Active ingredients: Cefpodoxime
CEFODOX CHILDREN 40 mg / 5 ml granules for oral suspension
Why is Cefodox Children used? What is it for?
CEFODOX CHILDREN contains a substance cefpodoxime which belongs to a class of antibiotics called "cephalosporins". CEFODOX CHILDREN is used in infants over 28 days old and in children up to 11 years of age to kill the bacteria that cause infection in the baby.
Your doctor may have prescribed CEFODOX CHILDREN for your child if he has:
- Tonsillitis (inflammation of the tonsils in the throat)
- Acute sinusitis (severe inflammation of the nose)
- Acute otitis media (severe inflammation of the ear)
- Bacterial pneumonia (infection of the lungs caused by germs).
Contraindications When Cefodox Children should not be used
DO NOT give your child CEFODOX CHILDREN
- if your child is allergic to cefpodoxime, cephalosporins, or any of the other ingredients of this medicine (listed in section 6)
- if the child has had a severe allergic reaction to particular antibiotics (penicillins, monobactams, and carbapenems) as they may also be allergic to cefpodoxime
- if the child has phenylketonuria (an inherited metabolic disease). See paragraph CEFODOX CHILDREN Contains Aspartame.
If you think any of these apply to your child, talk to your doctor before giving this medicine.In these cases, the doctor will not prescribe Cefpodoxime for the child.
Precautions for use What you need to know before taking Cefodox Children
Talk to your doctor or pharmacist before giving CEFODOX CHILDREN to your child.
In particular, tell your doctor:
- if you have been told that your child's kidneys are not working very well and / or if the child is undergoing some type of treatment (such as dialysis) for kidney failure. In this case, the doctor will prescribe a lower dose for the child of cefpodoxime
- if the child has ever had an "intestinal inflammation called colitis or other serious diseases affecting the digestive system (stomach) and / or intestines"
- if your child has to undergo certain medical blood tests such as cross-matching and Coombs test (tests which are usually done before a blood transfusion), as this medicine can alter the results
- if your child has diabetes and needs to check their urine frequently, as this medicine can alter the results of urinalysis to determine sugar levels (such as Benedict's or Fehling's tests). Your doctor will advise you to use other tests to control your child's diabetes while taking this medicine.
Children and adolescents
This medicine is only indicated for infants over 28 days old and for children up to 11 years of age.
Interactions Which drugs or foods can modify the effect of Cefodox Children
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
The way this medicine works can be affected by other medicines that are eliminated by the kidney. This is especially the case when given together with medicines that affect the proper functioning of the kidneys. Many medicines can influence the effect of cefpodoxime, so consult your doctor before giving CEFODOX CHILDREN to your child.
In particular, tell your doctor or pharmacist if your child is taking:
- Antacids (used to treat indigestion)
- Anti-ulcer drugs (used to treat ulcers), such as ranitidine and cimetidine
- Diuretics (used to increase urine flow)
- Aminoglycoside antibiotics used in the treatment of infections
- Probenecid (used in the treatment of gout)
- Anticoagulants such as warfarin.
Antacids and anti-ulcers (such as ranitidine and cimetidine) should be taken 2-3 hours after the child has taken CEFODOX CHILDREN. Your doctor is familiar with these medicines and will change your treatment if he deems it appropriate.
Warnings It is important to know that:
Medical exams
Tell your doctor if your child needs to have any medical tests (blood, urine or diagnostic tests) while you are taking this medicine, as this medicine can alter the test results (see section "Warnings and precautions"). CEFODOX CHILDREN with food and drink This medicine can be given to your child with or without food (see section 3 "How to give CEFODOX CHILDREN to your child").
Driving and using machines
Not relevant.
CEFODOX CHILDREN contains lactose, sucrose and sorbitol
If your child has diagnosed your child with intolerance to some sugars (such as lactose, sucrose or sorbitol), contact your doctor before giving your child this medicine.
CEFODOX CHILDREN contains aspartame
This medicine contains a source of phenylalanine. It can be harmful if the child has phenylketonuria (see the section "DO NOT give the child CEFODOX CHILDREN").
