Active ingredients: Bacterial vaccines
IMMUCYTAL Tablets
IMMUCYTAL Granules for oral solution
Indications Why is Immucytal used? What is it for?
Pharmacotherapeutic category
Bacterial vaccines.
Therapeutic indications
Prophylaxis of recurrent bacterial infections of the upper respiratory tract in children with a number of episodes higher than expected for age. Immucytal can help reduce the number and intensity of infectious episodes.
Contraindications When Immucytal should not be used
Hypersensitivity to the active substance or to any of the excipients.
The use of the preparation in patients with autoimmune diseases is contraindicated.
Precautions for use What you need to know before taking Immucytal
IMMUCYTAL is not recommended during pregnancy. The drug should be administered only in case of real need under the direct supervision of the doctor (see Pregnancy and lactation).
In subjects in whom hyperreactivity may be suspected, it is advisable to adopt a type of treatment with progressively increasing doses.
Concomitant intake of another immunostimulant should be avoided.
Interactions Which drugs or foods can change the effect of Immucytal
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
No interaction studies have been performed.
An interval of 4 weeks is recommended between the end of Immucytal treatment and the start of a vaccine administration. The immune response may be inhibited in subjects with congenital or acquired immunodeficiency, on immunosuppressive therapy or with corticosteroids.
Warnings It is important to know that:
In case of hypersensitivity reactions, treatment should be stopped immediately and not restarted.
Take special care with IMMUCYTAL:
- Treatment should be discontinued 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 above 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 laryngeal, nasal or otological conditions; in which case the treatment must be suspended and not resumed.
- if you suffer from asthma. In some cases the onset of asthma attacks has been observed in predisposed patients after taking drugs containing bacterial extracts. In this case, Immucytal should not be taken further.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no data from the use of IMMUCYTAL in pregnant women.
As a precautionary measure, the use of IMMUCYTAL during pregnancy and breastfeeding should be avoided.
Effects on ability to drive and use machines
IMMUCYTAL does not affect the ability to drive or use machines.
Important information about some of the ingredients:
IMMUCYTAL tablets contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
IMMUCYTAL granules for oral solution contains mannitol. It may have a mild laxative effect.
Dosage and method of use How to use Immucytal: Dosage
IMMUCYTAL granules for oral solution can be administered to children from 2 years of age.
IMMUCYTAL tablets are reserved for children over 6 years of age.
Dosage:
1st month:
1 tablet or sachet in the morning on an empty stomach for 4 consecutive days a week for 3 consecutive weeks.
From the 2nd month:
1 tablet or sachet in the morning on an empty stomach for 4 consecutive days per month for the next 5 months.
Method of administration
Dissolve the contents of the sachet in half a glass of water. The oral solution should be drunk immediately.
Overdose What to do if you have taken too much Immucytal
No cases of overdose have been reported. In case of accidental ingestion / intake of an excessive dose of Immucytal, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Immucytal, ask your doctor or pharmacist.
Side Effects What are the side effects of Immucytal
Like all medicines, Immucytal can cause side effects, although not everybody gets them.
The table below shows the adverse reactions observed in nine clinical studies including a total of 1,231 patients treated with oral Immucytal, for which the causality assessment was "not excluded" and in spontaneous reporting.
Adverse reactions are listed according to MedDRA system organ class and are defined below as: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1 / 1,000 , <1/100), rare (≥ 1 / 10,000, <1 / 1,000), very rare (<1 / 10,000) or not known (cannot be estimated from the available data).
No adverse reactions were found to be of "very rare", "rare", or "very common" frequency and therefore these frequencies are not shown in the table.
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. Undesirable effects can also be reported directly through the national reporting system at the address 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
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Tablets: Store at a temperature not exceeding 30 ° C.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
This will help protect the environment.
Keep this medicine out of the sight and reach of children.
Deadline "> Other information
Composition
Each tablet or each sachet of granules for oral solution contains:
Active principles:
Ribosomal fractions of:
- Klebsiella pneumoniae 3.5 parts
- Streptococcus pneumoniae 3.0 parts
- Streptococcus pyogenes (group A) 3.0 parts
- Haemophilus influenzae 0.5 parts
Membrane fractions of
- Klebsiella pneumoniae 15 parts
for a lyophilisate equal to 0.525 mg of ribosomal RNA
List of excipients
Tablets:
- Colloidal silica 1.5 mg
- Magnesium stearate 6 mg
- Sorbitol to taste to 294 mg
Sachets of granules for oral solution:
- polyvinylpyrrolidone 10 mg
- mannitol 488.12 mg
PHARMACEUTICAL FORM AND CONTENT
12 tablets for oral use
12 sachets of granules for oral solution
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 -
IMMUCYTAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
IMMUCYTAL tablets
Active principles :
Ribosomal fractions consisting of bacterial ribosomes in the following proportions:
- Klebsiella pneumoniae 3.5 parts
- Streptococcus pneumoniae 3.0 parts
- Streptococcus pyogenes (group A) 3.0 parts
- Haemophilus influenzae 0.5 parts
Membrane fractions of Klebsiella pneumoniae: 15 parts
for a lyophilisate equal to 0.525 mg of ribosomal RNA
Excipients with known effects: sorbitol.
IMMUCYTAL granules for oral solution
Active principles :
Ribosomal fractions consisting of bacterial ribosomes in the following proportions:
- Klebsiella pneumoniae 3.5 parts
- Streptococcus pneumoniae 3.0 parts
- Streptococcus pyogenes (group A) 3.0 parts
- Haemophilus influenzae 0.5 parts
Membrane fractions of Klebsiella pneumoniae: 15 parts
for a lyophilisate equal to 0.525 mg of ribosomal RNA
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM -
Tablets, for oral use
Granules for oral solution
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Prophylaxis of recurrent bacterial infections of the upper respiratory tract in children with a number of episodes higher than expected for age.
