AXSAIN Cream (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Axsain 0.075% w/w Cream.

2. Qualitative and quantitative composition

Capsaicin 0.075% w/w. Excipient(s) with known effect: Each cream tube contains; 450 mg benzyl alcohol which is equivalent to 0.01 mg/mg 3.6g cetyl alcohol which is equivalent to 0.08 mg/mg For ...

3. Pharmaceutical form

Cream. A smooth, white cream.

4.1. Therapeutic indications

1. For the symptomatic relief of neuralgia associated with and following Herpes Zoster infections (post-herpetic neuralgia) after open skin lesions have healed. 2. For the symptomatic management of painful ...

4.2. Posology and method of administration

Adults and the elderly For topical administration to unbroken skin. Apply only a small amount of cream (pea size) to the affected area 3 or 4 times daily. The cream should be gently rubbed in, there should ...

4.3. Contraindications

Axsain cream is contra-indicated for use on broken or irritated skin. Axsain Cream is contra-indicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section ...

4.4. Special warnings and precautions for use

Not for use under tight bandages. Keep away from the eyes. Skin irritation has been reported following application of Axsain. The hands should be washed immediately after application of the cream, unless ...

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Pregnancy and lactation

The safety of Axsain during pregnancy or lactation has not been established in either humans or animals. However, in the small amounts absorbed transdermally from Axsain Cream, it is considered unlikely ...

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Axsain may cause skin irritation or transient burning on application. This burning is observed more frequently when application schedules of more than 4 times daily are utilised. The burning can be enhanced ...

4.9. Overdose

Not applicable.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents ATC code: M02AB01 Although the precise mechanism of action of capsaicin is not fully ...

5.2. Pharmacokinetic properties

Absorption after topical application is unknown. Average consumption of dietary spice from capsicum fruit has been estimated as 2.5g/person/day in India and 5.0g/person/day in Thailand. Capsaicin content ...

5.3. Preclinical safety data

The available animal toxicity data relating to capsicum, capsicum extracts and capsaicin do not suggest that, in usual doses, they pose any significant toxicity hazard to man. Thus, in both single and ...

6.1. List of excipients

Purified Water Sorbitol Solution Isopropyl Myristate Cetyl Alcohol White Soft Parafin Glyceryl stearate and PEG-100 stearate (Arlacel 165) Benzyl Alcohol

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Aluminium tubes with epoxyphenolic lining and polypropylene cap, containing 45g of cream.

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

8. Marketing authorization number(s)

PA1986/088/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 14 June 1994 Date of last renewal: 14 June 2009

10. Date of revision of the text

March 2021

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