Active ingredients: Cefaclor
PANACEF 500 mg, hard capsules
PANACEF 250 mg / 5 ml, granules for oral suspension
Panacef package inserts are available for packs: - PANACEF 500 mg, hard capsules, PANACEF 250 mg / 5 ml, granules for oral suspension
- PANACEF 375 mg modified release tablets, PANACEF 500 mg modified release tablets, PANACEF 750 mg modified release tablets
- PANACEF 250 mg, hard capsules, PANACEF 375 mg / 5 ml, granules for oral suspension, PANACEF 187.5 mg / 5 ml, granules for oral suspension, PANACEF 125 mg / 5 ml, granules for oral suspension, PANACEF 50 mg / ml oral drops, suspension, PANACEF 375 mg, granules for oral suspension
Why is Panacef used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibiotic for oral use (cephalosporins).
THERAPEUTIC INDICATIONS
Treatment of the following infections caused by sensitive germs:
- Infections of the respiratory system, such as pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis.
- Otitis media (inflammatory processes of bacterial origin affecting the middle ear).
- Skin and soft tissue infections.
- Urinary tract infections, including pyelonephritis and cystitis.
- Sinusitis.
- Gonococcal urethritis.
Contraindications When Panacef should not be used
Panacef is contraindicated in patients with hypersensitivity to the active substance, to other cephalosporins or to any of the excipients.
Precautions for use What you need to know before taking Panacef
Before initiating therapy with Panacef, it is recommended that previous hypersensitivity reactions to cephalosporins and penicillins be investigated.
There have been patients who have experienced severe reactions (including anaphylaxis) following administration of penicillins or cephalosporins including Cefaclor, IgE mediated reactions usually occurring in the skin, gastrointestinal, respiratory and cardiovascular.
Symptoms may be: severe and sudden hypotension, rapid and slow heart rate, unusual tiredness or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty in breathing or swallowing, generalized itching especially of the soles of the feet and palms of the feet. hands, hives with or without angioedema (swollen and itchy skin areas located most frequently in the extremities, external genitalia and face, especially in the eye and lip region), redness of the skin especially around the ears, cyanosis, profuse sweating, nausea , vomiting, crampy abdominal pain, diarrhea.
In case of allergic reactions, the administration of the drug must be interrupted and the patient appropriately treated
Since pseudomembranous colitis may occur during treatment with broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins and cephalosporins), its onset should be kept in mind during treatment with these drugs.
Panacef should be administered with caution to patients with severely impaired renal function. In these cases, the dosage should be lower than generally recommended.
Broad-spectrum antibiotics should be administered with caution to individuals who have previously had intestinal disorders, due to the possibility that antibiotic-associated colitis may develop.
Prolonged use of Panacef can give rise to a proliferation of non-sensitive germs; if bacterial superinfection occurs during therapy with Panacef, it must be appropriately treated.
Use in infants
The efficacy and tolerability of Panacef in infants less than one month old are unknown.
Interactions Which drugs or foods can modify the effect of Panacef
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
There is evidence of partial cross-allergenicity between penicillins and cephalosporins.
False positive reactions to urinary glucose may occur after administration of Panacef both with the Benedict and Fehling solutions and with the Clinitest but not with the Tes-Tape (urine glucose test card, Lilly).
Positive Coombs tests (sometimes false) have been reported during treatment with cephalosporins. Renal elimination of cefaclor is inhibited by probenecid (antigout drug capable of promoting the elimination of uric acid)
Warnings It is important to know that:
Starch allergic patients (not suffering from celiac disease) should not take the medicine.
The granules for oral suspension and oral drops, suspension contain sucrose, in case of ascertained intolerance to sugars contact your doctor before taking the medicine.
Panacef has no effect on the ability to drive or use machines.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The tolerability of cefachlor during pregnancy has not been sufficiently proven.
In pregnant women, the drug should be used in case of real need and under direct medical supervision.
Small amounts of cefachlor were found in breast milk after single doses of 500 mg. During lactation caution is recommended in the use of the drug.
Dosage and method of use How to use Panacef: Dosage
Panacef is administered orally and can be taken with or without meals.
Adults: 250 mg every 8 hours; in more severe infections, higher dosages may be required. The maximum recommended dose is 2 g per day.
For the treatment of acute gonococcal urethritis in both sexes, a single administration of 3 g of cefaclor possibly in combination with 1 g of probenecid is recommended.
