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MIG Junior 40 mg. / ml. 100 ml.

Product Code: MIG Junior 40 mg. / ml. 100 ml.
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What is a MIG junior and what it is used for

MIG junior is a medicine that reduces pain and high temperature (non-steroidal anti-inflammatory, NSAID).

MIG junior is used for short-term symptomatic treatment of:

mild to moderately severe pain;
fever.
The MIG junior is used in children weighing over 10 kg (aged 1 year), adolescents and adults.

2. What you need to know before using a MIG junior

Do not use MIG junior:

if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
a history of bronchospasm, asthma attacks, nasal mucosal edema (rhinitis), angioedema or skin reactions (urticaria) following administration of acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs;
in case of unclear hemorrhage disorders;
a history of gastrointestinal haemorrhage or perforation associated with pre-existing NSAIDs;
an active or history of recurrent gastric / duodenal ulceration (peptic ulcers) or bleeding (two or more separate episodes of proven ulceration or haemorrhage);
cerebrovascular haemorrhage or other active bleeding;
severe hepatic or renal impairment or severe heart failure;
in severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
in the last three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before using a MIG® junior
Adverse reactions can be minimized if the lowest effective dose is used for symptom control in the shortest time.

Safety with respect to the gastrointestinal tract
The co-administration of MIG® juniper with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), should be avoided.

Elderly:
Elderly patients experience an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which may be fatal.

Gastrointestinal haemorrhage, ulceration and perforation:
Gastrointestinal haemorrhage, ulceration or perforation, which may be fatal, have 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 developing gastrointestinal haemorrhage, ulcers or perforation is higher with increasing NSAID doses and is higher in patients with a history of ulcer, especially if complicated by bleeding or perforation (see section 2: Do not use MIG® junior) and in the elderly. These patients should start treatment with the lowest possible dose.
For these patients as well as for patients requiring additional treatment with low-dose acetylsalicylic acid (ASA) or other active substances that may increase the risk of gastrointestinal disorders, combination therapy with protective agents (eg misoprostol or proton pump inhibitors).

If you have previously experienced gastrointestinal adverse reactions, especially if you are elderly, you should report any abnormal abdominal symptoms (especially gastrointestinal haemorrhage), especially in the early stages of treatment.

Caution should be exercised if you are using medicines that may increase the risk of ulcer or bleeding, oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (used to treat disorders such as depression) or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2. "Other medicines and MIG Junior").

If gastrointestinal haemorrhage or ulcer occurs during treatment with the MIG  junier, treatment should be stopped and medical advice sought.

NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may exacerbate (see section 4).

Effects on the cardiovascular and cerebrovascular system
Antiinflammatory / analgesic medicines such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially if used in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before moving on to a MIG junior if:

have heart problems, including heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor blood supply to the feet or legs due to narrowing or blockage of arteries) or any type of stroke & Quot; micro stroke & quot; or transient ischemic attack & quot; TIA & quot;);
have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Skin reactions
Very rarely when treated with
Especially careful follow-up by a physician is required:

in renal function impairment;
when liver function is impaired;
in dehydration;
immediately after serious surgical interventions;
(such as skin reactions to other medicines, asthma, hay fever), chronic nose mucosal edema, or chronic obstructive airway disease - you will be at a higher risk of hypersensitivity reactions.
Severe acute hypersensitivity reactions (eg anaphylactic shock) are very rare. At the first signs of a severe hypersensitivity reaction after receiving a MIG  junior, treatment should be discontinued. According to the symptoms, medical measures should be taken by specialized personnel.

Ibuprofen, the active ingredient of a MIG  juniper, may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with blood clotting disorders should be closely monitored.

Prolonged use of the MIG  junner requires regular monitoring of liver enzymes, renal function and blood count.

While you are taking a MIG junior, you should consult with your doctor or dentist before undergoing any surgical procedures.

If you are already taking other painkillers or medicines to lower your temperature or antibiotics, you can take a MIG  junior only at the advice of the treating physician.
If you suffer from a serious illness and / or regularly take medicines, you should consult your doctor before using a MIG junior.

Prolonged use of any type of painkiller for headaches can cause it to worsen. If this occurs or is suspected, a doctor should be consulted and discontinued. Diagnosis of headache due to drug overdose should be considered in patients who often have or have headaches, despite (or due to) regular use of headache medications.

In general, regular use of painkillers, especially a combination of several painkillers, may result in irreversible renal impairment at the risk of renal failure (analgesic nephropathy).

NSAIDs, such as ibuprofen, can mask the symptoms of infection or fever.

Children and adolescents
MIG junior is not recommended for use in children under 1 year of age or less than 10 kg body weight.

There is a risk of kidney damage in dehydrated children and adolescents.

Other medicines and MIG junior
Tell your doctor or pharmacist if you or the child to be treated are taking or have recently taken or might take any other medicines.

A MIG junior may affect or be affected by some other medicines. For example:

medicines that are anticoagulants (ie that dilute blood / prevent blood clots), for example aspirin / acetylsalicylic acid, warfarin, ticlopidine);
medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
Some other medicines can also affect or be affected by treatment with a MIG juniper. Therefore, always consult your doctor or pharmacist before using MIG junior with other medicines.

The use of a MIG  junier with digoxin (used to reinforce the heart), phenytoin (used to treat seizures) or lithium (used to treat certain psychiatric disorders) may increase the concentration of these medicines in the blood. In general, monitoring of serum levels of lithium, digoxin and phenytoin is not required if the drug is used as directed (maximum 4 days).

