Levomepromazine 25mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levomepromazine hydrochloride

Available from:

Wockhardt UK Ltd

ATC code:

N05AA02

INN (International Name):

Levomepromazine hydrochloride

Dosage:

25mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Subcutaneous; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5012727908618

Patient Information leaflet

Process Black
Keyline (non-printing)
Wockhardt UK Limited
Levomepromazine leaflet
105955/7
n-a
460 x 150mm
MPI
3
28/02/2017
831113
284
8pt (Main Body) / 8.5pt (Variables)
UK
English
Measure bar should be 150mm at 100% scale
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in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
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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.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them,
even if their symptoms are the same as yours.
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOMEPROMAZINE HYDROCHLORIDE 25MG/ML SOLUTION FOR INJECTION
Levomepromazine hydrochloride
(Referred to as Levomepromazine Injection in the remainder of the
leaflet)
WHAT IS IN THIS LEAFLET
1. What Levomepromazine Injection is and
what it is used for
2. What you need to know before you take
Levomepromazine Injection
3. How to take Levomepromazine Injection
4. Possible side effects
5. How to store Levomepromazine Injection
6. Contents of the pack and other information
1. WHAT LEVOMEPROMAZINE INJECTION IS AND
WHAT IT IS USED FOR
Levomepromazine Injection belongs to a group
of medicines called phenothiazines. It is used
for the relief of severe pain and as a sedative
to relieve anxiety and distress associated
with severe pain, particularly in terminally ill
pat

Summary of Product characteristics

OBJECT 1
LEVOMEPROMAZINE HYDROCHLORIDE 25MG/ML
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 09-May-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Levomepromazine hydrochloride 25mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each ml of the solution contains Levomepromazine hydrochloride 25mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless solution contained in a clear glass ampoule.
4. Clinical particulars
4.1 Therapeutic indications
Management of the terminally ill patient. Levomepromazine resembles
chlorpromazine and promethazine
in the pattern of its pharmacology. It possesses anti-emetic,
antihistamine and anti-adrenaline activity and
exhibits a strong sedative effect.
Levomepromazine Injection potentiates the action of other central
nervous system depressants but may be
given in conjunction with appropriately modified doses of narcotic
analgesics in the management of
severe pain. Levomepromazine Injection does not significantly depress
respiration and is particularly
useful where pulmonary reserve is low.
Levomepromazine Injection is indicated in the management of pain and
accompanying restlessness or
distress in the terminally ill patient.
4.2 Posology and method of administration
_Intramuscular and intravenous injection_
Dosage varies with the condition and individual response of the
patient. Levomepromazine Injection may
be administered by intramuscular injection or intravenous injection
after dilution with an equal volume of
normal saline.
The usual dose for adults and the elderly is 12.5mg to 25mg (0.5ml to
1ml) by intramuscular injection, or
by the intravenous route after dilution with an equal volume of normal
saline immediately before use. In
cases of severe agitation, up to 50mg (2ml) may be used, repeated
every 6 to 8 hours.
_Continuous subcutaneous infusion _
Levomepromazine Injection may be administered over a 24 hour period
via a syringe driver. The required
dose of Levome