JYLAMVO Oral solution (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Jylamvo 2 mg/ml oral solution.
2. Qualitative and quantitative composition
One ml of solution contains 2 mg methotrexate. <u>Excipients with known effect:</u> One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium salt), and 0.2 mg ethyl hydroxybenzoate. For the ...
3. Pharmaceutical form
Oral solution. Clear yellow solution.
4.1. Therapeutic indications
Jylamvo is for use in the following indications: In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic ...
4.2. Posology and method of administration
Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Posology Rheumatological and dermatological ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Hepatic impairment (bilirubin levels are >5 mg/dl [85.5 µmol/l], see section 4.2) Alcohol abuse Severe renal impairment ...
4.4. Special warnings and precautions for use
<b>The oral solution contains 2 mg of methotrexate in each ml of solution; the scaling of the dosing syringe is in ml and not mg; care should be taken that the correct dosing volume is prescribed.</b> ...
4.5. Interaction with other medicinal products and other forms of interaction
The risk of an interaction between NSAIDs and methotrexate should be considered in patients with a low methotrexate dose, particularly in the case of impaired kidney function. If combined treatment is ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least ...
4.7. Effects on ability to drive and use machines
Methotrexate has moderate influence on the ability to drive and use machines, since central nervous system disorders such as tiredness, dizzy spells or drowsiness can occur during treatment.
4.8. Undesirable effects
Summary of the safety profile In general, the incidence and severity of side effects are considered to be dose-related. In the antineoplastic treatment, myelosuppression and mucositis are the predominant ...
4.9. Overdose
Symptoms of overdose The symptoms following oral overdose predominantly affect the haematopoietic and gastrointestinal systems. Symptoms include leucocytopenia, thrombocytopenia, anaemia, pancytopenia, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues <b>ATC code:</b> L01BA01 Mechanism of action Methotrexate is a folic acid antagonist ...
5.2. Pharmacokinetic properties
Absorption After oral administration, methotrexate is absorbed from the gastrointestinal tract. When administered in low doses (7.5 mg/m² to 80 mg/m² body surface area), the mean bioavailability of methotrexate ...
5.3. Preclinical safety data
Chronic toxicity In chronic toxicity studies in mice, rats and dogs, toxic effects were seen in the form of gastrointestinal lesions, myelosuppression and hepatotoxicity. Mutagenic and carcinogenic potential ...
6.1. List of excipients
Macrogol 400 Glycerol Orange flavour Sucralose Ethyl parahydroxybenzoate (E214) Sodium methyl parahydroxybenzoate (E219) Citric acid monohydrate Tri-sodium citrate Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Unopened bottle: 18 months. After first opening: 3 months.
6.4. Special precautions for storage
Do not store above 25°C. Keep the bottle tightly closed (see section 6.6).
6.5. Nature and contents of container
75 ml amber type III glass bottle with tamper evident child-resistant closure (polypropylene with expanded polyethylene liner) containing 60 ml of oral solution. Each pack contains one bottle, an LDPE ...
6.6. Special precautions for disposal and other handling
Safe handling Anyone handling methotrexate should wash their hands before and after administering a dose. To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling ...
7. Marketing authorization holder
Therakind (Europe) Limited, Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ιreland
8. Marketing authorization number(s)
EU/1/17/1172/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29 March 2017
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