Nurofen for children suspension. for oral administration (orange) 100mg / 5ml fl. 150ml

pharmachologic effect

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug (NSAID).

ATX code: M01AE01

Pharmacological properties

Pharmacodynamics:

The mechanism of action of ibuprofen, a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction.

Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it inhibits the synthesis of prostaglandins.

In addition, ibuprofen reversibly inhibits platelet aggregation.

It has analgesic, antipyretic and anti-inflammatory effects.

The analgesic effect is most pronounced for inflammatory pain.

The action of the drug lasts up to 8 hours.

Pharmacokinetics:

Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract (GIT) (connection with blood plasma proteins - 90%). After taking the drug on an empty stomach in adults, ibuprofen is found in the blood plasma after 15 minutes, the maximum concentration (Cmax) of ibuprofen in the blood plasma is reached after 60 minutes. Taking the drug with food can increase the time to reach the maximum concentration (TCmax) up to 1-2 hours. The half-life (T1 / 2) is 2 hours. It slowly penetrates into the joint cavity, remains in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, with bile.

In limited studies, ibuprofen has been found in breast milk at very low concentrations.

Indications

Nurofen® suspension for children is used in children from 3 months of age to 12 years for symptomatic treatment as an antipyretic agent for acute respiratory diseases (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature ...

The drug is used as a symptomatic pain reliever for pain syndrome of mild or moderate intensity, including: toothache, headache, migraine, neuralgia, ear pain, sore throat, pain with sprains, muscle pain, rheumatic pain, joint pain ...

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

Hypersensitivity to ibuprofen or any of the components that make up the drug.

Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs.

A history of bleeding or perforation of gastrointestinal ulcers caused by NSAIDs.

Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or bleeding ulcer).

Severe liver failure or active liver disease.

Renal failure of severe severity (creatinine clearance < 30 ml / min), confirmed hyperkalemia.

Decompensated heart failure, the period after coronary artery bypass grafting.

Cerebrovascular or other bleeding.

Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.

Pregnancy (III trimester).

Fructose intolerance.

Child's body weight up to 5 kg.

Carefully

In the presence of the conditions specified in this section, before using the drug, you should consult

Name ENG

NUROFEN

Clinical and pharmacological group

NSAIDs

ATX code

Ibuprofen

Dosage

100mg / 5ml x 150ml

Structure

5 ml of Nurofen suspension for children contains the active ingredient - ibuprofen 100 mg and excipients: polysorbate 80 0.5 mg, glycerol 0.5 ml, maltitol syrup 1.625 ml, sodium saccharinate 10 mg, citric acid 20 mg, sodium citrate 25, 45 mg, xanthan gum 37.5 mg, sodium chloride 5.5 mg, domiphene bromide 0.5 mg, orange flavor 2M16014 or strawberry flavor 500244E 12.5 mg, purified water up to 5 ml.

Indications

Nurofen suspension for children is used in children from 3 months of age to 12 years for symptomatic treatment as an antipyretic agent for acute respiratory diseases (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature.

The drug is used as a symptomatic pain reliever for pain syndrome of mild or moderate intensity, including: toothache, headache, migraine, neuralgia, ear pain, sore throat, pain with sprains, muscle pain, rheumatic pain, joint pain ...

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

Hypersensitivity to ibuprofen or any of the components that make up the drug. Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs. A history of bleeding or perforation of gastrointestinal ulcers caused by NSAIDs. Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or bleeding ulcer). Severe liver failure or active liver disease. Renal failure of severe severity (creatinine clearance < 30 ml / min),confirmed hyperkalemia. Decompensated heart failure, the period after coronary artery bypass grafting. Cerebrovascular or other bleeding. Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis. Pregnancy (III trimester). Fructose intolerance. Child's body weight up to 5 kg. Precautions If you have the conditions listed in this section, you should consult before using the drug.With caution If you have the conditions listed in this section, you should consult before using the drug.Precautions If you have the conditions listed in this section, you should consult before using the drug.

INN / Active ingredient

Ibuprofen

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

after opening - 6 months

Specifications

Category

Pain and fever

Scope of the medicinal product

General

Release form

Oral suspension

Manufacturer country

Great Britain

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

3 months

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Shelf life after opening

Use within 6 months after opening the bottle.

Volume, ml.

150 ml

Brand name

Nurofen

Components

syringe dispenser

The amount of the dosage form in the primary package

150 ml

Primary packaging type

Bottle

Type of consumer packaging

Cardboard box

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M01AE01 Ibuprofen

Dosage form

Oral suspension, [orange]

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

100 mg

The target audience

Children

Package weight, g

150

Mode of application

:

Nurofen for children is a suspension specially designed for children. For oral administration. Patients with hypersensitivity of the stomach are advised to take the drug with meals. < br> < br> For short-term use only. Read the instructions carefully before taking the drug. < br> < br> Shake the bottle thoroughly before use. A convenient measuring syringe is included for accurate measurement of the dose. 5 ml of the preparation contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml. < br> < br> Using the measuring syringe: < br> < br> Insert the measuring syringe tightly into the neck of the bottle. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the syringe to the desired mark. Return the bottle to its original position and remove the syringe by gently turning it.Place the syringe in the oral cavity and slowly press the plunger, gradually releasing the suspension. < br> < br> After use, rinse the syringe in warm water and dry it out of the reach of the child. < br> < br> Fever (fever) and pain: < br> < br> The dosage for children depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg / kg of the child's body weight with intervals between doses of the drug 6-8 hours. < br> < br> Children aged 3-6 months (child weight from 5 to 7.6 kg): 2 , 5 ml (50 mg) up to 3 times within 24 hours, no more than 7.5 ml (150 mg) per day. < br> < br> Children aged 6-12 months (child weight 7.7 - 9 kg ): 2.5 ml (50 mg) up to 3-4 times within 24 hours, no more than 10 ml (200 mg) per day. < br> < br> Children aged 1-3 years (child weight 10 - 16 kg): 5,0 ml (100 mg) up to 3 times within 24 hours, not more than 15 ml (300 mg) per day. < br> < br> Children aged 4-6 years (child weight 17 - 20 kg): 7, 5 ml (150 mg) up to 3 times within 24 hours, no more than 22.5 ml (450 mg) per day. < br> < br> Children aged 7-9 years (child weight 21-30 kg): by 10 ml (200 mg) up to 3 times within 24 hours, no more than 30 ml (600 mg) per day. < br> < br> Children aged 10-12 years (child weight 31 - 40 kg): 15 ml (300 mg) up to 3 times within 24 hours, no more than 45 ml (900 mg) per day. < br> < br> Duration of treatment - no more than 3 days. Do not exceed the indicated dose. < br> < br> If symptoms persist or worsen after taking the drug within 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older),it is necessary to stop treatment and consult a doctor. < br> < br> Post-immunization fever: < br> < br> Children under 6 months: 2.5 ml (50 mg) of the drug. If necessary, another 2.5 ml (50 mg) after 6 hours. Do not use more than 5 ml (100 mg) in a 24 hour period.

Information on technical characteristics, delivery set, country of manufacture