מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Pethidine hydrochloride 50mg;
Noumed Pharmaceuticals Limited
Pethidine hydrochloride 50 mg
50 mg
Tablet
Active: Pethidine hydrochloride 50mg Excipient: Acacia Lactose monohydrate Magnesium stearate Maize starch
Bottle, glass, 10 tablets
Class B3 Controlled Drug
Class B3 Controlled Drug
Saneca Pharmaceuticals AS
For the relief of most types of moderate to severe pain. As it has some antispasmodic activity it may be the analgesic of choice in renal colic, bilary colic and acute pancreatitis.
Package - Contents - Shelf Life: Bottle, glass, - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
1969-12-30
New Zealand Consumer Medicine Information 1 PETHIDINE TABLETS (NOUMED) _Pethidine Hydrochloride BP _ _ _ Tablet, uncoated 50 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Pethidine Tablets (Noumed). This leaflet answers some common questions about Pethidine Tablets (Noumed). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using WARNINGS LIMITATIONS OF USE Pethidine Tablets (Noumed) should only be used when your doctor decides that other treatment options are not able to effectively manage your pain, or you cannot tolerate them. HAZARDOUS AND HARMFUL USE Pethidine Tablets (Noumed) poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION Pethidine Tablets (Noumed) can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing), even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Pethidine Tablets (Noumed) and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING PETHIDINE TABLETS (NOUMED) Pethidine Tablets (Noumed) with other medicines that can make you feel drowsy such as sleeping tablets (e.g., benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g., gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Pethidine Tablets (Noumed). New Zealand Consumer Medicine Informatio קרא את המסמך השלם
NEW ZEALAND DATA SHEET Page 1 of 14 1. PRODUCT NAME (strength pharmaceutical form) Pethidine, Tablet, 50 mg (NOUMED) Pethidine, Tablet, 100 mg (NOUMED) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Pethidine Hydrochloride 50 mg Pethidine Hydrochloride 100 mg Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral – tablet Presentation Pethidine Hydrochloride 50 mg tablets are: round, white, normal biconvex tablets, 8.0 mm diameter. Pethidine Hydrochloride 100 mg Tablets are: round, white, normal biconvex tablets, 9.5 mm diameter. _Note: Not all product strengths may be marketed. _ 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Pethidine Tablets given orally are indicated for the relief of most types of moderate to severe pain. As it has some antispasmodic activity, it may be the analgesic of choice in renal colic, biliary colic and acute pancreatitis. 4.2 Dose and method of administration _Adults: _ For the relief of pain, Pethidine Tablets given in oral doses of 50 to 150 mg by mouth every 4 hours if necessary. _Children_: For the relief of pain, 1.1 to 1.76 mg per kg of body weight, not to exceed 100 mg every 3 to 4 hours as needed. (See Section 4.4 Special Warnings and Precautions for use). Opioid agonist analgesics may suppress respiration, especially in the very young, NEW ZEALAND DATA SHEET Page 2 of 14 elderly, very ill or debilitated patients and those with respiratory problems. Lower doses may be required for these patients. Neonates (see also Pharmacology section 5 and Use in Pregnancy section 4.6) Excretion and metabolism of Pethidine in the neonate is reduced compared with adults. Safety has not been established in neonates and due to lack of data, no dosage regimen can be recommended. Geriatric patients Dose reduction to half normal adult dose is recommended in geriatric patients (over 70 years). Liver impairment Dosage reduction and/or increased dosage intervals are recommended. Renal impairment Due t קרא את המסמך השלם