Nozinan 25mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levomepromazine hydrochloride

Available from:

Neuraxpharm 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: 5000283653493

Patient Information leaflet

_I_
IS THIS LEAFLET HARD
TO SEE OR READ?
PHONE 0845
372 7101 FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START RECEIVING THIS MEDICINE.
- Please keep this leaflet. You may need
to read it again
- If you have any further questions, ask
your doctor
- If you suffer from any side effects that
get serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor
IN THIS LEAFLET:
1. What Nozinan Injection is and what it
is used for
2. Before Nozinan Injection is given
3. How Nozinan Injection is given
4. Possible side effects
5. How to store Nozinan Injection
6. Further information
1. WHAT NOZINAN
INJECTION IS AND
WHAT IT IS USED FOR
Nozinan 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 patients.
This medicine is given by a healthcare
professional either by injection into a
muscle or vein, or slowly via a needle
under the skin.
2. BEFORE NOZINAN INJECTION
IS GIVEN
YOU MUST NOT BE GIVEN NOZINAN
INJECTION IF YOU HAVE:
X
an
ALLERGY
(hypersensitivity)
to
levomepromazine hydrochloride or
any of the other ingredients in the
product (see Section 6 and end of
Section 2)
TAKE
SPECIAL
CARE
WITH
NOZINAN
INJECTION
Consult your doctor if you:
▲ have liver problems
▲ are elderly, frail or have heart disease
as you may feel faint or light-headed
when you are given the injection. (if
you receive a large initial dose, you
will have to stay in bed)
▲ suffer f ro m s l o w o r ir re g u l ar
heartbeats/palpitations (Torsades de
Pointes) or have a family history of
heart problems
▲ or someone else in your family have
a history of blood clots, as medicines
like these have been associated with
formation of blood clots
▲ are diabetic or have been told that
you have an increased risk of diabetes
▲ already know you have low levels of
potassium, calcium or magnesium
in your blood
▲ find it difficult, or are unable, to eat
�

Summary of Product characteristics

OBJECT 1
NOZINAN 25MG/ML SOLUTION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 05-Sep-2017 | SANOFI
1. Name of the medicinal product
Nozinan 25mg/ml Solution for Injection/Infusion
2. Qualitative and quantitative composition
Levomepromazine hydrochloride 25mg per ml.
For excipients, see 6.1.
3. Pharmaceutical form
Solution for injection/infusion.
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.
Nozinan 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.
Nozinan does not significantly depress respiration and is particularly
useful where pulmonary reserve is
low.
Nozinan 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. Nozinan 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_
Nozinan injection may be administered over a 24 hour period via a
syringe driver. The required dose of
Nozinan injection (25mg to 200mg per day) should be diluted with the
calculated volume of normal
saline. Diamorphine hydrochloride is compatible with this