Fraxiparine Forte

The recommended dose depends on the individual and the condition being treated. Fraxiparine Forte (Nadroparin) is injected under the skin (subcutaneously). Your doctor will recommend the dose that is most likely to prevent blood clots but that will not cause you to bleed easily. Your doctor or health care professional will show you how to inject the medication yourself. If you have any questions about how to use the medication, contact your doctor.

To use the medication:

• Before injecting Fraxiparine Forte (Nadroparin), wash your hands and the area of skin you will inject. Only use the injection if the solution appears clear and particle-free.
• Lie down and gently pinch a fold of skin (usually in the lower abdomen) between your finger and thumb. Choose alternate places on the lower abdomen for each injection (e.g., right side one day, left side the next day).
• Push the entire needle vertically into the skin and then press down on the syringe plunger to inject the medication. Make sure you are holding the skin the entire time you are injecting the needle and pressing down on the syringe plunger.
• After giving the injection, remove the needle from the skin. Use the safety shield to prevent the needle from injuring others.
• Use an alcohol swab to apply light pressure to the injection area for several seconds. Do not rub the site afterwards.
• Dispose of the syringe and needle safely (using a sharps container). Each syringe is for a single use only.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Fraxiparine Forte (Nadroparin) exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist. Do not inject a double dose to make up for a missed one.

Store Fraxiparine Forte (Nadroparin) at room temperature and keep it out of the reach of children. Do not refrigerate or freeze the medication.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Fraxiparine® Prefilled Syringes

Each mL of aqueous solution contains 9,500 anti-Xa IU of Fraxiparine Forte (Nadroparin) calcium. Single-dose, disposable prefilled glass syringes of 0.2 mL (ungraduated yellow syringes), 1,900 anti-Xa IU; 0.3 mL (ungraduated green syringes), 2,850 anti-Xa IU; 0.4 mL (ungraduated orange syringes), 3,800 anti-Xa IU; 0.6 mL (graduated brown syringes), 5,700 anti-Xa IU; and 1 mL (graduated violet syringes), 9,500 anti-Xa IU. The needle shield of the prefilled syringe may contain latex.

Fraxiparine Forte® Prefilled Syringes

Each mL of aqueous solution contains 19,000 anti-Xa IU of Fraxiparine Forte (Nadroparin) calcium. Single-dose, disposable prefilled glass syringes of 0.6 mL (graduated process blue syringes), 11,400 anti-Xa IU; 0.8 mL (graduated magenta syringes), 15,200 anti-Xa IU; and 1 mL (graduated reflex blue syringes), 19,000 anti-Xa IU. The needle shield of the prefilled syringe may contain latex.

Do not use Fraxiparine Forte (Nadroparin) if you:

• are allergic to Fraxiparine Forte (Nadroparin) or to any of the ingredients of the medication
• are allergic to other low-molecular-weight heparins or Heparin
• currently have or have previously had heparin-induced thrombocytopenia (decrease in the number of platelets), or test positive in a platelet-aggregation test while using Fraxiparine Forte (Nadroparin)
• have a history of bleeding in the brain
• have a severe blood clotting disorder
• have active bleeding, bleeding tendencies, or other conditions that could have an increased risk of bleeding
• have acute infective Endocarditis (bacterial infection of the heart)
• have bleeding due to ulcers (e.g., active stomach or duodenal ulcers)
• have eye problems due to Diabetes or bleeding
• have injuries to and have had operations on the brain, spinal cord, eyes, or ears
• have severe kidney problems (unless you are using Fraxiparine Forte (Nadroparin) to prevent clot formation during dialysis)
• have uncontrolled high blood pressure
• have received spinal anaesthesia and need continued daily treatment

There may be an interaction between Fraxiparine Forte (Nadroparin) and any of the following:

• acetylsalicylic acid (Asa)
• Aliskiren
• angiotensin-converting enzyme inhibitors (ACEIs; Captopril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• Apixaban
• Canagliflozin
• dabigatran
• Dasatinib
• Deferasirox
• Dipyridamole
• Eplerenone
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
• Ibrutinib
• Mesalamine
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• omega-3 fatty acids
• other low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Pentoxifylline
• platelet inhibitors (e.g., Ticlopidine, Clopidogrel, eptifibatide)
• progestins (e.g., Levonorgestrel, medroxyprogesterone, Progesterone)
• potassium-sparing diuretics (e.g., Amiloride, Spironolactone, triamterene)
• potassium supplements (e.g., potassium chloride)
• Prasugrel
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• Sulfasalazine
• Ticagrelor
• thrombolytic agents (e.g., alteplase, streptokinase, urokinase)
• vitamin E
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Fraxiparine Forte (Nadroparin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fraxiparine Forte (Nadroparin).

Bleeding: The most serious risk associated with Fraxiparine Forte (Nadroparin) is bleeding in any tissue or organ. It is extremely important to have regular blood tests (as prescribed by your doctor) to ensure that the correct level of blood thinning is occurring. If you have an increased risk of bleeding (for example, if you are over 65, have liver failure, reduced kidney function, high blood pressure, or a history of ulcers), your doctor should closely monitor your condition while you are taking Fraxiparine Forte (Nadroparin).

Body weight: The safety and efficacy of Fraxiparine Forte (Nadroparin) for very heavy people (e.g., over 120 kg) and very light people (e.g., under 45 kg) have not been fully established. If your weight is very high or low, your doctor will monitor you closely while you are taking Fraxiparine Forte (Nadroparin).

Cardiovascular problems: If you have Coronary Artery Disease or high blood pressure, discuss with your doctor how Fraxiparine Forte (Nadroparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fraxiparine Forte (Nadroparin), and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Fraxiparine Forte (Nadroparin) to build up in the body, causing side effects, including bleeding. If you have reduced kidney function or kidney disease, discuss with your doctor how Fraxiparine Forte (Nadroparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fraxiparine Forte (Nadroparin), and whether any special monitoring is needed.

Platelets: While you are using Fraxiparine Forte (Nadroparin), your doctor will also be monitoring your platelet count. If your platelet level drops very suddenly, you may have to stop Fraxiparine Forte (Nadroparin) and switch to another type of medication. Make sure to tell doctors involved in your care if you have had any problems with low platelets or platelet defects in the past.

Potassium levels: Fraxiparine Forte (Nadroparin) may increase blood potassium levels, especially in people who are at risk for high potassium levels (e.g., people with diabetes or who take certain medications). Your doctor will monitor your potassium levels while you are using Fraxiparine Forte (Nadroparin). If you experience symptoms of high levels of potassium in the blood, such as muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, or nausea, contact your doctor.

Prosthetic heart valves: There have been reports of people with prosthetic heart valves who developed clots in their valves when treated with low-molecular-weight heparin medications such as Fraxiparine Forte (Nadroparin). Your doctor will need to monitor you closely while you are taking Fraxiparine Forte (Nadroparin).

Stomach ulcers: If you have a history of stomach ulcers or bleeding in the digestive system, Fraxiparine Forte (Nadroparin) may cause the condition to reoccur. If you have any symptoms of bleeding in the digestive system, such as bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds, seek medical help immediately.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fraxiparine Forte (Nadroparin), contact your doctor immediately.

Breast-feeding: It is not known if Fraxiparine Forte (Nadroparin) passes into breast milk. If you are a breast-feeding mother and are taking Fraxiparine Forte (Nadroparin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fraxiparine Forte (Nadroparin) have not been established for children.

Seniors: People over the age of 65 years are more at risk of bleeding from Fraxiparine Forte (Nadroparin).