MIG for children - instructions for use, dose, side effects, contraindications

Excipients: sodium benzoate - 5.00 mg, citric acid anhydrous - 30.0 mg, sodium citrate - 35.00 mg, sodium saccharinate - 2.50 mg,sodium chloride - 50,00 mg, hypromellose (degree of substitution 2910) - 25,00 mg, xanthan gum - 20,00 mg, maltitol - 2500,00 mg, glycerol - 500,00 mg, thaumatin - 0.05 mg, flavoring Strawberry - 3.50 mg, water purified to 5.0 ml.

Description:Viscous suspension of white or almost white with a characteristic odor.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen, the active ingredient of MIG® for children, has antipyretic, analgesic and anti-inflammatory effects. The mechanism of action of ibuprofen is associated with inhibition of the activity of the enzyme cyclooxygenase (COX) 1 and 2 types, which leads to inhibition of the synthesis of prostaglandins - mediators of pain and inflammation. Ibuprofen reversibly inhibits the aggregation of platelets. Antipyretic effect in febrile states develops 15 minutes after taking the drug.

Pharmacokinetics:

Suction: after oral administration ibuprofen partially absorbed in the stomach and then completely - in the small intestine. Time to reach the maximum concentration (TC_m_Oh) ibuprofen in the blood plasma after a single dose of a single dose of the drug inside is 1-2 hours.

Distribution: communication with blood plasma proteins is about 99%.

Metabolism: after absorption about 60% of pharmacologically inactive Ribuprofen is slowly transformed into an active San isomer in the gastrointestinal tract and liver. Ibuprofen predominantly metabolized in the liver by hydroxylation and carboxylation of the isobutyl group. The metabolites of ibuprofen are pharmacologically inactive.

Excretion: has a two-phase kinetics of elimination. The half-life period (T1 / 2) is 1.8-3.5 hours. It is excreted in the urine (mainly in the form of metabolites) and to a lesser extent with bile.

In the dose range of 200-400 mg, the pharmacokinetics of ibuprofen are linear in nature, at higher doses, non-linear.

Pharmacokinetics in patients with renal insufficiency

In patients with mild renal insufficiency, the concentration of unbound S-ibuprofen, the area under the "concentration-time" curve (AUC) S-ibuprofen and the ratio AUC two enantiomers (S/R) were higher in comparison with those of healthy volunteers.

In patients with terminal stage of renal failure who are on hemodialysis, the average value of the free fraction of ibuprofen was about 3%, and in healthy volunteers - about 1%. With renal insufficiency of severe severity in the body metabolites of ibuprofen may accumulate, but the clinical significance of this fact is not established. Metabolites can be removed by hemodialysis.

Pharmacokinetics in patients with hepatic impairment

In patients with cirrhosis of the liver and moderate liver failure (6-10 on the Child-Pugh scale), T1 / 2 of ibuprofen increased by an average of 2-fold, and the ratio AUC two enantiomers (S/R) was significantly lower than in healthy volunteers, indicating a slowing of the transformation R-ibuprofen into the active (S) -ibuprofen.

Indications:

The drug is intended for short-term symptomatic use in children older than 1 year (with a body weight of more than 10 kg) as:

- antipyretic agents for acute respiratory infections, childhood infections and infectious and inflammatory diseases and other conditions accompanied by increased body temperature;

- Anesthetics with pain syndrome of mild and moderate intensity, including headache, sore throat (tonsillitis and pharyngitis), pain in the ears, toothache, pain in the muscles and joints, with damage to the ligaments, muscles or tendons and other conditions.

