Ampres 10mg/ml solution for injection

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

CHLOROPROCAINE HYDROCHLORIDE

Inapatikana kutoka:

B. Braun Melsungen AG

ATC kanuni:

N01BA; N01BA04

INN (Jina la Kimataifa):

CHLOROPROCAINE HYDROCHLORIDE

Kipimo:

10 milligram(s)/millilitre

Dawa fomu:

Solution for injection

Eneo la matibabu:

Esters of aminobenzoic acid; chloroprocaine

Idhini hali ya:

Marketed

Idhini ya tarehe:

2012-07-13

Taarifa za kipeperushi

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, 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, 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, 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 you have serious problems with cardiac conduction,
-
if you suffer from severe anaemia,
-
if you have general or specific contraindications to the method of
administration.
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:
-
diseases of the central nervous system such as meningitis, polio and
problems with

Tabia za bidhaa

Health Products Regulatory Authority
14 January 2022
CRN00C6L3
Page 1 of 8
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
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 side effects and complication 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 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 rega