TRUVELOG MIX 30 Suspension for injection (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Truvelog Mix 30 100 units/mL suspension for injection in cartridge. Truvelog Mix 30 100 units/mL suspension for injection in pre-filled pen.
2. Qualitative and quantitative composition
One mL suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg). <u>Truvelog Mix 30 100 units/mL suspension for injection in ...
3. Pharmaceutical form
<u>Truvelog Mix 30 100 units/mL suspension for injection in cartridge:</u> Suspension for injection. <u>Truvelog Mix 30 100 units/mL suspension for injection in pre-filled pen:</u> Suspension for injection ...
4.1. Therapeutic indications
Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
4.2. Posology and method of administration
Posology The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. Truvelog Mix 30 dosing is individual ...
4.3. Contraindications
Hypersensitivity to the active substance 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. Hyperglycaemia Inadequate dosing ...
4.5. Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce the patients insulin requirements: Oral antidiabetic medicinal products, GLP-1 receptor ...
4.6. Fertility, pregnancy and lactation
Pregnancy There is limited clinical experience with Truvelog Mix 30 in pregnancy. Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity ...
4.7. Effects on ability to drive and use machines
The patients ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car ...
4.8. Undesirable effects
Summary of the safety profile Adverse reactions observed in patients using Truvelog Mix 30 are mainly due to the pharmacological effect of insulin aspart. The most frequently reported adverse reaction ...
4.9. Overdose
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patients requirement are administered: Mild hypoglycaemic ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, insulins and analogues for injection, intermediateor long-acting combined with fast-acting <b>ATC code:</b> A10AD05 Truvelog Mix 30 is a biosimilar ...
5.2. Pharmacokinetic properties
Absorption, distribution and elimination In insulin aspart, substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin. ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. In <em>in ...
6.1. List of excipients
Glycerol Phenol Metacresol Zinc chloride Disodium hydrogen phosphate heptahydrate Sodium chloride Protamine sulfate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for ...
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Before opening for first use:</u> 2 years. <u>After first use:</u> 4 weeks. Store below 30°C. Do not refrigerate. Do not freeze. Keep the pen cap on the pen in order to protect from light.
6.4. Special precautions for storage
<u>Truvelog Mix 30 100 units/mL suspension for injection in cartridge:</u> Store in a refrigerator (2°C–8°C). Do not freeze. Keep the cartridge in the outer carton in order to protect from light. <u>Truvelog ...
6.5. Nature and contents of container
Truvelog Mix 30 100 units/mL suspension for injection in cartridge Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate ...
6.6. Special precautions for disposal and other handling
After removing Truvelog Mix 30 from the refrigerator, it is recommended to allow Truvelog Mix 30 to reach room temperature for 1 to 2 hours before resuspending the insulin as instructed for first time ...
7. Marketing authorization holder
sanofi-aventis groupe, 54, rue La Boétie, F 75008 Paris, France
8. Marketing authorization number(s)
EU/1/22/1639/001 EU/1/22/1639/002 EU/1/22/1639/003 EU/1/22/1639/004 EU/1/22/1639/005
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