Magnilek

Magnetec - a preparation of gadopentetova acid, used in the conduct of magnetic resonance imaging (MRI).

[1]

Indications Magnilek

Magnilek solution is used for magnetic resonance therapy (MRI) of the brain and spinal cord:

• In order to identify and differential diagnosis of meningiomas, neurion (and auditory nerve inclusive), invasive tumors (eg gliomas), metastases.
• To detect small tumors and tumors that are difficult to visualize.
• In differential diagnosis of the following types of tumors: hemangioblast, ependiomas, small adenomas of the pituitary gland.
• To determine the intracranial spread of primary (non-cerebral tumors).
• Diagnosis of tumor recurrence after surgery or radiotherapy.  

Magnilek solution is used for spinal magnetic resonance imaging (MRI) for differential diagnosis and evaluation of the spread of intramedullary and extramedullary tumors.

With magnetic resonance imaging (MRI) of the whole body, the drug is used:

• When the facial part of the skull is examined, the neck zone, thoracic and abdominal cavity, mammary glands, pelvic organs, musculoskeletal system, whole-body vessels (for evaluation of blood supply in normal tissues and tissues with pathological changes, in detecting tumor processes, inflammation, vascular injury ).
• In differential diagnosis of tumors and scar tissue.
• Diagnosis of recurrence of a herniated intervertebral disc after an operative intervention.
• With a simultaneous semiquantitative evaluation of renal function with zonal anatomical diagnosis.

[2], [3], [4]

Release form

The medicine is issued in the form of a transparent, unpainted solution or a solution of pale yellow color.

Composition:

• The active component of the solution is gadopentetic acid.
• One ml of the solution contains 469.01 mg of gadopentetic acid in the form of a dimeglumine salt.
• Ancillary is water for injection.  

  The form of the drug Magnilek is as follows:

1. Solution for injection 469.01 mg / ml, 10 ml bottle, No. 1.
2. Solution for injection 469.01 mg / ml, bottle 20 ml, No. 1.
    

[5], [6], [7], [8]

Pharmacodynamics

Pharmacodynamics of the drug Magnilek is as follows:

• Gadopentetat is a compound of gadolinium and pentetic acid, which has seven unpaired electrons, which determine its paramagnetic properties.
• The dimiglumin salt of gadopentetic acid is a stable chelate complex, which has an increased hydrophilicity and a powerful paramagnetic properties.
• The chelate complex is not toxic. The organic component of the complex is not assimilated by the body, and the metal does not dissociate.
• After intravenous administration, the dimeglumic salt of gadopentetic acid decomposes and forms meglumine and gadopetate ions.
• The hydrophilic chelate compound extends exclusively into the extracellular fluid and does not enter the intact hemato-encephalic barrier. Therefore, the connection is not capable of accumulating brain cells with normal functioning or in cells, with a difference from normal functioning, but with an intact hemato-encephalic barrier.
• Violation of the hemato-encephalic barrier or vascularization of tissues stimulates the accumulation of the dimeglumic salt of gadopentetic acid in the following tissues - in tumors, in abscesses, in the subacute period of myocardial infarction.

[9], [10], [11], [12], [13], [14]

Pharmacokinetics

The pharmacokinetics of Magnetec are as follows:

• In healthy patients, the pharmacokinetic profile of the injected drug is equal to the open two-phase model with an average half-distribution period of about 0.2 hours and an average T 1/2 of about an hour and a half.
• About eighty percent of the received amount of the drug is excreted in the urine within six hours after administration; about 93 percent solution - within 24 hours; with feces it is deduced less than 0,1 percent within five days.
•  
• Gadopentetova acid in small amounts (about 0.04 percent of the total amount of medication administered) penetrates into breast milk.

Association, transformation and disintegration of gadopentetic acid is not revealed.

