Chlorphenamine Solution for Injection 10mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHLORPHENAMINE MALEATE

Available from:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC code:

R06AB04

INN (International Name):

CHLORPHENAMINE MALEATE 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CHLORPHENAMINE MALEATE 10 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-03-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORPHENAMINE 10MG/ML SOLUTION FOR INJECTION
CHLORPHENAMINE MALEATE
(REFERRED TO AS CHLORPHENAMINE THROUGHOUT THIS 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 pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. 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 you are given Chlorphenamine
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 YOU ARE GIVEN CHLORPHENAMINE
YOU MUST NOT BE GIVEN CHLORPHENAMINE IF YOU:
•
are
ALLERGIC
to chlorphenamine or any of the other ingredients of this medicine
(listed in section 6)
•
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 before you are given Chlorphenamine if you:
•
are being treated for an
OVERACTIVE THYROID
or
ENLARGED PROSTATE GLAND
•
have
EPILEPSY
,
GLAUCOMA
,
VERY HIGH BLOOD PRESSURE
,
HEART
,
LIVER
,
ASTHMA
or
CHEST DISEASES
.
OTHER MEDICINES AND CHLORPHENAMINE
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
T

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 10mg/ml Solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 10mg of chlorphenamine maleate.
Excipient with known effect:
Each 1 ml of solution contains 0.13mmol (3.1mg) of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless sterile solution for injection.
The pH of the solution is 4.0 – 5.2 and the osmolality is 261 –
319 mOsm/Kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chlorphenamine injection is indicated for acute urticaria, control of
allergic reactions to
insect bites and stings, angioneurotic oedema, drug and serum
reactions, desensitisation
reactions, hayfever, vasomotor rhinitis, severe pruritus of
non-specific origin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The usual dose of chlorphenamine injection for adults is 10mg to 20mg,
but not more than
40mg should be given within a 24-hour period. The injection may be
given by the
subcutaneous, intramuscular or intravenous route.
When a rapid effect is desired, as in anaphylactic reactions, the
intravenous route is
recommended in addition to emergency therapy with adrenaline
(epinephrine),
corticosteroids, oxygen and supportive therapy as required. In this
case chlorphenamine
injection should be injected slowly over a period of one minute, using
the smallest adequate
syringe. Any drowsiness, giddiness or hypotension which may follow is
usually transitory.
In the event of a blood transfusion reaction, a dose of 10mg to 20mg
of chlorphenamine
injection should be given by the subcutaneous route. This can be
repeated to a total of 40mg
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within a 24-hour period, or oral forms of chlorphenamine may be given
until the symptoms
subside.
Chlorphenamine injection may be helpful in the prevention of delayed
reactions to penicillin
and other drugs when given separately by intramuscular injection
immediately prior to
administration of t