FLUMOX |
Composition:
Each dosage unit contains
Amonycillirr (as trihydrate)
Capsule
250mg
125mg
125mg
125mg
Flaclosacillin (as monofrydrate)
Amonycillin (as sodium salt)
Flucloxacillin (as Sodium salt)
Amonycillin (as sodium salt)
Flucloxacillin (as Sodium salt)
500mg
250mg
250mg
250mg
5mI Susp.
250mg
125mg
125mg
125mg
125mg
Vll5
500mg
250mg
250mg
250mg
ig
500mg
500mg
500mg
500mg
Properties:
FLUMOX® isa combination of two bactericidal penicillins: amoxycilin (broadspectwm penicillin) and flucloxacillin (penicillinase-resistant penicillin), to produce a wider spectrum of ac5vity. Flucloxacillin exerts a bactericidal action on penicillinase -producing microorganism including most staphylococci.This combination exhibits bactericidal activity against a wide range of Gram-positive and Gram-negative microorganisms including penicillinase and 41 on peniciiinase - producing Staphylococci, Streptococcus pyogenes, pneumoniae, and faecalis, Corynebacterillm diphtheriae, Clostridia S pp., Bacillus anthracis; H.influenzae, Moraxella (Branhamella) catarrhalis, N.gonorrheae and meningitidis, E,coli Proteus mirabilis, Salmonella, Bordetella pertussis . and Bacteroides melaninogenicus.
FLUMOX® isa combination of two bactericidal penicillins: amoxycilin (broadspectwm penicillin) and flucloxacillin (penicillinase-resistant penicillin), to produce a wider spectrum of ac5vity. Flucloxacillin exerts a bactericidal action on penicillinase -producing microorganism including most staphylococci.This combination exhibits bactericidal activity against a wide range of Gram-positive and Gram-negative microorganisms including penicillinase and 41 on peniciiinase - producing Staphylococci, Streptococcus pyogenes, pneumoniae, and faecalis, Corynebacterillm diphtheriae, Clostridia S pp., Bacillus anthracis; H.influenzae, Moraxella (Branhamella) catarrhalis, N.gonorrheae and meningitidis, E,coli Proteus mirabilis, Salmonella, Bordetella pertussis . and Bacteroides melaninogenicus.
11
Pharmacokinetics: Both amoxycillin and flucloxacillin are acid-stable and are well absorbed after oral administration. Amoxycillin is more rapidly absorbed than ampicillin producing higher plasma concentrations than those obtained with the same dose of ampicillin. Peak plasma concentrations of amosycillin and fluclosacillin are achieved in about ito 2 hours after oral administration; and in about 30 minutes after parenteral administration.FLUMOX® is widely distributed in body tissues and fluids. Amoxycillin and fluclosacillin are metabolized to a limited extent, and the unchanged drugs and metabolites are excreted in the urine by glomerular filtration and renal tubular secretion and also in bile.
Indications: FLUMOX® is indicated in the treatment ala wide range of infections including:
• Respiratory tract infections: Bronchitis, pneumonia and emphysema.
• Ear, nose and throat infections: Otitis media, sinusitis, tonsillitis and pharyngitis
• Gastro-irtlestinaf tract infections: Enteritis, chofecystitis, typhoid and
paratyphoid fever.
• Genito- urinary tract infections: Cystitis, pyelonephritis, prostatitis, gonorrhea,
and puerperal sepsis.
• Skin and soft-tissue infections: Boils, carbuncles, abscesses, cellulitis,
post-operative wound infections, and intra- abdominal sepsis.
• Bone infections: Osteomyelitis and septic arthritis.
• Other infections: Septicaemia, endocarditis, peritonitis, bitary tract infections,
and meningitis.
Indications: FLUMOX® is indicated in the treatment ala wide range of infections including:
• Respiratory tract infections: Bronchitis, pneumonia and emphysema.
• Ear, nose and throat infections: Otitis media, sinusitis, tonsillitis and pharyngitis
• Gastro-irtlestinaf tract infections: Enteritis, chofecystitis, typhoid and
paratyphoid fever.
• Genito- urinary tract infections: Cystitis, pyelonephritis, prostatitis, gonorrhea,
and puerperal sepsis.
• Skin and soft-tissue infections: Boils, carbuncles, abscesses, cellulitis,
post-operative wound infections, and intra- abdominal sepsis.
• Bone infections: Osteomyelitis and septic arthritis.
• Other infections: Septicaemia, endocarditis, peritonitis, bitary tract infections,
and meningitis.
Precautions: Doses should be reduced in severe renal impairment.
ml, In, Mediu,e,eet
.Medicament is a product which affects your health, and to oansumpvan oonlrary to instructions is dangerous for you.
.Faiiaw strictly the doctor’s presoription, the method of use, and the instructions sf the pharmacist who sold the medicament.
•The dootar and the pharmacist are eopsrts in medicine, its benefits and risks.
‘Do not interrupt the period of treatment prescribed by yaureeit.
.00 not repeat the same prescription without consulting your doctor.
•Keep medicines out of the reanh of children.
05.04-2004 PM5. eLucec D,:reaXrooMM 133 SOt PAM 000
.Medicament is a product which affects your health, and to oansumpvan oonlrary to instructions is dangerous for you.
.Faiiaw strictly the doctor’s presoription, the method of use, and the instructions sf the pharmacist who sold the medicament.
•The dootar and the pharmacist are eopsrts in medicine, its benefits and risks.
‘Do not interrupt the period of treatment prescribed by yaureeit.
.00 not repeat the same prescription without consulting your doctor.
