FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not store with attached needle.
Slovenian: Ne shranjujte z nameščeno iglo.
English: For dose steps from 30-60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen is available.
Slovenian: Za odmerne korake od 30 do 60 enot je na voljo zdravilo Suliqua 100 enot/ml + 33 mikrogramov/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku SoloStar.
English: Suliqua (10-40) pen contains insulin glargine and lixisenatide.
Slovenian: Injekcijski peresnik Suliqua (10-40) vsebuje insulin glargin in liksisenatid.
English: • The other ingredients are: 85% glycerol, methionine, metacresol, zinc chloride, concentrated hydrochloric acid, and sodium hydroxide (for pH adjustement) and water for injections.
Slovenian: • Druge sestavine so: 85 % glicerol, metionin, metakrezol, cinkov klorid, koncentrirana klorovodikova kislina in natrijev hidroksid (za prilagoditev pH) in voda za injekcije.
English: Number of subjects (mITT)
Slovenian: Izhodiščno (povprečje)
English: Each pen contains 3 ml of solution for injection, equivalent to 300 units insulin glargine and 100 micrograms lixisenatide.
Slovenian: En peresnik vsebuje 3 ml raztopine za injiciranje; to ustreza 300 enotam insulina glargin in 100 mikrogramom liksisenatida.
English: No pharmacokinetic interactions are known for insulin glargine.
Slovenian: Za insulin glargin ni znanih farmakokinetičnih medsebojnih delovanj.
English: • Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine in combination with 5-20 mcg lixisenatide (Suliqua (10-40) pen).
Slovenian: • Napolnjeni injekcijski peresnik Suliqua 100 enot/ml + 50 mikrogramov/ml zagotavlja odmerne korake 10-40 enot insulina glargin v kombinaciji s 5-20 mcg liksisenatida (peresnik Suliqua
English: Insulin glargine
Slovenian: Insulin glargin
English: Age has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Slovenian: Starost ni klinično pomembno vplivala na farmakokinetiko liksisenatida.
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Slovenian: Temeljno delovanje insulina je uravnavanje presnove glukoze; to velja tudi za insulin glargin.
English: • Read the instructions in your package leaflet carefully before using Suliqua.
Slovenian: • Pred uporabo zdravila Suliqua natančno preberite navodila, navedena v navodilu za uporabo zdravila.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Suliqua if:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Suliqua se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: • Suliqua 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20 mcg lixisenatide (Suliqua (30-60) pen).
Slovenian: • Napolnjeni injekcijski peresnik Suliqua 100 enot/ml + 33 mikrogramov/ml zagotavlja odmerne korake 30-60 enot insulina glargin v kombinaciji z 10-20 mcg liksisenatida (peresnik Suliqua
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of lixisenatide based on the results of pharmacokinetic studies in Caucasian, Japanese and Chinese subjects.
Slovenian: Glede na farmakokinetične študije pri belcih, Japoncih in Kitajcih etnično poreklo ni klinično pomembno vplivalo na farmakokinetiko liksisenatida.
English: It is not known if Suliqua harms your unborn child. Suliqua should not be used if breast-feeding.
Slovenian: Ni znano, ali zdravilo Suliqua škoduje nerojenemu otroku.
English: Reversible testicular and epididymal lesions were seen in dogs treated with lixisenatide.
Slovenian: Pri psih, ki so prejemali liksisenatid, so ugotovili reverzibilne lezije mod in obmodka.
English: LIST OF EXCIPIENTS glycerol 85%, methionine, metacresol (see leaflet for further information), zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Slovenian: 85 % glicerol, metionin, metakrezol (za dodatne informacije glejte navodilo za uporabo), cinkov klorid, koncentrirana klorovodikova kislina in natrijev hidroksid (za prilagoditev pH) in voda za injekcije.
English: N Documented symptomatic hypoglycaemia* Patients with event, n (%) 120 (25.6%) 110 (23.6%) 15 (6.4%) 146 (40.0) 155 (42.5)
Slovenian: N Dokumentirana simptomatska hipoglikemija* Bolniki z dogodkom, n (%) Dogodkov na bolnik-leto, n 1,44 Huda hipoglikemija** Dogodkov na bolnik-leto, n
English: Lixisenatide
Slovenian: Liksisenatid
English: Switch from basal insulin
Slovenian: Prehod z bazalnega insulina
English: The effect of some medicines you swallow might be affected by Suliqua.
Slovenian: Zdravilo Suliqua lahko vpliva na učinek nekaterih zdravil, ki jih zaužijete.
