MACUGEN Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Macugen 0.3 mg solution for injection.
Qualitative and quantitative composition
One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide. For the full ...
Pharmaceutical form
Solution for injection (injection). The solution is clear and colourless.
Therapeutic indications
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults (see section 5.1).
Posology and method of administration
Macugen should only be administered by ophthalmologists experienced in intravitreal injections. Posology The patients medical history for hypersensitivity reactions should be carefully evaluated prior ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or suspected ocular or periocular infection.
Special warnings and precautions for use
Endophtalmitis Intravitreal injection procedures are associated with a risk of endophthalmitis; in Macugen clinical trials, the incidence of endophthalmitis was 0.1% per injection (see section 4.2). Increased ...
Interaction with other medicinal products and other forms of interaction
Drug interaction studies have not been conducted with Macugen. Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely. Two early clinical studies conducted ...
Fertility, pregnancy and lactation
Pregnancy Pegaptanib has not been studied in pregnant women. Animal studies are insufficient, but have shown reproductive toxicity at high systemic exposure levels (see section 5.3). The potential risk ...
Effects on ability to drive and use machines
Macugen has a minor influence on the ability to drive and use machines due to the possible temporary visual blurring after administration of Macugen by intravitreal injection. Patients should be instructed ...
Undesirable effects
Summary of the safety profile The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure. In clinical trials the most frequently ...
Overdose
Overdose with Macugen has not been reported in clinical trials. Overdosing with increased injection volume (e.g. when the excess volume in the pre-filled syringe is not expelled before injection) may elevate ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals, Ocular vascular disorder agents ATC Code: S01LA03 Mechanism of action Pegaptanib is a pegylated modified oligonucleotide that binds with high specificity and ...
Pharmacokinetic properties
Absorption In animals, pegaptanib is slowly absorbed into the systemic circulation from the eye after intravitreal administration. The rate of absorption from the eye is the rate-limiting step in the disposition ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. There are no studies on the carcinogenic potential ...
List of excipients
Sodium chloride Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in a refrigerator (2ºC to 8ºC). Do not freeze. The solution to be injected should reach room temperature (below 25°C) before injecting. This medicinal product should be discarded if kept at room ...
Nature and contents of container
Each pack contains a pouch in a carton containing a 1 ml pre-filled syringe, Type 1 glass, sealed with an elastomeric (brombutyl rubber) plunger stopper and a pre-attached plunger rod, held by a plastic ...
Special precautions for disposal and other handling
Macugen is for single use only. If the solution appears cloudy, particles are observed or if there is evidence of damage to the syringe, or if the plastic clip is missing or not attached to the syringe, ...
Marketing authorization holder
PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Praha 7, Czech Republic
Marketing authorization number(s)
EU/1/05/325/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 31/01/2006 Date of latest renewal: 19/11/2015
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