The injection site must be changed regularly.See ‘Take special care with Betaferon’ and follow the instructions in Part II ‘Rotating injection sites’ and Part III (Betaferon Medication Record) of the Annex ’Self-injection procedure’.

In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.

Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bonviva and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.

Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorized, and must hold for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions).

Some general principles for the testing strategy are laid down by Dir. 93/67/EEC, but clear testing strategies may be found in the technical guidance document for Risk Assessment, which nevertheless is flexible and can be adapted as appropriate to specific circumstances.

In the event that special treatment under paragraph 7 is not to be continued beyond the tenth year following the beginning of the implementation period, the products concerned shall be subject to ordinary customs duties, established on the basis of a tariff equivalent to be calculated in accordance with the guidelines prescribed in the attachment hereto, which shall be bound in the Schedule of the Member concerned.

For the purposes of this Article, 'technology` means the specialised equipment and technical know-how, including manuals, designs, operating instructions, training and technical advice and assistance, necessary to assemble, maintain and operate a viable system and the legal right to use these items for that purpose on a non-exclusive basis.

whereas these provisions must, in particular, be in accordance with the criteria laid down in part II (B) of Annex VI, which lays down the definition of corrosion criteria and irritation criteria, and part II (D), which contains a guide to the labelling of dangerous substances and the criteria for the choice of phrases indicating the special risks (R phrases) and the safety advice (S phrases) assigned to dangerous substances;

4 Documented operating procedures for closing and securing all shell doors, loading doors and other closing appliances which, if left open or not properly secured, could lead to flooding of a special category space or ro-ro cargo space, shall be kept on board and posted at an appropriate place.

Notwithstanding the provisions of the preceding paragraph, the customs authorities of the Contracting Parties may permit, in special circumstances and under conditions of which they shall be sole judges, a vehicle circulating under cover of temporary importation papers to be driven by a person who is normally resident in the country of importation, in particular when the driver drives the vehicle on behalf of or under instructions from the holder of the temporary importation papers.

these parties need only report in the declarations referred to in Article 13(1) a maximum of ten of the finest relevant subheadings of the combined nomenclature that are the most important in terms of value and shall regroup the other products in residual subheadings according to detailed arrangements to be determined by the Commission pursuant to Article 30.

taking into account the above information and the ERA, a conclusion which proposes an appropriate risk management strategy which includes, as relevant to the GMO and product in question, a post-market monitoring plan and the identification of any special particulars which need to appear in the Summary of Product Characteristics, labelling and package leaflet;

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.

They might see new symptoms that you might not notice such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. • Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.

The targets should be established for zoonoses and zoonotic agents in animal populations taking account, in particular, of their frequency and epidemiological trends in animal and human populations, feed and food, their gravity for humans, their potential economic consequences, scientific advice and the existence of appropriate measures to reduce their prevalence.

If you develop any infection, or if you develop symptoms like an unexplained fever, severe diarrhoea, prolonged dizziness / headache / stiff neck, weight loss, or listlessness, or other symptoms potentially associated with an infection whilst receiving TYSABRI, speak to your doctor as soon as possible and show the Patient Alert Card and this package leaflet to him.

Without prejudice to general instructions which the Bank receives from the Community in respect of the recovery of principal and interest relating to special loans and operations under the special financing facility of the previous Conventions, the Commission shall undertake, on behalf of the Community, the financial execution of operations carried out with the Fund's resources in the form of grants, transfers or the special financing facility;

the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars in the label, the active-substance level, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where appropriate, a safety recommendation regarding use in the case of additives which are the subject of special provisions upon authorization;

For the purpose of establishing, pursuant to the first subparagraph of Article 3(1)(a) of Regulation (EC) No 141/2000, that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10000 persons in the Community, the following specific rules shall apply and the documentation listed below shall be provided in accordance with the guidance drawn up pursuant to Article 5(3) of Regulation (EC) No 141/2000:

The educational programme for laboratories should inform about the following key elements: • The main differences between ReFacto AF and ReFacto • Specific instructions regarding the proper monitoring of ReFacto AF. • The potential risks for medication errors in using different assays or laboratory standard for patient monitoring • Strong recommendation to use the chromogenic substrate assay when monitoring patients.

The Referral procedure under Article 30 of Directive 2001/ 83/ EC, as amended for Risperdal was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to the sections on indication, posology and method of administration, contraindications, special warnings and precautions for use and interactions with other medicinal products or other forms of interactions.

