Ropivacaine 100mg/10ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ropivacaine hydrochloride

Available from:

Advanz Pharma

ATC code:

N01BB09

INN (International Name):

Ropivacaine hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Epidural; Perineural

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5099602996229

Patient Information leaflet

CHILDREN
In children, the side effects are the same as in adults except for low
blood pressure which hap-
pens less often in children (affecting less than 1 in 10 children) and
being sick which happens
more often in children (affecting more than 1 in 10 children).
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE ROPIVACAINE
Keep this medicine out of the reach and sight of children.
Do not use Ropivacaine after the expiry date which is stated on the
ampoule or carton box. The
expiry date refers to the last day of that month.
Do not freeze.
Do not use Ropivacaine if you notice any precipitation in the solution
for injection.
Your doctor or the hospital will normally store Ropivacaine and they
are responsible for the
quality of the product when it has been opened if it is not used
immediately. They are also re-
sponsible for disposing of any unused Ropivacaine correctly.
Medicines should not be disposed of via wastewater or household waste.
Your doctor, nurse or
pharmacist will dispose of medicines no longer required. These
measures will help to protect
the environment.
6. FURTHER INFORMATION
WHAT ROPIVACAINE CONTAINS
-
The active substance is ropivacaine hydrochloride 10 mg/ml. Each 10 ml
polypropylene am-
poule contains 100 mg ropivacaine (as hydrochloride).
Each 20 ml polypropylene ampoule contains 200 mg ropivacaine, (as
hydrochloride).
-
The other ingredients are_ _sodium chloride, sodium hydroxide (for pH
adjustment) and water
for injections.
WHAT ROPIVACAINE LOOKS LIKE AND CONTENTS OF THE PACK
Ropivacaine solution for injection is a clear, colourless, sterile,
isotonic, isobaric aqueous solu-
tion for injection.
Ropivacaine 10 mg/ml solution for injection is available in 10 ml and
20 ml transparent
polypropylene ampoules.
Pack sizes:
10 sterile ampoules in plastic overwrap
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Mercury Pharmaceuticals Ltd
No. 1 Croydon,
12-16 Addiscombe Road,
Croydon,
CR0 0XT,

Summary of Product characteristics

ROPIVACAINE 10 MG / ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 25-Sep-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Ropivacaine 10 mg / ml solution for injection
2. Qualitative and quantitative composition
Ropivacaine 10 mg/ml:
Each ml solution for injection contains 10 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 100 mg ropivacaine hydrochloride.
Each 20 ml ampoule contains 200 mg ropivacaine hydrochloride.
Excipient:
Ropivacaine 10 mg/ml:
Each 10 ml ampoule contains 1.2 mmol (or 28 mg) of sodium.
Each 20 ml ampoule contains 2.4 mmol (or 56 mg) of sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear, colourless, sterile, isotonic, isobaric aqueous solution for
injection with a pH of 4.0 to 6.0.
4. Clinical particulars
4.1 Therapeutic indications
Ropivacaine 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
_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.
INDICATION
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 pain relief
7.5
5-15
(dependent on
the level of
injection)
38-113
10-20
--
MAJOR NERVE BLOCK*
Brachial plexus block
7.5
30-40
225-300
2)
10-25
6-10
FIELD