TALTZ Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Taltz 80 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 80 mg ixekizumab in 1 ml. Ixekizumab is a recombinant humanised monoclonal antibody produced in CHO cells. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection in pre-filled syringe (injection). The solution is clear and colourless to slightly yellow.
Therapeutic indications
Plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Taltz, alone or in combination with methotrexate, ...
Posology and method of administration
Taltz is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Taltz is indicated. Posology Plaque psoriasis The recommended ...
Contraindications
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Special warnings and precautions for use
Infections Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8). ...
Interaction with other medicinal products and other forms of interaction
In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated. Cytochrome P450 Substrates Results from a drug-drug interaction ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment. Pregnancy There is a limited ...
Effects on ability to drive and use machines
Taltz has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis). Tabulated ...
Overdose
Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity. Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have been ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC13 Mechanism of action Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (<3 pM) and specificity ...
Pharmacokinetic properties
Absorption Following a single subcutaneous dose of ixekizumab in patients with psoriasis, mean peak concentrations were achieved within 4 to 7 days, across a dose range of 5 to 160 mg. The mean (SD) maximum ...
Preclinical safety data
Non-clinical data from cynomolgus monkeys revealed no special hazards for humans based on repeatdose toxicity studies, safety pharmacology evaluations, and reproductive and developmental toxicity studies. ...
List of excipients
Sodium citrate Citric acid, anhydrous Sodium chloride Polysorbate 80 Water for injections
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in a refrigerator (2ºC–8ºC). Do not freeze. Store in the original package in order to protect from light. Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30ºC.
Nature and contents of container
1 ml solution in a type I clear glass syringe. Pack sizes of 1, 2, or 3 pre-filled syringes. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Instructions for use The instructions for using the syringe, included with the package leaflet, must be followed carefully. The pre-filled syringe is for single use only. Taltz should not be used if particles ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/15/1085/004 EU/1/15/1085/005 EU/1/15/1085/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 April 2016
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