Universal reference book for medicines
Product name: MAGNEVIST ® (MAGNEVIST ® )

Active substance: gadopentetic acid

Type: Contrast diagnostic drug for magnetic resonance imaging

Manufacturer: BAYER PHARMA (Germany)
Composition, form of production and packaging
The solution for intravenous administration is
clear, colorless or almost colorless.

1 ml

gadopentate dimeglumin 469.01 mg (0.5 mmol)

osmolality at 37 ° C - 1.96 Osm / kg H 2 O Viscosity at 20 ° C - 4.9 mPa? s, at 37 ° C - 2.9 mPa? s Density at 20 ° C - 1.21 g / ml, at 37 ° C - 1.195 g / ml pH 7.0-7.9

Excipients: meglumine (corresponding to 196.21 mg of total meglumine) - 0.99 mg, pentetic acid (DTTP) - 0.4 mg, water q / and - 738.5 mg.

5 ml - bottles of glass (1) - packs of cardboard.

5 ml - bottles of glass (5) - packs of cardboard.

5 ml - bottles of glass (10) - packs of cardboard.

10 ml - bottles of glass (1) - packs of cardboard.

10 ml - bottles of glass (5) - packs of cardboard.

10 ml - bottles of glass (10) - packs of cardboard.

15 ml - bottles of glass (1) - packs of cardboard.

15 ml - bottles of glass (5) - packs of cardboard.

15 ml - bottles of glass (10) - packs of cardboard.

20 ml - bottles of glass (1) - packs of cardboard.

20 ml - bottles of glass (5) - packs of cardboard.

20 ml - bottles of glass (10) - packs of cardboard.

30 ml - bottles of glass (1) - packs of cardboard.

30 ml - bottles of glass (5) - packs of cardboard.

30 ml - bottles of glass (10) - packs of cardboard.

10 ml - syringes glass (1) - containers (1) - packs cardboard.

10 ml - syringes glass (1) - containers (5) - packs cardboard.

10 ml - syringes glass (1) - containers (10) - packs cardboard.

15 ml - syringes glass (1) - containers (1) - packs cardboard.

15 ml - syringes glass (1) - containers (5) - packs cardboard.

15 ml - syringes glass (1) - containers (10) - packs cardboard.

20 ml - syringes glass (1) - containers (1) - packs cardboard.

20 ml - syringes glass (1) - containers (5) - packs cardboard.

20 ml - syringes glass (1) - containers (10) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

A paramagnetic contrast preparation for MRI.
The contrasting effect is due to the di-N-methylglucamine salt of gadopentetate, a gadolinium complex with pentetic acid (diethylenetriaminepentaacetic acid-DTPA). Using the appropriate scanning sequence (for example, the T1-weighted spin echo method) to obtain proton magnetic resonance imaging, the gadolinium ion shortens the spin-lattice relaxation time of the excited atomic nuclei, which increases the signal intensity and improves the contrast of the image of certain tissues.
Gadopentetova acid dimegluminovy ​​salt almost does not bind to proteins and does not inhibit the activity of enzymes (eg, myocardial Na + -K + -ATP-ase).
Magnevist® does not activate the complement system and therefore has a very low potential to cause anaphylactoid reactions.
PHARMACOKINETICS

The pharmacokinetics of dimegulmine gadopentetate is similar to the pharmacokinetics of other highly hydrophilic biologically inert compounds (eg mannitol or inulin).

The pharmacokinetics of Magnevist does not depend on the dose.

Distribution

After intravenous administration, the compound is rapidly distributed into the extracellular space.
In doses less than 0.25 mmol of dimoglumin gadopentetate / kg of body weight (equivalent to 0.5 ml of Magnevist / kg) after a rapid distribution phase (lasting several minutes), its concentration in the blood decreases; T 1/2 90 min. At a dose of 0.1 mmol dimeglumen gadopentetate / kg (equivalent to 0.2 ml of Magnevist / kg) at 3 min and 60 min after administration, its concentration in the blood plasma is 0.6 mmol and 0.24 mmol, respectively.
Magnevist ® does not penetrate intact BBB or the hematotestick barrier.
A small amount of the drug penetrating the placental barrier is rapidly excreted from the fetal organism.
Excretion

Gadopentetate of dimeglumine is excreted from the body by the kidneys in an unchanged form by glomerular filtration.
The extrarenal excretion is very insignificant.
On average, for 6 hours and 24 hours, 83% and 91% of the dose of the drug are excreted by the kidneys, respectively, with excrement less than 1% in 5 days.
The renal clearance of dimeglumin gadopentetate in humans with a body surface area of ​​1.73 m 2 is about 120 ml / min.
Pharmacokinetics in special clinical cases

