The instruction for medical use
of TOBREKS medicine 2nd
the Trade name
of Tobrex 2nd
the International unlicensed
name Tobramycinum Dosage Form
of the Drop eye 0.3% 5 ml
of 1 ml of drug contains
active agent Tobramycinum of 3.0 mg,
excipients: xanthane pitch, a benzododetsiniya bromide, Mannitolum, trometamol, boric acid, polysorbate 80, sulphuric acid or sodium hydroxide (for correction rn), the water purified to 1 ml.
Colourless or slabookrashenny transparent or opalescent solution.
Drugs for treatment of diseases of eyes. Antimicrobial drugs. Antibiotics. Tobramycinum.
The ATX S01AA12 code
Pharmacokinetics System Influence properties of Tobramycinum slightly at topical administration of eye drops of Tobrex of the 2nd.
Tobramycinum is emitted quickly and extensively in urine by glomerular filtration, generally as not changed medicine. T1/2 from plasma about 2 hours with clearance of 0.04 l/hour/kg and of distribution of 0.26 l/kg. Binding of proteins of plasma Tobramycinum of less than 10%. Oral bioavailability of Tobramycinum low (& lsaquo, 1%).
Tobramycinum is an antibiotic of a broad spectrum of activity from group of aminoglycosides. In low concentration works bacteriostatically (blocks 30S a subunit of ribosomes and breaks protein synthesis), and in higher bakteritsidno, breaking function of tsitoplazmichesky membranes and causing death of a microbic cell.
It is active concerning the following susceptible strains:
Staphylococcus aureus (Methicillin-sensitive or – steady *)
Staphylococcus epidermidis (Methicillin-sensitive or – steady *)
Others a coagualase – negative types of Staphylococcus
Other types of Streptococcus
* the Phenotype beta laktamnoy (that is methicillin, penicillin) stability has no relation to a phenotype of aminoglikozidny stability and both have no relation to a virulent and pathogenic phenotype. The majority Methicillinum of steady stafilokokk, are resistant to Tobramycinum (and to other aminoglikozidny antibiotics). Nevertheless, these steady staphylococcal isolates (according to the established MIC control points) usually successfully respond to treatment by locally applied Tobramycinum.
Types of Acinetobacter
of the Kind of Citrobacter
of the Kind
of Enterobacter Escherichia coli Haemophilus influenzae Klebsiella pneumoniae
of the Kind
of Moraxella Proteus mirabilis Pseudomonas aeruginosa Serratia mercescens
the Bacterial infections of an eye caused by bacteria, susceptible to drug:
A route of administration and doses
the Usual dose makes 1 drop in a conjunctival sac of the affected eye 2 times a day (in the morning and in the evening) during 7±, 1 days.
In acute infectious diseases: in the first day 4 instillations during wakefulness. Then on 1 drop in each eye 2 times a day during wakefulness before end of the general course of treatment 7±, 1 days.
It is not necessary to touch with a pipette tip eyes, or any other surface to avoid pollution of contents of a bottle and a tip of the pipette. You store a bottle densely closed after use.
When assigning eye drops of Tobrex of the 2nd in common with other eye drops it is necessary to observe an interval between burying of not less than 5-10 minutes.
Eye drops of Tobrex of the 2nd are applied at children (of 1 year and is more senior) in the same dosage, as to adults.
it is frequent:
an itching of an eye, hyperaemia, lacrimation
it is not frequent:
allergic reaction of an eye, discharge from eyes
discomfort of an eye
swelled centuries, an erythema of a century, disturbance of a century
– hypersensitivity to any component of drug
– children’s age till 1 year.
of Specific researches of medicinal interaction for eye drops of Tobrex of the 2nd it was not carried out.
Only for topical ophthalmologic administration.
Manifestations of hypersensitivity to locally applied aminoglycosides are possible. At emergence of signs of hypersensitivity, use of drug should be stopped.
As well as in a case with other drugs antibiotics, prolonged use can lead to the strengthened growth of irresponsive organisms, including, fungi. At emergence of signs of superinfection, it is necessary to begin the corresponding therapy.
In case of joint treatment with aminoglikozidny antibiotics, constant control of the general concentration in blood serum is necessary.
Eye drops of Tobrex of the 2nd pregnant women are recommended to appoint pregnancy and the period of a lactation only in urgent cases when the efficiency of treatment justifies possible risk for a fruit.
System absorption at topical ophthalmologic administration low, the risk is recognized as insignificant. Nevertheless the risk for the baby cannot be excluded. As the majority of medicines is distinguished in breast milk it is necessary to apply with care eye drops of Tobrex of the 2nd at the feeding women.
As eye drops of Tobrex of the 2nd contain a benzododetsiniya bromide, it is necessary to refrain from carrying soft contact lenses, or to remove them during burying. Lenses can be carried in breaks between use of drug and to put on not earlier than in 10-15 minutes after burying.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
After burying the temporary ambiguity of sight or other visual concerns is possible that it can negatively affect ability to drive the car or other potentially dangerous mechanisms. In this case it is necessary to wait some time before recovery of sight.
At topical administration overdose is improbable. At accidental intake the manifestation of toxicity is improbable.
Treatment: at local overdose it is necessary to wash out eyes plentiful amount of warm water. At accidental intake the treatment has to be symptomatic and supporting.
A form of release and packing
On 5 ml of drug in the Drop-Tainer system bottles from polyethylene of low density corked by a dropper and the screwed cover from polypropylene with control of the first opening.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature from 8C to 30C.
To store out of children’s reach!
A period of storage
the use Period after opening of a bottle 4 weeks.
Not to apply after an expiration date.
According to the prescription
Producer Alcon Cusi, S.A.
El Masnou, Barcelona, Spain
Owner of the registration certificate
of Alcon Cusi, S.A.
El Masnou, Barcelona, Spain
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