SOLIQUA Solution for injection in pre-filled pen (SoloStar) (2021)
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Περιεχόμενα
1. Name of the medicinal product
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen. Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen.
2. Qualitative and quantitative composition
Suliqua 100 units/ml + 50 microgram/ml solution for injection in pre-filled pen Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms lixisenatide in 3 ml solution. Each ml contains ...
3. Pharmaceutical form
Solution for injection in pre-filled pen (SoloStar). Clear colourless solution.
4.1. Therapeutic indications
Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or ...
4.2. Posology and method of administration
Suliqua is available in two pre-filled pens, providing different dosing options, i.e. Suliqua (10-40) pen, Suliqua (30-60) pen respectively. The differentiation between the pen strengths is based on the ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Type 1 diabetes mellitus Suliqua ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies with Suliqua have been performed. The information given below is based on studies with the monocomponents. Pharmacodynamic interactions A number of substances affect glucose metabolism ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Suliqua is not recommended in women of childbearing potential not using contraception. Pregnancy There is no clinical data on exposed pregnancies from controlled clinical ...
4.7. Effects on ability to drive and use machines
Suliqua has no or negligible influence on the ability to drive or use machines. However, the patients ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, ...
4.8. Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section Description of selected ...
4.9. Overdose
Hypoglycaemia and gastrointestinal adverse reactions may develop if a patient is dosed with more Suliqua than required. Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, insulins and analogues for injection, long-acting. <b>ATC Code:</b> A10AE54. Mechanism of action Suliqua combines two active substances with complementary ...
5.2. Pharmacokinetic properties
Absorption The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine and lixisenatide in Suliqua. After subcutaneous administration of insulin glargine/lixisenatide combinations ...
5.3. Preclinical safety data
No animal studies have been conducted with the combination of insulin glargine and lixisenatide to evaluate repeated dose toxicity, carcinogenesis, genotoxicity, or toxicity to reproduction. Insulin glargine ...
6.1. List of excipients
Glycerol 85% Methionine Metacresol Zinc chloride Concentrated hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
Before first use: 3 years. After first use: 28 days. After first use: Store below 25°C. Do not refrigerate. Do not freeze. Do not store with attached needle. Store pen away from direct heat or direct light. ...
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light. For storage conditions ...
6.5. Nature and contents of container
Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene ...
6.6. Special precautions for disposal and other handling
Before first use, the pen must be taken out of the refrigerator and stored below 25°C for 1 to 2 hours. The cartridge should be inspected before use. It must only be used if the solution is clear, colourless, ...
7. Marketing authorization holder
Sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France
8. Marketing authorization number(s)
EU/1/16/1157/001 EU/1/16/1157/002 EU/1/16/1157/003 EU/1/16/1157/004 EU/1/16/1157/005 EU/1/16/1157/006
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 January 2017 Date of latest renewal: 22 November 2021
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