Active ingredients: Bacterial vaccines
ISMIGEN 50 MG SUBLINGUAL TABLETS
Indications Why is Ismigen used? What is it for?
Pharmacotherapeutic group:
Bacterial vaccines
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
Contraindications When Ismigen should not be used
Do not take ISMIGEN if you are allergic to the active substance or to any of the other ingredients.
Do not take ISMIGEN in case of autoimmune diseases.
Do not take ISMIGEN in case of acute intestinal infections.
Precautions for use What you need to know before taking Ismigen
Taking ISMIGEN does not require any special precautions.
Interactions Which drugs or foods can modify the effect of Ismigen
No interaction studies have been performed. An interval of 4 weeks is recommended between the end of treatment with ISMIGEN and the start of a vaccine administration. The immune response can be inhibited in subjects with congenital or acquired immunodeficiency, on immunosuppressive therapy or with corticosteroids.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines.
Warnings It is important to know that:
Effects on driving and use of machines
To date, no effects on the ability to drive or on the use of machines have been reported. However, no specific studies have been carried out.
Treatment should be suspended in case of fever, particularly at the start of treatment. The patient should be informed of the possibility as a rare undesirable event of high fever over 39 ° C, isolated and with no known cause, and the type of fever should be differentiated from fever that arises as a result of the original pathology, on the basis of pharyngeal, nasal or otological conditions; in which case the treatment must be suspended and not resumed.
Concomitant intake of another immunostimulant should be avoided.
In some cases, the onset of asthma attacks has been observed in predisposed patients after taking drugs containing bacterial extracts. In this case, ISMIGEN should not be taken further.
In case of hypersensitivity reactions, treatment should be stopped immediately and not restarted. Keep out of sight and reach of children
ISMIGEN is not recommended during pregnancy. (See Use in Pregnancy and Lactation). The drug should be administered only in case of real need under the direct supervision of the doctor.
Use in pregnancy and lactation:
The use of ISMIGEN during pregnancy and breastfeeding should be avoided. Ask your doctor or pharmacist for advice before taking any medicine.
Dosage and method of use How to use Ismigen: Dosage
Route of administration: sublingual
One 50mg tablet per day, to be left to dissolve under the tongue, for 10 consecutive days a month, for three consecutive months.
Overdose What to do if you have taken too much Ismigen
To date, no cases of overdose have been reported.
If you have taken more ISMIGEN than you should, consult your doctor or pharmacist immediately
Side Effects What are the side effects of Ismigen
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases the following side effects have been reported:
- Respiratory, thoracic and mediastinal disorders: oropharyngeal pain
- Skin and subcutaneous tissue disorders: allergic reactions such as hives, rash, itching and edema
- General disorders and administration site conditions: fever and headache
- Gastrointestinal disorders: stomach pain and vomiting - Infection and infestations: rhinitis
In case of any disturbance the treatment should be stopped.
If you notice worsening of your symptoms or if you get any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
The expiry date refers to the product in intact packaging, correctly stored
Do not store above 25 ° C.
Do not use the medicine after the expiry date indicated on the package. The expiry date refers to the last day of that month.
Keep out of reach of children
Composition:
Each tablet contains:
Active principle:
Lyophilized bacterial lysate 50 mg, of which 7 mg corresponding to:
Staphylococcus aureus 6 billion - Streptococcus pyogenes 6 billion - Streptococcus oralis 6 billion - Klebsiella pneumoniae 6 billion - Klebsiella ozaenae 6 billion - Haemophilus influenzae 6 billion - Neisseria catarrhalis 6 billion - Streptococcus pneumoniae 6 billion (of which type 1, 1 billion - type 2 , 1 billion - type 3, 1 billion - type 5, 1 billion - type 8, 1 billion - type 47, 1 billion) glycocol as a lyophilization medium.
- The other ingredients are Silicon Dioxide, Microcrystalline Cellulose, Dibasic Calcium Phosphate, Magnesium Stearate, Ammonium Glycyrrhizinate, Powdered Mint Essence.
Pharmaceutical form and content
Ismigen sublingual tablets are off-white, have brown spots and are packaged in aluminum / PVC blisters of 10 tablets. The score line on the tablet is intended to make it easier to break when needed and not to divide into equal doses.
3 blisters placed in a lithographed cardboard box
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
ISMIGEN 50 MG SUBLINGUAL TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
• Lyophilized bacterial lysate 50 mg
• Excipients (For the full list of excipients, see section 6.1.)
q.s. 250mg
Lyophilized Bacterial Lysate contains:
• 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 1, 1 billion - Type 2, 1 billion - Type 3, 1 billion - Type 5, 1 billion - Type 8, 1 billion - Type 47, 1 billion)
• Glycol as a lyophilization support
03.0 PHARMACEUTICAL FORM
Whitish sublingual tablets with brownish dots.
