Immubron

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

LYOPHILIZED BACTERIAL, LYSATES

Tilgjengelig fra:

Bruschettini S.r.L. Via Isonzo 6 - 16147 Genova, Italy

ATC-kode:

J07AX

INN (International Name):

LYOPHILIZED BACTERIAL LYSATES 50 mg

Legemiddelform:

TABLET

Sammensetning:

LYOPHILIZED BACTERIAL LYSATES 50 mg

Resept typen:

POM

Terapeutisk område:

VACCINES

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2005-10-04

Informasjon til brukeren

 
_______________________________________________________ 
IMMUBRON
®

lyophilized bacterial lysate 
_______________________________________________________ 
COMPOSITION 
1 tablet of  IMMUBRON contains: 
_Active ingredient:_ lyophilized bacterial lysate
mg 50 of which 7 mg  corresponding to: Staphylcoccus aureus 6 
milliards, Streptococcus pyogenes
6 milliards, Streptococcus viridans 6 milliards, Klebsiella
pneumoniae 6 milliards, 
Klebsiella ozaenae 6 milliards, Haemophylus influenzae
type B 6 milliards, Neisseria catarrhalis 6 milliards, 
Diplococcus pneumoniae 6 milliards (of which type TY1/EQ11 1
milliard, TY2/EQ22  1 milliard, TY3/EQ14  1 
milliard,, TY5/EQ15  1 milliard, TY8/EQ23  1 milliard, TY47/EQ24
 1 milliard) and 43 mg of  lyophilization medium 
glycoll. 
_Excipients_:   
Silicic bioxide, microcrystalline cellulose, calcium phosphate
dibasic, magnesium stearate, ammonium glycyrrhizinate, 
essence of mint powder. 
PHARMACEUTICAL FORM. 30 tablets 250 mg each 
PHARMACOTHERAPEUTIC CATEGORY. Bacterial vaccines 
HOLDER OF REGISTRATION. 
BRUSCHETTINI s.r.l. - Genoa (Italy) 
MANUFACTURER. 
BRUSCHETTINI s.r.l. - Genoa (Italy) 
THERAPEUTIC INDICATIONS. Relapsing  infections of the
upper respiratory tract and of the bronchopulmonary tree. 
IMMUBRON reduces the number and severity of the episodes. 
INFORMATION WHICH MUST BE KNOWN BEFORE THE PRODUCT USE 
CONTRAINDICATIONS. No contraindications have been remarked. 
PREGNANCY AND LACTATION. No toxic effects resulted from tests
on animals during pregnancy, nevertheless it is not 
advisable the treatment with IMMUBRON during the first
three months of  pregnancy.  
SPECIAL PRECAUTIONS FOR USE. The use of IMMUBRON does not
need any particular precaution. 
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS
OF INTERACTION. Interaction with other medicaments are 
unknown neither with  antibiotics. 
EFFECT

Preparatomtale

Page 1 of 4 

SUMMARY OF PRODUCT CHARACTERISTICS  

1. TRADE NAME OF THE MEDICINAL PRODUCT 

IMMUBRON 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 tablet of  IMMUBRON contains: 
_Active ingredient:_ lyophilized bacterial lysate mg 50 of which 7
mg  corresponding to: 
Staphylcoccus aureus 6 miliards, Streptococcus pyogenes 6 miliards,
Streptococcus viridans 6 
miliards, Klebsiella pneumoniae 6 miliards, Klebsiella ozaenae 6
miliards, Haemophylus influenzae 
type b 6 miliards, Neisseria catarrhalis 6 miliards, Diplococcus
pneumoniae 6 miliards (of which 
type TY1/EQ11 1 miliard, TY2/EQ22  1 miliard, TY3/EQ14  1 miliard,,
TY5/EQ15  1 miliard, 
TY8/EQ23  1 miliard, TY47/EQ24  1 miliard) and 43 mg of 
lyophilization medium glycocoll. 
_Excipients_:   
Silicon dioxyde 10 mg, microcrystalline cellulose 150 mg,
calcium phosphate dibasic 35 mg, 
magnesium stearate 3 mg, ammonium glycyrrhizinate 1,2 mg, essence
of mint powder 0,8 mg. 

3. PHARMACEUTICAL FORM 

Tablet 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Acute, subacute or chronic  infections of the upper respiratory
tract and of the bronchopulmonary 
tree and their relapses; as immunomodulator IMMUBRON reduces the
number and severity of the 
episodes  having also a prophylaxis action on  relapses. 
The improvement of the clinical symptoms (cough, expectoration,
dyspnoea, etc.) is matched with 
the increase of the immunoglobulins IgA, IgM, IgG and IgE. 
The product, if necessary, can be used together with other
treatments (antibiotics,  mucolytic 
products) 
The effects of  IMMUBRON immunomodulation studied in
double blind versus placebo in the old 
people are evident about the frequency and length of infections of
the respiratory tract, even after 
60 days  since the treatment end, with  immune response at the
secretory IgA level.  

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Treatment of the acute ep