Children: 20 mg / kg per day in divided doses every 8 hours; in more severe infections (such as otitis media), a dosage of 40 mg / kg per day is recommended up to a maximum daily dose of 1 g.
In the treatment of infections caused by beta-haemolytic streptococcus, the therapeutic dosage with cefaclor should be maintained for at least 10 days.
MEASURE AND SYRINGE FOR PANACEF 250 mg / 5 ml granules for oral suspension
By way of example, for a daily dose of 40 mg / kg
(Panacef 250 mg / 5 ml granules for oral suspension)
Alternative administration scheme: in otitis media and pharyngitis, the total daily dose can be administered in divided doses every 12 hours; the amount of reconstituted product should be taken according to the following scheme:
By way of example, for a daily dose of 40 mg / kg
(Panacef 250 mg / 5 ml granules for oral suspension)
Note: the tables refer to the maximum daily dosage of 40 mg / kg; doses of 20 mg / kg correspond to half of the above values
Instructions for preparing the suspension
Shake the bottle well before preparation; then add water up to the level indicated by the arrow on the label, cap and shake the suspension well. Add water again, up to the level indicated by the arrow, and shake well until a uniform suspension is obtained.
When prepared according to these instructions, 5 ml of suspension contain cefaclor monohydrate equivalent to 250 mg of cefaclor.
Shake well before each administration.
Overdose What to do if you have taken too much Panacef
Signs and symptoms: they may include nausea, vomiting, epigastric disorders and diarrhea, the severity of which is related to the dose taken. If other symptoms are present, they are likely secondary to a pre-existing disease, allergic reaction, or other toxic state.
Treatment: Always bear in mind the possibility that overdose is caused by multiple drugs, drug interactions, or the patient's particular pharmacokinetics.
Gastric lavage is not necessary when the patient has not ingested a dose of Panacef 5 times higher than the recommended dose.
The patient should be followed carefully, checking in particular the state of the airways ensuring ventilation and perfusion, vital signs (heart rate and blood pressure), blood gas analysis, serum electrolytes etc.
Intestinal absorption can be reduced by administering activated charcoal which, in many cases, is more effective than induced vomiting or gastric lavage; therefore, consider charcoal as an alternative treatment or in addition to gastric emptying. Repeated administration of activated charcoal can facilitate the elimination of other drugs that may have been taken. Carefully check the patient's airways during gastric emptying and use of charcoal.
It is not known whether forced diuresis, peritoneal dialysis, hemodialysis or charcoal hemoperfusion are of benefit to the patient.
Side Effects What are the side effects of Panacef
Like all medicines, Panacef can cause side effects, although not everybody gets them.
Adverse reactions considered to be related to treatment with Panacef are the following:
Allergic manifestations: hypersensitivity reactions were observed (1.5%) including morbilliform rashes (1%); pruritus, hives and positive Coombs test are seen in less than 1 in 200 patients treated.
Generalized reactions called "serum-like diseases" have also been reported, characterized by the presence of erythema multiforme, rash and other manifestations affecting the skin accompanied by arthritis and / or arthralgia (disorders affecting the joints of an inflammatory or painful nature) , with or without fever. Serum-like reactions occur more often during and after a course of cefaclor treatment and, more frequently, in children than in adults.
The signs and symptoms appear a few days after the start of therapy and cease a few days after its termination. Antihistamines and steroids promote healing. No serious complications have been observed.
More severe hypersensitivity reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylaxis) have been observed rarely.
Gastro-intestinal manifestations: they can occur in about 2.5% of patients, even with the onset of diarrhea.
Pseudomembranous colitis can be observed during and after antibiotic treatment. Nausea and vomiting are rarely observed. Transient hepatitis and cholestatic jaundice have rarely been observed with some penicillins and other cephalosporins.
Other manifestations: angioedema (abnormal fluid retention in the tissues, of allergic origin), eosinophilia, itching of the genitals, vaginal moniliasis, vaginitis and, rarely, thrombocytopenia and reversible interstitial nephritis.
There have been reports of haemolytic anemia following treatment with cephalosporins.
Effects for which the correlation with the treatment is not certain:
Central nervous system: rarely reversible hyperactivity, restlessness, insomnia, mental confusion, hypertonia (increased muscle tone), hallucinations, dizziness and staggering, sleepiness.
