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What is a MIG for children and what it is used for
Children's MIG is an anti-inflammatory and painkiller (NSAID) with temperature-limiting (antipyretic) properties.
The MIG for children is intended for children from 5 kg (6 months) to 29 kg (9 years).
Children's MIG is used for short-term symptomatic treatment of:
mild to moderately severe pain.
2. Before using the MIG for children
Do not apply MIG for children:
in case of allergy (hypersensitivity) to ibuprofen or any of the other ingredients of the MIG for children;
in pre-existing allergic reactions following administration of acetylsalicylic acid or other non-steroidal anti-inflammatory agents, such as:
swelling of the lining of the nose;
skin reactions (eg redness, swelling, urticaria or the like);
in case of unclear hemorrhage disorders;
an active or history of recurrent gastric / duodenal ulceration (peptic ulcers) or bleeding (two or more separate episodes of proven ulceration or haemorrhage);
a history of gastrointestinal haemorrhage or perforation associated with pre-treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
brain haemorrhage (cerebrovascular haemorrhage) or other active bleeding;
in severe renal or hepatic impairment;
in coronary heart disease;
in severe heart failure;
in severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
in the last 3 months of pregnancy.
Pay special attention to the use of MIG for children
Undesirable effects can be minimized if the lowest effective dose is used for symptom control in the shortest possible time.
Safety with respect to the gastrointestinal tract
The concomitant use of MIG for children with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), should be avoided.
Elderly patients experience an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which may be fatal. Therefore, very careful monitoring by a doctor is required in elderly patients.
Gastrointestinal haemorrhage, ulceration or perforation, which may be fatal, has been reported with all NSAIDs at any time of treatment, with or without warning symptoms or severe gastrointestinal incidents in the past.
The risk of gastrointestinal bleeding, ulceration or perforation is higher when increasing NSAID doses in patients who have previously had an ulcer, especially if they have been complicated by haemorrhage or perforation (see section 2 "Do not take LAG for children ") as well as in the elderly. These patients should start treatment with the lowest possible dose.
For these patients as well as for patients requiring concomitant treatment with low-dose acetylsalicylic acid or other active substances that may increase gastrointestinal risk, combined treatment with protective drugs (eg misoprostol or proton pump inhibitors) ).
If your child has had gastrointestinal side effects, you should report any abnormal abdominal symptoms (especially gastrointestinal haemorrhage), especially in the early stages of treatment.
Care should be taken if your child is taking concomitant medications that may increase the risk of ulcer or haemorrhage, oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors that are used together with other medicines to treat depressive conditions or antiplatelet medicines such as acetylsalicylic acid (see section 2, "Taking other medicines").
If your child develops bleeding or stomach or intestinal ulcer during treatment, stop using the LAG for children. Tell your doctor immediately if your child has abnormal abdominal symptoms.
NSAIDs should be used with caution in patients who have had gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4: Possible side effects).
Effects on the cardiovascular and cerebrovascular system
Medicines such as children's MIG may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely at high doses and prolonged use. Do not exceed the recommended dose and duration of treatment (maximum 3 days).
If your child has heart problems with stroke, or if you think you are at an increased risk for these conditions (eg if you have high blood pressure, diabetes or high cholesterol), you should see your doctor or your doctor. pharmacist.
Very rarely, severe skin reactions with blistering and blistering have been reported with regard to NSAID administration, some of them fatal (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome) (see section 4 , "Possible Side Effects").
The risk of these reactions occurring in patients is highest early in the course of treatment: the onset of the reaction is usually in the first month of treatment.
The MIG for children should be stopped and a doctor should be consulted at the first appearance of a skin rash, mucosal irritation or other signs of hypersensitivity.
It is recommended to avoid the use of MIG for children during chickenpox.
The MIG for children should only be used in a rigorous benefit / risk assessment if your child:
has some autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease);
there is an increased risk of developing symptoms of noninfectious brain inflammation (aseptic meningitis) (see section 4 "Possible side effects");
there are some hereditary hemorrhagic disorders (eg acute intermittent porphyria).
Especially careful follow-up by a physician is required:
with impaired renal or hepatic function;
immediately after surgical interventions;
allergies (e.g., skin reactions to other medicines, asthma, urticaria), chronic nasal mucosal edema, or chronic respiratory disorders that narrow the airways;
in dehydration (dehydration).
Severe acute hypersensitivity reactions (eg anaphylactic shock) are very rare. At the first sign of a severe hypersensitivity reaction after taking a MIG for children, you should stop taking it immediately and consult a doctor.
