SEPTAL SCRUB

Israel - English - Ministry of Health

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Active ingredient:
CHLORHEXIDINE GLUCONATE
Available from:
TEVA MEDICAL LTD
ATC code:
D08AC02
Pharmaceutical form:
SOLUTION - EXTERNAL
Composition:
CHLORHEXIDINE GLUCONATE 4 %W/V
Administration route:
TOPICAL
Prescription type:
Not required
Manufactured by:
VITAMED PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
CHLORHEXIDINE
Therapeutic area:
CHLORHEXIDINE
Therapeutic indications:
• Antiseptic hand wash• Pre-operative Surgical Scrub • Pre-operative Skin Preparation
Authorization number:
043 08 23618 00
Authorization date:
2014-12-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

03-06-2020

Septal Scrub HA 12/2019 Certification

SUMMARY OF PRODUCT CHARACTERISTICS

Septal Scrub

®

1

NAME OF THE MEDICINAL PRODUCT

Septal Scrub

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Gluconate 4% w/v.

3

PHARMACEUTICAL FORM

Solution -External.

Clear or slightly opalescent, viscous red liquid.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Antiseptic hand wash

Pre-operative Surgical Scrub

Pre-operative Skin Preparation

4.2

Posology and method of administration

Antiseptic hand wash

- wet the hands and forearms, apply 5 ml of skin cleanser and

wash for one minute. Rinse thoroughly and dry.

Pre-operative Surgical Scrub

- wet hands and forearms, apply 5 ml of skin cleanser

and wash for one minute, cleaning the finger nails with a brush. Rinse and repeat the

procedure using a further 5 ml of skin cleanser and wash for 2 minutes. Rinse

thoroughly and dry.

Septal Scrub HA 12/2019 Certification

Pre-operative Skin Preparation

- the patient should wash his whole body with 25

ml of the cleanser on at least two occasions, usually the day before and on the day of

the operation.

4.3

Contraindications

Avoid contact with eyes, middle ear, brain and meninges.

Known hypersensitivity-to the product or any of its components, especially in those

with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and

4.8).

4.4

Special warnings and precautions for use

For external use only.

Keep out of the reach and sight of children.

Do not use in body cavities.

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis

prior to invasive procedures has been associated with chemical burns in neonates.

Based on available case reports and the published literature, this risk appears to be

higher in preterm infants, especially those born before 32 weeks of gestation and within

the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the

intervention. Do not use excessive quantities and do not allow the solution to pool in

skin folds or under the patient or drip on sheets or other material in direct contact with

the patient. Where occlusive dressings are to be applied to areas previously exposed to

Septal Scrub, care must be taken to ensure no excess product is present prior to

application of the dressing.

4.5

Interaction with other medicinal products and other forms of interaction

None known.

4.6

Pregnancy and lactation

No special precautions need to be taken when used in pregnancy and lactation.

4.7

Effects on ability to drive and use machines

None known.

Septal Scrub HA 12/2019 Certification

4.8

Undesirable effects

Immune disorders

Frequency not known:

Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4)

to chlorhexidine gluconate or amine oxide, particularly on repeated use.

Skin disorders

Frequency not known:

Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash,

urticarial, skin irritation, and blisters.

Chemical burns in neonates.

System Organ

Class

Very common

(> 1/10)

Common

(> 1/100 <

1/10)

Uncommon

(> 1/1,000 <

1/100)

Rare

(> 1/10,000 <

1/1,000)

Very rare

(< 1/10,000)

Not known

(cannot be

estimated from

available data)

Immune

System

Disorders

Hypersensitivity

Anaphylactic shock

Skin and

Subcutaneous

Tissue

Disorders

Allergic skin

reactions

Chemical burns

neonates

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Any suspected adverse events should be reported to the Ministry of Health

according to the National Regulation by using an online form

https://sideeffects.health.gov.il

4.9

Overdose

Chlorhexidine is poorly absorbed. If swallowed treat with gastric lavage. Employ

supportive measures as appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Chlorhexidine is a bisbiguanide disinfectant which is active against a wide range of

Septal Scrub HA 12/2019 Certification

Gram-positive and Gram-negative vegetative bacteria. It is also active against some

viruses and fungi. It is most active at neutral or slightly acid pH.

5.2

Pharmacokinetic properties

Percutaneous absorption of chlorhexidine gluconate is negligible and leads to clinically

insignificant plasma concentrations.

5.3

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of

repeated dose toxicity, carcinogenic potential and toxicity to reproduction.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Pluronic PE 6800

Ammonyx L0

Isopropanol

D-gluconolactone

Herbacol 15.393/T(B)

Spectracol ponceau 4R

Sodium hydroxide (for pH adjustment)

Water for injection.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4

Special precautions for storage

Store below 25°C.

The product can be used for up to 2 months after first opening the bottle.

6.5

Nature and contents of container

Septal Scrub is packaged in a 500ml HDPE bottle.

6.6

Special precautions for disposal

Not applicable.

7

LICENCE HOLDER AND MANUFACTURER

Teva Medical Ltd, Haorgim st. 8, Ashdod.

Septal Scrub HA 12/2019 Certification

8

REGISTRATION NUMBER

043.08.23618

This leaflet format has been determined by the Ministry of Health and the content has been

checked and approved in February 2020

:ךיראת ץרמ

2020

ה/דבכנ ת/חקור ,ה/ אפור

תא רשיא תואירבה דרשמש העידומ עבט תרבח ץומיא

אפורל ןולעה

ןכרצל ןולעהו

ב

-

UK

לש

רישכתה

Septal Scrub

Active ingredient: Chlorhexidine Gluconate 4%

.וז העדוהל םיפרוצמ ןכרצלו אפורל םינולעה

סונ ינוכדע ועצוב תואירבה דרשמ םע םואיתב ףסונב המאתהב היוותהב םילק ח תחא הרסוהו :תויותההמ

רשואמ היוותה חסונ

םדוק היוותה חסונ

Antiseptic hand wash

Surgical scrub and Hand wash for health-care

personnel pre-operative

Pre-operative Surgical Scrub

Pre-operative Skin Preparation

skin disinfection for patients undergoing

elective surgery

antimicrobial cleanser for minor skin wounds.

,הכרבב

יבא ירוח

מ"עב לקידמ עבט

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