Expiration date: 11/2025

Composition and form of issue:

Powder for preparation of suspension for oral administration 5 ml suspension

active substance:

amoxicillin (in trihydrate form) 125 mg

clavulanic acid (in the form of potassium salt) 31, 25 mg

ratio-4:1 

excipients: citric acid (anhydrous), sodium citrate (anhydrous), sodium benzoate MCC sodium carmellose, xanthan gum, silicon dioxide colloidal, silicon dioxide, sodium saccharinate, mannitol, flavoring agents (strawberry, wild cherry, lemon) 

powder for the preparation of a suspension for oral administration 125 + 31, 25 mg / 5 ml in bottles of dark glass with a ring mark (100 ml) 25 g (complete with a spoon or pipette dosage protective cap) in a pack of cardboard 1 bottle.

Powder for preparation of suspension for oral administration 5 ml suspension

active substance:

amoxicillin (trihydrate) 250 mg

clavulanic acid (in the form of potassium salt) 62, 5 mg

ratio-4:1 

excipients: citric acid (anhydrous), sodium citrate (anhydrous), sodium benzoate MCC sodium carmellose, xanthan gum, silicon dioxide colloidal, silicon dioxide, sodium saccharinate, mannitol, flavoring agents (strawberry, wild cherry, lemon) 

powder for the preparation of a suspension for oral administration 250 mg + 62, 5 mg / 5 ml in bottles of dark glass with a ring mark (100 ml) 25 g (complete with a spoon dosage or pipette dosage with a protective cap) in a pack of cardboard 1 bottle.

Powder for preparation of suspension for oral administration 5 ml suspension

active substance:

amoxicillin (trihydrate) 400 mg

clavulanic acid (in the form of potassium salt) 57 mg

the ratio — 7:1 

excipients: citric acid (anhydrous), sodium citrate (anhydrous), MCC sodium carmellose, xanthan gum, silicon dioxide colloidal, silicon dioxide, sodium saccharinate, mannitol, flavorings (strawberry, wild cherry, lemon) 

powder (8, 75 g-35 ml finished suspension, 12, 5 g-50 ml, 17, 5 g-70 ml, 35, 0 g — 140 ml) for the preparation of a suspension for oral administration with a concentration of 400 + 57 mg/5 ml in bottles of dark glass or 17, 5 g (70 ml finished suspension) in bottles of dark glass with an annular label (70 ml) in a pack of cardboard 1 bottle (complete with pipette

Method of application and doses:

Inside, vigorously shaking before use.

Daily doses of suspensions 125 + 31, 25 mg/5 ml and 250 + 62, 5 mg / 5 ml

To facilitate proper dosing, a dosing spoon with a capacity of 5 ml or 5 ml or a graduated pipette is placed in each package of 125 + 31, 25 mg/5 ml and 250 + 62, 5 mg/5 ml suspensions.

Newborns and children up to 3 months: 30 mg/kg (amoxicillin) per day, divided into 2 admission (every 12 hours).

Children older than 3 months: from 20 mg/kg in mild and moderate infections of up to 40 mg / kg in severe infection and respiratory infections (amoxicillin) per day, divided into 3 admission (every 8 hours).

Recommended doses of the suspension depending on the weight of the child and the severity of the infection

Body weight (kg)
Age (approx.)For mild to moderate
Severe course
125 mg+31, 25 mg/5 ml250 mg+62, 5 mg/5 ml125 mg+31, 25 mg/5 ml250 mg+62, 5 mg/5 ml
5–103–12 month3 × 2, 5 ml (1/2 l.)3 × 1, 25 ml (1/4 l.)3 × 3, 75 ml (3/4 l.)3 × 2 ml (1/4–1/2 l.)
10–121–2 years3 × 3, 75 ml (3/4 l.)3 × 2 ml (1/4–1/2 l.)3 × 6, 25 ml (1 1/4 l.)3 × 3 ml (1/2–3/4 l.)
12–152–4 years3 × 5 ml (1 l.)3 × 2, 5 ml (1/2 l.)3 × 7, 5 ml (1 1/2 l.)3 × 3, 75 ml (3/4 l.)
15–204–6 years3 × 6, 25 ml (1 1/4 l.)3 × 3 ml (1/2–3/4 l.)3 × 9, 5 ml (1 3/4–2 l.)3 × 5 ml (1 l.)
20–306–10 years3× 8, 75 ml (1 3/4 l.)3× 4, 5 ml (3/4–1 l.)-3 × 7 ml (1 1/4–1 1/2 l.)
30–4010–12 years-3× 6, 5 ml (1 1/4 l.)-3× 9, 5 ml (1 3/4–2 l.)
>40>12 yearsAmoxiclav pills

Daily doses of 400 + 57 mg/5 ml suspension

Dosage is calculated per kg of body weight, depending on the severity of the infection, and is 25-45 mg/kg/day (based on amoxicillin), divided into two doses.

To facilitate proper dosing, 400 + 57 mg/5 ml dosing pipette is placed in each package of the suspension, graduated at the same time by 1, 2, 3, 4, 5 ml and 4 equal parts.

Recommended doses of the suspension depending on the weight of the child and the severity of the infection:

Body weight (kg)
Age (approx.)
Severe course
For average weight
5–103–12 month2 × 2, 5 ml (1/2 pipettes)2 × 1, 25 ml (1/4 pipettes)
10–151–2 years2 × 3, 75 ml (3/4 pipettes)2 × 2, 5 ml (1/2 pipettes)
15–202–4 years2 × 5 ml (1 pipettes)2 × 3, 75 ml (3/4 pipettes)
20–304–6 years2 × 7, 5 ml (11/2 pipettes)2 × 5 ml (1 pipettes)
30–406–10 years2 × 10 ml (2 pipettes)2 × 6, 5 ml (11/4 pipettes)

The exact daily doses are calculated based on the body weight of the child, not his age.

The maximum daily dose of amoxicillin for adults is 6 grams, for children — 45 mg / kg. 

The maximum daily dose of clavulanic acid (in the form of potassium salt) is for adults — 600 mg, for children 10 mg/kg of body weight.

In patients with severe renal insufficiency (CL creatinine less than 10 ml/min) dose should be adequately reduced or increased interval between the two methods, with anuria — up to 48 h or more.

The course of treatment is 5-14 days. The duration of treatment is determined by the attending physician. Treatment should not last more than 14 days without re-medical examination.

Manual for the preparation of a suspension

Powder for suspension preparation 125 + 31, 25 mg / 5 ml: shake the bottle vigorously, add 86 ml of water (up to the mark) in 2 doses, shaking well each time until the powder is completely dissolved.

Powder for the preparation of the suspension 250 + 62, 5 mg / 5 ml: shake vigorously the bottle, add 85 ml of water (to mark) in 2 admission, each time shaking well until the powder is completely dissolved.

Powder for suspension preparation 400 + 57 mg / 5 ml: shake the bottle vigorously, add water in the amount indicated on the label and listed in the table (up to the mark) in 2 doses, shaking well each time until completely dissolved.

Bottle size, ml
Required amount of water, ml
3529, 5
5042
7059
140118

Comment:

Before prescribing the drug, please read the full instructions for use.

Storage conditions:

The finished suspension is stored at a temperature of 2° — 8 °C, in a tightly closed bottle.

Shelf life:

The finished suspension is 7 days.

Amoxiclav
(Amoxicillin
+
Clavulanic
acid)
powder