Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Hydromorphone hydrochloride 4mg (+ 9% system overage)
Janssen-Cilag (New Zealand) Ltd
Hydromorphone hydrochloride 4 mg (+ 9% system overage)
4 mg
Modified release tablet
Active: Hydromorphone hydrochloride 4mg (+ 9% system overage) Excipient: Butylated hydroxytoluene Cellulose acetate Hypromellose Iron oxide black Iron oxide yellow Macrogol 3350 Magnesium stearate Opacode black NS-78-17821 Opadry Clear YS-1-19025-A Polyethylene oxide Povidone Sodium chloride
Blister pack, PVC/Aclar-aluminium., 7 tablets
Class B3 Controlled Drug
Class B3 Controlled Drug
Janssen Pharmaceuticals Inc
JURNISTA is indicated in the treatment of moderate to severe chronic pain.
Package - Contents - Shelf Life: Blister pack, PVC/Aclar-aluminium. - 7 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 14 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 20 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 35 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 40 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 50 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar-aluminium. - 100 tablets - 24 months from date of manufacture stored at or below 25°C
2009-10-02
1 JURNISTA (170223) ACI JURNISTA ® PROLONGED-RELEASE TABLET _Hydromorphone hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about JURNISTA prolonged-release tablets. 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 taking JURNISTA against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING JURNISTA, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IS JURNISTA TAKEN FOR JURNISTA is taken to relieve moderate to severe pain, which requires strong painkillers. JURNISTA is only for patients with chronic, around the clock pain that is moderate to severe and expected to be long lasting. JURNISTA should not usually be the first medicine prescribed for your pain. JURNISTA prolonged-release tablets contain a medicine called hydromorphone hydrochloride. This strong pain reliever belongs to a group of medicines known as opioid analgesics. Hydromorphone hydrochloride relieves pain by blocking the nerves that recognise pain messages from the body. _ _ Your doctor may have prescribed JURNISTA for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE JURNISTA WHEN YOU MUST NOT TAKE IT DO NOT TAKE JURNISTA IF YOU: have an allergy to hydromorphone hydrochloride or any of the ingredients. See PRODUCT DESCRIPTION at the end of this leaflet for a list of ingredients. have been diagnosed with serious narrowing of the stomach and/or intestine (bowel) have pain resulting from very recent surgery or sudden pain which is long lasting have had surgery which may have left you with ‘blind loop’ in your intestine have seriously impaired liver function have serious breathing difficulties have severe acute asthma get sudden severe Prečítajte si celý dokument
CCDS 161123 1 JURNISTA(170706)ADS JURNISTA ® PROLONGED-RELEASE TABLETS DATA SHEET 1. PRODUCT NAME JURNISTA 4 mg modified-release tablets JURNISTA 8 mg modified-release tablets JURNISTA 16 mg modified-release tablets JURNISTA 32 mg modified-release tablets JURNISTA 64 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION JURNISTA is available as prolonged-release tablets containing 4, 8, 16, 32 and 64 mg hydromorphone hydrochloride. Excipient(s) with known effect: One tablet of 4 mg tablet contains 0.01 mg lactose One tablet of 8 mg tablet contains 4.37 mg lactose One tablet of 16 mg tablet contains 6.81 mg lactose One tablet of 32 mg tablet contains 10.02 mg lactose One tablet of 64 mg tablet contains 8.03 mg lactose For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM Modified-release tablets JURNISTA 4 mg tablets are pale beige, round, biconvex with ‘HM 4’ printed in black ink on one side. JURNISTA 8 mg tablets are red, round, biconvex with ‘HM 8’ printed in black ink on one side. JURNISTA 16 mg tablets are yellow, round, biconvex with ‘HM 16’ printed in black ink on one side. JURNISTA 32 mg tablets are white, round, biconvex with ‘HM 32’ printed in black ink on one side. JURNISTA 64 mg tablets are blue, round, biconvex with ‘HM 64’ printed in black ink on one side. JURNISTA tablets have been formulated using the OROS ® osmotic pump (push-pull) bilayer tablet with a semi-permeable cellulose acetate coating that controls the rate at which water is absorbed into the tablet after it has been swallowed. A laser-drilled hole on the drug side of the tablet allows the dissolved/suspended drug to be released from the tablet at a controlled rate as it passes through the gastrointestinal tract. The JURNISTA tablet is non-deformable and does not appreciably change in shape in the GI tract; patients should be advised not to be alarmed if they notice what appears to be the JURNISTA tablet in their stools, as it is simply the non-dissolvable shell. Prečítajte si celý dokument