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid) and to other components of the drug;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including, in the anamnesis);

- hyperergic reactions (bronchospasm, rhinitis, urticaria, angioedema) associated with the use of acetylsalicylic acid or other NSAIDs, including, in the anamnesis;

- erosive and ulcerative diseases of the gastrointestinal tract (GIT) (including gastric ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcer bleeding in the active phase or in anamnesis (two or more confirmed episodes of peptic ulcer or bleeding);

- gastrointestinal bleeding or perforation, including, in anamnesis, associated with the previous use of NSAIDs;

- cerebrovascular bleeding and other active bleeding;

- confirmed hyperkalemia;

- period after aortocoronary bypass surgery;

- hemophilia and other disorders of blood clotting (including, hypocoagulation, hemorrhagic diathesis);

- liver disease in the active phase;

- hepatic insufficiency of severe severity 10-15 points on the Child-Pugh scale);

- renal failure of severe severity (creatinine clearance <30 mL / min);

- cardiac ischemia;

- severe heart failure;

- bleeding disorders of unclear etiology;

- third trimester of pregnancy;

- hereditary intolerance to fructose;

- age up to 1 year (children under 1 year and children weighing less than 10 kg.)

Carefully:

- Allergic reactions in the anamnesis;

- bronchial asthma;

- simultaneous administration with other NSAIDs or previous long-term use of NSAIDs;

- presence in the anamnesis of a single episode of stomach ulcer or ulcerative bleeding from the gastrointestinal tract;

- gastritis;

- enteritis;

- colitis;

- infection Helicobacter pylori;

- blood diseases of unclear etiology (leukopenia, anemia);

- simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine , paroxetine, sertraline);

- bleeding disorders;

- systemic lupus erythematosus and other systemic connective tissue diseases;

- Conditions accompanied by severe dehydration (risk of kidney damage);

- renal failure of mild and moderate severity (creatinine clearance> 30 ml / min), nephrotic syndrome;

- hepatic insufficiency of mild to moderate severity (less than 10 on the Child-Pugh scale); cirrhosis of the liver with portal hypertension, hyperbilirubinemia;

- cerebrovascular diseases;

- diabetes mellitus, hyperlipidemia;

- diseases of peripheral arteries;

- heart failure, arterial hypertension;

- severe physical illness;

- condition after extensive surgical interventions;

- hereditary impairment of porphyrin metabolism;

- pregnancy (I-II trimester);

- the period of breastfeeding;

- elderly age.

Pregnancy and lactation:

MIG® for children is recommended for use in children.

Before applying the drug in the first and second trimester of pregnancy, it is recommended to consult a doctor. The use of MIG® for children in the third trimester of pregnancy is contraindicated because of the increased risk of complications for the mother and fetus.

Before using MIG® for children during breastfeeding it is recommended to consult a doctor. Ibuprofen penetrates into breast milk in small amounts. There have been no reports of negative consequences for newborn babies with short-term use of ibuprofen in lactating women, so there is no need to stop breastfeeding.

There is information about the possible effects of drugs that inhibit COX / prostaglandin synthesis on ovulation, which can adversely affect reproductive function in women. These effects are reversible and pass after drug withdrawal.

Dosing and Administration:

For oral administration.

The dose depends on the body weight and age of the child and averages 7-10 mg / kg of the child's body weight.

The maximum daily dose is 30 mg / kg of the child's body weight.

It is not recommended to take the drug again more than 6 hours later. It is not recommended to use a double dose in case of skipping the drug.

MIG® for children should be taken during or after a meal, washed down with water.

The dosage regimen is indicated in the table:

Age	Single dose ml of the drug /	The maximum daily
(Body mass)	mg ibuprofen	dose ml of the drug / mg ibuprofen
1-3 years	2.5 ml	7.5 ml
(10-15 kg)	(100 mg)	(300 mg)
4-5 years	3.75 ml	11.25 ml
(16-19 kg)	(150 mg)	(450 mg)
6-9 years	5 ml	15 ml
(20-29 kg)	(200 mg)	(600 mg)
10-11 years old	5 ml	20 ml
(30-39 kg)	(200 mg)	(800 mg)
12 years and over	5-10 ml	30 ml
(≥ 40 kg)	(200-400 mg)	(1200 mg)

For accurate dosing, it is recommended to use a syringe dispenser on which the fissions in milliliters are plotted (one division corresponds to 0.25 ml).

