Quirocrom 20 mg/ml + 0.70 ml/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Quirocrom 20 mg/ml + 0,70 ml/ml cutaneous solution
chlorhexidine digluconate / isopropyl alcohol
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve.
Contents of the leaflet
- What Quirocrom is and what it is used for
- What you need to know before using Quirocrom
- How to use Quirocrom
- Possible adverse effects
- How to store Quirocrom
- Contents of the pack and other information
1. What Quirocrom is and what it is used for
Quirocrom is a topical solution containing 20 mg/ml chlorhexidine digluconate and 0.70 ml/ml isopropyl alcohol, used as a skin antiseptic prior to performing invasive medical procedures, such as injections, insertion of intravascular catheters, and minor and major surgery in adults and children.
2. What you need to know before using Quirocrom
Do not use Quirocrom:
If you are allergic (hypersensitive) to chlorhexidine digluconate, isopropyl alcohol, or any of the other components of this medicine (listed in section 6).
Warnings and precautions:
Quirocrom is for external use on the skin only. Do not ingest or inhale.
- The solution is flammable. Fires in the operating room have been reported, resulting in serious burns to patients.
The risk of fire in the operating room is high when an ignition source (electrosurgical units, lasers, fiber-optic light sources, high-speed drills/burs) is used in combination with a combustible material (such as drapes, towels) and an oxidizing agent (oxygen, air, nitrous oxide).
To reduce the risk of fire:
Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
Remove any soaked materials, gauze, or surgical gowns before starting the procedure.
Do not use excessive amounts and avoid pooling of the solution in skin folds, under the patient, or soaking of sheets and other materials in direct contact with the patient.
When applying an occlusive dressing to areas previously exposed to Quirocrom, special care must be taken to ensure there is no excess product before applying the dressing.
Reduce the supply of oxygen or any other oxidizing agent to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5), combined with the use of an ignition source near an oxidizing agent, place the patient at risk of surgical fire.
Quirocrom may, in rare cases, cause severe allergic reactions that can lead to a drop in blood pressure and even loss of consciousness. Early signs of a severe allergic reaction may include skin rash or asthma. If you notice these symptoms, stop using Quirocrom immediately and contact your doctor as soon as possible (see section 4: Possible side effects).
Avoid prolonged contact with the skin.
Quirocrom must not be used:
- Near the eyes or on sensitive areas (mucous membranes), as it may cause irritation, pain, redness, vision problems, chemical burns, and eye injuries. In case of contact with the eyes or body entry mucous membranes, immediately rinse the affected area thoroughly with water.
Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord), and the middle ear.
Quirocrom must not come into contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse the eyes with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.
Serious cases of persistent corneal injury (damage to the surface of the eye) have been reported, which may require corneal transplantation, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).
- On open wounds
- On the inner part of the ear (middle ear)
- In direct contact with neural tissue (e.g., brain and spinal cord)
Quirocrom should only be applied gently to the skin. If the solution is applied too vigorously on fragile or sensitive skin, or after repeated use, erythema, inflammation, itching, dry and/or scaly skin, and pain may occur. Discontinue use at the first sign of any of these reactions.
Children
Use with caution in neonates, especially in premature infants. Quirocrom may cause chemical burns on the skin.
Other medicines and Quirocrom
Inform your doctor or nurse if you are using, have recently used, or might need to use any other medicines.
Inform your doctor or nurse if you have recently received a vaccine or a skin test injection (epicutaneous tests to detect allergies).
Concomitant use with other antiseptics should be avoided to minimize the risk of possible interactions between them.
Do not use Quirocrom together with anionic soaps, iodine, heavy metal salts, or acids.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.
It is unknown whether chlorhexidine digluconate or isopropyl alcohol are excreted in human breast milk. Since many medicines are excreted in breast milk, caution should be exercised when administering Quirocrom to breastfeeding women.
Driving and using machines
Quirocrom does not affect the ability to drive or operate machinery.
3. How to use Quirocrom
Your doctor or nurse will select the volume of solution depending on the area to be treated and the surface to be covered. Apply the product gently to the area of skin that needs to be prepared. Do not dilute.
If in doubt, consult your doctor or nurse.
If you use more Quirocrom than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rare adverse effects (less than 1 in 10,000 people) observed in the skin and subcutaneous tissue are:
Skin irritation, including: erythema, rash, urticaria, pruritus, and blisters or vesicles at the application site. Other local symptoms may include: burning sensation on the skin, pain, and inflammation.
Other possible adverse effects, for which the frequency is unknown, are:
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Allergic reactions including anaphylactic shock.
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Eye irritation, pain, hyperemia, vision problems, chemical burns, and eye injuries in cases of accidental contact.
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Chemical burns in neonates.
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Allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation, and blisters.
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Corneal lesion (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (induced painless deep sleep).
Stop using Quirocrom and seek immediate medical attention if you experience any of the following reactions: swelling of the face, lips, tongue, or throat; red, itchy rash; wheezing or difficulty breathing; feeling faint or dizzy; unusual metallic taste in the mouth; collapse. You may be having an allergic reaction.
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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Quirocrom
This medicine is flammable. Avoid exposing the container and its contents to open flames during use, storage, and disposal of the product.
Do not store above 30 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated. The medicine should be discarded 6 months after opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Quirocrom
The active substances are chlorhexidine digluconate 20 mg/mL and isopropyl alcohol 0.70 mL/mL.
The other components are purified water, Allura Red AC (E-129), and curcumin (E-100).
Appearance of the product and contents of the pack
Reddish transparent solution supplied in 100 mL and 250 mL plastic bottles. Available as:
- Clinical pack containing 30 bottles of 100 mL
- Clinical pack containing 15 bottles of 250 mL
Marketing Authorization Holder and Manufacturer
Laboratorios Salvat, S.A.
C/ Gall, 30-36 - 08950
Esplugues de Llobregat
Barcelona - Spain
Date of the most recent review of this leaflet: July 2024
Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es