Ampres 20 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLOROPROCAINE HYDROCHLORIDE

Available from:

B. Braun Melsungen AG

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 status:

Not marketed

Authorization date:

2020-06-26

Patient Information leaflet

PACKAGE
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 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 yo

Summary of Product characteristics

Health Products Regulatory Authority
14 January 2022
CRN00C6L3
Page 1 of 8
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
The duration of action of chloroprocaine is dose-dependent, the
smallest dose required to produce an effective block should
be used. Posology must be established on an individual basis and
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
physical condition of the patient.
When determining the dose, concomitant administration of other
med