Dose, Method and Time of Administration How to use Cefodox Children: Posology
Always give your child this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Infants (older than 28 days) and children (up to 11 years old)
- The average recommended dose is 8 mg / kg per day given to the child in two divided doses and at 12 hour intervals.
- The dose to be given to the child can be read directly on the measuring syringe (which is inside the package) which has graduated notches from 1 kg to 25 kg in weight.
- The graduated marks on the syringe refer to the weight of the child in kilos; and range from 1 kg (0.5 ml of suspension) to 25 kg (12.5 ml of suspension). The dosing syringe also has intermediate marks of 1 kg each (0.5 ml suspension).
- The following table indicates the doses according to the child's body weight.
Children weighing at least 25 kg can take 12.5 ml of suspension twice a day. It is important to give the medicine to the child at the same time every day.
Children with kidney problems
Depending on the severity of the kidney problems, the child may need to take cefpodoxime less often, for example once a day or every other day. Your doctor will decide on the dose your child needs.
Instructions for preparing the suspension
- Unscrew the bottle cap by applying pressure.
- Remove the capsule that protects the granulate from humidity by pulling the two small flaps.
- Discard the unopened capsule. The contents of the capsule must NOT be swallowed.
- Prepare the impromptu suspension by adding water up to the level indicated by the groove engraved on the glass of the bottle which can be 100 ml or 50 ml (the final volume of the suspension is 100 or 50 ml).
- Shake the bottle to make the suspension homogeneous.
- Withdraw the required dose with the graduated syringe by putting it directly into the bottle and pulling the plunger.
- Give the medicine to the child.
- Screw the child resistant cap back on after use.
- Rinse the graduated syringe with running water after each use (refill with water and release several times).
If you forget to give CEFODOX CHILDREN to your child
If you forget to give a dose of the medicine at the appointed time, you must give it to your child as soon as possible. However if it is almost time for the next dose, skip the missed dose. Do not give a double dose to make up for a forgotten dose. Just give it. the next dose at the right time and continue therapy as before.
If you stop taking your child with CEFODOX CHILDREN
Keep giving the medicine to your child until your doctor tells you to stop. Do not stop treatment just because the baby starts to feel better. If you stop taking the medicine, your baby's condition could come back or get worse.
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 Cefodox Children
If you give your child more CEFODOX CHILDREN than they should
If you have accidentally given your child too much medicine, contact your doctor or pharmacist immediately, who will tell you what to do.
Side Effects What are the side effects of Cefodox Children
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are listed by frequency.
Conditions that require special attention
The following serious side effects have occurred in a small number of people, but the exact frequency of incidence is not known:
- Severe allergic reaction. The signs include prominent and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.
- Rash, blistered and looks like small marks (central dark spot surrounded by a paler area, with a dark ring around the edge).
- Widespread rash with blisters and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.)
- Severe diarrhea or blood in diarrheal stools.
All of these adverse reactions need urgent medical attention. If you think or notice that your child has any of these types of reactions, STOP the child's treatment and CONTACT your nearest doctor or emergency department.
Common side effects (may affect up to 1 in 10 people)
- Stomach problems: bloating, nausea, vomiting, stomach pain, flatulence (wind) and diarrhea
- Loss of appetite.
Uncommon side effects (may affect up to 1 in 100 people)
- Allergic reactions which include skin rashes eg hives, itching
- Headache
- Tingling
- Dizziness
- Ringing in the ears
- Weakness and general ill feeling.
Rare side effects (may affect up to 1 in 1,000 people)
- Changes in blood tests that check how the liver is working
- Anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
- Low blood cell count (symptoms may include tiredness, new infections and easy bruising or bleeding)
- Increase in some types of white blood cells
- Increase in the number of small cells that are needed for blood clotting (platelets).
Very rare side effects (may affect up to 1 in 10,000 people)
- Allergic reactions (anaphylactic; for example bronchospasm, purpura and edema of the face, tongue, throat and extremities)
- Worsening of kidney function
- Liver damage
- A course of CEFODOX CHILDREN may temporarily increase the risk of getting infections caused by other types of germs. For example, thrush (infection of the mouth) may occur.