Digestive system: slight increases in transaminase (SGOT and SGPT) or alkaline phosphatase values.
Hemolymphatic system: transient lymphocytosis, leukopenia and, rarely, haemolytic anemia, aplastic anemia, agranulocytosis and reversible neutropenia. There have been rare reports of increased prothrombin time, with or without clinical consequences (e.g. bleeding), in patients receiving cefaclor and warfarin sodium (antithrombotic drug) concomitantly.
Genitourinary system: slight increases in blood urea nitrogen, blood creatinine and changes in urinalysis.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable 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 "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". 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.
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 30 ° C.
Once the oral suspension has been prepared, store in the refrigerator (between +2 and + 8 ° C) and use within 14 days. Keep this medicine out of the sight and reach of children
COMPOSITION
PANACEF 500 mg hard capsules
Each capsule contains:
Active principle:
Cefaclor monohydrate equivalent to cefaclor 500 mg
Excipients:
Pregelatinised starch; magnesium stearate; dimethicone 350 c.s.
PANACEF 250 mg / 5ml granules for oral suspension
5 ml of suspension contain:
Active principle:
Cefaclor monohydrate equivalent to cefaclor 250 mg
Excipients:
Erythrosine E-127 aluminum lake; methylcellulose 15; sodium lauryl sulfate; dimethicone 350 cs; polysaccharide rubber; pregelatinised starch; strawberry flavor; sucrose.
PHARMACEUTICAL FORM AND CONTENT
PANACEF 500 mg hard capsules - 8 capsules
PANACEF 250 mg / 5 ml granules for oral suspension - bottle of 100 ml
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
PANACEF
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Panacef 500 mg hard capsules:
Each capsule contains:
Active principle:
Cefaclor monohydrate eq. to cefaclor 500 mg
Panacef 250 mg / 5 ml granules for oral suspension:
5 ml of suspension prepared as prescribed contains:
Active principle:
Cefaclor monohydrate eq. to cefaclor 250 mg
Panacef 50 mg / ml oral drops, suspension:
Each ml of suspension prepared as prescribed contains:
Active principle:
Cefaclor monohydrate eq. to cefaclor 50 mg
Panacef 375 mg granules for oral suspension:
Each sachet contains:
Active principle;
Cefaclor monohydrate eq. to cefaclor 375 mg
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral suspension; hard capsules; oral drops, suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cefaclor is indicated for the treatment of the following infections caused by susceptible germs:
respiratory tract infections, including pneumonia, bronchitis, acute exacerbations of chronic bronchitis, pharyngitis and tonsillitis;
otitis media;
skin and soft tissue infections;
urinary tract infections, including pyelonephritis and cystitis;
sinusitis;
gonococcal urethritis.
04.2 Posology and method of administration
Cefaclor is administered orally.
Adults: The normal adult dosage is 250 mg every 8 hours. In more severe infections or those caused by less sensitive germs, higher dosages may be indicated. The maximum recommended dose is 2 g per day, although doses of 4 g per day. day have been administered to normal subjects for 28 days with no adverse effects.
For the treatment of acute gonococcal urethritis in both sexes, a single administration of 3 g of cefaclor possibly in combination with 1 g of probenecid is recommended.
Children: The normal daily dosage for children is 20 mg / kg in divided doses every 8 hours.
In the most severe infections, in otitis media, and in those caused by less sensitive germs, a dosage of 40 mg / kg / day is recommended up to a maximum daily dose of 1 g.
Alternative posology: in otitis media and pharyngitis, the total daily dose can be administered in divided doses every 12 hours.
For further examples of pediatric posology, see package leaflet.
In the treatment of infections caused by beta-haemolytic streptococcus, the therapeutic dosage with cefaclor should be maintained for at least 10 days.
04.3 Contraindications
Cefaclor is contraindicated in those patients with hypersensitivity to the active substance or to any of the excipients.
Generally contraindicated in pregnancy and lactation (see 4.6).
04.4 Special warnings and appropriate precautions for use
Before initiating therapy with Cefaclor, the benefit / risk ratio for the individual patient must be carefully evaluated, in particular it is recommended to carry out a careful family and individual medical history of the occurrence of hypersensitivity reactions to this or other medicinal products.
Careful consideration should be given to whether the patient has previously been hypersensitive to cephalosporins and penicillins.
