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AMPRES 20 mg/ml INJECTABLE SOLUTION

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About the medicine

How to use AMPRES 20 mg/ml INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Ampres 20mg/ml injectable solution

chloroprocaine hydrochloride

Read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Ampres and what is it used for
  2. What you need to know before you are given Ampres
  3. How to use Ampres
  4. Possible side effects
  5. Storage of Ampres
  6. Contents of the pack and other information

1. What is Ampres and what is it used for

Ampres contains the active substance chloroprocaine hydrochloride. It is a type of medicine called a local anesthetic belonging to the category of aminobenzoic acid esters.

Ampres is used to anesthetize (numb) specific parts of the body and prevent pain during surgical procedures by injecting the solution near the selected nerves.

Ampres is indicated only in adults.

Doctor consultation

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2. What you need to know before you are given Ampres

Do not use Ampres:

  • if you are allergic to chloroprocaine hydrochloride, to PABA (para-aminobenzoic acid) ester-type medicines, to other local anesthetics of the ester type, or to any of the other ingredients of this medicine (listed in section 6),
  • if there are general and specific contraindications for regional anesthesia, regardless of the local anesthetic used,
  • if you have been told you have a reduced blood volume (hypovolemia),
  • if you have severe cardiac conduction problems.

Warnings and precautions

If you have any of the following, you should discuss it with your doctor beforeyou are given this medicine.

  • if you have ever had a bad reaction to an anesthetic in the past.
  • if you have signs of skin infection or inflammation at the proposed injection site or nearby.
  • if you suffer from any of the following:
  • liver disease or kidney problems.
  • very low blood pressure.
  • blood clotting problems.
  • fluid in the lungs.
  • septicemia (blood poisoning).
  • if you have a heart condition (e.g., complete or partial heart block, heart failure, or arrhythmia).
  • if your general health is poor.

Other medicines and Ampres

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. In particular, if you are taking any medicine for an irregular heartbeat (class III antiarrhythmics), for the treatment of low blood pressure (vasopressors), and for pain relief.

Tell your doctor if you are taking any of the following medicines:

  • cholinesterase inhibitors (such as anticholinesterases or cyclophosphamide)

This is because your body takes longer to eliminate Ampres if you are taking these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine. Ampres is not recommended for local or regional anesthesia during pregnancy and should only be administered during pregnancy if absolutely necessary.

It is not known whether chloroprocaine is excreted in breast milk. If you are breastfeeding, you should inform your doctor, who will decide whether or not to administer Ampres.

Driving and using machines

The influence of Ampres on the ability to drive and use machines is important.

Your doctor is responsible for deciding in each individual case whether you can drive or use machines.

Ampres contains sodium

This medicine contains 37 mg of sodium (a major component of cooking/table salt) in each 20 ml vial. This is equivalent to 1.85% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ampres

This medicine will be administered to you by your doctor.

Regional anesthesia should only be administered by a doctor with the necessary knowledge and experience. The doctor in charge is responsible for taking the necessary measures to avoid injection into a blood vessel and for recognizing and treating undesirable effects.

The equipment, medicines, and personnel capable of dealing with a medical emergency should be available immediately.

Your doctor will decide what dose is suitable for you. The dose will depend on your state of health, the part of the body where the medicine is injected, and what the medicine is used for.

The maximum dose for healthy adults should not exceed 800 mg.

In patients with impaired general condition and in patients with confirmed concomitant disorders (e.g., vascular occlusion, arteriosclerosis, diabetic polyneuropathy), a reduced dose is indicated.

Use in children and adolescents

The safety and efficacy of Ampres in children have not been established. No data are available.

Ampres may be used to achieve local anesthesia by injecting the solution around a peripheral nerve or a network of nerves (perineural use), and the planned surgical procedure should not exceed 60 minutes.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Medicine questions

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4. Possible side effects

Like all medicines, Ampres can cause side effects, although not everybody gets them.

Important side effects to look out for:

Sudden, potentially life-threatening allergic reactions (such as anaphylaxis) are rare and affect up to 1 in 1,000 users.

Possible symptoms include sudden onset of itching, erythema (redness of the skin), edema (swelling), sneezing, vomiting, dizziness, excessive sweating, high temperature; and shortness of breath, wheezing, or difficulty breathing. If you think Ampres is causing an allergic reaction, tell your doctor immediately.

Other possible side effects:

Very common: may affect more than 1 in 10 people

Decrease in blood pressure, nausea

Common: may affect up to 1 in 10 people

Anxiety, restlessness, paresthesia, feeling of dizziness, vomiting, block failure, difficulty urinating.

