LEVOTHYROXINE Oral solution (2019)
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Περιεχόμενα
Name of the medicinal product
Levothyroxine 25 micrograms/5ml Oral Solution.
Qualitative and quantitative composition
Each 5ml of oral solution contains 25 micrograms levothyroxine sodium. Excipients with known effect: Sodium methyl parahydroxybenzoate (E219): 10 mg per 5ml dose. Glycerol: 3,780 mg per 5ml dose. For a ...
Pharmaceutical form
Oral Solution. Clear colourless, odourless solution.
Therapeutic indications
Levothyroxine Oral Solution is indicated for: Hypothyroidism (congenital or acquired). Diffuse non toxic goitre. Goitre associated with Hashimotos thyroiditis. Suppression therapy in thyroid carcinoma. ...
Posology and method of administration
Posology The treatment of any thyroid disorder should be determined on an individual basis, taking account of clinical response, biochemical tests and regular monitoring. The individual daily dose should ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In patients with adrenal insufficiency without adequate corticosteroid cover. Treatment with Levothyroxine Oral ...
Special warnings and precautions for use
Thyroid treatments should be used with caution in patients with cardiovascular disorders, including myocardial insufficiency and hypertension. To minimise the risk of adverse effects of undetected overtreatment, ...
Interaction with other medicinal products and other forms of interaction
Propylthiouracil, glucocorticoids, beta-sympatholytics, amiodarone and iodine containing contrast media These substances inhibit the peripheral conversion of T4 to T3. Due to its high iodine content amiodarone ...
Fertility, pregnancy and lactation
Pregnancy Women on a maintenance dose for hypothyroidism who become pregnant, must be monitored closely. Levothyroxine sodium does not readily cross the placenta in the second and third trimester, but ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, since levothyroxine is identical to the naturally occurring thyroid hormone, it is not expected that Levothyroxine ...
Undesirable effects
The following side effects are usually due to excessive dosage, and correspond to symptoms of hyperthyroidism: arrhythmias, anginal pain, tachycardia, disorders of menstruation, pseudotumor cerebri, cramps ...
Overdose
An elevated T3 value is a more reliable indicator of overdose than elevated T4 or FT4 values. In the event of an overdose, symptoms displaying a marked increase in metabolic activity occur (see section ...
Pharmacodynamic properties
Thyroid hormones ATC Code: H03AA01 Thyroxine (T4) is a naturally occurring hormone containing iodine, produced by the thyroid gland. It is converted to its more active principle triiodothyronine (T3) in ...
Pharmacokinetic properties
Levothyroxine sodium is incompletely and variably absorbed from the gastrointestinal tract. Levothyroxine is extensively metabolised in the thyroid, liver, kidney and anterior pituitary. Some enterohepatic ...
Preclinical safety data
Not applicable since levothyroxine has been used in clinical practice for many years and its effects in man are well known.
List of excipients
Glycerol Citric acid anhydrous Sodium methyl parahydroxybenzoate (E219) Citric acid 10% Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 18 months. After first opening do not store above 25°C and use within 2 months.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
Levothyroxine oral solution is packed in amber (Type III) glass bottle 100 ml, with child-resistant, tamper-evident screw cap with an LDPE liner, a 5ml graduated oral dosing syringe and a press-in syringe/bottle ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Colonis Pharma Limited, Quantum House, Hobson Industrial Estate, Burnopfield, County Durham, NE16 6EA
Marketing authorization number(s)
PL 41344/0031
Date of first authorization / renewal of the authorization
24/10/2016
Date of revision of the text
April 2018
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