Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level between 0. Whenever possible, administer benzyl alcohol-free formulations prefilled syringes in pediatric patients [see Warnings and Precautions 5. Target anti-Xa range is 0. It must not be administered by intramuscular injection. FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing. FRAGMIN may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock.
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Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level between 0. Whenever possible, administer benzyl alcohol-free formulations prefilled syringes in pediatric patients [see Warnings and Precautions 5. Target anti-Xa range is 0. It must not be administered by intramuscular injection. FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.
FRAGMIN may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock. The injection site should be varied daily. When the area around the navel or the thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection. The entire length of the needle should be inserted at a 45 to 90 degree angle. Inspect FRAGMIN prefilled syringes and vials visually for particulate matter and discoloration prior to administration After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks.
Discard any unused solution after 2 weeks. Instructions for using the prefilled single-dose syringes preassembled with needle guard devices Fixed dose syringes: To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose has been given.
The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers. Graduated syringes: Hold the syringe assembly by the open sides of the device. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner.
Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. Patients with prior hypersensitivity to dalteparin sodium e.
For prolonged VTE prophylaxis. Patients with prior hypersensitivity to heparin or pork products. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [see Boxed Warning , Adverse Reactions 6.
Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of FRAGMIN is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
No additional hemostasis-altering medications should be administered due to the additive effects. The second postoperative dose 2, or 5, IU should occur no sooner than 24 hours after the first dose. Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.
Although a specific recommendation for timing of a subsequent FRAGMIN dose after catheter removal cannot be made, consider delaying this next dose for at least 4 hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
Instruct patients to report immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Use FRAGMIN with extreme caution in patients who have an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal or ophthalmological surgery.
FRAGMIN may enhance the risk of bleeding in patients with thrombocytopenia or platelet defects; severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding. The incidence of this complication is unknown at present. In clinical practice, cases of thrombocytopenia with thrombosis, amputation and death have been observed [see Contraindications 4 ].
Closely monitor thrombocytopenia of any degree. In the same clinical trial, thrombocytopenia was reported as an adverse event in Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low-birth weight infants treated with medications that contain the preservative benzyl alcohol.
The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Use in Specific Populations 8.
Monitor anti-Xa level periodically in pediatric patients.
BRINTELLIX PACKAGE INSERT PDF
Fragmin is also available as the IU solution for injection. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. You may need to read it again. If your doctor has given you this medicine to use at home do not pass it on to others.
Bratilar Taking Brintellix with MAOIs may cause a serious reaction including sudden changes in mental state, twitching, rapid heartbeat, high blood pressure, fever and diarrhoea. Chemical Structure of Vortioxetine Brintellix contains the active substance vortioxetine. Sometimes they are serious, most of the time they are not. Vortioxetine Brintellix : A New Serotonergic Antidepressant Things you must packafe do Do not take Brintellix to treat any other complaints unless your doctor tells you to. The other ingredients are: Find out more here. What you need to know before you take Brintellix Do not take Brintellix: You can also report side effects directly via: Yellow, almond-shaped 5 x 8. Method of administration Take one tablet with a glass of water.
CROSS-REFERENCE TO RELATED APPLICATIONS
FRAGMIN 5000 IU/0.2 ML SOLUTION FOR INJECTION
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