COMBODART Capsule, hard (2020)
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Περιεχόμενα
1. Name of the medicinal product
Combodart 0.5 mg / 0.4 mg hard capsules.
2. Qualitative and quantitative composition
Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, (equivalent to 0.367 mg tamsulosin). <u>Excipients with known effect:</u> Each capsule contains lecithin (which may contain ...
3. Pharmaceutical form
Capsule, hard. Oblong, hard-shell capsules with a brown body and an orange cap imprinted with GS 7CZ in black ink. Each hard capsule contains tamsulosin hydrochloride modified release pellets and one dutasteride ...
4.1. Therapeutic indications
Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. ...
4.2. Posology and method of administration
Posology Adults (including elderly) The recommended dose of Combodart is one capsule (0.5 mg/0.4 mg) once daily. Where appropriate, Combodart may be used to substitute concomitant dutasteride and tamsulosin ...
4.3. Contraindications
Combodart is contraindicated in: women and children and adolescents (see section 4.6). patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including tamsulosin ...
4.4. Special warnings and precautions for use
Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment ...
4.5. Interaction with other medicinal products and other forms of interaction
There have been no drug interaction studies for Combodart. The following statements reflect the information available on the individual components. Dutasteride For information on the decrease of serum ...
4.6. Fertility, pregnancy and lactation
Combodart is contraindicated for use by women. There have been no studies to investigate the effect of Combodart on pregnancy, lactation and fertility. The following statements reflect the information ...
4.7. Effects on ability to drive and use machines
No studies on the effects of Combodart on the ability to drive and use machines have been performed. However, patients should be informed about the possible occurrence of symptoms related to orthostatic ...
4.8. Undesirable effects
The data presented here relate to the co-administration of dutasteride and tamsulosin from the 4 year analysis of the CombAT (Combination of Avodart and Tamsulosin) study, a comparison of dutasteride 0.5mg ...
4.9. Overdose
No data are available with regard to overdosage of Combodart. The following statements reflect the information available on the individual components. Dutasteride In volunteer studies, single daily doses ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists ATC code: G04CA52 Dutasteride-tamsulosin is a combination of two drugs: dutasteride, a dual 5 α-reductase inhibitor (5 ARI) and tamsulosin hydrochloride, ...
5.2. Pharmacokinetic properties
Bioequivalence was demonstrated between dutasteride-tamsulosin and concomitant dosing with separate dutasteride and tamsulosin capsules. The single dose bioequivalence study was performed in both the fasted ...
5.3. Preclinical safety data
Non-clinical studies have not been conducted with Combodart. Dutasteride and tamsulosin hydrochloride individually have been extensively evaluated in animal toxicity tests and findings were consistent ...
6.1. List of excipients
<u>Hard Capsule Shell:</u> Hypromellose Carrageenan (E407) Potassium Chloride Titanium Dioxide (E171) Iron Oxide Red (E172) Sunset Yellow (E110) Carnauba Wax Maize Starch <u>Contents in Dutasteride Soft ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Opaque, white high density polyethylene (HDPE) bottles with polypropylene child-resistant closures with polyethylene-faced, foil induction heat-seal liners: 7 hard capsules in 40 ml bottle 30 hard capsules ...
6.6. Special precautions for disposal and other handling
Dutasteride is absorbed through the skin, therefore contact with leaking capsules must be avoided. If contact is made with leaking capsules, the contact area should be washed immediately with soap and ...
7. Marketing authorization holder
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as: GlaxoSmithKline UK Limited
8. Marketing authorization number(s)
PL 19494/0046
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28 April 2010 Date of latest renewal: 11 June 2015
10. Date of revision of the text
31 March 2020
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