Terms & Conditions
Terms and Conditions BBio.nl and werkenbijBBio.nl
This document describes the legal terms and conditions for accessing and using the Bilthoven Biologicals website. By accessing or using this website ("Site") or any material contained therein, you agree to the following terms and conditions.
This site is owned and operated by Bilthoven Biologicals BV. ("BBio"), a company incorporated under the laws of the Netherlands. BBio maintains the Site for your personal information. BBio uses reasonable efforts to include accurate, up-to-date information on the Site. However, BBio makes no warranties or representations as to the accuracy of the information. BBio assumes no liability or responsibility for any errors or omissions in the content of this Site. BBio reserves the right, at its sole discretion, to make changes or improvements to the information on this Site at any time, and to discontinue access to or temporarily or permanently, part or all of the Site, including your account. and password access (if applicable) without liability or notice to you.
BBio may revise these Terms and Conditions at any time by updating this posting. You are bound by any such revisions. You should therefore periodically visit this page to review the current Terms and Conditions to which you are bound.
These Terms and Conditions shall be governed by, construed and enforced in accordance with the laws of the Netherlands. Any disputes arising hereunder shall be subject to the exclusive jurisdiction of the courts of The Haque.
Use of and access to the site
Feel free to browse the Site, but do so with the understanding that each user of this Site does so at his or her own risk. BBio makes no representations or warranties of any kind regarding the Site and its use, including the security of any data or information transmitted to the Site, implied warranties or warranties of fitness for a particular purpose or non-infringement of third party rights.
Neither BBio nor any other party involved in the creation, production or delivery of this Site assumes or accepts any liability for any costs, losses, damages, etc. arising out of or in connection with the use of and access to this Site, or with the failure of this Site to function for any reason.
Copyright and Trademark
You may download material displayed on the Site for non-commercial, personal use only, provided that you keep intact all copyright, trademark and other proprietary notices. You may not reproduce, republish, upload, post, transmit or distribute the content of this Site, including the text, images, audio and video, in any way for public or commercial purposes, without the written permission of BBio. The Site may contain documents, images, information and other materials belonging to others, such as trademarked text, images, audio and video. Use of these materials is strictly prohibited unless prior written permission has been obtained from the owner of the materials. Certain trademarks and logos displayed on the Site are trademarks of BBio. Without limitation, the BBio logo and other identifying marks of BBio are and shall remain the trademarks of BBio. Nothing contained on the Site should be construed as granting, by implication, estoppel, or otherwise, any license or right to use any Trademark displayed on the Site without the written permission of BBio or such third party that may own Trademarks displayed on the Site. All rights not expressly grantedLinks to Other Websites
BBio has not reviewed the content of all sites linked to the Site. Links or references to other sites and references to products and services offered by third parties are provided to you only as a convenience. It is expressly understood that the website links on this Site are not under the control of BBio. BBio assumes no responsibility with respect to the Website, or for any possible harm arising out of or in connection with the use of any such link or third party website. BBio reserves the right to terminate any link or linking program at any time. In addition, the existence of a link between this Site and any other website is not and shall not be construed as an endorsement or approval by BBio of the owner of such linked website or any products or services offered on such linked website. In no event shall BBio be liable for any direct, indirect, consequential or exemplary damages arising out of the use or performance of this Site, even if BBio has been advised of the possibility of such damages.
E-mail Communications
Communications via e-mail over the Internet and other publicly accessible networks are not secure and may be lost, intercepted or altered in transit. BBio assumes no liability for any damages you may experience or costs you may incur as a result of sending e-mail to BBio or BBio sending e-mail to you, including such e-mail which may contain your personal or confidential information.
Registration and Password
Certain areas of this Site may be password protected and require registration and disclosure of certain information about yourself in order to gain access, which information will not be disclosed by BBio except in accordance with the BBio Privacy Policy. When you register with us, you agree to provide complete and accurate information about yourself and to update such information as it changes. In the event that you do not provide or update such information, or BBio has reasonable grounds to suspect that you have not provided or updated such information, BBio has the right, at its sole discretion, to disable your password and prevent you from using such password-protected areas of this site. It is your responsibility to keep the password provided to you as part of the registration process confidential. In the event that you use your password without your permission or upon discovery by you of any other breach of security, you agree to immediately notify BBio.
