Active ingredients: Bacterial vaccines
LANTIGEN B Oral drops, suspension
Why is Lantigen B used? What is it for?
Adults: Prophylaxis of recurrent respiratory tract infections: the product may contribute, in certain patients, to reduce the number and intensity of infectious episodes.
Children: Prophylaxis of recurrent bacterial infections of the upper respiratory tract in children with a number of episodes higher than expected for age. The product can help reduce the number and intensity of infectious episodes.
Contraindications When Lantigen B should not be used
Hypersensitivity to the active substances or to any of the excipients.
Precautions for use What you need to know before taking Lantigen B.
Each dose must be kept in the mouth for about 2 minutes without swallowing, so as to allow the suspension to disperse in the salivary secretion of the oropharyngeal mucosa facilitating the absorption of the preparation.
Duration of treatment: two bottles (36 ml) in the adult and one bottle (18 ml) in the child, according to the respective dosage.
Discontinue treatment for 2-3 weeks.
Important information about some of the ingredients
As LANTIGEN B contains sodium methyl parahydroxybenzoate it can cause allergic reactions (even delayed) and exceptionally bronchospasm.
Interactions Which drugs or foods can modify the effect of Lantigen B.
Interactions with other drugs and other forms of interaction: not known.
Warnings It is important to know that:
Tell your doctor if you or your child have experienced side effects after receiving a vaccine and if you or your child have any form of allergy.
In case of hypersensitivity reactions, treatment should be stopped immediately and not restarted.
Discontinue treatment in case of fever, particularly at the start of treatment.
The patient must be informed of the possibility as a rare undesirable event of elevated fever above 39 ° C, isolated and without known cause and the type of fever must be differentiated from the fever that arises as a result of the original pathology, on the basis of the laryngeal, nasal conditions. or otological; in which case the treatment must be suspended and not resumed.
In some cases the onset of asthma attacks has been observed in predisposed patients after taking drugs containing bacterial extracts. In this case, BIOMUNIL should not be taken further. Lantigen B is not recommended during pregnancy. be administered only in case of real need under direct medical supervision (see section Pregnancy and lactation).
Pregnancy and breastfeeding: There are no known contraindications in case of pregnancy or breastfeeding. There are no or limited amount of data from the use of Lantigen B in pregnant women. As a precautionary measure, it is preferable to avoid the use of Lantigen B during pregnancy.
As regards breastfeeding, since no specific studies have been performed and there are no data available, as a precautionary measure it is preferable to avoid the use of the product.
Effects on driving and use of machines: no interference.
Shake before using.
The possible presence (even after stirring) of suspended aggregates does not compromise the safety of the product.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Dosage and method of use How to use Lantigen B: Dosage
Dosage for adults and children over 10 years of age: one dose, corresponding to 15 drops, is placed under the tongue, twice a day (morning and evening).
Dosage for children older than 3 months and up to 10 years: half dose, corresponding to (7-8 drops), twice a day, or one dose (15 drops) in a single administration in the morning, preferably on an empty stomach. (Sublingual route).
Duration of treatment:
- Administration of two bottles in adults and one bottle in children under the age of 10 years, including infants, with the respective posologies.
- Discontinuation of treatment for 2-3 weeks.
- Subsequently, as a booster treatment, one bottle in adults and half a bottle in children under 10 years of age, including infants, with the respective posologies.
In order to reach and maintain sufficient protection for the entire winter period, it is necessary to start the therapeutic cycle in the month of September and repeat it from the month of January.
Administration in the pediatric population: In very young children it is possible to administer Lantigen B during sleep, placing the drops between the lower lip and gum.
Indications for use:
A) Instructions for opening the bottle and using the dispenser
- Shake the bottle well and break the guarantee seal, grabbing the plastic appendix placed in the middle of the cap, and pulling it outwards, tear it completely by rotating around the bottle.
- Remove the cap and turn the bottle upside down, then press the dispenser between the index finger and thumb by gradually pressing the dispenser until the desired number of drops is obtained.
B) Dosage instructions
A dose of Lantigen B for adults is obtained by inverting the bottle and pressing the dispenser until a dose of 15 drops is obtained.
The half dose, for children, is obtained by pressing the dispenser until a dose of 7-8 drops is obtained.
