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Calprofen Ibuprofen Suspension, Sugar & Colour Free, Pain & Fever Relief for 3+ Months, Strawberry Flavour, 100 ml (Pack of 1)

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From the 20th week of pregnancy onward, Ibuprofen use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Ibuprofen should not be given unless clearly necessary. If Ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to Ibuprofen for several days from gestational week 20 onward. Ibuprofen should be discontinued if oligohydramnios or ductus arteriosus constriction are found. If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued Clinical studies suggest that use of ibuprofen particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). The following list of adverse events relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long- term treatment, additional adverse effects may occur. Calprofencontains children's doses of ibuprofen. Itcan be given to children for the following reasons:

Initial dose: 200 mg orally every 4 to 6 hours; may increase to 400 mg orally every 4 to 6 hours as needed The use of Ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). Severe forms of skin reactions such as bullous reactions, including Stevens- Johnson Syndrome, Erythema multiforme and Toxic Epidermal Necrolysis can occur Relieving aches, pains, fever and general discomfort associated with coldsand fluorfollowing childhood vaccinations.

Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). The usual dose for children aged 12 to 17 years is 200mg to 400mg (one or two 200mg tablets or capsules), up to 3 times in 24 hours.

IV Ibuprofen (Caldolor): Compatible with 0.9% Sodium Chloride Injection (normal saline), 5% Dextrose Injection USP (D5W), or Lactated Ringers Solution. GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Patients should be well hydrated prior to infusion to reduce the risk of renal adverse events; doses should be infused over at least 10 minutes.

Acute Overdose

Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, Erythema multiforme and Toxic Epidermal Necrolysis can occur This medicine contains 4.67mg propylene glycol (E1520) in each 5 ml dose, which is equivalent to 0.93 mg/ml. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course, alternative pharmacological therapy, or surgery may be needed. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. From the 20th week of pregnancy onward, this medicine use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, this medicine should not be given unless clearly necessary. If this medicine is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects. Post-immunisation fever: 2.5ml (50mg) followed by one further dose of 2.5ml (50mg) six hours later if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult a doctor. Remember to take your doses with food, or with a glass of milk. If the discomfort continues, speak with your doctorIbuprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, such as the following: Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.

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