LARIAM Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Lariam 250mg tablets.
Qualitative and quantitative composition
Each tablet contains 250 mg mefloquine (as 274.09 mg mefloquine hydrochloride). Each tablet contains 50.61 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white cylindrical biplanar tablets, cross scored and imprinted with LA-RI-AM-CP on one face.
Therapeutic indications
Therapy and chemoprophylaxis of malaria. Therapy Lariam is especially indicated for therapy of P. falciparum malaria in which the pathogen has become resistant to other antimalarial agents. Following treatment ...
Posology and method of administration
When chemoprophylaxis with Lariam fails, physicians should carefully evaluate which antimalarial to use for therapy. Regarding the use of halofantrine, see sections 4.3, 4.4 and 4.5. Chemoprophylaxis ...
Contraindications
Known hypersensitivity to mefloquine or related compounds (e.g. quinine, quinidine), or to any of the excipients contained in the formulation. Chemoprophylaxis in patients with active depression, a history ...
Special warnings and precautions for use
Neuropsychiatric Adverse Reactions Mefloquine may induce psychiatric symptoms such as anxiety disorders, paranoia, depression, hallucinations and psychosis. Psychiatric symptoms such as insomnia, abnormal ...
Interaction with other medicinal products and other forms of interaction
Halofantrine There is evidence that the use of halofantrine during mefloquine chemoprophylaxis or treatment of malaria, or within 15 weeks after the last dose of mefloquine, causes a significant lengthening ...
Pregnancy and lactation
Pregnancy Mefloquine was teratogenic in mice and rats and embryotoxic in rabbits; however, large clinical experience with Lariam as prophylactic treatment has not revealed an embryotoxic or teratogenic ...
Effects on ability to drive and use machines
Caution should be exercised with regard to activities requiring alertness and fine motor coordination such as driving, piloting aircraft, operating machinery and deep sea diving, as dizziness, vertigo ...
Undesirable effects
a) Summary of safety profile At the doses given for acute malaria, adverse reactions to mefloquine may not be distinguishable from symptoms of the disease itself. In chemoprophylaxis, the safety profile ...
Overdose
Symptoms and signs In cases of overdosage with mefloquine, the symptoms mentioned under section 4.8 may be more pronounced. Treatment Patients should be managed by symptomatic and supportive care following ...
Pharmacodynamic properties
Pharmaco-therapeutic group: Antiprotozoal agent ATC code: P01BC02 Lariam acts on and destroys the asexual intraerythocytic forms of the human malaria parasites: Plasmodium falciparum, P. vivax. P. malariae ...
Pharmacokinetic properties
Absorption The maximum plasma concentration is reached within 6 to 24 hours after a single oral dose of Lariam. The level in micrograms per litre is roughly equivalent to the dose in milligrams (for example ...
Preclinical safety data
Mefloquine crosses the placenta and is teratogenic when administered to rats and mice in early gestation (see section 4.6).
List of excipients
Microcrystalline cellulose Lactose Crospovidone Maize starch Ammonium-calcium alginate Poloxamer (polyoxyethylene-polyoxypropylene copolymer) Talc Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C, store in the original package in order to protect from moisture.
Nature and contents of container
Aluminium foil packs containing 8 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Marketing authorization number(s)
PL 27041/0012
Date of first authorization / renewal of the authorization
5 October 1989 / 1 February 2004
Date of revision of the text
13/03/2019
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