Hydrogen Peroxide Solution 6% BP (20 Vols)

Država: Malta

Jezik: angleščina

Source: Medicines Authority

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Navodilo za uporabo Navodilo za uporabo (PIL)
27-06-2023
Lastnosti izdelka Lastnosti izdelka (SPC)
27-06-2023

Aktivna sestavina:

HYDROGEN PEROXIDE

Dostopno od:

LCM Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

Koda artikla:

D08AX01

INN (mednarodno ime):

HYDROGEN PEROXIDE 15 % (V/V)

Farmacevtska oblika:

SOLUTION

Sestava:

HYDROGEN PEROXIDE 15 % (V/V)

Tip zastaranja:

OTC

Terapevtsko območje:

ANTISEPTICS AND DISINFECTANTS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2006-10-31

Navodilo za uporabo

                                PRINT LAYOUT DIAGRAM
65MM X 170MM MULTIPEEL WITH 50MM HINGE LEFT
CARRIER:
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MHRA HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
Landscape peelable label
200ml
22746109
65 x 170mm
1
19.09.2017
Hydrogen Peroxide Solution 6% 20 vols
Helvetica
Helvetica Neue
Univers
Optima BQ
7pt
6.6pt
9.5pt
12pt
9pt
15pt
9.5pt
12pt
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Process Magenta
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Keyline (Non-Printing)
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Text Free Area (Non-Printing)
POINT SIZES USED
MIN MAX
_HYDROGEN_
_PEROXIDE_
_SOLUTION 6%_
_20 VOLS_
FOR EXTERNAL USE ONLY
FOR USE AS A MILD SKIN DISINFECTANT,
MOUTHWASH OR GARGLE
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX
FOR FUTURE USE.
For use as a mild disinfectant for minor
cuts, wounds and skin ulcers or as a
mouthwash and gargle.
FOR SKIN DISINFECTION:
ADULTS, THE ELDERLY AND CHILDREN:
• Dilute a portion of the peroxide with an
equal amount of water.
• Soak some cotton wool in this solution
and use it to dress the wound as required.
AS A MOUTHWASH OR GARGLE:
ADULTS, THE ELDERLY AND CHILDREN OVER 12
YEARS:
• Dilute a portion of the peroxide with five
times the amount of water e.g. 5ml of
peroxide and 25ml of water.
• Use this solution to rinse the mouth for
2–3 minutes.
• Repeat up to three times a day.
DO NOT GIVE TO CHILDREN UNDER 12
YEARS OLD AS A MOUTHWASH unless
your doctor tells you to.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENT: hydrogen peroxide 6% w/v.
ALSO CONTAINS: phosphoric acid (E338),
phenacetin and purified water.
Do not store above 25°C. Protect from light.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder:
L.C.M. Ltd., Huddersfield, HD7 5QH, UK for
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK. PL 12965/0016
MA213/00701 22746109
This medicine contains hydrogen peroxide, a
disinfectant and deodorant. It kills bacteria by
releasing oxygen when in contact with body
tissues.
1. BEFORE YOU USE THIS MEDICINE
DO NOT
                                
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Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydrogen Peroxide Solution 6% BP 20 Vols
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrogen peroxide aqueous solution 35% w/w HSE 15.0% v/v.
3.
PHARMACEUTICAL FORM
Solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1. As a mild disinfectant for minor cuts, wounds and skin ulcers.
2. As a mouthwash or gargle.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Topical.
1.
As a disinfectant:
Use as required. Dress the wound with cotton wool soaked in a solution
of equal parts
of peroxide and water.
As a disinfectant this product is suitable for use by adults, children
and the elderly.
2.
As a mouthwash or gargle:
Dilute one part of peroxide to five parts of water. Rinse the mouth
for two to three
minutes. This may be repeated up to three times daily.
As a mouthwash or gargle the product is suitable for use by adults,
children over 12
years and the elderly. Due to the risk of swallowing it should only be
used by younger
children under the instruction of a doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients
Not for use in closed body cavities or on surgical wounds due to the
risk of oxygen
released into the circulation causing gas embolism.
Not for use as a disinfection agent for surgical instruments
(particularly endoscopes)
and as an enema.
Page
1
of
4
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep all medicines away from children.
Not for use in closed body cavities or on surgical wounds due to risk
of oxygen
released into the circulation causing gas embolism.
Avoid normal skin.
Product bleaches fabric.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6.
FERTILITY, PREGNANCY AND LACTATION
All medicines should be avoided if possible during pregnancy and
lactation. No
evidence is available as to the safety of use of this product in these
conditions.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8.
UNDESIRABLE EFFECTS
Cases of gas emboli
                                
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