Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-7053a |
| Trade Name | Dose Form | Strength | Identifier |
| Oliclinomel N5 - 800 | Emulsion for infusion | . | |
| Sponsor | Application date | Registration situation | Classification |
| Baxter Healthcare Ltd P O Box 14062 Panmure AUCKLAND 1741 | 31/3/2003 | Approval lapsed Approval date: 19/7/2007 Notification date: 15/10/2020 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| Amino Acids Solution compartment, emulsion for infusion | Active | |
| Alanine 14.49 g/L | Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | |
| Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | ||
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Arginine 8.05 g/L | Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | |
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Ajinomoto Co Inc Kyushu Plant 450 Morodomi-Cho Saga-Shi Saga 840-2193 JAPAN | ||
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Glycine 7.21 g/L | Yuki Gosei Kogyo Co Ltd Joban factory, 788 Ochiai Joban Nishigo-machi Iwaki City Fukushima 972-8316 JAPAN | |
| Evonik Rexim Nanning Pharmaceuticals Co Ltd 10 Wenjiang Road Wuming District Nanning City 530 100 CHINA | ||
| Histidine 3.36 g/L | Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | |
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Isoleucine 4.2 g/L | Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | |
| Ajinomoto Do Brazil Industria E Comercio De Alimentos LTDA. Via Anhanguera, Km 131 Bairro Jaguari Limeira 13480-970 BRAZIL | ||
| Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | ||
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Leucine 5.11 g/L | Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | |
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Amino GmbH An der Zucker-Raffinerie 10 Postfach 20 D-38373 Frellstedt GERMANY | ||
| Lysine hydrochloride 5.07 g/L equivalent to lysine 4.06 g/L | Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | |
| Ajinomoto Co Inc Kyushu Plant 450 Morodomi-Cho Saga-Shi Saga 840-2193 JAPAN | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Methionine 2.8 g/L | Sekisui Medical Co Ltd Iwate Plant 4-115 Matsuo Hachimantai Iwate 028 7305 JAPAN | |
| Great Lake Chemical Konstanz GmbH Reichenaustrasse 13-19 Konstanz 78467 GERMANY | ||
| Phenylalanine 3.92 g/L | Ajinomoto Co Inc Tokai Plant, 1730 Hinaga-chom Yokkaichi Mie Prefecture 510 JAPAN | |
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Proline 4.76 g/L | Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | |
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Kyowa Hakko Bio Co., Ltd Ube Plant 2548 Fujimagari Yamaguchi Ube 755-8501 JAPAN | ||
| Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | ||
| Serine 3.5 g/L | Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | |
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Kyowa Hakko Bio Co., Ltd Ube Plant 2548 Fujimagari Yamaguchi Ube 755-8501 JAPAN | ||
| Threonine 2.94 g/L | Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | |
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | ||
| Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | ||
| Tryptophan 1.26 g/L | Ajinomoto Co Inc Tokai Plant, 1730 Hinaga-chom Yokkaichi Mie Prefecture 510 JAPAN | |
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | ||
| Tyrosine 0.28 g/L | Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | |
| Amino GmbH An der Zucker-Raffinerie 10 Postfach 20 D-38373 Frellstedt GERMANY | ||
| Valine 4.06 g/L | Ajinomoto Co Inc Kawasaki Plant 1-1 Suzuki-cho, Kawasaki-ku Kawasaki 210-8680 JAPAN | |
| Great Lake Chemical Konstanz GmbH Reichenaustrasse 13-19 Konstanz 78467 GERMANY | ||
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | ||
| Ajinomoto North America Inc North Carolina Plant 4020 Ajinomoto Drive Raleigh North Carolina 27610 UNITED STATES OF AMERICA | ||
| Evonik Rexim SAS 33 rue de Verdun Ham 80400 FRANCE | ||
| Excipient | ||
| Acetic acid | ||
| Water for injection | ||
| Glucose Solution compartment, emulsion for infusion | Active | |
| Glucose monohydrate 275 g/L equivalent to glucose 250 g/L | Roquette Freres 1 Rue de la Haute Loge Lestrem 62080 FRANCE | |
| Cerestar Iberica SA P O Box 54 Avda Montserrat Martorell Barcellona E-08760 SPAIN | ||
| Roquette America Inc 1003 South Fifth Street Keokuk Iowa 52632 UNITED STATES OF AMERICA | ||
| Excipient | ||
| Hydrochloric acid | ||
| Water for injection | ||
| Lipid Emulsion compartment, emulsion for infusion | Active | |
| Olive oil 160 g/L ((refined olive oil) as an 80/20 mixture of olive/soya oil) | Societe Industrielle des Oleagineux 62-70 rue Ivan Tourgueneff Bougival F-78380 FRANCE | |
| Soya oil 40 g/L ((refined soya bean oil) as an 80/20 mixture of olive oil/soya oil) | Societe Industrielle des Oleagineux 62-70 rue Ivan Tourgueneff Bougival F-78380 FRANCE | |
| Lipoid GmbH Frigenstrasse 4 Ludwigshafen D-67065 GERMANY | ||
| Excipient | ||
| Egg phosphatidyl esters | ||
| Glycerol | ||
| Sodium hydroxide | ||
| Sodium oleate | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | Baxalta Belgium Manufacturing SA Boulevard Rene Branquart 80 Lessines B-7860 BELGIUM |
| Baxalta Belgium Manufacturing SA Boulevard Rene Branquart 80 Lessines B-7860 BELGIUM | |
| Manufacture of Intermediate Product | Ajinomoto OmniChem SA Parc Scientifique Fleming Rue du Fonds Jean Paques 8 Louvain-la-Neuve Brussels B-1348 BELGIUM |
| Ajinomoto OmniChem SA Parc Scientifique Fleming Rue du Fonds Jean Paques 8 Louvain-la-Neuve Brussels B-1348 BELGIUM | |
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | |
| Kyowa Hakko Bio Co., Ltd Hofu Plant 1-1, Kwoya-cho, Hofu-shi Yamaguchi 747-8522 JAPAN | |
| Packing | Baxalta Belgium Manufacturing SA Boulevard Rene Branquart 80 Lessines B-7860 BELGIUM |
| Baxalta Belgium Manufacturing SA Boulevard Rene Branquart 80 Lessines B-7860 BELGIUM | |
| NZ Site of Product Release | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
Packaging
| Package | Contents | Shelf Life |
| Bag, plastic, 3 compt, with a clear plastic overpouch. | 1 L | 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. |
| Bag, plastic, 3 compt, with a clear plastic overpouch. | 1.5 L | 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. |
| Bag, plastic, 3 compt, with a clear plastic overpouch. | 2 L | 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. |
| Bag, plastic, 3 compt, with a clear plastic overpouch. | 2.5 L | 24 months from date of manufacture stored at or below 25°C. reconsituted: 7 days stored 2-8 C, then 48 hrs at 25 C. |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 24/2/2015 | Self-Assessable Change Notification | Data sheet - miscellaneous changes (Self assessable) | Notified | 5/3/2015 |
