bhpardo/ema_en · Datasets at Hugging Face

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Exacerbation of rheumatoid arthritis has been observed in individual cases.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Magyarország Genzyme Europe B. V.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
No alteration of fertility was detected.
3.
Common
OTHER
The excipients methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol may cause allergic reactions.
4.8 [4.5, 5.2]
During use: do not refrigerate.
Your doctor or nurse must teach you how to inject BYETTA before you use it for the first time.
Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος Tηλ.: + 30-210 98 97 300
Assessment of progenitor cell yields In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
6.
SPECIAL STORAGE CONDITIONS
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Do not mix or co-infuse CANCIDAS with other medicinal products, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
Ísland Merck Sharp & Dohme Ísland ehf.
6.4 Special precautions for storage
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE Tηλ: +357 22 817690 Φαξ: +357 22 751855
3.
STATEMENT OF ACTIVE SUBSTANCE(S)
In clinical studies, 10-30 mg/ day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/ 3-methoxymorphinan ratio), 2C9 (warfarin), 2C19 (omeprazole), and 3A4 (dextromethorphan).
Powder Mannitol Sodium chloride Histidine Trehalose Calcium chloride Trometamol Polysorbate 80 Glutathione (reduced)
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Pre-filled syringes (glass type I) with plunger (Teflon-faced rubber) sealed in a blister.
Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 1992 467272 medinfo_uk@merck. com
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.
The treatment required depends on the nature and severity of side-effects (see also section 4.4).
Keep out of the reach and sight of children.
In this leaflet:
- iron supplementation, e. g.
0.4 ml (100 µg/ ml)
Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Keep out of the reach and sight of children.
Film-coated tablet
Therefore, the company withdrew its application for the use of Abraxane as first-line treatment during the assessment of the medicine.
Iron supplementation should be started prior to epoetin alfa therapy, to achieve adequate iron stores.
c - genotypic ETVr with virologic d breakthrough a
Your doctor may monitor your blood pressure regularly while you are using Binocrit, particularly at the start of therapy.
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAELYX LABEL 50 mg/ 25 ml
The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed.
Binocrit is a sterile but unpreserved product and is for single use only.
- The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal
Driving and using machines At the recommended dose, Aerius is not expected to cause you to be drowsy or less alert.
Dose adjustments in specific patient populations Patients with liver impairment Dose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.
Rosiglitazone Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
However, at high MPAG plasma concentrations (> 100µg/ ml), small amounts of MPAG are removed.
Common: dyspnoea
Ammonaps 500 mg [outer packaging only]
Not applicable.
75 Driving and using machines
ANNEX I
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.
These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Blood should not enter the syringe.
1 pre-filled syringe of 0.5 ml contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa
Solution for injection
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
This was renewed on 30 November 2000 and 30 November 2005.
Deutschland Thomas-Dehler-Straße 27 D-81737 München Tel: + 49-(0)89 627 31-0 Info@essex-pharma. de
100 Units/ ml
Cancidas is an antifungal medicine.
− If you have had depression or are depressed or previously had thoughts of suicide.
Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%).
4.2 Posology and method of administration
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out. • This pen is only for the patients use.
This leaflet was last approved in {MM/YYYY}
Investigations: international normalised ratio increased with concomitant warfarin, some reports associated with bleeding (see section 4.5).
0.5 mg/ ml
At two years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0; - no
Other things that can increase the risk of fractures include:
50 IU/ kg 3 times per week by the intravenous route.
15.
METHOD AND ROUTE(S) OF ADMINISTRATION
Following administration of multiple oral doses to healthy volunteers, steady- state conditions were reached within 4 days.
In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Mutagenicity/ Carcinogenicity:
Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
HBeAg positive (study 026): treatment with entecavir for up to 96 weeks (n = 141) resulted in cumulative response rates of 30% for HBV DNA < 300 copies/ ml by PCR, 85% for ALT normalisation and 17% for HBeAg seroconversion.
These problems may affect between 1 and 10 patients out of 100 treated.
The glucose excursion (AUC 0-6h) was 641 mg. h. dl-1 for insulin glulisine and 801mg. h. dl-1 for regular human insulin.
You should generally take Advagraf on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal.
Do not store above 30°C.
Slovenská republika Pfizer Luxembourg SARL, organizač ná zlož ka Tel: + 421-2-3355 5500
Titanium dioxide (E171), Yellow iron oxide (E 172), Red iron oxide (E 172), Gelatin.

Exacerbation of rheumatoid arthritis has been observed in individual cases.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands

Magyarország Genzyme Europe B. V.