In patients with impaired renal function (QC more than 20 ml / min), the active substance is almost completely excreted by the kidneys;
T 1/2 in plasma increases in proportion to the degree of impaired renal function; but an increase in extrarenal excretion is not observed. If patients with severe renal insufficiency (KC less than 20 ml / min) T 1/2 is up to 30 hours, then removal of dimeglyumin gadopentetate from the body by means of extracorporeal hemodialysis is possible.
INDICATIONS

To enhance the image contrast during the MRI of the brain and spinal cord (cranial and spinal MRI):

- for detection of tumors, incl.
small and poorly visualized, tumor recurrence after surgery or radiotherapy, metastases;
- for differential diagnostics with suspicion of meningioma, neurinic auditory nerve, tumor with infiltrative growth in nearby tissues (eg glioma);

- for differential diagnosis of some rare tumors (hemangioblastoma, ependymoma, small adenomas of the pituitary gland);

- to improve the visualization of intracranial spread of extracerebral tumors.

In addition, when conducting a spinal MRI:

- for differential diagnosis of intramedullary and extramedullary tumors;

- to determine the size of solid tumors in the spinal cord;

- to assess the prevalence of intramedullary tumors.

To enhance the contrast of the image during the whole body MRI (including studies of the facial skull, neck, chest and abdomen, mammary glands, pelvic organs, musculoskeletal system and obtaining images of the whole body):

- for detection of a tumor, inflammatory process, damage to blood vessels;

- to determine the prevalence and boundaries of the tumor, inflammation, vascular damage;

- for differential diagnosis of the structure of pathological changes;

- to assess the blood supply of normal and pathologically altered tissues;

- for differential diagnosis of tumors and scar tissue after therapy;

- to detect recurrence of intervertebral disk prolapse after surgery;

- for simultaneous semiquantitative evaluation of the function and their visualization.

DOSING MODE

Magnevist ® should be entered only in / in.
MRI with contrast should be started immediately after administration. Magnevist ® is not used for insertion under the membranes of the brain.
In the range from 0.14 to 1.5 T, the recommendations for Magnevist use are independent of the magnetic field strength.

Magnevist ® should be injected into the syringe immediately before use.
The remnants of contrast medium unused during examination should be destroyed.
With cranial and spinal MRI for adults and children (including newborns and infants) and adolescents, the recommended dose is 0.2 ml / kg of body weight.
In cases where there is a suspicion of a pathological focus, it is possible to conduct a second contrast study. Repeated administration at a dose of 0.2 ml / kg or 0.4 ml / kg (adult) should be performed 30 minutes after the first administration with immediate MRI.
The introduction of an increased dose of magnesium 0.6 mg / kg to adult patients increases the reliability of diagnosis with metastatic lesions or relapses of tumors.

At an MRI of the whole body, adults and children over 2 years of age are recommended to administer Magnesium in a dose of 0.2 ml / kg.
If the object is located in an area with poor vascularization and / or with a small extracellular space, an injection of 0.4 ml / kg may be required to obtain an adequate contrast effect, especially when using short T1-weighted sequences during scanning.
An administration of a dose of 0.6 ml / kg can increase the reliability of the diagnosis in a number of pathological lesions or relapses of tumors.

To visualize the vessels, depending on the area of ​​study and the MRI technique used, it may be necessary to administer an adult dose of Magnesium 0.6 mg / kg to an adult.

The experience of using Magnevist in conducting MRI of the whole body in children under 2 years is still limited.
In such cases, the physician must carefully weigh the ratio of the prospective benefit and the potential risk from conducting a study with Magnevist.
Preparation of the patient

For intravenous administration, it is advisable to use a flexible catheter.
The drug is used only in a hospital with the availability of equipment for resuscitation.
It is necessary to observe the generally accepted precautionary measures during MRI (including the absence of pacemakers, ferromagnetic implants in patients).

During intravascular injection of the contrast agent, the patient should be in a horizontal position.
After the injection, the patient should be observed for 30 minutes.
In adults and children older than 2 years , IV administration of Magnevist should be carried out in a "manual" way or with the help of an automatic injector.
Innewborns and in children under 2 years of age, the required dose should be administered "manually".
For studies using contrasting, T1-weighted sequences are commonly used for scanning.

SIDE EFFECT

The side effects associated with Magnevist use are usually mild, moderate, and transient.
However, the development of severe and life-threatening reactions has been reported.
Determination of the frequency of side effects: often> (1/100);
sometimes (? 1/100, but> 1/1000); rarely - (? 1/1000).
Frequency of adverse reactions according to post-registration clinical studies and according to spontaneous reports.