Cephalosporin C derivatives should be administered with caution to penicillin-sensitive patients. There is evidence of partial cross-allergenicity between penicillins and cephalosporins.
Therefore, precautions must be taken to prevent unwanted reactions.
There have been patients who have experienced severe reactions (including anaphylaxis) following administration of penicillins or cephalosporins, IgE mediated reactions usually occurring in the skin, gastrointestinal, respiratory and cardiovascular.
Symptoms may be: severe and sudden hypotension, rapid and slow heart rate, unusual tiredness or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty in breathing or swallowing, generalized itching especially of the soles of the feet and palms of the feet. hands, hives with or without angioedema (swollen and itchy skin areas located most frequently in the extremities, external genitalia and face, especially in the eye and lip region), redness of the skin especially around the ears, cyanosis, profuse sweating, nausea , vomiting, crampy abdominal pain, diarrhea.
Given the possible onset of pseudomembranous colitis in patients undergoing treatment with broad spectrum antibiotics, it is important to keep this possibility in mind in patients presenting with diarrhea during antibiotic chemotherapy.
Use in pregnancy: The tolerability of cefaclor during pregnancy has not been sufficiently proven.
Keep this medicine out of the reach of children.
If an allergic reaction to Panacef occurs, the administration of the drug must be suspended and the patient must be given appropriate treatment.
Prolonged use of cefaclor can induce the development of non-sensitive germs.
Careful observation of the patient is essential. If superinfection occurs during therapy with cefaclor, appropriate measures must be taken.
Panacef should be administered with caution to patients with severely impaired renal function. Under such conditions, the safe dosage should be lower than generally recommended.
False positive reactions to urinary glucose may occur after administration of cefaclor. These were observed with both the Benedict and Fehling solutions and the Clinitest, but not with the Tes-Tape (enzyme test for glycosuria, Lilly).
Broad-spectrum antibiotics should be prescribed with caution to people with a history of intestinal disorders, particularly colitis.
The granules for oral suspension and oral drops, suspension contain sucrose and are therefore not suitable for subjects with hereditary fructose intolerance, glucose / galactose malabsorption syndrome or sucrase-isomaltase deficiency.
The starch in the medicine contains trace gluten so it can be considered safe for patients with celiac disease.
04.5 Interactions with other medicinal products and other forms of interaction
As with other beta-lactam antibiotics, renal excretion of cefaclor is inhibited by probenecid.
Many observations have shown that the presence of food lowers and delays the maximum concentrations of cefaclor in serum without altering the total amount found in the urine.
04.6 Pregnancy and lactation
The tolerability of cefaclor during pregnancy has not been sufficiently proven.
In pregnant women, the drug should be used in case of real need and under direct medical supervision.
Small amounts of cefachlor were found in breast milk following single doses of 500 mg. Since the effects of cefaclor on the infant are not known, caution is recommended in the use of the drug during breastfeeding.
04.7 Effects on ability to drive and use machines
Cefaclor has no effect on the ability to drive and use machines.
04.8 Undesirable effects
Adverse reactions considered to be related to cefaclor treatment are reported here.
Hypersensitivity: Hypersensitivity reactions were observed in 1.5% of patients, including measles form rashes (1 in 100). Pruritus, urticaria and positive Coombs test are seen in less than 1 out of 200 treated patients.
Generalized "serum-like illness" reactions have been reported with the use of cefaclor. These are characterized by the presence of erythema multiforme, rash and other skin manifestations, accompanied by arthritis / arthralgia, with or without fever, and they differ from classic serum sickness in that lymphadenopathy and proteinuria are rarely present, circulating immune complexes are lacking and there is no "evidence to date" of sequelae of the reaction.
Such reactions were reported more frequently in children than in adults, with an incidence of 1 in 200 (0.5%) in one clinical work, 2 out of 8,346 (0.024%) in other clinical work (with an incidence in children equal to 0.055%) and finally 1 in 38,000 (0.003%) in the context of spontaneous events.
The signs and symptoms appear a few days after the start of therapy and cease a few days after its termination.
Only occasionally did these reactions cause hospitalization, which was generally short-lived (on average 2 to 3 days, according to the Post-Marketing Surveillance studies).
In the patients who had been hospitalized, the symptoms at the time of admission were mild to severe and in any case more severe in the child. Antihistamines and cortisones favor the remission of signs and symptoms.