Transmissions Over the Internet
The transmission of data or information (including communications by e-mail) over the Internet or other publicly accessible networks is not secure and is subject to possible loss, interception or alteration in transit. BBio assumes no liability for any damages or costs you incur as a result of transmissions over the Internet or other publicly accessible networks, such as transmissions involving the use of your password for this site or exchange of e-mail with BBio (including those that may contain your personal or confidential information).
User Indemnification
You agree to indemnify, defend and hold harmless BBio and its affiliates, officers, directors, employees and agents from any loss, liability, claim, demand, damages or expense (including reasonable legal fees) asserted by any third party relating in any way to your use of this site or violation of these Terms of Use. BBio reserves the right to assume the exclusive defense and control of
to you are reserved by BBio. to take on any matter subject to indemnification by you, which does not excuse your indemnification obligations.
Notification of Copyright Infringement
BBio's policy is to comply with all intellectual property laws and to act expeditiously upon receipt of a notice of claimed infringement. If you believe that your work has been reproduced in a way that constitutes copyright infringement, you must provide a notice of copyright infringement containing all of the following information:
A physical or electronic signature of a person authorized to act on behalf of the copyright owner for the purposes of the complaint. Identification of the copyrighted work claimed to have been infringed. Identification of the material on the site that is claimed to be infringing or to be the subject of infringing activity. The address, telephone number, or email address of the complaining party. A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law. A statement, under penalty of perjury, that the information in the notice of copyright infringement is accurate and that the complaining party is authorized to act on behalf of the owner of the right that is allegedly infringed.
Contact
If you have any questions or comments about the BBio site or these Terms of Use, please feel free to contact us.
These Terms of Use shall be governed by, construed and enforced in accordance with the laws of the Netherlands. Any disputes arising hereunder shall be submitted exclusively to the jurisdiction of the District Court of The Hague.
View the Privacy Policy of BBio.nl and werken.bijBBio.nl here [insert links].
Bilthoven Biologicals, Antonie v Leeuwenhoekln 9-13, 3721MA Bilthoven, The Netherlands
This medicinal product is subject to additional monitoring. Name: SIILTIBCY (0.5 microgram + 0.5 microgram)/mL solution for injection Mycobacterium tuberculosis derived antigens (rdESAT 6 and rCFP 10). Pharmaceutical form and composition: One dose (0.1 mL) contains 0.05 microgram of rdESAT 6* and 0.05 microgram of rCFP 10**. *Recombinant dimer of Mycobacterium tuberculosis early secretory antigenic target1; **Recombinant culture filtrate protein of Mycobacterium tuberculosis1; 1Produced in Lactococcus lactis cells. Multidose vial. One vial (1 mL) contains 10 doses of 0.1 mL. Therapeutic indication: SIILTIBCY is indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. This medicinal product is for diagnostic use only. Posology and method of administration: Posology The dose is 0.1 mL of SIILTIBCY. Method of administration SIILTIBCY should be prepared and administered via intradermal injection by healthcare professionals trained for the Mantoux technique. The medicinal product should be administered with adequate hygiene of the hands and using aseptic technique, as follows: Withdraw 0.1 mL of SIILTIBCY using a 1 mL syringe with a short bevel needle. Before drawing SIILTIBCY from the multidose vial, expel any air from the syringe. If the vial was already opened, swab it with an alcohol swab and let it dry before use; Administer the 0.1 mL of SIILTIBCY intradermally in the middle-third of the forearm using the Mantoux technique. Therefore, stretch the skin slightly and hold the needle almost parallel to the skin surface with the bevel upwards. Insert the tip of the needle into the superficial layer of the dermis. Make sure the needle is visible through the epidermis during the injection. Do not apply the test