Plenigraf 165 mg iodine/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PLENIGRAF 165 mg iodine/ml injection solution

(sodium amidotrizoate, meglumine amidotrizoate and calcium amidotrizoate)

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What PLENIGRAF 165 mg iodine/ml injection solution is and what it is used for
2. What you need to know before using PLENIGRAF 165 mg iodine/ml injection solution
3. How to use PLENIGRAF 165 mg iodine/ml injection solution
4. Possible side effects
5. How to store PLENIGRAF 165 mg iodine/ml injection solution
6. Contents of the pack and other information

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

This medicinal product is for diagnostic use only.

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

Plenigraf is an injectable contrast medium that enhances visualization of the renal system using certain radiological techniques: intravenous infusion urography, nephrotomography, and retrograde cystography.

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

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

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If you have manifest hyperthyroidism (increased thyroid gland function with clinical symptoms).
• If you have compensated heart failure.
• If you have multiple myeloma.

Warnings and precautions

Talk to your doctor or pharmacist before using Plenigraf 165 mg iodine/ml injectable solution.

• If you suffer from any allergies (e.g., allergy to seafood, hay fever, hives) or bronchial asthma.
• If you suspect you may be allergic to iodinated contrast media; in such cases, you must be carefully monitored, and some radiologists may administer antihistamines and glucocorticoids in advance. These should not be administered simultaneously with the contrast medium.
• If you have severe impairment of liver or kidney function.
• If you have any heart or circulatory disease.
• If you are diabetic.
• If you have pulmonary emphysema.
• If you have seizures due to brain disease.
• If you have cerebral circulatory problems; e.g., history of stroke.
• If you have latent hyperactivity of the thyroid gland (increased thyroid function without clinical symptoms).
• If you have soft nodular goiter (enlarged thyroid gland with nodules, often resulting in an enlarged neck).
• If you have cancer of blood cells in the bone marrow (multiple myeloma) or produce excessive amounts of certain proteins (paraproteinemia).
• If you are in a severely weakened general condition.

If you have any of the above conditions, your doctor will need to decide whether or not the planned examination using contrast medium can be performed.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Other medicines and Plenigraf 165 mg iodine/ml injectable solution

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are being treated with metformin (a biguanide: a medicine used in the treatment of certain forms of diabetes mellitus), administration of contrast media may cause lactic acidosis due to impaired kidney function. Treatment with biguanides (metformin) should be discontinued 48 hours before administration of the contrast medium and not resumed until 48 hours after its administration, and only after normal kidney function has been confirmed.

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 delayed reactions to contrast media (e.g., fever, skin rash, flu-like symptoms, joint pain, and itching) are more common.

As a pharmaceutical incompatibility, subsequent administration of radioactive iodine preparations for thyroid studies may be considered, since uptake of iodine by thyroid tissue is reduced for several days following administration of contrast media.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding is recommended to be suspended for 12–24 hours following the examination.

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

Patients on low-sodium diets should be aware that this medicine contains 700 mg (30.43 mmol) of sodium per 100 ml.

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

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

Plenigraf injectable solution is a contrast medium used to perform a diagnostic test, which must be carried out in the presence of qualified personnel, preferably under the supervision of a physician, who will provide you with specific instructions throughout the procedure.

In general, you should refrain from eating for 2 hours prior to undergoing the examination.

Better images are obtained in renal studies when the intestine is free of residues and gas. Therefore, during the 24 hours prior to the examination, your diet should be light and low in residue. Avoid flatulent foods, particularly legumes, salads, fruit, wholemeal or freshly baked bread, as well as all kinds of raw vegetables. On the day before the examination, the last meal should not be taken after 6:00 p.m. An intestinal evacuant is recommended afterwards.

Adequate hydration must be ensured before and after administration of the contrast medium, especially in infants, young children, elderly patients, or if you have renal insufficiency, multiple myeloma (a type of blood cell cancer), or long-standing diabetes. In normal patients, fluid intake may be withheld for several hours before the examination.

Food should be withheld before the examination to avoid aspiration of gastric contents in case of vomiting.

Recommended dose:

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

They also depend on the clinical condition, the diagnostic technique to be used, 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 slow intravenous infusion.

Use in children and adolescents:

The required dose will be assessed by the physician, as available data on the use of Plenigraf in the pediatric population do not allow for a specific posological recommendation.

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

Overdose with this medicine rarely occurs. If it does occur, the physician will treat any symptoms that appear (see section 6).

In case of overdose or accidental ingestion, contact the Toxicology Information Service; Telephone 91 562 04 20.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Children and elderly patients may more easily experience side effects, as they are particularly sensitive to this type of medicine.

Reactions associated with the use of contrast media depend directly on the concentration, volume administered, technique used, and existing pathology.

