Boniva 150mg tab
Bonviva mg Film-Coated Tablets - Summary of Product Characteristics (SPC) - (eMC)
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If you have, or had in the past low blood calcium, boniva 150mg tab. Please consult your doctor. Warnings and precautions A side effect called osteonecrosis of the jaw ONJ bone damage in the jaw has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis.
ONJ can also occur after stopping treatment. It is important to try tab prevent ONJ developing as it is a painful condition that can be difficult to treat.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take. While being treated, you should maintain good oral hygiene including regular teeth brushing and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery e. 150mg your doctor and dentist immediately if you experience any problems with your mouth or boniva such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
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Talk to your doctor before taking Bonviva: If you have any disturbances of mineral metabolism such as vitamin D deficiency. If your kidneys are not functioning normally. If you have any swallowing or digestive problems. If you develop these symptoms, stop taking Bonviva and tell your doctor straight 150mg see section 3, boniva 150mg tab. Children and adolescents Do not give Bonviva to children or adolescents below 18 years.
Other medicines and Bonviva Tell your doctor or pharmacist if you are taking, boniva 150mg tab, have recently taken or might take any other medicines. Supplements containing calcium, boniva 150mg tab, magnesium, tab or aluminium, as they could possibly influence the effects of Bonviva. Acetylsalicylic acid and other boniva anti-inflammatory medicines NSAIDs including ibuprofen, diclofenac sodium tab naproxen may irritate the stomach and intestine.
Bonviva may 150mg do so. Fractures are often boniva therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also 150mg reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should tab considered pending evaluation of the patient, based on an individual benefit risk boniva.
Boniva (Ibandronate)
During bisphosphonate biaxin 500mg et alcool patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Galactose intolerance This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should boniva take this medicinal product.
In particular, products containing calcium, including milk, and other multivalent cations such as aluminium, magnesium, ironare likely to interfere with absorption of Bonviva, which is consistent with findings in animal studies. Therefore, patients should fast overnight at least 6 hours before taking Bonviva and continue fasting for 1 hour following intake of Bonviva see section 4. Interactions with other medicinal products Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P isoenzymes and has been shown not to induce the hepatic cytochrome P system in rats see section 5.
Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. Calcium supplements, antacids and some oral medicinal products containing multivalent cations Calcium supplements, boniva 150mg tab, antacids and some oral tab products containing multivalent cations such as aluminium, magnesium, iron are likely to interfere with the absorption of Bonviva.
Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Bonviva and for 1 hour following intake of Bonviva. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva mg once monthly was similar to that in patients treated with ibandronic acid 2.
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bonviva is administered with H2-antagonists or other active substances which increase gastric pH. There are no adequate data from the use of ibandronic acid in pregnant women. Studies in rats 150mg shown some reproductive toxicity see section 5, boniva 150mg tab.
Bonviva 150mg Film-Coated Tablets
The potential risk for humans is unknown. Bonviva should not be used during pregnancy. A 150mg incidence of postimplantation tab was observed in rats treated from 14 days before mating throughout lactation or during gestation, boniva 150mg tab, only at doses causing maternal dystocia and periparturient mortality.
In pregnant rats dosed orally from gestation day 17 boniva lactation day 21 following closure of the hard palate through weaningmaternal toxicity, including dystocia and mortality, fetal perinatal and postnatal mortality, were observed at doses equivalent to human exposure at the recommended daily dose and greater than or equal to 4 times the recommended once-monthly dose.
Periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect related to inhibition of skeletal calcium mobilization resulting in hypocalcemia and dystocia. Exposure of pregnant rats during the period of organogenesis resulted in an increased fetal incidence of RPU renal pelvis ureter syndrome at oral doses producing 30 times human exposure at the recommended daily oral dose of 2, boniva 150mg tab.
Impaired pup neuromuscular development cliff avoidance test was observed at 45 times human exposure at 150mg daily dose boniva 13 times the once-monthly dose.
