VIBRAMYCIN-D Dispersible Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Vibramycin-D 100 mg Dispersible Tablets.
Qualitative and quantitative composition
100 mg doxycycline as doxycycline monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Dispersible Tablets. Vibramycin-D Dispersible Tablets are greyish yellow/light tan round tablets with a breaker score on one face and engraved VN on the other side.
Therapeutic indications
Vibramycin has been found clinically effective in the treatment of a variety of infections caused by susceptible strains of Gram-positive and Gram-negative bacteria and certain other micro-organisms. ...
Posology and method of administration
Posology Adults and children aged 12 years to less than 18 years The usual dosage of Vibramycin for the treatment of acute infections in adults and children aged 12 years to less than 18 years is 200 mg ...
Contraindications
Hypersensitivity to doxycycline or to any of the tetracyclines or to any of the excipients listed in section 6.1. Pregnancy Vibramycin is contraindicated in pregnancy. It appears that the risks associated ...
Special warnings and precautions for use
Paediatric population The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discolouration of the ...
Interaction with other medicinal products and other forms of interaction
The absorption of doxycycline may be impaired by concurrently administered antacids containing aluminium, calcium, magnesium or other drugs containing these cations; oral zinc, iron salts or bismuth preparations. ...
Pregnancy and lactation
See section 4.3.
Effects on ability to drive and use machines
The effect of doxycycline on the ability to drive or operate heavy machinery has not been studied. There is no evidence to suggest that doxycycline may affect these abilities.
Undesirable effects
The following adverse reactions have been observed in patients receiving tetracyclines, including doxycycline. Common ≥1/100 to <1/10 Uncommon ≥1/1000 to <1/100 Rare ≥1/10,000 to <1/1000 Not known Cannot ...
Overdose
Acute overdosage with antibiotics is rare. In the event of overdosage discontinue medication. Gastric lavage plus appropriate supportive treatment is indicated. Dialysis does not alter serum half-life ...
Pharmacodynamic properties
Pharmacotherapeutic group: Tetracyclines ATC code: J01AA02 Vibramycin is primarily bacteriostatic and is believed to exert its antimicrobial effect by the inhibition of protein synthesis. Vibramycin is ...
Pharmacokinetic properties
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and faeces at high concentrations and in ...
Preclinical safety data
None stated.
List of excipients
Anhydrous colloidal silica Microcrystalline cellulose Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Aluminium/PVC blister strips, a single strip of 8 tablets in a carton box.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0188
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 October 2000 Date of latest renewal: 15 December 2008
Date of revision of the text
01/2019
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