in areas of scars, rashes, burn or tattoos; Inject the drawn 0.1 mL solution slowly. A small-blanched papule of 8-10 millimetres (mm) in diameter will appear, which should disappear after about 10 minutes. If the papule does not appear, repeat a new injection of 0.1 mL of SIILTIBCY on the other arm or on the same arm at least 4 cm away from the first injection site. The induration is measured 48 to 72 hours after the injection by a trained healthcare professional. Measure the diameter of the induration transversely to the long axis of the forearm with a ruler. To allow ease with measurement, a flexible (or easily bendable) ruler is suggested. An induration of ≥ 5 mm is considered as a positive test result, which indicates infection with Mycobacterium tuberculosis. Contra-indications: Hypersensitivity to the active substances or to any of the excipients disodium hydrogen phosphate dihydrate (E339), potassium dihydrogen orthophosphate (E340), potassium chloride (E508), sodium chloride, polysorbate 20 (E432) and phenol. Hypersensitivity to Lactococcus lactis. Severe local or systemic reaction to other Mycobacterium tuberculosis derived products. Special warnings and precautions for use: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations: Anaphylaxis Anaphylactic or other allergic type reactions are possible following administration of SIILTIBCY. Appropriate equipment for management of such reactions should always be available during the conduct of the test. Close observation for at least 15 minutes is recommended following the test. Route of administration Adherence to the Mantoux technique when administering SIILTIBCY is essential for obtaining reliable results, therefore avoid subcutaneous or intramuscular injection. Special populations The reactivity to SIILTIBCY can be lower or give false negative results in immunocompromised individuals, including those receiving immunosuppressant therapy and human immunodeficiency virus (HIV) positive individuals if cluster of differentiation 4 positive (CD4+) thymus cell (T cell) count is < 100 T cells/mm3. A positive test result indicates infection with Mycobacterium tuberculosis regardless of the CD4+ T cell count. There may be an increased risk of false-negative results in the elderly population due to immunosenescence with age. Previous exposure to non-tuberculous mycobacteria SIILTIBCY does not identify subjects with previous exposure to non-tuberculous mycobacteria as well as those who received Bacillus Calmette-Guérin vaccine or therapy, and thus use for this purpose is not appropriate. Diagnosis of active tuberculosis SIILTIBCY cannot be used as stand-alone tool for diagnosis of active tuberculosis disease. In addition, risk assessment, radiography, and other diagnostic evaluations should be considered for subjects suspected to have active tuberculosis. Excipients This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. This medicinal product contains 0.011 mg of polysorbate 20 in each dose, which is equivalent to 0.11 mg/mL. Polysorbates may cause allergic reactions. Undesirable effects: Very common (≥ 1/10): Injection site pruritus. Common (≥ 1/100 to < 1/10): Headache, Injection site haematoma, Injection site vesicles, Injection site induration, Injection site swelling, Injection site pain, Injection site rash, Injection site erythema. Uncommon (≥ 1/1 000 to < 1/100): Gastroenteritis, Lymphadenopathy, Dizziness, Diarrhoea, Nausea, Rash, Pruritus, Pain in extremity, Injection site ulcer, Injection site haemorrhage, Pyrexia, Malaise, Fatigue, Injection site discolouration, Pain, Influenza-like illness. Rare (≥ 1/10 000 to < 1/1 000): Lymphadenitis, Eosinophilia, Head discomfort, Paraesthesia, Vomiting, Hepatitis, Jaundice, Transaminases increased, Night sweats, Urticaria, Myalgia, Arthritis, Axillary pain, Injection site inflammation, Injection site urticaria, Injection site nodule, Injection site papule, Chills, Injection site hypoaesthesia. Pharmacotherapeutic group: Tuberculosis diagnostics ATC code: V04CF Full product information: for the full product information, please consult the SmPC on www.ema.europa.eu. Date: March 2025. Marketing Authorisation Holder: Serum Life Science Europe GmbH, Ahrensburger Str. 1, 30659 Hannover, Germany, +49 511 169 90 80. For other information, Bilthoven Biologicals BV, PO Box 457, 3720 AL Bilthoven, The Netherlands, +31 (0)30 – 800 4800, info@bbio.nl. STBCY/EU/004-3/2025