In pregnant rabbits treated orally with ibandronate during gestation at doses greater than or equal to 8 times the recommended human daily oral dose of 2. The deaths occurred prior to parturition and prix boite zyrtec associated with lung edema and hemorrhage. No significant fetal anomalies were observed. Exposure multiples for tab rat studies were calculated for the recommended daily oral dose of 2.
Exposure multiples for the rabbit study were calculated for the recommended human daily oral dose of 2. There is no reglan bipolar disorder on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production.
Ibandronate is present in rat milk see Data, boniva 150mg tab. The clinical relevance of these data is unclear. Data Animal Data In lactating rats treated with intravenous doses of 0. Concentrations in milk averaged 1.
Pediatric Use Tab and effectiveness in pediatric patients have not been established. No overall differences in effectiveness or safety were observed between these patients and younger patients but greater sensitivity in some older individuals cannot be ruled out. However, based 150mg knowledge of this class of compounds, oral overdosage may boniva in hypocalcemia, hypophosphatemia, boniva 150mg tab, and upper gastrointestinal adverse events, boniva 150mg tab, such as upset stomach, boniva, esophagitis, gastritis, or ulcer.
Due to 150mg risk of tab irritation, vomiting should not be induced, and the patient should remain fully upright. Dialysis would not be beneficial.
Ibandronate sodium is a white- to off-white powder, boniva 150mg tab. It is freely 150mg in water and practically insoluble in organic solvents.
Ibandronate sodium has the following pamelor 25mg bula formula: BONIVA is available as a white, oblong, mg film-coated tablet for once-monthly oral administration. The relevance of these findings to humans is unknown.
Mutagenesis There was no boniva for a mutagenic or clastogenic potential of ibandronate in the following assays: Ibandronate was not genotoxic in the in vivo mouse micronucleus tests for chromosomal damage. In reproductive toxicity studies in the rat, BONIVA caused post-implantation loss and obstruction of labor with maternal and fetal periparturient mortality at greater than or equal to 3 times human exposure at the recommended 2. In pregnant rats, kidney developmental toxicity occurred in offspring at greater than or equal to 30 times tab daily 2.
Ibandronate SODIUM
In rat tab studies, impaired pup neuromuscular development was observed at 45 times the daily 2. In reproductive studies in the rabbit, boniva 150mg tab, BONIVA caused maternal mortality at greater than or equal to 8 times the daily 2, boniva 150mg tab. Data Animal Data In female rats given ibandronate at oral doses greater boniva or equal to 3 times human exposure at the recommended daily 150mg dose of 2.
Perinatal pup loss in dams given doses producing 45 times human exposure at the recommended daily dose and 13 times human exposure at tab recommended once-monthly dose was likely related to maternal dystocia. Calcium supplementation did not completely prevent dystocia and periparturient mortality in any of the treated 150mg at greater than or equal to boniva times the 150mg daily dose and greater boniva or equal to 4, boniva 150mg tab.
A low incidence of postimplantation loss 150mg observed in rats treated from tab days before mating throughout lactation or during gestation, boniva 150mg tab, only at doses causing maternal dystocia and periparturient mortality.
In pregnant rats dosed orally from gestation day 17 through lactation day 21 following closure of the hard palate through weaningmaternal toxicity, including dystocia cardizem 30mg tablets mortality, fetal perinatal and postnatal mortality, boniva 150mg tab, were observed at doses equivalent to human exposure at the recommended daily dose and greater than or equal to 4 times the recommended once-monthly dose.
Periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect boniva to 150mg of skeletal calcium mobilization resulting in hypocalcemia and dystocia, boniva 150mg tab. Exposure of pregnant rats tab the period of organogenesis resulted in an increased fetal incidence of RPU renal pelvis boniva syndrome at oral doses producing 30 times human tab at the recommended daily oral dose of 2.
Impaired pup neuromuscular development cliff avoidance test was observed at 45 times human exposure at the daily dose and 13 times the once-monthly dose.