Leaflet: information for the user

PLENIGRAF 165 mg iodo/ml injectable solution

(amidotrizoate sodium, amidotrizoate meglumine and amidotrizoate calcium

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is PLENIGRAF 165mg iodo/ml injectable solution and what it is used for

2. What you need to know before using PLENIGRAF 165mg iodo/ml injectable solution

3. How to use PLENIGRAF 165mg iodo/ml injectable solution

4. Possible side effects

5. Storage of PLENIGRAF 165mg iodo/ml injectable solution

6. Contents of the pack and additional information

This medication is solely for diagnostic use.

It belongs to the group of medications known as diagnostic agents.

Plenigraf is an injectable contrast medium that facilitates visualization of the renal system through certain radiological techniques: intravenous urography by perfusion, nephrotomography, and retrograde cystography.

Do not use Plenigraf 165 mg iodo/ml injectable solution:

- If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).

- If you have overt hyperthyroidism (increased function of the thyroid gland with clinical manifestations).

- If you have compensated heart failure.

- If you have multiple myeloma.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Plenigraf 165 mg iodo/ml injectable solution.

- If you suffer from any allergy (e.g., seafood allergy, hay fever, urticaria) or asthma.

- If you suspect you may be allergic to iodinated contrast media, in which case you should be closely monitored and some radiologists may administer, in advance, an antihistamine and corticosteroid treatment that should not be administered concurrently with the contrast medium.

- If you have severe liver or kidney function disorders.

- If you have any heart or circulatory disease.

- If you are diabetic.

- If you have pulmonary emphysema.

- If you suffer from seizures due to cerebral disease.

- If you have any cerebral circulatory problems; e.g., history of stroke.

- If you have latent hyperactivity of the thyroid gland (increased function of the thyroid gland without clinical manifestations).

- If you have nodular goiter (thyroid gland enlargement with nodules that often results in neck enlargement).

- If you suffer from blood cancer of the bone marrow (multiple myeloma) or produce an excessive amount of certain proteins (paraproteinemia).

- If you have a very poor general condition.

If you have any of the above conditions, your doctor will have to decide whether you can or cannot undergo the planned examination using contrast medium.

Consult your doctor, even if any of the aforementioned circumstances have occurred at some time.

Other medications and Plenigraf 165 mg iodo/ml injectable solution

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

If you are being treated with metformin (biguanide: medication used in the treatment of some forms of diabetes mellitus), the administration of contrast media may cause lactic acidosis due to renal function impairment. Treatment with biguanides (metformin) should be suspended 48 hours before contrast medium administration and not resumed until 48 hours after, and only when normal renal function has been recovered.

If you are being treated with beta-blockers, allergic reactions to contrast media may be exacerbated.

If you are being treated with interleukin, you should be aware that the prevalence of delayed reactions to contrast media (e.g., fever, skin rash, flu-like symptoms, joint pain, and itching) is higher.

As a pharmacological incompatibility, the administration of posterior iodine radioactive preparations for thyroid study may be considered, as the iodine uptake by the thyroid tissue is reduced for several days after contrast medium administration.

Your doctor will explain how to take these medications before the examination.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It is recommended to suspend breastfeeding for 12-24 hours after the examination.

The use of contrast media (such as Plenigraf) in pregnant patients has not been sufficiently demonstrated to be safe. Since exposure to X-rays should be avoided as much as possible during pregnancy, if you are pregnant, the radiological examination with Plenigraf should only be performed after your doctor has carefully evaluated the benefits against the potential risks.

Patients with low-sodium diets should note that this medication contains 700 mg (30.43 mmol) of sodium per 100 ml.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Plenigraf injectable solution is a contrast medium used for diagnostic testing, which should be performed in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at each moment.

Generally, you should abstain from eating for 2 hours before undergoing the study.

For renal explorations, better images are obtained when the intestine is free of residues and gases. Therefore, in the 24 hours prior to the exploration, food should be scarce and poor in residues. Foods that cause gas, particularly legumes, salads, fruit, whole grain bread or freshly cooked bread, as well as all types of raw vegetables, should be avoided. On the eve of the exploration, the last meal should not be taken after 6 in the evening. It is recommended to administer an intestinal evacuant afterwards.

You should ensure adequate hydration before and after administration of the contrast medium, especially in babies, small children, and elderly patients or those with renal insufficiency, multiple myeloma (a type of blood cancer) or long-term diabetes. In normal patients, liquid intake can be suppressed for a few hours before the examination.

The intake of food should be suppressed before the examination to avoid aspiration of gastric contents in case of vomiting.

The recommended dose is:

Generally, doses may vary depending on age, body weight, and the patient's general condition.

They also depend on the clinical problem presented, the diagnostic technique to be performed, and the region to be studied.

The recommended average dose in adults is 3-4 ml of Plenigraf per kg of body weight up to a maximum of 400 ml per intravenous infusion.

Use in children and adolescents:

The necessary dose will be evaluated by the doctor, as the available data on the use of Plenigraf in pediatric populations do not allow for a posological recommendation to be established.

If you use more Plenigraf 165 mg iodo/ml injectable solution than you should:

Overdose of this medication is rare. If it occurs, the doctor will treat any symptoms that appear (see section 6).

In the case of overdose or accidental ingestion, consult the Toxicological Information Service; Telephone 91 562 04 20

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Both children and the elderly may more easily present secondary effects, as they are especially sensitive to this type of medication.

The reactions that may accompany the use of contrast media depend directly on the concentration, volume used, technique employed, and existing pathology.

