Chlorphenamine 10 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorphenamine maleate

Available from:

Evolan Pharma AB

ATC code:

R06AB; R06AB04

INN (International Name):

Chlorphenamine maleate

Pharmaceutical form:

Solution for injection

Therapeutic area:

Substituted alkylamines; chlorphenamine

Authorization status:

Marketed

Authorization date:

1995-06-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHLORPHENAMINE
10 mg/ml Solution for Injection
(chlorphenamine maleate)
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)

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2023
CRN00DWTM
Page 1 of 5
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:
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
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 emergency
therapy as per current standard clinical practice guidelines e.g. with
adrenaline (epinephrine), corticosteroids, oxygen and
supportive therapy as required.
Health Products Regulatory Authority
03 November 2023
CRN00DWTM
Page 2 of 5
When administered intravenou