Active ingredients: Thiamphenicol glycinate acetylcysteinate
Fluimucil Antibiotic 500 mg / 4 ml powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation
Fluimucil Antibiotic 250 mg / 2 ml powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation
Why is the antibiotic Fluimucil used? What is it for?
Fluimucil Antibiotico belongs to the category of antibacterial medicines.
Fluimucil Antibiotico is used to treat respiratory tract infections caused by bacteria sensitive to thiamphenicol (an antibiotic), in which mucus build-up (mucostasis) complicates or slows the healing process.
For topical use:
- Respiratory tract disorders: inflammation of the bronchi (acute and chronic bronchitis), inflammation of the bronchi and lungs (bronchopneumonia) and slow-resolving pneumonia, inflammation of the lungs with the presence of pus inside a localized cavity (lung abscess) , damage to the walls of the alveoli (obstructive emphysema), dilation of some airways (bronchiectasis), inflammation of the bronchioles (bronchiolitis, a "typical disease of early childhood), pertussis (canine cough, infectious and contagious disease that occurs with violent attacks dry cough), mucoviscidosis (cystic fibrosis, a serious hereditary disease characterized by the production of particularly viscous glandular secretions).
- Treatment of bronchopulmonary complications from surgery, inflammation of the bronchi and lungs (bronchopneumonia), total or partial collapse of a lung due to lack of dilation of the pulmonary alveoli (atelectasis), facilitation of bronchoaspiration maneuvers (collection of bronchial secretions) in anesthesia and prevention of infectious complications.
- Nonspecific infectious forms with bronchial mucus (phlegm) associated with pulmonary tuberculosis, secretion retention with insufficient drainage of cavity lesions.
- Catarrhal and purulent otitis (inflammation of the middle ear, with collection of mucus and secretions at the level of the eardrum), infections of the Eustachian tube that connects the middle ear to the nasopharynx (tubal infections), inflammation of the paranasal sinuses ( sinusitis), inflammation of the mucous membrane of the nose and pharynx (nasopharyngitis), inflammation of the trachea and larynx (laryngotracheitis), treatment of infectious complications from tracheostomy (creation of a passageway for air in the neck), preparation for bronchoscopies (analysis of the bronchi through an instrument called a bronchoscope, introduced through the mouth or nose), bronchographs (radiological examination of the bronchi, by introducing a contrast agent, used to detect the presence of tumors and inflammatory diseases) and to bronchoaspirations (collection of bronchial secretions).
For systemic use (via injection):
- All cases of bronchopulmonary pathologies, among those listed above, which in the doctor's judgment require systemic antibiotic-mucolytic treatment. This can be done alone or in conjunction with topical treatment.
Contraindications When the antibiotic Fluimucil should not be used
Do not use Fluimucil Antibiotic
- if you are allergic to thiamphenicol glycinate acetylcysteinate or any of the other ingredients of this medicine (listed in section 6);
- if you have or have suffered from a condition called bone marrow failure, which is insufficient or non-production of blood cells by the bone marrow;
- if your kidneys produce only very small amounts of urine (anuria).
Precautions for use What you need to know before taking the antibiotic Fluimucil
Talk to your doctor or pharmacist before using Fluimucil Antibiotico.
Since it is an antibiotic preparation, use this medicine only for the period of time deemed necessary by your doctor to resolve the infection. If only the mucolytic treatment continues, your doctor may prescribe a preparation containing acetylcysteine as only active ingredient.
Thiamphenicol for systemic use (administered by injection) can cause reversible changes in blood values (see "Possible side effects") which depend on the doses administered and the duration of treatment. These changes are more pronounced and more prolonged in cases of overdose usually linked to reduced kidney function (renal failure), as well as in cases of history of bone marrow failure (insufficient or non-production of blood cells by the bone marrow) .
Do not exceed 10 days of therapy, unless otherwise prescribed by your doctor; in this case it will be necessary to periodically perform blood tests, interrupting the therapy if the number of leukocytes and granulocytes decreases significantly.
Take special care with Fluimucil Antibiotico:
- If you have kidney problems (moderate or severe kidney failure); in this case, the therapy with mucolytic medicinal products and antibiotics must be performed separately, because the dose of thiamphenicol must be reduced in relation to the functional reduction of the kidney (see "Use in patients with renal insufficiency").
- If you have to administer the medicine to premature babies and / or newborns up to 2 weeks of age, due to their incomplete kidney function. Take particular care with the dosage administered (see "Use in premature babies, newborns and children").