•Keep medicines out of the reanh of children.
05.04-2004 PM5. eLucec D,:reaXrooMM 133 SOt PAM 000
For the Medical Profession Only _______
EEEEEEEEEEEEEEEEEE EIPIfl IEEEEEEEEEEEEEEEEEEEEEEEEEEEEE
FLU MOX® Oradrnirdstragon. Administration: Adults: 250 mg - 1 g every 6 - 5 hours.
Capsules - Dry Mix (Oral Suspension )-Vials Children up ro 2 years: 125-250mg (1/2-1 teaspoonful) every e-8 hours.
Broad Spectrum Antibiotic Children 2 to 12 years: 250 -500 mg (1 - 2 teaspoonful) every 6-8 hours.
_____________________________________________________________________ ReconstitutIon of FLUMOX® Dry Mix: To make up , first shake the bottle to
loosen powder, then add about 50 ml of water to the content of bottle and shake
wolt. Fill to the mark on the bottle and keep for ubout 5 minutes. Once
_____________________ _____________ ________ ______________ reconstituted, FLUMOX® must be stored in refrigorator and uued within 10
days.Shuke well before use.
_________ Parenteral administrations:
Adults: 0.5g -10, every 6—8 hours.
Children: (2—12 years):1/2 adult dose; children (less than 2 years):1/4 adult dose.
Administration may be intramusculor, Intravenous injection or infusion.
FLUMOX® vials should be injected immediately offer reconstitution with distilled
wafer for injection.
In severe Infections, the vial maybe given in infusion, every 4—6 houro.
For intramuscular ieiectios, FLUMOX® vial 500 mg should be dissolved in 2 ml:
________________________________ _________ FLUMOX® vial 1000 mg should be dissolved In 4 ml of water for injection.
For intravenous injection, FLUMOX® vial 500 mg should be dissolved in 5
ml;FLUMOX® vial 1000 mg should be dissolved in 10 ml of water for injection,
given slowly over 3—4 minutes.
• FLUMOX® vial is stable with the commonly- used intravenous fluids at 25’C, if
nfused over a maximum period of 6 hours.
• Solutions containing dextrose or other carbohydrates should be infused within
30 -40 minutes and must be changed within 2 hours.
• Solutions containing sodium bicarbonate muet be changed within 4 hours.
FLUMOX® must not be wised with blond products or proteixaceous fluids,
EEEEEEEEEEEEEEEEEE EIPIfl IEEEEEEEEEEEEEEEEEEEEEEEEEEEEE
FLU MOX® Oradrnirdstragon. Administration: Adults: 250 mg - 1 g every 6 - 5 hours.
Capsules - Dry Mix (Oral Suspension )-Vials Children up ro 2 years: 125-250mg (1/2-1 teaspoonful) every e-8 hours.
Broad Spectrum Antibiotic Children 2 to 12 years: 250 -500 mg (1 - 2 teaspoonful) every 6-8 hours.
_____________________________________________________________________ ReconstitutIon of FLUMOX® Dry Mix: To make up , first shake the bottle to
loosen powder, then add about 50 ml of water to the content of bottle and shake
wolt. Fill to the mark on the bottle and keep for ubout 5 minutes. Once
_____________________ _____________ ________ ______________ reconstituted, FLUMOX® must be stored in refrigorator and uued within 10
days.Shuke well before use.
_________ Parenteral administrations:
Adults: 0.5g -10, every 6—8 hours.
Children: (2—12 years):1/2 adult dose; children (less than 2 years):1/4 adult dose.
Administration may be intramusculor, Intravenous injection or infusion.
FLUMOX® vials should be injected immediately offer reconstitution with distilled
wafer for injection.
In severe Infections, the vial maybe given in infusion, every 4—6 houro.
For intramuscular ieiectios, FLUMOX® vial 500 mg should be dissolved in 2 ml:
________________________________ _________ FLUMOX® vial 1000 mg should be dissolved In 4 ml of water for injection.
For intravenous injection, FLUMOX® vial 500 mg should be dissolved in 5
ml;FLUMOX® vial 1000 mg should be dissolved in 10 ml of water for injection,
given slowly over 3—4 minutes.
• FLUMOX® vial is stable with the commonly- used intravenous fluids at 25’C, if
nfused over a maximum period of 6 hours.
• Solutions containing dextrose or other carbohydrates should be infused within
30 -40 minutes and must be changed within 2 hours.
• Solutions containing sodium bicarbonate muet be changed within 4 hours.
FLUMOX® must not be wised with blond products or proteixaceous fluids,
MANUFACTURED BY E.I.P.I.CO.
EGYPTIAN INT. PHARMACEUTICALINDUSTRIES CO.
TENTH OF RAMADAN CITY A.R.E.
EGYPTIAN INT. PHARMACEUTICALINDUSTRIES CO.
TENTH OF RAMADAN CITY A.R.E.
Contra - indications:
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A Known hypersensitivity to penicillin.
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Side - Effects:
|
Au with other penlcillinu, side- effects are usually mild and transient including
|
diarrhoea, indigestion and skin rashes.
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Packaging:
|
FLUMOX® 250mg capsule Blisters of 6,8 oriocspsules each.
|
:Boseg of 12, 16 or 20 capsules.
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FLUMOX® 500 mg capsule Blisters of 5 org capsules each.
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Boxes of 8,16 or 20 capsules.
|
FLUMOX® Dry MIX Bottles 0160 or 100 ml after reconstitution.
|
FLUMOX® 500mg ,1 g Vial : Boxes of 1 or 50 or 100 vials each.
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