Overdose What to do if you have taken too much Lantigen B.
There are no known cases of overdose.
Side Effects What are the side effects of Lantigen B.
Possible unwanted side effects occur in the form of a temporary increase in symptoms (sense of constipation, rhinorrhea) at the first administration.
Frequency:
Rare (less than 1 in 1000, but more than 1 in 10,000 patients):
- Respiratory, thoracic and mediastinal disorders: sense of constipation, rhinorrhea These reactions are rare and generally mild.
Like all medicines Lantigen B oral drops, suspension can cause side effects, although not everybody gets them.
The patient should report to the treating physician or pharmacist any undesirable effects, if any, not described in this leaflet.
Expiry and Retention
See the expiry date indicated on the package: this date refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date indicated on the package. Shake before using.
Special precautions for storing the medicinal product: the product must always be closed with the cap. Store at a temperature not exceeding 25 ° C and in the original packaging to protect the product from light.
Composition and pharmaceutical form
Composition: 1 ml of suspension contains: antigenic extracts of Streptococcus pneumoniæ type 3 63.2 AU, Streptococcus pyogenes (group A) 126.2 AU, Branhamella catarrhalis 39.9 AU, Staphylococcus aureus 79.6 AU, Haemophilus influenzaæ (type b) 50.2 AU, Klebsiella pneumoniæ 39.8 AU Excipients: Polysorbate 80, chlorhexidine diacetate, sodium methyl parahydroxybenzoate, purified water.
Pharmaceutical form and content: oral drops, 18 ml bottle.
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
LANTIGEN B ORAL DROPS, SUSPENSION 1 BOTTLE OF 18 ML
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of product contains:
Active principles. Antigenic extracts of: Streptococcus pneumoniae type 3 63.2 Antigenic Units, Streptococcus pyogenes group A 126.2 Antigenic Units, Branhamella catarrhalis 39.9 Antigenic Units, Staphylococcus aureus 79.6 Antigenic Units, Haemophylus influenzae type b 50.2 Antigenic Units, Klebsiella pneumoniae 39.8 Antigenic Units.
For excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral drops, suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adults:
Prophylaxis of recurrent respiratory tract infections: the product may contribute, in certain patients, to reduce the number and intensity of infectious episodes.
Children:
Prophylaxis of recurrent bacterial infections of the upper respiratory tract in children with a number of episodes higher than expected for age. The product can help reduce the number and intensity of infectious episodes.
04.2 Posology and method of administration
Dosage for adults and children over 10 years of age: one dose, corresponding to the quantity delivered by pressing the dispenser twice (15 drops), is placed under the tongue, twice a day (morning and evening).
Dosage for children older than 3 months and up to 10 years: half dose, which is obtained by pressing the dispenser once (7-8 drops), twice a day, or one dose (15 drops) in a single administration in the morning , preferably on an empty stomach. (Sublingual route).
In very young children it is possible to administer Lantigen B during sleep by placing the drops between the lower lip and gum.
Shake before use. The possible presence (even after stirring) of suspended aggregates does not affect the safety of the product.
Important: each dose must be kept in the mouth for about 2 minutes without swallowing, so as to allow the suspension to disperse in the salivary secretion of the oropharyngeal mucosa facilitating the absorption of the preparation.
Duration of treatment: two bottles (36 ml) in the adult and one bottle (18 ml) in the child, according to the respective dosage.
Discontinue treatment for 2-3 weeks.
Then carry out a booster treatment with one bottle in the adult and half bottle in the child, according to the respective dosage.
In order to reach and maintain sufficient protection for the entire winter period, it is necessary to start the therapeutic cycle in the month of September and repeat it from the month of January.
04.3 Contraindications
Hypersensitivity to the components of the product.
04.4 Special warnings and appropriate precautions for use
Sodium methyl parahydroxybanzate can cause allergic reactions (including delayed) and exceptionally bronchospasm
Shake the bottle before use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
04.5 Interactions with other medicinal products and other forms of interaction
They are not known.
04.6 Pregnancy and lactation
There are no known contraindications in case of pregnancy or breastfeeding.
There are no or limited amount of data from the use of Lantigen B in pregnant women.
As a precautionary measure, it is preferable to avoid the use of Lantigen B during pregnancy.
