Each tablet contains 10 mg of cladribine. Excipients with known effect . Each tablet contains 64 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM . Tablet . White, round, biconvex tablets of 8.5 mm diameter, engraved with 'C' on one side and '10' on the other side. 4. CLINICAL PARTICULARS . 4.1 Therapeutic filexlib. BCG Vaccine USP Insert 900151-BCG-PWI-USPI-2 p1 of 13 . pyrazinamide, ethambutol, and streptomycin) and 2.2% of TB patients were infected with TB draft-labeling-text.pdf Page 3 of 16 genzyme Clolar® (clofarabine) injection 37 • Non-hematologic Toxicity . 38 • Withhold Clolar if a patient develops a clinically significant infection, until . 39 . the infection is clinically controlled and then restart at the full dose. 40 • Withhold Clolar if a Grade 3 non-infectious non-hematologic reactions from prescribed doses and overdoses are described in the package insert. Route of Exposure: Inhalation Ingestion Eye contact Skin Absorption. Injection. Potential Health Effects: Eye: Contact with eyes may cause irritation. Signs/Symptoms: Adverse reactions from therapeutic doses include: fatigue, nausea, rash, headache, injection site
- The active substance is cladribine. Each ml solution contains 2 mg cladribine. Each vial contains 10 mg cladribine in 5 ml solution. - The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections. What LITAK looks like and contents of the pack
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEPZELCA •safely and effectively. See full prescribing information for
BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material (see PRECAUTIONS and
Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose. In case of pregnancy during therapy with cladribine, the woman should be informed about the potential hazard to the foetus. Breast-feeding It is unknown whether cladribine is excreted in human milk.
MAVENCLAD contains the active substance cladribine, a cytotoxic (cell killing) substance that works mostly on lymphocytes, cells of the immune system that are involved in inflammation. MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults. MS is a disease in which inflammation destroys the protective sheath around the nerves.
Ovidrel® (choriogonadotropin alfa) DRAFT Annotated Package Insert Item 2, p. 3 Serono, Inc. CONFIDENTIAL FINAL 9/20/2000 37 Choriogonadotropin alfa stimulates late follicular maturation and resumption of oocyte 38 meiosis, and initiates rupture of the pre-ovulatory ovarian follicle. Choriogonadotropin alfa, 39 the active component of Ovidrel®, is an analogue of Luteinizing Hormone (LH) and
The actions of cladribine yield DNA damage (see TOXICOLOGY). Due to the known genotoxicity of cladribine and immunosuppression associated with the use of nucleoside analogues like MAVENCLAD, MAVENCLAD could potentially increase the risk of malignancies. In clinical trials, events of malignancies were observed more frequently in cladribine-treated
The mean end-of-infusion plasma cladribine injection concentration was 48 ± 19 ng/mL. For five of these patients, the disappearance of cladribine injection could be described by either a biphasic or triphasic decl