The score line on the tablet is intended to make it easier to break when needed and not to divide into equal doses.
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.
04.2 Posology and method of administration
Dosage:
1 tablet of 50 mg per day, to be allowed to dissolve under the tongue, for 10 consecutive days a month, for three consecutive months.
Method of administration:
Sublingual: to be allowed to melt under the tongue
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Autoimmune Diseases.
Acute intestinal infections.
04.4 Special warnings and appropriate precautions for use
Treatment should be stopped in case of fever, particularly at the start of treatment.
The patient should be informed of the possibility as a rare undesirable event of elevated fever over 39 ° C, isolated and with no known cause, and the type of fever should be differentiated from fever arising as a result of the original disease, based on the pharyngeal, nasal or otological; in which case the treatment must be suspended and not resumed.
Concomitant intake of another immunostimulant should be avoided.
In some cases, the onset of asthma attacks has been observed in predisposed patients after taking drugs containing bacterial extracts. In this case, ISMIGEN should not be taken further.
In case of hypersensitivity reactions, treatment should be stopped immediately and not restarted. Keep out of sight and reach of children.
ISMIGEN is not recommended during pregnancy. (See section 4.6). The drug should be administered only in case of real need under the direct supervision of the doctor.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed. An interval of 4 weeks is recommended between the end of treatment with ISMIGEN and the start of a vaccine administration. The immune response can be inhibited in subjects with congenital or acquired immunodeficiency, on immunosuppressive therapy or with corticosteroids.
04.6 Pregnancy and lactation
The use of Ismigen during pregnancy and lactation should be avoided.
04.7 Effects on ability to drive and use machines
To date, no effects on the ability to drive or use machines have been reported.
However, no specific studies have been carried out.
04.8 Undesirable effects
In very rare cases the following side effects have been reported:
• Respiratory, thoracic and mediastinal disorders: oropharyngeal pain
• Skin and subcutaneous tissue disorders: allergic reactions such as hives, rash, itching and edema
• General disorders and administration site conditions: fever and headache
• Gastrointestinal disorders: stomach pain and vomiting
• Infections and infestations: rhinitis
In case of any disturbance the treatment should be stopped.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. in "Annex V.
04.9 Overdose
There are no reported cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other bacterial vaccines, ATC J07AX
ISMIGEN ".s is an immunostimulating vaccine, obtained by mechanical bacterial lysis, which acts by increasing the body's defense powers against the microorganisms responsible for upper respiratory tract infections and the bronchopulmonary tree. ISMIGEN has shown 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". Depressive or stimulating effects on the cardiovascular and respiratory systems are absent.
The immunostimulating properties of ISMIGEN appear to be induced by:
• restoration of the deficient properties of T lymphocyte membranes during selective IgA deficiency;
• a marked 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 subjects treated with ISMIGEN ".s 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.
In the AIACE study involving 288 patients with moderate, severe or very severe COPD, including 146 on active treatment with Ismigen and 142 patients on placebo, overall the primary endpoint in terms of reduction in the number of exacerbations over a 12-month observation period.
05.2 Pharmacokinetic properties
Given the nature of the product, consisting of lyophilized bacterial lysates, it was not possible to carry out pharmacokinetic studies.
05.3 Preclinical safety data
Acute toxicity ".s was studied in mice and rats orally and by i.p .; there was no drug-dependent mortality or intolerance to the treatment for the maximum usable doses.
In the repeated dose toxicity study (110-150 days) in rats and dogs, ISMIGEN was equally devoid of toxic effects; no significant hematological, haematochemical and anatomo-pathological macroscopic 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 significant alterations compared to controls.
In addition, the controls of the peri and postnatal toxicity study in the rat showed no other toxicity.
Controlled studies have shown that the product has no harmful effects on reproduction in rats, no fetal toxicity in mice and rabbits, or no harmful effects on reproduction in the peri- and postnatal period in rats.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Silicon dioxide, microcrystalline cellulose, dibasic calcium phosphate, magnesium stearate, ammonium glycyrrhizinate, powdered mint essence.
06.2 Incompatibility
There are no known incompatibilities with other medicines.
06.3 Period of validity
3 years
06.4 Special precautions for storage
Do not store above 25 ° C. Store in the original packaging.
06.5 Nature of the immediate packaging and contents of the package
Aluminum / PVC blister of 10 tablets
3 blisters placed in a lithographed cardboard box.
06.6 Instructions for use and handling
Unused medicine should be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
LALLEMAND PHARMA EUROPE
Toftebakken 9B
3460 Birkerod
Denmark
Producer:
Bruschettini s.r.l
Via Isonzo, 6
16147 Genoa
Italy
08.0 MARKETING AUTHORIZATION NUMBER
AIC: 026224016
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
July 12, 2000
10.0 DATE OF REVISION OF THE TEXT
November 2014
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