Tobrex 0.3% 3.5g ophthalmic ointment

The instruction for medical use of TOBREKS medicine * the Trade name of TOBREKS * the International unlicensed name Tobramycinum Dosage Form Ointment of ophthalmologic, 3.5 g Structure of 1 g of drug contains active agent – Tobramycinum of 3.0 mg excipients: chlorbutanol anhydrous, liquid paraffin (mineral oil), vaseline white. Description Uniform ointment of white or almost white color. Pharmacotherapeutic group Sense bodys. Ophthalmologic drugs. Antimicrobial drugs. Antibiotics. Tobramycinum. The ATX S01AA12 code the Pharmacological Pharmacokinetics Absorption High Concentration properties of Tobramycinum in drug TOBREKS * delivers Tobramycinum in the defeat center an infection (eye surface) in concentration usually much more, than the minimum inhibiting concentration (MIC) of the steadiest isolates (MIK & gt, 64 mg/ml, after 1 minute concentration of Tobramycinum in an eye after a single dose of drug 848 ± 674 mg/ml). Concentration of Tobramycinum in tears at the healthy person remains MIK90 (16 mg/ml as are described for eye isolates), at least up to 44 minutes after drug TOBREKS* use. Distribution the Volume of distribution makes 0.26 l/kg. Linking of Tobramycinum with proteins of plasma of less than 10%. Metabolism Tobramycinum is allocated with urine, generally as not changed medicine. Removal Tobramycinum is allocated quickly and extensively in urine by glomerular filtration. Plasma elimination half-life about 2 hours. The system clearance at adult patients with normal function of kidneys varies from 0.05 to 0.1 l/hour/kg and decreases about reduction of functioning of kidneys. Use at patients with a liver and renal failure Drug TOBREKS * was not studied at this group of patients. However, because of low system absorption of Tobramycinum after ophthalmologic use of this drug, correction of a dosage is not required. Use in pediatrics Drug TOBREKS * can be used at children 1 years in the same dose, as for adults are more senior. However, at children 1 years are younger information on use is limited. A pharmacodynamics the action Mechanism Tobramycinum - a powerful, high-speed bactericidal aminoglikozidny antibiotic of a broad spectrum of activity. It has the main impact on bacterial cells by inhibition of assembly and synthesis of polypeptides on ribosomes. The resistance mechanism Resistance to Tobramycinum occurs by several various mechanisms, including (1) changes of a ribosomal subunit in a bacterial cell, (2) intervention in transfer of Tobramycinum in a cell and (3) inactivation of Tobramycinum a number of the adenililiruyushchy, phosphorylating and acetylating enzymes. Genetic information for production of the inactivating enzymes can be transferred to a bacterial chromosome or to plasmids. There can be a cross resistance to other aminoglycosides. Widespread sensitive types Aerobic gram-positive microorganisms of Bacillus megaterium Bacillus pumilus Corynebacterium accolens Corynebacterium bovis Corynebacterium macginleyi Corynebacterium pseudodiphtheriticum Kocuria kristinae Staphylococcus aureus, Staphylococcus epidermidis strains, sensitive to Methicillinum (koagulyaza-positive and koagulyaza-negative) Staphylococcus haemolyticus (Methicillinum - sensitive – MSSH) Streptococci (including beta and hemolytic streptococci of group A, not hemolytic microorganisms and some types of Streptococcus pneumonia). Aerobic gram-negative microorganisms of Acinetobacter calcoaceticus Acinetobacter junii Acinetobacter ursingii Citrobacter koseri Enterobacter aerogenes Escherichia coli H. aegyptius Haemophilus influenzae of Klebsiyell of oxycurrent (Klebsiella oxytoca) Klebsiella pneumoniae Morganella morganii Moraxella catarrhalis Moraxella oslonensis Moraxella lacunata Some types of the sort Neisseria Proteus mirabilis the Most part of strains of Proteus vulgaris Pseudomonas aeruginosa Serratia liquifaciens Antibacterial activity against other corresponding pathogens of Vida which acquired resistance can be a problem of Acinetobacter baumanii Bacillus cereus Bacillus thuringiensis Kocuria rhizophila Staphylococcus haemolyticus (Methicillinum - resistant MRSH) Staphylococcus (Staphylococcus) others a coagualase - negative types of Serratia marescens the Microorganisms having natural resistance Aerobic gram-positive microorganisms of Enterococci faecalis Staphylococcus aureus (Methicillinum - resistant - MRSA) the Piogenic streptococcus (Streptococcus pyogenes) Streptococcus sanguis Aerobic gram-negative microorganisms of Haemophilus influenzae Stenotrophomonas maltophilia Chryseobacterium indologenes Burkholderia cepacia Anaerobic bacteria the Propionic bacterium of an acne (Propionibacterium acnes) Indications Drug TOBREKS * is shown to Streptococcus mitis Streptococcus pneumoniae for the treatment of external infections of an eye and fabrics around it caused by pathogenic microorganisms, sensitive to Tobramycinum, especially in patients with resistance to other antibiotics, mainly Pseudomonas aeruginosa and also at adults and children aged from 1 year and is more senior. A route of administration and doses the Dosage - At weak and average force infectious diseases of an eye to cause a small amount of ointment in a conjunctival sac of the affected eye (eyes), 2-3 times a day, or in addition to drops before going to bed. In process of reduction of inflammation to reduce use frequency to complete cessation. - In acute infectious diseases of an eye to cause a small amount of ointment in a conjunctival sac of the affected eye (eyes) each 3 – 4 hours before improvement of a state then gradually reduce use frequency up to complete cessation of reception. Duration of treatment depends on a type of an infection and can fluctuate from two days to several weeks. The pediatrics Drug TOBREKS * can be used at children since 1 also is more senior in the same dosage, as for adults. A route of administration Only for ophthalmologic use. It is not necessary to touch with the tuba tip by centuries surrounding the surfaces of an eye or any other surface to avoid pollution of contents of a tuba. Densely close a tuba a cap after each use. In case of the combined use with other ophthalmologic drugs, the interval between uses has to make not less than 5 minutes. Oculentums have to be applied in the last turn. Side effects the Following side effects are classified according to the following symbols: very often (≥1/10), it is frequent (≥ 1/100 to & lt, 1/10), infrequently (≥1/1.000 to & lt, 1/100), is rare (≥1/10.000 to & lt, 1/1.000), is very rare (& lt, 1/10.000) or it is unknown (it cannot be estimated from available information). Local it is frequent: - discomfort of an eye, eye hyperaemia Infrequently: - a keratitis, attrition of a cornea, vision disturbance, disturbance of clearness of vision, an erythema of a century, hypostasis of a century, discharge from eyes, dysfunction a century, a chemosis, irritation of a mucous membrane of an eye, eye pain, xerophthalmus, an itching of eyes, increase in lachrymation Is unknown: - eye allergy, itching century System Infrequently: - hypersensitivity - a headache - urticaria - dermatitis - madaroz - a leukoderma - naggers - xeroderma Are unknown: - anaphylactic reactions - rash - an erythema - Stephens's syndrome – Johnson - the exudative mnogoformny erythema the Description of some side reactions At some patients can develop sensitivity to locally applied aminoglycoside. At simultaneous use of local ophthalmologic Tobramycinum and system antibiotics of aminoglycoside, it is necessary to watch the general concentration in plasma. Serious undesirable reactions, including neurotoxicity, ototoxicity and nephrotoxicity, 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). The reporting on expected undesirable reactions Providing messages about suspicious undesirable reactions after the statement of medicine is important very much. It allows to continue monitoring of balance advantage/risk of medicine. Experts of health care are offered to report about any expected undesirable reactions through national reporting system. Contraindications - hypersensitivity to Tobramycinum or to any component of drug - hypersensitivity to aminoglycosides Medicinal interactions Clinical trials of medicinal interaction were not conducted. It was reported about medicinal interaction with Tobramycinum after system use. Despite this, system absorption of Tobramycinum low therefore the risk of any medicinal interaction is not high. 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. At drug TOBREKS use * together with system antibiotics aminoglycosides, it is necessary to control carefully their general concentration in plasma. Special instructions Only for topical ophthalmologic administration. It is forbidden to apply in the form of injections or to use inside. Manifestations of hypersensitivity to locally applied aminoglycosides are possible. It is necessary to consider that there is a possibility that patients sensitive to local ophthalmologic Tobramycinum, can be sensitive to other local and/or system aminglycosides also. 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 violent reactions. At emergence of signs of hypersensitivity, drug use it is necessary to stop and use other medicine. 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, it is also necessary to watch the general concentration in plasma. 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. 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 the Pediatrics Efficiency and safety of drug TOBREKS * at children is younger than 1 year is not studied. Data are not available. Elderly patients Between elderly patients and other adult patients no clinical differences in safety and efficiency of use of drug TOBREKS* were observed. Use at patients with a liver or renal failure. The efficiency and safety of use of drug TOBREKS * at this category of patients was not studied. However, owing to low system absorption of Tobramycinum after topical administration of drug, correction of a dose is not required. Pregnancy Data on Tobramycinum use locally for eyes at pregnant women are limited or are absent. Tobramycinum does not cause ototoxicity at pre-natal influence. * pregnant women are recommended to appoint drug TOBREKS only in urgent cases when the efficiency of treatment justifies potential risk for a fruit. Lactation It is unknown whether Tobramycinum with breast milk after topical administration for treatment of organs of sight is emitted. 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. Despite this, risks for the child who is on breastfeeding cannot be excluded. The decision on interruption of breastfeeding or interruption/abstention from treatment by TOBREKS oculentum *, has to be accepted taking into account advantage of breastfeeding for the child and advantage of therapy for mother. Fertility Researches of influence of Tobramycinum on reproductive function of the person at topical administration of oculentum were not conducted. Contact lenses Carrying contact lenses is not recommended during the TOBREKS* drug treatment. Drug TOBREKS * does not render feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms or renders insignificant effect on ability to drive or operate the equipment. After putting ointment the temporary illegibility of sight or other disorders of vision are possible that it can negatively affect ability to drive the car or other potentially dangerous mechanisms. In this case the patient has to wait before recovery of clarity of vision before driving the car or to use mechanisms. Overdose Owing to characteristics of this drug any toxic system effects at its eye overdose or accidental ingestion of contents of one tube are not expected. In order to avoid overdose at excess local putting drugs TOBREKS * it is necessary to wash an eye(s) with warm water. The form of release and packing On 3.5 g of drug place in an aluminum tuba with a plastic tip and the screwed cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature from 8 °C to 30 °C to Store out of children's reach! A period of storage 2 years the use Period after opening of a tuba – 4 weeks. Not to apply after an expiration date. Prescription status According to the prescription Producer Alcon Cusi, S.A. El Masnou, Barcelona, Spain the Owner of the registration certificate of Novartis Pharm AG, Basel, Switzerland the Name, the address and a contact information (phone, the fax and e-mail) of the organization accepting in the territory of the Republic of Kazakhstan a claim (offer) from consumers on quality of medicines and responsible for post-registration observation of safety of medicine of Filial Novartis Pharm Servisez AG in Kazakhstan 050022 Almaty, Kurmangaza St., 95 ph.: (727) 258-24-47 fax: (727) 244-26-51
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