MIG  junior may weaken the action of drainage tablets (diuretics) and high blood pressure medications (antihypertensive agents) and there may be an increased risk for the kidneys.

A MIG  junior may weaken the action of ACE inhibitors (used to treat heart failure and high blood pressure). In addition, if used at the same time, there is an increased risk of a renal function disorder.

The combined use of MIG juniper and potassium-sparing diuretics (a type of drainage tablet) may lead to an increase in blood potassium levels.

The risk of gastrointestinal ulcers or haemorrhage increases when a MIG juniper is co-administered with glucocorticoids or other anti-inflammatory and analgesic agents from the NSAID group.

Acids that are inhibitors of platelet aggregation and certain antidepressants (selective serotonin reuptake inhibitors / SSRIs) may increase the risk of gastrointestinal haemorrhage.

Administration of a MIG juniper 24 hours before or after a methotrexate dose may result in higher concentrations of methotrexate and the potentiation of its adverse effects.

The probability of cyclospor
Driving and using machines
When administering a MIG  junier, side effects such as tiredness and dizziness may occur. As a result, in some cases, the ability to react and the ability to actively participate in street traffic can also be affected, machine operation may also be impaired. This is especially true when interacting with alcohol. Then you may not be able to react quickly and purposefully to unexpected and sudden incidents. If this happens, do not drive cars and other vehicles. Do not operate machinery or do any dangerous tasks.

MIG junior contains sodium
The highest single dose of this medicinal product, amounting to 10 ml, contains 2.5 mmol (57.9 mg) of sodium. To be taken into consideration in patients on a controlled sodium diet.

The MIG junior contains liquid maltitol
This medicine contains liquid maltitol. If your doctor has told you that your child has an intolerance to some sugars, contact your doctor before using this medicine.

3. How to use a MIG junior

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of MIG junior is:

Body weight (age) Single dose Maximum daily dose
10 kg - 15 kg (children 1 to 3 years old) 100 mg ibuprofen (equivalent to 2.5 ml suspension) 300 mg ibuprofen (equivalent to 7.5 ml suspension)
16 kg - 19 kg (children 4 to 5 years) 150 mg ibuprofen (equivalent to 3.75 ml suspension) 450 mg ibuprofen (equivalent to 11.25 ml of suspension)
20 kg - 29 kg (children 6 to 9 years) 200 mg ibuprofen (equivalent to 5 ml suspension) 600 mg ibuprofen (equivalent to 15 ml suspension)
30 kg-39 kg (children 10 to 11 years) 200 mg ibuprofen (equivalent to 5 ml suspension) 800 mg ibuprofen (equivalent to 20 ml suspension)
> 40 kg (adolescents> 12 years and adults) 200-400 mg ibuprofen (equivalent to 5 - 10 ml suspension) 1200 mg ibuprofen (equivalent to 30 ml of suspension)
In children and adolescents, the MIG junior is dosed according to body weight, generally from 7 to 10 mg / kg body weight as a single dose, up to a maximum of 30 mg / kg body weight as a total daily dose.
The interval between the individual receptions should be at least 6 hours.

Do not exceed the recommended dose.

Oral use.
The pack includes a 5 ml oral dosing syringe (graduated at 0.25 ml intervals).
The oral suspension can be taken regardless of nutrition. For patients with sensitive stomach, it is recommended that a MIG junior be taken during meals.

1. Shake the bottle before use.
2. To open the bottle, press the cap down and rotate it in the direction indicated 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 to its original position and carefully gently remove the syringe.
6. To apply the suspension, place the tip of the syringe in 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 parts with warm water and let them dry. Keep the syringe in a place that is out of the reach of children.

Ask your doctor or pharmacist if you feel that the effect of a MIG® juniper is too strong or too weak.

Duration of use
For short-term use only.

If the use of this medicine is required in children and adolescents for more than 3 days, or if the symptoms get worse, a doctor should be taken.
If your adult symptoms get worse or you need to use this medicine for more than 3 days in case of high fever or for more than 4 days to treat pain, a doctor should be taken.

If you have used more than the required dose of MIG junior
Stop taking ibuprofen and consult a doctor if you experience any symptoms of overdose such as headache, dizziness, vertigo, unconsciousness (also seizures in children), abdominal pain, nausea and vomiting, gastrointestinal haemorrhage, impaired function of liver or kidney, blood pressure drop, respiratory depression (respiratory depression) or cyanosis (bluish skin or lip color).

If you forget to use a MIG junior
Do not use a double dose to make up for the 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, this medicine can cause side effects, although not everyone gets them.

The list of side effects listed below covers all side effects that are known to date for ibuprofen,
How to store a MIG junior

Keep out of reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. After first opening, the product should be stored below 30 ° C.

After opening, the drug is stable for 6 months.

Do not dispose of medicines in the sewers. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What MIG Junior contains

The active substance is ibuprofen. 1 ml oral suspension contains 40 mg of ibuprofen.
The other ingredients are: sodium benzoate (E211), citric acid anhydrous, sodium citrate, saccharin sodium, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E422), thaumatin (E957) , triethyl citrate (E-1505), propylene glycol (E-1520) and benzyl alcohol), purified water.
What MIG junior looks like and what the package contains
MIG juniper oral suspension is a white or off-white viscous suspension.

MIG junior 40 mg / ml oral suspension is available in 30 ml, 100 ml, 150 ml, and 200 ml plastic bottles with child-resistant caps.

Not all pack sizes may be marketed.

For correct dosing and a polypropylene dosing syringe, graduated from 0.25ml to 5ml, is included in the pack.

 

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