Active ingredients: Bacterial vaccines
IMMUBRON 50 mg sublingual tablets
Indications Why is Immubron used? What is it for?
IMMUBRON contains as an active ingredient a mixture of lyophilized bacterial lysates (bacterial antigens), belonging to the group of bacterial vaccines, which locally stimulate the activity of the body's defense system (immune system).
IMMUBRON is indicated in adults for the prevention of recurrent infections affecting the respiratory tract.
IMMUBRON can contribute, in certain cases, to reduce the number and intensity of infectious episodes.
Contraindications When Immubron should not be used
Do not take IMMUBRON
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from diseases of the immune system (autoimmune diseases);
- if you have developed a "gut infection" (acute intestinal infections).
Precautions for use What you need to know before taking Immubron
Talk to your doctor or pharmacist before taking IMMUBRON.
Take this medicine with caution and tell your doctor if you have any allergies.
Stop treatment and contact your doctor, who will decide whether to permanently discontinue IMMUBRON therapy if you have the following conditions:
- allergic reactions (hypersensitivity reactions);
- asthma attacks in predisposed patients;
- fever, particularly if it occurs at the start of treatment;
The type of high fever above 39 ° C that could arise as a rare, isolated, undesirable event with no known cause, must be differentiated from the fever that arises as a result of the original pathology, on the basis of laryngeal, nasal or otological conditions.
Interactions Which drugs or foods can modify the effect of Immubron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking IMMUBRON together with other medicines that stimulate the activity of the immune system (immunostimulants).
An interval of 4 weeks is recommended between the end of treatment with IMMUBRON and the start of administration of any vaccine.
IMMUBRON may be less effective if you have immune system disorders (with congenital or acquired immunodeficiency), if you are being treated with medicines that reduce the activity of the immune system (immunosuppressive therapy) or if you are taking medicines used to treat allergies. and inflammation (corticosteroids).
IMMUBRON with food and drink
The medicine should be taken on an empty stomach.
Warnings It is important to know that:
Pregnancy and breastfeeding
Do not take IMMUBRON if you are pregnant, do not take IMMUBRON if you are breast-feeding.
Driving and using machines
No effects on the ability to drive or use machines have been reported and no specific studies have been performed.
Dosage and method of use How to use Immubron: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day, to be dissolved under the tongue.
The treatment involves the administration of 1 tablet for 10 consecutive days a month, for a duration of 3 months.
If you forget to take IMMUBRON
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Immubron
There are no known cases of overdose.
In case of accidental intake / ingestion of an excessive dose of IMMUBRON, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Immubron
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (the frequency of which cannot be estimated from the available data)
- pain in the mouth and pharynx (oropharyngeal pain);
- allergic skin reactions (hives, rash, itching, edema);
- fever and headache;
- stomach pain and vomiting;
- inflammation of the lining of the nose (rhinitis).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored.
Do not store above 25 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What IMMUBRON contains
- The active ingredient is a lyophilized bacterial lysate 50 mg of which 7 mg corresponds to:
- Staphylococcus aureus 6 billion
- Streptococcus pyogenes 6 billion
- Streptococcus oralis 6 billion
- Klebsiella pneumoniae 6 billion
- Klebsiella ozaenae 6 billion
- Haemophilus influenzae serotype B 6 billion
- Neisseria catarrhalis 6 billion
- Streptococcus pneumoniae 6 billion (of which type TY1 / EQ11 1 billion - TY2 / EQ22 1 billion - TY3 / EQ14 1 billion - TY5 / EQ15 1 billion - TY8 / EQ23 1 billion - TY47 / EQ24 1 billion)
- 43 mg of glycocol lyophilization support.
- The other ingredients are: silicon dioxide, microcrystalline cellulose, dibasic calcium phosphate, magnesium stearate, glycyrized ammonium, powdered mint essence.
Description of what IMMUBRON looks like and contents of the package
Carton containing 30 sublingual tablets of 50 mg.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
IMMUBRON
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
1 IMMUBRON tablet contains
Active principle:
Lyophilized bacterial lysate 50 mg of which 7 mg corresponding to: Staphylococcus aureus 6 billion - Streptococcus pyogenes 6 billion - Streptococcus viridans 6 billion - Klebsiella pneumoniae 6 billion - Klebsiella ozaenae 6 billion - Haemophilus influenzae serotype B 6 billion - Neisseria catarrhalis 6 billion pneumoniae 6 billion (of which type TY1 / EQ11 1 billion - TY2 / EQ22 1 billion - TY3 / EQ14 1 billion - TY5 / EQ15 1 billion - TY8 / EQ23 1 billion - TY47 / EQ24 1 billion) and 43 mg of freeze drying support glycol.
