STARLIX Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
STARLIX 60 mg film-coated tablets. STARLIX 120 mg film-coated tablets. STARLIX 180 mg film-coated tablets.
Qualitative and quantitative composition
STARLIX 60 mg film-coated tablets: Each film-coated tablet contains 60 mg nateglinide. Excipient with known effect: Lactose monohydrate: 141.5 mg per tablet. STARLIX 120 mg film-coated tablets: Each film-coated ...
Pharmaceutical form
Film-coated tablet. <u>STARLIX 60 mg film-coated tablets:</u> 60 mg pink, round, bevelled-edge tablets with STARLIX marked on one side and 60 on the other. <u>STARLIX 120 mg film-coated tablets:</u> 120 ...
Therapeutic indications
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Posology and method of administration
Posology Adults Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). The dosage of nateglinide should be determined by the physician according to the patient ...
Contraindications
Starlix is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Type 1 diabetes (C-peptide negative). Diabetic ketoacidosis, with ...
Special warnings and precautions for use
General Nateglinide should not be used in monotherapy. Hypoglycaemia Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia. Hypoglycaemia has been observed in patients with ...
Interaction with other medicinal products and other forms of interaction
A number of medicinal products influence glucose metabolism and possible interactions should therefore be taken into account by the physician. Combination with ACE-inhibitors, NSAIDs, salicylates, monoamine ...
Fertility, pregnancy and lactation
Pregnancy Studies in animals have shown developmental toxicity (see section 5.3). There is no experience in pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed. Starlix, ...
Effects on ability to drive and use machines
The effect of Starlix on the ability to drive or operate machinery has not been studied. Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important ...
Undesirable effects
Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); ...
Overdose
In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated. There is no experience of an overdose of Starlix in clinical trials. ...
Pharmacodynamic properties
Pharmacotherapeutic group: D-phenylalanine derivative ATC code: A10BX03 Mechanism of action Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from ...
Pharmacokinetic properties
Absorption Nateglinide is rapidly absorbed following oral administration of Starlix tablets prior to a meal, with mean peak drug concentration generally occurring in less than 1 hour. Nateglinide is rapidly ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and post-natal ...
List of excipients
<u>STARLIX 60 mg film-coated tablets:</u> Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Store in the original package.
Nature and contents of container
Blisters: PVC/PE/PVDC blisters, backed with a heat-sealable lacquered aluminium foil. Packs contain 12, 24, 30, 60, 84, 120 and 360 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
STARLIX 60 mg film-coated tablets: EU/1/01/174/001-007 STARLIX 120 mg film-coated tablets: EU/1/01/174/008-014 STARLIX 180 mg film-coated tablets: EU/1/01/174/015-021
Date of first authorization / renewal of the authorization
Date of first authorisation: 03 April 2001 Date of latest renewal: 24 April 2006
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