STUD 100 (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

STUD 100 Desensitizing Spray for Men. Premjact Desensitizing Spray for Men. Premjact Desensitizing Spray for Men, 9.6% w/w, cutaneous spray.

2. Qualitative and quantitative composition

STUD 100 contains Lidocaine Base 9.6% w/w as the active ingredient.

3. Pharmaceutical form

Cutaneous spray, solution (cutaneous spray).

4.1. Therapeutic indications

To reduce tactile sensitivity of the penis in advance of intercourse as a means of delaying ejaculation in cases of over rapid or precipitant ejaculation.

4.2. Posology and method of administration

Adults 3-8 sprays (23-62mg lidocaine base) applied to the glans and shaft of the penis 5 to 15 minutes prior to intercourse. Quantity and advance timing will be determined by individual requirements. ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

Discontinue use if a rash or irritation develops. If symptoms persist consult a doctor. If you have liver or kidney failure, consult your doctor before using this product. Keep medicines away from children. ...

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

Reports of interactions have been associated generally with systemic administration of lidocaine which results in high blood concentrations. The systemic uptake of lidocaine from STUD 100 is unlikely to ...

4.6. Fertility, pregnancy and lactation

STUD 100 is only indicated for use in males. However, possible transfer of lidocaine to the female partner could occur during intercourse. Whilst there is no, or inadequate, evidence of safety of lidocaine ...

4.7. Effects on ability to drive and use machines

The systemic uptake of lidocaine from STUD 100, applied topically, is unlikely to result in plasma concentrations sufficient to impair the ability to drive or operate machinery.

4.8. Undesirable effects

In extremely rare cases local anaesthetic preparations have been associated with allergic reactions. Occasional local skin irritation may occur following the use of STUD 100. Systemic adverse reactions ...

4.9. Overdose

Overdose of lidocaine with STUD 100 is unlikely due to the small container size and low systemic availability of lidocaine following topical application. Signs of overdosage include stimulation and/or ...

5.1. Pharmacodynamic properties

Lidocaine is a local anaesthetic, of the amide type, the effects of which are reversible. Lidocaine is also a Class 1A antiarrhythmic agent. It acts by preventing generation and transmission of impulses ...

5.2. Pharmacokinetic properties

Lidocaine is readily absorbed from the gastrointestinal tract, from mucous membranes, and through damaged skin. Lidocaine is rapidly distributed into the heart, brain, kidneys and other tissues with a ...

5.3. Preclinical safety data

No new data presented.

6.1. List of excipients

Isopropyl myristate BP 2-(2-Ethoxyethoxy)ethanol Stearic acid BP Perfume 120

6.2. Incompatibilities

None known.

6.3. Shelf life

Five (5) years.

6.4. Special precautions for storage

Store up to 25°C.

6.5. Nature and contents of container

Internally lacquered aluminium can with metered pump spray and aluminium cap, containing 12g STUD 100 Desensitizing Spray for Men.

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Pound International Ltd, 47b Welbeck Street, London, W1G 9XA, England

8. Marketing authorization number(s)

PL 02294/5000R

9. Date of first authorization / renewal of the authorization

19/10/1972 / 07/10/2002

10. Date of revision of the text

October 2019

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