[15], [16], [17], [18], [19], [20]

Dosing and administration

The method of application of Magnesium and the dose in which it is prescribed are as follows:

• The patient should refrain from eating two hours before the medication is administered.
• During the injection and for at least half an hour after it, the patient should lie on his back.
• In the whole body and cranial, spinal magnetic resonance imaging, the drug is administered to adults in a dosage of 0.2 ml per kilogram of body weight.
• Children older than two years of age, the drug is prescribed in a dosage of 0.2 ml per kilogram of body weight.
• The drug is used only in a hospital in the implementation and monitoring of the procedure of a specialist doctor. Before the procedure, a standard examination of the patient for lack of pacemakers, ferromagnetic implants and other precautionary procedures is performed.
• The solution is administered only by the intravenous route, preferably into large veins. The rate of magnesium administration is 10 ml per minute. Instead of the intravenous route, a bolus injection can be used, which is administered at a rate of 15 ml per second.
•  The medicine is typed in a syringe just before the introduction. Do not use the solution if it changes color or the transparency disappears with the appearance of impurities. That part of the medicine that has not been used with the injection is recyclable.
• The maximum total dose of the drug is 20 ml.
• After completion of Magnilek's injection, 5 ml of physiological solution is administered intravenously. This measure ensures the full introduction of the required amount of the drug.
• The examination begins immediately after the administration of the solution and ends no more than one hour later. Such terms are due to the fact that with an MRI of the brain, the optimal degree of contrast is recorded 27 minutes after the administration of the drug, and with MRI of the spinal cord - after 10 -30 minutes.

• The most qualitative for contrast studies are pulse sequences with T-weighted images.
• If there were no lesions of the brain and spinal cord during the tomography, but there are suspicions (thanks to the general clinical picture), the diagnostic level of the examination is increased. This occurs by injecting the solution for 30 minutes by re-injecting the drug at a dose that is equal to the previous one. Sometimes, a repeated dose for adult patients can be increased to 0.4 ml per 1 kg of body weight.

• Recurrences of tumors and the exclusion of metastases in adults are investigated by administering a dose of Magnileka in an amount of 0.6 ml per 1 kg of body weight.
• It happens that dimeglumine gadopentetate can help reduce the convulsive threshold in patients prone to it. Therefore, during the procedure, such patients should be under constant monitoring, and if necessary, they are injected with anticonvulsants.
• Patients who have bronchial asthma, allergic reactions and increased sensitivity to contrast agents, prior to the use of the drug, prescribe the administration of antihistamines and / or glucocorticoids.
• Patients who have a sensitivity to the components of the drug known to those skilled in the art can experience severe allergic reactions, including anaphylactic shock. Therefore, it is recommended to carefully monitor the patient during the procedure and always have ready medicines that can stop the symptoms of hypersensitivity.  

[30], [31], [32], [33],

Use Magnilek during pregnancy

The use of Magnolia during pregnancy is not recommended. Because there is no reliable data on the effect of gadopentetic acid on fetal development. It is also unknown how the magnetic and electric fields affect the formation of the fetus. Therefore, during pregnancy Magnilek and the method of examining MRI is not recommended.

During lactation, the drug and the MRI method should be used only for vital signs. Because gadopentetova acid is excreted in breast milk in small doses. Therefore, when taking Magnilek, it is necessary to resolve the issue of interruption of breastfeeding. The shortest period of pause in breastfeeding should be at least 24 hours after the introduction of the medication.
 

Contraindications

Contraindications in the use of Magnetics are available when:

• Hypersensitivity to Magnelic components.
• Severe renal failure (with creatinine clearance less than 20 ml per minute).
• Sickle-cell anemia.
• The age of the children is up to two years (since there is no experience of using the medication for children of this age period).
• Pregnancy.

 With special care, the drug should be applied to patients:

• With various liver diseases and / or manifestations of hemolysis.
• With various disorders of kidney function. In patients with kidney disease, the use of the drug should be carefully weighed against the risk of side effects. Since the use of Magnetics for MRI can cause acute renal failure or impaired renal function.
• With various allergic diseases and bronchial asthma.

[21], [22], [23], [24]

Side effects Magnilek

Adverse Reactions Magnetics for a patient are associated with the action of gadopentetic acid in magnetic resonance imaging. They have transient nature with light or medium severity. Prolonged adverse reactions of the body were recorded in isolated cases.