- If you use the nebulizer preparation, since the medicine can thin the bronchial secretions and increase their volume at the same time, especially at the beginning of the treatment; in case you have difficulty in expectorating effectively, it is advisable to consult the doctor who will evaluate whether to perform postural drainage (assuming a certain position in order to favor the elimination of bronchial secretions) or possibly bronchoaspiration (collection of bronchial secretions), to avoid the retention of secretions.
- If you use the nebulizer preparation and suffer from asthma; in this case you must carry out the aerosol treatment under supervision and stop it in case of accentuation of bronchospasm (narrowing of the caliber of the bronchi, which causes difficulty in breathing). If necessary, resume therapy with Fluimucil Antibiotic after your doctor has prescribed you to take a medicine that dilates the bronchi (bronchodilator).
Interactions Which drugs or foods can modify the effect of the antibiotic Fluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No cases of negative interactions have been reported between Fluimucil Antibiotico and other medicines.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Avoid the use of Antibiotic Fluimucil during pregnancy.
Since thiamphenicol for systemic use (administered by injection) is excreted in breast milk, stop breastfeeding during treatment with Fluimucil Antibiotico.
At higher than therapeutic doses, the drug may adversely affect fertility. This effect is reversible upon discontinuation of treatment.
Driving and using machines
It is not known whether Fluimucil Antibiotico affects the ability to drive and use machines.
Fluimucil Antibiotico contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, ie it is essentially "sodium-free".
Dose, Method and Time of Administration How to use the antibiotic Fluimucil: Posology
Always use this medicine as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Thiamphenicol glycinate acetylcysteinate can be administered both intramuscularly (injection into the muscle) and topically (aerosol or endotracheobronchial instillation, the latter carried out with the assistance of a healthcare professional).
The recommended doses are:
Topical uses
Adults
- use Fluimucil Antibiotic 500 mg / 4 ml;
Children
- use Fluimucil Antibiotic 250 mg / 2 ml;
- For aerosol administration, half a vial is sprayed per session, with 1-2 sessions per day. Use glass and plastic appliances, avoiding contact of the solution with rubber or metal parts other than stainless steel; after use, clean the parts with plenty of water. Do not mix the solution with other aerosol preparations before making sure they are compatible.
- For endo-tracheobronchial instillations (conducted with the assistance of a healthcare professional), administer 1-2 ml at a time with the chosen modalities (eg permanent tubes, bronchoscopy).
- The same dose will be used in case of nasal-sinus washes (transmeatic sinus), washes to remove secretions present at the level of the ear tympanum (transtympanics) or from nasal and mastoid operating cavities. For nasal, ear and tubal instillations, 2 -4 drops per application.
Systemic use
For systemic use the medicinal product must be injected intramuscularly (into the muscle).
Adults
- use 1 vial of Fluimucil Antibiotic 500 mg / 4 ml, repeated 2-3 times a day at regular intervals
Use in premature babies, infants and children
- use Fluimucil Antibiotic 250 mg / 2 ml;
- premature babies and newborns up to 2 weeks: on average 25 mg per kg per day;
- up to 2 years: half a vial, 2 times a day;
- from 3 to 6 years: 1 vial, 2 times a day;
- 7 to 12 years: 1 vial, 3 times a day.
In the opinion of the doctor, in particularly serious cases, during the attack therapy (the first 2-3 days) the doses can be increased up to double.
Dose escalation is not recommended in neonates and preterm infants and in persons over 65 years of age.
Use in patients with renal insufficiency
The dose of Fluimucil Antibiotico must be reduced in relation to the functional reduction of the kidney (see "Warnings and precautions").
The duration of the treatment should not exceed ten days.
Instructions for Use
Fluimucil Antibiotico must be dissolved at the time of use, operating as follows:
- lift the central part of the aluminum shield on the vial;
- transfer the contents of the solvent vial into the vial by means of a syringe, piercing the rubber stopper;
- shake the vial until the powder dissolves.
For topical use: complete the opening of the vial, pulling the tab until the cap of the aluminum ring is released. The rubber stopper below allows you to close the vial if the product is used in multiple applications.
For systemic use (intramuscular injection): withdraw the solution with the syringe, through the rubber stopper.
The solution must be used within 24 hours of preparation, keeping it in this case in a cool place. Any slight milky appearance of the solution does not indicate alteration of the product.
