Maxilene children (lidocaine 4%)

Pharmaceutical Form
1 gram of cream contains 40 mg of lidocaine.

Excipient with known effect:
1 gram of cream contains 75mg of propylene glycol
1 gram of cream contains 73.2mg of hydrogenated soy lecithin

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

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 Maxilene is 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 (6.25cm2) 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 Maxilene may be applied for up to 5 hours under a dressing.  Prior to starting the procedure, Maxilene should be removed using a clean gauze swab and the site for venous cannulation or venipuncture prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed.  Maximum application time for 1-month upto 3-month infant should not exceed 60 minutes. Maximum application time for 3-month upto 12-month infant should not exceed 4 hours. Maximum application for 12-month infant – adult should not exceed 5 hours.

Painful treatment on larger surface areas of intact skin
Posology:
Adults, including the elderly

Paediatric Population:
Use of Maxilene is not recommended for this indication in patients below 18 years of age.

Method of administration
Apply the cream at a dosage of approximately 1.5g to 2g Maxilene /10cm2 skin to be treated, or multiples thereof, up to a maximum area of 300cm2. Apply until response is achieved, which is generally for between 30 to 60 minutes in clinical studies.

Typical estimated larger quantities would be 30g-40g/200cm2 (approximately 10cm x 20cm, or covering a face), 45g-60g/300cm2 (approximately 10cm x 30cm or covering an arm).

Indirect evidence has shown that successive applications of lidocaine-based topical treatments can lead to systemic accumulation of lidocaine. Maxilene must therefore not be reapplied for 12 hours following its removal, giving a maximum of 2 doses in any 24 hour period.

Maxilene should be applied evenly at the specified dosage with a uniform thickness across the area where the topical treatment will occur. Measures may be taken to ensure the cream remains undisturbed until adequate analgesia has been achieved.

Prior to starting the procedure, Maxilene should be removed using a clean gauze swab and the site for topical treatment prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed.

Pack Sizes
A carton containing one 30g tube

info@frostpharma.com

Maxilene

For more information


Maxilene cosmetic (lidocaine 4%)

Pharmaceutical Form
1 gram of cream contains 40 mg of lidocaine.

Excipient with known effect:
1 gram of cream contains 75mg of propylene glycol
1 gram of cream contains 73.2mg of hydrogenated soy lecithin

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

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 Maxilene is 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 (6.25cm2) 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 Maxilene may be applied for up to 5 hours under a dressing.  Prior to starting the procedure, Maxilene should be removed using a clean gauze swab and the site for venous cannulation or venipuncture prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed.  Maximum application time for 1-month upto 3-month infant should not exceed 60 minutes. Maximum application time for 3-month upto 12-month infant should not exceed 4 hours. Maximum application for 12-month infant – adult should not exceed 5 hours.

Painful topical treatments on larger surface areas of intact skin
Posology:
Adults, including the elderly

Paediatric Population:
Use of Maxilene is not recommended for this indication in patients below 18 years of age.

Method of administration
Apply the cream at a dosage of approximately 1.5g to 2g Maxilene /10cm2 skin to be treated, or multiples thereof, up to a maximum area of 300cm2. Apply until response is achieved, which is generally for between 30 to 60 minutes in clinical studies.

Typical estimated larger quantities would be 30g-40g/200cm2 (approximately 10cm x 20cm, or covering a face), 45g-60g/300cm2 (approximately 10cm x 30cm or covering an arm).

Indirect evidence has shown that successive applications of lidocaine-based topical treatments can lead to systemic accumulation of lidocaine. Maxilene must therefore not be reapplied for 12 hours following its removal, giving a maximum of 2 doses in any 24 hour period.

Maxilene should be applied evenly at the specified dosage with a uniform thickness across the area where the topical treatment will occur. Measures may be taken to ensure the cream remains undisturbed until adequate analgesia has been achieved.

Prior to starting the procedure, Maxilene should be removed using a clean gauze swab and the site for topical treatment prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed.

Pack Sizes
A carton containing one 30g tube

info@frostpharma.com

Maxilene

For more information

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