If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.

No alteration of fertility was detected.

3.

Common

OTHER

The excipients methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol may cause allergic reactions.

4.8 [4.5, 5.2]

During use: do not refrigerate.

Your doctor or nurse must teach you how to inject BYETTA before you use it for the first time.

Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος Tηλ.: + 30-210 98 97 300

Assessment of progenitor cell yields In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.

6.

SPECIAL STORAGE CONDITIONS

Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.

Do not mix or co-infuse CANCIDAS with other medicinal products, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.

Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.

After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.

Ísland Merck Sharp & Dohme Ísland ehf.

6.4 Special precautions for storage

Kύπρος Wyeth Hellas (Cyprus Branch) AEBE Tηλ: +357 22 817690 Φαξ: +357 22 751855

3.

STATEMENT OF ACTIVE SUBSTANCE(S)

In clinical studies, 10-30 mg/ day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/ 3-methoxymorphinan ratio), 2C9 (warfarin), 2C19 (omeprazole), and 3A4 (dextromethorphan).

Powder Mannitol Sodium chloride Histidine Trehalose Calcium chloride Trometamol Polysorbate 80 Glutathione (reduced)

In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.

Pre-filled syringes (glass type I) with plunger (Teflon-faced rubber) sealed in a blister.

Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.

United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 1992 467272 medinfo_uk@merck. com

Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.

The treatment required depends on the nature and severity of side-effects (see also section 4.4).

Keep out of the reach and sight of children.

In this leaflet:

- iron supplementation, e. g.

0.4 ml (100 µg/ ml)

Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.

Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

Keep out of the reach and sight of children.

Film-coated tablet

Therefore, the company withdrew its application for the use of Abraxane as first-line treatment during the assessment of the medicine.

Iron supplementation should be started prior to epoetin alfa therapy, to achieve adequate iron stores.

c - genotypic ETVr with virologic d breakthrough a

Your doctor may monitor your blood pressure regularly while you are using Binocrit, particularly at the start of therapy.

Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.

QUALITATIVE AND QUANTITATIVE COMPOSITION

CAELYX LABEL 50 mg/ 25 ml

The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed.

Binocrit is a sterile but unpreserved product and is for single use only.

- The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal

Driving and using machines At the recommended dose, Aerius is not expected to cause you to be drowsy or less alert.

Dose adjustments in specific patient populations Patients with liver impairment Dose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.

Rosiglitazone Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.

However, at high MPAG plasma concentrations (> 100µg/ ml), small amounts of MPAG are removed.

Common: dyspnoea

Ammonaps 500 mg [outer packaging only]

Not applicable.

75 Driving and using machines

ANNEX I

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.

These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.

Blood should not enter the syringe.

1 pre-filled syringe of 0.5 ml contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa

Solution for injection

If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.

This was renewed on 30 November 2000 and 30 November 2005.

Deutschland Thomas-Dehler-Straße 27 D-81737 München Tel: + 49-(0)89 627 31-0 Info@essex-pharma. de

100 Units/ ml

Cancidas is an antifungal medicine.

− If you have had depression or are depressed or previously had thoughts of suicide.

Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%).

4.2 Posology and method of administration

Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out. • This pen is only for the patients use.

This leaflet was last approved in {MM/YYYY}

Investigations: international normalised ratio increased with concomitant warfarin, some reports associated with bleeding (see section 4.5).

0.5 mg/ ml

At two years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0; - no

Other things that can increase the risk of fractures include:

50 IU/ kg 3 times per week by the intravenous route.

15.

METHOD AND ROUTE(S) OF ADMINISTRATION

Following administration of multiple oral doses to healthy volunteers, steady- state conditions were reached within 4 days.

In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.

Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.

Mutagenicity/ Carcinogenicity:

Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).

Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.

HBeAg positive (study 026): treatment with entecavir for up to 96 weeks (n = 141) resulted in cumulative response rates of 30% for HBV DNA < 300 copies/ ml by PCR, 85% for ALT normalisation and 17% for HBeAg seroconversion.

These problems may affect between 1 and 10 patients out of 100 treated.

The glucose excursion (AUC 0-6h) was 641 mg. h. dl-1 for insulin glulisine and 801mg. h. dl-1 for regular human insulin.

You should generally take Advagraf on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal.

Do not store above 30°C.

Slovenská republika Pfizer Luxembourg SARL, organizač ná zlož ka Tel: + 421-2-3355 5500

Titanium dioxide (E171), Yellow iron oxide (E 172), Red iron oxide (E 172), Gelatin.