Prohance - instructions for use, doses, side effects, contraindications

Active substanceGadoteridolGadoteridol

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solution in / in

Dosage form: & nbspsolution for intravenous administration

Composition:Per 1 ml:
Active ingredient: gadoteridol 279.3 mg
Auxiliary components: trometamol 1.21 mg, calcium caliterid 0.23 mg, hydrochloric acid solution 10% to pH 7.3-7.5, sodium hydroxide solution 10% to pH 7.3-7.5, water for injection up to 1 ml.

Description:a clear, colorless or light yellow solution.

Pharmacotherapeutic group:contrast agent for MRI

ATX: & nbsp

V.08.C.A Paramagnetic contrast media

Pharmacodynamics:Gadoteridol - non-ionic paramagnetic contrast medium for magnetic resonance imaging. When localized in a magnetic field gadoteridol reduces the time of longitudinal (T1) relaxation of water protons in tissues of the investigated regions. In recommended doses, the effect is observed with the greatest sensitivity in the T1-weighted sequence of images.
Gadoteridol does not penetrate the intact blood-brain barrier, and thus does not cumulate in intact brain or pathological foci with an intact blood-brain barrier such as cysts, post-operative scars, etc. However, damage to the blood-brain barrier or normal vascularization allows gadoteridol to penetrate into such pathological foci as neoplasms,abscesses and subacute infarcts.

Pharmacokinetics:The pharmacokinetics of gadotheridol when administered intravenously to healthy people obeys the rules of a two-chamber open model with a half-distribution and a half-life of about 0.20 ± 0.04 h and 1.57 ± 0.08 h, respectively.
Gadoteridol is eliminated exclusively by the kidneys in the amount of 94.4 ± 4.8% of the administered dose within 24 hours after the injection. No detectable biotransformation or degradation of the gadoterol was detected.
Identical essentially the rates of renal and plasma clearance of gadotheridol 1.41 ± 0.33 ml / min / kg and 1.50 ± 0.35 ml / min / kg, respectively) demonstrate the absence of elimination-kinetic changes in gadoteradol as it passes through the kidneys, and the actual excretion of gadotheridol through the kidneys. The volume of the distribution of gadoterol (204 ± 58 ml / kg) is identical to the volume in the extracellular fluid, and its clearance is similar to the clearance of substances undergoing glomerular filtration.
There is no information on the relationship with plasma proteins.

Indications:Prohance is used only for diagnostic purposes.
Magnetic resonance imaging (MRI) to visualize foci with impaired blood supply to the brain and spinal cord and surrounding tissues, as well as foci with a broken blood-brain barrier.
MRI of the entire body, including the head, neck, liver, mammary glands, osteoarticular system and soft tissue.

Contraindications:Hypersensitivity to gadoterol, other auxiliary components of the drug or other contrast preparations containing gadolinium; Children under 18 years of age for whole body MRI and children under 6 months of age for all other indications.

Carefully:With caution: children age from 6 months to 2 years for all indications, except for the whole body MRI; due to gadoteridol is excreted from the body by the kidneys, with caution should be used in patients with impaired renal function (glomerular filtration rate <30 ml / min / 1.73 m2); in patients with acute renal failure against the background of hepatorenal syndrome; patients in the perioperative period of liver transplant; in patients with epilepsy; in patients with cardiovascular diseases; patients with circulatory disorders, incl. central nervous system (CNS); in patients with allergic diseases in history.

Pregnancy and lactation:Sufficient or correctly conducted studies in pregnant women were not conducted. In this regard, gadoteridol should not be used in pregnant women, except when the intended benefit to the mother from its use exceeds the potential risk to the fetus, and such a study is appointed by the doctor because of extreme necessity.
There is no data on the excretion of gadoterol with milk. Therefore, if it is necessary to carry out a breastfeeding study, breastfeeding should be stopped before the introduction of the drug and should not be resumed for at least 24 hours after the test.

