Summary of Person's Characteristics (SPC) 

Claire-Andrée Monnier 

1. NAME OF THE PRODUCT
Invented name: Claire-Andrée Monnier
Date of manufacture (MFD): approximately in 1964*

*Claire being a typical biological product with a lengthy and complex manufacturing process, the release date has been defined as the MFD.  

2. QUALITATIVE UND QUANTITATIVE COMPOSITION

As a consequence of its female nature the product will occasionally self-administer creams, colorants and chemo-attractants onto its surface, particularly so when preparing for interactions with regulatory bodies.

3. PHARMACEUTICAL FORM
Solution for nerve preservation. Female.
Primary and secondary packaging materials are subject to permanent change in that:

• eyes may or may not be lined with charcoal pen
• nail colour and form may vary widely on different encounters
• the hair which is normally brown and curly may infrequently take the structure of Rasta locks
• secondary packaging materials (clothes) are regularly exchanged and may be either purchased or home made.

Height: Model size, with normal body mass index (resistant to reduction)

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Substitution or replacement therapy in:

• Situations of regulatory overload resulting in depression or nerve crisis
• Beginning or fully blown regulatory crisis with imminent cardiac arrest of company general manager

First line therapy in situations of:

• Approaching deadline for dossier submission (Switzerland, FDA, EU) without dossier on the horizon
• Pre-or post-inspectional trauma
• Upcoming negotiations with regulators (especially with the bossy idiotype who is typically disarmed by the product within minutes after first contact)
• General demotivation (corrected by the product e.g. by administration of cookies or “Gummibärli” to suffering individuals).

Sociological studies demonstrate a very high efficacy and an excellent safety profile of Claire in all the above indications, particularly in the last one (therapeutic gold standard).

4.2 Posology and method of administration
Posology
The dose and dosage regimen is dependent on the indication. Typically, Claire is applied daily until the disease symptoms resolve. The actual dosage regimen is subject to negotiation. The regular daily dose should be in the order of magnitude of 8 hours, the weekly dose should preferentially not exceed 5 days. Higher daily or weekly doses may be agreed upon, however.

Method of administration
Claire can work either from her home office, at the clients premises, or at any other place according to agreements. The client is responsible for providing an appropriate working environment if Claire is to be administered outside her home office. A good working atmosphere is highly recommended in order to warrant full efficacy.

4.3 Contraindications
Claire is absolutely contraindicated in case of hypersensitivity to brain or to female biologicals in general. She considers herself to be relatively contraindicated in case of
(mini-)golf parties or singing contests.

4.4 Special warnings and special precautions for use
Sociological data reveal no special hazard for humans. Overreaction to Mr Know-it-all attitudes or related behaviour can occur in rare cases.

4.5 Interactions
Active surveillance indicates that interactions with Claire are strong but typically extremely benign. This claim is substantiated by the number of entries in the address book of Claire’s handy and by the fact that Claire is amongst those very few individuals on this planet who have received an electronic kiss from the FDA.

4.6 Incompatibilities
None observed to date. See also Special warnings and special precautions for use, however.

4.7 Effects on ability to drive and use machines
WARNING: May strongly interfere with the ability to drive and use machines by purposefully inducing episodes of long-lasting and uncontrollable laughter.

4.8 Undesirable effects
In the majority of cases, Claire does not evoke any undesired reactions. Rarely, incompatibility reactions like rise in blood pressure, moderate to severe headache and the desire to shout at Claire may be provoked by treatment. If you experience adverse reactions, especially of a type not described in this document, please inform Claire.
Under exceedingly high doses of treatment the clients’s treasurer may simulate a heart attack when receiving her invoice.

4.9 Overdose
Overdose has not commonly been observed. There are indications, however, that prolonged exposure to Claire may lead to addictive behaviour in sensitive individuals.

5. OTHER PROPERTIES
5.1 Pharmacodynamics
Claire shows strong affinity to electronic devices (computers, MP3-players, head-phones, photocopiers etc.) and to toys usually only of interest to engineers (e.g. HVAC systems). On the other hand, she is attracted by totally non-electronic items such as cats, chats, flowers, books, sports (karate, jogging, swimming, snowboarding) and flamenco dancing. Both affinities appear to be equally important for her mode of action.

5.2 Pharmacokinetics
After administration, Claire is immediately and completely bioavailable for the client’s projects. The distribution volume depends on the distance between the office, the photocopier and the cafeteria.

6. STORAGE AND STABILITY
6.1 Shelf life and storage conditions
If the recommended dosage regimen as described under "4.2 Dosage and administration" is followed, Claire shows no evidence of instability when kept at room temperature
(20 – 25°C).
Shaking before administration is not only unnecessary but may deteriorate the product by inducing foaming and denaturation.
Do not freeze.

7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Regulix LTD
Effingerstrasse 6a
3011 Bern
office@regulix.ch
+41 79 735 96 11

8. DATE OF REVISION OF THE TEXT
December 2005