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Tobrex 5 ml of 0.3% eyedrops

$12.10

0793b65fc259

Description

The instruction for medical use of TOBREKS medicine * the Trade name of TOBREKS * the International unlicensed name Tobramycinum Dosage Form of the Drop eye 0.3%, 5 ml contains Structure of 1 ml of drug: active agent – Tobramycinum of 3.0 mg, excipients: boric acid, sodium sulfate anhydrous, sodium chloride, tiloksapol, a benzalkoniya chloride, sodium hydroxide and/or sulphuric acid (for correction rn), the water purified. The description Transparent from colourless till light yellow or brown color solution. Pharmacotherapeutic group Drugs for treatment of diseases of sense bodys. Drugs for treatment of diseases of eyes. Antimicrobial drugs. Antibiotics. Tobramycinum. The ATX S01AA12 code the Pharmacological Pharmacokinetics At properties topical administration of drug TOBREKS * drops eye system absorption of Tobramycinum is insignificant. Tobramycinum is emitted quickly and extensively in urine by glomerular filtration, generally as not changed look. T1/2 from plasma about 2 hours with clearance of 0.04 l/hour/kg and of distribution of 0.26 l/kg. Linking of Tobramycinum with proteins of plasma of less than 10%. The pharmacodynamics 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 highly active concerning the following susceptible strains (are marked †): Sensitive types Aerobic gram-positive microorganisms of the Kind of Corynebacterium † † (methicillin-sensitive) Staphylococci a coagualase – negative † (methicillin-sensitive) Aerobic gram-negative microorganisms of the Kind of Acinetobacter † † Haemophilus influenzae † Types of Klebsiella † Types of Moraxella Morganella morganii † Pseudomonas aeruginosa † Steady types Aerobic gram-positive microorganisms of Staphylococcus † (methicillin-ustoychivyea) of Streptococcus pneumoniae † Types of Streptococcus † Aerobic gram-negative microorganisms of Chryseobacterium indologenes Haemophilus influenzae Stenotrophomonas maltophilia Indications Drug TOBREKS * drops eye is shown to the Kind of Bacillus Kocuria kristinae Staphylococcus aureus by Escherichia coli for treatment of external diseases of the eyes and adjacent bodies caused by bacteria, susceptible to drug. A route of administration and doses Before use to uncover, remove a ring with opening control if it is not tightened. – In slow diseases to dig in 1-2 drops in a conjunctival sac of the affected eye (eyes) each 4 hours. – In acute infectious diseases on 2 drops in a conjunctival sac of the affected eye (eyes) each hour before improvement of symptoms then gradually reduce a dose before complete cessation of reception. Duration of treatment depends on a type of an infection and can fluctuate from two days to several weeks. After burying it is recommended to press the lacrimonasal channel or to carefully cover eyelids. It reduces system absorption of medicine and serves as prevention of development of adverse system reactions. It is not necessary to touch with a pipette tip eyes, or any other surface to avoid pollution of contents of a bottle. Clinical trials established that Tobramycinum is effective and safe for treatment of children. Pediatrics Eye drops, TOBREKS solution * can be applied to treatment of children for 8 years also adults are more senior in the same doses, as well as. Reliable data on safety and efficiency of use of drug for children are younger than 8 years are absent. Side effects Local it is frequent (≥ 1/100 to & lt, 1/10): – discomfort of an eye, eye hyperaemia not often (≥1/1.000 to & lt, 1/100): – hypersensitivity – a headache – a keratitis, attrition of a cornea, a disorder of vision, disturbance of clearness of sight, an erythema of a century, conjunctiva hypostasis, hypostasis of a century, eye pain, xerophthalmus, discharges from eyes, an itching of eyes, increase in lachrymation – urticaria, dermatitis, madaroz, the leukoderma, an itching, dry skin the Additional side reactions revealed during post-marketing observation include following. On the basis of the available data it is impossible to determine frequency. Side reactions on systems – from the immune system: Anaphylactic reaction – from organs of sight and feelings: an allergy of eyes, irritation of eyes, naggers a century – from integuments: Stephens’s syndrome – Johnson, an exudative mnogoformny erythema, rash. The description of some side reactions At some patients can develop sensitivity to locally applied aminoglycoside. Serious side reactions, including neurotoxicity, ototoxicity and renal toxicity, developed at the patients receiving system therapy by Tobramycinum. However, after topical administration of Tobramycinum the above-stated reactions were not shown (see the section Special Instructions). Contraindications – hypersensitivity on Tobramycinum, any other aminoglycosides or to any of drug components. – children’s age up to 8 years. Medicinal interactions Special researches of medicinal interaction for drug TOBREKS * drops eye were not conducted. Interactions with Tobramycinum were noted after system use. However, system absorption after topical administration very low and the risk of any influences is minimum. Combined and/or consecutive use of drug-aminoglycoside TOBREKS * eye and other system, oral or local drug having neurotoxic, ototoksichesky or