Uncommon: may affect up to 1 in 100 people

Decrease in blood pressure (with high doses), high blood pressure (hypertension), slow heart rate, tremors, convulsions, numbness of the tongue, hearing problems, vision problems, speech problems, loss of consciousness.

Rare: may affect up to 1 in 1,000 people

Neuropathy, somnolence, leading to loss of consciousness and respiratory arrest, loss of bladder and bowel control, loss of perineal sensation and sexual function, and permanent neurological damage.

Double vision, irregular heartbeats (arrhythmias).

Myocardial depression, cardiac arrest (the risk increases with high doses or accidental intravascular injection).

Shortness of breath, wheezing, and difficulty breathing.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es.

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

5. Storage of Ampres

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

Do not use this medicine after the expiry date which is stated on the vials and on the outer packaging, after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C. Do not refrigerate or freeze. Keep the vial in the outer packaging to protect it from light.

Use immediately after first opening. For single use only.

Ampres should not be administered if the solution is not clear and free of particles.

Since this medicinal product is limited to hospital use, disposal is carried out directly by the hospital. Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ampres

The active substance is chloroprocaine hydrochloride.

1 ml of the injectable solution contains 20 mg of chloroprocaine hydrochloride.

1 vial with 20 ml of solution contains 400 mg of chloroprocaine hydrochloride.

The other ingredients are hydrochloric acid 3.7% (for pH adjustment), sodium chloride, and water for injectable preparations.

Appearance and packaging

This medicine is presented as an injectable solution. The injectable solution is a clear, colorless solution.

It is presented in a 20 ml glass vial of type I.

The vial closures are bromobutyl rubber stoppers and the closures used are aluminum flip-off caps.

Box with 1 vial containing 20 ml of injectable solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

B.Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 (Rubí) Barcelona

Spain

Manufacturer:

Sirton Pharmaceuticals S.p.A.

Piazza XX Settembre, 2

22079 Villa Guardia - Como

Italy

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State

Medicine name

Austria

Ampres 20 mg/ml Injektionslosung

Belgium

Ampres 20 mg/ml Solution for injection - Oplossing voor injectie - Solution injectable - Injektionslösung

France

Clorotekal 20 mg/ml solution pour injection

Germany

Ampres 20 mg/ml Injektionslosung

Ireland

Ampres 20 mg/ml solution for injection

Italy

Decelex

Poland

Decelex

Spain

Ampres 20 mg/ml solución inyectable

United Kingdom

(Northern Ireland)

Ampres 20 mg/ml solution for injection

Date of last revision of this leaflet:January 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

The Summary of Product Characteristics of the medicine is attached to the end of the printed leaflet as a separate section.

Online doctors for AMPRES 20 mg/ml INJECTABLE SOLUTION

Discuss questions about AMPRES 20 mg/ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Maria Martelli

Pain medicine 12 years exp.

Dr Maria Martelli is a medical doctor specialising in anaesthesiology and pain medicine. She provides online consultations for adults, focusing on the assessment and management of acute, chronic, and complex pain conditions, as well as supportive care in serious illness.

She graduated from the Medical University of Silesia in Katowice and completed her specialisation in Anaesthesiology and Intensive Care. Alongside hospital work, she has extensive experience in home and inpatient hospice care, supporting patients with severe pain and advanced disease. Since 2021, she has been a certified specialist and continues to work in anaesthesiology, intensive care, and pain treatment.

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Daria Portnova

Psychiatry 31 years exp.

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations.

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Sergey Ilyasov

Psychiatry 7 years exp.

Dr Sergey Ilyasov is an experienced neurologist and qualified psychiatrist who provides online consultations for adults and adolescents. Combining deep neurological expertise with a modern psychiatric approach, he ensures comprehensive diagnostics and effective treatment for a wide range of conditions affecting both physical and mental health.

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Frequently Asked Questions

Is a prescription required for AMPRES 20 mg/ml INJECTABLE SOLUTION?
AMPRES 20 mg/ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in AMPRES 20 mg/ml INJECTABLE SOLUTION?
The active ingredient in AMPRES 20 mg/ml INJECTABLE SOLUTION is chloroprocaine. This information helps identify medicines with the same composition but different brand names.
Who manufactures AMPRES 20 mg/ml INJECTABLE SOLUTION?
AMPRES 20 mg/ml INJECTABLE SOLUTION is manufactured by B Braun Medical S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AMPRES 20 mg/ml INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether AMPRES 20 mg/ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to AMPRES 20 mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (chloroprocaine) include AMPRES 10 mg/ml INJECTABLE SOLUTION, DENTISPRAY 50 mg/ml DENTAL SOLUTION, HURRICAINE 200 mg/g BUCAL GEL. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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