You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months. Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength.Serious.
In less than 1 of patients, intraocular inflammation was reported as iritis. Systemic adverse events reported in approximately 10 of patients were infections (primarily colds and upper respiratory tract infections). The following systemic adverse events reported in approximately 1 to 5 of patients, in descending.
I also think that the fact that they are only applying the medicine once per day is a good sign that phase one study tests produced considerably better regrowthj than can be achieved with minoxidil or else the company would go back to the drawing.The.
The applicator should be disposed after one use. A new sterile applicator should be used for the opposite eyelid margin. The onset of effect is gradual and is not apparent in the majority of patients until 2 months.Bimatoprost solution should be used with caution in.
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Only apply at base of upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes.
Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physicians advice. Contact lenses should be removed prior to instillation of LUMIGAN and may be reinserted 15 minutes following its administration.If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. If more than one topical ophthalmic product is to be used, the different products should be instilled at least. 4.8 Undesirable effects No adverse drug reactions (ADRs) specific for GANFORT have been observed in clinical studies. The ADRs have been limited to those earlier reported for bimatoprost and timolol. The majority of ADRs were ocular, mild in severity and none were serious.
Patients should be advised that LUMIGAN contains benzalkonium chloride, which may be absorbed by soft contact lenses. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections.
2 4.4 Special warnings and precautions for use. Like other topically applied ophthalmic agents, GANFORT may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed.There are no known adverse reactions of ocular timolol on liver function. Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with bimatoprost and.
After 12 months treatment with GANFORT, the incidence of iris pigmentation was 0.2. After 12 months treatment with bimatoprost eye drops alone, the incidence was 1.5 and did not increase following 3 years treatment.Contains benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who.
Ear and labyrinth disorders: tinnitus. Cardia).4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients. Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.
Nervous system disorders: dizziness Eye disorders: allergic conjunctivitis, cataract, eyelash darkening, increased iris pigmentation, blepharospasm, eyelid retraction, retinal haemorrhage, uveitis. Vascular disorders: hypertension. General disorders and administration site condition: asthenia, peripheral oedema.Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4). The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.
Bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life.Some patients may slowly develop darkening of the iris, which may be permanent. When only one eye is treated, patients should be informed of the potential for a cosmetic difference between the eyes in eyelash length, darkness or thickness, and/or color changes of the eyelid.
The following ADRs were reported during clinical trials with GANFORT (within each frequency grouping, undesirable effects are presented in order of decreasing seriousness 4 Nervous system disorders Uncommon (1/1000 to 1/100 headache Eye disorders Very common (1/10 conjunctival hyperaemia, growth of eyelashes.Based on 12-month clinical data, the most commonly reported ADR was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26 of patients and led to discontinuation in 1.5 of patients.
Cystoid macular oedema has been reported with GANFORT. Therefore, GANFORT should be used with caution in patients with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3). Consequently, GANFORT should not be used during pregnancy unless clearly necessary.
Patients should be informed that LUMIGAN has been reported to cause increased growth and darkening of eyelashes and darkening of the skin around the eye in some patients. These changes may be permanent.Product Characteristics ANNEUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT GANFORT 300 micrograms/ml 5 mg/ml eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).
Investigations: liver function tests (LFT) abnormal. Timolol Psychiatric disorders: insomnia, nightmares, decreased libido Nervous system disorders: dizziness, memory loss, increase in signs and symptoms of myasthenia gravis, paresthaesia, cerebral ischaemia Eye disorders: decreased corneal sensitivity, diplopia, ptosis, choroidal detachment (following filtration surgery refractive changes (due.Some of these changes may be permanent, and may lead to differences in appearance between the eyes if only one eye is treated. After discontinuation of GANFORT, pigmentation of iris may be permanent.
Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cardiac failure should be adequately controlled before beginning GANFORT therapy.The preservative in GANFORT, benzalkonium chloride, may cause eye irritation. Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
Contact with soft contact lenses must be avoided. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Therefore monitoring is required with frequent or prolonged use of GANFORT in dry eye patients or where the cornea is compromised.4.6 Pregnancy and lactation Pregnancy There are no adequate data from the use of GANFORT in pregnant women. Bimatoprost No adequate clinical data in exposed pregnancies are available. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).