ESRACAIN GEL

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

LIDOCAINE HYDROCHLORIDE

から入手可能:

RAFA LABORATORIES LTD

ATCコード:

N/A

医薬品形態:

GEL

構図:

LIDOCAINE HYDROCHLORIDE 2 %

投与経路:

LOCAL ORAL, MUCOSAL, TOPICAL

処方タイプ:

Not required

製:

RAFA LABORATORIES LTD, JERUSALEM

適応症:

Local anesthetic, not to be used for procedures requiring sterile products

承認日:

2021-11-30

情報リーフレット

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold without a doctor’s prescription
ESRACAIN GEL
ACTIVE INGREDIENT: Lidocaine hydrochloride 2%
For the list of inactive ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
Refer to your doctor if the symptoms get worse or do not improve after
3-5 days.
The gel is not intended for relieving teething pains in children and
infants.
The gel is usually not intended for children under the age of 2 years
and in any case children
under the age of 3 will be treated under medical supervision only (see
details below on use in
children).
Use this medicine in the correct manner. Consult the pharmacist if you
need additional
information.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for use as a topical anesthetic for local
relief of pain of the skin and
mucous membranes. Do not use this medicine in sterile procedures.
THERAPEUTIC GROUP: Local anesthetic of the amide group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

Do not use if you are sensitive (allergic) to the active ingredient,
to any other local anesthetic
of the amide group, or to any of the other ingredients the medicine
contains (for the list of
inactive ingredients, please see section 6).

Do not use in sterile procedures.

Do not use on festering sores or large areas of skin. Frequent use of
this medicine, on large
areas of skin or for a long period may cause side effects due to
excessive absorption (see
section 'side effects').
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:

Do not use this medicine frequently or for a long period without
consulting a doctor.

The recommended dosage should be strictly adhered to. Use of a too
high or too frequent
dosage, may cause serious and even life-threatening side effects,
including sei

製品の特徴

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Esracain® Gel
1.1
Qualitative and quantitative composition
Lidocaine hydrochloride 2%
1 ml of gel contains
20
mg lidocaine hydrochloride.
Excipients with known effect: Propylene glycol and benzalkonium
chloride.
1 ml of gel contains approximately
20
mg propylene glycol.
1 ml of gel contains 0.15 mg benzalkonium chloride.
For the full list of excipients, see 6 DOSAGE FORMS, STRENGTHS,
COMPOSITION AND
PACKAGING.
1.2 Pharmaceutical form
Clear, colorless gel
.
2
THERAPEUTIC INDICATIONS
Local anesthetic, not to be used for procedures requiring sterile
products.
3
CONTRAINDICATIONS
•
Lidocaine is contraindicated in patients who are hypersensitive to the
active substance
or to any of the excipients of the gel or components of the container.
For a complete
listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
•
Lidocaine is contraindicated in patients with a known history of
hypersensitivity to local
anesthetics of the amide type or to other components of the gel (see 6
DOSAGE
FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
•
Not to be used for procedures requiring sterile products.
•
Lidocaine is contraindicated in patients with congenital or idiopathic
methemoglobinemia and patients with glucose-6-phosphate dehydrogenase
deficiency, which are more susceptible to drug-induced
methemoglobinemia.
•
Lidocaine is contraindicated in infants who require treatment with
methemoglobininducing agents, e.g., sulfonamides and are 12 months of
age or
younger (see 9 DRUG INTERACTIONS).
2
4
DOSAGE AND ADMINISTRATION
4.1
Recommended Dose and Dosage Adjustment
Dosage for adults (over the age of 18):
Use the smallest amount necessary to control your symptoms.
•
Usually the effective dose is no more than 5 to 10 mL per application.
•
No more than 6 doses should be used per day (24 hours).
Dosage in Children:
The gel is usually not intended for children under the age of 2 years
and in any case children
under the age of 3 will be treated under med