- A type of anemia called "hemolytic anemia" which can be severe and is caused by the breakdown of red blood cells.
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 carton after EXP. The expiry date refers to the last day of the month.
Bottle containing the granules: do not store above 25 ° C. Reconstituted suspension: store in a refrigerator (+ 2 ° C to + 8 ° C) for no more than 10 days.
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.
Other_information "> Other information
What CEFODOX CHILDREN contains
- 100 g of granules contain: active ingredient: cefpodoxime proxetil 6,261 g (equal to cefpodoxime 4,800 g), corresponding to cefpodoxime 40 mg / 5ml of reconstituted suspension
- the other components are: Calcium Carmellose, Sodium chloride, Sodium glutamate, Carmellose sodium, Aspartame, Iron oxide, Citric acid monohydrate, Hydroxypropylcellulose, Sorbitan trioleate, Talc, Silica colloidal anhydrous, Banana flavor powder (isoamyl acetate, isoamyl isovalbylate , geranyl formate, acetic aldehyde, citral, nonyl aldehyde, orange oil, vegetable gum, sorbitol, malto dextran), sucrose, lactose monohydrate, potassium sorbate.
Description of CEFODOX CHILDREN's appearance and contents of the pack
CEFODOX CHILDREN is presented as a pale yellow granules for oral suspension.
The package may contain:
1 bottle of 50 ml + graduated syringe
1 bottle of 100 ml + graduated syringe
Not all pack sizes may be marketed.
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 -
CEFODOX CHILDREN 40 MG / 5 ML GRANULES FOR ORAL SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 grams of granules contain:
Active principle: cefpodoxime proxetil 6,261 g (equivalent to cefpodoxime 4,800 g).
Corresponding to cefpodoxime 40 mg / 5ml of reconstituted suspension.
Excipients: sucrose 601.33 mg / 5 ml dose
Lactose quantum satis at 0.835 g / 5 ml dose
Aspartame 20mg / 5ml serving
Banana flavor powder (contains sorbitol) 40mg / 5ml serving
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM -
Granules for oral suspension.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Cefpodoxime is indicated for the treatment of the following infections caused by organisms susceptible to cefpodoxime (see sections 4.4 and 5.1), in children up to 11 years of age:
Upper respiratory infections:
• Acute bacterial sinusitis
• Tonsillitis
• Otitis media, acute
Lower respiratory tract infections :
• Bacterial pneumonia
In case of bacterial pneumonia cefpodoxime may not be the suitable option depending on the pathogen involved, see section 4.4.
Official guidelines on the appropriate use of antibacterial agents should be considered.
04.2 Posology and method of administration -
Route of administration: oral.
Adults and the elderly :
Not applicable for this medicine.
Infants (> 28 days), children (up to 11 years) :
The average recommended dose for children is 8 mg / kg per day given in two divided doses at 12-hour intervals.
The dose to be taken is indicated on the graduated syringe. The graduations correspond to the weight of the child in kg from 1 kg (0.5 ml) to 25 kg (12.5 ml) with intermediate graduations of 1 kg each (0.5 ml).
The dose to be taken is read directly on the graduated syringe
The following table provides the dosing regimen for children according to the body weight graduations indicated on the graduated syringe:
Children weighing at least 25 kg can take 12.5 ml suspension twice daily or alternatively 1 100 mg film-coated tablet twice daily.
Hepatic impairment :
No dose adjustments are required in case of hepatic impairment.
Renal impairment :
No dose modification of cefpodoxime is required if creatinine clearance exceeds 40 ml / min-1 / 1.73m².
Below this value, pharmacokinetic studies indicate an increase in the plasma elimination half-life and maximum plasma concentrations and, therefore, the dosage should be adjusted appropriately.
The suspension can be taken with or without food.
04.3 Contraindications -
• Hypersensitivity to cefpodoxime, to any other cephalosporin or to any of the excipients.
• Previous history of immediate and / or severe hypersensitivity reactions (anaphylaxis) to penicillin or other beta-lactam antibiotics.
The product should not be administered to children with phenylketonuria due to the presence of aspartame among the excipients (20 mg / 5 ml).