On the part of the body as a whole: sometimes - a feeling of heat, a headache;
rarely - back pain, chest or joint pain, malaise, increased sweating, fainting, fever.
Local reactions: rarely with extravasation - local pain, sensation of heat or cold, edema, inflammation, tissue necrosis, phlebitis, thrombophlebitis.

Allergic reactions: rarely - angioedema, conjunctivitis, cough, rhinitis, sneezing, bronchospasm, laryngospasm, laryngeal / pharyngeal edema, arterial hypotension, shock, skin reactions (urticaria).

From the side of the central nervous system and peripheral nervous system: sometimes - dizziness, headaches, paresthesia;
rarely - agitation (agitation), confusion, convulsions, tremor, asthenia, coma, drowsiness, speech disorders.
From the senses: rarely - watery eyes, pain in the eyes, pain in the ears, impaired vision, hearing, smell.

From the cardiovascular system: rarely - lowering blood pressure, arrhythmia, cardiac arrest, peripheral vasodilation, arterial hypotension, syncope, reflex tachycardia, cyanosis.

On the part of the respiratory system: rarely - shortness of breath, respiratory failure, cough, respiratory arrest, pulmonary edema.

From the digestive system: sometimes - nausea, vomiting;
rarely - abdominal pain, diarrhea, taste distortion, dry mouth, hypersalivation, transient increase in liver enzymes and bilirubin in the blood.
From the urinary system: rarely - urinary incontinence, frequent urge to urinate;
in patients with a previous kidney pathology - an increase in the level of creatinine and acute renal failure.
Dermatological reactions: rarely - skin itching, redness of the skin (due to vasodilation), rash, swelling.

Other: rarely - transient increase in serum iron levels.

CONTRAINDICATIONS

- Hypersensitivity to the components of the drug.

With caution should be used in patients with allergic reactions in history, bronchial asthma, with severe circulatory failure, epilepsy, pregnancy.
In patients with severe renal dysfunction (CC less than 20 ml / min), the expected benefit and the potential risk of drug administration should be carefully compared. the excretion of contrast medium in this category of patients may be delayed.
PREGNANCY AND LACTATION

The safety of Magnesium during pregnancy has not been studied.
Care should be taken when using the drug.
With IV administration, gadopentetic acid is released in very limited quantities with breast milk (approximately 0.04% of the administered dose).
The experience shows that there is no danger for children who are breastfed.
APPLICATION FOR FUNCTIONS OF THE LIVER

When appointing MRI using Magnevist, patients with severe renal dysfunction (KC less than 20 ml / min) should carefully compare the intended benefit and potential risk of drug administration,
the excretion of contrast medium in this category of patients may be delayed.
APPLICATION FOR CHILDREN

The experience of using Magnevist in conducting MRI of the whole body in children under 2 years is still limited.
In such cases, the physician must carefully weigh the ratio of the prospective benefit and the potential risk from conducting a study with Magnevist.
SPECIAL INSTRUCTIONS

To reduce the risk of aspiration 2 hours before the study, the patient should refrain from eating.

Against the background of Magnevist use, serious allergic reactions (including anaphylactic shock) are possible, most of which occur within 30 minutes after drug administration, but in rare cases delayed reactions may develop (from several hours to several days).

Before prescribing the drug, you should carefully collect allergic patient history for hay fever, hives, allergic reactions to seafood and reactions to contrast agents, bronchial asthma.
This category of patients is recommended to carry out premedication (GCS and blockers of histamine H 1 -receptors).
Patients with bronchial asthma have an increased risk of developing bronchospasm or reactions of hypersensitivity.

With intracranial tumors or metastases, as well as with epilepsy in an anamnesis, an increase in the incidence of seizures after the administration of contrast agents is possible.

When determining the content of iron in the serum by complexometric methods (for example, using batofenantrolin) during the first 24 hours, the quantitative index can be reduced, which is explained by the presence of a free DTPA in the contrast medium.

Impact on the ability to drive vehicles and manage mechanisms

The effect of Magnevist ® on the ability to drive vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions has not been detected.

OVERDOSE

Symptoms: manifestations of hyperosmosis of the drug are possible - increased pressure in the pulmonary artery, increased diuresis, hypervolemia, dehydration.

Treatment: it is necessary to monitor kidney function (especially in patients with renal insufficiency).
Hypopen-tate of dimeglumine can be removed by hemodialysis.
DRUG INTERACTION

In patients taking beta-blockers, hypersensitivity reactions with contrast agents can be strengthened.

Interaction with other drugs is not known.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, protected from light.
Shelf life - 5 years.
After removing the lid from the protective cap of the vial or preparing the syringe for injection, Magnevist ® should be administered on the same day to avoid microbial contamination.

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