Naropin 20mg/10ml solution for injection ampoules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ropivacaine hydrochloride

זמין מ:

Aspen Pharma Trading Ltd

קוד ATC:

N01BB09

INN (שם בינלאומי):

Ropivacaine hydrochloride

כמות:

2mg/1ml

טופס פרצבטיות:

Solution for injection

מסלול נתינה (של תרופות):

Perineural; Epidural

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 15020100; GTIN: 5000455018297

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAROPIN
 2 MG/ML, 7.5 MG/ML, 10 MG/ML SOLUTION FOR INJECTION
NAROPIN
 2 MG/ML SOLUTION FOR INFUSION
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” or
“Naropin solution for infusion”.

It contains a medicine called ropivacaine hydrochloride.

It belongs to a group of medicines called local anaesthetics

It will be given to you either as an injection or as an infusion,
depending on what it is being used for.
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: Fur

מאפייני מוצר

OBJECT 1
NAROPIN 2 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 01-Mar-2018 | Aspen
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 (34 mg) sodium.
Each 20 ml ampoule contains 2.96 mmol (68 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:
- Continuous epidural infusion or intermittent bolus administration
during postoperative or labour pain.
- Field blocks.
- Continuous peripheral nerve block via a continuous infusion or
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.
- Continuous epidural infusion.
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 AG