Immucytal can help reduce the number and intensity of infectious episodes.
04.2 Posology and method of administration -
IMMUCYTAL granules for oral solution can be administered to children from 2 years of age.
IMMUCYTAL tablets are reserved for children over 6 years of age.
Dosage:
1st month:
1 tablet or sachet in the morning on an empty stomach for 4 consecutive days a week, for 3 consecutive weeks.
From the 2nd month:
1 tablet or sachet in the morning on an empty stomach for 4 consecutive days per month, for the next 5 months.
Dissolve the contents of the sachet in half a glass of water.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients of the vaccine listed in section 6.1.
Autoimmune Diseases.
Acute intestinal infections.
04.4 Special warnings and appropriate precautions for use -
In subjects in whom hyperreactivity may be suspected, it is advisable to adopt a type of treatment with progressively increasing doses.
Treatment should be stopped 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.
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, Immucytal should not be taken further.
In case of hypersensitivity reactions, treatment should be stopped immediately and not restarted.
Immucytal is not recommended during pregnancy. The drug should be administered only in case of real need under the direct supervision of the physician (see section 4.6).
Important information about some of the excipients
The medicine contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.
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 Immucytal treatment and the start of a vaccine administration. The immune response may be inhibited in subjects with congenital or acquired immunodeficiency, on immunosuppressive therapy or with corticosteroids.
04.6 Pregnancy and breastfeeding -
There are no data from the use of Immucytal in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
However, the use of Immucytal during pregnancy and lactation should be avoided as a precautionary measure (see section 4.4).
04.7 Effects on ability to drive and use machines -
IMMUCYTAL does not affect the ability to drive or use machines.
04.8 Undesirable effects -
The table below shows the adverse reactions observed in nine clinical studies including a total of 1,231 patients treated with oral Immucytal, for which the causality assessment was "not excluded" and in spontaneous reporting.
Adverse reactions are listed according to the MedDRA System Organ Class and are defined below as:
very common (≥ 1/10), common (≥ 1/100,
No adverse reactions were found to be of "very rare", "rare", or "very common" frequency and therefore these frequencies are not shown in the table.
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. "address http://www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose -
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: bacterial vaccines
ATC code: J07AX
IMMUCYTAL contributes to the development of nonspecific and specific immune responses by enhancing bacterial clearance and stimulating antiviral responses.
The immunogenic and immunomodulatory properties of IMMUCYTAL have been established in animal and human studies, indicating that IMMUCYTAL can cross the intestinal mucosa. This was confirmed using a model. in-vitro which reproduced the intestinal epithelium.
The membrane fraction and ribosomal fractions of K. pneumoniae, a Gram negative bacterium, have been shown in in vitro studies to interact with innate immunity cell receptors (TLRs), inducing activation of NK cells, producing defensins , increased function of neutrophils (adhesion and migration), activation of the monocyte-macrophage system, chemotactic activity on T lymphocytes.
The study of ribosomes by biochemical characterization showed the presence on ribosomes of antigenic epitopes of the bacterial membrane of Klebsiella pneumoniae. Thus ribosomes act as antigenic vectors, inducing specific antibody-secreting cells in the blood and mucous membranes that locally produce specific antibodies.
05.2 "Pharmacokinetic properties -
IMMUCYTAL is bioavailable and reaches Peyer's plaques for stimulation of immunocompetent cells.
Kinetic studies in rats and dogs have shown only a modest absorption of the macromolecules constituting IMMUCYTAL administered intragastrically.
After 6 hours, plasma levels of the order of 1-2% of the administered dose, liver levels of 0.25% and intestinal levels of 0.08% were detected.
Urinary excretion was 33% after 72 hours.
05.3 Preclinical safety data -
Effects in non-clinical studies were only observed at exposure levels considered sufficiently above the maximum human exposure, indicating little relevance for clinical use.
Acute toxicity is extremely low; no deaths or signs of toxicity were observed with the tablet formulation, although single doses exceeding 3,000 times the human dose were administered; with the granulate formulation a LD50 was determined in mice and rats, equal to about 2,500 times the human dose. Chronic toxicity was assessed after repeated administration in both rats and dogs: no signs of toxicity or changes in development, normal behavior and weight gain were found in any animal; in the treated animals the haematological and biochemical parameters and the histological findings were consistently within normal limits. Possible embryotoxic and / or teratogenic effects were sought in different animal species: mice, rats and rabbits. No negative effects on fecundity, on the percentage of placento-fetal reabsorption were highlighted. nor abnormalities in fetuses or newborns on microscopic examination of the viscera and skeleton.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Tablets:
colloidal silica 1.5 mg
magnesium stearate 6 mg
sorbitol to taste to 294 mg
Sachets of granules for oral solution:
polyvinylpyrrolidone 10 mg
mannitol 488.12 mg
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
Tablets: 3 years
Granules for oral solution: 3 years
06.4 Special precautions for storage -
Tablets: Store at a temperature not exceeding 30 ° C.
Granules for oral solution: this medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
- 12 tablets in Al / PVC blister
- 12 sachets of granules for oral solution in paper / Al / PVC
06.6 Instructions for use and handling -
No special instructions for disposal.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
PIERRE FABRE PHARMA S.r.l.
Via G.G. Winckelmann, 1 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
Tablets: AIC n. 026580023
Sachets of granules for oral solution: AIC n. 026580035
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
December 1994 / June 2010
10.0 DATE OF REVISION OF THE TEXT -
January 2015
