Bupivacaine 50mg/10ml (0.5%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Bupivacaine hydrochloride; Adrenaline acid tartrate

Доступно од:

0.5%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoules (Advanz Pharma

АТЦ код:

N01BB51

INN (Међународно име):

Bupivacaine hydrochloride; Adrenaline acid tartrate

Дозирање:

5mg/1ml ; 5microgram/1ml

Фармацеутски облик:

Solution for injection

Пут администрације:

Epidural

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 15020100; GTIN: 5099602992542

Информативни летак

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
The product is known by the above name but will be referred to as
Bupivacaine & Adrenaline Injection
throughout the rest of this leaflet.
In this leaflet:
1. What Bupivacaine & Adrenaline Injection is and what it is used for
2. Before you are given Bupivacaine & Adrenaline Injection
3. How Bupivacaine & Adrenaline Injection is given to you
4. Possible side effects
5. How to store Bupivacaine & Adrenaline Injection
6. Further information
1. WHAT BUPIVACAINE & ADRENALINE INJECTION IS AND WHAT IT IS USED FOR
Bupivacaine & Adrenaline Injection contains two active ingredients.
• Bupivacaine is a local anaesthetic; it produces loss of feeling or
sensation that is confined to one
part of the body. Bupivacaine belongs to a group of medicines called
amide-type anaesthetics
• Adrenaline narrows the blood vessels at the site of injection
which helps to keep the bupivacaine
where it is needed for longer.
Bupivacaine & Adrenaline Injection is used in adults and children
above 12 years to numb
(anaesthetise) parts of the body. It is used to stop pain happening or
to provide pain relief. It can be
used to:
• Numb parts of the body during surgery
• Relieve pain (0.25% w/v, 1 in 200,000 injection can be used in
adults, infants and children above 1
year of age).
It may also be used to give prolonged relief of pain when it is
injected around the spinal cord, e.g. as
an epidural injection in labour.
2. BEFORE YOU ARE GIVEN BUPIVACAINE & ADRENALINE INJECTION
DO NOT USE
Adrenaline containing Bupivacaine & Adrenaline injection for special
techniques (e.g. penile block

Карактеристике производа

OBJECT 1
BUPIVACAINE AND ADRENALINE
(EPINEPHRINE)INJECTION 0.5% W/V, 1 IN 200,000
Summary of Product Characteristics Updated 23-Jul-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Bupivacaine and Adrenaline (Epinephrine) Injection 0.5% w/v, 1 in
200,000
2. Qualitative and quantitative composition
Each 10ml of solution contains Bupivacaine Hydrochloride B.P. 52.75mg
equivalent to anhydrous
Bupivacaine Hydrochloride 50mg, Adrenaline Acid Tartrate B.P. 0.091mg
equivalent to Adrenaline
0.05mg.
3. Pharmaceutical form
Solution for Injection
Colourless or almost colourless, aqueous, sterile solution.
4. Clinical particulars
4.1 Therapeutic indications
Bupivacaine 0.25% and 0.5% solutions are used for the production of
local anaesthesia by percutaneous
infiltration, peripheral nerve block(s) and central neural block
(caudal or epidural), that is, for specialist
use in areas where prolonged anaesthesia is indicated. Bupivacaine is
particularly useful for pain relief
e.g. during labour, as its sensory nerve block is more marked than its
motor block. A list of indications
and suggested dose and strength of solution appropriate for each are
shown in the table under 4.2 below.
• Surgical anaesthesia in adults and children above 12 years of age.
• Acute pain management in adults and children above 12 years of
age.
Note:
Very limited paediatric data is available for the 5mg/ml and none 7.5
mg/ml solution for injection for any
anaesthetic technique. As for other local anaesthetics,
recommendations for the adolescent population
above 12 years remain included in the information for adults.
4.2 Posology and method of administration
Great care must be taken in order to prevent an accidental
intravascular injection, always including
careful aspirations. For epidural anaesthesia, a test dose of 3 - 5ml
of Bupivacaine containing adrenaline
should be administered, since an intravascular injection of adrenaline
will be quickly recognised by an
increase in heart rate. Verbal contact and frequent measure