bilo naročeno, se posvetujte z zdravnikom.
Do not pass it on to others.
Zdravila ne zamrzujte.
The diluted solution is a clear, colourless solution.
Razredčena raztopina je bistra in brezbarvna.
2 years.
2 ml/minuto.
L-histidine
Hagedornsvej 1
FXIII B-subunit deficiency is associated with a much reduced half-life of the administered pharmacologically active A-subunit.
Pri takšnih bolnikih je razpolovni čas injicirane farmakološko aktivne podenote A močno zmanjšan.
Date of first authorisation: 31 July 2013
Datum prve odobritve: 31. julij 2013
These symptoms may be a sign of a serious allergic reaction.
Ti simptomi so morda znaki resne alergijske reakcije.
Efficacy in animals
Učinkovitost pri živalih
Healthy 9 HIV 131
Zdravi 9 HIV 131
Therefore, dose intervals of less than 4 weeks should be avoided.
Zato se je treba intervalom odmerkov, krajšim od 4 tednov, izogniti.
In this case, your doctor will postpone the vaccination until you are feeling better.
V tem primeru bo zdravnik cepljenje prestavil na kasneje, ko se boste počutili bolje.
The use of this vaccine during pregnancy and breast-feeding is not recommended.
Uporaba tega cepiva med nosečnostjo ali dojenjem se ne priporoča.
Contact a doctor immediately, or go immediately to the emergency department of your nearest hospital if you experience any of the following symptoms:
Takoj se posvetujte z zdravnikom ali pojdite na urgentni oddelek najbližje bolnišnice, če se pojavi kateri od naslednjih simptomov:
Dispose of in accordance with local requirement.
Odstranite v skladu z lokalnimi zahtevami.
Healthy 200
Zdravi 200
Status to be reported annually within each annual reassessment application
O stanju se poroča letno v okviru vsake letne vloge o ponovni oceni
Seroconversion by ELISA and PRNT were as follows:
Serokonverzije po testih ELISA in PRNT so bile kot sledi:
Individuals with atopic dermatitis (AD)
Posamezniki z atopičnim dermatitisom (AD)
• You will receive one injection.
• Prejeli boste eno injekcijo.
• if you are ill with a high temperature.
• če ste bolni z močno povečano telesno temperaturo.
Adverse reactions from all clinical trials are listed according to the following frequency:
Neželeni učinki iz vseh kliničnih preskušanj so našteti v skladu z naslednjo pogostnostjo:
Tell your doctor or nurse if you are taking or have recently taken any other medicines or if you have recently received any other vaccine.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali katero koli drugo zdravilo ali pa ste bili pred kratkim cepljeni s katerim koli drugim cepivom.
This means that because of scientific reasons it has been impossible to get complete information on this medicine.
To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Long-term immunogenicity in humans
Dolgoročna imunogenost pri ljudeh
If you are a pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask to your doctor for advice.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
Thaw at room temperature.
Odtajajte pri sobni temperaturi.
Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX
Farmakoterapevtska skupina: cepivo, druga virusna cepiva, oznaka ATC: J07BX
Expiry date depends on storage temperature.
Potek roka uporabnosti je odvisen od temperature shranjevanja.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
• if you have atopic dermatitis (see section 4).
• če imate atopični dermatitis (glejte poglavje 4).
Day 7/141
Dan 7/141
Pack size of 20.
Velikost pakiranja je 20.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Preden vas bodo cepili s tem cepivom natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
N/A5
n/r5
Healthy 61
Zdravi 61
The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
Zaradi prisotnosti manjših okužb, na primer prehlada, cepljenja ni treba preložiti, vendar se kljub temu najprej pogovorite z zdravnikom ali medicinsko sestro.
You can be given this vaccine whether or not you have received smallpox vaccination in the past.
Cepivo lahko prejmete, ne glede na to, ali ste v preteklosti že prejeli cepivo proti črnim kozam ali ne.
• loss of appetite,
• izguba apetita
Most of them were mild to moderate in nature and resolved without any treatment within seven days.
Večinoma so bili blagi in so brez zdravljenja izzveneli v sedmih dneh.
Individuals with atopic dermatitis developed more local and general symptoms after vaccination (see section 4.8)
Pri posameznikih z atopičnim dermatitisom se je po cepljenju razvilo več lokalnih in splošnih simptomov (glejte poglavje 4.8).
Swirl the vial gently before use for at least 30 seconds.
Vialo pred uporabo nežno obračajte vsaj 30 sekund.
0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).
0,5 ml suspenzije v viali (steklo tipa I) z zamaškom (bromobutilna guma).
Active immunisation against smallpox in adults (see sections 4.4 and 5.1).
Aktivna imunizacija odraslih proti črnim kozam (glejte poglavji 4.4 in 5.1).
A dose of 0.5 ml is withdrawn into a syringe for injection.
Odmerek 0,5 ml se izvleče z injekcijsko brizgo za injiciranje.
• You will receive two injections.
• Prejeli boste dve injekciji.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte tudi poglavje 5.3).
Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl.
Za posameznike, okužene z virusom HIV s številom CD4 ≥ 100 celic/µl in ≤ 750 celic/µl so bili pridobljeni podatki.