(2) Maximum residue limits should be established after examination, within the Committee for Veterinary Medicinal Products (CVMP), of all the relevant information provided by applicants in accordance with the provisions of Regulation (EEC) No 2377/90 and taking into account all publicly available relevant scientific information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and in particular opinions of the Scientific Committee on Veterinary Measures related to Public Health (SCVPH) and the evaluations of the Joint FAO/WHO Expert Committee on Food Additives.

This medicinal product should be visually inspected before use.

Inspect the reconstituted product visually before use.

VISTIDE vials should be inspected visually prior to use.

Inspection prior to use The reconstituted product should be inspected visually before use.

- Eye examinations are recommended at regular intervals while using Neurpo.

Before use examine the product to ensure that the container and closure have not been damaged.

Further details for concomitantly administered medicinal products are provided below (see Table 2).

Reconstituted products should be inspected visually for particulate matter prior to administration.

The product should be inspected visually for particulate matter and discolouration prior to administration.

The product should be inspected visually for particulate matter and discoloration prior to administration.

The dose of ribavirin to be used in combination with Pegasys is given in Table 1.

70 % of the samples must be examined for the presence of residues of veterinary drugs.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.

As for all parenteral medicinal products, inspect visually the reconstituted solution prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discolouration 24

The recommended dosage and administration by infection is shown in the following table:

Instruct the patient that any extra needles and swabs that remain after the final dose has been taken from the pen, must be discarded appropriately and safely. t uc

Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration.

ge As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.

Visually inspect parenteral medicinal products for particulate matter or discolouration prior to administration.

Transparency, communication and provision of information to patients, healthcare professionals and users of medicines

The formal protocols for the sentinel monitoring surveillance should be reviewed by the CHMP.

Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit.

Instructions for dilution prior to administration Parenteral medicinal products should be inspected visually for particulate matter or discoloration prior to administration.

Dose modification guidelines for patients who use ViraferonPeg monotherapy are shown in Table 3a.

Macugen should be inspected visually for particulate matter and discoloration prior to administration (see section 6.6).

Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.

As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.

All parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.

Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the above Table.

Close clinical monitoring is required when deferasirox is combined with these substances.

The product must be examined before use to confirm that all solids are dissolved and that the container and closure are undamaged.

Method of preparation and administration VISTIDE vials should be visually inspected for particulate matter and discolouration prior to administration.

The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary.

36 The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.

The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.

Parenteral medicinal products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.

Parenteral medicines should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

The European Medicines Agency (EMEA) will review any new information on this medicine every year and this package leaflet will be updated as necessary.

Table 1 lists adverse drug reactions associated with the use of Avastin in combination with different chemotherapy regimens in multiple indications.

As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discolouration prior to administration.

Commission regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State

4.2.5 As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

Further clarification should be introduced as regards revision of the summary of product characteristics, labelling and package leaflet/insert;

As with all parenteral products, Docetaxel Winthrop premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

Adverse reactions listed in Table 3 are based on information available from the metformin Summary of Product Characteristics available in the EU.

 252 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.