Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Gabapentin 100mg equivalent to 97.09% w/w in the 97.09% granulation composition;
Clinect NZ Pty Limited
Gabapentin 100 mg (equivalent to 97.09% w/w in the 97.09% granulation composition)
100 mg
Capsule
Active: Gabapentin 100mg equivalent to 97.09% w/w in the 97.09% granulation composition Excipient: Croscarmellose sodium Gelatin Magnesium stearate
Bottle, plastic, HDPE bottles with polypropylene caps, 100 tablets, 100 capsules
Prescription
Prescription
Zhejiang Chiral Medicine Chemicals Co. Limited
Gabapentin is indicated for the treatment of neuropathic pain in adults over 18 years of age
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
2007-12-21
New Zealand Consumer Medicine Information APO-GABAPENTIN _GABAPENTIN _ 100mg, 300mg & 400mg Capsules and 600mg & 800mg Tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Apo-Gabapentin. This leaflet answers some common questions about Apo-Gabapentin. 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 Apo-Gabapentin against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT APO-GABAPENTIN IS USED FOR The name of your medicine is Apo-Gabapentin. It contains the active ingredient gabapentin. Apo-Gabapentin is used to: • Control epilepsy, a condition that causes repeated seizures (fits). There are many different types of seizures, ranging from mild to severe • Treat neuropathic pain (pain due to nerves being damaged or affected). _HOW IT WORKS _ Gabapentin belongs to a group of medicines called anticonvulsants. It is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. This medicine helps to relieve pain. Your doctor may prescribe gabapentin in addition to your current treatment when your current treatment is no longer working as well. Your doctor may have prescribed Apo-Gabapentin for another reason. 2 Ask your doctor if you have any questions about why Apo-Gabapentin has been prescribed for you. This medicine is available only with a doctor's prescription. THERE IS EVIDENCE THAT THIS MEDICINE CAN LEAD TO DEPENDENCE. _USE IN CHILDREN _ Gabapentin is not recommended for use in children under the age of: • 3 years to control epilepsy • 18 years for the treatment of neuropathic pain. BEFORE YOU USE APO-GABAPENTIN _ _ _WHEN YOU MUST NOT USE IT _ Do not use Apo-Gabapentin if: • YOU ARE HYPERSENSITIVE TO, Lugege kogu dokumenti
NEW ZEALAND DATA SHEET APO-GABAPENTIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 24 1. APO-GABAPENTIN (100MG, 300MG & 400MG CAPSULES AND 600MG & 800MG FILM COATED TABLETS) APO-GABAPENTIN 100mg capsules APO-GABAPENTIN 300mg capsules APO-GABAPENTIN 400mg capsules APO-GABAPENTIN 600mg film coated tablets APO-GABAPENTIN 800mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100mg capsule contains 100mg of gabapentin Each 300mg capsule contains 300mg of gabapentin Each 400mg capsule contains 400mg of gabapentin Each 600mg tablet contains 600mg of gabapentin Each 800mg capsule contains 800mg of gabapentin Chemical Structure: EXCIPIENT(S) WITH KNOWN EFFECT Apo-Gabapentin is gluten free and lactose free For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Apo-Gabapentin 100mg are hard gelatin capsules with a white opaque body and a white opaque cap. Each is imprinted with “Apo 112” in black ink. Apo-Gabapentin 300mg are hard gelatin capsules with a white opaque body and a yellow opaque cap. Each is imprinted with “Apo 113” in black ink. Apo-Gabapentin 400mg are hard gelatin capsules with a white opaque body and an orange opaque cap. Each is imprinted with “Apo 114” in black ink. APO-GABAPENTIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 24 Apo-Gabapentin 600 mg tablets are white, oval biconvex tablets; engraved “GAB” over partial bisect “600” on one side and “APO” on the other side. Apo-Gabapentin 800 mg tablets are white, oval biconvex tablets; engraved “GAB” over European bisect “800” on one side and “APO” on the other side. The tablets can be divided into equal doses 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EPILEPSY Gabapentin is indicated for the treatment of partial seizures with or without secondarily generalized tonic-clonic seizures, in adults and children age 3 years and above who have not achieved adequate control with standard Lugege kogu dokumenti