04.4 Special warnings and appropriate precautions for use -
Cefpodoxime is not the preferred antibiotic for the treatment of staph pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma And Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia caused by S. pneumoniae (see section 5.1).
As with all beta-lactam antibiotics, severe and occasionally fatal hypersensitivity reactions have been reported. In the event of severe hypersensitivity reactions, treatment with cefpodoxime should be stopped immediately and appropriate emergency measures taken.
Before starting treatment, it should be checked whether the patient has a history of severe hypersensitivity reactions to cefpodoxime, other cephalosporins or any other type of beta-lactam agent (see section 4.3). Caution should be exercised when cefpodoxime is administered to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
In severe renal insufficiency it may be necessary to reduce the dosage regimen depending on the creatinine clearance (see section 4.2).
Antibiotic agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibiotic agents, including cefpodoxime, and can range in severity from mild to life-threatening. Therefore it is important to consider this diagnosis in patients who present with diarrhea during or shortly after treatment with cefpodoxime (see section 4.8). The interruption of therapy with cefpodoxime and the administration of a specific treatment for Clostridium difficile must be taken into consideration. Medicinal products that inhibit peristalsis should not be given.
Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis.
As with all beta-lactam antibiotics, neutropenia and, more rarely, agranulocytosis may develop, particularly during prolonged treatment. For treatments longer than 10 days, blood counts should be monitored and treatment discontinued if neutropenia is observed.
Cephalosporins can be absorbed from the surface of red blood cell membranes and react with antibodies directed against the drug. This can result in a false positive in the Coombs test and, very rarely, in haemolytic anemia. Cross-reactivity with penicillin can occur due to this reaction.
Alterations in renal function have been observed with cephalosporin antibiotics, particularly when administered concomitantly with potentially nephrotoxic drugs such as aminoglycosides and / or potential diuretics. In these cases, renal function should be monitored.
As with other antibiotics, prolonged use of cefpodoxime can result in the proliferation of non-sensitive organisms (Candida and Clostridium difficile), which may require the interruption of treatment.
Interactions with laboratory tests:
A false positive for glucose in the urine can occur with Benedict's or Fehling's solutions or with the copper sulfate test, but not with tests based on enzymatic reactions of glucose oxidase.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
This medicine contains aspartame, a source of phenylalanine. It can be harmful if you have phenylketonuria.
The banana flavor powder of this 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 clinically significant interactions with other medicinal products were reported during the course of the clinical studies.
H2 blockers and antacids lead to a decrease in the bioavailability of cefpodoxime.
Probenecid reduces the excretion of cephalosporins. Cephalosporins potentially increase the anticoagulant effect of coumarins and reduce the contraceptive effect of estrogen.
Oral anticoagulants:
Co-administration of cefpodoxime and warfarin may enhance the anticoagulant effect. There have been numerous reports of increased oral anticoagulant activity in patients taking antibacterial agents, including cephalosporins. The risk may vary depending on the underlying infection, age and general status of the patient and therefore it is difficult to determine the contribution of cephalosporins to the increase in INR (International Normalized Ratio). Frequent monitoring of INR is recommended. during and immediately after co-administration of cefpodoxime with an oral anticoagulant agent.
Studies have shown that bioavailability decreases by approximately 30% when cefpodoxime is administered with drugs that neutralize gastric pH or inhibit acid secretion. Therefore, medicinal products such as mineral-type antacids and H2 blockers such as ranitidine, which can cause gastric pH increase, should be taken 2-3 hours after cefpodoxime administration.
04.6 Pregnancy and breastfeeding -
Not applicable.
04.7 Effects on ability to drive and use machines -
Not relevant.
04.8 Undesirable effects -
Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as follows:
Very common (≥1 / 10)
Common (≥1 / 100,
Uncommon (≥1 / 1,000 to
Rare (≥1 / 10,000,
Very rare (
Not known (frequency cannot be estimated from the available data)
Disorders of the blood and lymphatic system
Rare: Haematological disorders such as decreased hemoglobin, thrombocytosis, thrombocytopenia, leukocytopenia and / or eosinophilia
Very rare: Hemolytic anemia
Nervous system disorders
Uncommon: Headache, paraesthesia, dizziness
Ear and labyrinth disorders
Uncommon: Tinnitus
Gastrointestinal disorders
Common: Gastric pressure, nausea, vomiting, abdominal pain, flatulence, diarrhea. Bloody diarrhea can occur as a symptom of enterocolitis. The possibility of pseudomembranous enterocolitis should be considered if severe or prolonged diarrhea occurs during or shortly after treatment (see section 4.4).
