STEGLATRO Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Steglatro 5 mg film-coated tablets. Steglatro 15 mg film-coated tablets.
Qualitative and quantitative composition
Steglatro 5 mg film-coated tablets Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 5 mg ertugliflozin. <u>Excipient with known effect:</u> Each tablet contains 28 mg of lactose (as ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Steglatro 5 mg film-coated tablets:</u> Pink, 6.4 6.6 mm, triangular-shaped, film-coated tablets debossed with 701 on one side and plain on the other side. <u>Steglatro ...
Therapeutic indications
Steglatro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate ...
Posology and method of administration
Posology The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin 5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General Steglatro should not be used in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis (DKA) in these patients. Hypotension/Volume depletion Ertugliflozin causes ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Diuretics Ertugliflozin may add to the diuretic effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4). Insulin and insulin secretagogues ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of ertugliflozin in pregnant women. Based on results from animal studies, ertugliflozin may affect renal development and maturation (see section 5.3). Therefore, ...
Effects on ability to drive and use machines
Ertugliflozin has no or negligible influence on the ability to drive and use machines. Patients should be alerted to the risk of hypoglycaemia when Steglatro is used in combination with insulin or an insulin ...
Undesirable effects
Summary of the safety profile The safety and tolerability of ertugliflozin were assessed in 7 placebo- or active comparator-controlled studies with a total of 3 409 patients with type 2 diabetes mellitus ...
Overdose
Ertugliflozin did not show any toxicity in healthy subjects at single oral doses up to 300 mg and multiple doses up to 100 mg daily for 2 weeks. No potential acute symptoms and signs of overdose were identified. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, Sodium glucose co-transporter 2 (SGLT2) inhibitors <b>ATC code:</b> A10BK04 Mechanism of action SGLT2 is the predominant transporter responsible ...
Pharmacokinetic properties
General introduction The pharmacokinetics of ertugliflozin are similar in healthy subjects and patients with type 2 diabetes. The steady state mean plasma AUC and C<sub>max</sub> were 398 ng∙hr/mL and ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential. General toxicity ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose (E460) Lactose monohydrate Sodium starch glycolate (Type A) Magnesium stearate (E470b) <u>Film coating:</u> Hypromellose 2910/6 (E464) Lactose monohydrate ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Alu/PVC/PA/Alu blisters. Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters. Packs of 30x1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
<u>Steglatro 5 mg film-coated tablets:</u> EU/1/18/1267/001 EU/1/18/1267/002 EU/1/18/1267/003 EU/1/18/1267/004 EU/1/18/1267/005 EU/1/18/1267/006 EU/1/18/1267/013 <u>Steglatro 15 mg film-coated tablets: ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 March 2018 Date of latest renewal: 15 November 2022
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