1. Before use, the contents of the vial should be shaken thoroughly.

2. To open the vial, press the lid and turn it in the direction indicated by the arrows.

3. Insert the syringe into the hole.

4. While holding the syringe in place, turn the bottle upside down and carefully pull the piston to the desired mark.

5.Turn the bottle back to its original position and take out the syringe dispenser, gently rotating it.

6. Place the tip of the syringe in the mouth of the child and slowly press the plunger, gently releasing the slurry.

After use, rinse the syringe with warm water and dry. The duration of application of MIG® for children is:

- no more than 3 days as an antipyretic agent,

- no more than 4 days as an anesthetic.

If pain and fever persists, you should consult your doctor.

The lowest effective dose should be used for the shortest possible period of time.

Use in patients with renal insufficiency

In patients with mild and moderate renal insufficiency, dose adjustment is not required. The use of the drug in patients with severe renal failure is contraindicated.

Use in patients with hepatic impairment

In patients with mild to moderate hepatic insufficiency, dose adjustment is not required. The use of the drug in patients with hepatic insufficiency of severe severity is contraindicated.

Side effects:

The possible side effects are listed below in accordance with the classification of the World Health Organization in descending frequency: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100 ), rarely (≥ 1/1000, <1 / 10.000), very rarely (<1 / 10.000), is unknown (according to available data the frequency can not be established).

The listed list of side effects includes all the side effects that have occurred with the use of ibuprofen including, with its long-term use and use in high doses.

Disorders from the gastrointestinal tract

Often: NSAIDs-gastropathy (heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation), minor gastrointestinal bleeding;

Infrequently: gastric ulcer / duodenal ulcer (peptic ulcer), in some cases with bleeding and perforation; ulceration of the oral mucosa (ulcerative stomatitis), exacerbation of ulcerative colitis or Crohn's disease, gastritis;

Rarely: inflammation of the esophagus (esophagitis) and pancreas (pancreatitis), the formation of cicatricial narrowing in the small and large intestine (intestinal stricture).

Disturbances from the liver and bile ducts

Rarely: violations of liver function (with prolonged use), acute liver failure, acute inflammation of the liver (hepatitis).

Disorders from the cardiovascular system

Rarely: heart palpitations, heart failure, myocardial infarction, increased blood pressure.

Frequency unknown: with prolonged use increased risk of thrombotic complications, edema.

Violations of the blood and lymphatic system

Rarely: anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis; The first signs of development of these conditions can be fever, sore throat, erosion of the oral mucosa, influenza-like symptoms, increased fatigue, nosebleeds, skin hemorrhages. In case of such symptoms, stop taking the drug immediately and seek medical attention, and refrain from taking painkillers or antipyretics yourself.

Disturbances from the respiratory system of the chest and mediastinal organs

Rarely: exacerbation of bronchial asthma, bronchospasm, shortness of breath, dry wheezes.

Disturbances from the nervous system

Infrequently: headache, dizziness, insomnia, increased excitability, irritability, increased fatigue.

Hearing disorders and labyrinthine disorders

Rarely: noise in ears.

Disturbances on the part of the organ of sight

Infrequently: impaired vision.

Disorders from the kidneys and urinary tract

Rarely: damage to the renal tissue (necrosis of the renal papillae) and an increase in the concentration of uric acid in the blood plasma;

Rarely: edema (mainly in patients with arterial hypertension or with renal dysfunction), nephrotic syndrome, interstitial nephritis, acute renal failure.

Disturbances from the skin and subcutaneous tissues

Infrequently: skin rash;

Rarely: severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome));

In very rare cases Possible severe infections of the skin and soft tissues during chicken pox.

Immune system disorders

Infrequently: hypersensitivity reactions with skin rash and skin pruritus, attacks of bronchial asthma (in some cases accompanied by a marked decrease in blood pressure);

Rarely: severe general hypersensitivity reactions (angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm).

Disorders of the psyche

Rarely: psychotic reactions, depression.