As regards breastfeeding, since no specific studies have been performed and there are no data available, as a precautionary measure it is preferable to avoid the use of the product.
04.7 Effects on ability to drive and use machines
No known effects.
04.8 Undesirable effects
Possible unwanted side effects occur in the form of a temporary increase in symptoms (sense of constipation, rhinorrhea) at the first administration.
Frequency: rare (less than 1 in 1000, but more than 1 in 10,000 patients)
Respiratory, thoracic and mediastinal disorders: sense of constipation, rhinorrhea
Such reactions are rare and generally minor in nature.
Respiratory, thoracic and mediastinal disorders: sense of constipation, rhinorrhea
Such reactions are rare and generally minor in nature.
04.9 Overdose
There are no known cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Therapeutic category: J07AX.
Antibacterial vaccines.
Lantigen B consists of a suspension of bacterial antigens, obtained through an autolysis process under controlled conditions, of some microbial species that are most often responsible for respiratory infections (S. pneumoniae, S. pyogenes, B. catarrhalis, S. aureus , H. influenzae, K. pneumoniae).
This preparation, administered sublingually, causes a stimulation of local immune processes due to the absorption of bacterial antigens through the mucous membrane of the mouth and pharynx. This determines the production, by the plasma cells of the submucosa, of secretory immunoglobulins of class A ( IgA-S) whose importance in the defense of the mucous membranes of the respiratory tract is widely described in the literature.
It has been demonstrated, in a series of in vitro experiments, that the pharmacological action of the preparation is also expressed through an "immuno-stimulating action capable of:
- bring the functional parameters of neutrophil polymorphons back to normal;
- increase the production of interleukin 1 in mononuclear cell cultures;
- act as a lymphocytic polyclonal activator with activity higher than the "pokeweed mitogen";
- actively stimulate the production of IgM by lymphocyte cultures.
In vivo studies have also shown that Lantigen B:
- increases the number of IgA, IgM, IgG, both salivary and serum;
- determines a reduction in the frequency and intensity of infectious episodes;
- reduces the consumption of antibiotics.
05.2 "Pharmacokinetic properties
Given the nature of the product, consisting of bacterial lysates, it was not possible to carry out pharmacokinetic studies.
05.3 Preclinical safety data
Acute toxicity: LD50 not determinable. 50 ml / kg orally and 25 ml / kg / day intraperitoneally do not cause any toxic effect.
Chronic toxicity: doses up to 5,920 mg / kg / day are perfectly tolerated for 26 weeks.
The product is not irritating when applied to the conjunctival sac, it is devoid of peri and postnatal toxicity and of direct or indirect pharmacological effects on the smooth muscles of the various organs.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polysorbate 80, chlorhexidine diacetate, sodium methyl parahydroxybanzoate, purified water.
06.2 Incompatibility
They are not known.
06.3 Period of validity
In intact packaging: 3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C and protected from light.
06.5 Nature of the immediate packaging and contents of the package
Dark glass bottle containing 18 ml of suspension of bacterial antigens, complete with dispenser and safety closure in plastic material.
06.6 Instructions for use and handling
A) Instructions for opening the bottle and using the dispenser.
1) Shake the bottle well and break the guarantee seal, grabbing the plastic appendix placed in the middle of the cap, and pulling it outwards, tear it completely by rotating around the bottle.
2) Remove the cap and turn the bottle upside down, then, press the dispenser between the index finger and the thumb by gradually pressing the dispenser until the desired number of drops is obtained.
B) Dosage instructions
A dose of Lantigen B for adults is obtained by inverting the bottle and pressing the dispenser until a dose of 15 drops is obtained.
The half dose, for children, is obtained by pressing the dispenser until a dose of 7-8 drops is obtained.
Shake before use. The possible presence (even after stirring) of suspended aggregates does not affect the safety of the product.
07.0 MARKETING AUTHORIZATION HOLDER
Bruschettini S.r.l. Via Isonzo 6 - 16147 Genoa (Italy).
08.0 MARKETING AUTHORIZATION NUMBER
LANTIGEN B oral drops, suspension - bottle 18 ml A.I.C. n. 025709015.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
March 1983 / May 2005.
10.0 DATE OF REVISION OF THE TEXT
February 2014
