CHLORPHENAMINE 10 Mg/Ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORPHENAMINE MALEATE

Available from:

Archimedes Pharma UK Limited

ATC code:

R06AB04

INN (International Name):

CHLORPHENAMINE MALEATE

Dosage:

10 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Substituted alkylamines

Authorization status:

Authorised

Authorization date:

1995-06-10

Patient Information leaflet

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.
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 10mg/ml Solution for
Injection contains the active ingredient
chlorphenamine maleate which is an
antihistamine. 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.
This injection is usually given to you by
your doctor or someone else trained to give
it to you.
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 in the product
(_see section 6: Contents of the pack and _
_other information_)
•  are in a PRE-COMA state
•  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, GLAUCOMA or raised
pressure within the eye, 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: Possible side effects).
OTHER MEDICINES AND CHLORPHENAMINE
Tell your doctor or pharmacist if you ar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 10mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains:
Chlorphenamine Maleate 10 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear colourless sterile solution for injections.
4 CLINICAL PARTICULARS
Chlorphenamine maleate is a potent antihistamine (H
1
-receptor antagonist). Antihistamines diminish or abolish the
actions of histamine in the body by competitive reversible blockade of histamine 1 receptor sites on tissues.
Chlorphenamine also has anticholinergic activity.
4.1 THERAPEUTIC INDICATIONS
In the treatment of acute allergic reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intramuscular
Subcutaneous
Intravenous
When administered intravenously the injection should be given slowly over a period of one minute in order to avoid
hypotension or central nervous system stimulation.
Adults:
The usual dose is 10mg to 20mg, with a maximum dose of 40mg in 24 hours.
Children:
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
0.25mg/kg
1 to 5 years
2.5mg – 5mg
OR
0.20mg/kg
6 to 12 years
5mg – 10mg
OR
0.20mg/kg
12 to 18 years
10mg – 20mg
OR
0.20mg/kg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 20/05/2015_
_CRN 2162533_
_page number: 1_
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 0.2ml