KALYDECO Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Kalydeco 75 mg film-coated tablets. Kalydeco 150 mg film-coated tablets.
Qualitative and quantitative composition
Kalydeco 75 mg film-coated tablets Each film-coated tablet contains 75 mg of ivacaftor. <u>Excipient with known effect:</u> Each film-coated tablet contains 83.6 mg of lactose monohydrate. Kalydeco 150 ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Kalydeco 75 mg film-coated tablets:</u> Light blue, capsule-shaped film-coated tablets, printed with V 75 in black ink on one side and plain on the other (12.7 mm × 6.8 ...
Therapeutic indications
Kalydeco tablets are indicated: As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an <em>R117H</em> ...
Posology and method of administration
Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis. If the patients genotype is unknown, an accurate and validated genotyping method should be performed ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Only patients with CF who had a <em>G551D</em>, <em>G1244E</em>, <em>G1349D</em>, <em>G178R</em>, <em>G551S</em>, <em>S1251N</em>, <em>S1255P</em>, <em>S549N</em>, <em>S549R</em> gating (class III), <em> ...
Interaction with other medicinal products and other forms of interaction
Ivacaftor is a substrate of CYP3A4 and CYP3A5. It is a weak inhibitor of CYP3A and P-gp and a potential inhibitor of CYP2C9. <em>In vitro</em> studies showed that ivacaftor is not a substrate for P-gp. ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ivacaftor in pregnant women. Animals studies do not indicate direct or indirect harmful effects with ...
Effects on ability to drive and use machines
Ivacaftor has minor influence on the ability to drive and use machines. Ivacaftor may cause dizziness (see section 4.8) and, therefore, patients experiencing dizziness should be advised not to drive or ...
Undesirable effects
Summary of the safety profile The most common adverse reactions experienced by patients aged 6 years and older who received ivacaftor are headache (23.9%), oropharyngeal pain (22.0%), upper respiratory ...
Overdose
No specific antidote is available for overdose with ivacaftor. Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other respiratory system products <b>ATC code:</b> R07AX02 Mechanism of action Ivacaftor is a potentiator of the <em>CFTR</em> protein, i.e., <em>in vitro</em> ivacaftor ...
Pharmacokinetic properties
The pharmacokinetics of ivacaftor are similar between healthy adult volunteers and patients with CF. After oral administration of a single 150 mg dose to healthy volunteers in a fed state, the mean (± ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Pregnancy and fertility Ivacaftor ...
List of excipients
<u>Tablet core:</u> Cellulose, microcrystalline Lactose monohydrate Hypromellose acetate succinate Croscarmellose sodium Sodium laurilsulfate (E487) Silica, colloidal anhydrous Magnesium stearate <u>Tablet ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Thermoform (PolyChloroTriFluoroEthylene [PCTFE]/foil) blister or a High-Density PolyEthylene (HDPE) bottle with a polypropylene child-resistant closure, foil-lined induction seal and molecular sieve desiccant. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
Marketing authorization number(s)
EU/1/12/782/001 EU/1/12/782/002 EU/1/12/782/005 EU/1/12/782/007
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 July 2012 Date of latest renewal: 29 April 2022
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