Other

Rarely: exacerbation of infectious and inflammatory processes associated with the systemic use of NSAIDs; symptoms of aseptic meningitis - severe headache, nausea, vomiting, fever, neck stiffness of muscles, loss of consciousness (increased risk in patients with autoimmune diseases - systemic lupus erythematosus, mixed collagenosis).

Laboratory indicators

Frequency unknown: decrease in the level of hematocrit or hemoglobin; increased bleeding time; decrease in the concentration of glucose in the blood plasma; a decrease in the clearance of creatinine; increased plasma concentration of creatinine; increased activity of "liver" transaminases.

If any side effects occur, discontinue use and consult a doctor.

Overdose:

Symptoms: headache, dizziness, confusion and loss of consciousness (myoclonic cramps in children), abdominal pain, nausea, vomiting,decrease in blood pressure, dyspnea, cyanosis. There may be gastrointestinal bleeding and impaired liver and kidney function.

Treatment: gastric lavage (effective only within one hour after taking the drug), the use of adsorbents, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base balance, blood pressure). There is no specific antidote.

Interaction:

Simultaneous application with other NSAIDs, including acetylsalicylic acid, may increase the risk of gastrointestinal ulcers and bleeding. In this regard, the simultaneous use of drugs ibuprofen with other NSAIDs is not recommended.

Ibuprofen increases concentration digoxin, phenytoin and lithium preparations in the blood plasma, which can lead to an increase in their toxicity.

Ibuprofen may weaken the action diuretics and other antihypertensive drugs. Ibuprofen weakens the effect angiotensin-converting enzyme inhibitors, beta-blockers and angiotensin II receptor antagonists, there may be an increased risk of developing functional renal impairment.In case of simultaneous use, patients should receive a sufficient amount of fluid, and renal function should be carefully monitored.

It is not recommended to use the potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations because of the risk of developing hyperkalemia.

Glucocorticosteroids, platelet aggregation inhibitors and selective serotonin reuptake inhibitors while simultaneous use with ibuprofen increases the risk of gastrointestinal ulcers and / or bleeding. Experimental data show that the simultaneous use of ibuprofen can inhibit the effect of small doses acetylsalicylic acid on aggregation of platelets.

The use of ibuprofen for 24 hours before or after administration methotrexate can lead to an increase in the concentration of methotrexate in the blood plasma and increase its toxic effect.

Cyclosporin increases the nephrotoxicity of ibuprofen.

Ibuprofen, like other NSAIDs, intensifies the action indirect anticoagulants (eg, warfarin).

There are clinical data on the interaction of NSAIDs and some hypoglycemic agents for oral administration (eg, derivatives of sulfonylureas). Because of insufficient data on the interaction of ibuprofen and sulfonylureas, when the simultaneous application is recommended more careful control of plasma glucose concentration.

When used simultaneously with tacrolimus the risk of nephrotoxicity increases. There is an increased risk of hemarthrosis and hematoma in HIV-positive patients who are simultaneously taking zidovudine and ibuprofen.

Probenecid or sulfinpyrazone can increase the half-life of ibuprofen from the body.

With the simultaneous use of NSAIDs with quinolone antibiotics may increase the risk of seizures.

The use of ibuprofen should be started no earlier than 8-12 days after admission mifepristone, because NSAIDs may reduce effectiveness mifepristone.

With the simultaneous use of ibuprofen and inhibitors of isoenzyme CYP2C9 (voriconazole and fluconazole) it is possible to increase the action of ibuprofen, which may require a reduction in its dose.

Special instructions:

It is not recommended simultaneous use of MIG® for children with other NSAIDs, including selective blockers of COX-2.

The risk of side effects can be minimized by applying the lowest effective dose for the shortest period of time.

During the administration of any drug from the NSAID group, cases of bleeding from the gastrointestinal tract, ulcerative lesions or perforations with a lethal outcome were noted, regardless of the presence or absence of previous symptoms or the presence of serious gastrointestinal diseases in the patient's history.