Where a Member State establishes that all or part of the measuring instruments of a particular model that bear the "CE" marking and the supplementary metrology marking do not satisfy the essential requirements relating to metrological performance set out in this Directive, when correctly installed and used in accordance with the manufacturer's instructions, it shall take all appropriate measures to withdraw these instruments from the market, prohibit or restrict their further being placed on the market, or prohibit or restrict their further being used.

the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the active substance level, expiry date of the guarantee or storage life from the date of manufacture, batch reference number and date of manufacture, the indication: "to be used exclusively by manufacturers of premixtures for compound feedingstuffs", together with the directions for use and, where appropriate, a safety recommendation regarding use in the case of additives which are the subject of special provisions in the "other provisions" column of the Annexes;

For the purpose of establishing, pursuant to the second subparagraph of Article 3(1)(a) of Regulation (EC) No 141/2000, that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community, and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necesary investment, the following specific rules shall apply and the appropriate documentation shall be provided in accordance with the guidance drawn up pursuant to Article 5(3) of Regulation (EC) No 141/2000:

The marketing authorisation may require the holder to indicate on the immediate packaging and/or the outer wrapping and the package leaflet, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Article 12(3)(j) and in Articles 13 to 13d or from experience gained during the use of the veterinary medicinal product once it has been marketed.".

The marketing authorization may require the holder to indicate on the container and/or the outer wrapping and the package insert, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Articles 12(3)(j) and 13(1) or from experience gained during the use of the veterinary medicinal product once it has been marketed.

Healthcare professional’ s administration and monitoring guide − It is important to follow exactly the correct steps for reconstitution and administration of porfimer. − It is important to have an appropriate light dose and a proper setting for the laser. − Any unused product or waste material should be disposed of in accordance with local requirements. − Healthcare professionals should be aware of side effects that may arise during or shortly after treatment, and how to treat them. − Patients should be warned of the possibility of long term side effects, especially photosensitivity, and the need to seek medical assistance if they arise. − Record the patient’ s skin type and the date of injection on the patient alert card

identification of the strain(s) in accordance with the authorization granted, the file number of the strain(s), the number of colony-forming units (CFU per gram), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate an indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive.

the specific name of the active component(s) according to its (their) enzymatic activity(ies) in accordance with the authorization given, the identification number according to the International Union of Biochemistry, the activity units (activity units per g or activity units per ml), the additive's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive;

(units of activity per gram or units of activity per millilitre), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization for the additive;

The educational materials for Healthcare professionals, patients and haemophiliac patients associations should include the following key elements: • The main differences between ReFacto AF and ReFacto • Changes highlighted in the Summary of Product Characteristics and Patient Information Leaflet for ReFacto AF • The visual points of differentiation in packaging for ReFacto AF versus ReFacto • Specific instructions regarding the proper identification, dosing and monitoring of ReFacto AF. • That after switching to ReFacto AF, patients should remain on ReFacto AF and not switch back to ReFacto. • The potential risks for medication errors in using different assays or laboratory standard for patient monitoring Information that the chromogenic substrate assay is strongly recommended to be used by laboratories when monitoring patients receiving ReFacto AF and that typically one stage clotting assay results are 20-50 % lower than the chromogenic substrate assay results • The existence of another moroctocog alfa containing product for use outside Europe with a different potency assigned using a one stage clotting essay and the need for patients to take an adequate supply of their ReFacto AF for anticipated treatment while traveling.

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(5), Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens(6), Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals(7), Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down special provisions for proprietary medicinal products derived from human blood or human plasma(8), Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use(9), Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use(10), Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets(11), Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use(12), Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products(13) have been frequently and substantially amended.

a) Theory and core principles of Gliolan-fluorescence-guided surgery and malignant glioma resection, including methods of eloquent sites identification; b) On-site instructions on the use of the fluorescence-microscope, including pitfalls and recognition of problems; c) Differentiation of fluorescence intensity, maintaining safety distances from eloquent areas, etc. d) The practice of Gliolan-fluorescence-guided surgery (including participation in at least one cases using Gliolan-fluorescence-guided surgery in the operating room with on-site instructions on the use of the microscope or demonstration of a fluorescence-guided resection by video); e) The current understanding of the benefits and risks of cytoreductive surgery in the management of patients with malignant gliomas; f) The theoretical base for porphyrin accumulation in malignant gliomas; g) The technical principles behind fluorescence-guided resections using Gliolan; h) How to identify suitable candidates for fluorescence-guided resections using Gliolan; i) How to apply Gliolan in the correct dosage and timing regimen, and to understand the importance of concurrent corticosteroids; j) How to identify patients at risk for neurological deficits using fluorescence-guided resections with Gliolan with special focus on aphasias and other critical focal deficits; k) Techniques for intraoperative risk reduction (microsurgical technique, neurophysiological monitoring, choice of approach) and how to implement them; l) How to identify fluorescence for resection through using the operating microscope in a hands- on setting in the operating room; m) The benefits and risks of fluorescence-guided resections using Gliolan;