देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
METFORMIN HYDROCHLORIDE; SITAGLIPTIN AS MONOHYDRATE PHOSPHATE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A10BA02
TABLETS
SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 50 MG; METFORMIN HYDROCHLORIDE 1000 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
METFORMIN
Januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. Important limitations of use:Januet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.Januet has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Januet.
2023-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is marketed upon physician’s prescription only JANUET ® 50 MG/500 MG TABLETS Each tablet contains: Sitagliptin (as monohydrate phosphate) 50 mg Metformin Hydrochloride 500 mg JANUET ® 50 MG/850 MG TABLETS Each tablet contains: Sitagliptin (as monohydrate phosphate) 50 mg Metformin Hydrochloride 850 mg JANUET ® 50 MG/1000 MG TABLETS Each tablet contains: Sitagliptin (as monohydrate phosphate) 50 mg Metformin Hydrochloride 1000 mg For a list of inactive ingredients please refer to section 6 "FURTHER INFORMATION". See also section 2.7 “Important information about some of the ingredients of the medicine”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. • This leaflet contains concise information about JANUET. If you have any further questions, refer to the doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. • This medicine is not intended for administration to children under 18 years of age. 1. WHAT JANUET IS INTENDED FOR? 1.1 WHAT IS JANUET? THERAPEUTIC GROUP: Sitagliptin: DPP-4 enzyme inhibitor. Metformin: biguanide. 1.2 WHAT IS JANUET USED FOR? JANUET is a tablet that contains 2 prescription medicines, sitagliptin phosphate (JANUVIA ® ) and metformin, which lower blood sugar. Sitagliptin, a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, a member of the biguanide class of medicines, work together to control blood sugar levels in patients with type 2 diabetes mellitus, in whom this combination is appropriate. JANUET, along with a recommended diet and exercise program is intended to lower blood sugar in patients with type 2 diabetes. 2. BEFORE USING JANUET 2.1 DO NOT USE JANUET IF YOU: 2.2 SPECIAL WARNINGS REGARDING USE OF JANUET BEFORE STARTING TREATMENT WITH JANUET, TELL YOUR DOCTOR ABOUT ALL OF YOUR MEDI पूरा दस्तावेज़ पढ़ें
JANUET ® 50 MG/500 MG TABLETS Each tablet contains: Sitagliptin (as monohydrate phosphate) 50 mg Metformin Hydrochloride 500 mg JANUET ® 50 MG/850 MG TABLETS Each tablet contains: Sitagliptin (as monohydrate phosphate) 50 mg Metformin Hydrochloride 850 mg JANUET ® 50 MG/1000 MG TABLETS Each tablet contains: Sitagliptin (as monohydrate phosphate) 50 mg Metformin Hydrochloride 1000 mg WARNING: LACTIC ACIDOSIS POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE RESULTED IN DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. THE ONSET OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS IS OFTEN SUBTLE, ACCOMPANIED ONLY BY NONSPECIFIC SYMPTOMS SUCH AS MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN. METFORMIN-ASSOCIATED LACTIC ACIDOSIS WAS CHARACTERIZED BY ELEVATED BLOOD LACTATE LEVELS (>5 MMOL/LITER), ANION GAP ACIDOSIS (WITHOUT EVIDENCE OF KETONURIA OR KETONEMIA), AN INCREASED LACTATE/PYRUVATE RATIO, AND METFORMIN PLASMA LEVELS GENERALLY >5 MCG/ML _[SEE WARNINGS AND PRECAUTIONS (5.1)]_. RISK FACTORS FOR METFORMIN-ASSOCIATED LACTIC ACIDOSIS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN DRUGS (E.G., CARBONIC ANHYDRAE INHIBITORS SUCH AS TOPIRAMATE), AGE 65 YEARS OLD OR GREATER, HAVING A RADIOLOGICAL STUDY WITH CONTRAST, SURGERY AND OTHER PROCEDURES, HYPOXIC STATES (E.G., ACUTE CONGESTIVE HEART FAILURE), EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO REDUCE THE RISK OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK GROUPS ARE PROVIDED IN THE FULL PRESCRIBING INFORMATION _[SEE DOSAGE AND ADMINISTRATION _ _(2.2), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), DRUG INTERACTIONS (7), AND USE IN _ _SPECIFIC POPULATIONS (8.6, 8.7)]_. IF METFORMIN-ASSOCIATED LACTIC ACIDOSIS IS SUSPECTED, IMMEDIATELY DISCONTINUE JANUET AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED _[SEE WARNINGS AND PRECAUTIONS (5.1)]_. 1 INDICATIONS AND USAGE JANUET is indicated as an adjunct to diet and exercise to impr पूरा दस्तावेज़ पढ़ें