Chlorphenamine 10mg/1ml solution for injection ampoules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Chlorphenamine maleate

Prieinama:

Wockhardt UK Ltd

ATC kodas:

R06AB04

INN (Tarptautinis Pavadinimas):

Chlorphenamine maleate

Dozė:

10mg/1ml

Vaisto forma:

Solution for injection

Vartojimo būdas:

Subcutaneous; Intramuscular; Intravenous

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 03040100; GTIN: 5012727912707

Pakuotės lapelis

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
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 C

Prekės savybės

OBJECT 1
CHLORPHENAMINE MALEATE 10MG/ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 10-Nov-2017 | Wockhardt UK
Ltd
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 give