Ampres 50mg/5ml solution for injection ampoules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Chloroprocaine hydrochloride

Inapatikana kutoka:

B.Braun Medical Ltd

ATC kanuni:

N01BA04

INN (Jina la Kimataifa):

Chloroprocaine hydrochloride

Kipimo:

10mg/1ml

Dawa fomu:

Solution for injection

Njia ya uendeshaji:

Intrathecal

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 15020100; GTIN: 5099602996052

Taarifa za kipeperushi

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 MEDI-
CINE 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 = intrathe-
cal 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:
- diseases of the central nervous system such as meningitis,
polio and problems with your spinal cord due to anae

Tabia za bidhaa

OBJECT 1
AMPRES 10 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 19-Jun-2013 | Concordia
International - formerly AMCo
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
1. Name of the medicinal product
Ampres 10 mg/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 r