Bupivacaine 25mg/10ml (0.25%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Bupivacaine hydrochloride; Adrenaline acid tartrate

Dostępny od:

0.25%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoules (Advanz Pharma

Kod ATC:

N01BB51

INN (International Nazwa):

Bupivacaine hydrochloride; Adrenaline acid tartrate

Dawkowanie:

2.5mg/1ml ; 5microgram/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Epidural

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 15020100; GTIN: 5099602992535

Ulotka dla pacjenta

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

Charakterystyka produktu

OBJECT 1
BUPIVACAINE & ADRENALINE INJECTION B.P. 0.25%
W/V 1 IN 200,000
Summary of Product Characteristics Updated 25-Apr-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Bupivacaine and Adrenaline (Epinephrine) Injection 0.25% w/v, 1 in
200,000
2. Qualitative and quantitative composition
Each 10ml of solution contains Bupivacaine Hydrochloride B.P. 26.375mg
equivalent to anhydrous
Bupivacaine Hydrochloride 25mg, Adrenaline Acid Tartrate B.P. 0.091mg
equivalent to Adrenaline
0.05mg
3. Pharmaceutical form
Solution for injection. Colourless or almost colourless, aqueous,
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, infants and children above 1 year
of age
_Note: _
_From the reviewed literature only evidence for the use of bupivacaine
1.25 - 2.5 mg/ml + 2.5 - 5μg/ml _
_adrenaline for caudal epidural block in children > 1 year of age
could be derived. _
_Regarding other anaesthetic techniques, the investigated paediatric
population were mostly very small _
_and a variety of different applications were studied, so that no
reliable recommendations can be derived _
_from the literature. _
_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 i