For excipients see section 6.1.
03.0 PHARMACEUTICAL FORM -
50 mg tablets.
30 tablets.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Acute, subacute relapsing or chronic infections of the upper airways and of the bronchopulmonary tree; as an immunomodulator IMMUBRON reduces the number and intensity of episodes, also carrying out a prophylaxis action on relapses.
The improvement of clinical symptoms (cough, sputum, dyspnoea, etc.) is accompanied by a noticeable increase in IgA, IgM, IgG and IgE immunoglobulins.
If necessary, the product can be combined with other treatments (antibiotics, mucolytics).
The immunomodulating effects of IMMUBRON, studied in double blind versus placebo in the elderly, are clearly evident on the frequency and duration of respiratory tract infections, even after 60 days from the end of treatment, with an immune response at the level of secretory IgA.
04.2 Posology and method of administration -
Treatment of acute episodes: one tablet a day, fasting, to be allowed to dissolve under the tongue (for a minimum of 10 days) until the symptoms disappear.
Long-term treatment: one tablet a day, to be let dissolve under the tongue, for 10 consecutive days a month, for a period of three months.
04.3 Contraindications -
No contraindications have been reported.
04.4 Special warnings and appropriate precautions for use -
Keep this medicine out of the reach and sight of children. There are no special precautions for use.
04.5 Interactions with other medicinal products and other forms of interaction -
Drug interactions, including antibiotics, are not known to date.
04.6 Pregnancy and breastfeeding -
Although no toxic effects have been reported in experimental animals during pregnancy, treatment with IMMUBRON in the first three months of confirmed pregnancy or in the case of presumed pregnancy is not recommended.
04.7 Effects on ability to drive and use machines -
Nobody.
04.8 Undesirable effects -
To date, clinical trials have not reported any undesirable effects related to the use of IMMUBRON.
04.9 Overdose -
No cases of overdose have been reported to date.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
IMMUBRON is an immunostimulating vaccine that acts by increasing the body's defense powers against the microorganisms responsible for upper respiratory tract infections and the bronchopulmonary tree. IMMUBRON has demonstrated protective activity in experimental infections with induction of specific antibodies documented with immunoelectrodiffusion and represented by Ig, stimulation of splenic lymphocytes with formation of "rosettes". There are no depressive or stimulating effects on the cardiovascular and respiratory systems.
Toxicology.
Acute toxicity was studied in mice and rats by oral and i.p. route: there was no drug-dependent mortality or intolerance to treatment for the maximum usable doses.
In the repeated administration toxicity study (110 - 150 days) in rats and dogs, Immubron was equally devoid of toxic effects: no significant hematological, haematochemical and anatomic-pathological macro and microscopic alterations were highlighted.
Fetal toxicity and fertility study in mice, rats and rabbits and peri and postnatal toxicity in rats did not show any significant alterations compared to controls.
Human Pharmacology
Immubron's immunostimulating properties appear to be induced by:
- restoration of the deficient properties of T lymphocyte membranes during selective IgA deficiency;
- a net increase in the non-specific response to polyclonal mitogens in both the healthy and the sick subject;
- a slight increase in circulating immune complexes.
The specific response acquired by the subjects treated with IMMUBRON is demonstrated by the in vitro stimulation of their lymphocytes, in the presence of bacterial lysate which exerts an adjuvant effect on the macrophage-monocyte system.
Pharmacokinetics
Given the nature of the product, consisting of lyophilized bacterial lysates, it was not possible to carry out pharmacokinetic studies.
05.2 "Pharmacokinetic properties -
05.3 Preclinical safety data -
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Silicon dioxide 10 mg, microcrystalline cellulose 150 mg, dibasic calcium phosphate 35 mg, magnesium stearate 3 mg, ammonium glycyrizinated 1.2 mg, powdered mint essence 0.8 mg.
06.2 Incompatibility "-
None known.
06.3 Period of validity "-
36 months.
06.4 Special precautions for storage -
Store at a temperature not exceeding 25 ° C.
The expiry date indicated on the label must be observed carefully.
06.5 Nature of the immediate packaging and contents of the package -
IMMUBRON tablets is contained in a lithographed cardboard box, containing three blisters of 10 tablets each: the blister is made up of the coupling of an aluminum foil and a PVC foil, whose characteristics comply with the Ministerial Circular N ° 84 of 20 / 12/1977.
06.6 Instructions for use and handling -
See 4.2
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
BRUSCHETTINI S.r.l., Via Isonzo 6, Genoa (Italy).
08.0 MARKETING AUTHORIZATION NUMBER -
A.I.C. n. 026422028.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
May 1995 / June 2003.
10.0 DATE OF REVISION OF THE TEXT -
June 2008.
