Panadolum of BABY

General characteristics. Structure:

Active ingredients: 5 ml of suspension contain 120 mg of paracetamol; Excipients: malic acid, an azoruby (Е 122), gum xanthane, maltit liquid, fragrance strawberry, sorbite solution crystallizes, sodium нипасепт (sodium етилпарагидроксибензоат (Е 215), sodium пропилпарагидроксибензоат (Е 217), sodium methylparahydroxybenzoate (Е 219), sorbite (Е 420), the citric acid, water purified.

Pink viscous liquid with a strawberry smell, at suspension there are crystals.

Pharmacological properties:

Analgetic antipyretic. Has analgeziruyushchy and febrifugal effect. Blocks cyclooxygenase in TsNS, influencing the centers of pain and thermal control.

The antiinflammatory effect is practically absent.

The GIT and water salt metabolism as does not influence synthesis of prostaglandins in peripheral fabrics does not exert impact on a state mucous.
In the beginning

Pharmacokinetics.

Absorption and distribution

Absorption is high. Paracetamol is quickly and almost completely soaked up from a GIT. Cmax in plasma is reached in 30-60 min.

Communication with proteins of plasma about 15%. Distribution of paracetamol in organism liquids rather evenly.

Metabolism

It is metabolized preferential in a liver with formation of several metabolites. Newborn first two days have lives and at children of 3-10 years the main metabolite of paracetamol is paracetamol sulfate, children have 12 years and are more senior - the conjugated glucuronide.

Part of drug (about 17%) is exposed to a hydroxylation with formation of active metabolites which conjugate with glutathione. At a lack of glutathione these metabolites of paracetamol can block fermental systems of hepatocytes and cause their necrosis.

Removal

T1/2 at reception of a therapeutic dose makes of 2-3 h. At reception of therapeutic doses of 90-100% of the accepted dose it is allocated in urine within one day. The main amount of drug is distinguished after conjugation in a liver. In not changed look no more than 3% of the received paracetamol dose are allocated.

Indications to use:

Pain during a teething, a dentagra, a pharyngalgia, fever at cold, flu and children's infections, such as chicken pox, whooping cough, measles, parotitis (mumps). Drug is also recommended for treatment of a postvaccinal hyperthermia at babies at the age of 2-3 months.

Route of administration and doses:

Panadolum ® is intended to the Baby for treatment of children for 2 months up to 12 years.

Drug is intended only for oral administration. Drug is recommended for use in pediatrics. The paracetamol dose for all children is calculated depending on age and body weight.

The single dose of paracetamol makes 10-15 mg/kg, maximum daily - 60 mg/kg of body weight. It is possible to repeat administration of drug each 4-6 hours if necessary. Not to accept more than 4 doses a day. Not to accept more often than in 4 hours.

The maximum term of use of drug without recommendation of the doctor 3 days.

For children of 2-3 months: the single dose of 2,5 ml of suspension is applied to a symptomatic treatment of reactions to vaccination. If necessary the dose can be repeated, but not earlier than in 4 hours. If the body temperature of the child does not decrease after a repeated dose, it is necessary to see a doctor. Further use of drug to children of the specified age perhaps only under observation of the doctor.

To children from 3 months to 12 years. Find a dose in the table that corresponds to the child's weight. If the weight of the child it is unknown, find the dose corresponding to age of the child in the table.

Table of dosing of suspension of paracetamol of 120 mg / 5 ml to children: 

Body weight (kg)	Age	Single dose		Maximum daily dose
		ml	mg	ml	mg
4,5-6	2-3 months	Only according to doctor's instructions
6-8	3-6 months	4.0	96	16	384
8-10	6-12 months	5.0	120	20	480
10-13	1-2 years	7.0	168	28	672
13-15	2-3 years	9.0	216	36	864
15-21	3-6 years	10.0	240	40	960
21-29	6-9 years	14.0	336	56	1344
29-42	9-12 years	20.0	480	80	1920

For convenient dosing of suspension measured device of a mark from 0,5 to 8 ml. If it is necessary to measure a dose which makes more than 8 ml, measure at first the first 8 ml of suspension, and then other doses.

Features of use:

Use during pregnancy or feeding by a breast. Drug is used in pediatric practice.

Ability to influence speed of response at control of motor transport or other mechanisms.

Drug is used in pediatric practice.

Children.

It is not recommended to use drug to children up to 2 months.