The list of adverse reactions to the administration of the drug is as follows:

• From the side of the cardiovascular system, there was an appearance - arterial hypotension, tides, vasodilation, pallor of the skin, nonspecific ECG changes, phlebitis, chest pain.
• It is also possible the occurrence of attacks of angina pectoris, arrhythmia, tachycardia.
• From the side of the nervous system, manifestations are possible - headache, drowsiness, dizziness, increased excitability, speech disorders, confusion, hypersthenia, paresthesia, ringing in the ears, tremors, seizures, visual impairment (appearance of visual field defects).
• On the part of the gastrointestinal tract, there may be the appearance of nausea and vomiting, pains and spasms of the stomach and intestines, diarrhea, feelings of thirst, hypersalivation, taste disorders (especially after the bolus injection), pain and paresthesia of the soft tissues of the mouth and toothache.
• On the part of the respiratory system, there may be the occurrence of dryness in the mouth and throat pain, rhinorrhea, pain in the throat and larynx, sneezing and wheezing, laryngospasm, coughing, sniffing or apnea, edema of the larynx and pharynx, bronchial constipation, pulmonary edema, cyanosis.

• From the side of the musculoskeletal system, reactions in the form of pains in the back and extremities, and arthralgia were observed.
• On the part of the skin system and mucous membranes may manifestations - rash and itching, hives, sweating, angioedema.
• The following allergic manifestations were observed: in some cases anaphylactic or anaphylactoid recapitulations of the organism (including the appearance of anaphylactic shock), hyperthermia, hyperhidrosis, fluctuations in body temperature may occur.
• Perhaps the emergence of local reactions of the following nature - at the injection site there is the appearance of sensations of cold or burning, pain, swelling.
• Changes in laboratory indicators - there is an increase in the content of iron in blood plasma and total bilirubin of reversible character, as well as an increase in the level of hepatic enzymes.
• Other reactions - the emergence of general weakness of the body, toothache, increased fatigue, changes in taste (which can quickly disappear).      

 Special comments on side effects:

• If Magnilek is prescribed to patients who have a hypersensitivity to the components of the medicine known to those skilled in the art, the risk ratio to the usefulness of the test procedure should be carefully weighed. Since the use of Magnetics can cause anaphylactic reactions or hypersensitivity reactions. Other reactions of idiosyncrasy may occur, for example, symptoms from the cardiovascular, respiratory and dermal systems up to a severe degree of reaction, including shock. Most of the symptoms appear within half an hour after the introduction of the drug, although sometimes there is a delayed manifestation.
• Patients with cardiovascular diseases may exhibit symptoms of serious and even fatal consequences of hypersensitivity of a severe degree to the drug.
• Patients who suffer from bronchial asthma or allergies, hypersensitivity to contrast agents, are at high risk of developing hypersensitivity symptoms to Magnilec.

The influence of Magnilek on reaction speed and control of vehicles, robots and other mechanisms is as follows:

• Since the introduction of Magnilek solution can provoke individual psychosomatic reactions, patients who underwent a study should temporarily (at least six hours) abstain from driving vehicles or adhere to caution in the management of motor vehicles.
• It is not necessary to engage in processes that require an increased concentration of attention and speed of psychomotor reactions, for at least six hours after the introduction of Magnilec.

[25], [26], [27], [28], [29],

Overdose

• The overdose of Magnolia increases the above-mentioned adverse reactions.
• The hypersmolarity of the drug during an overdose provokes the appearance of osmotic diuresis, increased pressure, the emergence of hypervolemia and dehydration.
• In case of an overdose, a symptomatic treatment is used. Because special antidotes to the drug are not developed. Magnilek can be removed from the patient by hemodialysis. 

[34], [35], [36],

Interactions with other drugs

Interactions of Magnileuc with other drugs are as follows:

• Patients who use beta-blockers, for example, with bronchial asthma, can detect reactions of hypersensitivity to the drug. In this case, tolerance to standard therapy of hypersensitivity reaction by beta antagonists can be recorded.
• To date, no other reactions have been identified with other drugs.
• When interacting with diagnostic tests in determining the amount of iron in the blood plasma with the use of batofenantrolin, the quantitative index can be reduced during one day.  

[37], [38], [39], [40], [41], [42]

Storage conditions

Magnilek storage conditions are as follows:

1. The solution is stored at a temperature of up to 25 degrees Celsius in places protected from penetration of light and secondary X-rays.
2. The drug should not be frozen.
3. Store the solution in a place inaccessible to children.

[43]

Shelf life

Shelf life Magnilek - three years from the date of issue.

[44], [45]