Expiration date: 07/2025

Pharmacological group

Penicillins in combinations

Dosage form and composition

Film-coated tablets

1 tablet contains active substance:

amoxicillin (in the form of trihydrate amoxicillin) 875 mg

clavulanic acid (in the form of a mixture of potassium clavulanate and MCC (1:1) 125 mg

excipients: MCC-510, 35 mg, sodium carboxymethyl starch (type a) - 32, 8 mg, magnesium stearate-32 mg, silicon dioxide colloidal anhydrous-24 mg, butylhydroquinazol-0, 85 mg

shell film: gipromelloza-34, 84 mg, titanium dioxide E171-17, 42 mg, propylene glycol-8, 17 mg, talc-3, 57 mg

Pharmacological action

Pharmacological action-broad-spectrum antibacterial, bactericidal.

Method of application and doses

Inside, squeezed water, in beginning a meal (to reduce the risk of side effects from the gastrointestinal tract), 2 times a day, strictly observing the interval between doses in 12 hours.

Film-coated tablets

Adults and children over 12 years of age (body weight ?40 kg)

Take 1 table. 2 times a day, every 12 hours.

The maximum daily dose of amoxicillin for adults-6 g, for children — 45 mg/kg / day.

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

The course of treatment — 5-14 days, set individually, taking into account characteristics of the pathogen, localization, and severity of the infection. Treatment should not last more than 14 days without re-medical examination.

Dosing in renal failure

Tablets 875/125 mg should be used only in patients with creatinine Cl more than 30 ml/ min, with dose adjustment is not required.

Patients on peritoneal dialysis do not require dose adjustment. Patients on hemodialysis, you may need to adjust the dose.

Powder for preparation of suspension for oral administration

Dosing measuring spoon, given that 5 ml of prepared suspension contain amoxicillin 400 mg/clavulanic acid 57 mg. Drink 0, 5-1 glass of water.

Dose Panklav 2X appointed doctor, taking into account the characteristics of the pathogen, localization and severity of infection. Dosing regimen is established individually, depending on the age, body weight (for children) and kidney function. The course of treatment — 5-14 days, is individually.

In infections requiring long-term therapy (for example, osteomyelitis), exceeding the maximum recommended course of therapy in 14 days is possible only after a thorough evaluation by the doctor of the patient's condition, achieved and expected therapeutic effects and risks.

The maximum daily dose of amoxicillin for adults-6 g, for children — 45 mg/kg / day. The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children — 10 mg/kg/day.

Adults and children over 12 years of age (body weight ?40 kg)

Standard dosing regimen for all indications:

2 scoops (800/114 mg) 2 times a day, every 12 hours.

Children from 2 to 12 years old (body weight ?40 kg)

Powder for preparation of suspension for oral administration	5 ml prepared suspension
active substance:
amoxicillin (in the form of trihydrate amoxicillin)	400 mg
clavulanic acid (in the form of a mixture of potassium clavulanate and syloid (1:1)	57 mg
auxiliary substances: silicon dioxide-436, 143 mg, gipromelloza-100 mg, sodium saccharinate-10 mg, xanthan gum-10 mg, silicon dioxide colloidal-3, 2 mg, succinic acid-1, 5 mg, strawberry flavor-53, 571 mg

Children from 3 months to 3 years

Daily dose (amoxicillin)	??? ???????	???????????? ????????	?????????? ??????? ?????????
25 mg/kg	13–21 kg	2–6 years	2, 5 ml 2 times a day
	22–40 kg	7–12 years	5 ml 2 times a day
45 mg/kg	13–21 kg	2–6 years	5 ml 2 times a day
	22–40 kg	7–12 years	10 ml 2 times a day

The daily dose for children older than 3 months and up to 12 years (body weight ?40 kg) is 25-45 mg/kg/day (based on amoxicillin), divided into two doses, every 12 hours.Low doses of the drug (25 mg/kg/day) are used for the treatment of skin infections and soft tissue, as well as recurrent tonsillitis. High doses of the drug (45 mg/kg/day) are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections. The duration of treatment of uncomplicated acute otitis media is 5 to 7 days in children for 7-10 days.

Children and adults with renal insufficiency

At Cl creatinine less than 30 ml / min, the drug in this dose is not recommended, at Cl creatinine more than 30 ml/min — insufficiently substantiated data for the development of special recommendations on dosing regimen. It is allowed as a reduction in the dose of the drug, and the increase in the interval between doses.

Preparation of suspension for oral administration

In the bottle with the powder gradually add water to the mark (distilled water or boiled and cooled) and shake until the powder is evenly wetted (about 30 C). If the level of the prepared suspension is below the mark on the bottle label, re-add the water to the mark and shake.

The prepared suspension should be shaken before each use.

Importantly! If the drug is missed, you should take the tablet (or suspension) as soon as possible, without waiting for the next time. Continue to abide by equal time intervals between meals, for 12 h. Never take a double dose to compensate the missed dose!

Form release

Tablets, film-coated, 875 mg + 125 mg, 14 tabl. Bank brown glass (type III) closed with a plastic cap with silicagel and tamper-evident. 1 Bank in a pack of cardboard.

Powder for suspension preparation for intake (400 mg + 57 mg)/5 ml to 15 g or 30 g of powder in glass vial of hydrolytic class III, sealed with a plastic screw cap with tamper-evident. On the upper side of the lid is applied to the opening scheme of the bottle. 1 bottle complete with measuring spoon, volume 5 ml, with risque, for a volume of 2, 5 ml in a pack of cardboard.

Manufacturer

Hemofarm Ad, Serbia.

26300, vršac, Beograd route 66, Serbia.

Tel: 13/803100, Fax: 13/803424.

Consumer complaints should be sent to the address:

JSC "Nizhpharm", 603950, Russia, Nizhny Novgorod, GSP-459, Salganskaya St., 7.

Storage conditions of the drug Panklav 2X

In a dry place, protected from light, at a temperature not exceeding 30 °C. The finished suspension should be stored in the refrigerator (at a temperature of 2-8 °C) no more than 7 days.

Keep out of reach of children.

Shelf life of the drug Panklav 2X

2 years.

The weight of the baby	A daily dose of 25 mg/kg (on amoxicillin)	A daily dose of 45 mg/kg (on amoxicillin)
5 kg	0.8 ml 2 times a day	1.4 ml 2 times a day
6 kg	0.9 ml 2 times a day	1.7 ml 2 times a day
7 kg	1.1 ml 2 times a day	2 ml 2 times a day
8 kg	1.3 ml 2 times a day	2.3 ml 2 times a day
9 kg	1.4 ml 2 times a day	2.5 ml 2 times a day
10 kg	1.6 ml 2 times a day	2.8 ml 2 times a day
11 kg	1.7 ml 2 times a day	3.1 ml 2 times a day
12 kg	1.9 ml 2 times a day	3.4 ml 2 times a day