Chlorphenamine Solution for Injection 10mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHLORPHENAMINE MALEATE

Available from:

Wockhardt UK Limited

ATC code:

R06AB04

INN (International Name):

CHLORPHENAMINE MALEATE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CHLORPHENAMINE MALEATE 10 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Patient Information leaflet

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.
The following AFFEC

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 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 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 the other drug. The usual