DEXIMUNE Capsule, soft (2020)
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Περιεχόμενα
1. Name of the medicinal product
Deximune 25 mg soft capsules.
2. Qualitative and quantitative composition
Each soft capsule contains 25 mg Ciclosporin. For full list of excipients, see Section 6.1.
3. Pharmaceutical form
Capsule, soft. Deximune 25 mg soft capsules are gray soft gelatin capsules with imprinting DX 25 mg.
4.1. Therapeutic indications
Transplantation Indications Solid Organ Transplantation Prevention of graft rejection following solid organ transplantation. Treatment of transplant cellular rejection in patients previously receiving ...
4.2. Posology and method of administration
Posology The dose ranges given for oral administration are intended to serve as guidelines only. The daily doses of Deximune should always be given in two divided doses equally distributed throughout the ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Combination with products containing Hypericum perforatum (St John´s Wort) (see section 4.5). Combination with ...
4.4. Special warnings and precautions for use
Medical supervision Deximune should be prescribed only by physicians who are experienced in immunosuppressive therapy, and can provide adequate follow-up, including regular full physical examination, measurement ...
4.5. Interaction with other medicinal products and other forms of interaction
Drug interactions Of the many drugs reported to interact with ciclosporin, those for which the interactions are adequately substantiated and considered to have clinical implications are listed below. ...
4.6. Fertility, pregnancy and lactation
Pregnancy Animal studies have shown reproductive toxicity in rats and rabbits. Experience with Deximune in pregnant women is limited. Pregnant women receiving immunosuppressive therapies after transplantation, ...
4.7. Effects on ability to drive and use machines
No data exists on the effects of Deximune on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The principal adverse reactions observed in clinical trials and associated with the administration of ciclosporin include renal dysfunction, tremor, hirsutism, hypertension, ...
4.9. Overdose
The oral LD<sub>50</sub> of ciclosporin is 2,329 mg/kg in mice, 1,480 mg/kg in rats and >1,000 mg/kg in rabbits. Symptoms Experience with acute overdosage of ciclosporin is limited. Oral doses of ciclosporin ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Immunosuppressive agents, calcineurin inhibitors <b>ATC code:</b> L04AD01 Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide consisting of 11 amino acids. ...
5.2. Pharmacokinetic properties
Absorption The maximal blood concentration (C<sub>max</sub>) of ciclosporin after treatment with Deximune is achieved within 1-2 hours (T<sub>max</sub>). The absolute bioavailability is ~30%. The inter- ...
5.3. Preclinical safety data
Ciclosporin gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg/day and rabbits up to 30 mg/kg/day orally). At toxic doses (rats ...
6.1. List of excipients
Polysorbate 20 Sorbitan oleate Lecithin from Soya Triglyceride Macrogolglycerol hydroxystearate Ethyl lactate <u>Ingredients of the capsule shell:</u> Gelatin Glycerol Ferric oxide black (E172) Titanium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate and/or freeze. Deximune capsules should be left in the blister pack until required for use. When a blister is opened, a characteristic smell is noticeable. This ...
6.5. Nature and contents of container
The capsules are available in blister packs of double-sided aluminium consisting of an aluminium bottom foil and an aluminium covering foil, which are contained within a printed cardboard carton. Deximune ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
DEXCEL-PHARMA LTD, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry, Northamptonshire, NN11 8PB, United Kingdom
8. Marketing authorization number(s)
PL 14017/0215
9. Date of first authorization / renewal of the authorization
27 January 2010
10. Date of revision of the text
17/07/2020
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