ROPIVACAINE ALTAN 10 MGML

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

ROPIVACAINE HYDROCHLORIDE

Dostupné z:

PROPHARM LTD

ATC kód:

N01BB09

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

ROPIVACAINE HYDROCHLORIDE 10 MG / 1 ML

Spôsob podávania:

PERINEURAL, EPIDURAL

Typ predpisu:

Required

Výrobca:

ALTAN PHARMACEUTICALS S.A., SPAIN

Terapeutické oblasti:

ROPIVACAINE

Terapeutické indikácie:

Ropivacaine 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:Surgical anaesthesia: Lumbar epidural administration for surgery

Dátum Autorizácia:

2019-09-04

Súhrn charakteristických

1
1.
NAME OF MEDICINAL PRODUCT
ROPIVACAINE ALTAN 2 MG/ML, ROPIVACAINE ALTAN 10 MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ROPIVACAINE ALTAN 2 MG/ML
1 ml solution for injection contains 2 mg ropivacaine hydrochloride.
1 ampoule of 10 ml solution for injection contains 20 mg ropivacaine
hydrochloride
(
equivalent to 21.16 mg of ropivacaine hydrochloride
monohydrate
)
.
Excipient:
Each ml contains 3.34 mg of sodium.
ROPIVACAINE ALTAN 10 MG/ML
1 ml solution for injection contains 10 mg ropivacaine hydrochloride
1 ampoule of 10 ml solution for injection contains 100 mg ropivacaine
hydrochloride
(
equivalent to 105.80 mg of ropivacaine hydrochloride
monohydrate).
Excipient:
Each ml contains3.03 mg of Sodium.
For a full list of excipients see
_section 6.1_
.
3.
PHARMACEUTICAL FORM
Solution for injection Clear, colourless solution
Ropivacaine
Altan
solution for injection is a sterile solution.
The pH of the solution is adjusted to 4.5-5.8 with sodium hydroxide or
hydrochloric
acid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ROPIVACAINE
ALTAN 10 MG/ML IS INDICATED IN ADULTS AND ADOLESCENTS AGED ABOVE 12
YEARS OF AGE FOR:
Surgical Anaesthesia
Lumbar epidural administration for surgery.
ROPIVACAINE ALTAN 2MG/ML
IS INDICATED IN ADULTS AND ADOLESCENTS ABOVE 12 YEARS OF
AGE FOR:
Acute pain management:
a.
Continuous epidural infusion or intermittent bolus administration
during
postoperative or labour pain.
b.
Field blocks.
c.
Peripheral nerve block via continuous infusion or intermittent bolus
injections,
e.g. postoperative pain management.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Ropivacaine Altan
should only be used by or under the supervision of clinicians
experienced
in regional anaesthesia.
_ADULTS AND ADOLESCENTS 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 dos