Metabolism and nutrition disorders
common: Loss of appetite
Disorders of the immune system
Hypersensitivity reactions of all degrees of severity have been observed (see section 4.4).
Very rare: Anaphylactic reactions, bronchospasm, purpura and angioedema
Renal and urinary disorders
Very rare: Slightly increased levels of creatinine and urea in the blood
Hepatobiliary disorders
Rare: Temporary moderate increases in ASAT, ALAT and alkaline phosphatase and / or bilirubin. These laboratory abnormalities, which can also be explained by the presence of the infection, can rarely exceed twice the upper limit of the stated range and produce liver injury, usually cholestatic and very often asymptomatic.
Very rare : Liver damage
Skin and subcutaneous tissue disorders
Uncommon: Mucus cutaneous hypersensitivity reactions, rash, hives, itching
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme
Infections and infestations
Development of non-sensitive microorganisms may occur (see section 4.4).
General disorders and administration site conditions
Uncommon: Asthenia or malaise
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 -
In the event of overdose with cefpodoxime, symptomatic and supportive therapy should be instituted. In case of overdose, particularly in patients with renal insufficiency, encephalopathy may occur. Encephalopathy is usually reversible once plasma cefpodoxime levels have fallen.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: other beta-lactam antibacterials, third generation cephalosporins.
ATC code: J01DD13
Mechanism of action:
Cefpodoxime inhibits bacterial cell wall synthesis following binding to penicillin binding proteins (PBPs). This involves disruption of cell wall biosynthesis (peptidoglycan), which leads to bacterial cell lysis and cell death.
Pharmacokinetic / pharmacodynamic relationship
For cephalosporins it has been shown that the most important pharmacokinetic-pharmacodynamic index related to efficacy in vivo is the percentage of the dosing range for which the concentration of the unbound drug remains above the minimum inhibitory concentration (MIC) of cefpodoxime for individual target species (ie% T> MIC).
Resistance mechanism (s)
Bacterial resistance to cephalosporins is due to a number of mechanisms:
1) alteration of the permeability of the outer membrane in Gram-negative organisms;
2) alteration of penicillin-binding proteins (PBPs);
3) production of beta-lactamase;
4) efflux pumps in bacteria.
Breakpoints :
The clinical breakpoints for the European Commission's MIC tests on Antibiotic Sensitivity Testing (EUCAST) are shown below.
Clinical MIC breakpoints of EUCAST for cefpodoxime (05-01-2011, v. 1.3):
¹ Susceptibility of staphylococci to cephalosporins is inferred from susceptibility to cefoxitin.
² The sensitivity of betas-lactams of groups A, B, C and G of beta-haemolytic streptococcus can be inferred from the sensitivity to penicillin.
³ Species with MIC values above the breakpoint sensitivity are very rare and not yet reported. Antibiotic susceptibility testing and determination on any isolated organism should be repeated and if the result is confirmed the isolated organism should be sent to the reference laboratory.
* Insufficient data
Sensitivity
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
§ intermediate natural sensitivity
+ resistance speed> 50% in at least 1 region
% ESBL producing species are always resistant
05.2 "Pharmacokinetic properties -
Cefpodoxime proxetil is recovered in the intestine and is hydrolyzed to the active metabolite cefpodoxime. When cefpodoxime proxetil is administered orally to the fasting subject as a 100 mg tablet of cefpodoxime, 51.5% is absorbed and absorption is increased when given with food. The volume of distribution is 32.3. Peak levels of cefpodoxime are reached within 2-3 hours after dosing.The maximum plasma concentration is 1.2 mg / L and 2.5 mg / L after administration of a 100 mg and 200 mg dose, respectively. After oral intake of 100 and 200 mg twice daily for 14.5 days, the pharmacokinetic parameters of cefpodoxime remain unchanged.
