CHLORPHENAMINE 10 Mg/Ml Solution for Injection

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

CHLORPHENAMINE MALEATE

Prieinama:

Kyowa Kirin Ltd

ATC kodas:

R06AB04

INN (Tarptautinis Pavadinimas):

CHLORPHENAMINE MALEATE

Dozė:

10 Mg/Ml

Vaisto forma:

Solution for Injection

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Gydymo sritis:

Substituted alkylamines

Autorizacija statusas:

Authorised

Leidimo data:

2017-03-01

Pakuotės lapelis

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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 nurse.
−
If you get any side effects, talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Chlorphenamine is and what it is
used for
2.
What you need to know before
Chlorphenamine is given
3.
How Chlorphenamine is given
4.
Possible side effects
5.
How to store Chlorphenamine
6.
Contents of the pack and other information
1.
WHAT CHLORPHENAMINE IS AND WHAT IT
IS USED FOR
Chlorphenamine 10 mg/ml Solution for
Injection (i.e. injection) contains the active
ingredient chlorphenamine maleate which is
an antihistamine.
Chlorphenamine is indicated in adults, and
children (aged 1 month to 18 years) for the
treatment of acute allergic reactions.
These medicines inhibit the release of histamine
into the body that occurs during an allergic
reaction. This product relieves some of the
main symptoms of a severe allergic reaction.
2.
WHAT YOU NEED TO KNOW BEFORE
CHLORPHENAMINE IS GIVEN
YOU MUST NOT BE GIVEN CHLORPHENAMINE:
•
if you are ALLERGIC to chlorphenamine
maleate or any of the other ingredients of
this medicine (listed in section 6)
•
if you are in a PRE-COMA state
•
if you have had monoamine oxidase
inhibitor (MAOI) ANTIDEPRESSIVE
TREATMENT within the past 14 days.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are
given this medicine if you:
•
are being treated for an OVERACTIVE
THYROID or ENLARGED PROSTATE GLAND
•
have EPILEPSY, raised pressure within
the eye or GLAUCOMA, very HIGH BLOOD
PRESSURE, HEART DISEASE, LIVER DISEASE,
ASTHMA or other CHEST DISEASES.
Children and the elderly are more likely to
experience certain side effects (see section 4).
OTHER MEDICINES AND CHLORPHENAMINE
Tell your doctor if you are taking, have recently
taken, or might take any other medi

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 10 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains: Chlorphenamine Maleate 10 mg
Excipient(s) with known effect: 2.9 mg/ml sodium (as sodium chloride).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection. (Injection)
Clear colourless sterile solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chlorphenamine is indicated in adults, and children (aged 1 month to
18 years) for the treatment of acute allergic
reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dose is 10 mg to 20 mg, with a maximum dose of 40 mg in 24
hours.
_Paediatric population_
The dose for children should be calculated, based on either the
child’s age or their body weight, using the following
table:
Extra care should be taken when preparing the injection for children
under 1 year due to the small volumes that are
required. Dilution of chlorphenamine injection with sodium chloride
intravenous infusion (0.9% w/v) should facilitate
preparation. For example, diluting 0.2 ml chlorphenamine injection to
2 ml with sodium chloride 0.9% injection
produces a solution containing chlorphenamine 1 mg/ml. The diluted
product should be used immediately.
Method of Administration
Intramuscular
Subcutaneous
Intravenous
When a rapid effect is desired, as in anaphylactic reactions, the
intravenous route is recommended in addition to
Age
Dose
1 month to 1 year
0.25 mg/kg
1 to 5 years
2.5 mg to 5 mg
OR
0.20 mg/kg
6 to 12 years
5 mg to 10 mg
OR
0.20 mg/kg
12 to 18 years
10 mg to 20 mg
OR
0.20 mg/kg
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_