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Prosp. lotemicin ingles.indd

risk of secondary ocular infections.
Pharmacological features:
In those diseases causing thinning of the cornea or sclera, the use of topical steroids may cause Use in pediatrics
LOTEMICIN®
Pharmacological action
perforations. In acute ocular purulent diseases, steroids may hide or exacerbate the existing Safety and effectiveness of LOTEMICIN® have not been established in children.
Corticosteroids suppress inflammatory response of a variety of causal agent and probably infections. The ocular steroid use may extend the course and exacerbate the severity of numer- Adverse Reactions
delay healing. They inhibit edema, the fibrin deposit, capillary dilation, leukocyte migration, ous viral ocular infections (including herpes simplex).
Adverse reactions produced by drugs combining a corticosteroid and an anti-infectious agent capillary proliferation, fibroblast proliferation, collagen deposit and scar formation, associated Corticosteroids use in the treatment of patients with history of herpes simplex requires great may be due to the steroid component, the anti-infectious component or its combination.
In a safety study conducted during 42 days where LOTEMICIN® was compared with pla- The exact mechanism of action of the corticosteroids used at ophthalmic level is unknown. Steroids use after cataract surgery may delay healing and increase the incidence of blister cebo, the ocular adverse reactions observed in more than 10% of the patients included ocular However, it is believed that they could act inducing phospholipase A injection (20% approximately) and superficial keratitis punctata (15% approximately). The called lipocortins. These proteins could control the biosynthesis of inflammation potent media- It is recommended to determine intraocular pressure if LOTEMICIN® is administered during incidence of the increased pressure was 10% among the patients treated with LOTEMICIN® STERILE OPHTHALMIC SUSPENSION
tors, such as prostaglandins and leukotriens, inhibiting the release of its common precursor, the and 4% among the patients treated with placebo. 9% of the patients treated with LOTEMICIN® arachidonic acid. The arachidonic acid is released by the phospholipase A2 of the phospholip- Precautions
reported burning and itching sensation after instillation. The ocular adverse reactions reported ids membrane. The corticosteroids may produce the increased intraocular pressure.
General: For ophthalmic use only.
in less than 4% include vision disorders, secretion, itching, tear disorders, photophobia, corneal The Loteprednol etabonate is structurally similar to other corticosteroids, with the exception Before continuing the treatment beyond 14 days, an ophthalmologic study is recommended deposits, ocular and eyelid discomfort, and other unspecified disorders. Formula:
of the lack of the ketone group in position number 20. It is highly liposoluble, making cell including biomicroscopic examination with split lamp and, if appropriate, fluorescein color- As regards the incidence of non-ocular adverse reactions, approximately 14% of the patients penetration easy. The Loteprednol etabonate is synthesized through structural modifications of reported headaches. Other non-ocular adverse reactions had an incidence lower than 5%.
components related to the prednisolone, therefore its transformation to an inactive metabolite If signs and symptoms do not improve after two days of treatment, the patient should be The reactions related to the steroid ophthalmic topical use include increased intraocular pres- is predictive. Based on the in vivo and in vitro metabolization pre-clinical studies, Loteprednol sure possibly associated with optical nerve damage, defects in the visual sharpness and field, Tyloxapol 0.40 g; Povidone 2.00 g; Glycerin 0.70 g; Disodium phosphate anhydrous 0.76 g; etabonate undergoes extensive metabolism to inactive metabolites of carboxylic acid. The sus- If the product is used for 10 days or longer, intraocular pressure should be controlled, even in posterior subcapsular cataracts formation, delay in healing and microorganism secondary ocular Monosodium phosphate dihydrate 0.21 g; Benzalkonium chloride 0.010 g; Purified water pension contains an antibiotic component (tobramicyn) acting on the susceptible organisms. In children or non-cooperative patients.
infection including herpes simplex and perforation of the eyeball when there is a thinning of vitro studies have demonstrated that tobramicyn is effective against the following susceptible Long-term use of topical steroid agents favors the development of fungal infections in the cor- microorganisms: Staphylococcus, including S. aureus and S. epidermidis (coagulase-positive nea. The possibility of fungal infection should be considered in case of any persistent corneal In a set of randomized controlled studies of patients treated during 28 or more days with Therapeutical action:
and coagulase-negative), including strains resistant to penicillin, Streptococcus, including some ulceration when some steroid had been used or is being used. Fungal culture should be made Loteprednol etabonate, the incidence of significant increase of the intraocular pressure (≥10 LOTEMICIN® combines an ophthalmic steroid anti-inflammatory (Loteprednol etabonate) group A beta-hemolytic species, non-hemolytic and Streptococcus pneumoniae, Pseudomonas when appropriate. As well as with other antibiotic preparations, long-term use may produce mmHg) was 2% (15/901) among the patients treated with Loteprednol etabonate, 7% and an amino-glycoside antibiotic (Tobramicyn).
aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, the overgrowing of non-susceptible organisms, including fungi. If a superinfection is produced, (11/164) among the patients treated with 1 % prednisole acetate and 0.5% (3/583) among the Morganellas morganii, numerous strains of Proteus vulgaris, Haemophilus influenzae and H. the corresponding therapy should be started.
aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some species of Neisseria.
Cross-sensitivity may be caused to other amino-glycoside antibiotics. If hypersensitivity is devel- The most frequent adverse reactions to ophthalmic and topically administered Tobramicyn are Pharmacocinetics
oped with this product, discontinue its use and start the corresponding therapy.
hypersensitivity and localized ocular toxicity including itching and eyelid swelling and conjuncti- In a controlled clinical study of ocular penetration, Loteprednol etabonate levels were com- Product is packed in sterile conditions. Patients should be informed that they should avoid val erythema. These reactions occur in less than 4% of the patients. Similar reactions may occur pared in the aqueous humor between the groups treated with LOTESOFT® and LOTEMICIN®.
to contact the dropper-bottle tip with any other surface, which could contaminate the with the topical use of other systemic aminoglycosides antibiotics. Other adverse reactions have The results obtained in a bioavailability study carried out in healthy patients stated that the not been reported; however, if ocular topical Tobramicyn is administered, the precaution of plasma levels of Loteprednol etabonate and cortienic acid ∆1 etabonate (PJ 91), its primary Please see your physician if pain, reddening, and itching appear, or inflammation worsens.
controlling the total serum concentration should be taken.
inactive metabolite, were under the quantification limit (1 ng/mL) in all the sampling time. The As with other ophthalmic preparations containing benzalkonium chloride, patients should not Secondary infections: secondary infections have been developed after the combined use of results were obtained after the ocular administration of a drop of 0.5 % Loteprednol etabonate use soft contact lens during LOTEMICIN® administration.
steroids and antibiotic agents. The fungal infections of the cornea are particularly prone to be in each eye, 8 times a day during 2 days and 4 times a day during 42 days. This study suggests Carcinogenesis, Mutagenesis, Impairments of the fertility
developed together with the long-term use of local steroid agents. The possibility of fungal that there is a limited systemic absorption (<1 ng/mL) with 0.5 % Loteprednol etabonate.
Long-term carcinogenic studies in animals to evaluate the carcinogenic potential of Loteprednol infection should be taken into account in case of any persistent corneal ulceration when some Dosage and Administration
etabonate or Tobramicyn have not been conducted.
steroids have been used. Bacterial secondary ocular infections may be caused after the suppres- Shake well the suspension before instilling.
Loteprednol etabonate was not genotoxic in the Ames test, TK murine lymphoma test and The recommended dose of LOTEMICIN® is 1 to 2 drops LOTEMICIN® in the conjunctival chromosomal aberration test in human lymphocytes, performed in vitro; or in the murine Overdosage
sac of the affected eye(s) every 4 to 6 hours. During the first 24 to 48 hours, dosage may be micronucleous test performed in vivo.
Cases of overdosage with LOTEMICIN® have not been informed.
increased every 1 to 2 hours. The administration frequency should be gradually reduced as the The oral treatment in male and female rats with doses up to 50 mg/kg/day and 25 mg/kg/day In case of an overdosage, please go to the nearest hospital or toxicology centers.
clinical signs improve. The treatment should not be interrupted before the term indicated by of Loteprednol etabonate (500 and 250 times the maximum clinical dose, respectively) before Patient information:
the professional. The initial prescription should not be higher than 20 mL. In case of continuing and during the copulation phase did not modify the fertility in both genders. Impairments of The product is packed in sterile conditions. Patients should be informed that they should the treatment beyond the first prescription, new studies should be conducted.
the fertility were not observed in the studies conducted with subcutaneous Tobramicyn in rats, avoid to contact the dropper-bottle tip with any other surface, which could contaminate the Product is packed in sterile conditions. Patients should be informed that they should avoid with doses up to 100 mg/kg/day (1700 times the maximum clinical daily dose).
to contact the dropper-bottle tip with any other surface, which could contaminate the Pregnancy
Indications:
Please see your physician if pain, reddening, and itching appear, or inflammation worsens.
