BONSPRI Solution for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
BONSPRI 20 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe contains 20 mg ofatumumab solution for injection (0,4 ml of 50 mg/ml solution). Ofatumumab is a recombinant fully human monoclonal immunoglobulin G1 (IgG1) antibody against human ...
3. Pharmaceutical form
20 mg/0,4 ml Solution for injection in a pre-filled syringe. The single-use solution for injection is sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brownish-yellow. ...
4.1. Therapeutic indications
BONSPRI is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
4.2. Posology and method of administration
Posology The recommended dose is 20 mg BONSPRI administered by subcutaneous injection with: initial dosing at weeks 0, 1 and 2, followed by subsequent monthly dosing, starting at week 4. Missed Doses ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Injection-related reactions Injection site reaction (local) symptoms observed in clinical studies included erythema, swelling, itching and pain. Systemic injection-related reactions observed in clinical ...
4.5. Interaction with other medicinal products and other forms of interaction
Ofatumumab does not share a common clearance pathway with medicines that are metabolised by the cytochrome P450 system or other medicine metabolising enzymes. Additionally, there is no evidence that CD20 ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential / contraception in males and females Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) while receiving ...
4.7. Effects on ability to drive and use machines
BONSPRI is expected to have no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Approximately 1,500 patients with RMS received ofatumumab in clinical studies. In the two phase III pivotal studies, 1,882 patients with RMS were randomised, 946 of whom were ...
4.9. Overdose
No cases of overdose have been reported in RMS clinical studies. Doses up to 700 mg have been administered intravenously in clinical studies with MS patients without dose-limiting toxicity. In the event ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> selective immunosuppressants <b>ATC code:</b> not yet assigned Mechanism of action B cells play an important role in MS pathogenesis due to production of pro-inflammatory ...
5.2. Pharmacokinetic properties
Ofatumumab exhibits a long half-life and low volume of distribution similar to that of other monoclonal antibodies. Ofatumumab is eliminated through a non-linear target-mediated route as well as a target-independent ...
5.3. Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity including safety pharmacology endpoints. In all pivotal repeat-dose toxicity studies, the ...
6.1. List of excipients
L-arginine Sodium acetate trihydrate Sodium chloride Polysorbate 80 Disodium edetate dihydrate Hydrochloric acid (for pH adjustment) Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicine must not be mixed with other medicines.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
6.5. Nature and contents of container
BONSPRI is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield, containing 0,4 ml solution. The syringe is assembled with a plunger ...
6.6. Special precautions for disposal and other handling
Before injection, the pre-filled syringe should be taken out of the refrigerator for about 15 to 30 minutes to allow it to reach room temperature. The pre-filled syringe should be kept in the original ...
7. Marketing authorization holder
Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
8. Marketing authorization number(s)
550368
9. Date of first authorization / renewal of the authorization
28 September 2021
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