CLAVOMAF

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CLAVOMAF

Amoxicillin + Clavulanic Acid

COMPOSITION:

Each film coated tablet CLAVOMAF® 1000 contains:

Amoxicillin 875 mg (as Amoxicillin Trihydrate) Clavulanic acid 125 mg (as Potassium Clavulanate)

Each film coated tablet CLAVOMAF® 625 contains:

Amoxicillin 500 mg (as Amoxicillin Trihydrate) Clavulanic acid 125 mg (as Potassium Clavulanate)

Each film coated tablet CLAVOMAF® 375 contains:

Amoxicillin 250 mg (as Amoxicillin Trihydrate) Clavulanic acid 125 mg (as Potassium Clavulanate)

Each 5 ml of CLAVOMAF® 457 for oral suspension contains:

Amoxicillin 400 mg (as Amoxicillin Trihydrate) Clavulanic acid 57 mg (as Potassium Clavulanate)

Each 5 ml of CLAVOMAF® 312 for oral suspension contains:

Amoxicillin 250 mg (as Amoxicillin Trihydrate) Clavulanic acid 62.5 mg (as Potassium Clavulanate)

Each 5 ml of CLAVOMAF® 228 for oral suspension contains:

Amoxicillin 200 mg (as Amoxicillin Trihydrate) Clavulanic acid 28.5 mg (as Potassium Clavulanate)

Each 5 ml of CLAVOMAF® 156 for oral suspension contains:

Amoxicillin 125 mg (as Amoxicillin Trihydrate) Clavulanic acid 31.25 mg (as Potassium Clavulanate)

Each one ml of CLAVOMAF® 62.5 Infant drops contains:

Amoxicillin 50 mg (as Amoxicillin Trihydrate) Clavulanic acid 12.5 mg (as Potassium Clavulanate)

DESCRIPTION:

CLAVOMAF® is a broad spectrum combination of Amoxicillin and the β-lactamase inhibitor, Potassium Clavulanate.

CLAVOMAF ® exhibits bactericidal activity against many Gram-positive and Gram-negative organisms: Staphylococcus aureus (β-lactamase and non-β-lactamase producing), Streptococcus species, Enterobacter species, E. coli, Haemophilus influenzae, Klebsiella species, Moraxella catarrhalis and Clostridium species.

Amoxicillin and Potassium Clavulanate are well absorbed from the gastrointestinal tract. CLAVOMAF ® can be given without regard to meals.

INDICATION:

CLAVOMAF ® is indicated in the following infections caused by susceptible organisms:

– Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.

– Lower respiratory tract infections e.g. acute and chronic bronchitis, lobar and bronchopneumonia.

– Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

– Skin and soft tissue infections.

– Other infections: bone and joint infections, dental infections and intra-abdominal sepsis.

DOSAGE:

Adult and children over 12 years:

– In mild to moderate infection: one CLAVOMAF ® 625 mg tablet twice daily or one

CLAVOMAF ® 375 mg tablet three times daily.

– In severe infection and lower respiratory tract infection: one CLAVOMAF ® 1000 mg tablet twice daily or one CLAVOMAF ® 625 mg tablet three times daily.

– In dental infection: one CLAVOMAF ® 625 mg tablet twice daily or one CLAVOMAF ® 375 mg tablet three times daily for 5 days.

Children:

Children under 2 years should be dosed according to body weight.

Patients aged 12 weeks (3months) and older: as shown in the below:

– In mild to moderate infections: upper respiratory tract infections (recurrent tonsillitis), lower

respiratory tract infection, skin and soft tissue infections.

– In severe infection of upper respiratory tract infection (otitis media and sinusitis), lower

respiratory tract infections (bronchopneumonia) and urinary tract infection.

– Treatment should not be extended beyond 14 days without review to the physician.

– Pediatric patients weighing 40 kg and more should be dosed according to the adult.

– Dosage in renal impairment should be reduced.

Infants:

Based on the Amoxicillin component, CLAVOMAF ® should be used in neonates and infants aged less than 12 weeks (3 months): 30 mg/kg/day divided into 2 doses or 20 mg/kg/day

divided into 3 doses. In more serious infections the dosage may be increased up to 50 mg/kg/day divided into 3 doses.

CLAVOMAF ® Infant Drops should be administered using the supplied syringe doser.

The syringe doser has marking which correspond to the weight of the child. For example, for a child weighing 7 kg, the syringe piston should be withdrawn until the 7 kg marking is level with the top of the body of the syringe and the dose is given to child through mouth and the dose repeated each 8 hours.

For information: each 0.13 ml of CLAVOMAF ® infant Drops corresponds to 1 kg of body weight.

Over dose:

Cases of over dosage with CLAVOMAF ® are usually symptomatic. If encountered,

gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically, with attention to the water/ electrolyte balance. CLAVOMAF ® may be removed from the circulation by hemodialysis.

STORAGE CONDITIONS:

– Keep the medicine in a dry place at a temperature below 30 °C.

– Keep the medicine out of the reach of children.

– Protect the medicine from direct sunlight.

– Do not use Clavomaf (Tablets & Powder) after expire date

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