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 an overdose of the antibiotic Fluimucil
No cases of overdose have been reported. In case of accidental ingestion / intake of an excessive dose of Fluimucil Antibiotic, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of the antibiotic Fluimucil
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The main undesirable effects reported following systemic administration (intramuscular injection) of thiamphenicol include decreased bone marrow function (bone marrow depression) with deficiency of red blood cells (anemia), deficiency of platelets (thrombocytopenia) and deficiency of white blood cells (leukopenia). ). These manifestations are dose related and are reversible upon discontinuation of treatment.
Following systemic administration (intramuscular injection) of Fluimucil Antibiotico the following undesirable effects have been reported, the frequency of which cannot be estimated from the available data:
- severe rapid allergic reactions (anaphylactic reactions),
- deficiency of red blood cells (anemia),
- deficiency of platelets (thrombocytopenia),
- deficiency of white blood cells (leukopenia),
- inflammation of the optic nerve (optic neuritis),
- damage to the peripheral nervous system (peripheral neuropathy) resulting from prolonged use,
- nausea,
- He retched,
- diarrhea,
- rash,
- fever (pyrexia).
Additional side effects in neonates and preterm infants following systemic administration:
In newborns and premature babies, a syndrome can occur that manifests itself with swelling of the abdomen (abdominal distension) and bluish discoloration of the skin (pale cyanosis); once started, this syndrome can also evolve with severe heart dysfunction (cardiocirculatory dysfunction) and death.
Following the nebulisation of Fluimucil Antibiotico the following undesirable effects have been reported, the frequency of which cannot be estimated from the available data:
- allergy (hypersensitivity),
- swelling (edema) of the larynx,
- narrowing of the caliber of the bronchi (bronchospasm), which causes difficulty in breathing, mainly in asthmatic patients,
- runny nose (runny nose),
- inflammation of the lining of the mouth (stomatitis),
- nausea,
- rash.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature below 30 ° 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 Fluimucil Antibiotico contains
Fluimucil Antibiotic 500 mg / 4 ml powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation
- The active ingredient is thiamphenicol glycinate acetylcysteinate. One vial of powder contains 810 mg of thiamphenicol glycinate acetylcysteinate (equivalent to 500 mg of thiamphenicol).
- The other ingredients are: disodium edetate. The solvent vial contains: water for injections.
Fluimucil Antibiotic 250 mg / 2 ml powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation
- The active ingredient is thiamphenicol glycinate acetylcysteinate. One vial of powder contains 405 mg of thiamphenicol glycinate acetylcysteinate (equivalent to 250 mg of thiamphenicol).
- The other ingredients are: disodium edetate. The solvent vial contains: water for injections.
Description of the appearance of Fluimucil Antibiotico and contents of the pack
Fluimucil Antibiotico comes in the form of powder and solvent vial.
Fluimucil Antibiotic 500 mg / 4 ml
- 1 vial of 500 mg powder + 1 solvent ampoule
- 3 vials of 500 mg powder + 3 solvent vials
Fluimucil Antibiotic 250 mg / 2 ml
- 1 vial of 250 mg powder + 1 solvent ampoule
- 3 vials of 250 mg powder + 3 solvent vials
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 -
FLUIMUCIL ANTIBIOTIC POWDER AND SOLVENT FOR INJECTABLE SOLUTION, FOR NEBULIZER AND FOR ENDOTRACHEOBRONCHAL INSTILLATION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Fluimucil antibiotic 500 mg / 4 ml
One vial of powder contains:
Active principle
Thiamphenicol glycinate acetylcysteinate 810 mg
(equal to thiamphenicol 500 mg).
Excipients with known effects: edetate disodium.
One solvent vial contains:
Water for injections 4 ml.
Fluimucil antibiotic 250 mg / 2 ml
One vial of powder contains:
Active principle
Thiamphenicol glycinate acetylcysteinate 405 mg
(equal to thiamphenicol 250 mg).
Excipients with known effects: edetate disodium.
One solvent vial contains:
Water for injections 2 ml.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
FLUIMUCIL ANTIBIOTICO is indicated in bacterial respiratory infections from germs sensitive to thiamphenicol, in which the presence of mucostasis complicates or slows down the clinical evolution.
For topical use
- Acute and chronic bronchitis. Bronchopneumonia and slow-resolving pneumonia. Lung abscesses. Obstructive emphysema. Bronchiectasis, bronchiolitis, whooping cough, mucoviscidosis.
- Treatment of bronchopulmonary complications from surgical interventions (bronchopolmoÂ-nitis, atelectasis), facilitation of bronchoaspiration maneuvers in anesthesia and prophylaxis of infectious complications.
