BALNEUM PLUS

国家: 以色列

语言: 英文

来源: Ministry of Health

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资料单张 资料单张 (PIL)
09-03-2022
产品特点 产品特点 (SPC)
02-01-2022
公众评估报告 公众评估报告 (PAR)
27-08-2017

有效成分:

POLIDOCANOL; SOYA OIL

可用日期:

NEOPHARM LTD

ATC代码:

C05BB02

药物剂型:

SOLUTION

组成:

SOYA OIL 82.95 G / 100 G; POLIDOCANOL 15 G / 100 G

给药途径:

TOPICAL

处方类型:

Not required

厂商:

ALMIRALL HERMAL GMBH, GERMANY

治疗组:

POLIDOCANOL

治疗领域:

POLIDOCANOL

疗效迹象:

Refatting medical oil bath with antipruritic effect.

授权日期:

2021-10-31

资料单张

                                Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed without a doctor's prescription
BALNEUM PLUS
Medicated bath oil, solution for external use
ACTIVE INGREDIENT COMPOSITION IN 100 GRAMS OF BATH OIL:
soya oil 82.95 g
polidocanol 15.00 g
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of
this medicine’s ingredients’, and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
Take this medicine according to the instructions in the section about
dose in this leaflet.
Consult your pharmacist if you need further information. Consult your
doctor if your signs of
illness (symptoms) get worse or do not improve.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Medical bath oil that restores skin moisture and helps alleviate
itching.
THERAPEUTIC GROUP: skin emollients and refatting agents.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredients, refined
soybean oil,
soya, peanuts, d-Limonene, linalool or any of the other ingredients in
this medicine (see section 6).
•
in cases of recent psoriasis (psoriasis pustulosa, psoriasis
accompanied by
pustules and sometimes fever and reduced general well-being).
ln general, please consult your doctor before you take any full
baths—including baths
with Balneum Plus—if you have large skin lesions and acute
dermatological
problems for an unclear cause or if you suffer from severe febrile and
infectious
diseases, weak cardiac muscles (cardiac insufficiency) and high blood
pressure.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
Consult your doctor סr pharmacist before using Balneum Plus.
Undiluted Balneum Plus must not come into contact with the eyes and
mucous
membranes. ln case of accidental contact with eyes, rinse eyes
immediately with
                                
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产品特点

                                Page 1 of 4
The format of this leaflet was set by the Ministry of Health and its
content checked and
approved
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Balneum Plus, topical solution liquid.
Contains soya oil, polidocanol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of liquid bath additive contains:
soya oil (Ph.Eur.) 82.95 g
polidocanol (Ph. Eur.) 15.0 g
Excipients with known effect: propylene glycol, fragrance containing D
limes and linalool.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liquid bath additive
BALNEUM PLUS is a light yellow, opaque oily liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Refatting medical oil bath with antipruritic effect It is used for the
supportive treatment of all
skin diseases associated with drying out.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Shake well before use!
If used in baths, add BALNEUM PLUS to the bath water and mix well
until distributed evenly.
you can use the interior of the screw cap as a measuring cup to ensure
that you add the
recommended quantity of Balneum Plus:
Use 2 – 3 cups (30 – 45 ml) for a full bath (ca. 150 l);
Use a third of a cup (5 ml) for children's bathtub (ca. 25 l);
Use approx. quarter teaspoon (1 ml) for a soaking bath (5 l).
The bathwater temperature should not exceed 36 °C as the moisturising
effect diminishes at
higher temperatures. Lower bathwater temperature (around 32 °C) is
more suitable for
moisturising skin and for treating itches.
The bath time can be chosen individually but should not exceed 15 –
20 minutes. A
treatment time of a few minutes is usually sufficient for infants and
young children.
When used during a shower undiluted BALNEUM PLUS is applied to wet
skin and then rinsed
off with water.
Gently pat the skin dry with a towel after bathing or showering.
Rigorous towelling and
rubbing will reduce the therapeutic effects.
Page 2 of 4
How often BALNEUM PLUS has to be used depends on the severity and type
of symptoms and
should be decided individually. I
                                
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