BILTRICIDE Film-coated tablet (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Biltricide, 600 mg film coated tablet.
Qualitative and quantitative composition
Each film-coated tablet contains 600 mg praziquantel. For a full list of excipients, see Section 6.1.
Pharmaceutical form
The film-coated tablets are white to pale yellow lacquer-coated oblong shaped tablets with three scores with Bayer on one side and LG on the reverse.
Therapeutic indications
Treatment of schistosoma infections due to various types of blood fluke (eg Schistosoma haematobium, S.japonicum, S.mekongi, S.mansoni).
Posology and method of administration
The doctor must prescribe individual doses for individual cases, according to the diagnosis. Schistosoma haematobium 20 mg/kg body weight Schistosoma mansoni three times a day Schistosoma japonicum at ...
Contraindications
Known hypersensitivity to praziquantel or any of the excipients. Ocular cysticercosis parasite destruction within the eye may cause irreparable damage. The concomitant administration of strong inducers ...
Special warnings and precautions for use
Published in vitro data have shown a potential lack of efficacy of praziquantel against migrating schistosomulae. Data from two observational cohort studies in patients indicate that treatment with praziquantel ...
Interaction with other medicinal products and other forms of interaction
Praziquantel is believed to be metabolised via the CYP450 enzyme system. Many categories of medicines are known to inhibit or induce CYP450 enzymes causing an increase or decrease in serum concentrations ...
Fertility, pregnancy and lactation
Pregnancy Reproduction studies performed so far in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to praziquantel. An increase in abortion rate was seen in rats ...
Effects on ability to drive and use machines
Patients should be warned not to drive or operate machinery on the day of treatment (and during the subsequent 24 hours), as their ability to do so may be temporarily impaired by the use of praziquantel. ...
Undesirable effects
Summary of the safety profile Adverse Reactions are based on publications and on spontaneous reports sorted by CIOMS III categories of frequency and MedDRA System Organ Classes (in internationally agreed ...
Overdose
Information on overdosage in humans is not available. Treatment should be supportive and provide symptomatic care. Activated charcoal may reduce absorption of the medicine if given within one to two hours ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihelmintics ATC code: P02BA01 Praziquantel is 2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4H-pyrazino (2,1a) isoquinolin-4-one. CAS Number: 55268-74-1 Praziquantel is a ...
Pharmacokinetic properties
Absorption After oral administration praziquantel is rapidly absorbed (80%). It is, however, subject to first pass effect and extensive metabolism. One hour after administration approximately 6% only of ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on studies of systemic toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
List of excipients
Maize starch Magnesium stearate Microcrystalline cellulose Povidone 25 Sodium lauryl sulfate Macrogol 4000 Hypromellose Titanium dioxide (CI77891)
Incompatibilities
Not applicable.
Shelf life
48 months.
Special precautions for storage
Not applicable.
Nature and contents of container
Each brown glass bottle contains 8 tablets.
Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627, Free phone: 0800 233 988
Date of first authorization / renewal of the authorization
13 September 2012
Date of revision of the text
17 August 2017
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