Dosing and Administration:Adults.
The recommended dose for the study of most pathologies of the brain and spinal cord is 0.1 mmol / kg.
For patients with suspected brain metastases or other pathological foci with less accumulation of contrast, the recommended dose is 0.3 mmol / kg. To perform an entire body MRI, the recommended dose is 0.1 mmol / kg.
MRI of the head and neck recommended dose is 0.1 mmol / kg.
MRI of the liver for scanning into the dynamic phase the recommended dose is 0.1 mmol / kg.
MRI of mammary glands the recommended dose is 0.1 mmol / kg.
MRI of the osteoarticular system and soft tissues, the recommended dose is 0.1 mmol / kg.
Children aged from 6 months to 2 years.
Application in children from 6 months: MRI of the brain and spinal cord.
It is necessary to carefully evaluate the benefit / risk in using Prohance in children aged 6 months to 1 year due to incompletely formed excretory system in children of this age. The dose should not exceed 0.1 mmol / kg, in one study, the use of more than 1 dose of the drug is not recommended. Re-introduction is possible only in more than 7 days.
Use in children less than 6 months of age is not recommended.
Performing an entire body MRI is not recommended in children under the age of 18 years.
Children from the age of 2 years.
The recommended dose for the study of most pathologies of the brain and spinal cord is 0.1 mmol / kg (0.2 ml / kg).
Prohance was used in a limited number of children aged 6 months to 2 years, so when carrying out the study, you need to be extra careful. Data on the efficacy and safety of use of doses of more than 0.1 mmol / kg or the administration of the drug have not been received.
Elderly patients (over the age of 65).
Dose changes in elderly patients over the age of 65 years are not required.
Patients with impaired renal function
Careful use of Proense should be carefully evaluated in patients with severe acute or chronic renal failure (GFR <30 mL / min / 1.73 m2) and perioperatively in patients with liver transplantation and use Prohance in these patients in If the diagnosis of their condition is possible only with the use of MRI with contrast. The dose should not exceed 0.1 mmol / kg. re-introduction is possible only in more than 7 days.

Side effects:Adopted safety rules and instructions for MRI are applicable to this drug.
Isolated cases of nephrogenic systemic fibrosis recorded after administration of the drug were in most cases observed in patients with renal insufficiency, which at the same time were prescribed other gadolinium-containing contrast agents for MRI.

Group	Frequency of adverse reactions
Group	Often (≥1/100- <1/10)	Infrequently (≥1/1000-<1/100)	Rarely (≥1 / 10000 - <1/1000)	Frequency can not be estimated
Immunological reactions		anaphylactic / anaphylactoid reactions ***
From the side of the psyche			anxiety
From the nervous system		headache, paresthesia, dizziness, taste change	decline mental abilities, epileptiform convulsions, violation of coordination	loss of consciousness, vase-vagal reactions *
From the sense organs		increased tear	noise in ears
From the side of the cardiovascular system		decline arterial pressure, sensation "tides" to face	tachycardia	interval increase R-R
From the side respiratory systems			laryngospasm, wheezing, shortness of breath, rhinitis, cough	pulmonary edema, stop breathing
From the side digestive systems	nausea	dry mouth, vomiting	abdominal pain, swelling and / or tongue itching, gingivitis, diarrhea, increased salivation, difficult swallowing
From the skin		itching, dermal rashes, hives, increased sweating	swelling of the face
fromo hand support- impellent apparatus			muscular stiffness
From the side urinary systems				acute renal failure **
Other		pain at the injection site, asthenia	hyperthermia, chest pain

Description of some reactions:
* Vaso-vagal reactions
During the injection of Prochaps, or immediately after administration, vaso-vagal reactions may occur, which rarely turn into collapse. Such reactions are often associated with emotional state (for example, fear of venipuncture) and are accompanied by nausea, dizziness and increased sweating. Symptoms of collapse include: pallor of the skin, increased sweating, bradycardia, hypersalivation. Correct recognition of these reactions and differential diagnosis with anaphylactoid / anaphylactic reactions are extremely important for choosing correct correction tactics.
**Acute kidney failure
Cases of acute renal failure occurred in patients with impaired renal function.
*** Anaphylactoid / anaphylactic reactions
Gadoteridol can cause the development of anaphylactic / anaphylactoid reactions and hypersensitivity reactions of varying severity, including anaphylactic shock or death. Symptoms of such reactions are: heaviness and pain in the chest, shortness of breath, fever, dysphagia, edema of the face and neck, lowering blood pressure.
In some patients, after transdermal administration, transient changes in serum iron concentrations were observed (in most cases within the permissible range); as it was revealed, these changes were not clinically significant.

