Dolocopin 40mg/g Cream

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Lidocaine

Предлага се от:

Ferndale Laboratories Limited

АТС код:

N01BB02

INN (Международно Name):

Lidocaine

дозиране:

40 milligram(s)/gram

Лекарствена форма:

Cream

Терапевтична област:

lidocaine

Статус Оторизация:

Not marketed

Дата Оторизация:

2015-11-27

Листовка

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLOCOPIN 40MG/G CREAM
lidocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others, it may harm them.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dolocopin is and what it is used for
2.
What you need to know before you use Dolocopin
3.
How to use Dolocopin
4.
Possible side effects
5.
How to store Dolocopin
6.
Contents of the pack and other information
1.
WHAT DOLOCOPIN IS AND WHAT IT IS USED FOR
This medicine is called: Dolocopin
Dolocopin is a type of medicine called a local anaesthetic, used to
numb an area of the body.
Dolocopin temporarily numbs the surface of the skin, providing pain
relief when a needle is inserted into a
vein (venipuncture or venous cannulation) for medical purposes, such
as extracting blood for laboratory
tests, for adults and children aged one month and older.
It may also be used to numb the skin prior to administration of
painful topical treatments on larger surface
areas of intact skin for adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOLOCOPIN
DO NOT USE DOLOCOPIN:
Talk to your doctor or pharmacist and do not use Dolocopin if:
•
You are allergic (hypersensitive) to lidocaine or to any of the other
ingredients.
•
You are allergic to any similar local anaesthetics.
•
You are allergic to soya or peanuts (contains hydrogenated soy
lecithin).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Dolocopin if:
•
You are acutely ill, debilitated or elderly (you will be more
sensitive to lidocaine).
•
You have a history of being sensitive to the ingredients of any
medicines,

Данни за продукта

Health Products Regulatory Authority
27 March 2024
CRN00F7FT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolocopin 40mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of cream contains 40 mg of lidocaine.
Excipients with known effect:
1 gram of cream contains 75mg of propylene glycol
1 gram of cream contains 15mg of benzyl alcohol
1 gram of cream contains 73.2mg of hydrogenated soy lecithin
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white to off-white yellowish cream
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local anaesthetic for topical use to produce surface anaesthesia of
the skin prior to:
- venous cannulation or venipuncture in adults and in the paediatric
population ≥ one month
- administration of painful topical treatments on larger surface areas
of intact skin where use of a topical anaesthetic is
appropriate in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
VENOUS CANNULATION OR VENIPUNCTURE:
Posology:
Adults, including elderly, and children over one month of age:
_Paediatric Population:_
Use of Dolocopinis not recommended for this indication in infants
under one month of age.
Method of administration:
Apply 1g to 2.5g of cream onto the skin to cover a 2.5cm x 2.5cm
(6.25cm
2
) area where venous cannulation or venipuncture will
occur. No more than 1g of cream should be applied to infants below the
age of 1 year. 1g of cream equates to approximately
5cm of cream squeezed from the 5g tube, or 3.5cm from the 30g tube.
The cream should remain undisturbed and the area can be covered with
an occlusive dressing to prevent disturbance or
interference by the patient or other external factors. Adequate
anaesthesia should be obtained after 30 minutes, but the
Dolocopinmay be applied for up to 5 hours under a dressing. Prior to
starting the procedure, the Dolocopinshould be
removed using a clean gauze swab and the site for venous cannulation
or venipuncture prepared in the usual manner. The
p