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English

UMAN BIG

Slovak

UMAN BIG

Last Update: 2011-10-23
Usage Frequency: 1

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English

What is Uman Big?

Slovak

Čo je liek Uman Big?

Last Update: 2011-10-23
Usage Frequency: 1

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English

UMAN BIG 180 IU/ ml

Slovak

UMAN BIG 180 IU/ ml

Last Update: 2011-10-23
Usage Frequency: 1

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English

Why was Uman Big reviewed?

Slovak

Prečo bol liek Uman Big skúmaný?

Last Update: 2012-04-12
Usage Frequency: 1

English

positive safety profile of UMAN BIG,

Slovak

sú vhodné na stanovenie pozitívneho bezpečnostného profilu lieku UMAN BIG,

Last Update: 2011-10-23
Usage Frequency: 1

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English

7 adverse reaction related to UMAN BIG.

Slovak

7 nežiaducom účinku.

Last Update: 2011-10-23
Usage Frequency: 1

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English

OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF UMAN BIG

Slovak

CELKOVÝ SÚHRN VEDECKÉHO HODNOTENIA LIEKU UMAN BIG

Last Update: 2012-04-12
Usage Frequency: 1

English

Uman Big is a solution of human hepatitis B immunoglobulins.

Slovak

Liek Uman Big je roztok ľudskej hepatitídy typu B immunoglobulins.

Last Update: 2012-04-12
Usage Frequency: 1

English

UMAN BIG 180 180 IU/ ml I. E. / ml Injektionslösung

Slovak

UMAN BIG 180 180 IU/ ml

Last Update: 2011-10-23
Usage Frequency: 1

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English

- the CHMP considered that the benefit/ risk of UMAN BIG is positive,

Slovak

- výbor CHMP usúdil, že podiel prínosu a rizík lieku UMAN BIG je pozitívny,

Last Update: 2012-04-12
Usage Frequency: 1

English

- the CHMP considered the efficacy profile of UMAN BIG to be satisfactory for the indications

Slovak

- výbor CHMP usúdil, že bezpečnostný profil lieku UMAN BIG je uspokojivý pre indikácie uvádzané

Last Update: 2012-04-12
Usage Frequency: 1

English

Literature references show also that the pharmacokinetic profile of UMAN BIG is comparable to that of other intramuscular Hepatitis B immunoglobulin products.

Slovak

Literárne odkazy tiež ukazujú, že farmakokinetický profil lieku UMAN BIG je porovnateľný s profilom iných intramuskulárnych imunoglobulínových liekov proti hepatitíde B.

Last Update: 2012-04-12
Usage Frequency: 1

English

The Applicant concluded that no new information on tolerability is available to suggest a modification of the safety profile of UMAN BIG.

Slovak

Žiadateľ usudzoval, že nie sú k dispozícii žiadne nové informácie o tolerancii, ktoré by naznačovali zmenu bezpečnostného profilu lieku UMAN BIG.

Last Update: 2012-04-12
Usage Frequency: 1

English

UMAN BIG contains glycine as the excipient, a natural amino acid and therefore not expected to cause any problems.

Slovak

Liek UMAN BIG obsahuje ako pomocnú látku glycín, prírodnú aminokyselinu, a preto sa neočakáva, že by spôsobovala nejaké problémy.

Last Update: 2012-04-12
Usage Frequency: 1

English

Finally, the papers quoted by the Applicant indicate that UMAN BIG prevented newborns from HBeAg infected mothers from becoming chronic HBsAg carriers.

Slovak

Nakoniec články citované žiadateľom uvádzajú, že liek UMAN BIG môže zabrániť tomu, aby sa z novorodencov s matkami infikovanými HbeAg stali chronickí prenášači HbsAg.

Last Update: 2012-04-12
Usage Frequency: 1

English

Questions and answers on the referral for Uman Big Human Hepatitis B Immunoglobulins, 180 IU/ ml, solution for injection

Slovak

Otázky a odpovede týkajúce sa konania pre Uman Big Ľudská hepatitída typu B Immunoglobulins, 180 IU/ ml, injekčný roztok

Last Update: 2012-04-12
Usage Frequency: 1

English

The CHMP considered that based on the 28 years of clinical experience with the existing formulation of UMAN BIG, the safety in humans can be considered to have been extensively assessed.

Slovak

Výbor CHMP usúdil, že na základe 28 rokov klinických skúseností s existujúcou liekovou formou lieku UMAN BIG sa bezpečnosť lieku u ľudí môže považovať za dôkladne vyskúšanú.

Last Update: 2012-04-12
Usage Frequency: 1

English

There are enough data regarding the safety and PK of UMAN BIG in newborns, administered for the prevention of HBV transmission from HBsAg infected mothers.

Slovak

Existuje dostatok údajov týkajúcich sa bezpečnosti a farmakokinetiky lieku UMAN BIG u novorodencov, podávaného na prevenciu prenosu HBV z matiek infikovaných HBsAg.

Last Update: 2012-04-12
Usage Frequency: 1

English

Kedrion S. p. A. submitted Uman Big for mutual recognition on the basis of the initial authorisation granted by Italy on 2 June 1979.

Slovak

Spoločnosť Kedrion S. p. A. predložila liek Uman Big na vzájomné uznanie na základe pôvodného povolenia, ktoré vydalo Taliansko 2. jún 1979.

Last Update: 2012-04-12
Usage Frequency: 1

English

The Applicant provided comprehensive published data on the use of UMAN BIG in the prophylaxis of hepatitis B in newborns from HBsAg carrier mothers, demonstrating its efficacy in this particular subset of population.

Slovak

Žiadateľ poskytol rozsiahle publikované údaje o použití lieku UMAN BIG v prevencii hepatitídy B u novorodencov s matkami prenášajúcimi HbsAg, čo poukazuje na jeho účinnosť v tejto osobitnej podskupine populácie.

Last Update: 2012-04-12
Usage Frequency: 1

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