Ibuprofen, the active substance of the MIG for children, may temporarily inhibit blood clotting (platelet aggregation) function. Therefore, patients with blood clotting disorders should be closely monitored.
Long-term use of the MIG for children requires regular monitoring of liver function, renal function, and blood count.
You should consult or inform your doctor or dentist if a child's LLG is administered before a surgical procedure.
With prolonged use of painkillers, a headache may occur which should not be treated with higher doses of the drug. Ask your doctor if, despite the use of the MIG for children, your child regularly suffers from a headache.
In general, regular use of painkillers, especially a combination of several painkillers, may result in irreversible renal impairment with a risk of renal failure (analgesic nephropathy).
NSAIDs, such as ibuprofen, can mask the symptoms of infection or fever.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines that are anticoagulants (eg acetylsalicylic acid / aspirin, warfarin, ticlopidine), some medicines to treat high blood pressure (ACE inhibitors such as captopril, beta-receptor blockers, angiotensin II antagonists) and even some other medicines may affect or be affected by treatment with ibuprofen. Therefore, always consult a doctor before administering ibuprofen with other medicines.
The effect of the active substances or medicinal products listed below may be affected by co-administration of the LAG for children.
Effect Strengthening and / or Adverse Effects
If the following drugs are administered at the same time, their blood concentration may increase:
digoxin (a medicine for boosting the pumping function of the heart);
phenytoin (a medicine to treat seizures);
lithium (a medicine for the treatment of mental illness).
In general, the serum levels of lithium, digoxin and phenytoin are not required if the LLG for children is used correctly (for a maximum of 3 days):
anti-coagulants such as warfarin;
methotrexate (a medicine used to treat cancer or some rheumatic diseases). Do not take MIG for children 24 hours before and after administration of methotrexate. This may lead to an increase in blood methotrexate concentration and an increase in its undesirable effects;
acetylsalicylic acid and other anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs) as well as glucocorticosteroids (medicines containing cortisone or cortisone-like active substances): there is an increased risk of ulcers and bleeding from the gastrointestinal tract;
antiplatelet drugs and selective serotonin reuptake inhibitors (medicines to treat depressed mood): there is an increased risk of bleeding from the gastrointestinal tract;
medicines containing probenecid or sulphinpyrazone (medicines to treat gout). This may delay the broadcasting
How to Use Child MIG
Always apply a MIG for children exactly as directed in this leaflet. If you are not sure, ask your doctor or pharmacist.
The usual dose is:
Body weight (age) Single dose Maximum daily dose
5 - 6 kg (infants 6 to 8 months) 50 mg (equivalent to 2.5 ml suspension) 150 mg (equivalent to 7.5 ml suspension daily)
7 to 9 kg (infants 9-12 months) 50 mg (equivalent to 2.5 ml suspension) 200 mg (equivalent to 10 ml suspension daily)
10-15 kg (children 1 to 3 years) 100 mg (equivalent to 5 ml of suspension) 300 mg (equivalent to 15 ml suspension daily)
16-20 kg (children 4 to 6 years) 150 mg (equivalent to 7.5 ml suspension) 450 mg (equivalent to 22.5 ml suspension daily)
21 - 29 kg (children 7 to 9 years) 200 mg (equivalent to 10 ml of suspension) 600 mg (equivalent to 30 ml suspension daily)
The interval between applications must be at least 6 hours.
Do not exceed the recommended dose or duration of treatment (maximum 3 days).
Impaired renal or hepatic function: no dose reduction is required for mild to moderate impaired renal or hepatic function.
Children's MIG is not recommended for use in children under 6 months of age or less than 5 kg.
Method and route of administration
For oral use in children.
For accurate dosing, a dispensing syringe for oral administration (scored at intervals of one and half milliliters up to 5 ml) was given in the package.
1. Shake the bottle before use.
2. To open the bottle, push down the cap and rotate it in the direction shown by the arrows.
3. Place the metering syringe into the opening of the bottle.
4. Turn the bottle down while holding the syringe and gently pull the plunger to the appropriate measuring mark.
5. Straighten the bottle in its original position and gently rotate the syringe.
6. To apply the suspension, put the tip of the syringe into the child's mouth and slowly push the plunger down. Please take into account the swiftness of application with the swallowing of the child.
After use, close the bottle with the cap. Remove the plunger from the syringe, rinse both with warm water and allow them to dry. Keep the syringe in a place that is out of the reach of children.
In a small number of patients, mild digestive disorders may occur with the use of MIG for children. If this happens to your child, it may be helpful to use the drug while eating.
Please consult your doctor if you feel that the effect of the MIG on children is too strong or too weak.
Duration of use
For short-term use only.