Side effects:

Side reactions of paracetamol happen very seldom (<1/10 000):

- Disturbances from system of blood - anemia, a sulfhemoglobinemia and a methemoglobinemia (cyanosis, short wind, heartaches), hemolitic anemia;

- Disturbances from immune system - an anaphylaxis, skin reactions of hypersensitivity, including an itch, an enanthesis and mucous membranes (usually erythematic, a small tortoiseshell), a Quincke's disease, a multiformny erythema (Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease)

- Disturbances from respiratory system - a bronchospasm at the patients sensitive to aspirin and other NPVP;

- Disturbances from the alimentary system - nausea, pains in epigastriums, an abnormal liver function, increase in activity of liver enzymes, as a rule, without development of jaundice, гепатонекроз (dozozavisimy effect).

- Disturbances from endocrine system - a hypoglycemia, up to a hypoglycemic coma;

- Aseptic pyuria.

Interaction with other medicines:

Speed of absorption of paracetamol can increase Metoclopramidum and domperidony and decrease Colestyraminum. The anticoagulating effect of warfarin and other coumarins can amplify at simultaneous prolonged regular daily use of paracetamol, with increase in risk of bleeding. Periodic reception has no considerable effect. Barbiturates reduce febrifugal effect of paracetamol.

Antisudomni drugs (including Phenytoinum, barbiturates, carbamazepine) which stimulate activity of microsomal enzymes of a liver, can strengthen toxic impact of paracetamol on a liver owing to increase in extent of transformation of drug into gepatoksichn metabolites. At simultaneous use of paracetamol of a gepatoksichnima means toxic influence of drug on a liver increases. Simultaneous use of high doses of paracetamol with an isoniazid increases risk of development of a gepatoksichny syndrome. Paracetamol reduces efficiency of diuretics.

Not to apply along with alcohol.

Contraindications:

Hypersensitivity to any of drug components. Heavy renal failures and/or a liver, an inborn hyperbilirubinemia, deficit glyukozo-6-fosfatdegidrogenazy, alcoholism, blood diseases, the expressed anemia, a leukopenia. Patients with rare hereditary intolerance of fructose. Children up to 2 months.

Appropriate security measures at use.

It is necessary to consult to the doctor concerning a possibility of use of drug for patients with renal failures and a liver. Sodium methylparahydroxybenzoate, етилпарагидроксибензоат and пропилпарагидроксибензоат allergic reactions can cause. Children are 2-3 months old which were born premature, drug can be used only according to the recommendation of the doctor.

Not to give drug to children together with other means containing paracetamol.

If symptoms of a disease do not begin to disappear within 3 days of treatment by drug or, on the contrary, the state of health will worsen, it is necessary to see a doctor.

Each 120 mg / 5 ml of suspension contain 666,5 mg of sorbitol on 5 ml of suspension. Drug can have insignificant laxative effect.

Not to exceed the specified doses.

Overdose:

At prolonged use in high doses - aplastic anemia, a pancytopenia, an agranulocytosis, a neutropenia, a leukopenia, thrombocytopenia. At reception of high doses to mozhetrazvivatsya dizziness psychomotor excitement and disturbance of orientation, disturbance from an urinary system - nephrotoxicity (renal colic, intersticial nephrite, a papillary necrosis).

Overdose it is usually caused by paracetamol and it is shown by pallor of skin, anorexia, nausea, vomiting, abdominal pain, gepatonekrozy, increase in activity of "hepatic" transaminases and increase in a prothrombin ratio. In case of overdose the increased sweating, psychomotor excitement or oppression TsNS, drowsiness, disturbance of consciousness, disturbance of a cordial rhythm, tachycardia, premature ventricular contraction, a tremor, a hyperreflexia, spasms can be observed. Damage of a liver can be shown in 12-48 hours after overdose. There can be disturbances of metabolism of glucose and a metabolic acidosis. At a serious poisoning the liver failure can progress and lead to development of toxic encephalopathy, with consciousness disturbance, in some cases - with a lethal outcome. The acute renal failure with an acute necrosis of tubules can develop even in the absence of severe damage of kidneys. Also cardiac arrhythmia was noted. Damage of a liver is possible at adults who accepted more than 10 g and at children who accepted more than 150 mg/kg of body weight.

At overdose of paracetamol emergency medical service is necessary even if symptoms of overdose are not revealed. It is necessary to wash out a stomach with the subsequent purpose of absorbent carbon, a symptomatic treatment. Use of N-Acetylcysteinum or methionine orally effective within 48 hours after overdose. It is necessary to take also all-supporting measures. If necessary apply alpha adrenoblockers.

Storage conditions:

Period of validity. 3 years. To store at a temperature not above 25 °C, in the place, unavailable to children. Not to freeze.

Issue conditions:

Without recipe

Packaging:

On 100 ml of suspension in a bottle from orange glass, measured the device in the form of the syringe in a cardboard box.