The serum protein bond is about 40% mainly with albumin. The bond is of the non-saturable type.
Concentrations of cefpodoxime above the minimum inhibitory concentration (MIC) of common pathogenic microorganisms can occur in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.
Since most of the dose of cefpodoxime is excreted in the urine, the concentration is high. (Concentration observed in intervals of 0-4, 4-8, 8-12 hours after administration of a single dose exceeds the MIC90 of common pathogenic urinary tract microorganisms). Good distribution of cefpodoxime has also been observed in renal tissue, with concentrations above MIC90 of common pathogenic urinary tract organisms, 3-12 hours after administration of a single dose of 200 mg (1.6-3.1 mcg / g). Concentrations of cefpodoxime in bone marrow and cortical tissue are similar.
The major route of elimination is renal, 80% is eliminated unchanged in the urine, with a half-life of approximately 2.4 hours.
Children
In children, studies have shown that maximum plasma concentration occurs approximately 2-4 hours after administration. A single dose of 5 mg / kg in children aged 4-12 produced a similar maximum concentration to that in adults treated with a dose of 200 mg.
In patients less than 2 years of age who received repeated doses of 5 mg / kg every 12 hours, mean plasma concentrations, 2 hours post dose, are between 2.7 mg / L (1-6 months) and 2, 0 mg / L (7 months-2 years).
In patients aged 1 month to 12 years treated with repeated doses of 5 mg / kg every 12 hours, the residual plasma concentrations at steady-state are between 0.2 - 0.3 mg / L (1 month-2 years) and 0.1 mg / L (2-12 years).
05.3 Preclinical safety data -
There are no findings from chronic toxicity investigations to suggest that undesirable effects not known to date can occur in humans.
Furthermore, in vivo and in vitro studies did not give any indication of a potential cause of reproductive toxicity or mutagenicity. Carcinogenicity studies have not been conducted.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Calcium carmellose, sodium chloride, sodium glutamate, aspartame, iron oxide, carmellose sodium, sucrose, citric acid monohydrate, hydroxypropylcellulose, sorbitan trioleate, talc, colloidal anhydrous silica, banana powder flavor (isoamyl acetate, isoamyl isovalanutyrate, ethyl , acetic aldehyde, citral, nonyl aldehyde, orange oil, vegetable gum, sorbitol, malto dextran), potassium sorbate, lactose monohydrate.
06.2 Incompatibility "-
06.3 Period of validity "-
2 years.
The reconstituted solution can be stored for no more than 10 days in the refrigerator (+ 2 ° C to + 8 ° C).
06.4 Special precautions for storage -
The granulate must be stored at a temperature not exceeding + 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
CEFODOX children 40 mg / 5 ml granules for oral suspension - 1 bottle of 50 ml in amber glass with a 50 ml mark + graduated syringe with marks from 1 kg to 25 kg in weight
CEFODOX children 40 mg / 5 ml granules for oral suspension - 1 bottle of 100 ml in amber glass with one mark at 100 ml + graduated syringe with markings from 1 kg to 25 kg in weight
06.6 Instructions for use and handling -
Preparation of the suspension:
• Remove the capsule that protects the granulate from humidity by pulling the two small wings and discard the capsule.
• The preparation of the impromptu suspension is carried out by adding water up to the level indicated by the groove in the glass of the bottle (The final volume of the suspension is 50 or 100 ml)
• Shake the bottle in order to make the suspension homogeneous.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Scharper S.p.A. - Viale Ortles, 12 - MILAN
08.0 MARKETING AUTHORIZATION NUMBER -
Cefodox children 40 mg / 5 ml granules for oral suspension Bottle 50 ml A.I.C. n. 028463026
Cefodox children 40 mg / 5 ml granules for oral suspension 100 ml bottle A.I.C. n. 028463038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Cefodox children 40 mg / 5 ml granules for oral suspension 50 ml bottle: 4 March 1996 / 15/11/2009
Cefodox children 40 mg / 5 ml granules for oral suspension 100 ml bottle: 4 March 1996 / 15/11/2009
10.0 DATE OF REVISION OF THE TEXT -
January 2014
