Naropin® 2 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ropivacaine Hydrochloride

Available from:

Aspen Pharma Trading Limited

ATC code:

N01BB; N01BB09

INN (International Name):

Ropivacaine Hydrochloride

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Amides; ropivacaine

Authorization status:

Not marketed

Authorization date:

1996-06-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAROPIN
 2 MG/ML, 7.5 MG/ML, 10 MG/ML SOLUTION FOR INJECTION
Ropivacaine hydrochloride
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 any further questions, ask your doctor or nurse.
•
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 nurse. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Naropin is and what it is used for
2. What you need to know before you take Naropin
3. How to take Naropin
4. Possible side effects
5. How to store Naropin
6. Contents of the pack and other information
1.
WHAT NAROPIN IS AND WHAT IT IS USED FOR
The name of your medicine is “Naropin solution for injection”.
•
It contains a medicine called ropivacaine hydrochloride.
•
It belongs to a group of medicines called local anaesthetics
•
It will be given to you as an injection.
Naropin 7.5 and 10 mg/ml is used in adults and children above 12 years
of age 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.
Naropin 2 mg/ml is used in adults and children of all ages for acute
pain management. It numbs
(anaesthetises) parts of the body e.g. after surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAROPIN
DO NOT TAKE NAROPIN:
•
If you are allergic (hypersensitive) to ropivacaine hydrochloride or
any of the other ingredients of
Naropin (see Section 6: Further information).
•
If you are allergic to any other local anaesthetics of the same class
(such as lidocaine or bupivacaine).
•
If you have

Summary of Product characteristics

Health Products Regulatory Authority
24 October 2023
CRN00DTMM
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naropin® 2 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains ropivacaine hydrochloride
monohydrate equivalent to 2 mg ropivacaine hydrochloride.
1 ampoule of 10 ml or 20 ml solution for injection contains
ropivacaine hydrochloride monohydrate equivalent to 20 mg and
40 mg ropivacaine hydrochloride respectively.
Excipients with known effect:
Each 10 ml ampoule contains 1.48 mmol (33.87 mg) sodium.
Each 20 ml ampoule contains 2.96 mmol (67.74 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NAROPIN 7.5 MG/ML IS INDICATED IN ADULTS AND ADOLESCENTS AGED ABOVE 12
YEARS OF AGE FOR:
SURGICAL ANAESTHESIA:
‑ Epidural blocks for surgery, including Caesarean section.
‑ Major nerve blocks.
‑ Field blocks.
NAROPIN 10 MG/ML IS INDICATED IN ADULTS AND ADOLESCENTS AGED ABOVE 12
YEARS OF AGE FOR:
SURGICAL ANAESTHESIA:
‑ Epidural blocks for surgery.
NAROPIN 2 MG/ML IS INDICATED FOR ACUTE PAIN MANAGEMENT
In adults and adolescents above 12 years of age for:
‑ Intermittent bolus administration during postoperative or labour
pain.
‑ Field blocks.
‑ Continuous peripheral nerve block via intermittent bolus
injections, e.g. postoperative pain management
In infants from 1 year and children up to and including 12 years of
age (per- and postoperative):
- Single and continuous peripheral nerve block.
In neonates, infants and children up to and including 12 years of age
for(per- and postoperative):
- Caudal epidural block
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Naropin should only be used by, or under the supervision of,
clinicians experienced in regional anaesthesia.
POSOLOGY
ADULTS AND ADOLESCENTS ABOVE 12 YEARS OF AGE:
The following table is a guide to dosage for the more commonly used
blo