Patients should be informed of the need to immediately notify the physician of all symptoms (especially bleeding from the gastrointestinal tract) that appear against the background of the drug. In case of vomiting with blood, blood in the feces or tarry stools, it is necessary to stop using the drug and immediately seek medical help.

Caution should be exercised while using ibuprofen with drugs that increase the risk of complications from the gastrointestinal tract (including bleeding), such as glucocorticosteroids or anticoagulants and antiaggregants (warfarin, acetylsalicylic acid) (see section Interaction with other drugs). To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be administered within the shortest possible time.

To prevent the development of NSAID-gastropathy, simultaneous use with prostaglandin E preparations (for example, misoprostol).

In the case of prolonged use of ibuprofen, monitoring of peripheral blood and functional status of the liver and kidneys is necessary.

When symptoms of gastropathy appear, a thorough examination including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, and fecal occult blood test are shown.

Prior to use in patients with hypertension and / or heart failure, care should be taken and consult with a doctor, as in this category of patients the use of NSAIDs can lead to fluid retention, the appearance of edema and increased blood pressure.

Long-term use of any painkillers for the relief of headaches can lead to its aggravation.In a similar situation (or if there is a suspicion of its development), it is necessary to stop using pain medication and seek medical help. Diagnosis of headache associated with excessive use of pain medication, should be suspected in patients suffering from frequent or daily headache, despite / or due to the regular intake of painkillers.

Frequent was incorporated into the habit of use of analgesics (particularly combinations thereof) can lead to kidney damage with the risk of developing renal failure (analgesic nephropathy).

There is evidence of the rare cases of severe skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) when used NSAIDs. When the first signs of skin rash, mucosal lesions or other signs of allergic reaction to the use of the drug MIG® for children should be stopped immediately.

In very rare cases, severe skin infections of soft tissues and complications during infection of chicken pox are possible. The use of MIG® for children with chicken pox should be avoided.

Like other NSAIDs, ibuprofen can reduce the diagnostic significance of such symptoms as fever and inflammation, and thus influence the diagnosis of the disease. In patients with allergic diseases and / or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions with ibuprofen. Allergic reactions can manifest as asthma attacks, Quincke's edema or urticaria. In very rare cases, severe hypersensitivity reactions were observed (for example, anaphylactic shock). In cases of the first signs of a hypersensitivity reaction, the use of MIG® for children should be discontinued and consult a doctor.

Caution should be exercised when using MIG® for children in patients with bleeding disorders. ibuprofen suppresses platelet aggregation. If it is necessary to determine the concentration of 17-ketosteroid in the blood plasma, the drug should be discontinued 48 hours before the test.

During the period of treatment is not recommended the reception of alcoholic beverages.

MIG® for children contains maltitol, therefore its use in patients with hereditary intolerance to fructose is contraindicated.

MIG® for children can be used in children with diabetes mellitus because the drug does not contain glucose.

Does not contain dyes.

This preparation contains sodium in the amount of 3.7 mg / ml, which should be taken into account for patients who are on a diet with a restriction of consumption of edible salt.

Effect on the ability to drive transp. cf. and fur:

Ibuprofen in high doses can cause drowsiness and dizziness, which in some cases may lead to a slow reaction, so care must be taken when driving vehicles and other mechanisms, engaging in potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.

Form release / dosage:

Suspension for oral administration, 200 mg / 5 ml.

Packaging:

To 100 ml in bottles of brown color from polyethylene terephthalate with a screw cap with the system of control of the first opening and with protection against opening by children.

For 1 bottle complete with a syringe-dispenser and instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

After the first opening of the vial, the drug should be used within 6 months.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004238

Date of registration:12.04.2017

Expiration Date:12.04.2022

The owner of the registration certificate:Berlin-Chemie, AGBerlin-Chemie, AG Germany

Manufacturer: & nbsp

FARMASIERRA MANUFACTURING, S.L. Spain

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp08.06.2017

Illustrated instructions

Instructions

MIG® for children (MIG® for children)