OGLUO Solution for injection (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Ogluo 0.5 mg solution for injection in pre-filled pen. Ogluo 1 mg solution for injection in pre-filled pen. Ogluo 0.5 mg solution for injection in pre-filled syringe. Ogluo 1 mg solution for injection ...
2. Qualitative and quantitative composition
<u>Ogluo 0.5 mg solution for injection in pre-filled pen:</u> Each pre-filled pen contains 0.5 mg glucagon in 0.1 mL. <u>Ogluo 1 mg solution for injection in pre-filled pen:</u> Each pre-filled pen contains ...
3. Pharmaceutical form
Solution for injection (injection). A clear, colourless to pale yellow solution.
4.1. Therapeutic indications
Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
4.2. Posology and method of administration
Posology Adults and adolescents (≥6 years) The recommended dose is 1 mg, administrated by subcutaneous injection. Paediatric population (≥2 to <6 years) The recommended dose for paediatric patients who ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pheochromocytoma.
4.4. Special warnings and precautions for use
Glycogen stores and hypoglycaemia To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore the liver glycogen, when the patient has responded to the treatment. Glucagon will ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Insulin Insulin reacts antagonistically towards glucagon. Indomethacin When used with indomethacin, glucagon may lose its ability to raise blood glucose or paradoxically, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Glucagon does not cross the human placenta barrier. The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy ...
4.7. Effects on ability to drive and use machines
Ogluo has negligible influence on the ability to drive and use machines. After a severe hypoglycaemic event, the patients ability to concentrate and react may be impaired; therefore the patient should ...
4.8. Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions are nausea (30%) and vomiting (16%). Tabulated list of adverse reactions Frequencies of adverse reactions considered related ...
4.9. Overdose
If overdose occurs, the patient may experience nausea, vomiting, inhibition of gastro-intestinal tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Pancreatic hormones, glycogenolytic hormones: H04AA01 Mechanism of action Glucagon is a hyperglycaemic agent that mobilises hepatic glycogen, which is released into the ...
5.2. Pharmacokinetic properties
Absorption Subcutaneous injection of 1 mg Ogluo in adult type 1 diabetes mellitus subjects resulted in a mean glucagon C<sub>max</sub> of 2481.3 pg/mL, t<sub>max</sub> of 50 minutes and AUC<sub>0-240min ...
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, carcinogenic potential, toxicity to reproduction and development. ...
6.1. List of excipients
Trehalose dihydrate Dimethyl sulfoxide (DMSO) Sulfuric acid Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Ogluo 0.5 mg solution for injection in pre-filled pen. Ogluo 0.5 mg solution for injection in pre-filled syringe. 2 years. Ogluo 1 mg solution for injection in pre-filled pen. Ogluo 1 mg solution for injection ...
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Do not store below 15°C. Store in original sealed foil pouch until time of use in order to protect from light and moisture.
6.5. Nature and contents of container
<u>Ogluo 0.5 mg solution for injection in pre-filled pen:</u> A pre-filled, single-dose pen containing a 1 mL cyclic olefin polymer syringe with ETFE coated chlorobutyl rubber piston, 27-gauge staked stainless ...
6.6. Special precautions for disposal and other handling
This is a ready to use medicinal product and for single-use only. The single-dose device contains only one dose. The instructions for using the medicinal product in the package leaflet must be followed ...
7. Marketing authorization holder
Tetris Pharma B.V, Bargelaan 200, Element Offices, 2333 CW Leiden, Netherlands
8. Marketing authorization number(s)
EU/1/20/1523/001 EU/1/20/1523/002 EU/1/20/1523/003 EU/1/20/1523/004 EU/1/20/1523/005 EU/1/20/1523/006 EU/1/20/1523/007 EU/1/20/1523/008
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 February 2021
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