- Nonspecific infectious forms with bronchial catarrh associated with pulmonary tuberculosis. Retention of secretions with insufficient drainage of cavity lesions.
- Catarrhal and purulent otitis, tubal infections, sinusitis, nasopharyngitis, laryngotracheitis, treatment of infectious complications from tracheostomy, preparation for bronchoscopy, bronchography and bronchoaspirations.
For systemic use
- All cases of bronchopulmonary affections, among those listed above, which in the opinion of the Doctor require systemic antibiotic-mucolytic treatment. This can be done alone or in conjunction with topical treatment.
04.2 Posology and method of administration -
Thiamphenicol glycinate acetylcysteinate can be administered both intramuscularly and topically.
Topical uses
- For aerosol administration, half a vial is sprayed per session, with 1-2 sessions per day. "Fluimucil antibiotic 500 mg / 4 ml" is used in adults and "Fluimucil antibiotic 250 mg / 2 ml" in children.
It is advisable to use glass and plastic appliances, avoiding contact of the solution with rubber parts or metals other than stainless steel; after use, clean the parts with plenty of water.
- For endotracheobronchial instillations, 1-2 ml are administered at a time with the chosen modalities (eg permanent tubes, bronchoscopy).
- The same posology is to be used for transmeatic sinus, transtympanic or nasal and mastoid operating cavity washes. For nasal, ear and tubal instillations, 2-4 drops per application are used.
Systemic use
For systemic use, FLUIMUCIL ANTIBIOTICO must be injected intramuscularly. In adults, the average dosage is 1 vial of "Fluimucil antibiotic 500 mg / 4 ml", repeated 2-3 times a day at regular intervals.
In children the "antibiotic Fluimucil 250 mg / 2 ml" is used; the average recommended posologies are as follows:
- up to 2 years: half a vial 2 times a day.
- from 3 to 6 years: 1 vial 2 times a day.
- from 7 to 12 years: 1 vial 3 times a day.
These doses can be increased up to double, in the opinion of the doctor, during attack therapy (first 2-3 days) in particularly severe cases.
Dose escalation is not recommended in neonates and preterm infants and in persons over 65 years of age.
For patients with renal insufficiency see section 4.4.
Do not exceed ten days of treatment (see section 4.4).
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
History of bone marrow failure.
Anuria.
04.4 Special warnings and appropriate precautions for use -
Adult and pediatric patients
Since it is an antibiotic preparation, it should be used only for the time periods judged by the doctor necessary to completely dominate the infection. In cases where the continuation of mucolytic treatment alone is indicated, this can be implemented with preparations containing acetylcysteine. as the only active ingredient.
Since FLUIMUCIL ANTIBIOTICO is a medicine that originates from the esterification and salification of thiamphenicol, the same warnings valid for this antibiotic apply as a precaution, namely that thiamphenicol by injection can cause transient haematological alterations (see section 4.8 Undesirable effects). These alterations are reversible and influenced by the blood concentration of the product.
Consequently, the extent of the haematological changes essentially depends on the dosages and length of treatment.
These alterations are more pronounced and more protracted in cases of overdose generally linked to renal insufficiency, as well as in cases with a history of bone marrow failure.
It is therefore advisable to use thiamphenicol in infections with certainly sensitive germs, avoiding its use in chemoprophylaxis or in the treatment of trivial infections.
It is also advisable, as a rule, not to exceed 10 days of therapy; where this is necessary, periodically check the blood count, stopping the therapy if the leukocytes decrease below 4,000 per mmc and the granulocytes by 40%.
In the presence of medium or severe renal insufficiency, it is advisable to perform mucolytic and antibiotic therapy separately, because in these conditions the dose of thiamphenicol must be reduced in relation to the functional reduction of the kidney.
The fact that thiamphenicol is not glucuronoconjugated allows its use even in cases of hepatic functional insufficiency or immaturity.
However, in premature babies and newborns up to 2 weeks, given the incomplete renal function, caution is advisable in the dosage (on average 25 mg / kg).
When using the preparation for aerosol use it must be borne in mind that, especially at the beginning of the treatment, it can thin the bronchial secretions and at the same time increase their volume; if the patient is unable to expectorate effectively, to avoid retention of the secretions, postural drainage or possibly bronchoaspiration must be implemented.
The aerosol treatment of subjects with asthma must be performed under surveillance and interrupted in the case of accentuation of bronchospasm, to be eventually resumed after administration of a bronchodilator.
