Signitsef 5 ml of 0.5% eye drops

The instruction
for medical use


of SIGNITsEF medicine
the Trade name
Signitsef

Mezhdunarodnoye the unlicensed


name Levofloxacin Dosage Form
of the Drop eye 0.5%

Structure
of 1 ml of drug contains
active agent – a levofloksatsin gemigidrat
equivalent to a levofloksatsin of 5.0 mg
excipients: a benzalkoniya chloride, a gipromelloza, sodium chloride, sodium hydroxide, chlorohydrogen acid, water for injections.

Description
Transparent solution of light yellow color.

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Antimicrobial drugs
others. Levofloxacin
the ATX S01AX19 Code

the Pharmacological

Pharmacokinetics Later properties of instillation in an eye levofloxacin well remains in a plaintive film. Concentration of a levofloksatsin in plaintive liquid after a single dose (1 drop) quickly reaches high values and keeps at the level above the minimum inhibiting concentration (MIC) for the majority of sensitive activators (less or equally to 2 mkg/ml) within, at least, 6 hours. In researches on healthy volunteers it was shown that the average concentration of a levofloksatsin in a plaintive film measured in 4 and 6 hours after topical administration made 17.0 mkg/ml and 6.6 mkg/ml respectively. At five of six examinees of concentration of a levofloksatsin made 2 mkg/ml and above in 4 hours after instillation. At four of six examinees this concentration remained in 6 hours after instillation.
Average concentration of a levofloksatsin in blood plasma in 1 hour after use - from 0.86 ng/ml in the first day up to 2.05 ng/ml. The maximum concentration of a levofloksatsin in plasma, equal 2.25 ng/ml, is revealed for the fourth day after two days of use of drug each 2 hours up to 8 times a day. The maximum concentration of a levofloksatsin reached for the 15th day are more than 1000 times lower than those concentration which are noted after intake of standard doses of a levofloksatsin.
The pharmacodynamics
Levofloxacin is a L-isomer of racemic medicinal substance of an ofloksatsin. The antibacterial activity of an ofloksatsin belongs, mainly, to L-isomer. As antibacterial drug of a class of ftorkhinolon, levofloxacin blocks DNK-girazu and topoisomerase IV, breaks superspiralling and a stitching of ruptures of DNA, suppresses DNA synthesis, causes profound morphological changes in cytoplasm, a cell wall and membranes of bacteria. The activity of a levofloksatsin of in vitro is approximately twice more, than for an ofloksatsin against representatives of Enterobacteriaceae, P. aeruginosa and gram-positive microorganisms.
Signitsef is effective in the relation: gram-negative aerobes, such as Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, gram-positive aerobes, such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
Other microorganisms sensitive to Signitsef, Chlamydia trachomatis are. The maximum concentration Signitsef reached when using eye drops of 5 mg/ml, more than by 100 times exceeds value of the minimum inhibiting concentration of a levofloksatsin for sensitive microorganisms.

Indications
- the superficial bacterial infections of eyes caused by flora, sensitive to a levofloksatsin,
- prevention of infectious complications after surgical and laser eye surgeries

the Route of administration and doses
to Adults and children are more senior than 8 years.
Locally, in the affected eye. On 1-2 drop in the affected eye each two hours up to 8 times a day during wakefulness within the first 2 days, then four times a day from the 3rd to the 5th day. Duration of a course of treatment is defined by the doctor, usually 5 days.

Side effects
Side effects can arise approximately at 10% of patients. Side effects, as a rule, are shown in an easy or moderate form, have passing character and are usually limited to ophthalmologic symptoms.
The general (³1/100 & lt, 1/10)
- burning sensation in eyes
- decrease in visual acuity
- emergence of slime in the form of tyazhy
Rare (³1/1.000 & lt, 1/100)
- blepharitis, hemoz, conjunctival papillary reaction, swelled centuries, discomfort, an itching and eye pain, conjunctiva hyperaemia, conjunctiva follicles, xerophthalmus, an erythema a century, photophobia
- a headache
- rhinitis
Very rare (³1/10.000, & lt, 1/1.000)
- extraocular allergic reactions, including skin rash
Extremely rare (& lt, 1/10.000), (including separate messages)
- an anaphylaxis
-


the Contraindication laryngeal edema
- hypersensitivity to any of components of drug or to other hinolona
- pregnancy and in the period of a lactation
- children's age up to 8 years

Medicinal interactions
of Special researches on interaction of eye drops Signitsef of 0.5% was not carried out. As the maximum concentration of a levofloksatsin in plasma after topical administration in an eye is at least 1000 times lower, than after reception of standard doses inside, interaction with other medicines, characteristic of system use, clinically not significantly.

Special instructions
Eye drops Signitsef 0.5% cannot be entered subkonjyunktivalno and into an anterior chamber of an eye.
At simultaneous use of other ophthalmologic means the interval between instillations has to make at least 15 minutes.
Drops should not be applied during carrying hydrophilic (soft) contact lenses, in connection with existence in preservative drops a benzalkoniya of chloride which can be absorbed by contact lenses and make an adverse effect on eye tissues and also cause discoloration of contact lenses.
To avoid pollution of a tip of a dropper and solution, when burying it is not necessary to touch an eye.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug, it is necessary to be careful when driving or potentially dangerous mechanisms

Overdose
Symptoms: the total number of a levofloksatsin which is contained rolled into one eye drops is, not enough, to cause toxic reactions even after accidental intake.
Treatment: After topical administration of an excess dose of eye drops Signitsef of 0.5%, it is necessary to wash eyes with clear water of room temperature.

Form of release and packing
of the Drop eye 0.5%.
On 5 ml of drug in plastic bottles droppers.
On 1 bottle dropper together with the screw-on cap in which there is a device for opening of a bottle and with the instruction for medical use in the state and Russian languages place in a cardboard pack.


To Store storage conditions in the place protected from light at a temperature not above 30 °C.
Not to freeze.
To store out of children's reach!

A period of storage
2 years
the use Period after opening of a bottle 1 month.
Not to use after the expiry date specified on packing!

Prescription status
According to the prescription


of Proizvoditel SENTISS FARM Pvt. Ltd.
212/D-1, Greene Park, New Delhi, India
At the plant: Villidzh Khera Nikhla, Tekhsil Nalagarkh, Region of Solan, Himachal Pradesh 174,101, India

Name and country of the owner of the registration certificate
of SENTISS FARMA of Pvt. Ltd., India

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Republic of Kazakhstan, 050000, Almaty, Bogenbay St. of the Batyr 132, office 309
Ph./fax: +7 (7272) 96-45-99
Email: sentiss_kz@land.ru