ONCOTICE Powder for instillation fluid for intravesical use (2021)
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Περιεχόμενα
Name of the medicinal product
OncoTICE powder for instillation fluid for intravesical use containing 2-8 10<sup>8</sup> CFU Tice BCG.
Qualitative and quantitative composition
OncoTICE BCG 12.5mg per vial containing 2-8 108 CFU Tice BCG. After reconstitution in 50 ml saline the suspension contains 0.4-1.6 10<sup>7</sup> CFU/ml. OncoTICE is a freeze-dried preparation containing ...
Pharmaceutical form
Powder for instillation fluid for intravesical use.
Therapeutic indications
OncoTICE is indicated for treatment of primary or concurrent carcinoma-in-situ of the urinary bladder and for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional ...
Posology and method of administration
For preparation of the OncoTICE suspension see section 6.6. Posology Adults and the elderly The contents of one vial of OncoTICE, reconstituted and diluted as indicated, are instilled into the urinary ...
Contraindications
Urinary tract infections. Therapy with OncoTICE should be interrupted until the bacterial culture from urine becomes negative and therapy with antibiotics and/or urinary antiseptics is stopped. Gross haematuria. ...
Special warnings and precautions for use
Before the first intravesical instillation of OncoTICE, a Tuberculin test (PPD) should be performed. If the test is positive, OncoTICE instillations are contraindicated only if there is supplementary medical ...
Interaction with other medicinal products and other forms of interaction
Tice BCG is sensitive to most antibiotics and in particular to the routinely used anti-tuberculosis drugs like streptomycin, para-amino salicylic acid (PAS), isoniazid (INH), rifampicin and ethambutol. ...
Pregnancy and lactation
OncoTICE instillation for carcinoma of the bladder is contraindicated during pregnancy and lactation (see section 4.3).
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The side effects of intravesical OncoTICE therapy are generally mild and transient. Toxicity and side-effects appear to be directly related to the cumulative CFU count of BCG administered with the various ...
Overdose
Overdosage occurs when more than one vial of OncoTICE is administered per instillation. In case of overdosage, the patient should be closely monitored for signs of systemic BCG infection and if necessary ...
Pharmacodynamic properties
ATC code: L03-AX03 OncoTICE is an immunostimulating agent. It has anti-tumor activity, but the exact mechanism of action is not known. Study data suggest that an active non-specific immune response takes ...
Pharmacokinetic properties
For the treatment and recurrence prophylaxis of bladder cancer, the attachment of BCG to the bladder wall after voiding has been shown to be important. This allows a targeted pharmacological effect at ...
Preclinical safety data
As a result of the wide clinical application of BCG vaccination in the preceding decades the risks of BCG in human subjects are well-characterised. Intra-vesical administration to dogs has been found to ...
List of excipients
Lactose Asparagine Citric acid (E330) Dibasic potassium phosphate Magnesium sulfate Iron ammonium citrate Glycerol (E422) Zinc formate Ammonium hydroxide (E527)
Incompatibilities
OncoTICE is incompatible with hypo and hypertonic solutions. OncoTICE should only be mixed with physiological saline as described in section 6.6. Other incompatibility studies have not been performed. ...
Shelf life
12 months. In-use stability of the reconstituted product has been demonstrated for 2 hours at 2-8°C protected from light. From a microbiological point of view, unless the method of opening/reconstitution/dilution ...
Special precautions for storage
Store at 2-8°C, protect from light.
Nature and contents of container
2 ml Type 1 glass vials in packs of 1 and 3.
Special precautions for disposal and other handling
OncoTICE contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled and disposed of as a biohazard material (see section 4.4). Perform the following ...
Marketing authorization holder
Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
Marketing authorization number(s)
PL 53095/0003
Date of first authorization / renewal of the authorization
28 April 1998/28 April 2003
Date of revision of the text
29 January 2021
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