English: If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
Slovenian: Če imate prenizek krvni sladkor, upoštevajte navodila za ravnanje v primeru hipoglikemije (glejte informacije v okvirju na koncu tega navodila za uporabo).
English: • Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis.
Slovenian: • Če imate hudo hiperglikemijo ali ketoacidozo, se takoj posvetujte z zdravnikom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Suliqua 100 units/mL +33 mcg/mL solution for injection insulin glargine + lixisenatide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Suliqua 100 enot/ml + 33 mcg/ml injekcija insulin glargin + liksisenatid subkutana uporaba
English: Do not inject a dose higher than 40 dose steps.
Slovenian: Ne injicirajte odmerkov, večjih od 40 odmernih korakov.
English: Patients [n (%)] reaching HbA1c <7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean)
Slovenian: Število bolnikov (%), ki so 30. teden dosegli HbA1c < 7 %* Glukoza v plazmi na tešče (mmol/l) Izhodiščno (povprečje) Na koncu študije (povprečje) Sprememba od izhodišča (po metodi NK), povprečje
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Suliqua 100 units/mL + 50 mcg/mL solution for injection insulin glargine + lixisenatide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Suliqua 100 enot/ml + 50 mcg/ml injekcija insulin glargin + liksisenatid subkutana uporaba
English: See table and figure below for the other endpoints in the study.
Slovenian: Za druge opazovane dogodke v študiji glejte preglednico in sliko spodaj.
English: (such as acetylsalicylic acid).
Slovenian: propoksifen ali salicilate (na primer acetilsalicilno kislino).
English: Baseline (mean; post run-in phase) End of treatment (mean)
Slovenian: Izhodiščno (povprečje, po obdobju uvajanja) Na koncu zdravljenja (povprečje)
English: In patients with renal impairment, however, insulin requirements may be diminished due to reduced insulin metabolism.
Slovenian: Vendar se lahko bolnikom z okvaro ledvic potreba po insulinu zmanjša zaradi zmanjšane presnove insulina.
English: Do not inject a dose lower than 30 dose steps.
Slovenian: Ne injicirajte odmerkov, manjših od 30 odmernih korakov.
English: Proportion difference vs. lixisenatide [95% confidence interval]*
Slovenian: z liksisenatidom [95 % interval zaupanja]*
English: No dose adjustment is required for lixisenatide in patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka liksisenatida ni treba prilagoditi.
English: Do not inject a dose lower than 10 dose steps.
Slovenian: Ne injicirajte odmerkov, manjših od 10 odmernih korakov.
English: Your blood sugar level may either rise or fall if you drink alcohol.
Slovenian: Če pijete alkohol, se vam lahko krvni sladkor zniža ali zviša.
English: If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycaemia).
Slovenian: Če ste uporabili večji odmerek zdravila Suliqua, kot bi smeli Če ste si injicirali preveč zdravila, se vam lahko koncentracija krvnega sladkorja preveč zniža (hipoglikemija).
English: • a sharps container for used needles and pens.
Slovenian: • vsebnik za ostre odpadke za uporabljene igle in peresnike (glejte Kako zavreči peresnik).
English: Patients screened had type 2 diabetes were treated with basal insulin for at least 6 months, receiving a stable daily dose of between 15 and 40 U alone or combined with 1 or 2 OADs (metformin or a sulfonylurea or a glinide or a SGLT-2 inhibitor or a DPP-4 inhibitor), had an HbA1c between 7.5% and 10% (mean HbA1c of 8.5% at screening) and a FPG less than or equal to 10.0 mmol/L or 11.1 mmol/L depending on their previous anti-diabetic treatment.
Slovenian: Za zdravljenje so vsaj 6 mesecev uporabljali bazalni insulin v stabilnem dnevnem odmerku od 15 do 40 enot, samega ali v kombinaciji z 1 ali 2 POAD (metformin ali sulfonilsečnina ali glinid ali zaviralec SGLT-2 ali zaviralec DPP-4).
English: • Thyroid hormones, for thyroid gland problems.
Slovenian: • Ščitnične hormone, za težave s ščitnico.
English: • Cold, runny nose, sore throat
Slovenian: • prehlad, izcedek iz nosu, vnetje žrela
English: Each pen contains 3 ml of solution
Slovenian: En peresnik vsebuje 3 ml raztopine.
English: The differentiation between the pen strengths is based on the dose range of the pen.
Slovenian: Jakosti peresnikov se razlikujeta po razponu odmerkov enega in drugega peresnika.
English: 2 hour PPG (mmol/L)** Baseline (mean) End of study (mean)
Slovenian: PPG - 2 uri (mmol/l)** Izhodiščno (povprečje) Na koncu študije (povprečje) Sprememba od izhodišča (po metodi NK) Sprememba v prim.
