MYSIMBA Prolonged-release tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Mysimba 8 mg/90 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion. <u>Excipient with known effect:</u> Each prolonged-release ...
3. Pharmaceutical form
Prolonged-release tablet. Blue, biconvex, round tablet of 12-12.2 mm diameter debossed with NB-890 on one side.
4.1. Therapeutic indications
Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥30 kg/m² ...
4.2. Posology and method of administration
Posology Upon initiating treatment, the dose should be escalated over a 4-week period as follows: <u>Week 1:</u> One tablet in the morning <u>Week 2:</u> One tablet in the morning and one tablet in the ...
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Patients with uncontrolled hypertension (see section 4.4) Patients with a current seizure disorder or a history ...
4.4. Special warnings and precautions for use
The safety and tolerability of naltrexone/bupropion should be assessed at regular intervals. The treatment should be discontinued if there are concerns with the safety or tolerability of ongoing treatment, ...
4.5. Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors (MAOI) Since monoamine oxidase A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, naltrexone/bupropion must not be used ...
4.6. Pregnancy and lactation
Pregnancy There are no or limited amounts of data from the use of naltrexone/bupropion in pregnant women. The combination has not been tested in reproductive toxicity studies. Studies with naltrexone in ...
4.7. Effects on ability to drive and use machines
Naltrexone/bupropion has influence on the ability to drive and use machines. When driving vehicles or using machines, it should be taken into account that dizziness, somnolence, loss of consciousness and ...
4.8. Undesirable effects
Summary of the safety profile In clinical studies, 23.8% of subjects receiving naltrexone/bupropion and 11.9% of subjects receiving placebo discontinued treatment due to an adverse reaction. The most frequent ...
4.9. Overdose
Human overdose experience There is no clinical experience with overdose with combined use of bupropion and naltrexone. The maximum daily dose of combined use of bupropion and naltrexone administered in ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiobesity preparations excluding diet products, centrally acting antiobesity products <b>ATC code:</b> A08AA62 Mechanism of action and pharmacodynamic effects The exact ...
5.2. Pharmacokinetic properties
The results of a single dose relative bioavailability study in healthy subjects demonstrated that naltrexone/bupropion tablets, when dose adjusted, are bioequivalent based on AUC<sub>0-∞</sub> mean ratio ...
5.3. Preclinical safety data
The effects of combined bupropion and naltrexone use have not been studied in animals. Non-clinical data on individual components reveal no special hazard for humans based on conventional studies of safety, ...
6.1. List of excipients
<u>Tablet core:</u> Cysteine hydrochloride Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Lactose anhydrous Lactose monohydrate Crospovidone type A Indigo carmine aluminium lake ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
PVC/PCTFE/PVC/Aluminium blisters. <u>Pack sizes:</u> 28, 112 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Orexigen Therapeutics Ireland Limited, 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland
8. Marketing authorization number(s)
EU/1/14/988/001-002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 26 March 2015 Date of latest renewal: 17 January 2020
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