LOTEMICIN® is indicated for the treatment of the inflammatory ocular diseases responding As with other ophthalmic preparations containing benzalkonium chloride, patients should not Please see your physician if pain, reddening, and itching appear, or inflammation worsens.
Studies in female rata and rabbits treated with Loteprednol etabonate in oral doses of 5 and to corticosteroids, and where a bacterial infection exists on the ocular surface or its risk.
use soft contact lens during LOTEMICIN® administration.
As with other ophthalmic preparations containing benzalkonium chloride, patients should not 3 mg/kg/day (50 and 30 times the maximum clinical daily dose for rats and rabbits respec- Ophthalmic corticosteroids are indicated for the treatment of inflammatory diseases of use soft contact lens during LOTEMICIN® administration.
tively) during the organogenesis period showed that Loteprednol is not teratogenic. The oral How supplied:
eyelids and bulbar conjunctiva, cornea and anterior segment of the eyeball, such as allergic administration of 50 mg/kg/day (500 times the maximum clinical daily dose) to rats during Dropper-bottle containing 5 ml sterile ophthalmic suspension.
conjunctivitis, acne rosacea, superficial punctata keratitis, herpes zoster keratitis, iritis, Contraindications
the final period of pregnancy and breastfeeding caused a decreased growth and survival of cyclitis, and in those cases of infectious conjunctivitis where, to reduce edema and inflam- LOTEMICIN®, as other ophthalmic drugs combining corticosteroids with anti-infectious the offspring. However, adverse effects were not observed in the offspring with doses up to 5 Storage conditions:
mation, the risk of corticosteroids use is justified. They are also indicated for the treatment agents, is contraindicated in most viral corneal and conjunctival diseases, including herpes mg/kg/day (50 times the maximum clinical daily dose).
of chronic anterior uveitis and corneal injuries caused by chemical agents, radiation or simplex epithelial keratitis (dendritic keratitis), vaccinia varicella; as well as microbacterial ocular Parental administration up to 100 mg/kg/day of Tobramicyn (1700 times the maximum clinical Discard the product after one month of being opened.
burning, or by the penetration of foreign bodies.
infections and in mycotic diseases of ocular structures. LOTEMICIN® is also contraindicated in daily dose) to rats and rabbits did not show to cause fetal damage.
Keep the medicines out of the reach of children.
The combined use as an anti-infectious agent is indicated as an agent in which there is a persons with known or suspected hypersensibility to some of the formula components or to There are no adequate and well controlled studies in pregnant women.
high risk of infection in the ocular surface.
LOTEMICIN® may be used during pregnancy only when the expected benefit justifies the Delicate use product. To be administered under prescription and medical surveillance.
The anti-infectious agent used in this product (Tobramicyn) is effective against the following Warnings
pathogen microorganisms: Staphylococcus, including S. aureus and S. epidermidis (coagulase- Breastfeeding
LABORATORIOS POEN S.A.C.I.F.I.
positive and coagulase-negative), including strains resistant to penicillin, Streptococcus, Long-term use of corticosteroids may produce glaucoma with damages in the optical nerve, It is unknown whether the ophthalmic topical administration of corticosteroids may produce a Bermúdez 1004 - C1407BDR- Buenos Aires, Argentina including some group A beta-hemolytic species, non-hemolytic and Streptococcus pneumoniae, defects in the visual sharpness and visual field; and posterior subcapsular cataracts formation. systemic absorption enough to detect the substance in the mother milk. The steroids adminis- Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Steroids should be used with precaution in the cases of glaucoma. Some patients may develop tered by systemic routes are detected in the mother milk and may suppress growing, interfere Proteus mirabilis, Morganellas morganii, numerous strains of Proteus vulgaris, Haemophilus sensitivity to the topical application of aminoglycosides. If there is a sensitivity reaction, discon- with the endogenous production of the corticosteroids or cause other undesirable effects in influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some species tinue its use. Long-term use of corticosteroids may suppress the host response and increase the the infant. Great cautions should be taken when LOTEMICIN® is indicated to breastfeeding Laboratorio/Laboratory: LABORATORIOS POEN Elemento/Item: PROSPECTO (FRENTE Y DORSO)

Source: http://www.poen.com.ar/uploads/products_poen/prospectos/Prosp._Lotemicin_INGLES.pdf

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