No serious sequelae were reported.
More severe hypersensitivity reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylaxis have been rarely observed.
Cases with a fatal outcome have been reported very rarely; the onset and evolution of a severe anaphylactic reaction can be very rapid, therefore all necessary precautions must be taken to prevent such reactions (see section 4.4).
Anaphylaxis can be seen more readily in penicillin allergic patients.
Gastrointestinal Effects:They occur in about 2.5% of patients, including diarrhea (1 out of 70 treated). Pseudomembranous colitis can be observed during and after antibiotic treatment. Nausea and vomiting are rarely observed. Transient hepatitis and cholestatic jaundice rarely occur with some penicillins and other cephalosporins.
Others: Angioedema, eosinophilia (1 in 50 treated), itching of the genitals, vaginal mobiliasis and vaginitis (less than 1 in 100) and, rarely, thrombocytopenia and reversible interstitial nephritis.
There have been reports of haemolytic anemia following treatment with cephalosporins.
Events for which correlation is uncertain:
Central nervous system: Reversible hyperactivity, restlessness, insomnia, mental confusion, hypertonia, hallucinations, dizziness and dizziness, somnolence are rarely reported.
Changes in liver function: Slight increases in SGOT and SGPT values, or in alkaline phosphatase have been reported (1 in 40).
Hematological changes: As with other beta-lactam antibiotics, transient lymphocytosis, leukopenia and, rarely, haemolytic anemia, aplastic anemia, agranulocytosis and reversible neutropenia of possible clinical significance have been reported. There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving concomitant cefaclor and warfarin sodium.
Renal disorders: Mild increases in blood urea nitrogen or creatinine (less than 1 in 500) or changes in urinalysis (less than 1 in 200) have been reported.
04.9 Overdose
Signs and symptoms: Symptoms of toxicity observed after overdose with cefaclor may include nausea, vomiting, epigastric discomfort and diarrhea. The severity of epigastric disorders and diarrhea is labile at the dose taken. If other symptoms are highlighted, it is likely that they are secondary to the underlying disease, an allergic reaction or other intoxication.
Treatment. Always be aware of the possibility that overdose is caused by multiple drugs, drug interactions, or the patient's particular pharmacokinetics.
Intestinal lavage is not necessary when the patient has not ingested more than 5 times the normal dose of cefaclor.
The patient must be carefully monitored, particularly ventilation and lung perfusion, vital signs, blood gas analysis, serum electrolytes, etc.
Intestinal absorption can be reduced by administering activated charcoal which, in many cases, is more effective than induced vomiting or washing; therefore, consider charcoal as an alternative treatment or in addition to gastric emptying. Repeated administration of activated charcoal can facilitate the "elimination of some drugs that may have been taken. Carefully monitor the patient's airways during gastric emptying and use of activated charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis or activated charcoal hemoperfusion has not been established to benefit the patient with cefaclor overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibiotic belonging to the cephalosporin class.
ATC code: JOIDC04
In vitro tests have shown that the bactericidal action of cephalosporins is expressed through the inhibition of cell wall synthesis.
Cefaclor is active in vitro against the following microorganisms:
Alpha and beta-haemolytic streptococci.
Staphylococci, including coagulase positive and negative and penicillinase producing strains.
Streptococcus (Diplococcus) pneumoniae.
Escherichia coli.
Proteus mirabilis.
Klebsiella sp.
Moraxella (Branbarnella) catarrhalis.
Haemophilus influenzae, including ampicillin-resistant strains.
Note: Cefaclor is not active on Pseudomonas sp. and on most strains of enterococci (Streptococcus faecalis), Enterobacter sp., Proteus indole-positive and Serratia. Some rare strains of staphylococci are resistant to cefachlor.
05.2 Pharmacokinetic properties
Cefaclor is well absorbed after oral administration whether taken with food or on an empty stomach. After doses of 250 mg, 500 mg and 1 g the mean serum peaks detected after 30-60 minutes were respectively 7, 13 and 23 mcg / ml. Approximately 60-85% of the drug is excreted unchanged in the urine within 8 hours following administration.
During this period, the maximum concentrations in urine after administration of doses of 250 mg, 500 mg and 1 g were respectively approximately 600, 900 and 1,900 mcg / ml.