Important information about some of the excipients
The medicine contains a low concentration of sodium: one vial of FLUIMUCIL ANTIBIOTICO contains less than 1 mmol of sodium (23 mg).
04.5 Interactions with other medicinal products and other forms of interaction -
Adult and pediatric population
No interaction studies have been performed
No cases of drug interactions and particular incompatibilities with the drug are described.
No data on the interaction of thiamphenicol with laboratory tests are available to date.
Although thiamphenicol is not metabolised by the liver, it is reported to inhibit liver microsomal enzymes and may affect the metabolism of other drugs.
04.6 Pregnancy and breastfeeding -
Fertility
Chronic toxicity studies and fertility studies in rats showed a dose-dependent inhibition of spermatogenesis at higher than therapeutic doses.
However, fertility appears to be fully restored after discontinuation of treatment.
Pregnancy
A limited amount of data (less than 300 pregnancy outcomes) is available on the use of thiamphenicol glycinate acetylcysteinate in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precaution it is preferable to avoid the use of FLUIMUCIL ANTIBIOTICO during pregnancy.
Feeding time
Thiamphenicol for systemic use is excreted in breast milk to such an extent that effects on nursing newborns / infants are likely. Discontinue breastfeeding during treatment with FLUIMUCIL ANTIBIOTICO.
04.7 Effects on ability to drive and use machines -
No studies on the effects on the ability to drive and use machines have been performed with either thiamphenicol glycinate acetylcysteinate, thiamphenicol or N-acetylcysteine tested individually.
It is not known whether FLUIMUCIL ANTIBIOTICO affects the ability to drive and use machines.
04.8 Undesirable effects -
The main undesirable effects reported following systemic administration of thiamphenicol include bone marrow depression with anemia, thrombocytopenia and leukopenia. These are dose-related manifestations and reversible upon discontinuation of treatment.
Following systemic administration of FLUIMUCIL ANTIBIOTICO, the following undesirable effects have been reported and their frequency cannot be estimated from the available data:
In newborns and premature babies, a syndrome can occur that begins with abdominal distension and pale cyanosis and can also evolve with severe cardiovascular dysfunctions and death.
Following spraying with FLUIMUCIL ANTIBIOTICO, the following undesirable effects have been reported and their frequency cannot be estimated from the available data:
Topical Use: Pediatric population
From clinical trials and post-marketing surveillance, there is no evidence of a relevant clinical difference in the nature, frequency, seriousness and reversibility of adverse reactions between the safety profile in the adult and pediatric population, or in other age groups of interest.
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 www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
No cases of overdose have been reported in adult or pediatric patients.
Symptoms
In general, the symptoms of overdose do not differ qualitatively from the undesirable effects already described and from any non-specific problems attributable to overdosing of broad spectrum antibiotics (dysmicrobism, superinfections).
Management of overdose
Practice supportive care.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: antibacterials for systemic use; amphenicol; thiamphenicol.
ATC code: J01BA02.
FLUIMUCIL ANTIBIOTICO is a medicine with a fluidifying action on mucous and mucopurulent secretions and broad spectrum antibacterial action.
The characteristics of the preparation are such as to allow both intramuscular administration and topical applications with high local tolerability.
The mucolytic action occurs at the level of the airways with an intense fluidification effect on the viscous secretions, both of the mucous and mucopurulent type and is characterized by a high clinical tolerability superior to that found with the simple combination of acetylcysteine + thiamphenicol.
Given the simultaneous presence of a "broad spectrum antibiotic activity, the preparation finds appropriate indication in bronchopulmonary infections as it is particularly active on respiratory pathogenic germs: pneumococci, haemophili, Kl. Pneumoniae, etc., including anaerobic ones. FLUIMUCIL ANTIBIOTICO ensures an effective treatment of respiratory infections, as it helps to eliminate the vicious circle between the presence of viscous secretions and infection and, by facilitating the removal of exudates, allows a faster and more complete antibacterial effect.
In FLUIMUCIL ANTIBIOTICO there is an enhancement of the therapeutic activity of thiamphenicol, as the free sulfhydryl group lyses the mucus present, thus favoring the penetration and attack of the antibiotic and its tissue breakdown, and carries out an anti-adhesive activity, such as demonstrated for example against Pseudomonas in cellular preparations of the respiratory tract.
05.2 "Pharmacokinetic properties -
Pharmacokinetic studies with thiamphenicol glycinate acetylcysteinate in laboratory animals and in humans, were aimed at evaluating whether thiamphenicol glycinate acetylcysteinate was able to guarantee both orally and parenterally a complete absorption and normal elimination of thiamphenicol. .
