IMUNOVIR Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
IMUNOVIR 500 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 500mg Inosine Acedoben Dimepranol (INN, also known as inosine pranobex*) which is the p-acetamidobenzoic acid salt of N,N-dimethylamino-2-propanol [DIP.PAcBA] and β-inosine in a 3:1 ...
Pharmaceutical form
White to off-white oblong tablets with a faint amine odour, engraved with a score-line on one side and DN on the other. The score-line is only to facilitate breaking for ease of swallowing and not to divide ...
Therapeutic indications
Imunovir tablets are indicated in the management of: Mucocutaneous infections due to herpes simplex virus (type 1 and/or type II). Genital warts as adjunctive therapy to podophyllin or carbon dioxide laser. ...
Posology and method of administration
Posology Adults and the Elderly The recommended dosage is 50mg/kg–100mg/kg of body weight usually 3g/day up to a maximum of 4g/day, administered orally in 3-4 equally divided doses during waking hours. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Imunovir should not be used where the patient is presently suffering from gout or has elevated uric acid blood ...
Special warnings and precautions for use
Imunovir may cause a transient elevation of baseline serum and urinary uric acid, usually remaining within the normal range (using 8mg % as the upper limit), particularly in males and in the ageing population ...
Interaction with other medicinal products and other forms of interaction
The drug should be used with caution with xanthine oxidase inhibitors or uricosuric agents, including diuretics. Imunovir may be administered after but not concomitantly with immunosuppressive agents, ...
Pregnancy and lactation
Controlled trials monitoring foetal risk and impairment of fertility in humans are not available. It is not known if Imunovir is excreted in human milk. Therefore, Imunovir should not be administered during ...
Effects on ability to drive and use machines
Imunovir has no or negligible influence on the ability to drive and use machines.
Undesirable effects
During treatment with Imunovir, the only consistently observed drug-related side effects in adults as well as paediatric population is a transient elevation (usually remaining within normal range) of urine ...
Overdose
There has been no experience of overdose with Imunovir. However, serious adverse effects apart from increased levels of uric acid in the body, seem unlikely in view of the animal toxicity studies. Treatment ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antivirals ATC code: J05AX05 Imunovir is a synthetic purine derivative with immunomodulatory and antiviral properties, which result from an apparent in vivo enhancement ...
Pharmacokinetic properties
Each moiety of the drug exhibits separate pharmacological properties. Absorption When administered orally in man, Imunovir is rapidly and completely absorbed (≥90%) from the gastrointestinal tract and ...
Preclinical safety data
Imunovir showed a low toxicity profile in multivariate acute, subacute and chronic toxicology in mice, rats, dogs, cats and monkeys in doses up to 1500mg/kg/day and produced the lowest acute oral LD<sub> ...
List of excipients
Povidone Mannitol Wheat starch Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
100 (5 20) tablets in transparent, colourless PVC/PVDC blister packs sealed with aluminium foil.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Kora Corporation Ltd. (trading as Kora Healthcare), Swords Business Park, Swords, Co. Dublin, Ireland
Marketing authorization number(s)
PL 39972/0001
Date of first authorization / renewal of the authorization
15<sup>th</sup> November 1983/29<sup>th</sup> September 2009
Date of revision of the text
06/11/2019
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