TI cefaclor is not appreciably metabolised. The presence of food in the gastrointestinal tract delays absorption and reduces serum peaks but does not change the total amount of cefaclor absorbed.
05.3 Preclinical safety data
Tests performed on mice, rats, dogs and monkeys indicate that the drug has a low toxic power. The LD50 values were higher than 5 g / kg when the drug was administered to rodents orally or intraperitoneally. Dogs and monkeys also endured high doses of the drug (DLO> 1 g / kg), with occasional vomiting and diarrhea.
Cefaclor is neither teratogenic nor mutagenic.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Hard capsules:
Dimethicone 350 c.s., magnesium stearate, pregelatinized starch.
Empty capsule:
Patent blue V E-131, Erythrosine E-127 aluminum lake, titanium dioxide E-171, black iron oxide E-172, gelatin.
Granules for oral suspension:
Dimethicone 350 c.s., polysaccharide gum, pregelatinized starch, Erythrosine E-127 aluminum lake, strawberry flavor, sodium lauryl sulfate, methylcellulose 15, sucrose.
Oral drops, suspension and granules for oral suspension, sachets:
30% silicone emulsion, polysaccharide rubber, pregelatinised starch, Erythrosine E-127 aluminum lake, strawberry flavor, sodium lauryl sulfate, methylcellulose 15, sucrose.
06.2 Incompatibility
N.A.
06.3 Period of validity
Panacef 500 mg hard capsules, Panacef 375 mg granules for oral suspension and Panacef 50 mg / ml oral drops, suspension: 2 years.
Panacef 250 mg / 5 ml granules for oral suspension: 3 years.
These periods of validity refer to products in intact packaging, properly stored, at room temperature (not exceeding 30 ° C).
06.4 Special precautions for storage
Once prepared, all suspensions (Panacef 250 mg / 5 ml granules for oral suspension, Panacef 50 mg / ml oral drops, suspension) must be stored in the refrigerator and used within 14 days.
06.5 Nature of the immediate packaging and contents of the package
Panacef 500 mg hard capsules are packed in blisters of 8 capsules.
Panacef 250 mg / 5 ml granules for oral suspension, is packaged in 100 ml high density polyethylene bottles.
Panacef 50 mg / ml oral drops, suspension, is packaged in glass bottles of 20 ml. Panacef 375 mg granules for oral suspension, 12 sachets, is packaged in sachets consisting of a paper-polyethylene-aluminum-polyethylene laminate.
06.6 Instructions for use and handling
Instructions for preparing the suspension 250 mg / 5 ml:
Shake the bottle well before preparation; then add water up to the level indicated by the arrow on the label, cap and shake the suspension well. Add water again, up to the level indicated by the arrow, and shake well until a uniform suspension is obtained.
If prepared according to these instructions, 5 ml of suspension will contain cefaclor monohydrate equivalent to 250 mg of cefaclor.
Shake well before each administration.
Panacef 50 mg / ml oral drops, suspension (2.5 mg of cefaclor each drop):
A daily dosage of 8 drops (20 mg) per kg of body weight is recommended, in divided doses every eight hours.
In more severe infections (such as otitis media), a daily dosage of 16 drops (40 mg) per kg of body weight is recommended, up to a maximum daily dose of 1 g.
Instructions for preparing the oral drops:
At the time of preparation, add water to the dry granulate contained in the bottle up to the point indicated by the arrow. Screw the original cap back on and shake well until all the granulate is in suspension.
Then apply the capsule with the dropper.
Dropper:
One ml (20 drops) of the enclosed dropper is equivalent to 50 mg of cefaclor.
Panacef 375 mg granules for oral suspension:
Pour the contents of a sachet into a little water and shake.
07.0 MARKETING AUTHORIZATION HOLDER
VALEAS S.p.A. Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Panacef 500 mg hard capsules: AIC 024227023
Panacef 250 mg / 5 ml granules for oral suspension: AIC 024227050
Panacef 50 mg / ml, oral drops, suspension: AIC 024227047
Panacef 375 mg granules for oral suspension: AIC 024227136
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Panacef 500 mg hard capsules: June 2005
Panacef 250 mg / 5 ml granules for oral suspension: June 2005
Panacef 50 mglm1 oral drops, suspension: June 2005
Panacef 375 mg granules for oral suspension: June 1998
10.0 DATE OF REVISION OF THE TEXT
01/04/2007