Overdose:To date, no cases of overdose have been reported, therefore, signs and symptoms of an overdose can not be identified. In clinical studies, doses up to 0.3 mmol / kg were used, and no clinical manifestations associated with an increased dose were found. There is no specific antidote, treatment is symptomatic, hemodialysis is possible.

Interaction:There were no interactions with other drugs.

Special instructions:There is evidence of nephrogenic systemic fibrosis associated with gadolinium-containing contrast agents in patients with severe renal dysfunction (glomerular filtration rate <30 mL / min / 1.73 m2). Probably, the neurogenic systemic fibrosis arises in connection with the use of the drug, therefore in such patients the drug should be used only after a thorough examination.In patients on hemodialysis, it can be used briefly to remove the drug from the body. But for patients who have not previously undergone hemodialysis, it is unreasonable to initiate it for the prevention or treatment of nephrogenic systemic fibrosis.
According to the decision of the radiologist, if there is a medical indication, an additional dose may be administered in order to expand the diagnostic capabilities (contrast enhancement) of the study; the additional dose is 0.1 mmol / kg and can be administered no earlier than 30 minutes after the first injection.
In view of the fact that anaphylactic reactions have been registered after the introduction of gadoteridol, special attention should be paid to the availability of medications and proper tools for urgent interventions. The risk of developing hypersensitivity reactions is higher in the following cases:
-previous reaction to a contrast agent;
bronchial asthma;
-Allergic diseases in the anamnesis (bronchial asthma, hay fever).
Most of these reactions develop within 0.5-1 hour after administration. However, in rare cases, deferred reactions may develop.It should be noted that patients taking beta-blockers may be resistant to the treatment of hypersensitivity reactions with drugs that have a beta-agonist effect.
In patients with a predisposition to the development of allergic reactions, the decision to use the drug should be taken only after a thorough assessment of the risk / benefit ratio.
Before the introduction of a contrast agent in patients should learn allergic anamnesis (for example, the presence of hay fever, urticaria), sensitivity to contrast agents and the presence of bronchial asthma.
In such patients, the incidence of adverse reactions to contrast agents is higher and for them, prescription of antihistamines and / or glucocorticosteroids is indicated for premedication.
After conducting the diagnostic procedure with Prohance, monitoring of the patient's condition is recommended. The use of the drug should also be accompanied by observance of the generally accepted safety rules for conducting magnetic resonance imaging studies, which include excluding the use of ferromagnetic products by the patient, for example, pacemakers or aneurysmic clips.Magnetic resonance imaging with contrast agents containing other gadolinium chelate complexes should not be performed within 7 hours after application of the drug.
When a contrast agent is administered in patients with epilepsy, CNS lesions or seizures in the history, a decrease in the threshold of convulsive activity may be observed.
It is necessary to monitor the patient's condition. The doctor's office should contain the medicines needed to quickly cramp seizures.
In patients with acute or chronic renal failure of severe severity (glomerular filtration rate <30 ml / min / 1.73 m2), development of nephrogenic systemic fibrosis is possible, so the drug should be used with caution in such patients.

Effect on the ability to drive transp. cf. and fur:There is no information on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
However, given the likelihood of side effects in the form of dizziness, etc., such activities should be avoided within 24 hours after the administration of the drug.

Form release / dosage:The solution for intravenous administration is 279.3 mg / ml.

Packaging:For 10 ml, 15 ml or 20 ml in flasks of colorless glass type I, corked with an elastomer stopper (butyl rubber), crimped aluminum. 1 bottle is placed in a cardboard box together with instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years.
Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001781

Date of registration:24.07.2012 / 30.07.2013

The owner of the registration certificate:Brakko Imajing SpABrakko Imajing SpA Italy

Manufacturer: & nbsp

BIPSO, GmbH Germany

Representation: & nbspIMEX, CJSCIMEX, CJSCRussia

Information update date: & nbsp2015-12-06

Illustrated instructions

Instructions

Prohans (Prohens)