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Moventig 12.5 mg and 25mg tablets(一)
2018-10-23 04:40:45 来源: 作者: 【 】 浏览:6742次 评论:0

Moventig 12.5mg and 25mg tablets
1. Name of the medicinal product
Moventig 12.5 mg film-coated tablets
Moventig 25 mg film-coated tablets
2. Qualitative and quantitative composition
Moventig 12.5 mg film-coated tablets
Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.
Moventig 25 mg film-coated tablets
Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Moventig 12.5 mg film-coated tablet (tablet).
Oval, 10.5x5.5 mm, mauve tablet.
Moventig 25 mg film-coated tablet (tablet).
Oval, 13x7 mm, mauve tablet.
Tablets are engraved with “nGL” on one side and the strength of the tablet on the other.
4. Clinical particulars
4.1 Therapeutic indications
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
For definition of inadequate response to laxative(s), see section 5.1.
4.2 Posology and method of administration
Posology
The recommended dose of Moventig is 25 mg once daily.
When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical effect of naloxegol is determined.
Special populations
Elderly
No dose adjustment is recommended based on age (see section 5.2).
Renal impairment
The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg. If side effects impacting tolerability occur, naloxegol should be discontinued. The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2). No dosage adjustment is required for patients with mild renal impairment.
Hepatic impairment
No dose adjustment is required for patients with mild to moderate hepatic impairment. Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2). Use in patients with severe hepatic impairment is not recommended.
CYP3A4 inhibitors
The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily. The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.5).
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
Patients with cancer-related pain
No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4).
Paediatric population
The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Method of administration
Oral use
It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel movements in the middle of the night.
Moventig should be taken on an empty stomach at least 30 minutes prior to the first meal of the day or 2 hours after the first meal of the day.
For patients who are unable to swallow the tablet whole, the Moventig tablet can be crushed to a powder and mixed in half a glass of water (120 ml) and drunk immediately. The glass should be rinsed with a further half glass of water (120 ml) and the contents drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with water after administration of the mixture.
4.3 Con

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