IMMUKIN Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
IMMUKIN 2 10<sup>6</sup> IU (0.1 mg) solution for injection.
Qualitative and quantitative composition
Each vial (0,5 ml) contains 2 10<sup>6</sup> IU (0.1 mg) recombinant human interferon gamma-1b. Interferon gamma-1b is produced in an E. coli expression system. For the full list of excipients, see section ...
Pharmaceutical form
Solution for injection. A clear, colourless solution.
Therapeutic indications
IMMUKIN is indicated for the reduction of the frequency of serious infections in patients with chronic granulomatous disease (CGD) (see also section 4.4). IMMUKIN is indicated for the reduction in frequency ...
Posology and method of administration
Posology The recommended dosage of IMMUKIN for the treatment of patients with CGD or severe, malignant osteopetrosis is 50 mcg/m² for patients whose body surface area is greater than 0.5 m² and 1.5 mcg/kg/dose ...
Contraindications
Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to closely related interferons or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
The use of IMMUKIN does not exclude the need for any additional antimicrobial coverage that might be required for the management of CGD. In the pivotal clinical efficacy study the overwhelming majority ...
Interaction with other medicinal products and other forms of interaction
IMMUKIN does not reduce the efficacy of antibiotics or glucocorticoids in CGD or severe, malignant osteopetrosis patients. Drug interactions seen with IMMUKIN are similar to those seen with other interferons ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of interferon gamma-1b in pregnant women. Higher levels of endogenous interferon gamma were found in women with recurrent first trimester miscarriage compared ...
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as fatigue, convulsion, confusional ...
Undesirable effects
a) General Description The clinical and laboratory toxicity associated with multiple-dose IMMUKIN therapy is dose- and schedule-dependent. The most common adverse events are flu-like symptoms characterised ...
Overdose
IMMUKIN has been administered at higher doses (>100 mcg/m²) to patients with advanced malignancies by the intravenous or intramuscular route. Central nervous system adverse reactions including decreased ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunostimulants, Cytokines and immunomodulators ATC code: L03AB03 Mechanism of action and Pharmacodynamic effects Interferons are a family of functionally related proteins synthesised ...
Pharmacokinetic properties
Absorption Following subcutaneous single dose administration of 0.05 mg/m² of IMMUKIN in healthy male subjects, a mean peak plasma concentration (C<sub>max</sub>) of 631 pg/mL (CV=33.82%) interferon gamma-1b ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction, local ...
List of excipients
D-Mannitol Disodium succinate hexahydrate Polysorbate 20 Succinic acid Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. IMMUKIN is for single use only. The formulation does not contain a preservative. Once opened, the content of a vial should be used immediately. The unused portion of any vial should be discarded. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze.
Nature and contents of container
3 ml glass vials (Type I borosilicate glass) which are stoppered with grey butyl rubber stoppers with aluminium/polypropylene flip-off type caps. Pack sizes: 1, 3, 5, 6 and 12 vial(s) in one folding box. ...
Special precautions for disposal and other handling
Vials of IMMUKIN must not be shaken vigorously. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Any unused medicinial product or ...
Marketing authorization holder
Clinigen Healthcare Limited, Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom
Marketing authorization number(s)
PL 31644/0004
Date of first authorization / renewal of the authorization
29/09/2007
Date of revision of the text
11/10/2019
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