BUPIVACAINE

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

BUPIVACAINE HYDROCHLORIDE

から入手可能:

Accord Healthcare Limited

ATCコード:

N01BB01

INN（国際名）:

BUPIVACAINE HYDROCHLORIDE

投薬量:

5 Mg/Ml

医薬品形態:

Solution for Injection

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

bupivacaine

認証ステータス:

Not Marketed

承認日:

2017-05-19

情報リーフレット

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Bupivacaine Hydrochloride
IE
English
170 x 550 mm PIL
9
1 (Page 1 of 2)
21/03/17 (Bupivacaine Hydrochloride (ACC-IE)PIL)
Colours Used
Pantone Black
Prepared By
Regulatory Affairs
Checked By
Regulatory Affairs
Approved By
Quality Assurance
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bupivacaine 2.5 mg/ml
solution for injection
Bupivacaine 5 mg/ml
solution for injection
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please 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 signs of illness 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.
WHAT IS IN THIS LEAFLET:.
1. What Bupivacaine solution for injection is and
what it is used for
2. What you need to know before you use
Bupivacaine solution for injection
3. How to use Bupivacaine solution for injection
4. Possible side effects
5. How to store Bupivacaine solution for injection
6. Contents of the pack and other information 1. WHAT BUPIVACAINE SOLUTION
FOR INJECTION IS AND WHAT IT IS
USED FOR
Bupivacaine solution for injection contains the
active substance bupivacaine hydrochloride. It
belongs to a group of medicines called
amide-type local anaesthetics.
Bupivacaine solution for injection is used 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 in adults
and children above 12 years.
•
Relieve pain during childbirth.
•
Relieve pain in adults, infants and children
above 1 year of age 2. WHAT YOU NEED TO KNOW BEFORE
YOU USE BUPIVACAINE SOLUTION
FOR INJECTION

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bupivacaine 5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 5 mg bupivacaine hydrochloride (as monohydrate)
Each 2 ml contains 10 mg bupivacaine hydrochloride (as monohydrate)
Each 4 ml contains 20 mg bupivacaine hydrochloride (as monohydrate)
Each 5 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)
Each 10 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)
Each 20 ml contains 100 mg bupivacaine hydrochloride (as monohydrate)
Excipient with known effect:
Each ml of Bupivacaine 5 mg/ml solution for injection contains 0.14
mmol (3.2 mg) of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless or almost colourless solution.
The pH of solution is 4.0 to 6.5.
Osmolality of solution is 270 - 320 mOsmol/kg H2O
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bupivacaine is indicated for:
Surgical anaesthesia in adults and children above 12 years of age
Acute pain management in adults, infants and children above 1 year of
age
Bupivacaine is used for the production of prolonged local anaesthesia
by percutaneous infiltration, intra-articular block,
peripheral nerve block(s) and central neural block (caudal or
epidural), Bupivacaine is also used for pain relief during
labour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE
The following table is a guide to dosage for the more commonly used
techniques in the average adult. The figures
reflect the expected average dose range needed. Standard textbooks
should be consulted for factors affecting specific
block techniques and for individual patient requirements.
N.B. When prolonged blocks are used, either by continuous infusion or
by repeated bolus administration, the risks of
reaching a toxic plasma concentration or inducing a local neural
injury must be considered.
The clinician's experience and knowledge of the patient's physical
status is import