Ropivacaine 7.5 mg/ml solution for injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Ropivacaine Hydrochloride

זמין מ:

Fresenius Kabi Deutschland GmbH

קוד ATC:

N01BB; N01BB09

INN (שם בינלאומי):

Ropivacaine Hydrochloride

כמות:

7.5 milligram(s)/millilitre

טופס פרצבטיות:

Solution for injection

סוג מרשם:

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

איזור תרפויטי:

Amides; ropivacaine

מצב אישור:

Not marketed

תאריך אישור:

2010-08-06

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ropivacaine 2 mg/ml solution for injection
Ropivacaine 7.5 mg/ml solution for injection
Ropivacaine 10 mg/ml solution for injection
Ropivacaine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, nurse or any other
healthcare professional.
-
If you get any side effects, talk to your doctor, nurse or any other
healthcare professional. This includes any possible side
effects not listed in this leaflet. See section 4.
The full names of the medicines covered by this leaflet are:
Ropivacaine 2 mg/ml solution for injection
Ropivacaine 7.5 mg/ml solution for injection
Ropivacaine 10 mg/ml solution for injection
In this leaflet they are jointly referred to as Ropivacaine.
WHAT IS IN THIS LEAFLET
1. What Ropivacaine is and what it is used for
2. What you need to know before you are given Ropivacaine
3. How to use Ropivacaine
4. Possible side effects
5. How to store Ropivacaine
6. Contents of the pack and other information
1. WHAT ROPIVACAINE IS AND WHAT IT IS USED FOR
•
Ropivacaine contains a medicine called ropivacaine hydrochloride.
•
It belongs to a group of medicines called local anaesthetics.
Ropivacaine 2 mg/ml solution for injection is used in adults and
children of all ages for
acute pain management. It numbs (anaesthetises) parts of the body e.g.
after surgery.
Ropivacaine 7.5 mg/ml solution for 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, including having a baby by
Caesarean
section.
-
Relieve pain during childbirth, after surgery, or after an accident.
Ropivacaine 10 mg/ml solution for injection is used in adults and
children above 12
years to numb (anaesthetise) parts of the body during surgery.
2. WHAT YOU N

מאפייני מוצר

Health Products Regulatory Authority
05 October 2023
CRN00DTJ1
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ropivacaine 7.5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution for injection contains 7.5 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 75 mg ropivacaine hydrochloride.
Each 20 ml ampoule contains 150 mg ropivacaine hydrochloride.
Excipient with known effect:
Each 10 ml ampoule contains 1.3 mmol (or 29.9 mg) of sodium.
Each 20 ml ampoule contains 2.6 mmol (or 59.8 mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution with a pH of 4.0 to 6.0 and an osmolality
between 255 and 305 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ropivacaine 7.5 mg/ml and 10 mg/ml solution for injection is indicated
in adults and children above 12 years for:

Surgical anaesthesia :
- Epidural blocks for surgery, including Caesarean section
- Major nerve blocks
- Field blocks
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ropivacaine should only be used by, or under the supervision of,
clinicians experienced in regional anaesthesia.
POSOLOGY
_ROPIVACAINE 7.5 MG/ML AND ROPIVACAINE 10 MG/ML SOLUTION FOR
INJECTION_
_ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE _
The following table is a guide to dosage for the more commonly used
blocks. The smallest dose required to produce an
effective block should be used. The clinician's experience and
knowledge of the patient's physical status are of importance
when deciding the dose.
CONCENTRATION
MG/ML
VOLUME
ML
DOSE
MG
ONSET
MINUTES
DURATION
HOURS
SURGICAL ANAESTHESIA
LUMBAR EPIDURAL ADMINISTRATION
Surgery
7.5
15-25
113-188
10-20
3-5
10.0
15-20
150-200
10-20
4-6
Caesarean section
7.5
15-20
113-150
1)
10-20
3-5
THORACIC EPIDURAL ADMINISTRATION
To establish block for post-operative
7.5
5-15 (dependent on the level of
38-113
10-20
n/a
2)
Health Products Regulatory Authority
05 October 2023
CRN00DTJ1
Page 2 of 11
pain