Chlorphenamine 10mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorphenamine maleate

Available from:

Evolan Pharma AB

ATC code:

R06AB04

INN (International Name):

Chlorphenamine maleate

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous; Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5027229000265

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 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 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 blood pressure within the eye or
GLAUCOMA
, very
HIGH BLOOD
PRESSURE
,
HEART
,
LIVER
,
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 a

Summary of Product characteristics

OBJECT 1
CHLORPHENAMINE INJECTION
Summary of Product Characteristics Updated 08-Feb-2018 | Kyowa Kirin
Ltd
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 with known effect: Sodium (as sodium chloride) – please
refer to section 4.4 for further details.
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:
• 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
Posology
_Adults_
The usual dose of chlorphenamine injection for adults is 10 mg to 20
mg, but not more than 40 mg should
be given within a 24-hour period.
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 10 mg to 20 mg
of chlorphenamine injection should
be given by the subcutaneous route. This can be repeated to a total of
40 mg 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