PHARMACEUTICALS The pharmacokinetics of olmesartan medoxomil were studied in the elderly (65 years). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. The duration of treatment depends on the type, duration and course of your complaints. Silica, colloidal anhydrous. No interactions having a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille (g/l) corresponding to one glass of wine) and cetirizine used at the recommended doses. After 6 months of treatment, the median menstrual blood loss (MBL) was decreased by 88% from 142 mL to 17 mL in the Qlaira group compared to 24% from 154 mL to 117 mL in the placebo group. Both metabolites undergo secondary conjugation to form glucuronides. Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. The original leaflet can be viewed using the link above. Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use. Hemolytic anemia has been reported; a causal relationship to lisinopril cannot be excluded; Metabolic: Gout, weight loss, dehydration, fluid overload, weight gain; Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, joint pain, leg pain, arm pain, lumbago; Nervous System/Psychiatric: Ataxia, memory impairment, tremor, insomnia, stroke, nervousness, confusion, peripheral neuropathy (e.g., paresthesia, dysesthesia), spasm, hypersomnia, irritability, mood alterations (including depressive symptoms); hallucinations ; Respiratory: Malignant lung neoplasms, hemoptysis, pulmonary edema, pulmonary infiltrates, eosinophilic pneumonitis, bronchospasm, asthma, pleural effusion, pneumonia, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngitis, rhinitis, rhinorrhea, chest sound abnormalities; Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, psoriasis. Amlodipine and Olmesartan Medoxomil tablets contain amlodipine besylate at a dose equivalent to 5 mg or 10 mg Amlodipine and Olmesartan Medoxomil in the strengths described below. Symptoms that may occur in case of taking an overdose of active tablets are: nausea, vomiting and, in young girls, slight vaginal bleeding. If Qlaira has not been taken according to these directions prior to the first missed withdrawal bleed or if the withdrawal bleeding is missed in two consecutive cycles, pregnancy must be ruled out before Qlaira use is continued. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. A higher prevalence of low birth weight (<2500 grams) compared with a reference group. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death. 100 Tablets Rx only, Rising The clinical significance of this change is unknown. (. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. The antihypertensive effect of a single dose usually lasts for 24 hours. - Treatment of symptomatic heart failure. Subjects with known renal impairment may require a longer time to reach steady-state at each dose. This information is intended for use by health professionals. No evidence of tolerance has been demonstrated in man. Hydrochlorothiazide White round tablets, 6 mm in diameter, TOP on one side, 25 on the other side. For paediatric patients aged 6 to 15 years a one year, open-label study was conducted (see section 5.1). The effective half-lives of amlodipine (4511 hours) and olmesartan (71 hours) result in a 2- to 3- fold accumulation for amlodipine and negligible accumulation for olmesartan with once-daily dosing. In addition, patients taking other medicinal products associated with nephrolithiasis may be at increased risk. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. Symptoms of VTE (deep vein thrombosis and pulmonary embolism). A single oral dose of ramipril produced an undetectable level of ramipril and its metabolite in breast milk. (See DOSAGE AND ADMINISTRATION). The population had a mean age of 54 years and included approximately 55% males. There are no adequate and well-controlled studies in pregnant women. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. Patients whose blood pressure was still not adequately controlled were offered additional hydrochlorothiazide 12.5 mg and subsequently 25 mg as required to achieve adequate blood pressure goal. Quinolone antibiotics: Animal data indicates that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. As a result, higher steady-state topiramate plasma concentrations are expected for a given dose in renal-impaired patients as compared to those with normal renal function. ATC code: M01AG01. Distributed by: After oral administration approximately 3% of the dose is directly bioavailable as estradiol. Bioavailability is about 91 %. Thus latent diabetes mellitus may become manifest during thiazide therapy. Marketing experience has revealed rare cases of neutropenia and bone marrow depression in which a causal relationship to lisinopril cannot be excluded. Tell patients to report pregnancies to their physicians as soon as possible. Pack sizes: 100 and 500 tablets. Cough: Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. This dose may be benefit in some patients, nevertheless, caution is advised due to an increase incidence of side effects. Website hybrid overpouch front side clear-back side aluminum polyethylene-sorption-free bag aluminum overpouch with clear window aluminum overpouch polypropylene film and bag . No effects on ability to drive and use machines have been observed in users of COCs. In such cases Lisinopril and Hydrochlorothiazide Tablets should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. below 50). ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. 6.2 Incompatibilities. shortness of breath, coughing) are non-specific and might be misinterpreted as more common or less severe events (e.g. More marked increases have also been reported and were more likely to occur in patients with renal artery stenosis. Protect from excessive light and humidity. During the treatment phase of 2 mg estradiol valerate + 3 mg dienogest, maximum and average estradiol serum concentrations at steady state are 66.0 pg/ml and 51.6 pg/ml, respectively. Pregelatinized maize starch. Isomalt (E 953) Magnesium stearate. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Animal studies do not indicate a risk for reproductive toxicity (see section 5.3). Paediatric population (pharmacokinetics, up to 12 years of age). Electrophysiological and biochemical studies on cultured neurons have identified three properties that may contribute to the antiepileptic efficacy of topiramate. 