The most common adverse reactions with iodinated contrast media, generally mild and transient, are:

• Nervous system disorders: confusion, convulsions, dizziness, vertigo.
• Cardiovascular disorders: arrhythmias, hypertension, and vasodilation with flushing may occur.
• Respiratory disorders: shortness of breath, cyanosis, cough, asthma attacks.
• Gastrointestinal disorders: nausea and vomiting.
• Renal and urinary disorders: occasional transient proteinuria and rarely oliguria, anuria, and transient renal insufficiency.
• Dermatological disorders: skin reactions such as urticaria.
• General disorders: feeling of heat, headaches. In some cases, anaphylactic shock has occurred.

If any other reaction not described in this prospectus is observed, consult a doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of the medication.

Keep this medication out of the sight and reach of children.

Store protected from light and X-rays.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Plenigraf is supplied as a clear and colorless solution. Upon cooling, crystals may form, which can be easily redissolved by heating the solution in a water bath.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Plenigraf 165 mg iodine/ml injectable solution

The active principles are sodium amidotrizoate, meglumine amidotrizoate, and calcium amidotrizoate.

Each ml of Plenigraf contains:

Sodium amidotrizoate0.1928 g

Meglumine amidotrizoate0.0964 g

Calcium amidotrizoate0.0082 g

Equivalent to 165 mg/ml of iodine.

The other components are calcium edetate disodium and water for injectable preparations.

Appearance of the product and contents of the package

Plenigraf is presented as a clear and colorless solution in 250 ml bottles containing 250 ml of injectable solution.

The package includes an intravenous infusion set.

Holder of the Marketing Authorization and responsible for manufacturing

JUSTE FARMA S.L.U

Avda. de San Pablo, 27

28823 Coslada (Madrid)

Spain

Responsible for manufacturing:

SanochemiaPharmazeutikaGmbH

LandeggerStraße 7

2491 Neufeldan derLeitha

Austria

Last review date of this leaflet: July 2023

This information is intended solely for doctors or healthcare professionals:

Administration guidelines

Allergic reactions have been observed after the use of radiological contrast media such as Plenigraf injectable solution. Patients in whom hypersensitivity to iodinated contrast media is suspected should be closely monitored. In these patients or in others who have previously experienced allergic reactions to other products, some radiologists initiate, with sufficient advance, antihistamine and glucocorticoid treatment that should not be administered simultaneously with the contrast medium.

Appropriate time for radiography

The images will be acquired 10, 20, and 30 minutes after the start of the infusion.

The solution is administered, at body temperature, by intravenous infusion over a period of 5 to 10 minutes. In elderly patients or those with known or suspected cardiac decompensation, it is recommended to use a slower infusion rate.

Measures to take in case of contrast reaction

During the use of contrast media, it is essential to have available medications and instruments necessary for emergency treatment and trained personnel with the measures to be taken.

1. IV injection of a high-dose hydrocortisone steroid for 2-3 minutes. In very severe cases, continue injecting for the next 3-4 minutes. Leave the cannula in the vein for rapid access to the vascular system.
2. Inhalation of oxygen; if necessary, establish artificial respiration.

According to the patient's condition and/or predominant symptoms, the following measures may be taken:

a. Circulatory failure and shock:

• Lent IV injection of a peripheral circulatory stimulant.
• Constant monitoring of pulse and blood pressure.
• Avoid the use of adrenaline and analeptics.

b. Cardiac arrest:

• Rapid and energetic compression of the thoracic wall, followed, if necessary, by external cardiac massage and artificial respiration.
• 0.5 mg of orciprenaline via intracardiac injection.
• Calcium gluconate, 0.5-1.0 g IV.

c. Ventricular fibrillation:

• Cardiac massage and artificial respiration.
• Use of a cardiac defibrillator or administration of 0.5 g of procainamide via intracardiac injection.
• Solution of sodium bicarbonate IV (to combat hypoxic acidosis)
• Monitoring of blood pH.

d. Pulmonary edema:

• White blood transfusion; in adults, if necessary, bloody transfusion.
• IV diuretic of rapid action. In adults, 40% glucose solution
• Digitalization, if possible, with an appropriate cardiac glycoside.
• Except in shock, positive pressure respiration.

e. Cerebral symptoms:

• IV or IM tranquilizers, if there is restlessness.
• Neuroleptics in case of agitation.
• IM phenobarbital, in case of organic origin seizures.
• Short-acting narcotic, IV, in epileptic states.

f. Allergic manifestations:

• Severe urticaria: corticosteroids, antihistamines IV, and calcium compounds will be administered.
• Asthmatic attack: IV theophylline; if necessary, orciprenaline IV.
• Glottal edema: antihistamines IV.
• Obstruction of upper airways: a tracheotomy may be necessary.

Incompatibilities

Plenigraf injectable solution cannot be mixed with any medication or substance, as the variation of its pH or the introduction of metal salts may cause the contrast to precipitate. It can be diluted, if desired, with saline or glucose solution.

Infusion set

Drop-by-drop injection equipment, in sterile and apyrogenic plastic sanitary material (disposable), included in the package.

Instructions for using the equipment:

1. Move the regulating clip, leaving it approximately in the middle of the tube.

2. Close the clip, moving the wheel.

3. Remove the cap from the upper end (where the dropper is), leaving the needle exposed.

4. Pierce the cap of the bottle with the needle, introducing it as far as possible, using aseptic technique.

5. Hang the bottle in the injection position.

6. Remove the cap from the other end.

7. Purge the air from the equipment, opening the clip and allowing the necessary amount of liquid to flow.