If symptoms get worse or persist for more than 3 days, you should consult a doctor. Do not apply MIG for children longer than 3 days without consulting a doctor or dentist.
If you have used more than the required dose of MIG for children
Apply a MIG for children as directed by your doctor or as directed in this leaflet. If you think that your child is not relieved of pain, DO NOT increase your dose alone, but consult a doctor.
Possible symptoms of overdose are:
central nervous system disorders such as headache, vertigo, dizziness and loss of consciousness (and children and seizures);
gastrointestinal disorders such as stomach pain, nausea and vomiting, haemorrhage of the gastrointestinal tract;
impaired hepatic or renal function;
decrease in blood pressure;
weak breathing (respiratory depression);
bluish-reddish coloration of the skin and mucous membranes (cyanosis).
There is no specific antidote.
If you suspect overdose with a child MIG , immediately inform a doctor! Depending on the severity of the intoxication, the physician will consider what measures may be needed.
If you forget to accept a children's MIG
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist!
4. Possible side effects
Like all medicines, MIG for children can cause side effects, although not everybody gets them. If you notice any of the following side effects in your child, talk to your doctor who will decide what measures to take.
STOP ADMINISTERING this medicine and seek medical attention immediately if your child appears:
Signs of intestinal bleeding, such as: Relatively severe abdominal pain, wheezy stools, vomiting of blood or dark particles similar to coffee beans;
Signs of rare but severe allergic reactions such as asthma, unexplained whistling or shortness of breath, swelling of the face, tongue or throat, difficulty in breathing, rapid heartbeat, drop in blood pressure, which can lead to shock. This can occur even with the first use of these medicines. If any of these symptoms occur, immediately call a doctor;
Severe skin reactions, such as whole body rashes, peeling,
Blood and lymphatic system: disorders of blood formation (anemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis).
The first scars may be fever, sore throat, mouth sores, flu-like complaints, severe weakness, nose and skin bleeding.
In these cases, the medicine should be stopped immediately and a doctor should be taken.
No self-medication with painkillers and low-temperature medicines should be given.
Immune system: severe generalized allergic reactions
They can manifest as facial fluid (edema), swelling of the tongue, laryngeal edema with narrowing of the airways, shortness of breath, rapid heartbeat, drop in blood pressure to life-threatening shock. If any of these symptoms occur, which may occur even on first administration, immediate medical attention is required.
Psychiatric disorders: psychotic reactions, depression.
Heart and vessels: palpitations, heart failure, heart attack (myocardial infarction), high blood pressure (arterial hypertension).
Respiratory, thoracic and mediastinal disorders: asthma, bronchospasm, shortness of breath and whistling.
Stomach and digestive system: inflammation of the esophagus and pancreas, formation of membranous narrowing of the small intestine and the colon (bowel-like diaphragm, narrowing).
Liver and gallbladder: liver function abnormalities, hepatic impairment, especially in prolonged treatment, hepatic failure, acute hepatic inflammation (hepatitis).
Prolonged use should closely monitor the liver function parameters.
Skin and hair: severe skin reactions such as skin rash with redness and blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis / Lyell syndrome), hair loss (alopecia).
Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox (see also "Infections and parasitoses").
Kidney and urinary tract: decreased urine output and increased fluid retention in the tissues (swelling), especially in patients with high blood pressure or impaired renal function, nephrotic syndrome (water retention in the body [edema] and increased protein secretion with urinary incontinence), inflammation of the kidneys (interstitial nephritis), which may be accompanied by severely impaired renal function.
Reduced urine output, water retention in the body (edema), and a feeling of general malaise may be a sign of kidney failure to kidney failure.
If the symptoms listed appear or worsen, you should stop using the MIG for children and immediately visit a doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store a MIG for children
Keep out of the reach of children!
Do not use MIG for children after the expiry date which is stated on the bottle and on the carton after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening: 6 months when stored below 25 ° C.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. Additional information
What contains a MIG for children
The active substance is ibuprofen.
1 ml of suspension contains 20 mg of ibuprofen.
The other ingredients are:
Sodium benzoate; citric acid, anhydrous; sodium citrate; saccharin sodium; sodium chloride; hypromellose; xanthan gum; liquid maltitol; glycerol; Purified water; aroma strawberry (contains substances identical to natural flavors, natural aromatic ingredients, propylene glycol).
What the MIG looks like for children and what the package contains
The MIG for children is a white to geranium-like oral suspension.
The MIG for children is in bottles of 100 ml or 200 ml of oral suspension.
A dosing syringe for oral administration, scored at intervals of half a milliliter to 5 ml, was administered.
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