GILBERT Compresse d'Alcool - 12 Unités de 2,5ml

ANSM - Updated on : 05/02/2020

1. DRUG NAME

ALCOHOL FOR MEDICAL USE GILBERT 2.5 ml, impregnated compress

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ethyl alcohol 70°............................................................................................................. 2.5 ml

for one impregnated compress

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Impregnated compress.

135 mm x 165 mm cellulose douate compress

4. CLINICAL DATA

4.1. therapeutic indications

- Antisepsis of small, superficial wounds,

Skin preparation prior to injection or puncture

Note: antiseptic agents are not sterilizing agents: they temporarily reduce the number of micro-organisms

4.2. Dosage and administration

Method of administration

to the skin.

Remove the compress from its packaging and apply to the area to be treated. Discard after use.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Linked to the presence of terpene derivatives (camphor):

Infants under 30 months,

Children with a history of convulsions (febrile or not).

4.4 Special warnings and precautions for use

Warnings

For external use. Do not swallow.

Alcohol must not be used to perform alcohol tests

This product contains terpene derivatives which, in excessive doses, may cause neurological accidents such as convulsions in infants and children

Follow dosage and use instructions, in particular:

Do not apply to large areas of the body

Do not apply to breasts if breast-feeding

Precautions for use

Bear

in mind the presence of an azo dye (tartrazine E102) in this formula, particularly in polysensitized subjects

Do not apply to mucous membranes (70° ethyl alcohol)

Do not use under occlusive dressing (increased risk of sensitization)

Alcohol may be irritating to damaged tissue,

If you have a history of seizures, be aware of the presence of terpene derivatives

4.5. Interactions with other drugs and other forms of interaction

In view of possible interference (antagonism, inactivation), simultaneous or successive use with other antiseptics should be avoided.

4.6. Fertility, pregnancy and breast-feeding

In the event of breast-feeding, it is preferable not to use this medicine due to :

No kinetic data on the passage of terpene derivatives into milk,

And their potential neurological toxicity in infants

4.7. Effects on ability to drive and use machines

Please note.

4.8. Undesirable effects

Tartrazine (E102) may cause sensitization.

Tartrazine (E102) is cross-reactive with laspirin.

Risk of allergic reactions, particularly cutaneous.

Due to the presence of terpene derivatives and in case of non-observance of recommended doses:

Risk of convulsions in infants and children

Possible agitation and confusion in the elderly

Reporting suspected adverse reactions

Reporting suspected adverse reactions after a drug has been authorized is important. It enables ongoing monitoring of the drug's risk/benefit ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

Please note.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: low potency ANTISEPTIC, ATC code: D: dermatology.

Ethyl alcohol at 70° has rapid antibacterial activity. It is partially inactivated by organic matter (blood, serum, pus).

Non-bactericidal.

Contains terpene derivatives which may lower the epileptogenic threshold

5.2. Pharmacokinetic properties

To be completed.

5.3. Preclinical safety data

To be completed.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Synthetic camphor, tartrazine (E102).

135 mm x 165 mm cellulose douate compress.

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

36 months

6.4. Special storage precautions

No special storage precautions.

6.5. Nature and contents of outer packaging

Sachets (paper/polyethylene/aluminium/polyethylene) with cellulose douate compress.

Boxes of 12 or 200 sachets.

6.6. Special precautions for use and handling

No special disposal requirements.

7. MARKETING AUTHORIZATION HOLDER

LABORATOIRES GILBERT

AVENUE DU GENERAL DE GAULLE

BP 115

14200 HEROUVILLE SAINT-CLAIR

8. MARKETING AUTHORIZATION NUMBER(S)

34009 318 652 5 4: impregnated compress with 2.5 ml solution in sachet (paper/polyethylene/aluminium/polyethylene), box of 12.

34009 560 819 5 0: impregnated compress with 2.5 ml solution in sachet (paper/polyethylene/aluminium/polyethylene), box of 200

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder

10. TEXT UPDATE DATE

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.