nephrotoxic action can result drops in additional toxicity and has to be whenever possible excluded. When using a combination of drug TOBREKS * drops eye and local corticosteroids, the last can mask clinical signs of a bacterial, fungal or viral infection, or can suppress reactions of hypersensitivity. At use of several local ophthalmologic drugs – it is necessary to sustain at least a 5-minute interval between each use. Oculentum is applied in the last turn. Special instructions Only for topical ophthalmologic administration. It is forbidden to apply to injections or to use inside. Degree of hypersensitivity can vary from local effects before the general reactions among which an erythema, an itching, urticaria, skin rash, an acute anaphylaxis, anaphylactoid reaction, or bullous reactions. If the hypersensitivity to drug TOBREKS * drops eye is observed, use should be stopped. The cross sensitivity with other aminoglikozila is possible. In case of development of hypersensitivity during a usage time of this drug, treatment has to be other drug for treatment is stopped and is used. At topical administration of drug TOBREKS * drops eye together with system antibiotics aminoglycosides, it is necessary to control their general concentration in plasma. At the patients receiving system therapy by Tobramycinum serious undesirable reactions, including neurotoxicity, ototoksichnot and nephrotoxicity developed. The care at combined use with system aminoglycosides is necessary. As well as in a case with other drugs antibiotics, prolonged use can lead to the strengthened growth of irresponsive organisms, including, mushrooms. In case of superinfection it is necessary to begin the corresponding treatment. For prevention of a system resorption after use of eye drops it is recommended to undertake the following measures: – to close eyes for 2 minutes. – to press a finger on the plaintive canal within 2 minutes Pregnancy Data on topical administration of Tobramycinum during pregnancy either are absent, or are provided in limited volume. After intravenous administration to pregnant women, Tobramycinum does not get through a placenta into a fruit organism. Tobramycinum does not cause ototoxicity at pre-natal influence. Thereof, drug TOBREKS * drops eye is not recommended to be used during pregnancy and drug has to be appointed only at urgent need. A lactation It is unknown whether Tobramycinum with breast milk after topical administration for treatment of organs of sight is emitted. Tobramycinum is removed from an organism in breast milk after system use. It is improbable that Tobramycinum will be found in breast milk or will be able to render clinical effect on the newborn after drug use by mother. Risks for the child who is on breastfeeding cannot be excluded. The decision on interruption of breastfeeding or interruption/abstention from the TOBREKS drug treatment * drops eye, in view of advantages of breastfeeding for the child and advantage of treatment for the woman. Fertility Researches of influence of Tobramycinum on reproductive function of the person at topical administration of eye drops were not conducted. Contact lenses As drug TOBREKS * drops eye contains chloride a benzalkoniya which can be absorbed on contact lenses, decolour them or cause irritation in an eye, it is necessary to refrain from carrying rigid or soft (hydrophilic) contact lenses, or to delete them during burying. Lenses can be carried in breaks between use of drug and to insert not earlier than in 15 minutes after burying, Carrying contact lenses is not recommended during treatment of infections of an eye. Therefore patients are recommended to refrain from carrying contact lenses during treatment by this drug. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms * do not render Eye drops of TOBREKS or render insignificant effect on ability to drive or operate the equipment. As well as in a case with other eye drops, after burying the temporary illegibility of sight or other disorders of vision 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. Overdose Clinically confirmed signs and symptoms of overdose by drug TOBREKS * drops eye (the dot keratitis, an erythema, increase in lachrymation, an itching also swelled centuries) are similar to the side reactions observed at some patients. At topical administration the overdose is improbable. Treatment: it is necessary to wash out eyes plentiful amount of warm water. A form of release and packing On 5 ml of drug in 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 8 °C to 30 °C. To store the place, inaccessible for children! 3 years not to apply a period of storage after an expiration date. The use period after opening of a bottle – 4 weeks. Prescription status According to the prescription the Name and the address of the manufacturing organization of page and. Alkon-Kuvrer of N of century of B-2870 of Puurs, Belgium the Name and the address of the holder of the registration certificate of Novartis Pharm AG, Basel, Switzerland the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan accepting of a claim (offer) on quality of medicines from consumers, responsible for post-registration observation of safety of medicinal sredstvafiliat Novartis Pharm Servisez AG in Kazakhstan 050022 Almaty, st. Kurmangazy, 95
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