100 Tablets Rx only, Rising Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. In a randomized, double-blind clinical study involving 244 paediatric patients with hypertension (73% primary hypertension), aged 6-16 years, patients received either low dose, medium dose or high dose of ramipril to achieve plasma concentrations of ramiprilat corresponding to the adult dose range of 1.25 mg, 5 mg and 20 mg on the basis of body weight. In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs. In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation. ACE inhibitors can cause hyperkalemia because they inhibit the release of aldosterone. Lisinopril and Hydrochlorothiazide Tablets should be used cautiously, if at all, with these agents and with frequent monitoring of serum potassium. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. (See. Effects of Topamax on other antiepileptic medicinal products. It is not known whether lisinopril is secreted in human milk. In total, 269 women were randomised on Qlaira and 152 patients on placebo. However, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. The blood pressure lowering effect was maintained throughout the 24-hour period with olmesartan medoxomil once daily, with trough-to-peak ratios for systolic and diastolic response between 60% and 80%. Angiotensin II inhibitors with calcium channel blockers, Drug class: angiotensin II inhibitors with calcium channel blockers, manufacture(16729-392, 16729-394, 16729-393, 16729-395), analysis(16729-392, 16729-394, 16729-393, 16729-395). Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone acetate. Some patients may experience a benefit at a total daily dose of 50 mg/day. The most frequently reported side effects associated with mefenamic acid involve the gastrointestinal tract. Renal function should be monitored in these patients (see also section 4.3). Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing. Help us improve emc by letting us know which of the following best describes you, 2. Assigned frequencies are as follows: cannot be estimated from the available data. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users. A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4). It is important that the recommended dose is not exceeded and the regime adhered to since some reports have involved daily dosages under 3g. 100 Tablets Rx only. The ramipril treatment was started 3 to 10 days after the acute myocardial infarction. In addition, lisinopril did not produce increases in chromosomal aberrations in an in vitro test in Chinese hamster ovary cells or in an in vivo study in mouse bone marrow. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. In humans, experience with intentional overdosage of amlodipine is limited. In preclinical studies, topiramate has been shown to have teratogenic effects in the species studied (mice, rats and rabbits). What you need to know before you take Cetirizine 10 mg Tablets Starch versatility in industrial applications is largely defined by its physicochemical properties and functionality. Antidepressants: Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4). Effects of other medicinal products on Qlaira. In juvenile rats, daily oral administration of topiramate at doses up to 300 mg/kg/day during the period of development corresponding to infancy, childhood, and adolescence resulted in toxicities similar to those in adult animals (decreased food consumption with decreased body weight gain, centrolobullar hepatocellular hypertrophy). In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 mg to 80 mg and hydrochlorothiazide doses of 6.25 mg to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component. Enter the email address you signed up with and we'll email you a reset link. To find similar products you must sign up and log in. Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Assay of stools over a 3-day period accounted for 10-20 % of the dose chiefly as unconjugated metabolite II. Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality. Amlodipine and Olmesartan Medoxomil tablets were studied in one placebo-controlled factorial trial [see Clinical Trials(14.1)] . Package insert / prescribing information The structural formula for amlodipine besylate is: The structural formula for olmesartan medoxomil is: Amlodipine and Olmesartan Medoxomil tablets contain amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index). Start typing to retrieve search suggestions. To bookmark a medicine you must sign up and log in. Treatment is symptomatic and supportive. It must not be chewed or crushed. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Olmesartan medoxomil. Due to the profile of cetirizine, no interactions with other drugs are expected. Hypotension: In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (1.4 percent), orthostatic hypotension (0.5 percent), other orthostatic effects (3.2 percent). Therefore, the combination of ramipril with the above-mentioned drugs is not recommended. After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days. Each tablet contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. Chronic, untreated metabolic acidosis increases the risk of nephrolithiasis and nephrocalcinosis, and may potentially lead to osteopenia (see above - Nephrolithiasis). Help us improve emc by letting us know which of the following best describes you. The recommended initial target dose range for topiramate monotherapy in children over 6 years of age is 100 mg/day depending on clinical response, (this is about 2.0mg/kg/day in children 6-16 years). b) HDPE DUMA and polypropylene container. Changes generally remain within the normal laboratory range. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Continue typing to refine. Women on treatment with enzyme-inducing drugs should temporarily use a barrier method or another method of contraception in addition to the COC. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of mefenamic acid should be considered. Cetirizine passes into breast milk. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant. Overdoses of topiramate have been reported. This medicine is available without prescription. Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see Section 4.5 and 5.1). Start typing to retrieve search suggestions. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Female fertility: There were no relevant effects on long bone (tibia) growth or bone (femur) mineral density, preweaning and reproductive development, neurological development (including assessments on memory and learning), mating and fertility or hysterotomy parameters. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started. Topiramate antagonised the ability of kainate to activate the kainate/AMPA ( -amino-3-hydroxy-5-methylisoxazole-4-propionic acid) subtype of excitatory amino acid (glutamate) receptor, but had no apparent effect on the activity of N-methyl-D-aspartate (NMDA) at the NMDA receptor subtype. Because of the potential fall in blood pressure in these patients, therapy should be started under very close medical supervision. NDC 16571-791-01 Cetirizine 10mg Tablets should be avoided in pregnant women. The effect is usually not significant in patients with normal renal function. When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect. The ratio of urinary to fecal excretion is about 3:1 after oral administration of 0.1 mg/kg. Ramipril may be used in monotherapy or in combination with other classes of antihypertensive medicinal products. The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Orally administered dienogest is rapidly and almost completely absorbed. The antihypertensive effects of olmesartan medoxomil have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. Its frequency was calculated based on the incidence in clinical trials, or was calculated if the event did not occur in clinical trials. Continue typing to refine. Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in: - Patients with decompensated congestive heart failure, - Patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. On day 21 of the treatment cycle, SHBG was approximately 148% of the baseline, it decreased to about 141% of the baseline by day 28 (end of placebo phase). Enter the email address you signed up with and we'll email you a reset link. They are supplied as follows: Topiramate did not affect metformin tmax. In both studies, Topamax (50-200 mg/day in healthy volunteers and 200-800 mg/day in epilepsy patients) did not significantly affect exposure to NET. If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment. Pregelatinized Maize Starch. Particularly important in women with additional risk factors. Topamax (topiramate) is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2). Paediatric population. Dry mouth, nausea (feeling sick), diarrhoea (children only), Pharyngitis (sore throat), rhinitis (swelling and irritation inside the nose (children only)), Asthenia (feeling of weakness), malaise (feeling of being generally unwell), Paraesthesia (abnormal feelings of the skin), tingling in the hands and feet, Oedema (generalised swelling due to water retention), Aggression, confusion, depression, hallucination (hearing or seeing things), insomnia (difficulty sleeping), Urticaria (swelling,redness and itchiness of the skin), Thrombocytopenia (low level of blood platelets), which increases risk of bleeding or bruising, Accommodation disorder (impaired ability of the eye to focus), blurred vision, oculogyration (eyes moving in an uncontrolled circular manner), Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions),tremor, dysgeusia (altered taste), Tics (sudden abnormal repetitive muscle movement), Fixed drug eruption (may look like round or oval patches of redness and swelling of the skin), Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water), Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare, Amnesia (loss of memory), memory impairment, Vertigo (sensation of rotation or movement), Urinary retention (inability to completely empty the urinary bladder), Pruritus (intense itching) and /or urticaria upon discontinuation. Maize starch. CONTENTS OF THE PACK AND OTHER INFORMATION, What Cetirizine 10 mg Tablets look like and contents of the pack. Povidone K25 (E1201) Magnesium stearate (E572) Tablet coating: Hypromellose type 2910 (E464) Macrogol 6000. WHAT ARE POSSIBLE SIDE EFFECTS OF Nebivolol TABLETS? The overall frequency of adverse events was not dose-related. Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss. Dual blockade of the renin-angiotensin-aldosterone system (RAAS): Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial), VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes) have examined the use of combination of an ACE-inhibitor with an angiotensin II receptor blocker. Microcrystalline cellulose, pregelatinized maize starch, magnesium stearate, hypromellose, macrogol 400, titanium dioxide, colloidal anhydrous silica, povidone, yellow iron oxide, red iron oxide PRECAUTIONS 28 Paediatric population. Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole. If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors in this case her total risk of VTE should be considered. Like all medicines, Cetirizine 10 mg Tablets can cause side effects, although not everybody gets them. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Non-oliguric renal failure and proctocolitis have been reported mainly in elderly patients who have not discontinued mefenamic acid after the development of diarrhoea. Do not use Cetirizine 10 mg Tablets after the expiry date which is stated on the box and blister. In double-blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5% in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3-fold higher incidence than those treated with placebo (0.2%; 8 out of 4,045 patients treated). Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. However, milk of lactating rats contains radioactivity following administration of 14C lisinopril. When mefenamic acid is ranked in both these tests it falls between indomethacin and phenylbutazone and it is probable that inhibition of prostaglandin synthesis contributes to the pharmacological activity and clinical efficacy of mefenamic acid. Pregelatinized starch. Adequate hydration while using topiramate is very important. Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. Normotensive subjects experienced no clinically significant change in blood pressures (+1/-2 mmHg). - Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction. Serious adverse reactions are arterial and venous thromboembolism, which are discussed in section 4.4. The text only version may be available in large print, Braille or audio CD. Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. Hydrochlorothiazide The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Phenytoin and carbamazepine decrease the plasma concentration of topiramate. Povidone K25 (E1201) Magnesium stearate (E572) Tablet coating: Hypromellose type 2910 (E464) Macrogol 6000. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. A reduced initial dose of 1.25 mg ramipril should be considered. - Patients undergoing major surgery or during anaesthesia with agents that produce hypotension. See section 4. Patients should be observed carefully for signs of lithium toxicity. Secondary prevention after acute myocardial infarction. In well-controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and its clinical efficacy. 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