Palonosetron Hydrochloride (Page 6 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Palonosetron Hydrochloride injection is supplied as a sterile, clear and colorless solution:
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- 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial in an individual carton, available as a multi-pack carton of 10 (NDC # 69543-371-10).
Storage
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- Store at controlled temperature of 20–25°C (68°F–77°F). Excursions permitted to 15–30°C (59–86°F).
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- Protect from freezing.
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- Protect from light.
17 PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron Hydrochloride injection [see Warnings and Precautions (5.1) ].
Serotonin Syndrome
Advise patients of the possibility of serotonin syndrome, especially with concomitant use of Palonosetron Hydrochloride injection and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.2) ].
Manufactured by:
RAFARM S.A.
Thesi Pousi-Hatzi, Agiou Louka,
19002, Paiania, Attiki
Greece
Distributed by:
Virtus Pharmaceuticals, LLC
Langhorne, PA 190471-888-848-3593
Rev. 04/2020
| PATIENT INFORMATION Palonosetron (PAL-oh-NOE-se-tron) Hydrochloride injection, for intravenous use |
| Read this Patient Information before you receive Palonosetron Hydrochloride and each time you receive Palonosetron Hydrochloride. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. |
| What is Palonosetron Hydrochloride? Palonosetron Hydrochloride is a prescription medicine called an “antiemetic.” Palonosetron Hydrochloride is used in adults to help prevent the nausea and vomiting that happens:
Palonosetron Hydrochloride is used in children 1 month old to less than 17 years of age to help prevent the nausea and vomiting that happens right away with certain anti-cancer medicines (chemotherapy).
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| Who should not receive Palonosetron Hydrochloride? Do not receive Palonosetron Hydrochloride if you are allergic to palonosetron hydrochloride or any of the ingredients in Palonosetron Hydrochloride. See the end of this leaflet for a complete list of ingredients in Palonosetron Hydrochloride. |
| What should I tell my doctor before receiving Palonosetron Hydrochloride? Before receiving Palonosetron Hydrochloride, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.Palonosetron Hydrochloride and certain other medicines can affect each other, causing serious side effects. |
| How will I receive Palonosetron Hydrochloride?
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| What are the possible side effects of Palonosetron Hydrochloride? Palonosetron Hydrochloride may cause serious side effects, including:
The most common side effects in adults who receive Palonosetron Hydrochloride to help prevent nausea and vomiting that happens with certain anti-cancer medicine (chemotherapy) include: headache and constipation. The most common side effects in adults who receive Palonosetron Hydrochloride to help prevent nausea and vomiting that happens while recovering from anesthesia after surgery include: serious or life-threatening heart rhythm changes (QT prolongation), slow heartbeat, headache, and constipation. These are not all the possible side effects from Palonosetron Hydrochloride. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| General information about the safe and effective use of Palonosetron Hydrochloride Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about Palonosetron Hydrochloride that is written for health professionals. |
| What are the ingredients in Palonosetron Hydrochloride? Active ingredient: palonosetron hydrochloride Inactive ingredients: mannitol, disodium edetate, and citrate buffer in waterManufactured by: RAFARM S.A. Thesi Pousi-Hatzi, Agiou Louka, 19002, Paiania, Attiki Greece Distributed by: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 1-888-848-3593 |
This Patient Information has been approved by the U.S. Food and Drug Administration.
Rev. 04/2020
30804543-1
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