Ampres 10mg/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:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Esters of aminobenzoic acid; chloroprocaine

Authorization status:

Not marketed

Authorization date:

2012-07-13

Patient Information leaflet

Page 1
AMPRES 10 MG/ML SOLUTION FOR INJECTION
1.3.1.3: PACKAGE LEAFLET
PACKAGE
LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMPRES 10 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.
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 is a type of medicine called local anaesthetic, belonging to
the category of the esters, and is a
solution for injection. Ampres is used to anaesthetise (numb) specific
parts of the body and prevent pain
during surgery.
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, other ester-type
local anaesthetics or any of the
other ingredients of this medicine (listed in section 6),
-
if you have serious problems with cardiac conduction,
-
if you suffer from severe anaemia,
It is also necessary to take into consideration general and specific
contraindications for the technique of
spinal anaesthesia = intrathecal anaesthesia (decompensated cardiac
insufficiency, hypovolemic shock).
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 are suffering from any of the following:
Page 2
AMPRES 10 MG/ML SOLUTION FOR INJECTION
1.3

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2020
CRN009DQQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ampres 10mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 10 mg of chloroprocaine
hydrochloride
1 ampoule with 5 ml solution, contains 50 mg of chloroprocaine
hydrochloride
Excipients with known effect:
1 ml of solution contains 2.8 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 3.0 and 4.0.
The osmolality of the solution is comprised between 270 – 300
mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Spinal anaesthesia in adults where the planned surgical procedure
should not exceed 40 minutes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Posology must be established on an individual basis in accordance with
the characteristics of the specific case. When
determining the dose, take into consideration the patient’s physical
condition and the concomitant administration of other
medicinal products.
The duration of action is dose-dependent.
The indications relating to recommended doses are valid in adults of
average height and weight (approximately 70 kg) for
obtaining an effective block with one single administration. There are
wide individual variations with regard to extent and
duration of action. The experience of the anaesthetist and knowledge
of the patient’s general condition are essential for
establishing the dose.
With regard to posology the following guidelines are applied:
_Posology Adults_
_Extension of sensory blockade required T10_
_ml_
_mg_
_Average duration of action (minutes)_
4
5
40
50
80
100
The maximum recommended dose is 50mg (=5ml) of chloroprocaine
hydrochloride.
_Special population_
It is advisable to reduce the dose in patients in a compromised
general condition.
In addition, in patients with established concomitant disorders (e.g.
vascular