SIFROL Prolonged-release tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
SIFROL 0.26 mg prolonged-release tablets. SIFROL 0.52 mg prolonged-release tablets. SIFROL 1.05 mg prolonged-release tablets. SIFROL 1.57 mg prolonged-release tablets. SIFROL 2.1 mg prolonged-release tablets. ...
2. Qualitative and quantitative composition
<u>SIFROL 0.26 mg prolonged-release tablets:</u> Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole. <u>SIFROL 0.52 mg prolonged-release ...
3. Pharmaceutical form
Prolonged-release tablet. <u>SIFROL 0.26 mg prolonged-release tablets:</u> The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P1, ...
4.1. Therapeutic indications
SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinsons disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through ...
4.2. Posology and method of administration
Posology SIFROL prolonged-release tablets are a once-a-day oral formulation of pramipexole Initial treatment Doses should be increased gradually from a starting dose of 0.26 mg of base (0.375 mg of salt) ...
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
When prescribing SIFROL in a patient with Parkinsons disease with renal impairment a reduced dose is suggested in line with section 4.2. Hallucinations Hallucinations are known as a side effect of treatment ...
4.5. Interaction with other medicinal products and other forms of interaction
Plasma protein binding Pramipexole is bound to plasma proteins to a very low (<20%) extent, and little biotransformation is seen in man. Therefore, interactions with other medicinal products affecting ...
4.6. Fertility, pregnancy and lactation
Pregnancy The effect on pregnancy and lactation has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section ...
4.7. Effects on ability to drive and use machines
SIFROL can have a major influence on the ability to drive and use machines. Hallucinations or somnolence can occur. Patients being treated with SIFROL and presenting with somnolence and/or sudden sleep ...
4.8. Undesirable effects
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,778 Parkinsons disease patients on pramipexole and 1,297 patients on placebo, adverse drug reactions were frequently reported ...
4.9. Overdose
There is no clinical experience with massive overdose. The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> anti-Parkinson drugs, dopamine agonists <b>ATC code:</b> N04BC05 Mechanism of action Pramipexole is a dopamine agonist that binds with high selectivity and specificity ...
5.2. Pharmacokinetic properties
Absorption Pramipexole is completely absorbed following oral administration. The absolute bioavailability is greater than 90%. In a Phase I trial, where pramipexole immediate release and prolonged-release ...
5.3. Preclinical safety data
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect ...
6.1. List of excipients
Hypromellose 2208 Maize starch Carbomer 941 Colloidal anhydrous silica Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in the original package in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
6.5. Nature and contents of container
OPA/aluminium/PVC-aluminium blisters. Each blister strip contains 10 prolonged-release tablets. Cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets). Not all pack sizes ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
8. Marketing authorization number(s)
SIFROL 0.26 mg prolonged-release tablets: EU/1/97/050/013-015 SIFROL 0.52 mg prolonged-release tablets: EU/1/97/050/016-018 SIFROL 1.05 mg prolonged-release tablets: EU/1/97/050/019-021 SIFROL 1.57 mg ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14 October 1997 Date of latest renewal: 14 October 2007
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