Ampres 20 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLOROPROCAINE HYDROCHLORIDE

Available from:

Sintetica Ireland Limited

ATC code:

N01BA; N01BA04

INN (International Name):

CHLOROPROCAINE HYDROCHLORIDE

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Esters of aminobenzoic acid; chloroprocaine

Authorization date:

2020-06-26

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
AMPRES 20 MG/ML
SOLUTION FOR INJECTION
chloroprocaine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE GIVEN THIS MEDICINE
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 or pharmacist.
• If you get any side effects, talk to
your doctor, or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What Ampres is and what it is
used for
2. What you need to know before
you are given Ampres
3. How Ampres is used
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 the active
substance called chloroprocaine
hydrochloride. It is a type of
medicine called local anaesthetic,
belonging to the category of the
esters of aminobenzoic acid.
Ampres is used to anaesthetise
(numb) specific parts of the body
and prevent pain during surgery by
injecting the solution in proximity to
the selected nerves.
Ampres is indicated in adults only.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN AMPRES
DO NOT USE AMPRES:
• if you are allergic to
chloroprocaine hydrochloride,
medicinal products of the PABA
(para-aminobenzoic acid) ester
group, other ester-type local
anaesthetics or any of the other
ingredients of this medicine (listed
in section 6),
• if there are general and specific
contra-indications to regional
anaesthesia regardless of the local
anaesthetic used,
• if you have been told that you
have decreased volume of blood
(hypovolemia),
• if you have serious problems with
cardiac conduction.
WARNINGS AND PRECAUTIONS
If you suffer of any of these, you
should discuss it with your doctor
before being given this medicine.
• if you have ever had a bad
reaction to an anaesthetic in the
past
• if you have signs of skin infection
or inflammation at or near the
proposed site of the injection
• if you a

Summary of Product characteristics

Health Products Regulatory Authority
26 June 2020
CRN008K69
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ampres 20 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 20 mg of chloroprocaine
hydrochloride
1 vial with 20 ml solution, contains 400 mg of chloroprocaine
hydrochloride
Excipients with known effect:
1 ml of solution contains 1.85 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
The pH of the solution is comprised between 2.7 and 4.0.
The osmolality of the solution is comprised between 250 – 300
mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perineural anaesthesia (peripheral nerve block) in adults for
short-duration surgeries (not exceeding 60 minutes).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The equipment, medicinal products and personnel capable of dealing
with an emergency, e.g. maintaining the patency of the
airways and administering oxygen, must be immediately available, since
in rare cases severe reactions, sometimes with a fatal
outcome, have been reported after using local anaesthetics, even in
the absence of individual hypersensitivity in the patient's
case history. The doctor in charge is responsible for taking the
measures needed to avoid an intravascular injection and should
be fully trained in emergency medicine and resuscitation to be ready
to prevent and treat the undesirable effects and
complications of the procedure.
Posology
Posology must be established on an individual basis in accordance with
the characteristics of the specific case. When
determining the dose, the patient's physical condition and the
concomitant administration of other medicinal products should
be taken into consideration.
The dose administered varies with the anaesthetic procedure, the
vascularity of the tissues, the depth of anaesthesia and
degree of muscle relaxation required, the duration of anaesthesia
desired, and the