English: 30 dose steps (30 units/10 mcg)* * units insulin glargine (100 units/ml) / mcg lixisenatide
Slovenian: *enot insulina glargin (100 enot/ml) / mcg liksisenatida
English: • Each dose step you dial contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Slovenian: • Vsak odmerni korak, ki ga nastavite, vsebuje 1 enoto insulina glargin in 0,5 mikrograma liksisenatida.
English: STEP 2: Attach a new needle
Slovenian: KORAK, Namestite novo iglo),
English: Always keep the cap on the pen when you are not using it in order to protect it from light.
Slovenian: Kadar peresnika ne uporabljate, naj ima vedno nameščen pokrovček za zagotovitev zaščite pred svetlobo.
English: Previous therapy
Slovenian: Predhodno zdravljenje
English: Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.
Slovenian: Če hipoglikemije ne morete obvladati ali se ponovi, se takoj posvetujte z zdravnikom.
English: • in a vein.
Slovenian: • Za injiciranje v veno.
English: A. Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back.
Slovenian: Držite iglo naravnost in jo usmerite nazaj v zunanji pokrovček igle.
English: Fatigue Injection site reactions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost reakcije na mestu injiciranja
English: LS difference versus lixisenatide (mean) [95%CI] (p-value)
Slovenian: z liksisenatidom (po metodi NK), povprečje [95 % IZ] (vrednost p)
English: 5x 3 mL pens
Slovenian: 5x 3 ml injekcijski peresniki
English: • Do not use this pen if you need a daily dose less than 30 dose steps or if you need more than 60 dose steps.
Slovenian: • Ne uporabljajte tega peresnika, če potrebujete dnevni odmerek, manjši od 30 odmernih korakov ali večji od 60 odmernih korakov.
English: • Store the pen with your pen cap on.
Slovenian: • Peresnik shranjujte z nameščenim pokrovčkom.
English: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Slovenian: Suliqua 100 enot/ml + 33 mikrogramov/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin + liksisenatid
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Slovenian: Suliqua 100 enot/ml + 50 mikrogramov/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin + liksisenatid
English: Proportion difference versus insulin glargine [95% confidence interval] (p-value)
Slovenian: Razlika v primerjavi z insulinom glargin [95 % interval zaupanja] (vrednost p)
English: Suliqua is an injectable diabetes medicine that contains two active substances:
Slovenian: • Zdravilo Suliqua je na voljo v dveh napolnjenih injekcijskih peresnikih, ki vsebujeta dve različni jakosti liksisenatida in različna razpona odmerkov:
English: 60 dose steps.
Slovenian: KORAK in 2.
English: • Do not use this pen if you need a daily dose less than 10 dose steps or if you need more than 40 dose steps.
Slovenian: • Ne uporabljajte tega peresnika, če potrebujete dnevni odmerek, manjši od 10 odmernih korakov ali večji od 40 odmernih korakov.
English: Handle your pen with care • If you think that your pen may be damaged, do not try to fix it. Use a new one.
Slovenian: • Če menite, da je peresnik pokvarjen, ga ne poskušajte popraviti.
English: Each dose step of Suliqua contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide,.
Slovenian: En odmerni korak zdravila Suliqua vsebuje 1 enoto insulina glargin in 0,5 mikrogramov liksisenatida.
English: • Do not use this pen if you need a single daily dose that is less than 10 dose steps, or more than 40 dose steps.
Slovenian: • Peresnika ne uporabljajte, če potrebujete samo en dnevni odmerek, ki je manjši od 10 odmernih korakov ali večji od 40 odmernih korakov.
English: • Explain to your patient that: You are prescribing a number of dose steps which corresponds to a set number of units of insulin plus a fixed amount lixisenatide For Suliqua, one dose step always contains one unit of insulin, regardless of the Suliqua pre filled pen being used (10-40 pen or 30 60 pen) The dose counter of the pen device shows the number of dose steps to be injected,
Slovenian: • Pri zdravilu Suliqua en odmerni korak vedno vsebuje eno enoto insulina, ne glede na to, kateri napolnjeni injekcijski peresnik zdravila Suliqua je uporabljen (peresnik 10-40 ali peresnik
English: Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
Slovenian: En odmerni korak vsebuje 1 enoto insulina glargin in 0,33 mikrogramov liksisenatida.
English: Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide.
Slovenian: En mililiter vsebuje 100 enot insulina glargin in 33 mikrogramov liksisenatida.
