Ampres

Package leaflet: Information for the user

Ampres, 10 mg/mL, solution for injection
chloroprocaine hydrochloride
Please read all of this leaflet carefully before receiving the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Ampres is and what it is used for
2. Important information before using Ampres
3. How to use Ampres
4. Possible side effects
5. How to store Ampres
6. Contents of the pack and other information

1. What Ampres is and what it is used for

Ampres contains an active substance called chloroprocaine hydrochloride. It is a type of medicine
known as a local anaesthetic, belonging to the ester group, and is provided as a solution for
injection. Ampres is used to numb specific parts of the body and to prevent pain during a surgical
procedure.
Ampres is indicated for use in adults only.

2. Important information before using Ampres

When not to use Ampres:

• if the patient is allergic to chloroprocaine hydrochloride, drugs from the ester group of para-aminobenzoic acid (PABA), other ester-type local anaesthetics, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe disorders affecting cardiac conduction;
• if the patient has severe anaemia;
• if the patient has general or specific contraindications regarding the route of administration of the medicine.

Warnings and precautions
If any of the conditions listed below apply, discuss them with your doctor before
using this medicine.

• if the patient has ever previously experienced an adverse reaction to an anaesthetic drug;
• if the patient has signs of infection or inflammation of the skin at or near the proposed injection site;
• if the patient has any of the following diseases:
  • disorders of the central nervous system, such as meningitis, polio, or spinal cord problems caused by anaemia
  • severe headache
  • brain or spinal tumours, or any other tumours
  • spinal tuberculosis
• recent spinal cord injury
• very low blood pressure or low blood volume
• blood clotting disorders
• acute porphyria
• fluid in the lungs
• sepsis (blood poisoning)
  • if the patient has heart disease;
  • if the patient has a neurological disorder such as multiple sclerosis, hemiplegia, paraplegia, or neuromuscular disorders.

Ampres and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking,
has recently taken, or plans to take. Especially important are medicines used for irregular
heart rhythm (class III antiarrhythmics), medicines used to treat low blood pressure (vasopressors),
and painkillers.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor before receiving this medicine. Ampres is not recommended for
local or regional anaesthesia in pregnant women. The use of Ampres in pregnant women should be
considered only if absolutely necessary. This does not preclude the use of Ampres during childbirth.
It is unknown whether chloroprocaine passes into human milk. If the patient is breastfeeding,
she should inform her doctor, who will decide whether or not the patient should receive Ampres.
Driving and operating machinery
Ampres has a significant effect on the ability to drive and operate machinery.
The decision as to whether the patient may drive or operate machinery must be made by the doctor in each individual case.
Ampres contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose corresponding to 5 mL of Ampres injection solution), meaning the medicine is considered "sodium-free".

3. How to use Ampres

This medicine will be administered to the patient by a doctor.
Regional anaesthetic agents may be administered only by a physician with the necessary knowledge and experience.
The physician is responsible for taking all necessary measures to avoid intravascular injection of the anaesthetic and must be able to recognize and treat adverse reactions.
Equipment, medications, and personnel trained to manage emergencies must be immediately available.
The physician will determine the appropriate dose for the patient. Usually, this will be 4–5 mL (40–50 mg hydrochloride chloroprocaine).
In patients with poor general health (e.g. vascular occlusion, vascular atherosclerosis, diabetic polyneuropathy), a reduced dose should be considered.
Use in children and adolescents
The safety and efficacy of Ampres in children and adolescents have not been established.
Data are not available.
Ampres is administered intrathecally (spinally) when the duration of the planned surgical procedure is not expected to exceed 40 minutes.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, Ampres may cause adverse reactions, although not everyone will experience them.
Important adverse reactions include:
Sudden, life-threatening allergic reactions (such as anaphylaxis) are rare and occur in no more than 1 in 1,000 patients.
Possible symptoms include sudden itching, rash (reddening of the skin), swelling, sneezing, vomiting, dizziness, excessive sweating, elevated temperature; shortness of breath, wheezing, and difficulty breathing. If the patient suspects that Ampres is causing an allergic reaction, this should be reported to a doctor immediately.
Additionally, in case of persistent disturbances in movement, sensation, and (or) autonomic nervous system disorders (bladder control) affecting the lower segments of the spine, the physician should be informed immediately to avoid permanent neurological damage.

Other adverse reactions:
Very common: may occur in more than 1 in 10 patients
Low blood pressure, feeling nauseous (nausea).

Common: may occur in no more than 1 in 10 patients
Anxiety, motor restlessness, paresthesia, dizziness, vomiting, difficulty urinating.

Uncommon: may occur in no more than 1 in 100 patients
Decreased arterial blood pressure (with high doses), slow heart rate, chills, seizures, numbness of the tongue, hearing problems, vision problems, speech difficulties, loss of consciousness.

Rare: may occur in no more than 1 in 1,000 patients
Neuropathy, drowsiness progressing to loss of consciousness and respiratory arrest, spinal block (including total spinal block), low blood pressure following spinal block, loss of bladder control and involuntary defecation, loss of sensation in the perineal area and loss of sexual function, meningitis, cauda equina syndrome, and permanent neurological damage.
Double vision, irregular heartbeat.
Myocardial depression, cardiac arrest (risk increases with high doses or inadvertent intravascular injection).
Respiratory depression.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ampres

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule label and the outer carton. The expiry date refers to the last day of the specified month.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Store the ampoule in the outer packaging to protect from light.
Use immediately after first opening. For single use only.
Do not administer Ampres if the solution appears not clear or contains particulate matter.
Due to restricted use in hospital settings, any unused medicine is disposed of directly by the hospital. Medicines should not be disposed of via wastewater. This will help protect the environment.

6. Contents of the pack and other information

What Ampres contains
The active substance is chloroprocaine hydrochloride.
One mL of injection solution contains 10 mg of chloroprocaine hydrochloride.
One 5 mL ampoule contains 50 mg of chloroprocaine hydrochloride.
The other ingredients are: hydrochloric acid 3.7% (for pH adjustment), sodium chloride, water for injections.

What Ampres looks like and contents of the pack
This medicine is a solution for injection. The solution is clear and colourless.
It is supplied in ampoules made of colourless type I glass.
Pack size: box of 10 ampoules containing 5 mL of solution for injection each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany

Manufacturers
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
Sirton Pharmaceutical S.p.A.
Piazza XX Settembre 2
22079 Villa Guardia – Como
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Country | Name of the medicinal product | |---------|-------------------------------| | Austria | Ampres 10 mg/ml Injektionslösung | | Belgium | Oplossing voor injectie – Solution injectable – Injektionslösung | | France | Clorotekal 10 mg/ml solution pour injection | | Spain | Ampres 10 mg/ml solución inyectable | | Ireland | Ampres 10 mg/ml solution for injection | | Germany | Ampres 10 mg/ml Injektionslösung | | Poland | Ampres | | United Kingdom (Northern Ireland) | Ampres 10 mg/ml solution for injection | | Italy | Decelex |

Information intended exclusively for doctors or healthcare professionals:

ChPL is added at the end of the printed patient leaflet as a detachable section.