In rats, plasma and tissue (lung) levels of thiamphenicol were evaluated after oral or parenteral administration of: thiamphenicol glycinate acetylcysteinate, thiamphenicol glycinate and thiamphenicol base. The results revealed no differences between the absorption of the three compounds.
In the guinea pig, the intramuscular administration of FLUIMUCIL ANTIBIOTICO determined the maximum levels of thiamphenicol in the plasma already after 15 minutes.
In dogs, intravenous administration of thiamphenicol glycinate acetylcysteinate in plasma showed a half-life of approximately 70 minutes (56 to 83) calculated on the beta curve.
05.3 Preclinical safety data -
Acute toxicity studies were performed and the LD50 values in mice (HAM / ICR) for the venous, intraperitoneal and oral routes were respectively 510, 1460 and higher than 5000 mg / kg.
In the rat (Wistar) for the same routes of administration, values of 758, 1980 and above 5000 mg / kg were obtained.
In relation to the therapeutic doses these values indicate a considerable safety margin.
Repeat dose toxicity studies were also conducted in rat by the oral route and by the intraperitoneal route, in the rabbit by the intramuscular route and in the dog by the oral route and by the intramuscular route.
All the tests conducted did not highlight toxic effects even at doses 10 times higher than the therapeutic one.
The histocompatibility of thiamphenicol glycinate acetylcysteinate solutions has been demonstrated on the erythrocytes (haemolytic power) and on the muscle tissue surrounding the injection site.
The medicine is not teratogenic.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Excipients: edetate disodium.
06.2 Incompatibility "-
Systemic use
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Aerosol use
It is advisable to use glass and plastic appliances, avoiding contact of the solution with rubber parts or metals other than stainless steel; after use, clean the parts with plenty of water.
The solution of FLUIMUCIL ANTIBIOTICO must not be mixed with other preparations for aerosol use, unless after having ascertained their chemical and physical compatibility.
06.3 Period of validity "-
3 years.
The reconstituted solution in the vials and stored in the refrigerator can be used within 24 hours for topical use only. Any slight opalescence of the solution is not indicative of alteration of the product which therefore can be administered as it is.
06.4 Special precautions for storage -
Store at a temperature below 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
White glass vial, with butyl rubber stopper sealed with aluminum cap + solvent vial.
FLUIMUCIL ANTIBIOTICO 500 mg / 4 ml, powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation
- box of 3 vials with powder + 3 solvent vials
- box of 1 vial with powder + 1 solvent ampoule
FLUIMUCIL ANTIBIOTICO 250 mg / 2 ml, powder and solvent for solution for injection, for nebulizer and for endotracheobronchial instillation
- box of 3 vials with powder + 3 solvent vials
- box of 1 vial with powder + 1 solvent vial
06.6 Instructions for use and handling -
Fluimucil Antibiotic must be dissolved at the time of use, operating as follows:
- lift the central part of the aluminum protection placed on the vial.
- transfer the contents of the solvent vial into the vial by means of a syringe, piercing the rubber stopper
- shake the vial until the powder dissolves.
For topical use: complete the opening of the vial by pulling the tab until the cap is released from the aluminum cap. The rubber stopper below allows the vial to be closed if the product is used in several applications.
For systemic use: withdraw the solution with the syringe, through the rubber stopper.
The solution must be used within 24 hours of preparation, keeping it in this case in a cool place. Any slight opalescence of the solution is not indicative of alteration of the product which therefore can be administered as it is.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
ZAMBON ITALIA s.r.l.
Via Lillo del Duca, 10 - 20091 Bresso (MI)
08.0 MARKETING AUTHORIZATION NUMBER -
Fluimucil Antibiotico 500 mg / 4 ml, 3 vials of powder + 3 solvent vials of 4 ml A.I.C.n. 020660066
Fluimucil Antibiotico 500 mg / 4 ml, 1 vial of powder + 1 solvent vial of 4 ml A.I.C. n. 020660054
Fluimucil Antibiotico 250 mg / 2 ml, 3 vials of powder + 3 solvent vials of 2 ml A.I.C. n. 020660080
Fluimucil Antibiotico 250 mg / 2 ml, 1 vial of powder + 1 solvent vial of 2 ml A.I.C. n. 020660078
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 21.2.1970
Date of most recent renewal: 1.6.2010
10.0 DATE OF REVISION OF THE TEXT -
AIFA resolution of 29 May 2014
