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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 Active ingredient: One brain / soul (female) per unit. Certificate of suitability: University of Berne (1989), Dipl. Pharm. Excipients: Proteins, carbohydrates, lipids, salts and water. Free from TSE risk materials. Impurities: The product may contain traces of alkaloids (caffeine, nicotine) as impurities, especially around 10 a.m. 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 - her hair which is normally brown and curly may infrequently be extended and take the structure of braids - 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)  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 Dosage and 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 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 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.  Incompatibilities None observed to date. See also Special warnings and special precautions for use, however.  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. Schwanengasse 3 CH 3011 Bern office@regulix.ch Fon: +41 79 735 96 11 Fax: +41 31 311 06 37   8. DATE OF REVISION OF THE TEXT December 2005

Summary of Person's Characteristics (SPC)
Esther Imboden

1. NAME OF THE PRODUCT
Invented name: Esther Imboden
Date of manufacture (MFD): approximately in 1961*
* Esther 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
Active ingredient: Energy (unlimited) / Brain (1 per unit)
Certificate of suitability: 
University of Berne (1986), Dipl. Pharm.
Excipients: Proteins, carbohydrates, salts and water. 
The product contains no detectable levels of lipids* as it is regularly
delipidated by processing steps such as marathonisation 
(see Pharmacokinetics). 
(*WARNING: read the instructions under 
Storage and Stability before first use of product or the user warranty will be void!). Free from TSE risk materials.
This female product regularly wears perfume.
Impurities: May contain non-negligible levels of ISOSTAR (especially on weekends) and traces of alkaloids (caffeine).

3. PHARMACEUTICAL FORM
Immediate release female Multi-FitAmin-Energizer formulated as soft gelatine capsule with regulator-resistant hard coating.
Primary and secondary packaging materials are subject to regular and carefully planned changes in that
- hair colour may be brown, blonde or chestnut to copper, with or without mèches (no evidence for seasonal pattern of variation discovered to date).
- lip and nail colour are adjusted in agreement with the requirements of product and, if necessary, corporate identity
- secondary packaging materials (clothes) are subject to regular changes and may be either purchased or home made.
Height: Medium sized, with optimal body mass index (resistant to increase)

CLINICAL PARTICULARS
4.1 Therapeutic indications
Substitution or replacement therapy in:
- Situations of regulatory overload resulting in energy deprivation
- 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 90%-competent idiotype who is typically disarmed by the product within minutes after first contact)
- Emergency set-up of affiliate companies
Sociological studies demonstrate a very high efficacy and an excellent safety profile of Esther in all the above indications, particularly in the last one (therapeutic gold standard).

4.2 Dosage and administration
Posology
The dose and dosage regimen is dependent on the indication. Typically, Esther 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
Esther can work either from her office, at the clients premises, or at any other place according to agreements. The client is responsible for providing an appropriate working environment if Esther is to be administered outside her office. A good working atmosphere is highly recommended in order to warrant full efficacy.

4.3 Contraindications
Esther is absolutely contraindicated in case of hypersensitivity to energy, brain or to female biologicals in general. She considers herself to be relatively contraindicated for administration to clients who wish slow repair of near-lethal acute injury or are not inclined to hearing the truth.

4.4 Special warnings and special precautions for use
Sociological data reveal no special hazards for humans. De-energization is discouraged unless performed in a carefully controlled environment as it may result in fireworks or, in extremely rare cases, in uncontrolled energy-release (explosion).

4.5 Interactions
Active surveillance indicates that Esther works exclusively by interactions. Attempts to minimize the level of interactions may result in decreased efficacy.

Incompatibilities
Incompatibilities with humans are extremely rare (see also Special warnings and special precautions for use, however). Regarding incompatibilities with non-human bodies see "Effects on ability to drive and use machines". Esther is incompatible with water below 30'C if no special precautions are taken (see "Shelf-life and Storage conditions").

Effects on ability to drive and use machines
WARNING: Contact with product may destroy electronic devices (computers, screens) if product is pregnant (mode of action unknown). Avoid flying in the same plane as Esther as the flight may be delayed or cancelled (mode of action unknown).

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

4.9 Overdose
Overdose has not commonly been observed. Although no placebo controlled studies have been performed anecdotal evidence suggests that the more of Esther you get the better you feel.

5. OTHER PROPERTIES
5.1 Pharmacodynamics
Mode of action: 
The product acts as a catalyser by lowering the energy level of the transition state between "done" and "not done".

5.2 Pharmacokinetics
After administration, Esther 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.

An interesting aspect of Esther's pharmacokinetics is her tendency to almost constantly maintain a high level of physical activity. This is likely to be a strategy to escape a life-threatening drop in body temperature caused by her delipidated status. Her preferred counter-measures against freezing include bio-oscillations such as jogging, marathon running or re-painting her tertiary packaging materials (= walls of her apartment). You may also find her on Montblanc if you manage to get up there. If there is something special in the air think of Esther paragliding. If Esther is found motionless think of a counterfeit product.
Another strategy of Esther's to maintain her body temperature at physiological levels is regular caloric intake. This may result in situations such as a "last call for lunch" at 10 a.m. Surprisingly, Esther's body seems to purposefully ignore what she is eating as she remains as slim as ever even when taking ten meals a day. 
Fortunately, Esther likes to socialize with friends. This is of great help in keeping her warm as food, physical exercise (e.g. hiking, skiing) or grilling / a chimney fire are often parts of such meetings. 

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, Esther shows no evidence of instability when kept at room temperature (20 - 25'C).
CAUTION: Esther is incompatible with water below 30'C. Do not expose her unless protected by a neoprene suit or the user warranty will be void. Exposure without adequate protection may result in permanent damage by freezing.

7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Regulix Ltd.
Schwanengasse 3
CH 3011 Bern
office@regulix.ch
Fon: +41 79 735 96 12
Fax: +41 31 311 06 37

8. DATE OF REVISION OF THE TEXT December 2005