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

• Nervous system disorders: confusion, convulsions, dizziness, vertigo.
• Cardiovascular disorders: cases of cardiac arrhythmias, hypertension, and vasodilation with flushing.
• Respiratory disorders: dyspnea, cyanosis, cough, asthma attacks.
• Gastrointestinal disorders: nausea and vomiting.
• Renal and urinary disorders: occasionally transient proteinuria, and rarely oliguria, anuria, and transient renal failure.
• Skin disorders: skin reactions such as urticaria.
• General disorders: sensation of warmth, headache. Anaphylactic shock has occasionally occurred.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

Store protected from light and X-rays.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of Plenigraf 165 mg iodine/ml injectable solution

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

Each ml of Plenigraf contains:

Sodium amidotrizoate 0.1928 g
Meglumine amidotrizoate 0.0964 g
Calcium amidotrizoate 0.0082 g

Equivalent to 165 mg/ml of iodine.

The other components are disodium calcium edetate and water for injections.

Appearance of the medicine and contents of the container

Plenigraf is presented as a clear, colourless solution in 250 ml bottles containing 250 ml of injectable solution.

The pack includes an intravenous infusion set.

Marketing Authorisation Holder and Manufacturer

JUSTE FARMA S.L.U
Avda. de San Pablo, 27
28823 Coslada (Madrid)
Spain

Manufacturer:
Sanochemia Pharmazeutika GmbH
Landegger Straße 7
2491 Neufeld an der Leitha
Austria

Date of the most recent revision of this leaflet: July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This Information is intended solely for healthcare professionals:

Administration instructions

Allergic-type reactions have been observed following the use of radiological contrast agents such as Plenigraf injectable solution. Patients in whom hypersensitivity to iodinated contrast media is suspected should be carefully monitored. In these patients, or in others who have previously shown allergic-type reactions to other products, some radiologists initiate, with sufficient advance, antihistamine and glucocorticoid treatment, which must not be administered simultaneously with the contrast agent.

Optimal timing for radiographs:

Imaging should be performed at 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 in those with known or suspected cardiac decompensation, a slower infusion rate is advisable.

Measures to take in case of contrast reaction

During the use of contrast media, it is essential to have available the necessary medications, equipment and trained personnel for emergency treatment.

1. Intravenous injection of a water-soluble corticosteroid at a high dose, administered over 2–3 minutes. In very severe cases, administration should continue for the following 3–4 minutes. The intravenous cannula should remain in place to ensure rapid vascular access.
2. Oxygen inhalation; if necessary, artificial respiration should be initiated.

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

• Circulatory failure and shock:

  • Slow intravenous injection of a peripheral circulatory stimulant.
  • Continuous monitoring of pulse and blood pressure.
  • Avoid the use of adrenaline and analeptics.

• Cardiac arrest:

  • Rapid and forceful compression of the chest wall, followed, if necessary, by external cardiac massage and artificial respiration.
  • 0.5 mg of orciprenaline administered intracardially.
  • Calcium gluconate, 0.5–1.0 g intravenously.

• Ventricular fibrillation:

  • Cardiac massage and artificial respiration.
  • Use of a cardiac defibrillator or administration of 0.5 g of procainamide intracardially.
  • Intravenous sodium bicarbonate solution (to counteract hypoxic acidosis).
  • Monitoring of blood pH.

• Pulmonary oedema:

  • Venesection; in adults, if necessary, bloodletting.
  • Rapid-acting diuretic administered intravenously. In adults, 40% glucose solution.
  • Digitalization, if possible, with an appropriate cardiac glycoside.
  • Except in cases of shock, positive-pressure ventilation.

• Cerebral symptoms:

  • Intramuscular or slowly intravenous administration of tranquilizers, if restlessness is present.
  • Neuroleptics in case of agitation.
  • Phenobarbital intramuscularly, in case of organic seizures.
  • Short-acting narcotic administered intravenously, in epileptic states.

• Allergic manifestations:

  • Severe urticaria: administer corticosteroids, intravenous antihistamines, and, if necessary, calcium compounds.
  • Asthmatic attack: slow intravenous theophylline; if necessary, slow intravenous orciprenaline.
  • Glottic oedema: antihistamines administered intravenously.
  • Upper airway obstruction: tracheotomy may be necessary.

Incompatibilities

Plenigraf injectable solution must not be mixed with any medication or substance, as changes in its pH or the introduction of metallic salts may cause precipitation of the contrast agent. It may, however, be diluted, if desired, with saline or glucose solution.

Infusion equipment

Drip infusion set made of sterile, pyrogen-free, plastic medical material (disposable), included in the pack.

Instructions for use of the equipment:

1. Move the flow regulator clamp to approximately the middle third of the tubing.
2. Close the clamp by turning the wheel.
3. Remove the cap from the upper end (where the drip chamber is located), exposing the needle.
4. Pierce the bottle stopper with the needle, inserting it as far as possible, using aseptic technique.
5. Hang the bottle in the infusion position.
6. Remove the cap from the other end.
7. Purge the air from the equipment by opening the clamp and allowing the necessary amount of liquid to flow through.