English: 10x 3 mL pens
Slovenian: 10x 3 ml injekcijski peresniki
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen
Slovenian: Suliqua 100 enot/ml + 50 mikrogramov/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: • For total daily doses >60 dose steps/day, Suliqua must not be used.
Slovenian: • Zdravila Suliqua se ne sme uporabljati za celotne dnevne odmerke, večje od 60 odmernih korakov na dan.
English: • Each dose step of Suliqua you dial contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
Slovenian: • Vsak odmerni korak zdravila Suliqua, ki ga nastavite, vsebuje 1 enoto insulina glargin in 0,33
English: Each mL contains 100 units of insulin glargine and 50 micrograms lixisenatide.
Slovenian: En mililiter vsebuje 100 enot insulina glargin in 50 mikrogramov liksisenatida.
English: Talk to your doctor beforeGarling.
Slovenian: S peresnikom ravnaje previdno.
English: How to store Suliqua
Slovenian: Shranjevanje zdravila Suliqua
English: Concentrated hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: 85 % glicerol metionin metakrezol cinkov klorid koncentrirana klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH) voda za injekcije
English: Proportion difference vs. insulin glargine [95% confidence interval] (p-value)
Slovenian: Primerjava z insulinom glargin [95 % interval zaupanja] (vrednost p)
English: Dizziness
Slovenian: Stegna
English: Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Slovenian: En odmerni korak vsebuje 1 enoto insulina glargin in 0,5 mikrogramov liksisenatida.
English: Suliqua
Slovenian: Peresnik Suliqua
English: Each pen contains 300 units of insulin glargine and 150 micrograms lixisenatide in 3 ml solution.
Slovenian: En peresnik vsebuje 300 enot insulina glargin in 150 mikrogramom liksisenatida v 3 ml raztopine.
English: • Do not use the pen if the medicine looks cloudy, coloured or contains particles.
Slovenian: • Če je zdravilo motno, obarvano, ali so v njem delci, peresnika ne uporabite.
English: • Suliqua is available in two pre filled pens containing different strengths of lixisenatide, and different dose ranges: Both pre filled pens contain insulin glargine in a strength of 100 units/ml Suliqua 10-40 pen allows daily doses between 10 and 40 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 50 mcg/ml; dose range: 10 to 40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide) Suliqua 30-60 pen allows daily doses between 30 and 60 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 33 mcg/ml; dose range: 30 to 60 units insulin glargine in combination with 10 to 20 mcg lixisenatide)
Slovenian: Injekcijski peresnik Suliqua 30-60 omogoča dajanje zdravila Suliqua v dnevnih odmerkih od 30 do 60 odmernih korakov (jakost: insulin glargin 100 enot/ml in liksisenatid 33 mcg/ml; razpon odmerkov: od 30 do 60 enot insulina glargina v kombinaciji z 10 do 20 mcg liksisenatida).
English: 3x 3 mL pens
Slovenian: 3x 3 ml injekcijski peresniki
English: - Keep this leaflet.
Slovenian: Pokrovček trdno namestite.
English: Lixisenatide Suliqua Insulin glargine
Slovenian: Bolniki, ki še niso prejemali insulina Prehod z bazalnega insulina zdravilo Suliqua insulin glargin liksisenatid zdravilo Suliqua insulin glargin
English: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen INSTRUCTIONS FOR USE
Slovenian: Suliqua 100 enot/ml + 33 mikrogramov/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Plunger* Dose window Dose pointer
Slovenian: Okence odmerka Kazalnik odmerka
English: Each pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 mL solution.
Slovenian: En injekcijski peresnik vsebuje 300 enot insulina glargin in 100 mikrogramov liksisenatida v 3 ml raztopine.
English: Each pen contains 300 units insulin glargine and 150 micrograms lixisenatide in 3 ml of solution.
Slovenian: En injekcijski peresnik vsebuje 300 enot insulina glargin in 150 mikrogramov liksisenatida v 3 ml raztopine.
English: • Make sure that you get the correct dose.
Slovenian: • da boste zagotovili injiciranje pravilnega odmerka.
English: Nausea Diarrhoea Vomiting
Slovenian: Bolezni imunskega sistema urtikarija
English: • Do not put the inner needle cap back on. A. Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back.
Slovenian: A. Primite najširši del zunanjega pokrovčka igle.
English: • Stomachache
Slovenian: • omotica
English: LS change from baseline (mean) Difference versus insulin glargine [95% confidence interval]
Slovenian: Razlika v primerjavi z insulinom glargin [95 % interval zaupanja]
English: • Do not use this pen if you need a single daily dose that is less than 30 dose steps, or more than
Slovenian: • Ne uporabljajte tega peresnika, če potrebujete enkratni dnevni odmerek, ki je manjši od 30 odmernih korakov ali večji od 60 odmernih korakov.
English: Nervous system disorders
Slovenian: Srčna frekvenca
English: NA
Slovenian: teden
English: LS difference versus glargine (mean) [95%CI]
Slovenian: z glargin (po metodi NK), povprečje [95 % IZ]
English: Scale
Slovenian: Merilo
English: For in-use pens
Slovenian: Za peresnike, ki so v uporabi
English: LS difference versus lixisenatide (mean) [95%CI]
Slovenian: z liksisenatidom (po metodi NK), povprečje [95 % IZ]
English: Heart rate
Slovenian: Kazalnik odmerka
English: Never use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.
Slovenian: Tako boste preprečili napake pri odmerjanju in možno preveliko odmerjanje.
English: This summary was last updated in 04-2010.
Slovenian: Povzetek je bil nazadnje posodobljen 01-2010.
English: The patients were followed up for up to a year.
Slovenian: Stanje bolnikov so spremljali do enega leta.
English: This is comparable to the protection rate seen with similar treatments in published literature.
Slovenian: To je primerljivo s stopnjo zaščite pri podobnih zdravljenjih iz objavljene literature.
English: The European Commission granted a marketing authorisation valid throughout the EU for ImmunoGam to Cangene Europe Limited on 16 March 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom ImmunoGam, veljavno po vsej Evropski uniji, odobrila družbi Cangene Europe Limited dne 16. marca 2010.
English: ImmunoGam can be used in the following people, who need immediate protection:
Slovenian: Zdravilo ImmunoGam se lahko uporablja pri naslednjih skupinah ljudi, ki potrebujejo takojšnjo zaščito:
English: Although ImmunoGam itself was not tested in experimental models, the applicant presented adequate data from studies using similar medicines.
Slovenian: Čeprav zdravilo ImmunoGam ni bilo preskušeno na poskusnih modelih, je predlagatelj predložil ustrezne podatke iz študij s podobnimi zdravili.
English: In these patients it is used until vaccination against the virus becomes effective;
Slovenian: Pri teh bolnikih se zdravilo uporablja, dokler cepivo proti virusu ne začne učinkovati;
English: • newborn babies whose mothers are carriers of the virus;
Slovenian: • pri novorojenčkih, katerih matere so prenašalke virusa;
English: • patients who have had haemodialysis (a blood clearance technique used in people with kidney problems).
Slovenian: • pri bolnikih, ki so prejemali hemodializo (tehniko čiščenja krvi, ki se uporablja pri ljudeh, ki imajo težave z ledvicami).
English: ImmunoGam has been investigated in one main study involving 253 newborn babies whose mothers were carriers of the virus and 42 adults who had potentially been exposed to the virus.
Slovenian: Zdravilo ImmunoGam so proučevali v eni glavni študiji z 253 novorojenčki, katerih matere so prenašalke virusa, in 42 odraslimi, ki so bili potencialno izpostavljeni virusu.
English: Other information about ImmunoGam:
Slovenian: Druge informacije o zdravilu ImmunoGam:
English: Because only a small number of adults were involved in the study, the assessment of the medicine's benefits was based mainly on the results from the babies.
Slovenian: Ker je bilo v študijo vključeno le malo odraslih, temeljijo ocene koristi zdravil predvsem na rezultatih pri dojenčkih.
English: Antibodies are proteins in the blood that help the body to fight infections and other diseases.
Slovenian: Protitelesa so beljakovine v krvi, ki pomagajo telesu pri premagovanju okužb in drugih bolezni.
English: This document is a summary of the European Public Assessment Report (EPAR) for ImmunoGam.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ImmunoGam.
English: For more information about treatment with ImmunoGam, read the Package Leaflet (also part of the EPAR).
Slovenian: Za več informacij o zdravljenju z zdravilom ImmunoGam preberite navodilo za uporabo (ki je prav tako del EPAR).
English: This may need to be repeated until the babies show an immune response against the virus after vaccination.
Slovenian: To bo morda treba ponavljati, dokler pri dojenčkih po cepljenju ni viden imunski odziv proti virusu.
English: People accidentally exposed to the virus should receive at least 500 international units (IU) as soon as possible and preferably within 24 to 72 hours of exposure.
Slovenian: Ljudje, ki so bili naključno izpostavljeni virusu, morajo čimprej prejeti najmanj 500 mednarodnih enot (i.e.) zdravila, po možnosti v 24 do 72 urah po izpostavljenosti.